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## Protocol Section ### Identification Module **NCT ID:** NCT06413979 **Acronym:** Fam-AID **Brief Title:** Family Support Protocol for Adolescent Internalizing Disorders **Official Title:** Testing the Feasibility of a Family-based Adjunctive Treatment Protocol for Targeting Co-Occurring Internalizing Disorders Among Adolescents With SUD #### Organization Study ID Info **ID:** 1R34DA056026 **Link:** https://reporter.nih.gov/quickSearch/1R34DA056026 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** The National Center on Addiction and Substance Abuse at Columbia University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-04-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The National Center on Addiction and Substance Abuse at Columbia University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively. A promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD/ID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. The Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment. To achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD/ID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month follow-up. ### Conditions Module **Conditions:** - Internalizing Disorders - Substance Use Disorders ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Interrupted Time Series Study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID) **Label:** Fam-Aid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fam-Aid **Description:** (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. **Name:** Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Therapist and observer report on dose of treatment delivered using Fam-AID Fidelity Checklist. The checklist will measure extensiveness of treatment technique use on a 3-point scale from 0 = not at all to 2 = quite a bit/extensively. The checklist will be developed during the study pilot phase. **Measure:** Treatment Fidelity **Time Frame:** Baseline to 6 months follow-up **Description:** Family member session attendance in terms of number of sessions attended. **Measure:** Family Involvement **Time Frame:** Baseline to 6 months follow-up **Description:** Adolescent and caregiver report on Revised Children's Anxiety and Depression Scale (RCADS). RCADS is a 47-item measure of youth's anxiety and depressive symptoms rated on a 4-point scale from 0 = Never to 3 = Always (range = 0 to 141). Higher numbers represent greater anxiety and depression. **Measure:** Internalizing disorder symptoms **Time Frame:** Baseline to 6 months follow-up **Description:** Adolescent and caregiver report on Difficulties in Emotion Regulation Scale (DERS). DERS is a 16-item scale assessing difficulties with emotion regulation on a 5-point scale from 1 = almost never to 5 = almost always (range - . Higher numbers indicate greater difficulties regulating emotions. **Measure:** Emotion Regulation **Time Frame:** Baseline to 6 months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Youth is age 13-18. * Youth lives with a primary caregiver who can attend treatment sessions. * Youth endorses one or more DSM-5-TR symptoms for SUD and meets American Society of Addiction Medicine criteria for outpatient SU treatment. * Youth meets DSM-5-TR criteria, or has elevated symptoms and impairment, for any of the following IDs: Current or Recurrent Major Depressive Episode, Pervasive Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder. * Youth completes intake and is enrolled as an active case at study site Exclusion Criteria: * Illness requiring hospitalization * Current psychotic symptoms * Severe SU problems that require immediate relief (detox or residential placement) * Pervasive developmental disorder. **Maximum Age:** 18 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nporter@toendaddiction.org **Name:** Nicole P Porter, PhD **Phone:** (212) 841-5211 **Phone Ext:** 9566 **Role:** CONTACT **Contact 2:** **Email:** ahogue@toendaddiction.org **Name:** Aaron Hogue, PhD **Phone:** 212 841-5200 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05069779 **Brief Title:** Diazepam and Blood Pressure Regulation **Official Title:** The Acute Effects of Diazepam on Blood Pressure Regulation #### Organization Study ID Info **ID:** 70101717.1.0000.5103 #### Organization **Class:** OTHER **Full Name:** University of Brasilia ### Status Module #### Completion Date **Date:** 2019-05-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-10-06 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-20 **Type:** ACTUAL #### Start Date **Date:** 2017-08-01 **Type:** ACTUAL **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2021-10-06 **Type:** ACTUAL **Study First Submit Date:** 2021-09-15 **Study First Submit QC Date:** 2021-09-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Brasilia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control. **Detailed Description:** Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Blood pressure - Benzodiazepine - Autonomic nervous system ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral **Intervention Names:** - Drug: Diazepam **Label:** Diazepam **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Oral **Intervention Names:** - Drug: Diazepam **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Diazepam - Placebo **Description:** Oral administration of 10 mg of diazepam **Name:** Diazepam **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Finger photoplethysmography **Measure:** Resting beat-to-beat blood pressure variability **Time Frame:** Change from baseline at 60 min **Description:** Oscillometric device **Measure:** Systolic and diastolic blood pressure **Time Frame:** Change from baseline at 60 min #### Secondary Outcomes **Description:** Microneurography **Measure:** Muscle sympathetic nerve activity **Time Frame:** Change from baseline at 60 min **Description:** The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex). **Measure:** Baroreflex sensitivity **Time Frame:** Change from baseline at 60 min ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 to 40 years of age * Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease Exclusion Criteria: * History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months * Diagnosed cardiovascular or metabolic disease(s) * Prescription of chronic medications other than oral contraceptives * History of hypertension or presence of arrhythmia **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Brasília **Country:** Brazil **Facility:** University of Brasilia **State:** DF **Zip:** 70910-900 ### IPD Sharing Statement Module **Description:** The data underlying this project will be shared on reasonable request to the principal investigator. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000759 - Term: Adjuvants, Anesthesia - ID: D000000927 - Term: Anticonvulsants - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000009125 - Term: Muscle Relaxants, Central - ID: D000009465 - Term: Neuromuscular Agents - ID: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000018757 - Term: GABA Modulators - ID: D000018682 - Term: GABA Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: AnEm - Name: Antiemetics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: MuRelCen - Name: Muscle Relaxants, Central - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7167 - Name: Diazepam - Relevance: HIGH - As Found: ALA - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20827 - Name: GABA Modulators - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003975 - Term: Diazepam ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04119479 **Acronym:** ImPRoVe **Brief Title:** Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients **Official Title:** Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe #### Organization Study ID Info **ID:** IMPROVE #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2020-10-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-02-03 **Type:** ACTUAL **Last Update Submit Date:** 2021-01-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-10-31 **Type:** ACTUAL #### Start Date **Date:** 2017-06-27 **Type:** ACTUAL **Status Verified Date:** 2021-01 #### Study First Post Date **Date:** 2019-10-08 **Type:** ACTUAL **Study First Submit Date:** 2019-09-26 **Study First Submit QC Date:** 2019-10-06 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Deutsche Rentenversicherung #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Observational study of functional recovery of stroke patients after discharge from rehabilitation **Detailed Description:** Cerebrovascular diseases, such as stroke, are among the greatest challenges in healthcare. This proves the importance of neuro-rehabilitative research. Stroke research is often focused on the acute treatment phase as well as the inpatient rehabilitation. A remaining question is how do stroke patients clinically develop after being discharged from the hospital? How stable are the achieved rehabilitation effects and how much more clinical improvement is seen in the following time period, especially with regard to ICF functionality? In this observational longitudinal study, the current practice of neurorehabilitation will be investigated and the influence of motor skills, cognition, care situation, depression, information and fatigue on functional recovery as well as participation, autonomy and quality of life will be evaluated. Stroke patients will be examined at the end of rehabilitation, after three, six and 12 months. In addition, a group of chronic patients undergoes the same examinations and thereby represents a comparison group. ### Conditions Module **Conditions:** - Stroke **Keywords:** - Functional recovery - Neurorehabilitation - Stroke ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 227 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test). **Measure:** Compound score **Time Frame:** 12 months after discharge from rehabilitation #### Secondary Outcomes **Description:** Standardized test for differential diagnosis Aphasia - no aphasia. **Measure:** Aphasia test **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The Apraxia Screen from TULIA is a short assessment to diagnose apraxia with 12 hand movements, dichotomous scale: 0 = not fulfilled, 1 = fulfilled motion task. **Measure:** Apraxia screen of TULIA (AST) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** Autonomy and participation is measured via different tools, for example with the Index for the Assessment of Health Impairments (IMET) or the subscale Participation/Role function extracted from the Stroke Impact Scale. **Measure:** Autonomy and participation **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** Fatigue scale for motor and cognitive functions, an assessment of fatigue, containing two subscales (mental and physical fatigue), ranging from 20 (no fatigue at all) to 100 (severest grade of fatigue). **Measure:** Fatigue scale for motor function and cognition (FSMC) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The section motor function of upper limb is one of five domains, a three-point scale is used for rating performance as 0=cannot perform, 1=performs partially and 2=performs fully, max. possible score: 66 points. **Measure:** Fugl-Meyer assessment upper extremity (FMA) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** A dynamometer is used to measure grip strength and a pinch gauge to measure pinch force. **Measure:** Grip and pinch force **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The Index of measurement of participation restrictions (IMET) records patient-related participation as a self-evaluation tool, on a scale from 0 (no impairment) to 10 (no more activity possible). **Measure:** Index for measuring restrictions on participation (IMET) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** A questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke). **Measure:** Knowledge and information needs **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The line bisection test (LBS) is a test to detect the presence of unilateral spatial neglect. To complete the test, the middle of several horizontal lines must be marked. **Measure:** Line bisection test (LBS) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The modified Rankin scale (MRS) is a standardized measure that describes the extent of disability after a stroke. It ranges from 0 (no symptoms) to 6 (death due to stroke). **Measure:** Modified Rankin Scale (MRS) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved. **Measure:** Montreal cognitive assessment (MoCA) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The National Institutes of Health Stroke Scale, NIHSS, is a score system to quantify the impairment caused by a stroke. The sum of the values from the investigations results in a maximum of 42 points. The higher the score, the more extensive the stroke. **Measure:** National institutes of health stroke scale (NIHSS) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible. **Measure:** Nine hole peg test (NHPT) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The Patient Health Questionnaire 9 (PHQ-9) is a screening tool for diagnosing depressivity and includes questions on the nine DSM-IV criteria for the diagnosis of major depression. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire. **Measure:** Patient reported health status (EQ-5D) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** A questionnaire developed by the research group (including questions on occupation and lifestyle). **Measure:** Return to work **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** Measurement of subjective stroke-specific health status, 64 items in eight domains, domain scores range between 0-100, with higher scores represent better health status. **Measure:** Stroke impact scale (SIS) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation **Description:** The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling. **Measure:** Time up and go test (TUG) **Time Frame:** 3, 6 and 12 months after discharge from rehabilitation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 * Patients in or after completion of rehabilitation phases C and D according to BAR criteria * Age \>= 18 * Sufficient knowledge of German * Existing declaration of consent * Deficit still existing (Rankin score of at least 1 at inclusion) Exclusion Criteria: * need for care prior stroke * SAB, craniocerebral trauma, TIA as primary diagnosis * Severe pre-existing psychiatric disease * Participation in follow-up examination not possible **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with the diagnoses cerebral infarction and/or cerebral hemorrhage corresponding to the diagnoses of ICD 10 I61-I69 from rehabilitation phases C and D according to the criteria of the Bundesarbeitsgemeinschaft für Rehabilitation (BAR) shall be included at the end of inpatient rehabilitation therapy. The spectrum of patients recruited should focus on patients who are still of working age (up to the age of 67). ### Contacts Locations Module #### Locations **Location 1:** **City:** Bad Bramstedt **Country:** Germany **Facility:** Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation **Zip:** 24576 **Location 2:** **City:** Damp **Country:** Germany **Facility:** Rehaklinik Damp - Neurologie **Zip:** 24351 **Location 3:** **City:** Geesthacht **Country:** Germany **Facility:** Rehaklinik Geesthacht - Neurologie **Zip:** 21502 **Location 4:** **City:** Hamburg **Country:** Germany **Facility:** RehaCentrum Hamburg - Neurologische Rehabilitation **Zip:** 20097 **Location 5:** **City:** Hamburg **Country:** Germany **Facility:** Universitätsklinikum Hamburg-Eppendorf, Neurologie **Zip:** 20246 **Location 6:** **City:** Soltau **Country:** Germany **Facility:** MediClin Klinikum Soltau - Neurologische Rehabilitation **Zip:** 29614 #### Overall Officials **Official 1:** **Affiliation:** Department of Neurology, University Medical Center Hamburg-Eppendorf **Name:** Götz Thomalla, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Department of Neurology, University Medical Center Hamburg-Eppendorf **Name:** Christian Gerloff, Prof. Dr. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** Personal login into UKE data repository. **Description:** Data sharing is planned after main publication of results. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Within 24 months after main publication. ### References Module #### References **Citation:** Birke G, Wolf S, Ingwersen T, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). Neurol Res Pract. 2020 Apr 6;2:10. doi: 10.1186/s42466-020-00056-2. eCollection 2020. **PMID:** 33324916 **Citation:** Wolf S, Holm SE, Ingwersen T, Bartling C, Bender G, Birke G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Pre-stroke socioeconomic status predicts upper limb motor recovery after inpatient neurorehabilitation. Ann Med. 2022 Dec;54(1):1265-1276. doi: 10.1080/07853890.2022.2059557. **PMID:** 35510813 **Citation:** Ingwersen T, Wolf S, Birke G, Schlemm E, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Long-term recovery of upper limb motor function and self-reported health: results from a multicenter observational study 1 year after discharge from rehabilitation. Neurol Res Pract. 2021 Dec 27;3(1):66. doi: 10.1186/s42466-021-00164-7. **PMID:** 34955097 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04722679 **Acronym:** BELANCE **Brief Title:** A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention. **Official Title:** BELgian ANtiCoagulation Survey for Elderly Patients With NVAF #### Organization Study ID Info **ID:** 21740 #### Organization **Class:** INDUSTRY **Full Name:** Bayer ### Status Module #### Completion Date **Date:** 2022-01-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Start Date **Date:** 2021-05-11 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2021-01-25 **Type:** ACTUAL **Study First Submit Date:** 2021-01-21 **Study First Submit QC Date:** 2021-01-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Atrial fibrillation is a heart condition that causes an abnormal and fast heart rate. For people with non-valvular atrial fibrillation (NVAF), this is caused by problems such as high blood pressure and diabetes. NVAF happens more often in elderly people and can lead to stroke, heart failure, and death. Doctors are currently able to give patients a type of treatment called an anticoagulant. Anticoagulants work by making the blood thinner. They are thought to help reduce the risk of stroke and death caused by NVAF. In this study, researchers wanted to learn more about what elderly people think of taking anticoagulants that do not have any vitamin K in them. These are called non-VKA oral anticoagulants (NOACs). This study will include up to about 150 Belgian men and women aged 75 years and over who have NVAF and have been treated with NOACs. The study will also include about 10 doctors who have treated these patients. In this study, there will be no required tests or visits. Instead, patients will answer a paper questionnaire about their use of NOACs. The researchers will ask the doctors questions about how they treat their patients using NOACs. The main types of questions the researchers will focus on are: * The patient characteristics of the elderly with NVAF who are treated with NOACs * The level of fear of the elderly about bleeding while using a blood thinner and the fear of stroke/thrombosis. * The geriatrician's thoughts about using NOACs to treat NVAF in elderly patients * Those patient characteristics geriatrician's find most important when deciding on the anticoagulation treatment in the elderly patients. The information from this study will be collected between February and April 2021. But, the whole study will take about 6 months to finish and is expected to end in July 2021. ### Conditions Module **Conditions:** - Non-Valvular Atrial Fibrillation ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 103 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC. **Intervention Names:** - Drug: Non-VKA Oral Anticoagulants (NOAC) **Label:** Patient #### Arm Group 2 **Description:** Geriatricians (hospital or office-based). **Intervention Names:** - Drug: Non-VKA Oral Anticoagulants (NOAC) **Label:** Physician ### Interventions #### Intervention 1 **Arm Group Labels:** - Patient - Physician **Description:** Follow clinical practice. **Name:** Non-VKA Oral Anticoagulants (NOAC) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Age categories of patients and the geriatricians **Time Frame:** Approximate 3 months for data collection **Measure:** Gender of patients and the geriatricians **Time Frame:** Approximate 3 months for data collection **Measure:** Patient's weight **Time Frame:** Approximate 3 months for data collection **Measure:** Patient's kidney function range (normal, mild, moderate, severe) **Time Frame:** Approximate 3 months for data collection **Description:** CHA2DS2-VASc score is a clinical prediction rule for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. **Measure:** CHA₂DS₂-VASc range **Time Frame:** Approximate 3 months for data collection **Measure:** Clinical Frailty Scale (CFS) range **Time Frame:** Approximate 3 months for data collection **Measure:** Timeframe of patient's diagnosis with NVAF **Time Frame:** Approximate 3 months for data collection **Description:** HCP: HealthCare Professionals **Measure:** Specification of HCP that initiated the elderly patient's NOAC treatment **Time Frame:** Approximate 3 months for data collection **Measure:** Specification of NOAC treatment **Time Frame:** Approximately 3 months for data collection **Measure:** Use of low-dose NOAC treatment (not related to an (S)AE) **Time Frame:** Approximate 3 months for data collection **Measure:** Confirmation of the use of anti-aggregants **Time Frame:** Approximate 3 months for data collection **Measure:** Level of agreement with various statements regarding the use of NOACs in general, using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree) **Time Frame:** Approximate 3 months for data collection **Measure:** Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10 **Time Frame:** Approximate 3 months for data collection **Measure:** Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10 **Time Frame:** Approximate 3 months for data collection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF * Elderly patients treated with a NOAC * Ambulatory patients visiting the geriatrician Exclusion Criteria: * Contra-indications according to the local marketing authorization * Patients suffering from dementia who are, according to the geriatrician's opinion, not able to understand and answer the questions * Hospitalized patients **Minimum Age:** 75 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** The source population of this study would be elderly patients population (defined as ≥ 75 years old) diagnosed with NVAF who are treated with a NOAC for this indication. In order to ensure the representativeness of the study population, 100-150 Belgian elderly patients will be taken into account. ### Contacts Locations Module #### Locations **Location 1:** **City:** Multiple Locations **Country:** Belgium **Facility:** Many Locations ### IPD Sharing Statement Module **Description:** Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4244 - Name: Anticoagulants - Relevance: HIGH - As Found: High Grade ### Intervention Browse Module - Meshes - ID: D000000925 - Term: Anticoagulants ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03236779 **Brief Title:** A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain **Official Title:** A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial #### Organization Study ID Info **ID:** ALBOLOUSHI #### Organization **Class:** OTHER **Full Name:** Universidad de Zaragoza ### Status Module #### Completion Date **Date:** 2019-12-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-01-26 **Type:** ACTUAL **Last Update Submit Date:** 2021-01-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-10-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2021-01-26 **Type:** ACTUAL **Results First Submit Date:** 2020-07-30 **Results First Submit QC Date:** 2021-01-23 #### Start Date **Date:** 2018-01-14 **Type:** ACTUAL **Status Verified Date:** 2021-01 #### Study First Post Date **Date:** 2017-08-02 **Type:** ACTUAL **Study First Submit Date:** 2017-07-25 **Study First Submit QC Date:** 2017-08-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Universidad San Jorge **Class:** OTHER_GOV **Name:** Ministry of Health, Kuwait #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Zaragoza #### Responsible Party **Investigator Affiliation:** Universidad de Zaragoza **Investigator Full Name:** ZAID AL BOLOUSHI **Investigator Title:** PhD student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health. **Detailed Description:** Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN. From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP. ### Conditions Module **Conditions:** - Plantar Fascitis - Myofacial Pain Syndromes - Trigger Point Pain, Myofascial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 102 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. **Intervention Names:** - Other: dry needling **Label:** Dry needling (DN) arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. **Intervention Names:** - Other: dry needling **Label:** Percutaneous needle electrolysis (PNE) arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dry needling (DN) arm - Percutaneous needle electrolysis (PNE) arm **Description:** The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **Name:** dry needling **Other Names:** - Percutaneous needle electrolysis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain **Measure:** Foot Health Status Questioner (FHSQ) PAIN **Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks #### Secondary Outcomes **Description:** Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable **Measure:** VAS Maximum **Time Frame:** 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4) **Description:** The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL. **Measure:** The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) **Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks" ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association * Age greater than 21 years according to the Kuwaiti law. * History of plantar heel pain for greater than one month. * Walking 50 meters without any support * Having MTPs on initial physical examination on plantar and calf muscles * Accepting to be treated by a male physiotherapist. * Capacity to understand the study and the informed consent, as well as having signed the document. Exclusion Criteria: * - Needle phobia * Allergy from needles or hypersensitivity to metals * Presence of coagulopathy or use of anticoagulants * Presence of peripheral arterial vascular disease * Pregnancy * Dermatological disease with the dry needling area * The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy. * Treatment of plantar heel pain with needling or acupuncture during last 4 weeks. * A history of injection therapy in the heel in the previous three months. * Previous history of foot surgery or fracture. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kuwait **Country:** Kuwait **Facility:** Physical Medicine and rehabilitation Kuwait ### IPD Sharing Statement Module **Description:** ACCORDING TO THE LAW AND REGULATIONS FROM THE ETHICAL COMMITTEE IN KUWAIT. I CAN'T SHARE THE NAME OF THE PATIENTS, THEIR CONTACT OR ID. OTHER DATA WHICH ARE RELATED TO THE STUDY I CAN SHARE. **IPD Sharing:** NO ### References Module #### References **Citation:** Fernandez D, Al-Boloushi Z, Bellosta-Lopez P, Herrero P, Gomez M, Calvo S. Cost-Effectiveness of Two Dry Needling Interventions for Plantar Heel Pain: A Secondary Analysis of an RCT. Int J Environ Res Public Health. 2021 Feb 12;18(4):1777. doi: 10.3390/ijerph18041777. **PMID:** 33673068 **Citation:** Al-Boloushi Z, Gomez-Trullen EM, Arian M, Fernandez D, Herrero P, Bellosta-Lopez P. Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial. BMJ Open. 2020 Aug 20;10(8):e038033. doi: 10.1136/bmjopen-2020-038033. **PMID:** 32819949 **Citation:** Al-Boloushi Z, Gomez-Trullen EM, Bellosta-Lopez P, Lopez-Royo MP, Fernandez D, Herrero P. Comparing two dry needling interventions for plantar heel pain: a protocol for a randomized controlled trial. J Orthop Surg Res. 2019 Jan 25;14(1):31. doi: 10.1186/s13018-019-1066-4. **PMID:** 30683124 ## Document Section ### Large Document Module #### Large Docs - Date: 2021-01-23 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 2505166 - Type Abbrev: ICF - Upload Date: 2021-01-23T05:03 - Date: 2021-01-23 - Filename: Prot_SAP_001.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 217179 - Type Abbrev: Prot_SAP - Upload Date: 2021-01-23T05:11 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005534 - Term: Foot Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000005155 - Term: Facial Nerve Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M8351 - Name: Fasciitis - Relevance: HIGH - As Found: Fasciitis - ID: M24656 - Name: Fasciitis, Plantar - Relevance: HIGH - As Found: Plantar Fasciitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: LOW - As Found: Unknown - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Trigger Point Pain, Myofascial - ID: M12381 - Name: Neuralgia - Relevance: LOW - As Found: Unknown - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M8299 - Name: Facial Neuralgia - Relevance: HIGH - As Found: Myofacial Pain Syndromes - ID: M8300 - Name: Facial Pain - Relevance: HIGH - As Found: Myofacial Pain - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M8298 - Name: Facial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005208 - Term: Fasciitis - ID: D000036981 - Term: Fasciitis, Plantar - ID: D000009209 - Term: Myofascial Pain Syndromes - ID: D000005156 - Term: Facial Neuralgia - ID: D000005157 - Term: Facial Pain ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Unable to tolerate pain of the treatment #### Event Groups **Group ID:** EG000 **Title:** Dry Needling **Deaths Num At Risk:** 51 **Description:** Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries). **ID:** EG000 **Other Num Affected:** 9 **Other Num at Risk:** 51 **Serious Number At Risk:** 51 **Title:** Dry Needling **Group ID:** EG001 **Title:** Percutaneous Needle Electrolysis **Deaths Num At Risk:** 51 **Description:** The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance). **ID:** EG001 **Other Num Affected:** 14 **Other Num at Risk:** 51 **Serious Number At Risk:** 51 **Title:** Percutaneous Needle Electrolysis **Frequency Threshold:** 5 #### Other Events **Term:** unable to tolerate pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Unable to tolerate pain of the treatment **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** drop out **Time Frame:** 1 year follow up ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 51 **Group ID:** BG001 **Value:** 51 **Group ID:** BG002 **Value:** 102 **Units:** Participants ### Group **ID:** BG000 **Title:** Dry Needling (DN) Arm **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. ### Group **ID:** BG001 **Title:** Percutaneous Needle Electrolysis (PNE) Arm **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 51 #### Measurement **Group ID:** BG001 **Value:** 51 #### Measurement **Group ID:** BG002 **Value:** 102 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.9 **Value:** 49.5 #### Measurement **Group ID:** BG001 **Spread:** 8.8 **Value:** 48.1 #### Measurement **Group ID:** BG002 **Spread:** 8.8 **Value:** 48.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 36 #### Measurement **Group ID:** BG001 **Value:** 36 #### Measurement **Group ID:** BG002 **Value:** 72 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 30 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 51 #### Measurement **Group ID:** BG001 **Value:** 51 #### Measurement **Group ID:** BG002 **Value:** 102 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 51 #### Measurement **Group ID:** BG001 **Value:** 51 #### Measurement **Group ID:** BG002 **Value:** 102 **Class Title:** Kuwait **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Region of Enrollment **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** pherrero@usj.es **Organization:** Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy **Phone:** (+34) 646168248 **Title:** Dr. Pablo Herrero Gallego. PT, PhD. ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.8 - **Upper Limit:** - **Value:** 38.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 21.9 - **Upper Limit:** - **Value:** 40.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 27.7 - **Upper Limit:** - **Value:** 73.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 25.7 - **Upper Limit:** - **Value:** 71.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 28.4 - **Upper Limit:** - **Value:** 70.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 26.8 - **Upper Limit:** - **Value:** 67.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 24.8 - **Upper Limit:** - **Value:** 66.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 26.8 - **Upper Limit:** - **Value:** 63.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.3 - **Upper Limit:** - **Value:** 68.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 27.1 - **Upper Limit:** - **Value:** 67.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.1 - **Upper Limit:** - **Value:** 68.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 29.0 - **Upper Limit:** - **Value:** 73.1 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.0 - **Upper Limit:** - **Value:** 7.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.3 - **Upper Limit:** - **Value:** 7.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.3 - **Upper Limit:** - **Value:** 6.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.9 - **Upper Limit:** - **Value:** 5.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.6 - **Upper Limit:** - **Value:** 5.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.1 - **Upper Limit:** - **Value:** 5.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.9 - **Upper Limit:** - **Value:** 4.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.0 - **Upper Limit:** - **Value:** 4.5 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.23 - **Upper Limit:** - **Value:** 0.63 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.22 - **Upper Limit:** - **Value:** 0.67 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.22 - **Upper Limit:** - **Value:** 0.78 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.24 - **Upper Limit:** - **Value:** 0.76 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.23 - **Upper Limit:** - **Value:** 0.72 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.23 - **Upper Limit:** - **Value:** 0.74 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.30 - **Upper Limit:** - **Value:** 0.64 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.27 - **Upper Limit:** - **Value:** 0.70 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.29 - **Upper Limit:** - **Value:** 0.65 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.27 - **Upper Limit:** - **Value:** 0.73 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.27 - **Upper Limit:** - **Value:** 0.66 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.25 - **Upper Limit:** - **Value:** 0.77 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.8 - **Upper Limit:** - **Value:** 38.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 21.9 - **Upper Limit:** - **Value:** 40.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 27.7 - **Upper Limit:** - **Value:** 73.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 25.7 - **Upper Limit:** - **Value:** 71.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 28.4 - **Upper Limit:** - **Value:** 70.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 26.8 - **Upper Limit:** - **Value:** 67.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 24.8 - **Upper Limit:** - **Value:** 66.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 26.8 - **Upper Limit:** - **Value:** 63.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.3 - **Upper Limit:** - **Value:** 68.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 27.1 - **Upper Limit:** - **Value:** 67.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.1 - **Upper Limit:** - **Value:** 68.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 29.0 - **Upper Limit:** - **Value:** 73.1 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks **Title:** Foot Health Status Questioner (FHSQ) PAIN **Type:** PRIMARY **Unit of Measure:** score on a scale ##### Group **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG000 **Title:** Dry Needling (DN) Arm ##### Group **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG001 **Title:** Percutaneous Needle Electrolysis (PNE) Arm #### Outcome Measure 2 **Description:** Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4) **Title:** VAS Maximum **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain **ID:** OG000 **Title:** VAS DN ##### Group **Description:** the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain **ID:** OG001 **Title:** VAS PNE #### Outcome Measure 3 **Description:** The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks" **Title:** The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG000 **Title:** Dry Needling (DN) Arm ##### Group **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG001 **Title:** Percutaneous Needle Electrolysis (PNE) Arm #### Outcome Measure 4 **Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks **Title:** Foot Health Status Questioner (FHSQ) PAIN **Type:** PRIMARY **Unit of Measure:** score on a scale ##### Group **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG000 **Title:** Dry Needling (DN) Arm ##### Group **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** OG001 **Title:** Percutaneous Needle Electrolysis (PNE) Arm ### Participant Flow Module #### Group **Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** FG000 **Title:** Dry Needling (DN) Arm #### Group **Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current. dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied. **ID:** FG001 **Title:** Percutaneous Needle Electrolysis (PNE) Arm #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 13 ###### Reason **Group ID:** FG001 **Number of Subjects:** 21 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 51 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 51 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 30 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 13 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 21 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04063579 **Brief Title:** Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction **Official Title:** Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction #### Organization Study ID Info **ID:** UW18-022 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-05-10 **Type:** ACTUAL **Last Update Submit Date:** 2023-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09-29 **Type:** ACTUAL #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2019-08-21 **Type:** ACTUAL **Study First Submit Date:** 2019-08-16 **Study First Submit QC Date:** 2019-08-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction. **Detailed Description:** Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations. It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures. The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging. ### Conditions Module **Conditions:** - Heart Failure With Preserved Ejection Fraction ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 172 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization **Label:** Patients with heart failure with preserved ejection fraction **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization **Label:** Non-heart failure patients **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) **Label:** Normal Volunteers **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-heart failure patients - Patients with heart failure with preserved ejection fraction **Description:** Imaging, blood tests, LV pressure measurement **Name:** Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Normal Volunteers **Description:** Imaging and Blood tests **Name:** Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers **Time Frame:** 2 years #### Secondary Outcomes **Measure:** Complication rate of cardiac catheterisation **Time Frame:** 2 years **Measure:** Unexpected findings by CMR (eg. Cardiac amyloidosis) **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients presenting with symptoms and signs suggestive of HFpEF * Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction \<50% or significant coronary artery disease (ie. \>50% narrowing of one or more coronary arteries) * Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history Exclusion Criteria: * Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF. * Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated. * Contraindication to CMR study * Estimated glomerular filtration rate \<30 ml/min/1.73 m2 * More than moderate valvular disease * Severe pulmonary disease (ie. FEV1 \<- 50% predicted) * Cardiomyopathy * Constrictive pericarditis **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** The University of Hong Kong ### References Module #### References **Citation:** Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar. **PMID:** 36992915 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Ancestors - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21935 - Name: Natriuretic Peptide, Brain - Relevance: HIGH - As Found: Tiragolumab ### Intervention Browse Module - Meshes - ID: D000020097 - Term: Natriuretic Peptide, Brain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01385579 **Brief Title:** Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population **Official Title:** A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population #### Organization Study ID Info **ID:** STU00015652 #### Organization **Class:** OTHER **Full Name:** Northwestern University ### Status Module #### Completion Date **Date:** 2010-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-01-06 **Type:** ESTIMATED **Last Update Submit Date:** 2013-11-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-06 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-01-06 **Type:** ESTIMATED **Results First Submit Date:** 2013-11-18 **Results First Submit QC Date:** 2013-11-18 #### Start Date **Date:** 2010-01 **Status Verified Date:** 2013-11 #### Study First Post Date **Date:** 2011-06-30 **Type:** ESTIMATED **Study First Submit Date:** 2011-06-28 **Study First Submit QC Date:** 2011-06-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Northwestern University #### Responsible Party **Investigator Affiliation:** Northwestern University **Investigator Full Name:** Bechara Choucair **Investigator Title:** Adjunct Associate Professor in Family and Community Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population. **Detailed Description:** Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared. ### Conditions Module **Conditions:** - Malignant Neoplasm of Large Intestine **Keywords:** - colorectal cancer screening - fecal occult blood testing (FOBT) - vulnerable populations - community health center ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 202 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. **Label:** usual care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit **Intervention Names:** - Other: Care manager outreach **Label:** Care manager outreach **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Care manager outreach **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager. **Name:** Care manager outreach **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010) **Measure:** Completion of a Colorectal Cancer Screening **Time Frame:** within 4 months of the initiation of outreach (by June 30, 2010) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009 Exclusion criteria: Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009) **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Heartland International Health Center **State:** Illinois **Zip:** 60645 #### Overall Officials **Official 1:** **Affiliation:** Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine **Name:** Bechara N Choucair, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381. **PMID:** 22966104 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Usual Care **Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. **ID:** EG000 **Other Num at Risk:** 98 **Serious Number At Risk:** 98 **Title:** Usual Care **Group ID:** EG001 **Title:** Care Manager Outreach **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit **ID:** EG001 **Other Num at Risk:** 104 **Serious Number At Risk:** 104 **Title:** Care Manager Outreach **Frequency Threshold:** 1 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 98 **Group ID:** BG001 **Value:** 104 **Group ID:** BG002 **Value:** 202 **Units:** Participants ### Group **ID:** BG000 **Title:** Usual Care **Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. ### Group **ID:** BG001 **Title:** Care Manager Outreach **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8 **Value:** 60 #### Measurement **Group ID:** BG001 **Spread:** 7 **Value:** 60 #### Measurement **Group ID:** BG002 **Spread:** 8 **Value:** 60 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 58 #### Measurement **Group ID:** BG001 **Value:** 67 #### Measurement **Group ID:** BG002 **Value:** 125 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 37 #### Measurement **Group ID:** BG002 **Value:** 77 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Limitations and Caveats **Description:** Single site study ### Point of Contact **Email:** mjean@nmff.org **Organization:** Northwestern University **Phone:** 312-503-9642 **Title:** Dr. Muriel Jean-Jacques, Assistant professor ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 31 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010) **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** within 4 months of the initiation of outreach (by June 30, 2010) **Title:** Completion of a Colorectal Cancer Screening **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. **ID:** OG000 **Title:** Usual Care ##### Group **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit **ID:** OG001 **Title:** Care Manager Outreach ### Participant Flow Module #### Group **Description:** Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. **ID:** FG000 **Title:** Usual Care #### Group **Description:** Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit **ID:** FG001 **Title:** Care Manager Outreach #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 98 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 104 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 98 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 104 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Recruitment Details:** All eligible patients within the health center were randomized to usual care or care manager outreach. Eligibility for randomization was assessed on 12/31/2009. Outreach was conducted from 2/25/2010 through 4/30/2010. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02892279 **Brief Title:** Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure **Official Title:** Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure #### Organization Study ID Info **ID:** Umu-2016-57-31 #### Organization **Class:** OTHER **Full Name:** Umeå University ### Status Module #### Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-02-06 **Type:** ACTUAL **Last Update Submit Date:** 2018-02-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Start Date **Date:** 2016-09 **Status Verified Date:** 2018-02 #### Study First Post Date **Date:** 2016-09-08 **Type:** ESTIMATED **Study First Submit Date:** 2016-09-02 **Study First Submit QC Date:** 2016-09-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Umeå University #### Responsible Party **Investigator Affiliation:** Umeå University **Investigator Full Name:** Jenny Bosson **Investigator Title:** MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The adverse effects of air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. In the current project the investigators aim to determine whether an acute exposure to diesel exhaust causes impacts on sympathetic nervous system activation in healthy volunteers. **Detailed Description:** Brief as well as chronic exposures to air pollution have been linked with increases in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations between air pollution exposure and adverse cardiovascular effects are found for combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is found in diesel engine emissions. Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine particulate air pollution alters vascular function has yet to be determined. Microneurography is a method that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic nervous activity. The current study will employed microneurography techniques to evaluate autonomic function in association with inhaled air pollution exposure in healthy human volunteers. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Microneurography - Air pollution ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A single arm study in which first a baseline muscle sympathetic nerve activity (MSNA) is recorded with and without an exposure mask. When measurements have been secured exposure to dilute diesel exhaust will start. **Intervention Names:** - Other: Diesel exhaust exposure **Label:** Diesel exhaust exposure **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Diesel exhaust exposure **Description:** Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute diesel exhaust via mask. **Name:** Diesel exhaust exposure **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Microneurography recording of muscle sympathetic nervous system activity **Measure:** Microneurography **Time Frame:** 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy (normal ECG, lung function, blood sample, clinical examination) Exclusion Criteria: * Metabolic disease * Cardiovascular disease * Respiratory disease * BMI ≥ 30 * Use of psychoactive medication * Infection within 2 weeks of the study * Smokers or regular snus usage **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Umeå **Country:** Sweden **Facility:** Dept of Medicine, Lung and Allergy section, University Hospital #### Overall Officials **Official 1:** **Affiliation:** Umeå University **Name:** Jenny Bosson, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Rankin GD, Kabele M, Brown R, Macefield VG, Sandstrom T, Bosson JA. Acute Exposure to Diesel Exhaust Increases Muscle Sympathetic Nerve Activity in Humans. J Am Heart Assoc. 2021 May 18;10(10):e018448. doi: 10.1161/JAHA.120.018448. Epub 2021 May 4. **PMID:** 33942621 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00574379 **Brief Title:** Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR **Official Title:** A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen #### Organization Study ID Info **ID:** BILA 2607/RAE #### Organization **Class:** INDUSTRY **Full Name:** Faes Farma, S.A. #### Secondary ID Infos **ID:** CTFZ07001 ### Status Module #### Completion Date **Date:** 2008-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-02-15 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-03 **Type:** ACTUAL #### Start Date **Date:** 2007-12 **Status Verified Date:** 2019-02 #### Study First Post Date **Date:** 2007-12-17 **Type:** ESTIMATED **Study First Submit Date:** 2007-12-14 **Study First Submit QC Date:** 2007-12-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC **Class:** INDUSTRY **Name:** Allied Research International #### Lead Sponsor **Class:** INDUSTRY **Name:** Faes Farma, S.A. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment. ### Conditions Module **Conditions:** - Seasonal Allergic Rhinitis - Hay Fever - Allergic Conjunctivitis - Hypersensitivity **Keywords:** - Allergic Rhinitis - Mountain Cedar Pollen - Pollen Allergy - Rhinoconjunctivitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 805 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bilastine 20mg once per day **Intervention Names:** - Drug: Bilastine **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Bilastine 20mg twice per day **Intervention Names:** - Drug: Bilastine **Label:** 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Bilastine 10mg once per day **Intervention Names:** - Drug: Bilastine **Label:** 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Bilastine 10mg twice per day **Intervention Names:** - Drug: Bilastine **Label:** 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Intervention Names:** - Drug: Placebo **Label:** 5 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 - 2 - 3 - 4 **Description:** Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets **Name:** Bilastine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 5 **Description:** Placebo tablets twice daily for 14 days **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change in nasal symptom scores **Time Frame:** 14 days #### Secondary Outcomes **Measure:** Change in ocular symptom scores and quality of life scores; standard safety assessments **Time Frame:** 14 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms * documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: * significant medical condition * significant nasal abnormality * significant cardiac condition * recent infection * use of other allergy medication during the study **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Oklahoma City **Country:** United States **Facility:** Oklahoma Allergy and Asthma Clinic **State:** Oklahoma **Zip:** 73104 **Location 2:** **City:** Austin **Country:** United States **Facility:** MetaClin Research Inc. **State:** Texas **Zip:** 78704 **Location 3:** **City:** Austin **Country:** United States **Facility:** Austin Clinical Research **State:** Texas **Zip:** 78750 **Location 4:** **City:** Austin **Country:** United States **Facility:** Lovelace Scientific Resources **State:** Texas **Zip:** 78759 **Location 5:** **City:** Kerrville **Country:** United States **Facility:** Kerrville Research Associates **State:** Texas **Zip:** 78028-6071 **Location 6:** **City:** San Antonio **Country:** United States **Facility:** Biogenics Research Institute **State:** Texas **Zip:** 78229 **Location 7:** **City:** San Antonio **Country:** United States **Facility:** DGD Research **State:** Texas **Zip:** 78229 **Location 8:** **City:** San Antonio **Country:** United States **Facility:** Diagnostics Research Group **State:** Texas **Zip:** 78229 **Location 9:** **City:** San Antonio **Country:** United States **Facility:** Southwest Allergy and Asthma Centre **State:** Texas **Zip:** 78229 **Location 10:** **City:** San Antonio **Country:** United States **Facility:** Sylvana Research Associates **State:** Texas **Zip:** 78229 **Location 11:** **City:** San Antonio **Country:** United States **Facility:** Live Oak Allergy and Asthma **State:** Texas **Zip:** 78233 **Location 12:** **City:** Waco **Country:** United States **Facility:** Allergy & Asthma Care of Waco **State:** Texas **Zip:** 76708 **Location 13:** **City:** Waco **Country:** United States **Facility:** Allergy Asthma Research Institute **State:** Texas **Zip:** 76712 #### Overall Officials **Official 1:** **Affiliation:** Faes Farma, S.A. **Name:** Ander Sologuren, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Sylvana Research Associates **Name:** Paul Ratner, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000007154 - Term: Immune System Diseases - ID: D000003229 - Term: Conjunctival Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M15049 - Name: Rhinitis - Relevance: HIGH - As Found: Rhinitis - ID: M30545 - Name: Rhinitis, Allergic - Relevance: HIGH - As Found: Allergic Rhinitis - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M6455 - Name: Conjunctivitis - Relevance: HIGH - As Found: Conjunctivitis - ID: M9345 - Name: Rhinitis, Allergic, Seasonal - Relevance: HIGH - As Found: Seasonal Allergic Rhinitis - ID: M6457 - Name: Conjunctivitis, Allergic - Relevance: HIGH - As Found: Allergic Conjunctivitis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M6453 - Name: Conjunctival Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012220 - Term: Rhinitis - ID: D000065631 - Term: Rhinitis, Allergic - ID: D000006255 - Term: Rhinitis, Allergic, Seasonal - ID: D000003231 - Term: Conjunctivitis - ID: D000003233 - Term: Conjunctivitis, Allergic - ID: D000006967 - Term: Hypersensitivity ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03188679 **Brief Title:** Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection **Official Title:** Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection #### Organization Study ID Info **ID:** S58404 #### Organization **Class:** OTHER **Full Name:** Universitaire Ziekenhuizen KU Leuven ### Status Module #### Completion Date **Date:** 2019-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2017-06-15 **Type:** ACTUAL **Last Update Submit Date:** 2017-06-13 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-07 **Type:** ESTIMATED #### Start Date **Date:** 2017-07 **Type:** ESTIMATED **Status Verified Date:** 2017-06 #### Study First Post Date **Date:** 2017-06-15 **Type:** ACTUAL **Study First Submit Date:** 2017-06-12 **Study First Submit QC Date:** 2017-06-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Melbourne #### Lead Sponsor **Class:** OTHER **Name:** Universitaire Ziekenhuizen KU Leuven #### Responsible Party **Investigator Affiliation:** Universitaire Ziekenhuizen KU Leuven **Investigator Full Name:** prof. dr. Luc De Catte **Investigator Title:** Head of Fetal Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately 0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs in about one third of women who are infected in first trimester. Babies infected before birth are at risk for serious neurological complications such as intellectual disability, seizures, deafness, and even death. Most couples facing a diagnosis of congenital cytomegalovirus infection in their unborn baby focus heavily on the predicted neurological outcome for their child. To date, methods to assess brain development in fetuses have been mainly limited to detecting structural brain abnormalities by ultrasound. However, these ultrasound signs may not become apparent until very late in pregnancy, and some neurological disability is not accompanied by any structural brain changes. More research on methods of predicting neurodevelopmental outcome independent of structural brain malformations before third trimester is urgently needed. The purpose of this study is to investigate a new method of studying the health of unborn babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection to diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in amniotic fluid can provide meaningful information from multiple organs including the fetal brain. The investigators propose to collect and analyse a small sample of amniotic fluid to detect which genes are turned "on" or "off" (gene expression) in a fetus that has a congenital CMV infection, compared to those without any infection. The genes that are differentially expressed in CMV infected fetuses will then be analysed to provide information on the broad physiological processes that are altered due to the infection ("functional analysis") and identify neurodevelopmental gene transcripts of interest for future studies ("biomarker discovery"). **Detailed Description:** Rationale for the study Current tools for prediction of perinatal outcome after fetal infection with CMV are very limited. Amniocentesis is usually offered from 20 weeks gestation to diagnose fetal infection. This sampling provides an opportunity to investigate novel approaches to predicting perinatal outcome. This study aims to develop an mRNA based approach to studying the impact of CMV on the developing fetus. Dr Hui's PhD thesis was based on the study of amniotic fluid mRNA as a gene expression "summary fluid" of the fetus that provides meaningful information about development. This work suggested that information about fetal neurodevelopment is obtainable from amniotic fluid via cell-free fetal brain specific transcripts (mRNAs). If a woman at risk of congenital CMV chooses to have an amniocentesis for diagnosis of fetal infection, this sampling provides an opportunity to collect an aliquot of AF for RNA analysis. RNA sequencing (RNAseq) is a relatively new technology that enables detailed analysis of the genes that are actively expressed ('switched on') during a particular disease state. The investigators will apply RNAsequencing methods to amniotic fluid to search for potential gene expression differences that may assist in understanding the disease through functional analysis and identifying candidate biomarkers for future studies. Hypothesis That fetuses infected with CMV will have an altered gene expression profile compared with noninfected fetuses, as ascertained in amniotic fluid cell-free RNA. Aims To perform comparative whole transcriptome analysis of AF RNA from CMV-infected and uninfected fetuses using RNA sequencing technology. Methods This will be a multicentre study involving fetal medicine units in Melbourne (Mercy Hospital for Women), Sydney (Royal Hospital for Women, Randwick) and Leuven (UZ Leuven, Leuven). The investigators aim to recruit 20 women (10 cases, 10 controls) over 2 years. Samples will be collected during clinically-indicated amniocentesis performed for the purposes of diagnosing the presence or absence of congenital infection. This is usually performed at 20-21 weeks gestation for women with seroconversion in early pregnancy, or at the time of fetal assessment in cases of referrals with structural abnormalities. An amniotic fluid (AF) volume of 5-10ml would be required for the research study. This sample volume does not pose a significant burden on the clinician performing the procedure (only 10-20 seconds additional collection time) and does not increase the risk of the procedure for the pregnancy or woman as there is NO additional needle insertion (no increase in miscarriage or impact on fetal or maternal well-being). The research sample will be stored in a separate vial to the clinical sample at the respective recruitment sites. It is stored at 4 degrees Celsius and then centrifuged at 300 x g for 10 minutes within 6 hours of collection. The AF supernatant will be taken off and stored in a separate tube. Both the cellular portion and the supernatant will be frozen and stored at - 80°C. The Sydney recruitment site will transport the specimens to the University of Melbourne laboratory at the Mercy Hospital for Women on dry ice, where they will be processed. All samples will be given a study sample ID number before transport to the University of Melbourne research lab at the Mercy Hospital for Women to protect the participants privacy. Total RNA from AF samples from 10 CMV infected and 10 uninfected fetuses, matched for gestational age and fetal sex, will be analysed. Total RNA will be extracted from the AF supernatant samples will be performed using the Qiagen Circulating Nucleic Acid extraction kit. Whole transcriptome amplification and RNA-sequencing of the cell free RNA will be performed and the expression profiles of the case and control groups compared in a paired analysis as performed in previous studies of AF RNA. Pathway analysis of the differentially-regulated genes will be used for the biological interpretation. The investigators will employ both widely used commercial software (Ingenuity Pathway Analysis™) and a fetus-specific functional analysis tool developed by collaborators at Tufts University (DFLAT). The most down- and up-regulated brain transcripts will be identified as candidate biomarkers of abnormal outcome for future validation studies. Pregnancy outcomes to six weeks postpartum for mother and baby will be collected from the hospital medical record, including fetal abnormalities detected on ultrasound or MRI, gestation and mode of birth, birth weight, use of prenatal therapies (CMV immunoglobulin or other), newborn investigations such as urine/saliva/ cord blood test results, cranial ultrasound, physical examination and results of newborn hearing screening. Expected outcomes: Compared to uninfected fetuses, CMV-infected fetuses will show altered neurodevelopmental pathways and gene expression on functional analysis. Fetal-brain specific transcripts that are differentially expressed in CMV-infected fetuses will be identified as candidate biomarkers of neurodevelopmental outcome for future validation studies. Data storage and security The database will be set up within RedCap (Research Electronic Data Capture), a free, secure, web-based application designed to support patient data capture for research studies. The University of Melbourne REDCap service provides secure storage and backup policies that comply with University standards and the the United States Health Information and Privacy Act. Only the study investigators will have access to this database. Hard copies of consent forms and other study information will be kept in locked filing cabinets. Only the study investigators and the HREC will have access to the files. 6.0 Inclusion criteria Women undergoing clinically-indicated amniocentesis for suspected congenital CMV infection through the Department of Perinatal Medicine at the Mercy Hospital for Women or the Royal Hospital for Women, Randwick will be identified from the perinatal clinic referrals by Dr Hui or Dr Shand respectively. These women will include (i) women with evidence of maternal primary CMV infection during pregnancy (ii) Fetuses with structural abnormalities suggestive of congenital CMV infection (as listed in Hui L and Wood G. Perinatal outcome after maternal primary cytomegalovirus infection in first trimester: a practical update and counseling aid. 2015 Prenatal Diagnosis; 35:1-7. ) Any English-speaking woman aged 18 or over who is capable of giving informed consent will be eligible. Subjects with confirmed fetal CMV infection will form the case group. Fetuses without evidence of congenital infection will form the control group. Structurally abnormal fetuses that are CMV negative will be excluded from the control group analysis. The rate of infected vs noninfected fetuses following maternal infection is approximately 40%, so we anticipate a reasonable ratio of cases and controls for our target sample size. Initial contact will be made by the clinical team, but follow up by a research midwife to discuss the research study in detail will be made, either by telephone, or face-to-face following the clinical consultation wherever possible. This is to minimize potential conflicts from having the clinicians obtain patient consent for the study. Patients will be reassured that they will be under no obligation to participate and that their decision will not affect their clinical care or relationship with their treating medical practitioner Written, informed consent will be obtained from women prior to their procedure and be stored in a locked filing cabinet in the respective Departments of Perinatal Medicine. Exclusion criteria Women who do not give consent, who are not capable of consent for medical procedures, non-English speaking, or who are under 18 years of age. Statistical analyses Sample size In general, the more biological replicates (larger sample size), the stronger the inferences that can be made from the gene expression data. Biological variation between samples and the expected spread of differential gene expression are important factors influencing the ideal sample size. For this study, the investigators do not know in advance how the gene expression levels would be distributed, thus restricting our ability to use sample size algorithms for RNA-seq experiments. In addition to the restrictions on sample availability discussed above, the high costs associated with laboratory processing limited the feasibility of using large numbers of AF samples. The main factors that influence formal sample size calculations for RNA-sequencing experiments are: depth of sequencing, coefficient of variation, magnitude of differential expression detected, false positive rate and power. Assuming average read depth of 20, equal within group coefficient of variation of 0.4, an effect size of 2 fold, 0.05 false positive rate and 80% power, the number of subjects per group required is 7.1 The investigators therefore aim for a minimum target of ten samples per group. Analysis of differential gene expression and functional analysis A consultant bioinformatics specialist within the Translational Obstetric Group will be available for statistical and analysis support for the gene expression data. Genes that are significantly dysregulated in the CMV infected cases compared with non-infected controls will be identified. Functional analyses of the differentially expressed genes will be performed using Ingenuity Pathways Analysis (IPA) Version 9.0 software (Ingenuity; Redwood City, CA). Ingenuity is a manually-curated database that identifies over-represented biological processes in a given data set and calculates a significance score for each result using the right tailed Fisher's test. The investigators will also use a publicly available fetus-specific functional annotation "Developmental FunctionaL Annotation at Tufts" (DFLAT) that has previously been shown to enhance biological interpretation of perinatal datasets (http://dflat.cs.tufts.edu).2 ### Conditions Module **Conditions:** - Cytomegalovirus Infections - Neurologic Dysfunction **Keywords:** - CMV - neurological impairment - outcome prediction - amniotic fluid biomarkers ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients with seroconversion for CMV undergo amniocentesis. RNA markers for neurological outcome in amniotic fluid CMV PCR negative foetuses are compared with those with amniotic fluid CMV positive PCR. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** amniotic fluid for patients with CMV seroconversion during pregnancy will undergo mRNA sequencing **Intervention Names:** - Device: amniocentesis **Label:** mRNA sequencing **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - mRNA sequencing **Description:** mRNA sequencing on amniotic fluid samples of fetuses after maternal seroconversion for CMV **Name:** amniocentesis **Other Names:** - mRNA sequencing **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** That fetuses infected with CMV will have an altered gene expression profile compared with noninfected fetuses, as ascertained in amniotic fluid cell-free RNA **Measure:** gene expression in amniotic fluid after CMV seroconversion **Time Frame:** 30 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * women with evidence of maternal primary CMV infection during pregnancy * Fetuses with structural abnormalities suggestive of congenital CMV infection * all patients consent to amniocentesis * age 18 years or over and capable of giving informed consent Exclusion Criteria: * Women who do not give consent * not capable of consent for medical procedures * language barrier * under 18 years of age. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** luc.decatte@uzleuven.be **Name:** Luc E De Catte, MD, PhD **Phone:** 016 34 84 38 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Melbourne University **Name:** Lisa Hui, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data on pregnancy outcome (birth weight, gestational age at birth, Apgar score) and neonatal development in relation to CMV infection (clinical signs relevant to neonatal CMV infection: jaundice, petechia, hepatosplenomegaly, neurological impairment, hearing deficit, visual impairment) will be recorded. Dat will be availabe within six months after delivery. Data will be obtained from the digitalised patient records. **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006566 - Term: Herpesviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M6791 - Name: Cytomegalovirus Infections - Relevance: HIGH - As Found: Cytomegalovirus Infections - ID: M12404 - Name: Neurologic Manifestations - Relevance: HIGH - As Found: Neurologic Dysfunction - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9643 - Name: Herpesviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T1720 - Name: Cytomegalic Inclusion Disease - Relevance: HIGH - As Found: Cytomegalovirus Infections - ID: T1480 - Name: Congenital Cytomegalovirus - Relevance: HIGH - As Found: Congenital CMV Infection ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000003586 - Term: Cytomegalovirus Infections - ID: D000009461 - Term: Neurologic Manifestations ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04304079 **Brief Title:** A Novel Augmented Reality System (ARssist) for the Assistant Surgeon in Robotic Assisted Surgery **Official Title:** A Novel Augmented Reality System (ARssist) for the Assistant Surgeon in Robotic Assisted Surgery: A Pilot Study #### Organization Study ID Info **ID:** CRE 2019.607-T #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-21 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2024-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2020-03-11 **Type:** ACTUAL **Study First Submit Date:** 2020-03-09 **Study First Submit QC Date:** 2020-03-09 **Why Stopped:** No funding ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese University of Hong Kong #### Responsible Party **Investigator Affiliation:** Chinese University of Hong Kong **Investigator Full Name:** Jeremy Yuen Chun TEOH **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Robotic prostatectomy is a surgery for treating localized prostate cancer. The ARssist system is a novel augmented reality system designed for the assistant surgeon, allowing delivery of augmented reality information via Microsoft HoloLens 2 (a head mount display developed by Microsoft) to better delineate the 3-D operative environment and enable better visualization. To date, there is no prospective study on the clinical performance and utilization of the ARssist system. This study is to evaluate the clinical feasibility and safety of the ARssist system during robotic surgery with the da Vinci Xi system. **Detailed Description:** The da Vinci robotic surgery system offers advantages such as immersive three-dimensional visualization, intuitive control, and high degree of movement freedom to the chief surgeon. However, major surgery remains a team-based effort. Apart from the chief surgeon who remotely controls the da Vinci system at the console, the success of robotic assisted surgical procedures also relies on the assistant surgeon positioned at the patient side, who provides assistance laparoscopically. Throughout a robotic assisted operation, the patient side surgeon is responsible for tasks such as the exchange of instruments, retraction of tissue to enhance operative fields, manipulation of instruments, etc. Literature has demonstrated that the performance of the assistant surgeon has an effect on the outcomes of robotic surgery such as operative time. Traditionally the patient side surgeon relies on the monitor mounted on the vision cart to guide his/her movement. The monitor provides real-time relay of the image captured from the endoscope, but does not provide the full three-dimensional stereo endoscopy view unless set up with specialized stereo-vision equipment. The position of the monitor is also often awkward, creating problems such as obstructed views and non-ergonomic positioning of the patient side surgeon to overcome the view obstruction. The complex three-dimensional set-up of endoscope, robotic instruments, and hand-held instruments inside the patient body could prove difficult to imagine from the patient side surgeon's perspective, and guesswork could be involved during transfer of instruments/objects towards the operative field as the hand-held instruments are often out of the visualized field of the endoscope. Augmented reality (AR) technology delivered via optical see-through head-mounted display (OST-HMD) could potentially be the solution to the aforementioned issues. OST-HMD, such as Microsoft HoloLens, can superimpose computer graphics on top of real-world view through optical combiners. The clinical application of such a technology has been gaining interest in the surgical community, with preliminary study demonstrating feasibility of AR technology in ureteroscopic procedures. The ARssist system is a novel AR system designed for the patient side surgeon in robotic assisted surgeries. It integrates the da Vinci surgical system and Microsoft HoloLens, and provides valuable AR information to the patient side surgeon including (i) three-dimensional real-time rendering of the endoscope, robotic instruments, and hand-held instruments within the patient body, and (ii) real-time stereo endoscopy that is configurable for the assistant surgeon's preferred hand-eye coordination. The ARssist system would in theory grant the patient side surgeon improved orientation and navigation of hand-held laparoscopic instruments, thus improving their laparoscopic performance and the performance of the surgery as a whole. Based on the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) Collaboration group methodology of promoting surgical innovation and research through planned prospective studies within an established staged process, we propose a stage 1 (Innovation) study to evaluate the feasibility and safety of the ARssist system. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - Prostate cancer - Augmented reality - ARssist system ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is a prospective case series to be conducted as a pilot study to evaluate the clinical feasibility and safety of the ARssist system during robotic surgery with the da Vinci Xi system. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The surgery will follow the same steps of a standard robotic assisted radical prostatectomy procedure, with the addition of the ARssist system used by the patient side surgeon. **Intervention Names:** - Device: ARssist system **Label:** ARssist system **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ARssist system **Description:** As stated in ARssist system arm description **Name:** ARssist system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Complications which occur within 30 days after the operation **Measure:** 30-day complications **Time Frame:** Thirty days after the allocated treatment #### Secondary Outcomes **Description:** Performance of the patient side surgeon will be assessed using Global Operative Assessment of Laparoscopic Skills (GOALS) by different evaluators, including the patient side surgeon him/herself (self-evaluation), the console surgeon, and a third-party evaluator **Measure:** Performance parameters **Time Frame:** Immediately post-operative **Description:** The surgeries will be recorded audio-visually, with the captured video clips later reviewed by an independent assessor to determine objective performance outcomes of included tasks via motion analysis parameters **Measure:** Performance parameters **Time Frame:** Immediately post-operative **Description:** Specific feedback on the use of ARssist system will be collected from the patient side surgeon at the pre-operative and post-operative time points using a customized questionnaire of 10 items on a 5-point Likert scale **Measure:** User-generated usability feedbacks **Time Frame:** Immediately post-operative **Description:** Duration of operation **Measure:** Operating time **Time Frame:** Immediately post-operative **Description:** Volume of blood loss during operation **Measure:** Blood loss **Time Frame:** Immediately post-operative **Description:** Patients undergoing robotic radical prostatectomy have an average hospital stay of three days **Measure:** Length of hospital stay **Time Frame:** Three days after the allocated treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years old with informed consent * Suitable for minimally invasive surgery * Clinically diagnosed with urological conditions that are indicated for robotic assisted radical prostatectomy with or without lymph node dissection Exclusion Criteria: * Body mass index ≥ 35 kg/m2 * Contraindication to general anaesthesia * Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention * Untreated active infection * Uncorrectable coagulopathy * Presence of another malignancy or distant metastasis * Emergency surgery **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Prince of Wales Hospital #### Overall Officials **Official 1:** **Affiliation:** Chinese University of Hong Kong **Name:** Jeremy Yuen Chun TEOH, MBBS, FRCSEd **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Nayyar R, Yadav S, Singh P, Dogra PN. Impact of assistant surgeon on outcomes in robotic surgery. Indian J Urol. 2016 Jul-Sep;32(3):204-9. doi: 10.4103/0970-1591.185095. **PMID:** 27555678 **Citation:** Sgarbura O, Vasilescu C. The decisive role of the patient-side surgeon in robotic surgery. Surg Endosc. 2010 Dec;24(12):3149-55. doi: 10.1007/s00464-010-1108-9. Epub 2010 May 22. **PMID:** 20495980 **Citation:** Al Janabi HF, Aydin A, Palaneer S, Macchione N, Al-Jabir A, Khan MS, Dasgupta P, Ahmed K. Effectiveness of the HoloLens mixed-reality headset in minimally invasive surgery: a simulation-based feasibility study. Surg Endosc. 2020 Mar;34(3):1143-1149. doi: 10.1007/s00464-019-06862-3. Epub 2019 Jun 18. **PMID:** 31214807 **Citation:** Qian L, Deguet A, Kazanzides P. ARssist: augmented reality on a head-mounted display for the first assistant in robotic surgery. Healthc Technol Lett. 2018 Sep 17;5(5):194-200. doi: 10.1049/htl.2018.5065. eCollection 2018 Oct. **PMID:** 30800322 **Citation:** McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8. **PMID:** 19782876 **Citation:** Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM; Balliol Collaboration; Altman DG, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Flum DR, Glasziou P, Marshall JC, McCulloch P, Nicholl J, Reeves BC, Seiler CM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. Evaluation and stages of surgical innovations. Lancet. 2009 Sep 26;374(9695):1089-96. doi: 10.1016/S0140-6736(09)61083-7. **PMID:** 19782874 **Citation:** Ahmed K, Miskovic D, Darzi A, Athanasiou T, Hanna GB. Observational tools for assessment of procedural skills: a systematic review. Am J Surg. 2011 Oct;202(4):469-480.e6. doi: 10.1016/j.amjsurg.2010.10.020. Epub 2011 Jul 28. **PMID:** 21798511 **Citation:** Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004. **PMID:** 15972181 **Citation:** Wolf R, Medici M, Fiard G, Long JA, Moreau-Gaudry A, Cinquin P, Voros S. Comparison of the goals and MISTELS scores for the evaluation of surgeons on training benches. Int J Comput Assist Radiol Surg. 2018 Jan;13(1):95-103. doi: 10.1007/s11548-017-1645-y. Epub 2017 Aug 20. **PMID:** 28825199 **Citation:** Faulkner H, Regehr G, Martin J, Reznick R. Validation of an objective structured assessment of technical skill for surgical residents. Acad Med. 1996 Dec;71(12):1363-5. doi: 10.1097/00001888-199612000-00023. **PMID:** 9114900 **Citation:** Mason JD, Ansell J, Warren N, Torkington J. Is motion analysis a valid tool for assessing laparoscopic skill? Surg Endosc. 2013 May;27(5):1468-77. doi: 10.1007/s00464-012-2631-7. Epub 2012 Dec 12. **PMID:** 23233011 **Citation:** Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. **PMID:** 15273542 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00636779 **Acronym:** BraveNet **Brief Title:** BraveNet Integrative Medicine Descriptive Study **Official Title:** BraveNet Multi-Center Integrative Medicine Survey #### Organization Study ID Info **ID:** Pro00006850 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2011-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-06-14 **Type:** ESTIMATED **Last Update Submit Date:** 2011-06-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-06 **Type:** ACTUAL #### Start Date **Date:** 2008-03 **Status Verified Date:** 2011-06 #### Study First Post Date **Date:** 2008-03-14 **Type:** ESTIMATED **Study First Submit Date:** 2008-03-09 **Study First Submit QC Date:** 2008-03-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Bravewell Collaborative **Class:** OTHER **Name:** Alliance Institute for Integrative Medicine **Class:** OTHER **Name:** Allina Health System **Class:** OTHER **Name:** Scripps Center for Integrative Medicine **Class:** OTHER **Name:** University of California, San Francisco **Class:** OTHER **Name:** University of Maryland **Class:** UNKNOWN **Name:** The Continuum Center for Health and Healing **Class:** OTHER **Name:** Thomas Jefferson University **Class:** OTHER **Name:** Venice Family Clinic #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Old Name Title:** Rowena Dolor, Coordinating Principal Investigator **Old Organization:** Bravewell Integrative Medicine Research Network (BraveNet) ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Bravewell Integrative Medicine Research Network (BraveNet) is a newly formed practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of integrative medicine. **Detailed Description:** Specific Aims of BraveNet: 1. Demonstrate feasibility for the nine sites of BraveNet to coordinate in specifying data elements, developing and implementing smooth data collection procedures, analyzing the data, publishing and disseminating the results through scientific conferences and journals. 2. Describe the patients seeking care at Integrative Medicine centers, in terms of: 1. demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment; 2. quality of life, mood, stress; and 3. lifestyle factors. 3. Explore potential patterns within the sample \[e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.\]. 4. Utilize above data as pilot data for future studies and funding opportunities. Up to five hundred eligible patients seen at each of the nine participating Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study. The patient survey will clearly state that participation is voluntary with a written consent to participate on the front. Individual practices will report the response rate in order to monitor the potential effect of volunteer bias. Participant completion of questionnaires should take 15 to 30 minutes, and should be completed within 2 weeks of the patient visit., The corresponding provider form will be completed by the provider/research staff within 5 days of the visit. Measures: 1. Baseline Questionnaires - Demographics and reason for visit 2. Quality of Life. The SF-12 (Short Form 12) 3. Mood (Depression). The Center for Epidemiologic Studies Depression Scale (CES-D) 4. Stress. The Perceived Stress Scale (PSS) 5. Visual Analog Scales (VAS). Four self-report VASs will be used to measure aspects of pain, fatigue and restfulness of sleep. 6. Provider Form. Providers/ Research Staff will complete this form to indicate the type of provider seen, the CPT codes used to describe/bill for the service, the services provided, and the provider's assessment of current medical conditions/co-morbidities. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 4340 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Up to five hundred eligible patients seen at each of the nine participating Integrative Medicine Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study. **Label:** 1 ### Outcomes Module #### Primary Outcomes **Measure:** Describe the patients seeking care at Integrative Medicine centers, in terms of:a.demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment; b.quality of life, mood, stress; and c.lifestyle factors. **Time Frame:** Once per patient #### Secondary Outcomes **Measure:** Explore potential patterns within the sample [e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.]and utilize data as pilot data for future studies and funding opportunities. **Time Frame:** Once all surveys have been entered into the EDC system ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects will be eligible for inclusion in this study only if all of the following criteria apply: 1. Age: At least 18 years of age. 2. Patient Status: Participants are eligible if seen individually by any type of clinician on the day of the visit. 3. English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent. Exclusion Criteria: * Subjects will be excluded from this study if any of the following criteria apply: 1. Cognitive Impairment: A subject will not be eligible if he/she has a history of psychiatric disease, dementia, Alzheimer's disease, or other conditions which will limit the validity of providing informed consent to participate in the study. 2. Inability to read and write in English or Spanish. 3. Participating only in educational Center activities, not as a clinical patient. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 500 patients from each of the nine participating Integrative Medicine Centers who are seeing any type of clinicial on the day of their visit. ### Contacts Locations Module #### Locations **Location 1:** **City:** La Jolla **Country:** United States **Facility:** Scripps Center for Integrative Medicine **State:** California **Zip:** 92037 **Location 2:** **City:** San Francisco **Country:** United States **Facility:** Osher Center for Integrative Medicine **State:** California **Zip:** 94143 **Location 3:** **City:** Santa Monica **Country:** United States **Facility:** Venice Family Clinic **State:** California **Zip:** 90405 **Location 4:** **City:** Baltimore **Country:** United States **Facility:** University of Maryland Center for Integrative Medicine **State:** Maryland **Zip:** 21207 **Location 5:** **City:** Minneapolis **Country:** United States **Facility:** Penny George Institute for Health and Healing **State:** Minnesota **Zip:** 55407 **Location 6:** **City:** Durham **Country:** United States **Facility:** Duke Integrative Medicine **State:** North Carolina **Zip:** 27710 **Location 7:** **City:** Cincinnati **Country:** United States **Facility:** Alliance Center for Integrative Medicine **State:** Ohio **Zip:** 45236 **Location 8:** **City:** Philadelphia **Country:** United States **Facility:** Jefferson-Myrna Brind Center of Integrative Medicine **State:** Pennsylvania **Zip:** 19107 #### Overall Officials **Official 1:** **Affiliation:** Duke Clinical Research Institute **Name:** Rowena Dolor, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Duke Integrative Medicine Center **Name:** Ruth Wolever, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04521179 **Brief Title:** Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors **Official Title:** A Phase II, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With KN046 in Patients With Locally Advanced Unresectable or Metastatic HER2-positive Solid Tumors #### Organization Study ID Info **ID:** KN026-203 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu Alphamab Biopharmaceuticals Co., Ltd ### Status Module #### Completion Date **Date:** 2023-05-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-21 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-01-12 **Type:** ACTUAL #### Start Date **Date:** 2020-12-07 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2020-08-20 **Type:** ACTUAL **Study First Submit Date:** 2020-08-18 **Study First Submit QC Date:** 2020-08-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Peking University #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu Alphamab Biopharmaceuticals Co., Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors. **Detailed Description:** KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The study composes of two stages. The first stage plans to enroll HER2-positive solid tumors. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W at the first stage.A SMC meeting will decide whether to proceed to the nest stage. ### Conditions Module **Conditions:** - HER2-positive Solid Tumors **Keywords:** - KN026 and KN046 - HER2-Positive Solid Tumor ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 102 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** KN026 combination therapy **Intervention Names:** - Drug: KN026 combination **Label:** KN026 combined with KN046 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - KN026 combined with KN046 **Description:** 30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046 **Name:** KN026 combination **Other Names:** - IO therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate as assessed by the investigator according to RECIST 1.1 criteria **Measure:** Objective response rate (ORR ) **Time Frame:** Throughout the duration of the study; up to 2 years **Description:** Duration of response (DOR) as assessed by the investigator according to RECIST 1.1 criteria **Measure:** Duration of response (DOR) **Time Frame:** Throughout the duration of the study; up to 2 years #### Secondary Outcomes **Description:** Progression free survival (PFS) rates **Measure:** Progression free survival (PFS) rates **Time Frame:** 6 months and 12 months **Description:** Clinical benefit rate **Measure:** Clinical benefit rate (CBR) **Time Frame:** CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks **Description:** Overall survival (OS) rates **Measure:** Overall survival (OS) **Time Frame:** 6 months and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The subject can understand the informed consent, voluntarily participate and sign the informed consent ; * Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent； * Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive solid tumors; * Prior antitumor therapy needs to meet the following conditions: Her2-positive GC/GEJ: has not received prior systemic treatment for metastatic or locally advanced unresectable GC/GEJ, or has received prior systemic treatment≥1 line of systemic treatment with disease progression, front-line systemic treatment includes at least platinum or fluorouracil based chemotherapy with or without trastuzumab; Subjects who relapsed within 6 months after the end of neoadjuvant/adjuvant chemotherapy were considered as line 1 treatment failure; Her2-positive BC: prior treatment with ≥1 line of HER2-targeted therapy for metastatic disease and disease progression; Subjects who relapsed within 12 months after the end of neoadjuvant/adjuvant chemotherapy were considered as line 1 treatment failure; Other HER2-positive solid tumors: previous ≥1 line of systemic therapy for metastatic or locally advanced unresectable tumors with disease progression, no clear standard therapy for prolongation of survival, or after subjects rejected 1 line of systemic therapy; Frontline systemic therapy for ovarian and cervical cancer includes at least platinum-based (cisplatin or carboplatin) chemotherapy; Frontline systemic therapy for ESCC and mCRC includes at least platinum combined with fluorouracil or tax-based chemotherapy; MCRC requires ≥2 lines of systemic therapy for metastatic or locally advanced unresectable tumors and disease progression; Subjects who relapsed within 6 months after completion of neoadjuvant/adjuvant platinum-containing chemotherapy Line 1 treatment failure; * At least 1 measurable lesion at baseline according to RECIST1.1 criteria； * ECOG score 0 or 1; * Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA; * Liver function met the following criteria within 7 days prior to initial administration: Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation); -Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN; * TSH normal range： If TSH is abnormal, total or free T3 and free T4 should be in the normal range * Life expectancy \>3 months; * Fertile female subjects or fertile male subjects with a partner agreed to use hepa beginning 7 days prior to the first dose pregnancy continued until 24 weeks after drug withdrawal. Fertile female subjects must have a negative serum pregnancy test within 7 days prior to first dosing; * The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol Exclusion Criteria: * Untreated active brain metastasis or leptomeningeal metastasis; * Historyof Left ventricular ejection fraction (LVEF) decline to \< 45% or absolute decrease for \> 15% during the treatment course from prior HER2-targeted therapy; * Previous cumulative doses of anthracycline exceeded doxorubicin or liposomal doxorubicin \>320mg/m2 or equivalent doses of other anthracyclines; * Has received other anti-tumor treatment or an investigational drug within 28 days or 5 half-lives prior(whichever is shorter, but at least 2 weeks) to the first trial treatment; * Major surgery (transabdominal, transthoracic, etc.) within 28 days prior to initial administration; Diagnostic puncture or peripheral vascular is not included pathway replacement) * Radical radiotherapy within 3 months prior to initial administration; Palliative radiotherapy is allowed 2 weeks before administration, and the dose of radiotherapy is in line with local palliative the diagnosis and treatment standard of sexual therapy and the coverage of radiotherapy is less than 30% of the bone marrow region; * Prior treatment with immune checkpoint blockers or T cell costimulators; * Systemic corticosteroid or immunosuppressant therapy is required for 7 consecutive days within 14 days of initial dosing * Received live vaccines (including attenuated live vaccines) within 28 days of initial administration; * Have interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous glucocorticoid treatment; * Have a past or current autoimmune disease; * Other malignant tumors occurred within 5 years prior to initial administration; * With uncontrolled comorbidities; * Toxicity from previous antitumor therapy did not return to CTCAE grade ≤1 (NCI-CTCAEV 5.0) or baseline levels; * Prior allo-HSCT or solid organ transplant; * History of allergic reaction, hypersensitivity reaction and intolerance to antibody drugs; Prior allergic reaction to medication ; * Pregnant or nursing females; * Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance; * BMI less than 18.5kg/m2 or weight loss ≥10% within 2 months prior to screening. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Beijing Cancer Hospital **State:** Beijing **Zip:** 100142 #### Overall Officials **Official 1:** **Affiliation:** Peking University Cancer Hospital & Institute **Name:** Lin Shen, professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00059579 **Brief Title:** Brain Regulation of Emotions in People With Depression and Anhedonia **Official Title:** Functional MRI Study of Brain Mechanism Mediating Anhedonia in Major Depression #### Organization Study ID Info **ID:** 030149 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 03-M-0149 ### Status Module #### Completion Date **Date:** 2010-11-12 #### Expanded Access Info #### Last Update Post Date **Date:** 2017-07-02 **Type:** ACTUAL **Last Update Submit Date:** 2017-06-30 **Overall Status:** COMPLETED #### Start Date **Date:** 2003-04-24 **Status Verified Date:** 2010-11-12 #### Study First Post Date **Date:** 2003-04-29 **Type:** ESTIMATED **Study First Submit Date:** 2003-04-29 **Study First Submit QC Date:** 2003-04-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute of Mental Health (NIMH) ### Description Module **Brief Summary:** This study will use magnetic resonance imaging (MRI) to examine how the brain regulates emotions in healthy people and in patients who have major depression and anhedonia (loss of feeling of pleasure in things that normally give pleasure). Healthy normal volunteers and patients between 18 and 50 years of age with major depression, with or without significant anhedonia, are eligible for this study. Candidates will be screened with a psychiatric interview, a physical examination that will include blood and urine samples, and an electrocardiogram, and a questionnaire about their emotions. Participants will perform a monetary reward task while lying in an MRI scanner. The task is similar to playing a computer video game with the possibility of winning cash. The amount of cash is largely dependent on the subject's performance. The accumulated amount of cash earned in a session will fluctuate depending on the subject's continuing performance level. That is, during a single session, a subject could lose money earned early in the session if his or her performance later in the session is not as good as earlier. MRI pictures will be taken during performance of the task. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that is moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure will last about 1 to 1-1/2 hours. **Detailed Description:** Anhedonia has been one of the two key diagnostic criteria for major depressive disorder (MDD) since the publication of The Diagnostic and Statistical Manual of Mental Disorders, Third Edition, yet little is known about its neural substrates. Neuroimaging studies have identified numerous brain regions that are thought to be involved with MDD. Most studies dealt with MDD as a syndromal entity, and not surprisingly, yielded quite variable results with respect to the areas of the brain identified, the nature of the functional changes (i.e., decrease or increase in activities), lateralization, and correlation with clinical symptoms. Clinical heterogeneity and lack of symptom-specific targets are presumably among the factors contributing to the variability. The hypothesis that a functionally impaired mesolimbic dopaminergic pathway may comprise a part of neural substrate underlying core MDD symptoms of anhedonia and loss of motivation has been proposed. Nevertheless, the roles of brain reward mechanisms in mediating anhedonia in MDD remain unclear. Availability of appropriate experimental paradigms that can be used empirically to measure anhedonia is a prerequisite to test such a hypothesis. Recent studies using monetary incentive paradigms coupled with neuroimaging techniques have identified hemodynamic responses in structures that serve as part of the mesolimbic dopaminergic pathway during processing rewards in healthy humans. We hypothesize that anhedonia in MDD is associated with impairment of brain reward mechanisms such that dysfunction of the orbital and ventromedial frontal cortices involved in the impaired hedonic attribution capacity, while dysfunction of the ventral striatum area that contains the nucleus accumbens is involved with the reduced or lack of reactivity to rewarding environmental stimuli in patients with MDD. Our hypothesis is to link specific neural substrates to the two psychiatric components of anhedonia, i.e., loss of interest and lack of reactivity, as defined in the diagnostic criteria for MDD. We plan to operationally test our hypothesis by using empirical measurement of reward responses in MDD patients with and without significant anhedonia using a conditioning task assessing appetitive and aversive learning without any performance aspects and spatial delayed response task assessing the relationship between reward, performance and mood with the event-related functional magnetic resonance imaging method. We expect to find reduced activation of the ventral striatum, orbital and ventromedial frontal cortices in response to monetary incentive stimuli in MDD patients with significant anhedonia relative to MDD patients without anhedonia and healthy control. In order to assess the role of dopamine in anhedonia and in reward processing, we propose to assess the effect of dietary tyrosine plus phenylalanine depletion on the neural and behavioral responses associated with the performing of the monetary reward tasks investigated herein in an additional sample of subjects. Dietary depletion of tyrosine and phenylalanine, two DA precursors, is a validated method to induce significant reduction of the brain DA concentration as shown in two previous \[11C\]Raclopride PET studies. We hypothesize that depressed patients will show less activation than controls in brain regions associated with the mesolimbic DA system, such as striatum, amygdala, anterior cingulate gyrus and orbitofrontal cortex in response to reward in the placebo condition. We expect tyrosine and phenylalanine depletion to induce a similar neural impairment to reward in healthy subjects, including a reduction of the neural activation in the striatum, amygdala, anterior cingulate gyrus and orbitofrontal cortex in response to reward. The reduction of the neural activation in those regions will be stronger in healthy controls than in depressed patients. Finally, we hypothesize that tyrosine depletion will influence negatively the valence ratings of rewarding stimuli in healthy subjects. In depressed patients, anhedonia scores will correlate negatively with the valence ratings of rewarding stimuli in the placebo condition already. The outcome of the proposed work may provide clues for diagnosis, classification, and treatment of MDD, and may also yield leads for identifying the fundamental neural mechanisms underlying anhedonia in other disabling psychiatric conditions such as schizophrenia and addiction. ### Conditions Module **Conditions:** - Major Depressive Disorder **Keywords:** - Reward - Cortex - Dopamine - Neuroimaging - Strirtum - Major Depressive Disorder (MDD) - Melancholic Features - Brain Imaging - Functional Magnetic Resonance Imaging (fMRI) - Dopaminergic Mechanisms - Anhedonia - Depression - Major Depressive Disorder - MDD - Healthy Volunteer - HV ### Design Module #### Enrollment Info **Count:** 163 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA For both patient and control groups: Age 18 to 50 of any ethnicity without other significant medical conditions Not in active use of illicit drugs and heavy consumption of alcohol No metallic implants or onplants that are ferromagnetic Competent to sign consent forms to participate in the study. For patient groups: For the group with significant anhedonia, current MDD, as defined by DSM-IV criteria, with significant anhedonia defined as having PAS and/or SAS scores at or above one standard deviation of appropriate norm. For the group without significant anhedonia, current MDD, as defined by DSM-IV criteria, without significant anhedonia defined as having PAS and/or SAS scores within or below one standard deviation of appropriate norm. The BPD subjects will meet DSM-IV criteria for bipolar I or II disorder, most recent episode depressed and will currently be in a major depressive episode. We will use the Young Mania Rating Scale to assess the severity of the disorder Subjects may be enrolled as either inpatients or outpatients at their entrance to the study. For control group: No prior history of any psychiatric conditions including substance dependence No family history of MDD, bipolar disorder, or psychosis PAS and/or SAS scores within or below one standard deviation of appropriate norm. EXCLUSION CRITERIA: Medical conditions or concomitant medications that are likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases; History of psychosis, current mania and substance dependence; Exposure to psychiatric medications in the past 4 weeks; History of repeated self-mutilation or homicidal attempts, current active suicidal / homicidal ideations; Current or recent (within past six weeks) illicit drug use or heavy alcohol consumption (more than 2 six-packs of beer or equivalent alcoholic beverages per week); Pathological gamblers as defined by DSM-IV. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Institutes of Health Clinical Center, 9000 Rockville Pike **State:** Maryland **Zip:** 20892 ### References Module #### References **Citation:** Blanchard JJ, Horan WP, Brown SA. Diagnostic differences in social anhedonia: a longitudinal study of schizophrenia and major depressive disorder. J Abnorm Psychol. 2001 Aug;110(3):363-71. doi: 10.1037//0021-843x.110.3.363. **PMID:** 11502079 **Citation:** Boyer P, Tassin JP, Falissart B, Troy S. Sequential improvement of anxiety, depression and anhedonia with sertraline treatment in patients with major depression. J Clin Pharm Ther. 2000 Oct;25(5):363-71. doi: 10.1046/j.1365-2710.2000.00302.x. **PMID:** 11123488 **Citation:** Barbier EL, Silva AC, Kim SG, Koretsky AP. Perfusion imaging using dynamic arterial spin labeling (DASL). Magn Reson Med. 2001 Jun;45(6):1021-9. doi: 10.1002/mrm.1136. **PMID:** 11378880 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M29467 - Name: Anhedonia - Relevance: HIGH - As Found: Anhedonia - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059445 - Term: Anhedonia - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Intervention Browse Module - Browse Branches - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20595 - Name: Dopamine Agonists - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00397579 **Brief Title:** DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes **Official Title:** Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients With Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome With DTIL3 (IND# 11314): a Phase I/II Clinical Trial #### Organization Study ID Info **ID:** STU 012013-061 #### Organization **Class:** OTHER **Full Name:** University of Texas Southwestern Medical Center ### Status Module #### Completion Date **Date:** 2017-07-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-04-23 **Type:** ACTUAL **Last Update Submit Date:** 2019-03-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-07-27 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-04-23 **Type:** ACTUAL **Results First Submit Date:** 2018-11-21 **Results First Submit QC Date:** 2019-03-29 #### Start Date **Date:** 2013-05 **Status Verified Date:** 2019-03 #### Study First Post Date **Date:** 2006-11-09 **Type:** ESTIMATED **Study First Submit Date:** 2006-11-08 **Study First Submit QC Date:** 2006-11-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Texas Southwestern Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to carry cancer killing substances directly to the cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion protein and to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes. **Detailed Description:** OBJECTIVES: * Determine the maximum tolerated dose of DT_388IL3 fusion protein in patients with refractory or relapsed or poor-risk acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). * Define the dose-limiting toxicities of this regimen in these patients. * Measure the pharmacokinetics of this regimen in these patients. * Measure the immune responses in patients treated with this regimen. * Evaluate response and correlate with disease type (relapsed/refractory or poor-risk de novo AML or high-risk MDS), pretreatment marrow blast percentage, and leukemia blast interleukin-3 receptor density. OUTLINE: This is a phase I, multicenter, dose-escalation study followed by a phase II, open-label study. * Phase I: Patients receive DT_388IL3 IV over 15 minutes daily for 5 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DT_388IL3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: An additional 15 patients receive DT_388IL3 at the MTD as in phase I. Patients undergo serum and blast collection periodically for laboratory studies, including analysis of expression of interleukin-3 receptors and anti-DT_388IL3 antibodies at baseline. Samples are also analyzed by immunoenzyme assays and flow cytometry. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. ### Conditions Module **Conditions:** - Leukemia - Myelodysplastic Syndromes - Blastic Plasmacytoid Dendritic Cell Neoplasm **Keywords:** - adult acute myeloid leukemia with 11q23 (MLL) abnormalities - adult acute myeloid leukemia with inv(16)(p13;q22) - adult acute myeloid leukemia with t(15;17)(q22;q12) - adult acute myeloid leukemia with t(16;16)(p13;q22) - adult acute myeloid leukemia with t(8;21)(q22;q22) - recurrent adult acute myeloid leukemia - secondary acute myeloid leukemia - untreated adult acute myeloid leukemia - de novo myelodysplastic syndromes - previously treated myelodysplastic syndromes - secondary myelodysplastic syndromes - blastic plasmacytoid dendritic cell neoplasm - plasmacytoid dendritic cell leukemia - CD123+ ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 11 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. **Intervention Names:** - Drug: DT388IL3 **Label:** SL-401 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SL-401 **Description:** Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days. **Name:** DT388IL3 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. Response to Treatment will be evaluated as follows: Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement. Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen. Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months. Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size. Reported is the percentage of participants experiencing either CR, PR or SD. **Measure:** Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria: * Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy * Patients in early first relapse must not have a matched donor available and/or be ineligible for allogeneic stem cell transplantation * Poor-risk AML, as defined by any of the following criteria: * Treatment-related AML, unless associated with favorable cytogenetics (e.g., inversion 16, t\[16;16\], t\[8;21\], t\[15;17\]), and ineligible for stem cell transplantation * Antecedent hematological disease (e.g., myelodysplastic syndromes, myelofibrosis, or polycythemia vera) that evolved to AML (≥ 20% blasts) and ineligible for stem cell transplantation * De novo AML (must be \> 70 years of age) * AML with unfavorable cytogenetics (e.g., abnormalities of chromosomes -7, -5, 7q-, or 5q-; complex \[≥ 3\] abnormalities; or abnormalities of 11q23, excluding t\[9;11\], t\[9;22\], inversion 3, t\[3;3\], and t\[6;9\]), regardless of age, and ineligible for allogeneic stem cell transplantation * High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria * Resistant or intolerant to chemotherapy * Ineligible for or unwilling to undergo immediate allogeneic stem cell transplantation * Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment * No active CNS leukemia PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Bilirubin ≤ 1.5 mg/dL * ALT and AST \< 2.5 times upper limit of normal * Albumin ≥ 3 mg/dL * Creatinine ≤ 1.5 mg/dL * LVEF ≥ 50% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment * No complicated medical or psychiatric problems that would preclude study compliance * No concurrent serious uncontrolled infection or disseminated intravascular coagulation * No myocardial infarction within the past 6 months * No allergies to diphtheria toxin * No requirement for oxygen PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other concurrent antineoplastic drugs * No concurrent radiotherapy * No concurrent corticosteroids as antiemetics * No concurrent hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\]) * No concurrent intravenous immunoglobins **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** UT Southwestern Medical Center **State:** Texas **Zip:** 75390 #### Overall Officials **Official 1:** **Affiliation:** UT Southwestern Medical Center **Name:** Arthur E. Frankel, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Frankel AE, Woo JH, Ahn C, Pemmaraju N, Medeiros BC, Carraway HE, Frankfurt O, Forman SJ, Yang XA, Konopleva M, Garnache-Ottou F, Angelot-Delettre F, Brooks C, Szarek M, Rowinsky E. Activity of SL-401, a targeted therapy directed to interleukin-3 receptor, in blastic plasmacytoid dendritic cell neoplasm patients. Blood. 2014 Jul 17;124(3):385-92. doi: 10.1182/blood-2014-04-566737. Epub 2014 May 23. **PMID:** 24859366 ## Document Section ### Large Document Module #### Large Docs - Date: 2016-11-22 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 247246 - Type Abbrev: Prot_SAP - Upload Date: 2018-11-19T13:14 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000011230 - Term: Precancerous Conditions ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M14164 - Name: Preleukemia - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M12145 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T3993 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: T1792 - Name: Dendritic Cell Tumor - Relevance: HIGH - As Found: Dendritic Cell Neoplasm - ID: T773 - Name: Blastic Plasmacytoid Dendritic Cell - Relevance: HIGH - As Found: Blastic Plasmacytoid Dendritic Cell ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute - ID: D000011289 - Term: Preleukemia - ID: D000009190 - Term: Myelodysplastic Syndromes - ID: D000013577 - Term: Syndrome ### Misc Info Module #### Removed Countries - Country: Canada - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** SL-401 **Deaths Num At Risk:** 11 **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days. **ID:** EG000 **Other Num Affected:** 11 **Other Num at Risk:** 11 **Serious Number At Risk:** 11 **Title:** SL-401 **Frequency Threshold:** 0 #### Other Events **Term:** AST **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** **Term:** Neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** ALT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** **Term:** Thrombocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Hyponatremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Time Frame:** 10 days ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 11 **Units:** Participants ### Group **ID:** BG000 **Title:** SL-401 **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days. ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 10 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 40 **Upper Limit:** 77 **Value:** 68 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 11 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 11 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 11 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants **Population Description:** Patients with BPDCN treated with SL-401. ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** studyfinder@utsouthwestern.edu **Organization:** University of Texas Southwestern Medical Center at Dallas **Phone:** 214-648-7097 **Title:** Clinical Research Office ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.8 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. Response to Treatment will be evaluated as follows: Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement. Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen. Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months. Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size. Reported is the percentage of participants experiencing either CR, PR or SD. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months **Title:** Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days. **ID:** OG000 **Title:** SL-401 ### Participant Flow Module #### Group **Description:** Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days. **ID:** FG000 **Title:** SL-401 #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 11 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 11 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04027179 **Acronym:** TODY **Brief Title:** Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients **Official Title:** Effects of Tongue Bacterial Dysbiosis Related to Periodontal Therapy on Arterial Pressure Control Based on Salivary Nitrite Availability: a Periodontitis Patients Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** CAAE17482019.5.0000.5501 #### Organization **Class:** OTHER **Full Name:** University of Taubate ### Status Module #### Completion Date **Date:** 2022-07 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2019-07-23 **Type:** ACTUAL **Last Update Submit Date:** 2019-07-18 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-12 **Type:** ESTIMATED #### Start Date **Date:** 2020-08 **Type:** ESTIMATED **Status Verified Date:** 2019-07 #### Study First Post Date **Date:** 2019-07-19 **Type:** ACTUAL **Study First Submit Date:** 2019-07-18 **Study First Submit QC Date:** 2019-07-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico #### Lead Sponsor **Class:** OTHER **Name:** University of Taubate #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Blood pressure control is crucial for individuals' wellbeing. However, many daily aspects such as diet could impair blood pressure control. In addition, many people living under different conditions in different countries are affected by some kind of gum disease. These people experience gingival bleeding, bad breath, teeth mobility and pain. Throughout gum disease development the number of oral germs in the mouth increases including their levels in tongue surface. Oral bacterial are able to convert nitrate widely found in food in nitrite which influences blood pressure. Frequently treatment of gum diseases general combines manual instrumentation with mouthwashes. However, it has been suggested that reduction of oral bacteria by mouthwashes, especially chlorhexidine, is accompanied by decreased conversion of nitrate to nitrite and that this minor nitrite availability would increase blood pressure. Therefore, this is a point to be clarified for patients, physicians and dentists. This study will investigate the relation between treatment with mouthwashes and blood pressure of patients with destructive gum disease based on nitrite levels in saliva, bacterial levels in tongue and values of arterial blood pressure which will be monitored over 6 months. In addition, usual clinical parameters and alteration of oral cells' DNA will be also monitored overtime. Patients will be treated under local anesthesia and manual instrumentation within 24 hours. They will receive oral care products too. There will be 3 treatment groups (manual instrumentation + chlorhexidine mouthwash \[2 times a day for 3 weeks\], manual instrumentation + placebo mouthwash \[2 times a day for 3 weeks\] and manual instrumentation + no mouthwash) and 2 dental appointments before treatment. After treatment, patients will be examined at 7, 14, 21, 90 and 180 days. Saliva, plaque and cell sampling will be fast and by no invasive methods. ### Conditions Module **Conditions:** - Periodontitis - Normal Blood Pressure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Full-mouth scaling and root planning with manual curettes, 20 ml of 0.12% chlorhexidine gluconate mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with 0.12% chlorhexidine gluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). **Intervention Names:** - Drug: 0.12% chlorhexidine digluconate mouthwash - Procedure: Periodontal instrumentation **Label:** FMS chlorhexidine mouthwash **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Full-mouth scaling and root planning with manual curettes, 20 ml of placebo mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). **Intervention Names:** - Procedure: Periodontal instrumentation - Drug: Placebo mouthwash **Label:** FMS placebo mouthwash **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Full-mouth scaling and root planning with manual curettes. **Intervention Names:** - Procedure: Periodontal instrumentation **Label:** FMS no mouthwash **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - FMS chlorhexidine mouthwash **Description:** 0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). **Name:** 0.12% chlorhexidine digluconate mouthwash **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - FMS chlorhexidine mouthwash - FMS no mouthwash - FMS placebo mouthwash **Description:** Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each. **Name:** Periodontal instrumentation **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - FMS placebo mouthwash **Description:** placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). **Name:** Placebo mouthwash **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal **Measure:** Efficacy - comparative tongue bacterial counts **Time Frame:** Baseline and 3 months #### Secondary Outcomes **Description:** Differences in mean nitrite levels from saliva samples pre- and post-treatment **Measure:** Safety - comparative nitrite levels in saliva **Time Frame:** Baseline and 3 months **Description:** Changes in the percentage of hypertension episode **Measure:** Safety - Percentage of hypertension episodes **Time Frame:** Baseline and 3 months **Description:** Mean changes of DNA methylation statuses in oral cells **Measure:** Safety - status of DNA methylation in oral cells **Time Frame:** Baseline and 3 months **Description:** Changes in the percentage of deep periodontal pockets **Measure:** Efficacy - Percentage of periodontal pockets **Time Frame:** Baseline and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 12 natural teeth; chronic periodontitis stages II and III; no systemic medication; non smokers; normal blood pressure; no mouthwash regular use; antibiotics \> 3 months prior to study; dental treatment \> 3 months prior to study. Exclusion Criteria: - known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taubate **Country:** Brazil **Facility:** University of Taubate - Nucleus of periodontal research **State:** SP **Zip:** 12020330 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M30405 - Name: Dysbiosis - Relevance: HIGH - As Found: Dysbiosis - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000064806 - Term: Dysbiosis ### Intervention Browse Module - Ancestors - ID: D000000891 - Term: Anti-Infective Agents, Local - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004202 - Term: Disinfectants - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: HIGH - As Found: Digital - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: HIGH - As Found: Hesperidin - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown - ID: M7383 - Name: Disinfectants - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002710 - Term: Chlorhexidine - ID: C000010882 - Term: Chlorhexidine gluconate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01947179 **Acronym:** CAST **Brief Title:** Cognitive Anxiety Sensitivity Treatment for Suicide **Official Title:** Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity #### Organization Study ID Info **ID:** 03969 #### Organization **Class:** OTHER **Full Name:** Florida State University ### Status Module #### Completion Date **Date:** 2013-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-09-26 **Type:** ESTIMATED **Last Update Submit Date:** 2013-09-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-01 **Type:** ACTUAL #### Start Date **Date:** 2011-09 **Status Verified Date:** 2013-09 #### Study First Post Date **Date:** 2013-09-20 **Type:** ESTIMATED **Study First Submit Date:** 2013-09-12 **Study First Submit QC Date:** 2013-09-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** United States Department of Defense #### Lead Sponsor **Class:** OTHER **Name:** Florida State University #### Responsible Party **Investigator Affiliation:** Florida State University **Investigator Full Name:** Norman Schmidt **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder. **Detailed Description:** CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment. ### Conditions Module **Conditions:** - Anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Physical Health Training condition will include information on the importance and benefits of a healthy lifestyle. Additionally, the program will discuss guidelines for a healthy lifestyle including information on diet, water consumption, exercise, and sleep. **Label:** Physical Health Training **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The anxiety risk reduction intervention will include psychoeducation focused on the nature of stress and its effect on the body. Interoceptive exposure exercises that were designed to correct the conditioned fear of bodily sensations will be explained and practiced. **Intervention Names:** - Behavioral: Anxiety Risk Reduction **Label:** Anxiety Risk Reduction **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Anxiety Risk Reduction **Description:** Involves psychoeducation and interoceptive exposure exercises **Name:** Anxiety Risk Reduction **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The PDS is a self-report measure used to assess the severity of posttraumatic stress symptoms during the past month. The measure was designed based on Diagnostic and Statistical Manual-IV criteria. Respondents report if they have experienced any of 12 traumatic events, including an "other" category, and then indicate which event was the most disturbing. Additionally, respondents rate the frequency of 17 PTSD symptoms experienced in the past month in relation to the most disturbing event they endorsed. The PDS has excellent psychometric properties and can be used as a continuous measure of PTSD symptom severity. **Measure:** Posttraumatic Diagnostic Scale (PDS) **Time Frame:** Month one follow-up #### Primary Outcomes **Description:** The ASI is a 16-item self-report measure of anxiety sensitivity. Each item consists of a possible negative consequence of anxiety symptoms. The scale assesses three AS subfactors including cognitive, physical, and social concerns. The measure has shown good psychometric properties. **Measure:** Anxiety Sensitivity Index (ASI) **Time Frame:** Month one follow-up #### Secondary Outcomes **Description:** The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity. **Measure:** Beck Suicide Scale (BSS) **Time Frame:** Month one follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * At or above the community sample mean on the ASI * English speakers * 18 years of age or older Exclusion Criteria: * Significant medical illness * Current substance dependence * Current or past psychotic-spectrum disorders * Uncontrolled bipolar disorder * Serious suicidal intent that warranted immediate medical treatment **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tallahassee **Country:** United States **Facility:** Florida State University **State:** Florida **Zip:** 32304 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000016728 - Term: Self-Injurious Behavior - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M16191 - Name: Suicide - Relevance: HIGH - As Found: Suicide - ID: M2958 - Name: Suicide Prevention - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M19089 - Name: Self-Injurious Behavior - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders - ID: D000013405 - Term: Suicide ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02961179 **Acronym:** PRODIGE **Brief Title:** Dairy Products, Diabetes and Genetics **Official Title:** Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis #### Organization Study ID Info **ID:** 2017-3228 #### Organization **Class:** OTHER **Full Name:** CHU de Quebec-Universite Laval ### Status Module #### Completion Date **Date:** 2018-07-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-03-01 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-07-13 **Type:** ACTUAL #### Start Date **Date:** 2017-01 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2016-11-10 **Type:** ESTIMATED **Study First Submit Date:** 2016-11-03 **Study First Submit QC Date:** 2016-11-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Canadian Institutes of Health Research (CIHR) #### Lead Sponsor **Class:** OTHER **Name:** CHU de Quebec-Universite Laval #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period. **Detailed Description:** More than 9 million Canadians are living with diabetes or prediabetes. Type 2 diabetes is a disorder characterized by high blood glucose. Dietary modification is a key component in type 2 diabetes management. For example, dairy product consumption has beneficial effects on metabolic health. Yet, researchers have shown that mixed results exists for insulin sensitivity. ### Conditions Module **Conditions:** - Insulin Sensitivity - Type2 Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 33 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be asked to consume a total of 3 to 5 servings per day.They will be instructed on options and variations for incorporating the dairy foods into their routine dietary pattern. **Intervention Names:** - Behavioral: Increased dairy product **Label:** Increased dairy product **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian. **Intervention Names:** - Behavioral: Dietary counselling **Label:** Dietary counselling **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Increased dairy product **Name:** Increased dairy product **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Dietary counselling **Name:** Dietary counselling **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** 2h-oral glucose tolerance test (OGTT) **Measure:** Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks #### Secondary Outcomes **Measure:** Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Description:** Insulinogenic index **Measure:** Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Description:** Area under the curve of C-peptide **Measure:** Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Description:** Dual-energy X-ray absorptiometry **Measure:** Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in inflammatory profile (C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks **Measure:** Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases **Time Frame:** Change from 0 to 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Caucasian men and postmenopausal women (absence of menstrual cycles for \>12 months) aged \>18 yrs; * BMI between 25-40 kg/m2; * Hyperinsulinemia (fasting plasma insulin \>90 pmol/l); * Fasting plasma glucose (FPG) \<7.0 mmol/l; HbA1c \<6.5%); * If treated with lipid-lowering agents, the dose must have been stable over the last 3 months; * Stable body weight (±5%) for 3 months; * Willing to consume study foods and able to follow protocol and give informed consent. Exclusion Criteria: * Failure to meet any one or more of the inclusion criteria; * Diagnosis of type 2 diabetes; * High dairy consumption ( 2 servings/day or more); * Major surgery in the 3 months prior to study onset; * Smoking; * Incompatibility with dairy consumption (allergy, intolerance or dislike); * Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption; * Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia; * Diseases known to affect glucose metabolism. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Quebec **Country:** Canada **Facility:** Research Center CHU de Quebec-Université Laval **Zip:** G1V 4G2 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Khorraminezhad L, Rudkowska I. Dairy Product Intake Modifies MicroRNA Expression among Individuals with Hyperinsulinemia: A Post-Intervention Cross-Sectional Study. Lifestyle Genom. 2022;15(3):77-86. doi: 10.1159/000523809. Epub 2022 Feb 25. **PMID:** 35220313 **Citation:** O'Connor S, Julien P, Weisnagel SJ, Gagnon C, Rudkowska I. Impact of a High Intake of Dairy Product on Insulin Sensitivity in Hyperinsulinemic Adults: A Crossover Randomized Controlled Trial. Curr Dev Nutr. 2019 Jul 24;3(8):nzz083. doi: 10.1093/cdn/nzz083. eCollection 2019 Aug. **PMID:** 31453424 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10370 - Name: Insulin Resistance - Relevance: HIGH - As Found: Insulin Sensitivity - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007333 - Term: Insulin Resistance ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01336179 **Brief Title:** Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health **Official Title:** The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial #### Organization Study ID Info **ID:** UTFD201127021 #### Organization **Class:** OTHER **Full Name:** Taibah University ### Status Module #### Completion Date **Date:** 2011-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-06-01 **Type:** ESTIMATED **Last Update Submit Date:** 2011-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-04 **Type:** ACTUAL #### Start Date **Date:** 2011-03 **Status Verified Date:** 2011-04 #### Study First Post Date **Date:** 2011-04-15 **Type:** ESTIMATED **Study First Submit Date:** 2011-04-06 **Study First Submit QC Date:** 2011-04-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taibah University #### Responsible Party **Old Name Title:** Dr Tareq Abu Saleh **Old Organization:** Department of Preventive Dental Sciences, Faculty of Dentistry, Taibah University ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health. **Detailed Description:** Dental plaque removal is essential in maintaining oral health. Methods for oral hygiene vary from country to country and from culture to culture. The use of a wood stick (miswak or chewing stick) for brushing the teeth is considered an important tool for oral hygiene care in many Afro-Asian communities. The aim of the study is to compare the effect of the chewing stick (miswak), and toothbrushing on plaque removal and gingival health. The participants comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University in Saudi Arabia. The study was designed as a single, blind, randomized split-mouth study. Professional tooth cleaning was conducted, and after six weeks use of either the miswak or toothbrush on each quadrant, modified plaque and gingival indices, were recorded. ### Conditions Module **Conditions:** - Plaque Induced Gingivitis **Keywords:** - gingivitis - dental plaque - oral hygiene - toothbrush - chewing sticks ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Salvadora persica **Label:** Miswak, dental plaque and gingivitis **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Toothbrush **Label:** Toothbrush, dental plaque and gingivitis **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Miswak, dental plaque and gingivitis **Description:** twice daily use, two minutes interval **Name:** Salvadora persica **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Toothbrush, dental plaque and gingivitis **Description:** Twice daily use two minutes interval **Name:** Toothbrush **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Miswak will be compared to toothbrush as a mechanical plaque control device, by calculating plaque index and gingival index scores for participants after 6 weeks of use. **Measure:** Miswak is useful for removing plaque and preventing gingivitis **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy individuals * presence of at least 14 teeth Exclusion Criteria: * Subjects on medications (antiinflammatory or antibiotics) **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Almadinah **Country:** Saudi Arabia **Facility:** Faculty of Dentistry Taibah University **Zip:** 04 #### Overall Officials **Official 1:** **Affiliation:** Assistant professor in Periodontics, Taibah University **Name:** Tareq AS Abu Saleh, MSc, MRD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9003 - Name: Gingivitis - Relevance: HIGH - As Found: Gingivitis - ID: M6970 - Name: Dental Plaque - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005891 - Term: Gingivitis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04287179 **Acronym:** SUSTAIN SWITCH **Brief Title:** SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes **Official Title:** Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs #### Organization Study ID Info **ID:** NN9535-4650 #### Organization **Class:** INDUSTRY **Full Name:** Novo Nordisk A/S #### Secondary ID Infos **Domain:** World Health Organization (WHO) **ID:** U1111-1242-5426 **Type:** OTHER **Domain:** European Medicines Agency (EudraCT) **ID:** 2019-004234-42 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2021-01-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-02 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2020-11-16 **Type:** ESTIMATED #### Start Date **Date:** 2020-03-09 **Type:** ACTUAL **Status Verified Date:** 2022-02 #### Study First Post Date **Date:** 2020-02-27 **Type:** ACTUAL **Study First Submit Date:** 2020-02-25 **Study First Submit QC Date:** 2020-02-25 **Why Stopped:** COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novo Nordisk A/S #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg. **Intervention Names:** - Drug: Semaglutide **Label:** Semaglutide 0.50 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg. **Intervention Names:** - Drug: Semaglutide **Label:** Semaglutide 0.25 mg **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Semaglutide 0.25 mg - Semaglutide 0.50 mg **Description:** Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period. **Name:** Semaglutide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percent-point **Measure:** Change in glycosylated haemoglobin (HbA1c) **Time Frame:** From baseline (week 0) to week 12 #### Secondary Outcomes **Description:** mmol/L **Measure:** Change in fasting plasma glucose **Time Frame:** From baseline (week 0) to week 12 **Description:** Kg **Measure:** Change in body weight **Time Frame:** From baseline (week 0) to week 12 **Description:** Count **Measure:** Number of treatment emergent adverse events (TEAEs) **Time Frame:** From baseline (week 0) to week 12 **Description:** Count **Measure:** Number of treatment emergent gastrointestinal adverse events **Time Frame:** From baseline (week 0) to week 12 **Description:** Count **Measure:** Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes **Time Frame:** From baseline (week 0) to week 12 **Description:** Beats per minute (bpm) **Measure:** Change in pulse rate **Time Frame:** From baseline (week 0) to week 12 **Description:** Count **Measure:** Number of treatment emergent adverse events (TEAEs) **Time Frame:** From week 12 to week 17 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female, age 18 years or older at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. * The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator. * HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive). * Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion. Exclusion Criteria: * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. * Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Buena Park **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** California **Zip:** 90620 **Location 2:** **City:** Fresno **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** California **Zip:** 93720 **Location 3:** **City:** San Jose **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** California **Zip:** 95148 **Location 4:** **City:** Walnut Creek **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** California **Zip:** 94598 **Location 5:** **City:** Waterbury **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Connecticut **Zip:** 06708 **Location 6:** **City:** Honolulu **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Hawaii **Zip:** 96814 **Location 7:** **City:** Idaho Falls **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Idaho **Zip:** 83404-7596 **Location 8:** **City:** Indianapolis **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Indiana **Zip:** 46260 **Location 9:** **City:** Troy **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Michigan **Zip:** 48098 **Location 10:** **City:** Albany **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** New York **Zip:** 12206 **Location 11:** **City:** West Seneca **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** New York **Zip:** 14224 **Location 12:** **City:** Dallas **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Texas **Zip:** 75390-9302 **Location 13:** **City:** Round Rock **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Texas **Zip:** 78681 **Location 14:** **City:** Sugar Land **Country:** United States **Facility:** Novo Nordisk Investigational Site **State:** Texas **Zip:** 77478 **Location 15:** **City:** Graz **Country:** Austria **Facility:** Novo Nordisk Investigational Site **Zip:** 8036 **Location 16:** **City:** Stockerau **Country:** Austria **Facility:** Novo Nordisk Investigational Site **Zip:** 2000 **Location 17:** **City:** Wien **Country:** Austria **Facility:** Novo Nordisk Investigational Site **Zip:** 1090 **Location 18:** **City:** Wien **Country:** Austria **Facility:** Novo Nordisk Investigational Site **Zip:** 1130 **Location 19:** **City:** Jyväskylä **Country:** Finland **Facility:** Novo Nordisk Investigational Site **Zip:** 40100 **Location 20:** **City:** Kuopio **Country:** Finland **Facility:** Novo Nordisk Investigational Site **Zip:** 70100 **Location 21:** **City:** Lahti **Country:** Finland **Facility:** Novo Nordisk Investigational Site **Zip:** 15100 **Location 22:** **City:** Raisio **Country:** Finland **Facility:** Novo Nordisk Investigational Site **Zip:** 21200 **Location 23:** **City:** Seinäjoki **Country:** Finland **Facility:** Novo Nordisk Investigational Site **Zip:** 60220 **Location 24:** **City:** Göteborg **Country:** Sweden **Facility:** Novo Nordisk Investigational Site **Zip:** 413 45 **Location 25:** **City:** Malmö **Country:** Sweden **Facility:** Novo Nordisk Investigational Site **Zip:** 205 02 #### Overall Officials **Official 1:** **Affiliation:** Novo Nordisk A/S **Name:** Clinical Reporting Anchor & Disclosure (1452) **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials. com **IPD Sharing:** YES **URL:** http://novonordisk-trials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M353561 - Name: Semaglutide - Relevance: HIGH - As Found: Physical therapy - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M16204 - Name: Sulfamethazine - Relevance: LOW - As Found: Unknown - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000591245 - Term: Semaglutide ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00501579 **Brief Title:** Study of Difluprednate in the Treatment of Uveitis #### Organization Study ID Info **ID:** ST-601A-001 #### Organization **Class:** INDUSTRY **Full Name:** Sirion Therapeutics, Inc. ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2008-08-29 **Type:** ESTIMATED **Last Update Submit Date:** 2008-08-27 **Overall Status:** COMPLETED **Status Verified Date:** 2008-08 #### Study First Post Date **Date:** 2007-07-16 **Type:** ESTIMATED **Study First Submit Date:** 2007-07-13 **Study First Submit QC Date:** 2007-07-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sirion Therapeutics, Inc. #### Responsible Party **Old Name Title:** Chief Medical Officer **Old Organization:** Sirion Therapeutics ### Description Module **Brief Summary:** The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis. ### Conditions Module **Conditions:** - Uveitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Difluprednate **Type:** DRUG #### Intervention 2 **Name:** Prednisolone Acetate **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of endogenous anterior uveitis in at least 1 eye Exclusion Criteria: * Presence of intermediate uveitis, posterior uveitis or panuveitis * Corneal abrasion * Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease * Allergy to similar drugs, such as other corticosteroids **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New Albany **Country:** United States **Facility:** John-Kenyon American Eye Institute **State:** Indiana **Zip:** 47150 #### Overall Officials **Official 1:** **Affiliation:** Sirion Therapeutics **Name:** Roger Vogel, MD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059. **PMID:** 20809807 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014603 - Term: Uveal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17353 - Name: Uveitis - Relevance: HIGH - As Found: Uveitis - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014605 - Term: Uveitis ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000018696 - Term: Neuroprotective Agents - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M14120 - Name: Prednisolone - Relevance: HIGH - As Found: Vein - ID: M11749 - Name: Methylprednisolone - Relevance: HIGH - As Found: Smart phone - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: HIGH - As Found: Smart phone - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: HIGH - As Found: Smart phone - ID: M229449 - Name: Prednisolone acetate - Relevance: HIGH - As Found: Smart phone - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: HIGH - As Found: Smart phone - ID: M248881 - Name: Prednisolone phosphate - Relevance: HIGH - As Found: Smart phone - ID: M289314 - Name: Difluprednate - Relevance: HIGH - As Found: Skilled - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M20773 - Name: Neuroprotective Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011239 - Term: Prednisolone - ID: D000077555 - Term: Methylprednisolone Acetate - ID: D000008775 - Term: Methylprednisolone - ID: D000008776 - Term: Methylprednisolone Hemisuccinate - ID: C000009935 - Term: Prednisolone acetate - ID: C000021322 - Term: Prednisolone hemisuccinate - ID: C000009022 - Term: Prednisolone phosphate - ID: C000015808 - Term: Difluprednate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01637779 **Brief Title:** A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain **Official Title:** A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge #### Organization Study ID Info **ID:** 11-0231-E #### Organization **Class:** OTHER **Full Name:** University of Toronto #### Secondary ID Infos **Domain:** The Hospital for Sick Children **ID:** 1000032989 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2013-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-10-29 **Type:** ESTIMATED **Last Update Submit Date:** 2013-10-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-02 **Type:** ACTUAL #### Start Date **Date:** 2012-07 **Status Verified Date:** 2013-10 #### Study First Post Date **Date:** 2012-07-11 **Type:** ESTIMATED **Study First Submit Date:** 2012-07-08 **Study First Submit QC Date:** 2012-07-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Hospital for Sick Children #### Lead Sponsor **Class:** OTHER **Name:** University of Toronto #### Responsible Party **Investigator Affiliation:** University of Toronto **Investigator Full Name:** Anna Taddio **Investigator Title:** Associate Professor, Leslie Dan Faculty of Pharmacy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods. **Detailed Description:** Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed. ### Conditions Module **Conditions:** - Mothers of Newborn Infants **Keywords:** - randomized controlled trial - parent education - pain management - infant - immunization ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward **Intervention Names:** - Behavioral: Fact sheet **Label:** fact sheet review **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** mothers will review material unrelated to pain management during immunization then complete a knowledge test **Intervention Names:** - Behavioral: Fact sheet **Label:** control unrelated material **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test **Intervention Names:** - Behavioral: Fact sheet **Label:** pre-test, review of fact sheet **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** mothers do a pre-test, then read unrelated material, then repeat the test **Intervention Names:** - Behavioral: Fact sheet **Label:** pre-test, control unrelated information **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - control unrelated material - fact sheet review - pre-test, control unrelated information - pre-test, review of fact sheet **Description:** fact sheet about pain management during immunization **Name:** Fact sheet **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization) **Measure:** knowledge **Time Frame:** 10 minutes after intervention (educational material) #### Secondary Outcomes **Description:** maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations **Measure:** utilization of pain relieving interventions **Time Frame:** 2 months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * new mothers with health full-term infants * 5 minute Apgar 7 or more Exclusion Criteria: * non-english speaking mothers * mothers with psychiatric conditions * infants admitted to intensive care unit **Maximum Age:** 60 Years **Minimum Age:** 15 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** Mount Sinai Hospital **State:** Ontario **Zip:** M5G 1X5 #### Overall Officials **Official 1:** **Affiliation:** University of Toronto **Name:** Anna Taddio, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05229679 **Brief Title:** HPV-based Screening Among Women 23-29 Years of Age **Official Title:** Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women #### Organization Study ID Info **ID:** 2020-00053 #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2038-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-06 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2038-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2020-11-16 **Type:** ACTUAL **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2022-02-08 **Type:** ACTUAL **Study First Submit Date:** 2021-11-30 **Study First Submit QC Date:** 2022-01-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Joakim Dillner **Investigator Title:** Professor of Infectious Disease Epidemiology; Director of R&D **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology. **Detailed Description:** The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology. ### Conditions Module **Conditions:** - Human Papilloma Virus - Cervical Intraepithelial Neoplasia - Cervical Cancer **Keywords:** - Organized screening - HPV vaccination - Human papilloma virus - Prevention ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 180000 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Women 23-29 invited to cervical screening will have their samples analyzed for HPV. **Intervention Names:** - Diagnostic Test: HPV testing **Label:** HPV-based screening **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HPV-based screening **Description:** All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method. **Name:** HPV testing **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 1. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 2. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 3. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 4. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 5. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 6. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 7. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 8. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 9. **Description:** Cervical cancer incidence in the intervention group compared to a historical control group. **Measure:** Incidence of cervical cancer **Time Frame:** Measured once during 1 year, year 10. #### Secondary Outcomes **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 1. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 2. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 3. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 4. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 5. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 6. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 7. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 8. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 9. **Description:** Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. **Measure:** Cost-effectiveness of the new screening method **Time Frame:** Measured once during 1 year, year 10. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women ages 23-29 invited to screening. Exclusion Criteria: * Women who do not show up for screening or do not consent. **Gender Based:** True **Gender Description:** Individuals with a cervix and with a personal ID number indicating that they are a female, are eligible. **Maximum Age:** 29 Years **Minimum Age:** 23 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** joakim.dillner@ki.se **Name:** Joakim Dillner, MD, PhD **Phone:** +46 (0) 72-468 24 60 **Role:** CONTACT **Contact 2:** **Email:** miriam.elfstrom@ki.se **Name:** Miriam Elfström, PhD **Phone:** +46 (0) 70-381 62 77 **Role:** CONTACT #### Locations **Location 1:** **City:** Lund **Country:** Sweden **Facility:** Region of Skåne **State:** Skåne **Status:** ACTIVE_NOT_RECRUITING **Zip:** 221 00 **Location 2:** **City:** Stockholm **Contacts:** ***Contact 1:*** - **Email:** joakim.dillner@ki.se - **Name:** Joakim Dillner, MD, PhD - **Phone:** +46 (0) 72-468 24 60 - **Role:** CONTACT **Country:** Sweden **Facility:** Region Stockholm **Status:** RECRUITING **Zip:** 102 39 #### Overall Officials **Official 1:** **Affiliation:** Karolinska University Hospital/Karolinska Institutet **Name:** Joakim Dillner, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** IPD has been discussed but a plan isn't finalized. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000011230 - Term: Precancerous Conditions ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M13131 - Name: Papilloma - Relevance: HIGH - As Found: Papilloma - ID: M5826 - Name: Uterine Cervical Dysplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown - ID: T1074 - Name: Cervical Intraepithelial Neoplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia ### Condition Browse Module - Meshes - ID: D000010212 - Term: Papilloma - ID: D000002578 - Term: Uterine Cervical Dysplasia ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05611879 **Brief Title:** Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC **Official Title:** Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial #### Organization Study ID Info **ID:** 21416-0-02 #### Organization **Class:** OTHER **Full Name:** Beijing Tsinghua Chang Gung Hospital ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-29 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-02-29 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-12 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2022-11-10 **Type:** ACTUAL **Study First Submit Date:** 2022-11-04 **Study First Submit QC Date:** 2022-11-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tsinghua Chang Gung Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC. ### Conditions Module **Conditions:** - NSCLC, Stage III ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection. **Intervention Names:** - Drug: Tislelizumab - Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) - Drug: Carboplatin **Label:** Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery **Description:** Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles **Name:** Tislelizumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery **Description:** Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. **Name:** Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery **Description:** AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2. **Name:** Carboplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy. **Measure:** Resectability rate **Time Frame:** At time of surgery #### Secondary Outcomes **Description:** MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. **Measure:** Major pathological response rate (MPR) **Time Frame:** At time of surgery **Description:** pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens. **Measure:** Pathology complete response rate(pCR) **Time Frame:** At time of surgery **Description:** R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy. **Measure:** R0 Resection rate **Time Frame:** At time of surgery **Description:** The number of participants experiencing an perioperative G3-4 AE will be assessed. **Measure:** Perioperative G3-4 Adverse Events (AEs) **Time Frame:** Up to 1 month post surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent provided. * Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology. * ECOG score is 0 or 1. * Adequate hematological function, liver function and renal function. Exclusion Criteria: * Previously received systemic anti-tumor therapy for non-small cell lung cancer. * history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment. * History or active pulmonary tuberculosis. * Active infections that require systemic treatment. * History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy. * Untreated active Hepatitis B. * Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). * Grade 3 or above peripheral neuropathy. * Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs. * Underlying severe or uncontrolled disease. * Malignant tumors other than NSCLC within 5 years. * Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Yfa01087@btch.edu.cn **Name:** Fan Yang, Dr. **Phone:** +86-10-56112345 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** Yfa01087@btch.edu.cn - **Name:** Fan Yang, Dr. - **Phone:** +86-10-56112345 - **Role:** CONTACT **Country:** China **Facility:** Beijing Tsinghua Chang Gung Hospital **State:** Beijing **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Beijing Tsinghua Chang Gung Hospital **Name:** Donghong Chen, Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Healthcare - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: General - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000016190 - Term: Carboplatin - ID: D000068437 - Term: Pemetrexed - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02667379 **Brief Title:** Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat **Official Title:** Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat #### Organization Study ID Info **ID:** ZU-HypoCat-001 #### Organization **Class:** OTHER **Full Name:** University of Zurich ### Status Module #### Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-05-09 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Start Date **Date:** 2016-02 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2016-01-28 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-20 **Study First Submit QC Date:** 2016-01-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Zurich #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat ### Conditions Module **Conditions:** - Hypersensitivity **Keywords:** - Cat - allergy - dander - Fel d 1 - Felis domesticus ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 7 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Diagnostic skin testing with cat dander samples on volar forearms. **Intervention Names:** - Other: Diagnostic skin testing **Label:** Diagnostic skin testing **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Diagnostic skin testing **Description:** 14 Skin prick tests on each volar forearm with cat dander samples. **Name:** Diagnostic skin testing **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary variable will be the wheal size area of the immediate phase reaction in mm² measured after 15 minutes. Determination of the concentration threshold at which no more skin reactivity can be observed. **Measure:** Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance **Time Frame:** 15 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Informed Consent as documented by signature (Appendix Informed Consent Form) * Male or female between 18 years to 65 years * Confirmed cat allergy (positive skin prick test) Exclusion Criteria: * Diseases or medications, influencing the skin tests or impairing the correct conduct and evaluation of the study * History of anaphylactic reaction * Pregnancy * Skin irritations in test area * Participation in another clinical trial within the last 30 days and during the present study **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Zurich **Country:** Switzerland **Facility:** University Hospital Zurich, Dept of Dermatology **State:** ZH **Zip:** 8091 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Zurich, Dept Dermatology **Name:** Thomas Kuendig, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006967 - Term: Hypersensitivity ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01867879 **Brief Title:** Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors **Official Title:** A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** TPU-TAS-102-103 #### Organization **Class:** INDUSTRY **Full Name:** Taiho Oncology, Inc. #### Secondary ID Infos **ID:** 2013-000650-21 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2015-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-11-09 **Type:** ESTIMATED **Last Update Submit Date:** 2015-11-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-08 **Type:** ACTUAL #### Start Date **Date:** 2013-06 **Status Verified Date:** 2015-11 #### Study First Post Date **Date:** 2013-06-04 **Type:** ESTIMATED **Study First Submit Date:** 2013-05-24 **Study First Submit QC Date:** 2013-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Taiho Oncology, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. **Detailed Description:** This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles). ### Conditions Module **Conditions:** - Advanced Solid Tumors (Excluding Breast Cancer) **Keywords:** - Advanced solid tumors (excluding breast cancer) for which no standard therapy exists ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 44 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: TAS-102 **Label:** TAS-102 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TAS-102 **Description:** 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. **Name:** TAS-102 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo tablets, orally, single dose. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1) **Measure:** QTc interval **Time Frame:** Days -2, -1, 1, and 12 of Cycle 1 #### Secondary Outcomes **Description:** Predose (Day -2) to postdose changes and absolute values in quantitative Holter ECG parameters (heart rate, RR, PR and QRS intervals) after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1). In addition, qualitative assessments of Holter ECG recordings will be performed. **Measure:** Quantitative and Qualitative ECG parameters **Time Frame:** Days -2, -1, 1, and 12 of Cycle 1 **Description:** Pharmacokinetic samples are taken on Days 1 and 12 of Cycle 1. The relationship between plasma concentrations of TAS-102 and the change from baseline in QTc adjusted by placebo will be quantified using a linear mixed effect model approach. **Measure:** Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization **Time Frame:** Days 1 and 12 of Cycle 1 **Description:** Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used. **Measure:** Safety monitoring including adverse events, vital signs, and laboratory assessments **Time Frame:** Through 30 days following last administration of study medication or until initiation of new anticancer treatment **Measure:** Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) **Time Frame:** Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Has provided written informed consent 2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists 3. Has received no more than 5 prior cancer therapies 4. ECOG performance status of 0 or 1 5. Is able to take medications orally 6. Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG 7. Has adequate organ function (bone marrow, kidney and liver) 8. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control. Exclusion Criteria: 1. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. Certain serious illnesses or medical condition(s) 3. Has a family history of unexplained sudden death or long QT syndrome 4. Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment 5. Is a patient for whom it is not technically possible to obtain quality ECG tracings 6. Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic 7. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 8. Known sensitivity to TAS-102 or its components 9. Is a pregnant or lactating female 10. Refuses to use an adequate means of contraception (including male patients) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nashville **Country:** United States **Facility:** Sarah Cannon Research Institute **State:** Tennessee **Zip:** 37203 #### Overall Officials **Official 1:** **Affiliation:** SCRI Development Innovations, LLC **Name:** Johanna Bendell, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Bendell JC, Patel MR, Yoshida K, Seraj J, Weaver R, Lemech C, Todaro TG, Pant S, Arkenau HT. Phase 1 study of cardiac safety of TAS-102 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Jun;77(6):1275-83. doi: 10.1007/s00280-016-3031-9. Epub 2016 May 5. **PMID:** 27151157 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05893979 **Acronym:** BIRCH **Brief Title:** Myopia Control Spectacle Lens Cessation Study **Official Title:** Myopia Control Spectacle Lens Use Cessation Study #### Organization Study ID Info **ID:** CPRO-2303-001 #### Organization **Class:** INDUSTRY **Full Name:** SightGlass Vision, Inc. ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-22 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-21 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-23 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2023-06-08 **Type:** ACTUAL **Study First Submit Date:** 2023-05-30 **Study First Submit QC Date:** 2023-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** SightGlass Vision, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses. ### Conditions Module **Conditions:** - Myopia - Myopia Progression - Juvenile Myopia ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Spectacle Lenses **Label:** Test Lens Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Spectacle Lenses **Label:** Control Lens Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Lens Group - Test Lens Group **Description:** Standard Spectacle Lenses **Name:** Spectacle Lenses **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Change in cSER **Measure:** Cycloplegic Spherical Equivalent Refraction (cSER) **Time Frame:** 12 months #### Secondary Outcomes **Description:** Change in cSER **Measure:** Cycloplegic Spherical Equivalent Refraction (cSER) **Time Frame:** 6 months **Description:** Change in AL **Measure:** Axial Length (AL) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Previously a successfully completed participant in the CYPRESS Extension study; * Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); * Willingness to participate in the trial for up to 12 months without contact lens wear; * The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. Exclusion Criteria: * Known allergy to proparacaine, tetracaine, or tropicamide. **Healthy Volunteers:** True **Maximum Age:** 16 Years **Minimum Age:** 9 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Whittier **Country:** United States **Facility:** Golden Optometric Group **State:** California **Zip:** 90606 **Location 2:** **City:** Longwood **Country:** United States **Facility:** Omega Vision Center PA **State:** Florida **Zip:** 32779 **Location 3:** **City:** Pittsburg **Country:** United States **Facility:** Kannarr Eye Care **State:** Kansas **Zip:** 66762 **Location 4:** **City:** Raytown **Country:** United States **Facility:** Advanced Eyecare PC **State:** Missouri **Zip:** 64133 **Location 5:** **City:** Vestal **Country:** United States **Facility:** Sacco Eye Group **State:** New York **Zip:** 13850 **Location 6:** **City:** Memphis **Country:** United States **Facility:** Total Eye Care **State:** Tennessee **Zip:** 38119 **Location 7:** **City:** Houston **Country:** United States **Facility:** Vision Optique **State:** Texas **Zip:** 77205 **Location 8:** **City:** Salt Lake City **Country:** United States **Facility:** William J Bogus, OD, FAAO **State:** Utah **Zip:** 84106 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012030 - Term: Refractive Errors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M12168 - Name: Myopia - Relevance: HIGH - As Found: Myopia - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009216 - Term: Myopia ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05201079 **Brief Title:** Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin **Official Title:** A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin. #### Organization Study ID Info **ID:** ICD-01 #### Organization **Class:** INDUSTRY **Full Name:** Mikrobiomik Healthcare Company S.L. #### Secondary ID Infos **ID:** 2020-004591-17 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2023-11-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-12 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-15 **Type:** ACTUAL #### Start Date **Date:** 2021-10-29 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-01-21 **Type:** ACTUAL **Study First Submit Date:** 2021-12-14 **Study First Submit QC Date:** 2022-01-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Mikrobiomik Healthcare Company S.L. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with Fidaxomicin, in 66 patients with primary or r-CDI. **Detailed Description:** This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered an episode of Clostridioides difficile infection (either the first episode or subsequent recurrences) will be randomly assigned (1:1) to one of the following arms: * Dificlir (Fidaxomicina) * MBK-01 (heterologous lyophilized fecal microbiota) Objective: To assess the efficacy of FMT with capsules of lyophilized fecal microbiota (MBK-01), compared to the control (fidaxomicin) at 8 weeks after the start of the treatment. To assess the safety of MBK-01 and the quality of life of patients participating in the study. Follow up: participants will return for clinic visits at 72 hours, week 3 and week 8 after the start of the treatment, and will receive follow-up phone calls at month 3 and month 6 after the start of the treatment. Stool samples will be collected from participants for further studies at time 0 and week 8 after the start of the treatment. Study Outcomes are detailed in the specific section of this website. Rationale: The transferred microbiota restores the recipient's intestinal microbiota by reintroducing bacterial taxa that were absent or in low proportion in the recipient before the FMT, supporting the expansion of the recipient's own commensal microbiota and re-establishing a microbiota community with a high biodiversity. Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01. Justification: The treatment of Clostridioides difficile infections (CDI) with antibiotics is usually effective for acute symptoms, but after the initial treatment, the probability of recurrence at 8 weeks ranges from 10-20 % of cases, and once a patient has a recurrence, the probability of further recurrences increases up to 40-65 %. In recent years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure, with recurrences occurring in up to 30-40% of patients. Furthermore, antibiotic treatment does not correct deficiencies in the intestinal microbiota that facilitate CD infection and is associated with the risk of the emergence of antibiotic-resistant bacteria. Moreover, the treatment of recurrences is not adequately standardized. In recent years, although the most widely used alternatives have been fidaxomicin and bezlotoxumab, their efficacy in patients who already suffer from r-CDI is not proven. The administration of the FMT through oral capsules, although it is not standardized, has proven to be effective in the restoration of intestinal microbiota of patients with r-CDI. In addition, the use of lyophilized formulas facilitates the concentration of bacteria and further optimizes the donors' sample and reduces the amount of capsules that the patient has to ingest. ### Conditions Module **Conditions:** - Recurrent Clostridium Difficile Infection - Primary Clostridium Difficile Infection **Keywords:** - Clostridium difficile - FMT - Fecal Microbiota Transfer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 93 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (33 patients). **Intervention Names:** - Biological: MBK-01 **Label:** MBK-01 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive Fidaxomicin (33 patients). **Intervention Names:** - Drug: Dificlir **Label:** Fidaxomicin **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MBK-01 **Description:** A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. **Name:** MBK-01 **Other Names:** - Fecal microbiota transfer **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Fidaxomicin **Description:** Oral administration of 200mg/12 hours of fidaxomicin for 10 days. **Name:** Dificlir **Other Names:** - Fidaxomicin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. **Measure:** Global Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours) 8 weeks after the start of the treatment **Time Frame:** 8 weeks after the start of the treatment **Description:** Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. **Measure:** Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours) 72 hours after the start of the treatment **Time Frame:** 72 hours after the start of the treatment **Description:** Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. **Measure:** Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours) 3 weeks after the start of the treatment **Time Frame:** 3 weeks after the start of the treatment **Description:** Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. **Measure:** Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours) 3 months after the start of the treatment **Time Frame:** 3 months after the start of the treatment **Description:** Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. **Measure:** Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours) 6 months after the start of the treatment **Time Frame:** 6 months after the start of the treatment #### Secondary Outcomes **Description:** Time, in days, that the patient remains in the hospital as a result of CDI. **Measure:** Duration of hospitalisation **Time Frame:** Up to 8 weeks after the start of the treatment **Description:** A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors: * Increase in C-reactive protein (CRP) value (\> 5 % of the baseline value). * Increase in white blood cell count (\> 5 % of the baseline value). * Progression to sepsis: hypotension or organ failure with no other apparent cause. **Measure:** Good/bad progress of the patient **Time Frame:** Up to 72 hours after the start of the treatment **Description:** Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks. **Measure:** Time to recurrence depending on randomisation groups **Time Frame:** Up to 6 months after the start of the treatment **Description:** Duration in days of the treatment. **Measure:** Duration of treatment **Time Frame:** Up to 10 days **Description:** Percentage of patients that are still alive after a defined period of time from the beginning of the treatment. **Measure:** Overall survival **Time Frame:** Up to 6 months after the start of the treatment **Description:** Number of Adverse Events per randomisation group since baseline. **Measure:** Number of Adverse Events per randomisation group **Time Frame:** Up to 6 months after the start of the treatment **Description:** Type of Adverse Events per ramdomisation group since baseline. **Measure:** Type of Adverse Events per ramdomisation group **Time Frame:** Up to 6 months after the start of the treatment **Description:** Number of Serious Adverse Events per ramdomisation group since baseline. **Measure:** Number of Serious Adverse Events per ramdomisation group **Time Frame:** Up to 6 months after the start of the treatment **Description:** Type of Serious Adverse Events per ramdomisation group since baseline. **Measure:** Type of Serious Adverse Events per ramdomisation group **Time Frame:** Up to 6 months after the start of the treatment **Description:** Adverse Events related to the treatment since baseline. **Measure:** Adverse Events related to the treatment **Time Frame:** Up to 6 months after the start of the treatment **Description:** Adverse Event Seriousness since baseline. **Measure:** Adverse Event Seriousness **Time Frame:** Up to 6 months after the start of the treatment **Description:** Adverse Events related to the CDI since baseline. **Measure:** Adverse Events related to the CDI **Time Frame:** Up to 6 months after the start of the treatment **Description:** Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment. **Measure:** Mortality associated with CDI **Time Frame:** Up to 6 months after the start of the treatment **Description:** Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment. **Measure:** Intensive Care Unit admissions (ICU) **Time Frame:** Up to 6 months after the start of the treatment **Description:** Adverse Events of special interest since baseline. **Measure:** Adverse Events of special interest **Time Frame:** Up to 6 months after the start of the treatment **Description:** For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status). **Measure:** SF36 questionnaire (The Short Form-36 Health Survey) to evaluate the quality of life **Time Frame:** Day 0, 8 weeks and 6 months after the start of the treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients of both genders, over 18 years. 2. Patients that undergo an episode of CD infection (either the first episode or subsequent recurrences). 3. Presence of an episode of diarrhea defined as ≥3 stools/24 hours, at the beginning of the episode. 4. Confirmation of the presence of CD toxin A and/or B in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin/s producing genes, at the start of the episode that is going to be treated in the clinical trial (the toxin test must be positive within 7 days prior to the enrolment of the patient in the trial). Exclusion Criteria: 1. Previous faecal microbiota transfer. 2. Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function. 3. Absolute neutrophil count \<500 cells /μL at the time of the enrollment in the study. 4. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study. 5. Active treatment with bile acid sequestrants (for instance: cholestyramine). 6. Positive patients for the human immunodeficiency virus (HIV) except those with lymphocytes T CD4 count \> 200 cells/μL and viral load less than 20 copies. 7. Swallowing dysfunction or no oral motor coordination. 8. Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness. 9. History of significant medical conditions that, in the opinion of the investigator, would not allow an adequate evaluation or follow-up of the patient. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Santander **Country:** Spain **Facility:** Hospital Universitario Marqués de Valdecilla **State:** Cantabria **Zip:** 39008 **Location 2:** **City:** Alicante **Country:** Spain **Facility:** Hospital General Universitario de Alicante **Zip:** 03010 **Location 3:** **City:** Barakaldo **Country:** Spain **Facility:** Hospital Universitario de Cruces **Zip:** 48903 **Location 4:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Quirónsalud Barcelona **Zip:** 08023 **Location 5:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Clínic de Barcelona **Zip:** 08036 **Location 6:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Universitario de Bellvitge **Zip:** 08907 **Location 7:** **City:** Bilbao **Country:** Spain **Facility:** Hospital Universitario de Basurto **Zip:** 48013 **Location 8:** **City:** Córdoba **Country:** Spain **Facility:** Hospital Universitario Reina Sofía **Zip:** 14004 **Location 9:** **City:** Donostia **Country:** Spain **Facility:** Hospital Universitario de Donostia **Zip:** 20014 **Location 10:** **City:** Girona **Country:** Spain **Facility:** Hospital Josep Trueta de Gerona **Zip:** 17007 **Location 11:** **City:** Logroño **Country:** Spain **Facility:** Hospital San Pedro **Zip:** 26006 **Location 12:** **City:** Madrid **Country:** Spain **Facility:** Hospital General Universitario Gregorio Marañón **Zip:** 28007 **Location 13:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Ramón y Cajal **Zip:** 28034 **Location 14:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario 12 de Octubre **Zip:** 28041 **Location 15:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario La Paz **Zip:** 28046 **Location 16:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Puerta de Hierro **Zip:** 28222 **Location 17:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Quirónsalud Madrid **Zip:** 28223 **Location 18:** **City:** Palma De Mallorca **Country:** Spain **Facility:** Hospital Universitario Son Espases **Zip:** 07120 **Location 19:** **City:** Valencia **Country:** Spain **Facility:** Hospital Universitario y Politécnico La Fe **Zip:** 46026 **Location 20:** **City:** Vitoria-Gasteiz **Country:** Spain **Facility:** Hospital Universitario de Araba **Zip:** 01009 **Location 21:** **City:** Zaragoza **Country:** Spain **Facility:** Hospital Clínico Universitario Lozano Blesa **Zip:** 50009 #### Overall Officials **Official 1:** **Affiliation:** Hospital Universitario Ramon y Cajal **Name:** Javier Cobo, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Reigadas E, Bouza E, Olmedo M, Vazquez-Cuesta S, Villar-Gomara L, Alcala L, Marin M, Rodriguez-Fernandez S, Valerio M, Munoz P. Faecal microbiota transplantation for recurrent Clostridioides difficile infection: experience with lyophilized oral capsules. J Hosp Infect. 2020 Jun;105(2):319-324. doi: 10.1016/j.jhin.2019.12.022. Epub 2019 Dec 26. **PMID:** 31883938 **Citation:** Reigadas E, Olmedo M, Valerio M, Vazquez-Cuesta S, Alcala L, Marin M, Munoz P, Bouza E. Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. Rev Esp Quimioter. 2018 Oct;31(5):411-418. Epub 2018 Sep 14. **PMID:** 30221898 #### See Also Links **Label:** EU Clinical Trials Register **URL:** https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004591-17/ES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M6247 - Name: Clostridium Infections - Relevance: HIGH - As Found: Clostridium Difficile Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000003015 - Term: Clostridium Infections - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1890 - Name: Fidaxomicin - Relevance: HIGH - As Found: Aneurysm Repair - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077732 - Term: Fidaxomicin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04029779 **Acronym:** PRF **Brief Title:** Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites **Official Title:** Evaluation of Immediately Placed Dental Implants With Local Application of Injectable-Platelet Rich Fibrin in Periodontally Compromised Sites. A Randomized Controlled Split Mouth Study #### Organization Study ID Info **ID:** 02_D012_81520 #### Organization **Class:** OTHER **Full Name:** Krishnadevaraya College of Dental Sciences & Hospital ### Status Module #### Completion Date **Date:** 2019-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-12 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-11-30 **Type:** ACTUAL #### Start Date **Date:** 2017-11-11 **Type:** ACTUAL **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2019-07-23 **Type:** ACTUAL **Study First Submit Date:** 2019-07-19 **Study First Submit QC Date:** 2019-07-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Krishnadevaraya College of Dental Sciences & Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to explore the efficacy of injectable PRF around dental implants. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. **Detailed Description:** Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants. The injectable -PRF was coated on implants as well as injected in the socket in both the maxillary and mandibular anterior region. The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively. ### Conditions Module **Conditions:** - Bone Density - Bone Loss, Alveolar **Keywords:** - Injectable platelet rich fibrin - Bone density - Crestal bone loss - Immediate implants ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Two groups were made one test and control. All the subjects were treated with immediate implants. In the test group subjects, injectable platelet-rich fibrin was coated around dental implants and was also injected in the socket. The control group received only dental implants. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The test group received implants coated with injectable platelet-rich fibrin and also the sockets were injected with injectable- platelet rich fibrin **Intervention Names:** - Biological: I-PRF **Label:** Immediate implant placement coated with I-PRF **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group received immediate dental implants only after extraction of the teeth without any local coating. **Label:** immediate implant only **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Immediate implant placement coated with I-PRF **Description:** Local anaesthesia was administered and mucoperiosteal flap was reflected. Atraumatic tooth extraction was performed. Socket was curetted to remove the granulation tissue present in the socket with the help of curettes. The socket was well irrigated with saline. Implant osteotomies wasl performed with sequential drilling with standardized drills.I-PRF was freshly prepared 600rpm for 7 min(50g). 1ml of the i-PRF was applied in to the osteotomy site and the implant surface will be thoroughly coated followed by placing of the implant. The surgical site was thoroughly irrigated and debrided. Flap closure was achieved using 3-0 silk sutures to protect the implant site. **Name:** I-PRF **Other Names:** - injectable platelet rich fibrin coated to dental implants. **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Measured using CBCT scan both on mesial and distal sides .The coronal surface of the implant will be taken as reference line from where two perpendicular lines are dropped on both mesial and distal aspect of implants to first bone to implant contact. **Measure:** Crestal bone level **Time Frame:** 6 months **Description:** measured using CBCT scan using Hounsfield units at mid point of the implant both on mesial and distal side with coronal portion of implant as reference line. **Measure:** Bone density **Time Frame:** 6 months #### Secondary Outcomes **Description:** A periodontal probe passed along the buccal margin at 60 degrees angulation in gingival sulcus. The resultant bleeding is recorded as present (+) or absent (-). **Measure:** Angular bleeding index **Time Frame:** 6 months **Description:** measured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA). **Measure:** Peri-implant Probing pocket depth **Time Frame:** 6 months **Description:** Digital photographs will be used for evaluation of the pink esthetic score(PES). Charts containing the seven variables will be designed. These include: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour and texture. Each variable will be recorded with a 2-1-0 score, where 2 is the best and 0 is the poorest score. **Measure:** Pink esthetic score **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Cooperative patients willing to participate in the study 2. At least two maxillary or mandibular anterior teeth indicated for extraction due to chronic periodontitis (chronic or aggressive) 3. Patients above 18 years of age 4. Patients with esthetic concerns 5. Patients with good oral hygiene maintenance 6. Adequate bone height apical to alveolus of the failing teeth (more than or equal to 5mm) to accommodate an implant - Exclusion Criteria: 1. Persistent \& unresolved infection at implant site 2. Teeth with close proximity to anatomical structure and adjacent roots 3. Patients on radiotherapy 4. Patients with systemic disorders 5. Patients with parafunctional habits 6. Patients with history of alcohol, drug dependency and smoking **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bangalore **Country:** India **Facility:** Krishnadevaraya college of dental sciences **State:** Karnataka **Zip:** 562157 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001862 - Term: Bone Resorption - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000055093 - Term: Periodontal Atrophy - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M18747 - Name: Alveolar Bone Loss - Relevance: HIGH - As Found: Bone Loss, Alveolar - ID: M5141 - Name: Bone Resorption - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016301 - Term: Alveolar Bone Loss ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02097979 **Brief Title:** The Impact of a Brief Educational Intervention on Glaucoma Adherence **Official Title:** The Impact of a Brief Educational Intervention on Glaucoma Adherence #### Organization Study ID Info **ID:** Pfizer Canada NRA6110029 #### Organization **Class:** OTHER **Full Name:** Maisonneuve-Rosemont Hospital ### Status Module #### Completion Date **Date:** 2013-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-03-27 **Type:** ESTIMATED **Last Update Submit Date:** 2014-03-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-06 **Type:** ACTUAL #### Start Date **Date:** 2007-07 **Status Verified Date:** 2014-03 #### Study First Post Date **Date:** 2014-03-27 **Type:** ESTIMATED **Study First Submit Date:** 2014-03-13 **Study First Submit QC Date:** 2014-03-24 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pfizer #### Lead Sponsor **Class:** OTHER **Name:** Maisonneuve-Rosemont Hospital #### Responsible Party **Investigator Affiliation:** Maisonneuve-Rosemont Hospital **Investigator Full Name:** Ellen Freeman **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** OBJECTIVE Our objective was to determine whether two group educational sessions plus one-on-one eye drop instillation training would improve adherence to glaucoma therapy as measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was that adherence would be improved in the intervention group and that patients would better understand their disease and how to manage it. METHODS Study Design and Population: A randomized controlled clinical trial was conducted in newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half of the participants were randomized to receive the intervention and half were randomized to receive a delayed intervention at the conclusion of the study. Inclusion criteria included a diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the Quebec Health Insurance Program) throughout the course of the study. There were three sources of data for this study: a questionnaire, the medical record, and RAMQ prescription drug claims data. Follow-up was for one year. Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached eligible patients to determine their interest in participating in the study. Interested participants signed the informed consent form and were randomized. Participants in the intervention group were given an appointment to come back to the Hospital for the group intervention. Participants in the control group were given an appointment to receive the group intervention at the end of the study. Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each patient received one-on-one teaching on how to properly instill drops without touching the eye or using unnecessary drops. Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the end of the study to all participants. The intervention group completed the questionnaire after the intervention while the control group completed the questionnaire before the intervention. Questions were included on demographics, systemic comorbidities, ocular medications, eye drop practices and difficulties, and glaucoma knowledge. The instructor rated the ability of the participant to put eye drops in the eye taking into account the number of drops that were used and whether contact with the lid or conjunctiva occurred (good, fair, bad). We created a composite score on the perception of the importance of glaucoma eye drop therapy using the following four questions: 1) do you think glaucoma is a serious disease, 2) do you believe that your treatment will be effective, 3) do you think your drops can lower the pressure in your eyes, 4) do you think your drops can help to preserve vision. Answers of no or do not know were given 0 points and answers of yes were given 1 point. Scores were summed and the composite score ranged from 0 to 4. Medical Chart Review: At the end of the follow-up period, information was obtained on: the prescribed eye drop therapy for each patient per eye, whether the patient had undergone glaucoma filtering surgery, whether the patient had died or was no longer being followed, the most recent visual field mean deviation in the better eye using the Humphrey Visual Field Analyzer 24-2 SITA Standard Program. Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by the number of days in which a prescription was required. Each person gave consent to contact the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on the date of purchase, and the name, dose, and class of the medicine. Data on the number of days of medication available per bottle were taken from the Rylander and Friedman studies with the minimum value used. For the numerator of the MPR, we calculated how many days of medication were available using RAMQ data. For the denominator of the MPR, we calculated the number of days that medication was prescribed in the medical chart. We took into account whether drops were needed for one or two eyes. If a participant was on multiple medications, we calculated a single mean MPR for all medications. We then dichotomized the MPR so that those having medication less than 75% of the days were defined as non-adherent, as we did previously in Djafari et al. SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily eye drops despite not noticing any benefit to their vision and despite frequent side effects. Low cost interventions that help to improve adherence are needed. ### Conditions Module **Conditions:** - Glaucoma Medication Adherence **Keywords:** - glaucoma - adherence - medication possession ratio - intervention ### Design Module **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Glaucoma Educational Intervention **Label:** Glaucoma Educational Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Delayed Intervention **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Glaucoma Educational Intervention **Name:** Glaucoma Educational Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Medication Possession Ratio **Time Frame:** 1-year post enrollment #### Secondary Outcomes **Description:** Eye drop instillation technique was measured by direct observation. This was done in the experimental group immediately after the educational session and in the control group immediately before the educational session. **Measure:** Eye drop instillation technique **Time Frame:** At beginning or end of educational session **Description:** Perception of the importance of glaucoma eye drop therapy was measured by questionnaire. In the experimental group this was done immediately after the educational session and in the control group this was done just before the educational session. **Measure:** Perception of the importance of glaucoma eye drop therapy **Time Frame:** At beginning or end of educational session ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion criteria included a diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and prescription drug insurance through the Régie de l'Assurance Maladie du Québec (the Quebec Health Insurance Program) throughout the course of the study. - Exclusion Criteria: - **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Montreal **Country:** Canada **Facility:** Maisonneuve-Rosemont Hospital **State:** Quebec **Zip:** H1T2M4 ### References Module #### References **Citation:** Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421. **PMID:** 19295380 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05585879 **Brief Title:** Demonstrating Effective Salvage of Inadequate Colonoscopies **Official Title:** Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System #### Organization Study ID Info **ID:** CL00052 #### Organization **Class:** INDUSTRY **Full Name:** Motus GI Medical Technologies Ltd ### Status Module #### Completion Date **Date:** 2024-04-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-13 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2024-04-26 **Type:** ACTUAL #### Start Date **Date:** 2022-11-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2022-10-19 **Type:** ACTUAL **Study First Submit Date:** 2022-09-23 **Study First Submit QC Date:** 2022-10-14 **Why Stopped:** Strategy changed ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Motus GI Medical Technologies Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs. **Detailed Description:** The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF). ### Conditions Module **Conditions:** - Colorectal Screening ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal. **Intervention Names:** - Device: Pure-Vu EVS **Label:** Pure-Vu EVS **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Pure-Vu EVS **Description:** Subjects will be enrolled until 115 inadequate bowel prep cases via SOC are accrued and subsequently treated with Pure-Vu EVS. Inadequate OCs defined as such if any of the following are met: * Boston Bowel Preparation Score (BBPS) \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps **Name:** Pure-Vu EVS **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure. **Measure:** User Satisfaction **Time Frame:** Day 0(Procedure Day) **Description:** Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%) **Measure:** Comparison Rates **Time Frame:** Day 0 (Procedure Day) - 1-14 day follow up **Description:** Economic Impact: Impact will be calculated by utilizing both data generated as part of the study and data published on the costs associated with outpatient colonoscopies and subsequent findings. **Measure:** Economic Impact **Time Frame:** Through study completion, an average of 1 year. #### Primary Outcomes **Description:** Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal. **Measure:** Rate of incomplete colonoscopies **Time Frame:** Day 0 (Procedure Day) #### Secondary Outcomes **Description:** The following secondary endpoint will be assessed: Number of polyps and adenomas: type, location, size, pathology and morphology **Measure:** Assessment of Screening **Time Frame:** Day 0 (Procedure Day) **Description:** Boston Bowel Prep Score (BBPS) before and after Pure-Vu EVS use. Throughout the procedure, the study endoscopist will be requested to document the pre-cleansing BBPS and post- cleansing BBPS for each colon segment. **Measure:** Assessment of Screening **Time Frame:** Day 0 (Procedure Day) **Description:** Sedation type The type of sedation will not be dictated by the study but will be documented. **Measure:** Procedural Outcome **Time Frame:** Day 0 (Procedure Day) **Description:** Cecum Intubation Rate **Measure:** Procedural Outcome **Time Frame:** Day 0 (Procedure Day) **Description:** Polyp Miss Rate (PMR) **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Adenoma Detection Rate (ADR) **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Adenoma Miss Rate (AMR) **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Adenoma Per Colonoscopy (APC) **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Adenomas Per Positive Patient (APP) **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Sessile Serrated Adenoma Detection Rate **Measure:** Assessment screening **Time Frame:** Day 0 (Procedure Day) **Description:** Polyp Detection Rate (PDR) **Measure:** Assessment Screening **Time Frame:** Day 0 (Procedure Day) **Description:** Procedure Time: Time to cecum and withdrawal time **Measure:** Procedural Outcomes **Time Frame:** Day 0 (Procedure Day) **Description:** Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented. **Measure:** Procedural Outcomes **Time Frame:** Day 0 (Procedure Day) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Eligible adults aged between 40-80 2. Elective outpatient colonoscopy by participating gastroenterologist Exclusion Criteria: 1. Not competent to consent 2. Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease 3. History of colonic resection 4. Prior incomplete colonoscopy due to patient anatomy 5. Diverticulitis 6. Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate) 7. Known or suspected colon stricture 8. Hereditary Colorectal Cancer Syndrome 9. Subject is pregnant or suspected pregnant **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** NYU **State:** New York **Zip:** 02241 #### Overall Officials **Official 1:** **Affiliation:** Motus GI Medical Technologies Ltd **Name:** Mark Pomeranz **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** clinicaltrials.gov **Description:** Information regarding the study and study data will be made available via publication on clinicaltrials.gov. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Upon completion of the study. **URL:** http://www.clinicaltrials.gov ### References Module #### See Also Links **Label:** More information about Pure-VU® EVS **URL:** https://www.motusgi.com/physicians-nurses/pure-vu-system/ ## Document Section ### Large Document Module #### Large Docs - Date: 2022-10-31 - Filename: Prot_001.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 972494 - Type Abbrev: Prot - Upload Date: 2022-11-15T15:50 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03131479 **Brief Title:** Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function. **Official Title:** An Open-label, Parallel-group Study to Assess the Effect of LIK066 on Urinary Glucose Excretion, Pharmacokinetics, Safety and Tolerability Following Multiple Dose Administration in Patients With Decreased Renal Function Compared to Subjects With Normal Renal Function #### Organization Study ID Info **ID:** CLIK066B2202 #### Organization **Class:** INDUSTRY **Full Name:** Novartis #### Secondary ID Infos **ID:** 2016-004770-18 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2018-01-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-01-05 **Type:** ACTUAL **Last Update Submit Date:** 2020-12-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-01-16 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-02-06 **Type:** ACTUAL **Results First Submit Date:** 2019-01-11 **Results First Submit QC Date:** 2019-01-11 #### Start Date **Date:** 2017-04-28 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2017-04-27 **Type:** ACTUAL **Study First Submit Date:** 2017-04-17 **Study First Submit QC Date:** 2017-04-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen. ### Conditions Module **Conditions:** - Renal Impairment **Keywords:** - renal function - sodium-glucose co-transporter - pharmacokinetics - decreased renal function - decreased kidney function - kidney disease - urinary glucose excretion - UGE ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 53 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **Intervention Names:** - Drug: LIK066 **Label:** Mild **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **Intervention Names:** - Drug: LIK066 **Label:** Moderate A **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **Intervention Names:** - Drug: LIK066 **Label:** Moderate B **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **Intervention Names:** - Drug: LIK066 **Label:** Severe **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **Intervention Names:** - Drug: LIK066 **Label:** Normal **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mild - Moderate A - Moderate B - Normal - Severe **Description:** LIK066 50 mg tablets taken orally once daily before breakfast for 7 days. **Name:** LIK066 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. **Measure:** Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7 **Time Frame:** Baseline , Day 7 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Measure:** Maximum Observed Plasma Concentration (Cmax) for LIK066 **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Measure:** Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066 **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066 **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done. **Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7 **Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done. **Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1 **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done. **Measure:** Terminal Elimination Half-life (T1/2) for LIK066 on Day 7 **Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done. **Measure:** Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1 **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Measure:** Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1 **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Description:** Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Measure:** Renal Clearance From Plasma (CLr) for LIK066 **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening. * patients with Type 2 diabetes, HbA1c \<10% at screening. * Body mass index (BMI) ≤ 50 kg/m\^2 at screening. Exclusion Criteria: * Patients with Type 1 diabetes * Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase \>3 X ULN; serum bilirubin \> 1.5 X ULN. * Patients undergoing any method of dialysis * clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption. * subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit. **Maximum Age:** 78 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Orlando **Country:** United States **Facility:** Novartis Investigative Site **State:** Florida **Zip:** 32809 #### Overall Officials **Official 1:** **Affiliation:** Novartis Pharmaceuticals **Name:** Novartis Pharmaceuticals **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com **IPD Sharing:** YES **URL:** https://www.clinicalstudydatarequest.com ### References Module #### See Also Links **Label:** A Plain Language Trial Summary is available on novartisclinicatrials.com **URL:** https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=371 ## Document Section ### Large Document Module #### Large Docs - Date: 2017-01-11 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 494778 - Type Abbrev: Prot - Upload Date: 2019-01-11T04:15 - Date: 2018-02-15 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 302705 - Type Abbrev: SAP - Upload Date: 2019-01-11T04:15 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Renal Impairment - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000051437 - Term: Renal Insufficiency ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M342197 - Name: Licogliflozin - Relevance: HIGH - As Found: Extrusion - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000709456 - Term: Licogliflozin ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Normal **Deaths Num At Risk:** 10 **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** EG000 **Other Num Affected:** 9 **Other Num at Risk:** 10 **Serious Number At Risk:** 10 **Title:** Normal **Group ID:** EG001 **Title:** Mild **Deaths Num At Risk:** 10 **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** EG001 **Other Num Affected:** 10 **Other Num at Risk:** 10 **Serious Number At Risk:** 10 **Title:** Mild **Group ID:** EG002 **Title:** Moderate A **Deaths Num At Risk:** 10 **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** EG002 **Other Num Affected:** 10 **Other Num at Risk:** 10 **Serious Number At Risk:** 10 **Title:** Moderate A **Group ID:** EG003 **Title:** Moderate B **Deaths Num At Risk:** 11 **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** EG003 **Other Num Affected:** 11 **Other Num at Risk:** 11 **Serious Number Affected:** 1 **Serious Number At Risk:** 11 **Title:** Moderate B **Group ID:** EG004 **Title:** Severe **Deaths Num At Risk:** 12 **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** EG004 **Other Num Affected:** 11 **Other Num at Risk:** 12 **Serious Number Affected:** 1 **Serious Number At Risk:** 12 **Title:** Severe **Frequency Threshold:** 1 #### Other Events **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Flatulence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Hypoglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Metabolic acidosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Muscle spasms **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Tremor **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (20.0) **Term:** Vaginal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA (20.0) #### Serious Events **Term:** Acute left ventricular failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (20.0) ##### Stats **Group ID:** EG000 **Num At Risk:** 10 **Group ID:** EG001 **Num At Risk:** 10 **Group ID:** EG002 **Num At Risk:** 10 **Group ID:** EG003 **Num At Risk:** 11 **Group ID:** EG004 **Num Affected:** 1 **Num At Risk:** 12 **Term:** Acute myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (20.0) ##### Stats **Group ID:** EG000 **Num At Risk:** 10 **Group ID:** EG001 **Num At Risk:** 10 **Group ID:** EG002 **Num At Risk:** 10 **Group ID:** EG003 **Num Affected:** 1 **Num At Risk:** 11 **Group ID:** EG004 **Num At Risk:** 12 **Time Frame:** Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 10 **Group ID:** BG001 **Value:** 10 **Group ID:** BG002 **Value:** 11 **Group ID:** BG003 **Value:** 12 **Group ID:** BG004 **Value:** 10 **Group ID:** BG005 **Value:** 53 **Units:** Participants ### Group **ID:** BG000 **Title:** Mild **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. ### Group **ID:** BG001 **Title:** Moderate A **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. ### Group **ID:** BG002 **Title:** Moderate B **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. ### Group **ID:** BG003 **Title:** Severe **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. ### Group **ID:** BG004 **Title:** Normal **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. ### Group **ID:** BG005 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.03 **Value:** 65.4 #### Measurement **Group ID:** BG001 **Spread:** 8.10 **Value:** 66.3 #### Measurement **Group ID:** BG002 **Spread:** 9.10 **Value:** 65.8 #### Measurement **Group ID:** BG003 **Spread:** 12.66 **Value:** 63.3 #### Measurement **Group ID:** BG004 **Spread:** 8.17 **Value:** 59.3 #### Measurement **Group ID:** BG005 **Spread:** 9.66 **Value:** 64.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 8 #### Measurement **Group ID:** BG003 **Value:** 3 #### Measurement **Group ID:** BG004 **Value:** 6 #### Measurement **Group ID:** BG005 **Value:** 28 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 3 #### Measurement **Group ID:** BG003 **Value:** 9 #### Measurement **Group ID:** BG004 **Value:** 4 #### Measurement **Group ID:** BG005 **Value:** 25 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 1 #### Measurement **Group ID:** BG005 **Value:** 1 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 3 #### Measurement **Group ID:** BG003 **Value:** 3 #### Measurement **Group ID:** BG004 **Value:** 4 #### Measurement **Group ID:** BG005 **Value:** 14 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 8 #### Measurement **Group ID:** BG003 **Value:** 9 #### Measurement **Group ID:** BG004 **Value:** 5 #### Measurement **Group ID:** BG005 **Value:** 38 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 #### Measurement **Group ID:** BG004 **Value:** 0 #### Measurement **Group ID:** BG005 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.96 **Value:** 4.7 #### Measurement **Group ID:** BG001 **Spread:** 6.27 **Value:** 2.9 #### Measurement **Group ID:** BG002 **Spread:** 0.12 **Value:** 0.1 #### Measurement **Group ID:** BG003 **Spread:** 0.77 **Value:** 0.3 #### Measurement **Group ID:** BG004 **Spread:** 0.07 **Value:** 0.1 #### Measurement **Group ID:** BG005 **Spread:** 5.25 **Value:** 1.5 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** 24-hour Urinary glucose excretion (UGE) **Unit of Measure:** gram (g) ## Results Section - More Information Module ### Certain Agreement **Other Details:** The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** Novartis.email@novartis.com **Organization:** Novartis Pharmaceuticals **Phone:** 862-778-8300 **Title:** Study Director ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -19.88 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** 1.45 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates. **Non-Inferiority Type:** EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.154 **P-Value Comment:** **Parameter Type:** adjusted arithmetic mean difference **Parameter Value:** -9.21 **Statistical Comment:** An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1. **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -16.65 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** 4.55 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates. **Non-Inferiority Type:** EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.343 **P-Value Comment:** **Parameter Type:** adjusted arithmetic mean difference **Parameter Value:** -6.05 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -31.79 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** 4.55 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates. **Non-Inferiority Type:** EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.001 **P-Value Comment:** **Parameter Type:** adjusted arithmetic mean difference **Parameter Value:** -21.5 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -46.00 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** -25.11 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates. **Non-Inferiority Type:** EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.000 **P-Value Comment:** **Parameter Type:** adjusted arithmetic mean difference **Parameter Value:** -35.6 **Statistical Comment:** **Statistical Method:** Regression, Logistic **Tested Non-Inferiority:** ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.93 - **Upper Limit:** - **Value:** 40.45 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13.79 - **Upper Limit:** - **Value:** 31.87 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 19.51 - **Upper Limit:** - **Value:** 36.27 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 18.66 - **Upper Limit:** - **Value:** 19.88 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 3.75 - **Upper Limit:** - **Value:** 5.50 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 176 - **Upper Limit:** - **Value:** 565 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 176 - **Upper Limit:** - **Value:** 590 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 142 - **Upper Limit:** - **Value:** 492 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 147 - **Upper Limit:** - **Value:** 569 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 199 - **Upper Limit:** - **Value:** 650 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 11 - **Group ID:** OG004 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 250 - **Upper Limit:** - **Value:** 650 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 219 - **Upper Limit:** - **Value:** 678 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 243 - **Upper Limit:** - **Value:** 686 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 301 - **Upper Limit:** - **Value:** 743 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 268 - **Upper Limit:** - **Value:** 800 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 10 - **Group ID:** OG004 - **Value:** 10 **Units:** Participants #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 4.03 - **Value:** 1.00 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 4.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 1.00 - **Spread:** - **Upper Limit:** 8.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 3.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 4.00 - **Value:** 1.00 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 11 - **Group ID:** OG004 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 3.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 4.00 - **Value:** 1.03 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 6.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 2.00 - **Value:** 1.00 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** 0.500 - **Spread:** - **Upper Limit:** 2.00 - **Value:** 1.00 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 10 - **Group ID:** OG004 - **Value:** 10 **Units:** Participants #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 650 - **Upper Limit:** - **Value:** 2830 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 563 - **Upper Limit:** - **Value:** 3330 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 567 - **Upper Limit:** - **Value:** 3120 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 886 - **Upper Limit:** - **Value:** 3360 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 1040 - **Upper Limit:** - **Value:** 4150 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 9 - **Group ID:** OG003 - **Value:** 11 - **Group ID:** OG004 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 790 - **Upper Limit:** - **Value:** 3440 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 981 - **Upper Limit:** - **Value:** 4170 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 1040 - **Upper Limit:** - **Value:** 4080 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 1240 - **Upper Limit:** - **Value:** 4510 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 2280 - **Upper Limit:** - **Value:** 6290 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 10 - **Group ID:** OG004 - **Value:** 10 **Units:** Participants #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1090 - **Upper Limit:** - **Value:** 4190 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1540 - **Upper Limit:** - **Value:** 5280 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 1740 - **Upper Limit:** - **Value:** 5440 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 2160 - **Upper Limit:** - **Value:** 6410 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 3910 - **Upper Limit:** - **Value:** 9620 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 688 - **Upper Limit:** - **Value:** 310 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 649 - **Upper Limit:** - **Value:** 3610 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 551 - **Upper Limit:** - **Value:** 3440 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 1000 - **Upper Limit:** - **Value:** 3520 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 1480 - **Upper Limit:** - **Value:** 4450 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 20.3 - **Upper Limit:** - **Value:** 22.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 10.8 - **Upper Limit:** - **Value:** 21.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 9.25 - **Upper Limit:** - **Value:** 21.1 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 8.91 - **Upper Limit:** - **Value:** 20.9 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 9.52 - **Upper Limit:** - **Value:** 22.8 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.20 - **Upper Limit:** - **Value:** 17.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.59 - **Upper Limit:** - **Value:** 14.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.55 - **Upper Limit:** - **Value:** 14.9 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 4.87 - **Upper Limit:** - **Value:** 15.4 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 4.53 - **Upper Limit:** - **Value:** 12.4 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 59.4 - **Upper Limit:** - **Value:** 160 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 28.6 - **Upper Limit:** - **Value:** 140 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 79.9 - **Upper Limit:** - **Value:** 164 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 67.8 - **Upper Limit:** - **Value:** 176 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 50.5 - **Upper Limit:** - **Value:** 134 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.179 - **Upper Limit:** - **Value:** 0.389 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.141 - **Upper Limit:** - **Value:** 0.348 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.114 - **Upper Limit:** - **Value:** 0.259 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.0919 - **Upper Limit:** - **Value:** 0.173 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 0.0237 - **Upper Limit:** - **Value:** 0.0522 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 9 - **Group ID:** OG003 - **Value:** 11 - **Group ID:** OG004 - **Value:** 12 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.275 - **Upper Limit:** - **Value:** 0.474 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.0815 - **Upper Limit:** - **Value:** 0.367 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.119 - **Upper Limit:** - **Value:** 0.294 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.0636 - **Upper Limit:** - **Value:** 0.174 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 0.0461 - **Upper Limit:** - **Value:** 0.0694 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 10 - **Group ID:** OG001 - **Value:** 10 - **Group ID:** OG002 - **Value:** 10 - **Group ID:** OG003 - **Value:** 10 - **Group ID:** OG004 - **Value:** 10 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacodynamic Analysis Set (PD), which consisted of all participants with an observed PD value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. **Reporting Status:** POSTED **Time Frame:** Baseline , Day 7 **Title:** Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7 **Type:** PRIMARY **Unit of Measure:** gram (g) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 2 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Maximum Observed Plasma Concentration (Cmax) for LIK066 **Type:** PRIMARY **Unit of Measure:** nanogram per milliliter (ng/mL) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 3 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066 **Type:** PRIMARY **Unit of Measure:** hour (hr) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 4 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066 **Type:** PRIMARY **Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 5 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7 **Type:** PRIMARY **Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 6 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1 **Type:** PRIMARY **Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 7 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Terminal Elimination Half-life (T1/2) for LIK066 on Day 7 **Type:** PRIMARY **Unit of Measure:** hour (hr) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 8 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1 **Type:** PRIMARY **Unit of Measure:** Liter per hour (L/h) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 9 **Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1 **Type:** PRIMARY **Unit of Measure:** Liter (L) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe #### Outcome Measure 10 **Description:** Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. **Reporting Status:** POSTED **Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose) **Title:** Renal Clearance From Plasma (CLr) for LIK066 **Type:** PRIMARY **Unit of Measure:** Liter per hour (L/hr) ##### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG000 **Title:** Normal ##### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG001 **Title:** Mild ##### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG002 **Title:** Moderate A ##### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG003 **Title:** Moderate B ##### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** OG004 **Title:** Severe ### Participant Flow Module #### Group **Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days. **ID:** FG000 **Title:** Mild #### Group **Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days. **ID:** FG001 **Title:** Moderate A #### Group **Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days. **ID:** FG002 **Title:** Moderate B #### Group **Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days. **ID:** FG003 **Title:** Severe #### Group **Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days. **ID:** FG004 **Title:** Normal #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ###### Reason **Group ID:** FG003 **Number of Subjects:** 1 ###### Reason **Group ID:** FG004 **Number of Subjects:** 0 ##### Withdraw **Type:** Subject/Guardian Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ###### Reason **Group ID:** FG003 **Number of Subjects:** 1 ###### Reason **Group ID:** FG004 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 11 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 10 ##### Milestone **Type:** Safety Analysis Set (SS) **Comment:** All subjects that received study drug ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 11 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 10 ##### Milestone **Type:** Pharmacokinetic Analysis Set (PAS) **Comment:** At least one dose of study drug and had at least 1 valid PK concentration measurement ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 11 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 10 ##### Milestone **Type:** Pharcodynamic Analysis Set (PD) **Comment:** At least one dose of study drug and had at least 1 valid post baseline PD ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 11 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 12 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 10 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 10 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 10 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG004 **Number of Subjects:** 0 **Recruitment Details:** This study was conducted at 1 centers in the United States. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00604279 **Brief Title:** A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia **Official Title:** A Randomized, Open-Label, Parallel Group Comparative Study of Paliperidone Palmitate (50, 100, 150 mg eq) and Risperidone LAI (25, 37.5, or 50 mg) in Subjects With Schizophrenia #### Organization Study ID Info **ID:** CR013150 #### Organization **Class:** INDUSTRY **Full Name:** Xian-Janssen Pharmaceutical Ltd. #### Secondary ID Infos **ID:** R092670PSY3008 ### Status Module #### Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-07-10 **Type:** ESTIMATED **Last Update Submit Date:** 2013-06-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2013-07-10 **Type:** ESTIMATED **Results First Submit Date:** 2013-02-21 **Results First Submit QC Date:** 2013-06-04 #### Start Date **Date:** 2008-01 **Status Verified Date:** 2013-06 #### Study First Post Date **Date:** 2008-01-30 **Type:** ESTIMATED **Study First Submit Date:** 2008-01-17 **Study First Submit QC Date:** 2008-01-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Xian-Janssen Pharmaceutical Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability. **Detailed Description:** This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed. ### Conditions Module **Conditions:** - Schizophrenia **Keywords:** - Schizophrenia - Paliperidone - Paliperidone palmitate - Risperidone - Risperidone long acting injection - R092670 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 452 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. **Intervention Names:** - Drug: Paliperidone palmitate (R092670) **Label:** Paliperidone palmitate **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **Intervention Names:** - Drug: Risperidone **Label:** Risperidone long acting injection (LAI) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Paliperidone palmitate **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. **Name:** Paliperidone palmitate (R092670) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Risperidone long acting injection (LAI) **Description:** Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **Name:** Risperidone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening. **Measure:** Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal **Time Frame:** Baseline, Day 92 or early withdrawal #### Secondary Outcomes **Description:** This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision. **Measure:** Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal **Time Frame:** Baseline, Day 92 or early withdrawal **Description:** The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening. **Measure:** Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal **Time Frame:** Baseline, Day 92 or early withdrawal **Description:** The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time). **Measure:** Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal **Time Frame:** Baseline, Day 92 or early withdrawal **Description:** A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more. **Measure:** Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal **Time Frame:** Day 92 or early withdrawal ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia * A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline * Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m\^2) * Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study * Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria: * A primary, active DSM-IV diagnosis on Axis I other than schizophrenia * A decrease of at least 25 percent in the total PANSS score between screening and baseline * Participants who have previously participated in this study * A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary) * History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baoding **Country:** China **Location 2:** **City:** Beijing **Country:** China **Location 3:** **City:** Guangzhou **Country:** China **Location 4:** **City:** Hangzhou **Country:** China **Location 5:** **City:** Nanjing **Country:** China **Location 6:** **City:** Shanghai **Country:** China **Location 7:** **City:** Wuhan **Country:** China **Location 8:** **City:** Xian **Country:** China #### Overall Officials **Official 1:** **Affiliation:** Xian-Janssen Pharmaceutical Ltd. **Name:** Xian-Janssen Pharmaceutical Ltd. Clinical Trial **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012559 - Term: Schizophrenia ### Intervention Browse Module - Ancestors - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018492 - Term: Dopamine Antagonists - ID: D000015259 - Term: Dopamine Agents - ID: D000058830 - Term: Serotonin 5-HT2 Receptor Antagonists - ID: D000065127 - Term: Dopamine D2 Receptor Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M20999 - Name: Risperidone - Relevance: HIGH - As Found: Evening - ID: M329 - Name: Paliperidone Palmitate - Relevance: HIGH - As Found: Canadian - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000018967 - Term: Risperidone - ID: D000068882 - Term: Paliperidone Palmitate ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Paliperidone Palmitate **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** EG000 **Other Num Affected:** 115 **Other Num at Risk:** 229 **Serious Number Affected:** 3 **Serious Number At Risk:** 229 **Title:** Paliperidone Palmitate **Group ID:** EG001 **Title:** Risperidone Long Acting Injection (LAI) **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** EG001 **Other Num Affected:** 127 **Other Num at Risk:** 223 **Serious Number Affected:** 8 **Serious Number At Risk:** 223 **Title:** Risperidone Long Acting Injection (LAI) **Frequency Threshold:** 5 #### Other Events **Term:** Constipation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Upper respiratory tract infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA Version 12.0 **Term:** Blood prolactin increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA Version 12.0 **Term:** Musculoskeletal stiffness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Akathisia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Bradykinesia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Tremor **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Anxiety **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Insomnia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 **Term:** Restlessness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 #### Serious Events **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Vomiting **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Lumbar vertebral fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Overdose **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Road traffic accident **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Cerebral infarction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 229 **Group ID:** EG001 **Num At Risk:** 223 **Term:** Convulsion **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Completed suicide **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Psychiatric symptom **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 229 **Group ID:** EG001 **Num At Risk:** 223 **Term:** Schizophrenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 229 **Group ID:** EG001 **Num At Risk:** 223 **Term:** Hydronephrosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Nephrolithiasis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 **Term:** Refusal of treatment by patient **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Social circumstances **Source Vocabulary:** MedDRA Version 12.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 229 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 223 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 229 **Group ID:** BG001 **Value:** 223 **Group ID:** BG002 **Value:** 452 **Units:** Participants ### Group **ID:** BG000 **Title:** Paliperidone Palmitate **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. ### Group **ID:** BG001 **Title:** Risperidone Long Acting Injection (LAI) **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.75 **Value:** 32 #### Measurement **Group ID:** BG001 **Spread:** 11.03 **Value:** 31.5 #### Measurement **Group ID:** BG002 **Spread:** 10.88 **Value:** 31.7 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 142 #### Measurement **Group ID:** BG001 **Value:** 129 #### Measurement **Group ID:** BG002 **Value:** 271 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 94 #### Measurement **Group ID:** BG002 **Value:** 181 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 92 #### Measurement **Group ID:** BG002 **Value:** 179 **Class Title:** 18-25 Years #### Measurement **Group ID:** BG000 **Value:** 125 #### Measurement **Group ID:** BG001 **Value:** 114 #### Measurement **Group ID:** BG002 **Value:** 239 **Class Title:** 26-50 Years #### Measurement **Group ID:** BG000 **Value:** 17 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 34 **Class Title:** 51-65 Years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Class Title:** >65 Years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Class Title:** <18 Years **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Age Categorical **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** The disclosure restriction on the PI is that the sponsor can review results communications prior to publication and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The paper that incorporates confidential information requires Sponsor's written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Organization:** Xian-Janssen Pharmaceutical Ltd **Phone:** 86-10-5821 8213 **Title:** Local Trial Manager ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -5.20 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 0.63 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 1.48 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Least Square Mean Difference **Parameter Value:** -2.3 **Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used. **Statistical Method:** ANCOVA **Tested Non-Inferiority:** True ### Outcome Measure 2 #### Analysis **CI Lower Limit:** -2.14 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 3.12 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 1.34 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Least Square Mean Difference **Parameter Value:** 0.5 **Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used. **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** -0.33 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 0.10 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.11 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Least Square Mean Difference **Parameter Value:** -0.1 **Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used. **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** -0.67 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 7.50 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 2.08 **Estimate Comment:** **Group Description:** Statistical Analysis for Quality of sleep **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Least Square Mean Difference **Parameter Value:** 3.4 **Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used. **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False #### Analysis **CI Lower Limit:** -5.04 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 2.90 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 2.02 **Estimate Comment:** **Group Description:** Statistical Analysis for Daytime drowsiness **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Least Square Mean Difference **Parameter Value:** -1.1 **Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used. **Statistical Method:** ANCOVA **Tested Non-Inferiority:** False ### Outcome Measure 5 #### Analysis **CI Lower Limit:** 0.81 **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** 1.01 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Point estimate of relative risk **Parameter Value:** 0.9 **Statistical Comment:** **Statistical Method:** Cochran-Mantel-Haenszel **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.95 - **Upper Limit:** - **Value:** 82.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 12.69 - **Upper Limit:** - **Value:** 84.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.28 - **Upper Limit:** - **Value:** -23.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 15.43 - **Upper Limit:** - **Value:** -26.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12.42 - **Upper Limit:** - **Value:** 47.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 11.29 - **Upper Limit:** - **Value:** 45.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 14.76 - **Upper Limit:** - **Value:** 16.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13.92 - **Upper Limit:** - **Value:** 18.6 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.82 - **Upper Limit:** - **Value:** 4.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.81 - **Upper Limit:** - **Value:** 5.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.24 - **Upper Limit:** - **Value:** -1.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.16 - **Upper Limit:** - **Value:** -1.7 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.40 - **Upper Limit:** - **Value:** 64.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 24.22 - **Upper Limit:** - **Value:** 66.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 26.95 - **Upper Limit:** - **Value:** 8.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 26.18 - **Upper Limit:** - **Value:** 10.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.25 - **Upper Limit:** - **Value:** 29.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 23.50 - **Upper Limit:** - **Value:** 29.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 27.26 - **Upper Limit:** - **Value:** -4.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 24.12 - **Upper Limit:** - **Value:** -4.9 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.40 - **Upper Limit:** - **Value:** 70.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 24.22 - **Upper Limit:** - **Value:** 78.4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations. **Reporting Status:** POSTED **Time Frame:** Baseline, Day 92 or early withdrawal **Title:** Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal **Type:** PRIMARY **Unit of Measure:** Units on scale ##### Group **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** OG000 **Title:** Paliperidone Palmitate ##### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** OG001 **Title:** Risperidone Long Acting Injection (LAI) #### Outcome Measure 2 **Description:** This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. **Reporting Status:** POSTED **Time Frame:** Baseline, Day 92 or early withdrawal **Title:** Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal **Type:** SECONDARY **Unit of Measure:** Units on scale ##### Group **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** OG000 **Title:** Paliperidone Palmitate ##### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** OG001 **Title:** Risperidone Long Acting Injection (LAI) #### Outcome Measure 3 **Description:** The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. **Reporting Status:** POSTED **Time Frame:** Baseline, Day 92 or early withdrawal **Title:** Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal **Type:** SECONDARY **Unit of Measure:** Units on scale ##### Group **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** OG000 **Title:** Paliperidone Palmitate ##### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** OG001 **Title:** Risperidone Long Acting Injection (LAI) #### Outcome Measure 4 **Description:** The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per Protocol Analysis Set. **Reporting Status:** POSTED **Time Frame:** Baseline, Day 92 or early withdrawal **Title:** Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal **Type:** SECONDARY **Unit of Measure:** millimeter (mm) ##### Group **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** OG000 **Title:** Paliperidone Palmitate ##### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** OG001 **Title:** Risperidone Long Acting Injection (LAI) #### Outcome Measure 5 **Description:** A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more. **Parameter Type:** NUMBER **Population Description:** Per Protocol Analysis Set. **Reporting Status:** POSTED **Time Frame:** Day 92 or early withdrawal **Title:** Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** OG000 **Title:** Paliperidone Palmitate ##### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** OG001 **Title:** Risperidone Long Acting Injection (LAI) ### Participant Flow Module #### Group **Description:** Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. **ID:** FG000 **Title:** Paliperidone Palmitate #### Group **Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. **ID:** FG001 **Title:** Risperidone Long Acting Injection (LAI) #### Period **Title:** Overall Study ##### Withdraw **Type:** Lack of Efficacy ###### Reason **Group ID:** FG000 **Number of Subjects:** 22 ###### Reason **Group ID:** FG001 **Number of Subjects:** 9 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 9 ###### Reason **Group ID:** FG001 **Number of Subjects:** 14 ##### Withdraw **Type:** Pregnancy ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 16 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 4 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Other ###### Reason **Group ID:** FG000 **Number of Subjects:** 8 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 229 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 223 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 165 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 185 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 64 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 38 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04406779 **Brief Title:** The Frequency of Thyroid Diseases in Women With Breast Cancer **Official Title:** The Frequency of Thyroid Diseases in Women With Breast Cancer #### Organization Study ID Info **ID:** UsakU-Cevdet1 #### Organization **Class:** OTHER **Full Name:** Uşak University ### Status Module #### Completion Date **Date:** 2017-03-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2020-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-03-31 **Type:** ACTUAL #### Start Date **Date:** 2016-03-01 **Type:** ACTUAL **Status Verified Date:** 2020-05 #### Study First Post Date **Date:** 2020-05-28 **Type:** ACTUAL **Study First Submit Date:** 2020-05-22 **Study First Submit QC Date:** 2020-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Uşak University #### Responsible Party **Investigator Affiliation:** Uşak University **Investigator Full Name:** Cevdet Duran **Investigator Title:** M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients ### Conditions Module **Conditions:** - Breast Cancer - Thyroid Diseases ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 160 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with breast cancer **Intervention Names:** - Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies **Label:** Patients with breast cancer #### Arm Group 2 **Description:** Healthy patients without breast cancer **Intervention Names:** - Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies **Label:** Control ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - Patients with breast cancer **Description:** thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies **Name:** thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** to investigate the frequency of thyroid diseases in breast cancer patients. **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * women, the age between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study Exclusion Criteria: * Those with pregnancy, known liver and renal failure, the history of any malignancy other than breast cancer, undergoing a surgical operation due to breast cancer, also those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or complete thyroid surgery or a surgical operation within the past 6 months, and also the patients taking oral anti-diabetic medication, insulin, steroids, thiazide, anti-psychotics and immuno-suppressive medicines affecting the levels of blood glucose, insulin and IR, smokers and those consuming alcohol were excluded **Gender Based:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** women, aged between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study as patients groups. Age matched healthy controls were enrolled as controls. ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid Diseases - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000007155 - Term: Immunologic Factors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4625 - Name: Autoantibodies - Relevance: HIGH - As Found: Relate - ID: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones - ID: D000001323 - Term: Autoantibodies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01506479 **Acronym:** SPARX **Brief Title:** Study in Parkinson's Disease of Exercise **Official Title:** Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease #### Organization Study ID Info **ID:** 11-1237 #### Organization **Class:** OTHER **Full Name:** University of Colorado, Denver #### Secondary ID Infos **ID:** R01NS074343 **Link:** https://reporter.nih.gov/quickSearch/R01NS074343 **Type:** NIH ### Status Module #### Completion Date **Date:** 2016-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-10-13 **Type:** ACTUAL **Last Update Submit Date:** 2017-09-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-11 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-10-13 **Type:** ACTUAL **Results First Submit Date:** 2017-06-23 **Results First Submit QC Date:** 2017-09-12 #### Start Date **Date:** 2012-05 **Type:** ACTUAL **Status Verified Date:** 2017-09 #### Study First Post Date **Date:** 2012-01-10 **Type:** ESTIMATED **Study First Submit Date:** 2011-12-16 **Study First Submit QC Date:** 2012-01-05 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Illinois at Chicago **Class:** OTHER **Name:** University of Pittsburgh **Class:** OTHER **Name:** Rush University Medical Center **Class:** NIH **Name:** National Institute of Neurological Disorders and Stroke (NINDS) **Class:** OTHER **Name:** Northwestern University #### Lead Sponsor **Class:** OTHER **Name:** University of Colorado, Denver #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit. **Detailed Description:** The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol. ### Conditions Module **Conditions:** - Parkinson Disease **Keywords:** - Parkinson Disease - Basal Ganglia Disease - Central Nervous System Diseases - Nervous System Diseases - Movement Disorders - Neurodegenerative Diseases - Brain Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 128 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise. **Intervention Names:** - Behavioral: No Intervention **Label:** Control Group **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **Intervention Names:** - Behavioral: Vigorous Exercise **Label:** Vigorous Exercise **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. **Intervention Names:** - Behavioral: Moderate Exercise **Label:** Moderate Exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderate Exercise **Description:** Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **Name:** Moderate Exercise **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Vigorous Exercise **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **Name:** Vigorous Exercise **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Control Group **Description:** No-exercise control (i.e., usual care); **Name:** No Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The number of days the participant exercised per week **Measure:** Number of Days of Exercise Per Week **Time Frame:** 9 to 26 weeks #### Primary Outcomes **Description:** To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol. **Measure:** Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise **Time Frame:** 9 to 26 weeks #### Secondary Outcomes **Description:** Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms. **Measure:** 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score **Time Frame:** Baseline and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of primary Parkinson's disease * In a Hoehn and Yahr stage less than stage III * Disease duration is less than 5 years * Not likely to require dopaminergic therapy within 6 months Exclusion Criteria: * Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl). * Duration of previous use of medications for PD that exceeds 90 days * Expected to require dopaminergic therapy in the next 6 months * Poorly controlled or unstable cardiovascular disease * Uncontrolled hypertension * Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function * Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30) * Depression that precludes ability to exercise (Beck depression score\>13) * Disorders that interfere with ability to perform endurance exercises * Regular participation in vigorous endurance exercise * Evidence of serious arrhythmias or ischemic heart disease * Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aurora **Country:** United States **Facility:** University of Colorado Denver **State:** Colorado **Zip:** 80045 **Location 2:** **City:** Chicago **Country:** United States **Facility:** University of Illinois, Chicago **State:** Illinois **Zip:** 60612 **Location 3:** **City:** Pittsburgh **Country:** United States **Facility:** University of Pittsburgh **State:** Pennsylvania **Zip:** 15213 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado, Denver **Name:** Margaret Schenkman, PT, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Illinois at Chicago **Name:** Daniel Corcos, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z. **PMID:** 30428907 **Citation:** Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517. **PMID:** 29228079 **Citation:** Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14. **PMID:** 23770108 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Control Group **Deaths Num At Risk:** 40 **Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); **ID:** EG000 **Other Num Affected:** 13 **Other Num at Risk:** 40 **Serious Number At Risk:** 40 **Title:** Control Group **Group ID:** EG001 **Title:** Vigorous Exercise **Deaths Num At Risk:** 43 **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **ID:** EG001 **Other Num Affected:** 28 **Other Num at Risk:** 43 **Serious Number At Risk:** 43 **Title:** Vigorous Exercise **Group ID:** EG002 **Title:** Moderate Exercise **Deaths Num At Risk:** 45 **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **ID:** EG002 **Other Num Affected:** 24 **Other Num at Risk:** 45 **Serious Number Affected:** 2 **Serious Number At Risk:** 45 **Title:** Moderate Exercise **Frequency Threshold:** 0 #### Other Events **Term:** Blood and lymphatic system disorders - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Palpitations **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Gastric ulcer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Gastrointestinal disorders - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Flu like symptoms **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Flu like symptoms **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Bladder infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Lung infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Rhinitis infective **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Skin infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Upper respiratory infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (4.0) **Term:** Fall **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** CTCAE (4.0) **Term:** Injury, poisoning and procedural complications - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** CTCAE (4.0) **Term:** Injury, poisoning and procedural complications - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** CTCAE (4.0) **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Arthritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Buttock pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Neck pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Pain in extremity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** CTCAE (4.0) **Term:** Nervous system disorders - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Renal calculi **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Urine discoloration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Sore throat **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Dry skin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Skin and subcutaneous tissue disorders - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Surgical and medical procedures - Other, specify **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** CTCAE (4.0) **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** CTCAE (4.0) **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** CTCAE (4.0) #### Serious Events **Term:** Renal calculi **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num At Risk:** 40 **Group ID:** EG001 **Num At Risk:** 43 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 45 **Num Events:** 1 **Term:** Gastric ulcer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (4.0) ##### Stats **Group ID:** EG000 **Num At Risk:** 40 **Group ID:** EG001 **Num At Risk:** 43 **Group ID:** EG002 **Num Affected:** 1 **Num At Risk:** 45 **Num Events:** 1 **Time Frame:** Adverse event data were collected monthly until the primary time point at 6 months. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Units:** Participants ### Group **ID:** BG000 **Title:** Control Group **Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); ### Group **ID:** BG001 **Title:** Vigorous Exercise **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. ### Group **ID:** BG002 **Title:** Moderate Exercise **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10 **Value:** 64 #### Measurement **Group ID:** BG001 **Spread:** 9 **Value:** 64 #### Measurement **Group ID:** BG002 **Spread:** 10 **Value:** 63 #### Measurement **Group ID:** BG003 **Spread:** 9 **Value:** 64 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 16 #### Measurement **Group ID:** BG001 **Value:** 21 #### Measurement **Group ID:** BG002 **Value:** 18 #### Measurement **Group ID:** BG003 **Value:** 55 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 27 #### Measurement **Group ID:** BG003 **Value:** 73 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 6 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 41 #### Measurement **Group ID:** BG003 **Value:** 119 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 3 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 6 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 #### Measurement **Group ID:** BG003 **Value:** 5 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 36 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 40 #### Measurement **Group ID:** BG003 **Value:** 115 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 #### Measurement **Group ID:** BG003 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 2 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7 **Value:** 17 #### Measurement **Group ID:** BG001 **Spread:** 7 **Value:** 17 #### Measurement **Group ID:** BG002 **Spread:** 7 **Value:** 16 #### Measurement **Group ID:** BG003 **Spread:** 7 **Value:** 17 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 2987 **Value:** 5005 #### Measurement **Group ID:** BG001 **Spread:** 3107 **Value:** 5146 #### Measurement **Group ID:** BG002 **Spread:** 2521 **Value:** 5702 #### Measurement **Group ID:** BG003 **Spread:** 2856 **Value:** 5306 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 36 **Group ID:** BG001 **Value:** 36 **Group ID:** BG002 **Value:** 42 **Group ID:** BG003 **Value:** 114 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 8 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 13 #### Measurement **Group ID:** BG003 **Value:** 33 **Category Title:** Stage 1 #### Measurement **Group ID:** BG000 **Value:** 32 #### Measurement **Group ID:** BG001 **Value:** 31 #### Measurement **Group ID:** BG002 **Value:** 32 #### Measurement **Group ID:** BG003 **Value:** 95 **Category Title:** Stage 2 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 43 **Group ID:** BG002 **Value:** 45 **Group ID:** BG003 **Value:** 128 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Description:** Sum of 27 items scored 0 to 4, minimum score is 0, maximum score is 108. Higher score indicates worse motor symptoms. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation **Unit of Measure:** units on a scale ### Measure 6 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** Several participants did not wear the activity monitor devices for recording total number of daily steps. **Title:** Total daily steps **Unit of Measure:** steps per day ### Measure 7 **Description:** Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Hoehn and Yahr Stage **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** cgp22@pitt.edu **Organization:** University of Pittsburgh **Phone:** 412-383-6630 **Title:** Dr. Charity G. Moore ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 12.0 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 16.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** <0.0001 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 14.3 **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** ONE_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** 4.6 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation. **Non-Inferiority Comment:** **Non-Inferiority Type:** OTHER **Other Analysis Description:** **P-Value:** 0.34 **P-Value Comment:** The a priori threshold for statistical significance was 0.10 **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 2.9 **Statistical Comment:** **Statistical Method:** t-test, 1 sided **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** **CI Number of Sides:** ONE_SIDED **CI Percentage Value:** 90 **CI Upper Limit:** 2.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The estimate is the difference between the control group and the moderate exercise group. The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis. **Group Description:** The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation . **Non-Inferiority Comment:** **Non-Inferiority Type:** OTHER **Other Analysis Description:** **P-Value:** 0.03 **P-Value Comment:** The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation). **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 1.2 **Statistical Comment:** **Statistical Method:** t-test, 1 sided **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1334 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 78.8 - **Spread:** - **Upper Limit:** 81.7 - **Value:** 80.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 64.2 - **Spread:** - **Upper Limit:** 67.7 - **Value:** 65.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.4 - **Spread:** - **Upper Limit:** 5.1 - **Value:** 3.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.7 - **Spread:** - **Upper Limit:** 2.3 - **Value:** 0.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 0.4 - **Spread:** - **Upper Limit:** 3.7 - **Value:** 2.0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.4 - **Spread:** - **Upper Limit:** 3.2 - **Value:** 2.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.8 - **Spread:** - **Upper Limit:** 3.6 - **Value:** 3.2 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** Only for participants who contributed heart rate monitor data. **Reporting Status:** POSTED **Time Frame:** 9 to 26 weeks **Title:** Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise **Type:** PRIMARY **Unit of Measure:** percentage of maximum heart rate ##### Group **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **ID:** OG000 **Title:** Vigorous Exercise ##### Group **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **ID:** OG001 **Title:** Moderate Exercise #### Outcome Measure 2 **Description:** Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included. **Reporting Status:** POSTED **Time Frame:** Baseline and 6 months **Title:** 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score **Type:** SECONDARY **Unit of Measure:** units on the UPDRS Motor scale ##### Group **Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); **ID:** OG000 **Title:** Control Group ##### Group **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **ID:** OG001 **Title:** Vigorous Exercise ##### Group **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **ID:** OG002 **Title:** Moderate Exercise #### Outcome Measure 3 **Description:** The number of days the participant exercised per week **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Population Description:** Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention. **Reporting Status:** POSTED **Time Frame:** 9 to 26 weeks **Title:** Number of Days of Exercise Per Week **Type:** OTHER_PRE_SPECIFIED **Unit of Measure:** Number of days per week ##### Group **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **ID:** OG000 **Title:** Vigorous Exercise ##### Group **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **ID:** OG001 **Title:** Moderate Exercise ### Participant Flow Module #### Group **Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); **ID:** FG000 **Title:** Control Group #### Group **Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months. **ID:** FG001 **Title:** Vigorous Exercise #### Group **Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. **ID:** FG002 **Title:** Moderate Exercise #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ###### Reason **Group ID:** FG002 **Number of Subjects:** 2 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ###### Reason **Group ID:** FG002 **Number of Subjects:** 1 ##### Withdraw **Type:** Missing assessment ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 40 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 43 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 45 ##### Milestone **Type:** COMPLETED **Comment:** Number of participants with 6 month follow-up. ###### Achievement **Group ID:** FG000 **Number of Subjects:** 37 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 42 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 5 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 3 **Pre-Assignment Details:** Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales. **Recruitment Details:** Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01406379 **Brief Title:** Comparison of Prophylactic Clip and Detachable Snare **Official Title:** Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study #### Organization Study ID Info **ID:** Prophylatic clip #### Organization **Class:** OTHER **Full Name:** The Catholic University of Korea ### Status Module #### Completion Date **Date:** 2013-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-08-20 **Type:** ESTIMATED **Last Update Submit Date:** 2013-08-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-01 **Type:** ACTUAL #### Start Date **Date:** 2010-07 **Status Verified Date:** 2013-08 #### Study First Post Date **Date:** 2011-08-01 **Type:** ESTIMATED **Study First Submit Date:** 2011-07-29 **Study First Submit QC Date:** 2011-07-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Catholic University of Korea #### Responsible Party **Investigator Affiliation:** The Catholic University of Korea **Investigator Full Name:** Jeong-Seon Ji **Investigator Title:** MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps. ### Conditions Module **Conditions:** - Colonic Polyp ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 203 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Prophylactic clip **Intervention Names:** - Procedure: Prophylactic clip **Label:** Prophylactic clip **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Detachable snare **Intervention Names:** - Procedure: Detachable snare **Label:** Detachable snare **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Prophylactic clip **Description:** Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group **Name:** Prophylactic clip **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Detachable snare **Description:** In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy **Name:** Detachable snare **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Postpolypectomy bleeding **Time Frame:** Immediate (bleeding occurring immediately after polypectomy and lasting for 30 s or more) and delayed bleeding complications were assessed. Delayed bleeding was subdivide into early (<24 h) and late (>24 h-30 days). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included. Exclusion Criteria: * bleeding tendency * poor preparation * sessile polyp **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### References Module #### References **Citation:** Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15. Erratum In: Endoscopy. 2014 Dec;46(12):1123. Endoscopy. 2014 Sep;46(9):817. **PMID:** 24830400 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007417 - Term: Intestinal Polyps ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M6339 - Name: Colonic Polyps - Relevance: HIGH - As Found: Colonic Polyps - ID: M14011 - Name: Polyps - Relevance: HIGH - As Found: Polyps - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10451 - Name: Intestinal Polyps - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011127 - Term: Polyps - ID: D000003111 - Term: Colonic Polyps ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02777879 **Brief Title:** Lung Microbiome and Inflammation in Early COPD **Official Title:** Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD) #### Organization Study ID Info **ID:** 14-01546 #### Organization **Class:** OTHER **Full Name:** NYU Langone Health ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2014-05 **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2016-05-19 **Type:** ESTIMATED **Study First Submit Date:** 2016-05-17 **Study First Submit QC Date:** 2016-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** NYU Langone Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls. ### Conditions Module **Conditions:** - Chronic Obstuctive Pulmonary Disease **Keywords:** - Chronic Obstructive Pulmonary Disease (COPD) ### Design Module #### Bio Spec **Description:** Microbial DNA will be extracted from sputum and BAL fluid. Variable 16S rRNA gene regions will be amplified by PCR using bar-coded primers flanking a portion of marker gene. PCR products will be sequenced in the NYU Genome Technology Center using MiSeq platform (Illumina). **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 230 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Case of early COPD (GOLD 1-2, FEV1/FVC\<70 and FEV1\>50%) **Intervention Names:** - Procedure: Bronchoscopy **Label:** Chronic Obstructive Pulmonary Disease (COPD) #### Arm Group 2 **Description:** No obstruction (FEV1/FVC\<70). Controls will be recruited after each case and will be matched by: age (±5 year), 2) gender, 3) smoking (±5 pack-year) and 4) BMI (±5). **Intervention Names:** - Procedure: Bronchoscopy **Label:** Control ### Interventions #### Intervention 1 **Arm Group Labels:** - Chronic Obstructive Pulmonary Disease (COPD) - Control **Description:** Flexible bronchoscopy with bronchoalveolar lavage (BAL) and bronchial brushings will be done in a standardized manner. The bronchoscope tip is sequentially wedged in sub-segments where BAL will be performed on a total of two segments of the lung (120 ml in each segment for a total of 360 ml). Two brushes will be done under direct visualization in both segments. Selection of segments to sample will be based on where abnormalities are in imaging. **Name:** Bronchoscopy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL **Time Frame:** 4 Hours #### Secondary Outcomes **Description:** Bioinformatic methods such as Procrustes will be used to integrate the analysis of the generated multi-omic datasets through this study to attain a more accurately defined COPD phenotype. By elucidating the interplay between bacterial composition, microbiome functional repertoire, metabolism, and immunological status in the human lung, we will obtain further insights for hypothesis generation into the pathophysiological mechanisms underlying COPD. **Measure:** Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches **Time Frame:** 4 Hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Case definition: Smokers (\>20 pack-year) with airflow obstruction (FEV1/FVC\<70) and FEV1\>50% predicted (early COPD GOLD 1 or 2) * Control definition: Smokers with normal spirometry will serve as controls. Exclusion Criteria: * FEV1 \< 50% NOT 70 * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure. * Diabetes mellitus * Significant liver or renal disease * Severe coagulopathy (INR \> 1.4, PTT \> 40 seconds and platelet count \< 150x103 cells). * Pregnancy * ETOH use of more than \>6 beers or \>4 mixed drinks daily * Lack of capacity to provide informed consent. * Antibiotic use within the prior 2months **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Utilizing cohorts built at NYU over the last several years, this project is uniquely positioned to investigate the microbiome signatures among subjects with COPD. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Rosemary.Schluger@nyulangone.org **Name:** Rosemary Schluger **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** Kathryn.Norris@nyumc.org - **Name:** Kathryn Norris - **Role:** CONTACT ***Contact 2:*** - **Email:** Adrienne.Scott@nyumc.org - **Name:** Adrienne Scott - **Role:** CONTACT ***Contact 3:*** - **Name:** Doreen J Addrizzo-Harris, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Rany Condos, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Stephanie Lau, MD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Ashwin Basavaraj, MD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Michael D Weiden, MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Yonghua Li, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** New York University School of Medicine **State:** New York **Status:** RECRUITING **Zip:** 10016 #### Overall Officials **Official 1:** **Affiliation:** New York University Medical School **Name:** Leopoldo Segal, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Pulmonary Disease - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7296 - Name: Dimercaprol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03479879 **Brief Title:** Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage **Official Title:** Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial #### Organization Study ID Info **ID:** AS1731 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2018-12-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-01-29 **Type:** ACTUAL **Last Update Submit Date:** 2019-01-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12-20 **Type:** ACTUAL #### Start Date **Date:** 2018-03-21 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2018-03-27 **Type:** ACTUAL **Study First Submit Date:** 2018-03-21 **Study First Submit QC Date:** 2018-03-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Mohamed S Sweed, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage. ### Conditions Module **Conditions:** - Miscarriage ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Estradiol - Drug: Misoprostol **Label:** Estradiol + Misoprostol **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo Oral Tablet - Drug: Misoprostol **Label:** Placebo + Misoprostol **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Estradiol + Misoprostol **Description:** Estradiol **Name:** Estradiol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo + Misoprostol **Description:** Placebo **Name:** Placebo Oral Tablet **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Estradiol + Misoprostol - Placebo + Misoprostol **Description:** Misoprostol **Name:** Misoprostol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Duration of induction of abortion **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Maternal age more than 18 years old (age of legal consent). * Gestational age between 12-26 weeks. * Hb level \> 10 g/dL. * BMI between 25 kg/m2 and 35 kg/m2. * Missed abortion. * Living fetus with multiple congenital malformations incompatible with life. * PPROMS with drained liquor and parents are consenting for termination of pregnancy. Exclusion Criteria: * Maternal age less than 18 years old. * Gestational age less than 12 weeks or more than 26 weeks. * Hb level \< 10 g/dL. * Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus). * Polyhydramnios. * Anencephaly. * Fibroid uterus. * BMI less than 25 kg/m2 and more than 35 kg/m2. * Coagulopathy. * Previous attempts for induction of abortion in the current pregnancy. * Allergy to misoprostol or estradiol. * Placenta previa. * Medical disorder that contraindicate induction of abortion (e.g. heart failure). **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Ain Shams University Maternity Hospital ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21 - Name: Abortion, Spontaneous - Relevance: HIGH - As Found: Miscarriage - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000022 - Term: Abortion, Spontaneous ### Intervention Browse Module - Ancestors - ID: D000004967 - Term: Estrogens - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000012102 - Term: Reproductive Control Agents - ID: D000000020 - Term: Abortifacient Agents, Nonsteroidal - ID: D000000019 - Term: Abortifacient Agents - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000010120 - Term: Oxytocics ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M266279 - Name: Estradiol 17 beta-cypionate - Relevance: LOW - As Found: Unknown - ID: M266280 - Name: Estradiol 3-benzoate - Relevance: LOW - As Found: Unknown - ID: M8108 - Name: Estradiol - Relevance: HIGH - As Found: Cell lymphoma - ID: M234941 - Name: Polyestradiol phosphate - Relevance: LOW - As Found: Unknown - ID: M18979 - Name: Misoprostol - Relevance: HIGH - As Found: Liquid - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016595 - Term: Misoprostol - ID: D000004958 - Term: Estradiol ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03059979 **Brief Title:** The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc ) **Official Title:** Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial. #### Organization Study ID Info **ID:** HHaE #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2021-07-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-11-29 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-27 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2017-01 **Status Verified Date:** 2019-09 #### Study First Post Date **Date:** 2017-02-23 **Type:** ACTUAL **Study First Submit Date:** 2017-01-25 **Study First Submit QC Date:** 2017-02-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline **Detailed Description:** Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients. In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients ### Conditions Module **Conditions:** - Systemic Sclerosis - Raynaud Phenomena ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days **Intervention Names:** - Drug: Methylprednisolone **Label:** Methylprednisolone 1000 mg **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The placebo intervention with physiologic salt solution is identical in appearance **Intervention Names:** - Other: sodium chloride **Label:** sodium chloride **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Methylprednisolone 1000 mg **Description:** methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8. **Name:** Methylprednisolone **Other Names:** - Solu-Medrol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - sodium chloride **Description:** 100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8. **Name:** sodium chloride **Other Names:** - NaCl 0,9% **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications. **Measure:** the change in capillary density from baseline **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Plasma biomarkers consist soluble inflammatory mediators platelet factor 4, interleukin-1β, interleukin-6, tumor necrosis factor-α, endothelin-1, intercellular adhesion molecule-1 and vascular endothelial growth factor **Measure:** change in selected biomarkers: the interferon signature in peripheral blood from baseline **Time Frame:** 1 year **Description:** changes in nail fold capillary pattern (early, active, late, normal **Measure:** change in nail fold capillary changes other than capillary density and giant capillaries from baseline **Time Frame:** 1 year **Measure:** change in modified Rodnan skin score (mRSS) from baseline **Time Frame:** 1 year **Measure:** presence of puffy fingers from baseline **Time Frame:** 1 year **Measure:** presence of synovitis from baseline **Time Frame:** 1 year **Measure:** presence of tendon friction rubs from baseline **Time Frame:** 1 year **Measure:** fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline **Time Frame:** 1 year **Measure:** pulmonary function tests from baseline **Time Frame:** 1 year **Measure:** presence of interstitial lung disease from baseline **Time Frame:** 1 year **Measure:** suspicion of pulmonary hypertension from baseline **Time Frame:** 1 year **Measure:** Change in physical function from baseline **Time Frame:** 1 year **Measure:** general health score from baseline **Time Frame:** 1 year **Measure:** Change in 36-Item Short Form Survey (SF-36) total score from baseline **Time Frame:** 1 year **Measure:** Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline **Time Frame:** 1 year **Measure:** Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline **Time Frame:** 1 year **Measure:** Change in gastrointestinal tract ( GIT ) total score from baseline **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent * Age over 18 years * Fulfilling VEDOSS criteria (9): * Raynauds' Phenomenon and * Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and * typical nail fold capillaroscopic findings * Puffy fingers \< 3 years * Modified Rodnan skin score = 0 Exclusion Criteria: * Presence of acroosclerosis, acrosteolysis and digital ulcers * Presence of anti-RNA polymerase III auto antibodies Previous systemic treatment for SSc, namely: * methotrexate, * prednisone (\> 14 days in previous 6 months), * mofetil mycophenolate * cyclophosphamide. Clinically significant internal organ involvement: * diffusion capacity of lung for carbon monoxide (DLCO) \< 80% predicted, * vital capacity (VC) \< 70% predicted * renal dysfunction with glomerular filtration rate (GFR) \< 60 ml/min * diastolic dysfunction \> grade 1 on echocardiography * pulmonary hypertension * weight loss \>10% in the last 6 months with unknown cause Contra-indications for methylprednisolone, such as: * pregnancy, lactation * psychotic or depressive disorder * ulcus duodeni or ventriculi * untreated hypertension (\> 160-90 mmHg) * acute infections **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sjoukje.mulder@radboudumc.nl **Name:** Sjoukje Mulder **Phone:** +31 24 3619398 **Role:** CONTACT **Contact 2:** **Name:** Brigit Kersten **Phone:** +31 24 361 4580 **Role:** CONTACT #### Locations **Location 1:** **City:** Nijmegen **Contacts:** ***Contact 1:*** - **Email:** sjoukje.mulder@radboudumc.nl - **Name:** Sjoukje Mulder - **Phone:** +31 24 3619398 - **Role:** CONTACT ***Contact 2:*** - **Email:** B.Kersten@radboudumc.nl - **Name:** Brigit Kersten - **Role:** CONTACT ***Contact 3:*** - **Name:** Brigit Kersten - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Madelon Vonk - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Radboudumc, Rheumatology department **State:** Gelderland **Status:** RECRUITING **Zip:** 6500 HB #### Overall Officials **Official 1:** **Affiliation:** Radboud University Medical Center **Name:** Madelon Vonk, Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Geyer M, Muller-Ladner U. The pathogenesis of systemic sclerosis revisited. Clin Rev Allergy Immunol. 2011 Apr;40(2):92-103. doi: 10.1007/s12016-009-8193-3. **PMID:** 20087791 **Citation:** van Bon L, Affandi AJ, Broen J, Christmann RB, Marijnissen RJ, Stawski L, Farina GA, Stifano G, Mathes AL, Cossu M, York M, Collins C, Wenink M, Huijbens R, Hesselstrand R, Saxne T, DiMarzio M, Wuttge D, Agarwal SK, Reveille JD, Assassi S, Mayes M, Deng Y, Drenth JP, de Graaf J, den Heijer M, Kallenberg CG, Bijl M, Loof A, van den Berg WB, Joosten LA, Smith V, de Keyser F, Scorza R, Lunardi C, van Riel PL, Vonk M, van Heerde W, Meller S, Homey B, Beretta L, Roest M, Trojanowska M, Lafyatis R, Radstake TR. Proteome-wide analysis and CXCL4 as a biomarker in systemic sclerosis. N Engl J Med. 2014 Jan 30;370(5):433-43. doi: 10.1056/NEJMoa1114576. Epub 2013 Dec 18. **PMID:** 24350901 **Citation:** Radstake TR, Gorlova O, Rueda B, Martin JE, Alizadeh BZ, Palomino-Morales R, Coenen MJ, Vonk MC, Voskuyl AE, Schuerwegh AJ, Broen JC, van Riel PL, van 't Slot R, Italiaander A, Ophoff RA, Riemekasten G, Hunzelmann N, Simeon CP, Ortego-Centeno N, Gonzalez-Gay MA, Gonzalez-Escribano MF; Spanish Scleroderma Group; Airo P, van Laar J, Herrick A, Worthington J, Hesselstrand R, Smith V, de Keyser F, Houssiau F, Chee MM, Madhok R, Shiels P, Westhovens R, Kreuter A, Kiener H, de Baere E, Witte T, Padykov L, Klareskog L, Beretta L, Scorza R, Lie BA, Hoffmann-Vold AM, Carreira P, Varga J, Hinchcliff M, Gregersen PK, Lee AT, Ying J, Han Y, Weng SF, Amos CI, Wigley FM, Hummers L, Nelson JL, Agarwal SK, Assassi S, Gourh P, Tan FK, Koeleman BP, Arnett FC, Martin J, Mayes MD. Genome-wide association study of systemic sclerosis identifies CD247 as a new susceptibility locus. Nat Genet. 2010 May;42(5):426-9. doi: 10.1038/ng.565. Epub 2010 Apr 11. **PMID:** 20383147 **Citation:** Greenblatt MB, Aliprantis AO. The immune pathogenesis of scleroderma: context is everything. Curr Rheumatol Rep. 2013 Jan;15(1):297. doi: 10.1007/s11926-012-0297-8. **PMID:** 23288576 **Citation:** Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. 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Epub 2009 Jan 15. **PMID:** 19147617 **Citation:** van Laar JM, Farge D, Sont JK, Naraghi K, Marjanovic Z, Larghero J, Schuerwegh AJ, Marijt EW, Vonk MC, Schattenberg AV, Matucci-Cerinic M, Voskuyl AE, van de Loosdrecht AA, Daikeler T, Kotter I, Schmalzing M, Martin T, Lioure B, Weiner SM, Kreuter A, Deligny C, Durand JM, Emery P, Machold KP, Sarrot-Reynauld F, Warnatz K, Adoue DF, Constans J, Tony HP, Del Papa N, Fassas A, Himsel A, Launay D, Lo Monaco A, Philippe P, Quere I, Rich E, Westhovens R, Griffiths B, Saccardi R, van den Hoogen FH, Fibbe WE, Socie G, Gratwohl A, Tyndall A; EBMT/EULAR Scleroderma Study Group. Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomized clinical trial. JAMA. 2014 Jun 25;311(24):2490-8. doi: 10.1001/jama.2014.6368. **PMID:** 25058083 **Citation:** Czirjak L, Matucci-Cerinic M. 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Ann Rheum Dis. 2013 Mar;72(3):319-21. doi: 10.1136/annrheumdis-2012-202295. Epub 2012 Nov 23. No abstract available. **PMID:** 23178210 **Citation:** Auphan N, DiDonato JA, Rosette C, Helmberg A, Karin M. Immunosuppression by glucocorticoids: inhibition of NF-kappa B activity through induction of I kappa B synthesis. Science. 1995 Oct 13;270(5234):286-90. doi: 10.1126/science.270.5234.286. **PMID:** 7569976 **Citation:** Davies CA, Jeziorska M, Freemont AJ, Herrick AL. The differential expression of VEGF, VEGFR-2, and GLUT-1 proteins in disease subtypes of systemic sclerosis. Hum Pathol. 2006 Feb;37(2):190-7. doi: 10.1016/j.humpath.2005.10.007. Epub 2005 Dec 15. **PMID:** 16426919 **Citation:** Stratton RJ, Coghlan JG, Pearson JD, Burns A, Sweny P, Abraham DJ, Black CM. Different patterns of endothelial cell activation in renal and pulmonary vascular disease in scleroderma. QJM. 1998 Aug;91(8):561-6. doi: 10.1093/qjmed/91.8.561. **PMID:** 9893759 **Citation:** Greenberg SA, Higgs BW, Morehouse C, Walsh RJ, Kong SW, Brohawn P, Zhu W, Amato A, Salajegheh M, White B, Kiener PA, Jallal B, Yao Y. Relationship between disease activity and type 1 interferon- and other cytokine-inducible gene expression in blood in dermatomyositis and polymyositis. Genes Immun. 2012 Apr;13(3):207-13. doi: 10.1038/gene.2011.61. Epub 2011 Sep 1. **PMID:** 21881594 **Citation:** Higgs BW, Liu Z, White B, Zhu W, White WI, Morehouse C, Brohawn P, Kiener PA, Richman L, Fiorentino D, Greenberg SA, Jallal B, Yao Y. Patients with systemic lupus erythematosus, myositis, rheumatoid arthritis and scleroderma share activation of a common type I interferon pathway. Ann Rheum Dis. 2011 Nov;70(11):2029-36. doi: 10.1136/ard.2011.150326. Epub 2011 Jul 28. **PMID:** 21803750 **Citation:** Miniati I, Guiducci S, Conforti ML, Rogai V, Fiori G, Cinelli M, Saccardi R, Guidi S, Bosi A, Tyndall A, Matucci-Cerinic M. Autologous stem cell transplantation improves microcirculation in systemic sclerosis. Ann Rheum Dis. 2009 Jan;68(1):94-8. doi: 10.1136/ard.2007.082495. Epub 2008 Feb 28. **PMID:** 18308744 **Citation:** Hunzelmann N, Moinzadeh P, Genth E, Krieg T, Lehmacher W, Melchers I, Meurer M, Muller-Ladner U, Olski TM, Pfeiffer C, Riemekasten G, Schulze-Lohoff E, Sunderkoetter C, Weber M; German Network for Systemic Scleroderma Centers. High frequency of corticosteroid and immunosuppressive therapy in patients with systemic sclerosis despite limited evidence for efficacy. Arthritis Res Ther. 2009;11(2):R30. doi: 10.1186/ar2634. Epub 2009 Mar 4. **PMID:** 19261182 **Citation:** Smith V, Decuman S, Sulli A, Bonroy C, Piettte Y, Deschepper E, de Keyser F, Cutolo M. Do worsening scleroderma capillaroscopic patterns predict future severe organ involvement? a pilot study. Ann Rheum Dis. 2012 Oct;71(10):1636-9. doi: 10.1136/annrheumdis-2011-200780. Epub 2012 Mar 8. **PMID:** 22402146 **Citation:** Valentini G, Marcoccia A, Cuomo G, Vettori S, Iudici M, Bondanini F, Santoriello C, Ciani A, Cozzolino D, De Matteis GM, Cappabianca S, Vitelli F, Spano A. Early systemic sclerosis: analysis of the disease course in patients with marker autoantibody and/or capillaroscopic positivity. 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Trials. 2018 Aug 22;19(1):449. doi: 10.1186/s13063-018-2798-x. **PMID:** 30134971 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000090122 - Term: Livedoid Vasculopathy - ID: D000013927 - Term: Thrombosis - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000017445 - Term: Skin Diseases, Vascular ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M14772 - Name: Raynaud Disease - Relevance: HIGH - As Found: Raynaud's Phenomenon - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M2750 - Name: Livedoid Vasculopathy - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Systemic Sclerosis - ID: T3486 - Name: Livedoid Vasculopathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011928 - Term: Raynaud Disease - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018696 - Term: Neuroprotective Agents - ID: D000020011 - Term: Protective Agents - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M14120 - Name: Prednisolone - Relevance: HIGH - As Found: Smoking - ID: M11749 - Name: Methylprednisolone - Relevance: HIGH - As Found: Smoking - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: HIGH - As Found: Smoking - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: HIGH - As Found: Erythropoietin - ID: M229449 - Name: Prednisolone acetate - Relevance: HIGH - As Found: Smoking - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: HIGH - As Found: Smoking - ID: M248881 - Name: Prednisolone phosphate - Relevance: HIGH - As Found: Smoking - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20773 - Name: Neuroprotective Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008775 - Term: Methylprednisolone - ID: D000077555 - Term: Methylprednisolone Acetate - ID: D000008776 - Term: Methylprednisolone Hemisuccinate - ID: D000011239 - Term: Prednisolone - ID: C000009935 - Term: Prednisolone acetate - ID: C000021322 - Term: Prednisolone hemisuccinate - ID: C000009022 - Term: Prednisolone phosphate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00293579 **Brief Title:** Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer **Official Title:** A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer #### Organization Study ID Info **ID:** OSU-0482 #### Organization **Class:** OTHER **Full Name:** Ohio State University Comprehensive Cancer Center ### Status Module #### Completion Date **Date:** 2008-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-02-10 **Type:** ACTUAL **Last Update Submit Date:** 2020-01-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2016-03-10 **Type:** ESTIMATED **Results First Submit Date:** 2015-10-30 **Results First Submit QC Date:** 2016-02-11 #### Start Date **Date:** 2006-02 **Type:** ACTUAL **Status Verified Date:** 2020-01 #### Study First Post Date **Date:** 2006-02-17 **Type:** ESTIMATED **Study First Submit Date:** 2006-02-15 **Study First Submit QC Date:** 2006-02-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ohio State University Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck. **Detailed Description:** Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12. Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life. Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects. ### Conditions Module **Conditions:** - Head and Neck Cancer **Keywords:** - head and neck cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 5 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **Intervention Names:** - Drug: Pemetrexed **Label:** Pemetrexed **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pemetrexed **Description:** 500 mg/m2 IV every 3 weeks for 6 cycles **Name:** Pemetrexed **Other Names:** - ALIMTA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. **Measure:** Overall Response Rate **Time Frame:** Up to 3 years #### Secondary Outcomes **Description:** Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. **Measure:** Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer **Time Frame:** Up to 3 years **Description:** Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health). **Measure:** Impact of Pemetrexed Chemotherapy on Quality of Life **Time Frame:** Baseline, End of Treatment [up to 3 years] **Description:** Overall survival was measured from the time of initial study entry to death due to any cause. **Measure:** Overall Survival **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Advanced, metastatic, or recurrent head and neck cancers * Poor risk patients with ECOG performance status of 2 Exclusion Criteria: * Prior treatment for recurrent or metastatic disease * No clinical or radiological evidence of brain metatases * Patients with bone only disease are not eligible * Patients with pleural or peritoneal effusion as only manifestation of diesase **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Columbus **Country:** United States **Facility:** Ohio State University **State:** Ohio **Zip:** 43210 #### Overall Officials **Official 1:** **Affiliation:** Ohio State University **Name:** Anterpreet Neki, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Urba S, van Herpen CM, Sahoo TP, Shin DM, Licitra L, Mezei K, Reuter C, Hitt R, Russo F, Chang SC, Hossain AM, Frimodt-Moller B, Koustenis A, Hong RL. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer. 2012 Oct 1;118(19):4694-705. doi: 10.1002/cncr.27449. Epub 2012 Mar 20. **PMID:** 22434360 #### See Also Links **Label:** Jamesline **URL:** http://cancer.osu.edu ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Cancer ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: General - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Pemetrexed **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **ID:** EG000 **Other Num Affected:** 5 **Other Num at Risk:** 5 **Serious Number At Risk:** 5 **Title:** Pemetrexed **Frequency Threshold:** 5 #### Other Events **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE version 3 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE version 3 **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Hypercalcemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** CTCAE version 3 **Term:** Increased/Thicker saliva **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Body jerking **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE version 3 **Term:** Neck pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE version 3 **Term:** Gum pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE version 3 **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** CTCAE version 3 **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Stomach Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Loss of balance **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE version 3 **Term:** Increased secretions **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Increased urination **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE version 3 **Term:** Vocal changes **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Conjunctivitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE version 3 **Term:** Disorientation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE version 3 **Term:** Rapid Heart rate **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** CTCAE version 3 **Term:** Bleeding from Tumor **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** CTCAE version 3 **Term:** Upper Respiratory Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE version 3 **Term:** Alkaline phosphatase **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE version 3 **Term:** ALT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE version 3 **Term:** AST **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE version 3 **Term:** Gamma-Glutamyl transpeptidase **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE version 3 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 5 **Units:** Participants ### Group **ID:** BG000 **Title:** Pemetrexed **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 49 **Upper Limit:** 71 **Value:** 52 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 3 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** Anterpreet.Neki@osumc.edu **Organization:** Ohio State University Comprehensive Cancer Center **Phone:** 614-257-2900 **Title:** Anterpreet Neki ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 80 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 141.6 - **Upper Limit:** - **Value:** 524 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 185.9 - **Upper Limit:** - **Value:** 335.5 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.4 - **Spread:** - **Upper Limit:** 15.4 - **Value:** 4.4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Up to 3 years **Title:** Overall Response Rate **Type:** PRIMARY **Unit of Measure:** patients ##### Group **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **ID:** OG000 **Title:** Pemetrexed #### Outcome Measure 2 **Description:** Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Up to 3 years **Title:** Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer **Type:** SECONDARY **Unit of Measure:** percent of patients ##### Group **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **ID:** OG000 **Title:** Pemetrexed #### Outcome Measure 3 **Description:** Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, End of Treatment [up to 3 years] **Title:** Impact of Pemetrexed Chemotherapy on Quality of Life **Type:** SECONDARY **Unit of Measure:** Units on a scale ##### Group **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles **ID:** OG000 **Title:** Pemetrexed #### Outcome Measure 4 **Description:** Overall survival was measured from the time of initial study entry to death due to any cause. **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** All patients were deceased at the time of terminating this study. **Reporting Status:** POSTED **Time Frame:** Up to 2 years **Title:** Overall Survival **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **ID:** OG000 **Title:** Pemetrexed ### Participant Flow Module #### Group **Description:** pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles **ID:** FG000 **Title:** Pemetrexed #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 5 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 **Recruitment Details:** Patients were enrolled to the study from March 2006 to January 2008 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04491279 **Brief Title:** Neuropilates Compared to General Exercise Classes in Chronic Stroke **Official Title:** An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study #### Organization Study ID Info **ID:** ITSligo EC #### Organization **Class:** OTHER **Full Name:** Institute of Technology, Sligo ### Status Module #### Completion Date **Date:** 2022-01-31 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2020-08-11 **Type:** ACTUAL **Last Update Submit Date:** 2020-08-09 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2020-10-30 **Type:** ESTIMATED **Status Verified Date:** 2020-08 #### Study First Post Date **Date:** 2020-07-29 **Type:** ACTUAL **Study First Submit Date:** 2020-07-25 **Study First Submit QC Date:** 2020-07-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sligo General Hospital **Class:** OTHER **Name:** Institute of Technology, Sligo #### Lead Sponsor **Class:** OTHER **Name:** Dr. John Bartlett #### Responsible Party **Investigator Affiliation:** Institute of Technology, Sligo **Investigator Full Name:** Dr. John Bartlett **Investigator Title:** Head of Research **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee. **Detailed Description:** Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns. This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland ### Conditions Module **Conditions:** - Stroke **Keywords:** - Neuroplasticity - Neuropilates - Chronic Stroke - Rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Pilot Randomised Controlled Trial ##### Masking Info **Masking:** SINGLE **Masking Description:** Outcome assessor will be blinded to treatment allocation. They will evaluate participant's prior to neuropilates treatment commencing and after neuropilates 6 week treatment has been completed. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor). Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate. Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant. Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants. Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary. **Intervention Names:** - Procedure: Home 'Neuropilates' exercise instructions. - Procedure: Supervised Neuropilates Group Class **Label:** Neuropilates class. **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class. Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary. **Intervention Names:** - Procedure: Home 'General' exercise instructions. - Procedure: Supervised General Exercises Group Class **Label:** Generalised exercise class. **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Generalised exercise class. **Description:** Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary. **Name:** Home 'General' exercise instructions. **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Neuropilates class. **Description:** Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary. **Name:** Home 'Neuropilates' exercise instructions. **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Neuropilates class. **Description:** Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). **Name:** Supervised Neuropilates Group Class **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Generalised exercise class. **Description:** Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility **Name:** Supervised General Exercises Group Class **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A performance-based scale to assess everyday motor function in post stroke patients. Evaluation is based upon a task-orientated approach. The scale comprises 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded. Tasks include; Supine to side lying, Supine to sitting over the edge of a bed, Balanced sitting, Sitting to standing, Walking, Upper-arm function, Hand movements, Advanced hand activities. General tonus of the affected side is also measured. All items (with the exception of the general tonus item) are assessed using a 7-point scale from 0 - 6. A score of 6 indicates optimal motor behaviour. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response. A score \> 4 indicates persistent hypertonus and a score \< 4 indicates various degrees of hypotonus. The maximum score possible is 48 points. **Measure:** Motor Assessment Scale (Carr and Shepherd 1985). **Time Frame:** Over a 6 week period. (15 min testing time). #### Secondary Outcomes **Description:** Assesses functional mobility and can be used as a screening tool for detecting potential balance impairments and falls risk in older adults. During the test the subject must rise from a chair, walk 3 metres at a comfortable pace to a mark placed on the floor, turn around at the 3 metre mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. The longer it takes the poorer the patient function.If a subject takes longer than 14 seconds to complete the test, they are considered to be at a high risk of falling. **Measure:** Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000). **Time Frame:** Over a 6 week period. (1 min testing time). **Description:** Most commonly accepted method of evaluating muscle strength. It involves testing key muscles from the upper and lower limbs against resistance applied by the examiner. The subject's strength is graded on a 0 - 5 scale with 0 being no movement or muscle activity visible or palpable and 5 being full strength through full range against strong resistance. It can take a few minutes up to 20 minutes to test, depending on the experience level of the examiner, the ability of the subject and the number of muscle groups being tested. **Measure:** Muscle Strength: Oxford Grading Scale. **Time Frame:** Over a 6 week period. (5-20 min testing time). **Description:** Measure muscle tone. During testing, the examiner extends the subject's limb from a position of maximal flexion to maximal extension until the first soft resistance is felt. Moving a client's limb through its full range of motion should be done within one second by counting "one thousand and one" Scores range from 0 to 4 where lower scores represent normal muscle tone and higher scores represent increased tone (spasticity) or increased resistance to passive movement. Again, time varies greatly depending on number of muscles being tested, examiner experience and patient ability, and can range from 5 minutes to 20 minutes. **Measure:** Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987). **Time Frame:** Over a 6 week period. (5-20 min testing time). **Description:** The FIM is a valid, reliable, 18-item global measure of disability, which is responsive to functional change. The FIM assesses six areas of function (Self-care, Sphincter control, Transfers, Locomotion, Communication and Social cognition), which fall under two Domains (Motor and Cognitive). Each item on the FIM is scored on a 7-point Likert scale. The score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). The ratings are based on performance rather than capacity and can be acquired by observation, patient interview, telephone interview or medical records. The developers of the FIM recommend that the scoring be derived by consensus with a multi-disciplinary team. The final score can range from 18 - 126 points, where 18 represents complete dependence or total assistance and 126 represents complete independence. **Measure:** Function: Functional Independence Measure (FIM), (Granger et al 1993). **Time Frame:** Over a 6 week period. (30-45 min testing time). **Description:** Generates a profile of handicaps on 6 different dimensions, including mobility, independence, occupation, social integration, orientation, and economic self-sufficiency. Each dimension has six levels arranged in order of increasing disadvantage with 1 being no disadvantage and 6 being most severe disadvantage. An overall handicap severity score is generated. **Measure:** London Handicap Scale (LHS), (Harwood et al 1994). **Time Frame:** Over a 6 week period. (5 min testing time). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged \> 18 years 2. Diagnosis of chronic stroke (\>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed. 3. Able to transfer (sit to stand and lateral transfers) independently with or without assistive device 4. Access to transport to enable attendance at one class per week 5. Cognitive ability to understand the programme. Exclusion Criteria: 1. Involvement in other studies or rehabilitation programmes. 2. Severe cognitive deficits or difficulty following instructions. 3. Significant hearing difficulties. 4. Significant visual deficit 5. Uncontrolled pain or uncontrolled high blood pressure **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** monaghan.kenneth@itsligo.ie **Name:** Kenneth Monaghan, PhD **Phone:** 0879480448 **Role:** CONTACT #### Locations **Location 1:** **City:** Sligo **Country:** Ireland **Facility:** Institute of Technology, Sligo **State:** Co Sligo **Zip:** F91YW50 #### Overall Officials **Official 1:** **Affiliation:** Study Principal Investigator **Name:** Eimear Cronin, MSc Res **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2020-08-04 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 246122 - Type Abbrev: Prot - Upload Date: 2020-08-05T02:56 - Date: 2020-08-04 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 176437 - Type Abbrev: SAP - Upload Date: 2020-08-05T02:57 - Date: 2020-08-04 - Filename: ICF_002.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 420861 - Type Abbrev: ICF - Upload Date: 2020-08-09T04:26 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00348179 **Brief Title:** Vascular Function in Adolescent, Diabetic Children **Official Title:** Vascular Function in Adolescent, Diabetic Children #### Organization Study ID Info **ID:** 04 04-036E #### Organization **Class:** OTHER **Full Name:** Children's Mercy Hospital Kansas City ### Status Module #### Completion Date **Date:** 2007-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2008-01-24 **Type:** ESTIMATED **Last Update Submit Date:** 2008-01-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-04 **Type:** ACTUAL #### Start Date **Date:** 2004-04 **Status Verified Date:** 2007-04 #### Study First Post Date **Date:** 2006-07-04 **Type:** ESTIMATED **Study First Submit Date:** 2006-06-30 **Study First Submit QC Date:** 2006-07-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Mercy Hospital Kansas City #### Responsible Party **Old Name Title:** Kurt Midyett **Old Organization:** Children's Mercy Hospitals and Clinics ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objectives of this investigator initiated study are to: 1. Determine if and when vascular abnormalities occur during early adolescence 2. Determine if poor diabetic control is related to vascular abnormalities. The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment. **Detailed Description:** Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects. ### Conditions Module **Conditions:** - Type 1 Diabetes **Keywords:** - Vascular abnormalities - Type 1 diabetes - Healthy control subjects ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 85 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Pressure tonometer will be used on various vessels, non-invasive. **Name:** Measurement of vascular function per SphymgnoCor equipment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Vascular abnormalities as measured by the SyphmgnoCor equipment **Time Frame:** End of study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls Exclusion Criteria: * Children and adolescents who do not meet inclusion criteria **Healthy Volunteers:** True **Maximum Age:** 14 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Kansas City **Country:** United States **Facility:** Children's Mercy Hospital **State:** Missouri **Zip:** 64108 #### Overall Officials **Official 1:** **Affiliation:** Children's Mercy Hospital Kansas City **Name:** Kurt Midyett, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03478579 **Acronym:** 3D-QUAMU **Brief Title:** Non-technical Skills of Emergency Physicians in a Virtual Emergency Department **Official Title:** Nontechnical Skills Assessment of Emergency Physicians and Quality of Care in a Virtual Emergency Department #### Organization Study ID Info **ID:** RC 31/16/8763 #### Organization **Class:** OTHER **Full Name:** University Hospital, Toulouse ### Status Module #### Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-09-01 **Type:** ACTUAL #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2022-02 #### Study First Post Date **Date:** 2018-03-27 **Type:** ACTUAL **Study First Submit Date:** 2017-06-08 **Study First Submit QC Date:** 2018-03-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Toulouse #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care. **Detailed Description:** The ability to manage multiple patients and anticipate the risk of error related to task interruptions or disruptions has been identified among relevant non-technical skills (NTS) for practicing emergency medicine. However, the link between these skills and the quality of care has not been quantified. NTS are usually analyzed by qualitative methods such as interviews, direct observations, or questionnaires that have low performance according to the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation). The investigators have created and validated an experimental model of a virtual, authentic and realistic Emergency Department (ED). The platform has been modelled in a "Second Life" environment. The NTS of emergency physicians will be assessed and recorded during simulated care of multiple virtual patients. The NTS association with ED length of stay and disposition decision will be analyzed. This study will be an internal pilot study and will include 30 emergency physicians who practice emergency medicine for at least two years. Sessions will be performed in the Toulouse Institute of Health Care Simulation, Toulouse University Hospital. They will be composed of three stages: briefing (30 minutes), simulated practice (3 hours), and debriefing with an explicit interview (30 minutes). Two researchers and a computer technician will supervise the sessions. The data will be obtained by analyzing the video recorded during the simulated practice and the interview. ### Conditions Module **Conditions:** - Emergencies **Keywords:** - serious game - simulation - virtual emergency department - nontechnical skills ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The observational group will be composed of emergency physicians working in the French Midi-Pyrenees region. Physicians must work since 2 years in emergency service **Intervention Names:** - Other: observational **Label:** Emergency physicians ### Interventions #### Intervention 1 **Arm Group Labels:** - Emergency physicians **Description:** No intervention, it is observational study **Name:** observational **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The nontechnical skills will be assessed by the Anaesthetists' Non-Technical Skills (ANTS) system. **Measure:** Nontechnical skills **Time Frame:** 3 hours #### Secondary Outcomes **Description:** Quality of care will be measured by a composite criterion associating a process indicator and a result indicator : * The process indicator is the average time to medical care of patients * The result indicator corresponds to the relevance of the choice of the orientation of each patient by the emergency doctor at the end of medical care **Measure:** Quality of care will be measured by a composite criteria (process and result) **Time Frame:** 3 hours **Description:** The quality of care will be assessed by ED length of stay : ED length of stay will be measured from triage completion to disposition decision **Measure:** ED length of stay **Time Frame:** 3 hours **Description:** Evaluation of the consistency : perceived internal consistency in the proposed rules and situations will be assessed using a 4-item questionnaire by answering yes or no **Measure:** The authenticity of the virtual emergency medicine service **Time Frame:** 3 hours **Description:** Evaluation of the realism (the assumed resemblance with a real life reference) will be evaluated through a questionnaire containing 3 areas of comparison between the virtual and real environment (layout of the premises, duration of the actions, staff / patient ratio) with as answer possible for each comparison: Realistic or not realistic. **Measure:** The authenticity of the virtual emergency medicine service **Time Frame:** 3 hours **Description:** Evaluation of the relevance (necessary to allow users to take ownership of the problems posed by the designers) will be assessed through direct observation with a yes / no evaluation of the acceptance to use the virtual environment, to test the environment, to make choices during the scenario and to control the environment. **Measure:** The authenticity of the virtual emergency medicine service **Time Frame:** 3 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Active emergency physicians working in an ED of the French Midi-Pyrenees region * Two years of practice in emergency medicine or more * Volunteer to participate in the study Exclusion Criteria: * Emergency physician working in another setting than ED, outside the Midi-Pyrenees region, or practicing emergency medicine for less than 2 years. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Emergency physicians working in the French Midi-Pyrénées region ### Contacts Locations Module #### Locations **Location 1:** **City:** Toulouse **Country:** France **Facility:** CHU Toulouse **Zip:** 31059 #### Overall Officials **Official 1:** **Affiliation:** Toulouse CHU **Name:** Dominique Lauque, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03045679 **Acronym:** MGBvsRYGB **Brief Title:** One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass **Official Title:** The Evidence of One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass in Metabolic Surgery - a Prospective Randomized Controlled Trial #### Organization Study ID Info **ID:** FF 74/2016 #### Organization **Class:** OTHER **Full Name:** Sana Klinikum Offenbach ### Status Module #### Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-01-17 **Type:** ACTUAL **Last Update Submit Date:** 2023-01-13 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2023-01 #### Study First Post Date **Date:** 2017-02-07 **Type:** ESTIMATED **Study First Submit Date:** 2017-02-05 **Study First Submit QC Date:** 2017-02-05 **Why Stopped:** Hospital changed in 2019, no recruitment performed ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sana Klinikum Offenbach #### Responsible Party **Investigator Affiliation:** Sana Klinikum Offenbach **Investigator Full Name:** Sonja Chiappetta, MD **Investigator Title:** Principal investigator: Dr. Sonja Chiappetta **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery. **Detailed Description:** OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB. In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month. Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Roux-en Y gastric bypass - One-anastomosis gastric bypass - Mini-gastric bypass - metabolic surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B) ##### Masking Info **Masking:** SINGLE **Masking Description:** envelope randomization **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50 **Intervention Names:** - Other: RYGB **Label:** RYGB-group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50 **Intervention Names:** - Other: OAGB/MGB **Label:** OAGB/MGB-group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RYGB-group **Description:** laparoscopic RYGB **Name:** RYGB **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - OAGB/MGB-group **Description:** laparoscopic OAGB/MGB **Name:** OAGB/MGB **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** complications classified next to Clavien-Dindo **Measure:** complications **Time Frame:** up to 2 years after surgery #### Secondary Outcomes **Description:** death up to 2 years after surgery **Measure:** mortality **Time Frame:** up to 2 years after surgery **Description:** HbA1c \< 6.5% without medication **Measure:** remission of type 2 diabetes mellitus **Time Frame:** up to 2 years after surgery **Description:** blood pressure \< 140/90 mmHg without medication **Measure:** remission of hypertonus **Time Frame:** up to 2 years after surgery **Description:** GERD-HRGL Heartburn Scale **Measure:** gastro-esophageal reflux disease **Time Frame:** up to 2 years after surgery **Description:** presence/absence of CPAP **Measure:** remission of sleep apnea **Time Frame:** up to 2 years after surgery **Description:** triglyceride \< 200mg/dl without medication **Measure:** remission of hypertrigliceridemia **Time Frame:** up to 2 years after surgery **Description:** cholesterin \< 155 mg/dl without medication **Measure:** remission of hypercholesterinemia **Time Frame:** up to 2 years after surgery **Description:** changing in quality of life measured by questionnaire **Measure:** quality of life questionnaire **Time Frame:** up to 2 years after surgery **Description:** postoperative excess weight loss in % **Measure:** weight loss **Time Frame:** up to 2 years after surgery **Description:** operation time during surgery in minutes **Measure:** operation time **Time Frame:** operation time during surgery in minutes **Description:** postoperative malnutrition: protein \< 64 g/l **Measure:** malnutrition 1 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: albumin \< 35 g/l **Measure:** malnutrition 2 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: ferritin (\< 30 µg/l) **Measure:** malnutrition 3 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: vitamin E \< 12 µmol/l **Measure:** malnutrition 4 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: vitamin K \< 90 ng/l **Measure:** malnutrition 5 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: vitamin 25-OH- Vitamin D3 \< 50 nmol/l **Measure:** malnutrition 6 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: vitamin A \< 1.05 µmol/l **Measure:** malnutrition 7 **Time Frame:** up to 2 years after surgery **Description:** postoperative malnutrition: vitamin B12 \< 145 pmol/l **Measure:** malnutrition 8 **Time Frame:** up to 2 years after surgery **Description:** revisional surgery during follow up **Measure:** revisional surgery **Time Frame:** up to 2 years after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. primary obesity surgery and indication for gastric bypass 2. age: 18 - 65 years 3. BMI \> 40 kg/m² or BMI \> 35 kg/m² with obesity related comorbidities 4. informed consent Exclusion Criteria: 1. obesity surgery in the anamnesis 2. visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy) **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Offenbach **Country:** Germany **Facility:** Sana Klinikum Offenbach **State:** Hessen **Zip:** 63069 #### Overall Officials **Official 1:** **Affiliation:** Sana Klinikum Offenbach **Name:** Sonja Chiappetta, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z. **PMID:** 25585612 **Citation:** Jammu GS, Sharma R. A 7-Year Clinical Audit of 1107 Cases Comparing Sleeve Gastrectomy, Roux-En-Y Gastric Bypass, and Mini-Gastric Bypass, to Determine an Effective and Safe Bariatric and Metabolic Procedure. Obes Surg. 2016 May;26(5):926-32. doi: 10.1007/s11695-015-1869-2. **PMID:** 26337694 **Citation:** Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6. **PMID:** 26341086 **Citation:** Guenzi M, Arman G, Rau C, Cordun C, Moszkowicz D, Voron T, Chevallier JM. Remission of type 2 diabetes after omega loop gastric bypass for morbid obesity. Surg Endosc. 2015 Sep;29(9):2669-74. doi: 10.1007/s00464-014-3987-7. Epub 2015 Jan 1. **PMID:** 25552228 **Citation:** Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98. **PMID:** 15973097 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01862679 **Brief Title:** Randomised Study of High-flux Haemodialysis and Haemodiafiltration **Official Title:** Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration #### Organization Study ID Info **ID:** GN12RE153 #### Organization **Class:** OTHER **Full Name:** NHS Greater Glasgow and Clyde ### Status Module #### Completion Date **Date:** 2014-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-06-07 **Type:** ESTIMATED **Last Update Submit Date:** 2016-06-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-03 **Type:** ACTUAL #### Start Date **Date:** 2013-07 **Status Verified Date:** 2016-06 #### Study First Post Date **Date:** 2013-05-24 **Type:** ESTIMATED **Study First Submit Date:** 2013-04-22 **Study First Submit QC Date:** 2013-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** NHS Greater Glasgow and Clyde #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine. During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD. It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions: 1. Does HDF make patients feel better? 2. Is blood pressure more stable on HDF in comparison with HF-HD? 3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD? The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters. ### Conditions Module **Conditions:** - End Stage Renal Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration **Intervention Names:** - Other: High-flux haemodialysis - Procedure: Haemodiafiltration **Label:** 8 weeks HF haemodialysis / 8 weeks HD-filtration **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis **Intervention Names:** - Other: High-flux haemodialysis - Procedure: Haemodiafiltration **Label:** 8 weeks HD-filtration /8 weeks HF haemodialysis **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 8 weeks HD-filtration /8 weeks HF haemodialysis - 8 weeks HF haemodialysis / 8 weeks HD-filtration **Description:** High-flux haemodialysis is the standard dialysis modality currently in use in the UK **Name:** High-flux haemodialysis **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - 8 weeks HD-filtration /8 weeks HF haemodialysis - 8 weeks HF haemodialysis / 8 weeks HD-filtration **Description:** During Haemodiafiltration, the dialysis machine removes more water from the blood than during "normal" hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood. **Name:** Haemodiafiltration **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Self-assessment by patient of hours/mins to full recovery after dialysis **Measure:** Change in the average time taken to fully recover post dialysis **Time Frame:** Baseline compared 8 week treatment point #### Secondary Outcomes **Measure:** Number of symptomatic hypotension events **Time Frame:** Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks **Measure:** Number of dialysis circuit clotting events **Time Frame:** Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks **Measure:** Pre-dialysis serum concentrations of potassium **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of phosphate **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of vitamin B12. **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of PTH. **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of beta-2-microglobulin **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of betaine **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Pre-dialysis serum concentrations of interleukin-6 **Time Frame:** Measured at baseline, and after 4 and 8 weeks of each treatment period **Measure:** Kt/V urea. **Time Frame:** : Measured at baseline, and after 4 and 8 weeks of each treatment period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Receiving HF-HD for at least 3 months * Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month) * Aged 18 or older Exclusion Criteria: * Currently receiving HDF * Emergency hospital admissions within the preceding 4 weeks * Life expectancy less than 6 months * Neoplasia * Unable to give informed consent * Unable to perform QoL questionnaire or self report recovery post-dialysis time **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Glasgow **Country:** United Kingdom **Facility:** NHS Greater Glasgow andClyde **Zip:** G12 0XH #### Overall Officials **Official 1:** **Affiliation:** NHS Greater Glasgow and Clyde **Name:** Robert MacTier, Md, FRCP **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01018979 **Brief Title:** Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients **Official Title:** A Phase II, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease #### Organization Study ID Info **ID:** TG-0054-02 #### Organization **Class:** INDUSTRY **Full Name:** GPCR Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2011-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-05-11 **Type:** ACTUAL **Last Update Submit Date:** 2021-04-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-01-15 **Type:** ESTIMATED **Results First Submit Date:** 2014-12-18 **Results First Submit QC Date:** 2015-01-13 #### Start Date **Date:** 2010-02 **Status Verified Date:** 2021-04 #### Study First Post Date **Date:** 2009-11-25 **Type:** ESTIMATED **Study First Submit Date:** 2009-11-24 **Study First Submit QC Date:** 2009-11-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GPCR Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease. ### Conditions Module **Conditions:** - Multiple Myeloma - Non-Hodgkin Lymphoma - Hodgkin Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 19 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **Intervention Names:** - Drug: TG-0054 (2.24 mg/kg) **Label:** TG-0054 (2.24 mg/kg) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **Intervention Names:** - Drug: TG-0054 (3.14 mg/kg) **Label:** TG-0054 (3.14 mg/kg) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TG-0054 (2.24 mg/kg) **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **Name:** TG-0054 (2.24 mg/kg) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - TG-0054 (3.14 mg/kg) **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **Name:** TG-0054 (3.14 mg/kg) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success. **Measure:** Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD). **Time Frame:** 1 week #### Secondary Outcomes **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Measure:** Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. **Time Frame:** Baseline, 3 hours and 6 hours after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Measure:** Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Time Frame:** 36 hrs after infusion **Measure:** Circulating CD34+ Cell Counts in Peripheral Blood. **Time Frame:** Baseline, 3 hours and 6 hours after infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female 18 to 70 years of age inclusive * Patients with confirmed pathology diagnosis of MM, NHL or HD * Potential candidate for autologous stem cell transplantation at Investigator's discretion * ≦ 2 prior regimens of cytotoxic chemotherapy (rituximab, thalidomide, and bortezomib will not be considered as cytotoxic chemotherapy) * \> 4 weeks since last cycle of chemotherapy prior to the study drug administration * Total dose of melphalan received ≦ 200 mg in the most recent chemotherapy treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion * White blood cell (WBC) count ≧ 3.0 x 109/L on screening laboratory assessments * Absolute neutrophil count ≧ 1.5 x 109/L on screening laboratory assessments * Platelet count ≧ 100 x 109/L on screening laboratory assessments * Serum creatinine ≦ 2.2 mg/dL on screening laboratory assessments * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin \< 2 x upper limit of normal (ULN) on screening laboratory assessments * Negative for human immunodeficiency virus (HIV) * Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion * For females, one of the following criteria must be fulfilled: 1. At least one year post-menopausal, or 2. Surgically sterile, or 3. Willing to use a double-barrier method \[intrauterine device (IUD) plus condom, spermicidal gel plus condom\] of contraception throughout the study * Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054 * Able to provide the signed informed consent Exclusion Criteria: * Received radiation therapy around the pelvic or spinal area within 6 months prior to the study drug administration * \>10% bone marrow involvement of lymphoma in NHL patients * Failed previous stem cell collection \[failed to collect 2 x 106 CD34+ cells/kg within 4 apheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)\] * Patients who have undergone previous stem cell transplantation procedure * Received G-CSF within 2 weeks prior to the study drug administration * History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin * History of other hematologic disorders including bleeding or thromboembolic disease * History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease * Diagnosis of sickle cell anemia or documented sickle cell trait * Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion * Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing * Pregnant or breast-feeding * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study * Received any other investigational drug within 1 month before entering the study **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chiayi **Country:** Taiwan **Facility:** Chang-Gung Memorial Hospital Chiayi **Location 2:** **City:** Hualien **Country:** Taiwan **Facility:** Buddist Tzu Chi General Hospital **Location 3:** **City:** Kaohsiung **Country:** Taiwan **Facility:** Kaohsiung Medical University Hospital **Location 4:** **City:** Linkou **Country:** Taiwan **Facility:** Chang-Gung Memorial Hospital Linkou **Location 5:** **City:** Taipei **Country:** Taiwan **Facility:** National Taiwan University Hospital **Location 6:** **City:** Taipei **Country:** Taiwan **Facility:** Taipei Veterans General Hospital #### Overall Officials **Official 1:** **Affiliation:** Taipei Veterans General Hospital, Taiwan **Name:** Tzeon-Jye Chiou, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Buddist Tzu Chi General Hospital **Name:** Tso-Fu Wang, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Kaohsiung Medical University **Name:** Sheng-Fung Lin, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Chang Gung Memorial Hospital, Chiayi **Name:** Chih-Cheng Chen, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Chang Gung Memorial Hospital **Name:** Po-Nan Wang, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** National Taiwan University Hospital **Name:** Jih-Luh Tang, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M9751 - Name: Hodgkin Disease - Relevance: HIGH - As Found: Hodgkin's Disease - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: HIGH - As Found: Non-Hodgkin Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T2817 - Name: Hodgkin Lymphoma - Relevance: HIGH - As Found: Hodgkin's Disease ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell - ID: D000008228 - Term: Lymphoma, Non-Hodgkin - ID: D000006689 - Term: Hodgkin Disease ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study. #### Event Groups **Group ID:** EG000 **Title:** TG-0054 (2.24 mg/kg) **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** EG000 **Other Num Affected:** 6 **Other Num at Risk:** 7 **Serious Number Affected:** 2 **Serious Number At Risk:** 7 **Title:** TG-0054 (2.24 mg/kg) **Group ID:** EG001 **Title:** TG-0054 (3.14 mg/kg) **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** EG001 **Other Num Affected:** 8 **Other Num at Risk:** 12 **Serious Number Affected:** 6 **Serious Number At Risk:** 12 **Title:** TG-0054 (3.14 mg/kg) **Frequency Threshold:** 0 #### Other Events **Term:** ABDOMINAL PAIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably related to study drug. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** ABNORMAL DATA OF INCREASE BILIRUBIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** CHEST TIGHTNESS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** CLONIC OF RIGHT KNEE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** DIARRHEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. 1 probably related and 1 definitely related. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** DIZZINESS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. 2 definitely not related and 1 possible related. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** DRY COUGH **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related. **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** ECCHYMOSIS OVER FEMORAL PUNCTURE SITE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** EMESIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** FEVER **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPERCALCEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. All possible related to study drug. **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPERTENSION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOCALCEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOCALCIUM **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOKALEMIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOTENSION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOTENSION BP 82/51MMHG **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** HYPOVOLEMIC HYPOTENSION BP 78/56MMHG **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** INCREASE ALANINE AMINOTRANS-FERASE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** ITCHY SKIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably not related to study drug. **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** LEUKOCYTOSIS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment Ae. 3 possible related and 2 probably related. **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** LOW BACK PAIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably related to study drug. **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** MILD ABDOMINAL PAIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably related to study drug. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** MILD DIARRHEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably related to study drug. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** MILD DIZZINESS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** MILD HEADACHE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Possible related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NAUSEA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Probably related to study drug. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NUMBNESS OF FACE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NUMBNESS OF FACE AND PALM **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NUMBNESS OF FACE HANDS AND LEGS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NUMBNESS OF LEGS AND LIPS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** NUMBNESS OF LIPS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment AE. Definitely not related to study drug. **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 #### Serious Events **Term:** ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 7 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 12 **Term:** AUTOLOGOUS STEM CELL TRANSPLANT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 7 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 12 **Term:** HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 7 **Group ID:** EG001 **Num At Risk:** 12 **Term:** AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 7 **Group ID:** EG001 **Num At Risk:** 12 **Term:** TREATMENT OF NON-HODGKIN LYMPHOMA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 7 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 12 **Term:** PEIPHERAL BLOOD STEM CELL HARVEST **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Post-treatment SAE. Definitely not related to study drug **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 7 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 12 **Time Frame:** The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose) ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 7 **Group ID:** BG001 **Value:** 12 **Group ID:** BG002 **Value:** 19 **Units:** Participants ### Group **ID:** BG000 **Title:** TG-0054 (2.24 mg/kg) **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) ### Group **ID:** BG001 **Title:** TG-0054 (3.14 mg/kg) **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 15.5 **Value:** 47.3 #### Measurement **Group ID:** BG001 **Spread:** 9.3 **Value:** 52.4 #### Measurement **Group ID:** BG002 **Spread:** 11.8 **Value:** 50.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.1 **Value:** 162.7 #### Measurement **Group ID:** BG001 **Spread:** 8.6 **Value:** 158.7 #### Measurement **Group ID:** BG002 **Spread:** 9.1 **Value:** 160.2 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 23.1 **Value:** 67.3 #### Measurement **Group ID:** BG001 **Spread:** 10.2 **Value:** 60.6 #### Measurement **Group ID:** BG002 **Spread:** 15.9 **Value:** 63.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.0 **Value:** 25.1 #### Measurement **Group ID:** BG001 **Spread:** 3.0 **Value:** 24.0 #### Measurement **Group ID:** BG002 **Spread:** 4.2 **Value:** 24.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 7 **Class Title:** Multiple myeloma #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 10 **Class Title:** Non-Hodgkin lymphoma #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Class Title:** Hodgkin disease **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Height **Unit of Measure:** centimeters ### Measure 4 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Weight **Unit of Measure:** kilogram ### Measure 5 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Body Mass Index **Unit of Measure:** kilogram/ meter^2 ### Measure 6 **Parameter Type:** NUMBER **Title:** Diagnosis **Unit of Measure:** participants **Population Description:** 19 subjects met all eligibility criteria and received at least one dose of TG-0054. ## Results Section - More Information Module ### Certain Agreement **Other Details:** PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** cetsai@taigenbiotech.com **Organization:** TaiGen Biotechnology Co., Ltd. **Phone:** +886-2-8177-7072 **Phone Extension:** 1211 **Title:** Chen-En Tsai, M.D., Ph.D. ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Analyze whether the mean fold increase from the baseline to the peak time change was significant or not. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.023 **P-Value Comment:** P values less than 0.05 are considered statistically significant in this study. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Analyze whether the mean fold increase from the baseline to the peak time change was significant or not. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.038 **P-Value Comment:** P values less than 0.05 are considered statistically significant in this study. **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6995 - **Upper Limit:** - **Value:** 20971 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 18583 - **Upper Limit:** - **Value:** 29665 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.9 - **Upper Limit:** - **Value:** 7.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.1 - **Upper Limit:** - **Value:** 6.1 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 5.9 - **Upper Limit:** - **Value:** 6.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.2 - **Upper Limit:** - **Value:** 7.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 10.4 - **Upper Limit:** - **Value:** 7.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 9.1 - **Upper Limit:** - **Value:** 7.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.5 - **Upper Limit:** - **Value:** 9.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.9 - **Upper Limit:** - **Value:** 10.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 8.4 - **Upper Limit:** - **Value:** 10.0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0 - **Upper Limit:** - **Value:** 0.25 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0 - **Upper Limit:** - **Value:** 0.25 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.4 - **Upper Limit:** - **Value:** 4.65 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.6 - **Upper Limit:** - **Value:** 4.28 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.01 - **Upper Limit:** - **Value:** 0.15 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.02 - **Upper Limit:** - **Value:** 0.16 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7034 - **Upper Limit:** - **Value:** 43610 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 12153 - **Upper Limit:** - **Value:** 55814 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7039 - **Upper Limit:** - **Value:** 43713 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 12170 - **Upper Limit:** - **Value:** 55920 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.4 - **Upper Limit:** - **Value:** 52.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13.0 - **Upper Limit:** - **Value:** 58.6 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 62 - **Upper Limit:** - **Value:** 351 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 112 - **Upper Limit:** - **Value:** 366 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 64 - **Upper Limit:** - **Value:** 179 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 76 - **Upper Limit:** - **Value:** 193 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.7 - **Upper Limit:** - **Value:** 1.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.5 - **Upper Limit:** - **Value:** 0.9 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.6 - **Upper Limit:** - **Value:** 1.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.0 - **Upper Limit:** - **Value:** 5.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.1 - **Upper Limit:** - **Value:** 4.0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 2.9 - **Upper Limit:** - **Value:** 4.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.9 - **Upper Limit:** - **Value:** 6.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.7 - **Upper Limit:** - **Value:** 4.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.3 - **Upper Limit:** - **Value:** 5.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.4 - **Upper Limit:** - **Value:** 7.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.7 - **Upper Limit:** - **Value:** 5.2 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 4.1 - **Upper Limit:** - **Value:** 6.5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success. **Parameter Type:** NUMBER **Population Description:** In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure. In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure. **Reporting Status:** POSTED **Time Frame:** 1 week **Title:** Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD). **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 2 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** ng/mL ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 3 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 3 hours and 6 hours after infusion **Title:** Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. **Type:** SECONDARY **Unit of Measure:** fold ##### Group **Description:** 7 patients with MM were enrolled. **ID:** OG000 **Title:** Multiple Myeloma (MM) ##### Group **Description:** 10 patients and 2 patients with NHL and HD were enrolled, respectively. **ID:** OG001 **Title:** Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD) ##### Group **Description:** All patents = MM + NHL + HD **ID:** OG002 **Title:** All Patients #### Outcome Measure 4 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** hr ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 5 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** hr ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 6 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** 1/hr ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 7 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** hr*ng/mL ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 8 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** hr*ng/mL ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 9 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** mL/ hr/kg ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 10 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** mL/kg ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 11 **Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. **Reporting Status:** POSTED **Time Frame:** 36 hrs after infusion **Title:** Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. **Type:** SECONDARY **Unit of Measure:** mL/kg ##### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG000 **Title:** TG-0054 (2.24 mg/kg) ##### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** OG001 **Title:** TG-0054 (3.14 mg/kg) #### Outcome Measure 12 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline, 3 hours and 6 hours after infusion **Title:** Circulating CD34+ Cell Counts in Peripheral Blood. **Type:** SECONDARY **Unit of Measure:** cells/μL ##### Group **Description:** 7 patients with MM were enrolled. **ID:** OG000 **Title:** Multiple Myeloma (MM) ##### Group **Description:** 10 patients and 2 patients with NHL and HD were enrolled, respectively. **ID:** OG001 **Title:** Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD) ##### Group **Description:** All patents = MM + NHL + HD **ID:** OG002 **Title:** All Patients ### Participant Flow Module #### Group **Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** FG000 **Title:** TG-0054 (2.24 mg/kg) #### Group **Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) **ID:** FG001 **Title:** TG-0054 (3.14 mg/kg) #### Period **Title:** Overall Study ##### Withdraw **Type:** Peak CD34+ cell count in PB < 10 cell/uL ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 9 ##### Withdraw **Type:** Not received at least one dose ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 13 ##### Milestone **Type:** Received at Least One Dose ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 12 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 10 **Pre-Assignment Details:** A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02738879 **Brief Title:** Randomized Sitagliptin Withdrawal Study (MK-0431-845) **Official Title:** A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of the Continuation of Sitagliptin Compared With the Withdrawal of Sitagliptin During Initiation and Titration of Insulin Glargine (LANTUS®) in Subjects With Type 2 Diabetes Mellitus #### Organization Study ID Info **ID:** 0431-845 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **ID:** 2015-004990-34 **Type:** EUDRACT_NUMBER **Domain:** Merck Protocol Number **ID:** MK-0431-845 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2018-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-02-25 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-01-22 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-02-25 **Type:** ACTUAL **Results First Submit Date:** 2019-01-18 **Results First Submit QC Date:** 2019-02-22 #### Start Date **Date:** 2016-05-09 **Type:** ACTUAL **Status Verified Date:** 2019-02 #### Study First Post Date **Date:** 2016-04-14 **Type:** ESTIMATED **Study First Submit Date:** 2016-04-11 **Study First Submit QC Date:** 2016-04-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative to withdrawing sitagliptin. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 746 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **Intervention Names:** - Drug: Sitagliptin - Drug: Metformin - Drug: Metformin XR - Drug: Insulin glargine **Label:** Sitagliptin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **Intervention Names:** - Drug: Placebo to sitagliptin - Drug: Metformin - Drug: Metformin XR - Drug: Insulin glargine **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Sitagliptin **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **Name:** Sitagliptin **Other Names:** - Januvia® **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **Name:** Placebo to sitagliptin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo - Sitagliptin **Description:** At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC). **Name:** Metformin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Placebo - Sitagliptin **Description:** At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC. **Name:** Metformin XR **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Placebo - Sitagliptin **Description:** Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously. **Name:** Insulin glargine **Other Names:** - LANTUS®) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. **Measure:** Change From Baseline in A1C at Week 30 **Time Frame:** Baseline and Week 30 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Measure:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Time Frame:** Up to 30 weeks **Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. **Measure:** Percentage of Participants Who Discontinued Study Drug Due to an AE **Time Frame:** Up to 30 weeks **Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. **Measure:** Percentage of Participants Who Experienced One or More Adverse Events (AEs) **Time Frame:** Up to 32 weeks #### Secondary Outcomes **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. **Measure:** Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Time Frame:** Up to 30 weeks **Description:** Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. **Measure:** Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 **Time Frame:** Baseline and Week 30 **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Measure:** Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Time Frame:** Up to 30 weeks **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Measure:** Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Time Frame:** Up to 30 weeks **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). **Measure:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Time Frame:** Up to 30 weeks **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. **Measure:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 **Time Frame:** Week 30 **Description:** Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0). **Measure:** Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 **Time Frame:** Baseline and Week 30 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Measure:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Time Frame:** Up to 30 weeks **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). **Measure:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Time Frame:** Up to 30 weeks **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). **Measure:** Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Time Frame:** Up to 30 weeks **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. **Measure:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30 **Time Frame:** Week 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Have T2DM based on American Diabetes Association guidelines * Be on one of the following treatment regimens: 1. Stable dose of sitagliptin (100 mg/day) and metformin IR or XR (metformin) (≥1500 mg/day) either co-administered or as a fixed dose combination (FDC) for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive. OR 2. Stable dose of metformin (≥1500 mg/day) and another dipeptidyl peptidase-4 (DPP-4) inhibitor (at maximum labeled dose, other than sitagliptin, either co-administered or as a FDC, for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive. OR 3. Stable dose of sitagliptin (100 mg/day) and metformin (≥1500 mg/day) either co administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and sitagliptin (100 mg/day) with A1C between 7.0% and 10.0%, inclusive. OR 4. Stable dose of metformin (≥1500 mg/day) and another DPP-4 inhibitor (at maximum labeled dose), other than sitagliptin, either co-administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and another DPP-4 inhibitor other than sitagliptin with A1C between 7.0% and 10.0%, inclusive OR 5. Stable dose of metformin (≥1500 mg/day) and a sulfonylurea either co-administered or as a FDC for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive. * Meet one of the following categories: 1. The participant is a male 2. The participant is a female who is not of reproductive potential 3. The participant is a female who is of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by practicing abstinence from heterosexual activity OR use (or have her partner use) acceptable contraception during heterosexual activity Exclusion Criteria: * Has been treated with any anti-hyperglycemic agent (AHA) other than protocol-specified agents (i.e., other than metformin, DPP-4 inhibitor, or sulfonylurea agent) within the prior 12 weeks. * Has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, OR has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks. * Has a history of type 1 diabetes mellitus (T1DM) or ketoacidosis, or has a history of latent autoimmune diabetes of adults (LADA), is assessed by the investigator as possibly having T1DM or LADA confirmed with a C-peptide \<0.7 ng/mL (\<0.23 nmol/L), or has a history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, or post-organ transplant). * Is assessed by the investigator to be not appropriate for, or does not agree to target, a fasting glucose of 72-100 mg/dL (4.0-5.6 mmol/L). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### References **Citation:** Roussel R, Duran-Garcia S, Zhang Y, Shah S, Darmiento C, Shankar RR, Golm GT, Lam RLH, O'Neill EA, Gantz I, Kaufman KD, Engel SS. Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study. Diabetes Obes Metab. 2019 Apr;21(4):781-790. doi: 10.1111/dom.13574. Epub 2018 Dec 9. **PMID:** 30393950 ## Document Section ### Large Document Module #### Large Docs - Date: 2016-07-14 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 3838059 - Type Abbrev: Prot_SAP - Upload Date: 2019-01-18T10:19 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes Mellitus - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000054873 - Term: Dipeptidyl-Peptidase IV Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M11667 - Name: Metformin - Relevance: HIGH - As Found: Assessment - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M347 - Name: Insulin Glargine - Relevance: HIGH - As Found: Gait - ID: M335 - Name: Sitagliptin Phosphate - Relevance: HIGH - As Found: Anesthetic - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M27957 - Name: Dipeptidyl-Peptidase IV Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008687 - Term: Metformin - ID: D000069036 - Term: Insulin Glargine - ID: D000068900 - Term: Sitagliptin Phosphate ### Misc Info Module #### Removed Countries - Country: Argentina - Country: Australia - Country: Canada - Country: Czech Republic - Country: Czechia - Country: Denmark - Country: Estonia - Country: France - Country: Germany - Country: Guatemala - Country: Hungary - Country: Israel - Country: Korea, Republic of - Country: Latvia - Country: Mexico - Country: New Zealand - Country: Philippines - Country: Poland - Country: Puerto Rico - Country: Romania - Country: Russian Federation - Country: Spain - Country: Turkey - Country: United Kingdom - Country: United States - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators. #### Event Groups **Group ID:** EG000 **Title:** Sitagliptin **Deaths Num At Risk:** 373 **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** EG000 **Other Num Affected:** 79 **Other Num at Risk:** 373 **Serious Number Affected:** 14 **Serious Number At Risk:** 373 **Title:** Sitagliptin **Group ID:** EG001 **Title:** Placebo **Deaths Num Affected:** 2 **Deaths Num At Risk:** 370 **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** EG001 **Other Num Affected:** 72 **Other Num at Risk:** 370 **Serious Number Affected:** 18 **Serious Number At Risk:** 370 **Title:** Placebo **Frequency Threshold:** 5 #### Other Events **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 **Term:** Hypoglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 20.1 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 #### Serious Events **Term:** Acute myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Atrial fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Coronary artery disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Phimosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Congenital, familial and genetic disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Strangulated umbilical hernia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Cholecystitis acute **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Bronchitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Gastroenteritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Groin abscess **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Pyelonephritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Sialoadenitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Tracheitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Fibula fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Ligament rupture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Heart rate irregular **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Hyponatraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Endometrial adenocarcinoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Gastrointestinal tract adenoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Non-Hodgkin's lymphoma **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Prostate cancer **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Carotid artery stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Cerebral ischaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Cerebrovascular accident **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 370 **Num Events:** 2 **Term:** Ischaemic stroke **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 370 **Num Events:** 2 **Term:** Lumbar radiculopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Neuralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Term:** Sciatica **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Acute respiratory failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 373 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 370 **Term:** Diabetic foot **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 20.1 ##### Stats **Group ID:** EG000 **Num At Risk:** 373 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 370 **Num Events:** 1 **Time Frame:** Up to 32 weeks ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Units:** Participants ### Group **ID:** BG000 **Title:** Sitagliptin **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks ### Group **ID:** BG001 **Title:** Placebo **Description:** Placebo to sitagliptin 100 mg, oral, once daily for 30 weeks ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.5 **Value:** 58.5 #### Measurement **Group ID:** BG001 **Spread:** 9.7 **Value:** 58.1 #### Measurement **Group ID:** BG002 **Spread:** 9.6 **Value:** 58.3 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** In utero #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Preterm newborn infants (gestational age < 37 wks) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Newborns (0-27 days) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Infants and toddlers (28 days-23 months) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Children (2-11 years) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Adolescents (12-17 years) #### Measurement **Group ID:** BG000 **Value:** 275 #### Measurement **Group ID:** BG001 **Value:** 272 #### Measurement **Group ID:** BG002 **Value:** 547 **Category Title:** Adults (18-64 years) #### Measurement **Group ID:** BG000 **Value:** 99 #### Measurement **Group ID:** BG001 **Value:** 100 #### Measurement **Group ID:** BG002 **Value:** 199 **Category Title:** From 65-84 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** 85 years and over #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 204 #### Measurement **Group ID:** BG001 **Value:** 181 #### Measurement **Group ID:** BG002 **Value:** 385 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 170 #### Measurement **Group ID:** BG001 **Value:** 191 #### Measurement **Group ID:** BG002 **Value:** 361 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 19 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 37 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 42 #### Measurement **Group ID:** BG001 **Value:** 37 #### Measurement **Group ID:** BG002 **Value:** 79 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 12 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 24 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 259 #### Measurement **Group ID:** BG001 **Value:** 270 #### Measurement **Group ID:** BG002 **Value:** 529 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 68 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 36 #### Measurement **Group ID:** BG001 **Value:** 26 #### Measurement **Group ID:** BG002 **Value:** 62 **Category Title:** Asia #### Measurement **Group ID:** BG000 **Value:** 158 #### Measurement **Group ID:** BG001 **Value:** 172 #### Measurement **Group ID:** BG002 **Value:** 330 **Category Title:** Europe #### Measurement **Group ID:** BG000 **Value:** 85 #### Measurement **Group ID:** BG001 **Value:** 83 #### Measurement **Group ID:** BG002 **Value:** 168 **Category Title:** Latin America #### Measurement **Group ID:** BG000 **Value:** 80 #### Measurement **Group ID:** BG001 **Value:** 78 #### Measurement **Group ID:** BG002 **Value:** 158 **Category Title:** North America #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 28 **Category Title:** Other #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 0.9 **Value:** 8.8 #### Measurement **Group ID:** BG001 **Spread:** 1.0 **Value:** 8.8 #### Measurement **Group ID:** BG002 **Spread:** 0.9 **Value:** 8.8 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 373 **Group ID:** BG001 **Value:** 370 **Group ID:** BG002 **Value:** 743 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 50.8 **Value:** 199.0 #### Measurement **Group ID:** BG001 **Spread:** 51.8 **Value:** 201.2 #### Measurement **Group ID:** BG002 **Spread:** 51.3 **Value:** 200.1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 373 **Group ID:** BG001 **Value:** 370 **Group ID:** BG002 **Value:** 743 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 30.3 **Value:** 103.7 #### Measurement **Group ID:** BG001 **Spread:** 28.1 **Value:** 106.4 #### Measurement **Group ID:** BG002 **Spread:** 29.2 **Value:** 105.1 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 373 **Group ID:** BG001 **Value:** 370 **Group ID:** BG002 **Value:** 743 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 19.8 **Value:** 84.8 #### Measurement **Group ID:** BG001 **Spread:** 18.9 **Value:** 85.6 #### Measurement **Group ID:** BG002 **Spread:** 19.4 **Value:** 85.2 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 373 **Group ID:** BG001 **Value:** 370 **Group ID:** BG002 **Value:** 743 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 184 #### Measurement **Group ID:** BG001 **Value:** 184 #### Measurement **Group ID:** BG002 **Value:** 368 **Category Title:** Met + DPP-4i #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 86 #### Measurement **Group ID:** BG002 **Value:** 173 **Category Title:** Met + DPP-4i + sulfonylurea (SU) #### Measurement **Group ID:** BG000 **Value:** 103 #### Measurement **Group ID:** BG001 **Value:** 102 #### Measurement **Group ID:** BG002 **Value:** 205 **Category Title:** Met + SU #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 374 **Group ID:** BG001 **Value:** 372 **Group ID:** BG002 **Value:** 746 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Geographic Region **Unit of Measure:** Participants ### Measure 6 **Description:** Percent A1C= Glycated hemoglobin/total hemoglobin x 100 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** All randomized and treated participants **Title:** Hemoglobin A1C (A1C) **Unit of Measure:** Percent A1C ### Measure 7 **Description:** Fasting plasma glucose level after a 10-hour overnight fast. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** All randomized and treated participants **Title:** Fasting Plasma Glucose (FPG) **Unit of Measure:** mg/dL ### Measure 8 **Description:** Estimated Glomerular Filtration Rate (eGFR) is a test of renal function. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** All randomized and treated participants **Title:** Estimated Glomerular Filtration Rate **Unit of Measure:** mL/min/1.73 m^2 ### Measure 9 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** All randomized and treated participants **Title:** Body Weight **Unit of Measure:** Kilograms ### Measure 10 **Description:** Background Anti-Hyperglycemic Agent (AHA) at Screening metformin = Met) dipeptidyl peptidase 4 inhibitor = DPP-4i **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Anti-Hyperglycemic Agent **Unit of Measure:** Participants **Population Description:** The overall number of baseline participants included all randomized participants. ## Results Section - More Information Module ### Certain Agreement **Other Details:** The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** ClinicalTrialsDisclosure@merck.com **Organization:** Merck Sharp & Dohme Corp. **Phone:** 1-800-672-6372 **Title:** Clinical Trials Disclosure ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -0.58 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -0.34 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM **Non-Inferiority Comment:** Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%. **Non-Inferiority Type:** NON_INFERIORITY **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Between Group Difference in the LSM **Parameter Value:** -0.46 **Statistical Comment:** **Statistical Method:** LDA **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.58 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -0.34 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. **Non-Inferiority Comment:** Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin. **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** < 0.001 **P-Value Comment:** **Parameter Type:** Between Group Difference in the LSM **Parameter Value:** -0.46 **Statistical Comment:** **Statistical Method:** LDA **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** 0.54 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.98 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale). **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.039 **P-Value Comment:** **Parameter Type:** Event Rate Ratio **Parameter Value:** 0.73 **Statistical Comment:** **Statistical Method:** Negative Binomial Model **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** -2.3 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.7 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** 95% CI **Non-Inferiority Type:** OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -0.3 **Statistical Comment:** **Statistical Method:** Miettinen & Nurminen **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** -11.2 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.9 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.250 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -4.1 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** -14.6 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -1.5 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.016 **P-Value Comment:** **Parameter Type:** Between Group Difference in the LSM **Parameter Value:** -8.0 **Statistical Comment:** **Statistical Method:** LDA model **Tested Non-Inferiority:** ### Outcome Measure 6 #### Analysis **CI Lower Limit:** 0.67 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.99 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale). **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.041 **P-Value Comment:** **Parameter Type:** Event Rate Ratio **Parameter Value:** 0.81 **Statistical Comment:** **Statistical Method:** Negative Binomial Model **Tested Non-Inferiority:** ### Outcome Measure 7 #### Analysis **CI Lower Limit:** 0.51 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.37 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale). **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.473 **P-Value Comment:** **Parameter Type:** Event Rate Ratio **Parameter Value:** 0.83 **Statistical Comment:** **Statistical Method:** Negative Binomial Model **Tested Non-Inferiority:** ### Outcome Measure 8 #### Analysis **CI Lower Limit:** -6.2 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 3.7 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.624 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -1.2 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ### Outcome Measure 9 #### Analysis **CI Lower Limit:** 11.6 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 25.7 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** < 0.001 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** 18.8 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ### Outcome Measure 10 #### Analysis **CI Lower Limit:** -11.9 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -1.0 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.020 **P-Value Comment:** **Parameter Type:** Between Group Difference in the LSM **Parameter Value:** -6.5 **Statistical Comment:** **Statistical Method:** LDA **Tested Non-Inferiority:** ### Outcome Measure 11 #### Analysis **CI Lower Limit:** -9.1 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 5.0 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** 95% CI **Non-Inferiority Type:** OTHER **Other Analysis Description:** **P-Value:** **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -2.1 **Statistical Comment:** **Statistical Method:** Miettinen & Nurminen **Tested Non-Inferiority:** ### Outcome Measure 12 #### Analysis **CI Lower Limit:** 0.40 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.44 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale). **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.394 **P-Value Comment:** **Parameter Type:** Event Rate Ratio **Parameter Value:** 0.76 **Statistical Comment:** **Statistical Method:** Negative Binomial Model **Tested Non-Inferiority:** ### Outcome Measure 13 #### Analysis **CI Lower Limit:** -8.2 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 5.8 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.740 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -1.2 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ### Outcome Measure 14 #### Analysis **CI Lower Limit:** -4.7 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 3.2 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.712 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** -0.7 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ### Outcome Measure 15 #### Analysis **CI Lower Limit:** 0.5 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 10.1 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** = 0.030 **P-Value Comment:** **Parameter Type:** Between Group Difference in Percentages **Parameter Value:** 5.3 **Statistical Comment:** **Statistical Method:** Miettinen and Nurminen **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -1.98 - **Spread:** -1.98 - **Upper Limit:** -1.78 - **Value:** -1.88 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -1.52 - **Spread:** -1.52 - **Upper Limit:** -1.32 - **Value:** -1.42 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.22 - **Spread:** 1.22 - **Upper Limit:** 1.96 - **Value:** 1.55 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.70 - **Spread:** 1.70 - **Upper Limit:** 2.66 - **Value:** 2.12 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.6 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 28.5 - **Spread:** 28.5 - **Upper Limit:** 38.6 - **Value:** 33.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 32.7 - **Spread:** 32.7 - **Upper Limit:** 42.6 - **Value:** 37.7 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 48.5 - **Spread:** 48.5 - **Upper Limit:** 58.0 - **Value:** 53.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 56.5 - **Spread:** 56.5 - **Upper Limit:** 66.0 - **Value:** 61.3 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.34 - **Spread:** 4.34 - **Upper Limit:** 5.88 - **Value:** 5.05 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.33 - **Spread:** 5.33 - **Upper Limit:** 7.24 - **Value:** 6.21 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.20 - **Spread:** 0.20 - **Upper Limit:** 0.45 - **Value:** 0.30 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.25 - **Spread:** 0.25 - **Upper Limit:** 0.53 - **Value:** 0.36 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 8.9 - **Spread:** 8.9 - **Upper Limit:** 15.8 - **Value:** 12.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 10.0 - **Spread:** 10.0 - **Upper Limit:** 17.2 - **Value:** 13.6 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 54.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 35.4 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** -90.0 - **Spread:** -90.0 - **Upper Limit:** -79.6 - **Value:** -84.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** -83.5 - **Spread:** -83.5 - **Upper Limit:** -73.1 - **Value:** -78.3 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 57.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 60.0 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.10 - **Spread:** 0.10 - **Upper Limit:** 0.28 - **Value:** 0.17 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0.14 - **Spread:** 0.14 - **Upper Limit:** 0.36 - **Value:** 0.22 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 61.9 - **Spread:** 61.9 - **Upper Limit:** 71.7 - **Value:** 66.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 63.2 - **Spread:** 63.2 - **Upper Limit:** 72.9 - **Value:** 68.0 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.9 - **Spread:** 4.9 - **Upper Limit:** 10.3 - **Value:** 7.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.4 - **Spread:** 5.4 - **Upper Limit:** 11.2 - **Value:** 8.3 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10.0 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). **Reporting Status:** POSTED **Time Frame:** Baseline and Week 30 **Title:** Change From Baseline in A1C at Week 30 **Type:** PRIMARY **Unit of Measure:** Percent A1C ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race). **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Type:** PRIMARY **Unit of Measure:** Events/Participant-Years ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 3 **Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Percentage of Participants Who Discontinued Study Drug Due to an AE **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 4 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 5 **Description:** Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). **Reporting Status:** POSTED **Time Frame:** Baseline and Week 30 **Title:** Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 **Type:** SECONDARY **Unit of Measure:** Insulin Units ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 6 **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Type:** SECONDARY **Unit of Measure:** Events/Participant-Years ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 7 **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Type:** SECONDARY **Unit of Measure:** Events/Participant-Years ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 8 **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 9 **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Week 30 **Title:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 10 **Description:** Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). **Reporting Status:** POSTED **Time Frame:** Baseline and Week 30 **Title:** Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 **Type:** SECONDARY **Unit of Measure:** mg/dL ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 11 **Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 32 weeks **Title:** Percentage of Participants Who Experienced One or More Adverse Events (AEs) **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 12 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race). **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Type:** SECONDARY **Unit of Measure:** Events/Participant-Years ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 13 **Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 14 **Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Up to 30 weeks **Title:** Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo #### Outcome Measure 15 **Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. **Parameter Type:** NUMBER **Population Description:** All randomized participants who received at least one dose of study treatment. **Reporting Status:** POSTED **Time Frame:** Week 30 **Title:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30 **Type:** SECONDARY **Unit of Measure:** Percentage of participants ##### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** OG000 **Title:** Sitagliptin ##### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** OG001 **Title:** Placebo ### Participant Flow Module #### Group **Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks **ID:** FG000 **Title:** Sitagliptin #### Group **Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks **ID:** FG001 **Title:** Placebo #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Pregnancy ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Screen Failure ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Site Discontinued Study Participation ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ###### Reason **Group ID:** FG001 **Number of Subjects:** 7 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 374 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 372 ##### Milestone **Type:** Treated ###### Achievement **Group ID:** FG000 **Number of Subjects:** 373 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 370 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 361 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 347 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 13 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 25 **Pre-Assignment Details:** Male and female participants with Type 2 diabetes mellitus (T2DM) ≥18 years of age were enrolled in this trial. **Recruitment Details:** A total of 746 participants were randomized across 149 study sites in 22 countries. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02430779 **Acronym:** IRE **Brief Title:** Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms **Official Title:** Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms: Phase I and Phase II Clinical Trial #### Organization Study ID Info **ID:** pelvis ureter Neoplasms-IRE-01 #### Organization **Class:** OTHER **Full Name:** Fuda Cancer Hospital, Guangzhou ### Status Module #### Completion Date **Date:** 2021-01-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-05 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-01 **Type:** ACTUAL #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2015-04-30 **Type:** ESTIMATED **Study First Submit Date:** 2015-04-26 **Study First Submit QC Date:** 2015-04-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fuda Cancer Hospital, Guangzhou #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms. **Detailed Description:** By enrolling patients with unresectable Renal Pelvic and Ureteral Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Renal Pelvic and Ureteral Neoplasms. ### Conditions Module **Conditions:** - Renal Pelvic and Ureteral Neoplasms **Keywords:** - irreversible electroporation - Unresectable Renal Pelvic and Ureteral Neoplasms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** irreversible electroporation for Unresectable Renal Pelvic and Ureteral Neoplasms **Intervention Names:** - Procedure: rreversible electroporation (IRE) - Device: NanoKnife **Label:** IRE Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patients without treatment **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - IRE Group **Description:** Irreversible Electroportion For Unresectable Renal Pelvic and Ureteral Neoplasms guide with ultrasound or/and CT. **Name:** rreversible electroporation (IRE) **Other Names:** - NanoKnife **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - IRE Group **Name:** NanoKnife **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants with Adverse events **Time Frame:** 6 month #### Secondary Outcomes **Measure:** Percentage of lesions that show no sign of recurrence 12 months after IRE **Time Frame:** 12 months **Description:** A minimum and maximum range of voltage for safe and effective IRE will be **Measure:** Voltage (A minimum and maximum range of voltage for safe and effective IRE) **Time Frame:** 3 months **Measure:** Progress free disease (PFS) **Time Frame:** 12 months **Description:** Patients will be followed for 36 months after IRE for OS analyzed. **Measure:** Overall survival (OS) **Time Frame:** 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Renal Pelvic and Ureteral Neoplasms diagnosed by positive biopsy or non-invasive criteria, * Not suitable for surgical resection, * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * A prothrombin time ratio \> 50%, * Platelet count \> 80x10\^9/L, * Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * Able to comprehend and willing to sign the written informed consent form (ICF), * Have a life expectancy of at least 3 months. Exclusion Criteria: * Cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * Any active implanted device (eg Pacemaker), * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Biological treatment center in Fuda cancer hospital **State:** Guangdong **Zip:** 510000 #### Overall Officials **Official 1:** **Affiliation:** Fuda Cancer Hospital **Name:** Lizhi Niu, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000014515 - Term: Ureteral Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17266 - Name: Ureteral Neoplasms - Relevance: HIGH - As Found: Ureteral Neoplasms - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M17265 - Name: Ureteral Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000014516 - Term: Ureteral Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06404879 **Brief Title:** The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery. **Official Title:** The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery. #### Organization Study ID Info **ID:** 25.09.2023/07 #### Organization **Class:** OTHER **Full Name:** Giresun University ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-07 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-08 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Giresun University #### Responsible Party **Investigator Affiliation:** Giresun University **Investigator Full Name:** Dilek Yeniay **Investigator Title:** Anesthesiology and Reanimation physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\&#39;s preoperative anxiety level and postoperative pain level. **Detailed Description:** Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\&#39;s preoperative anxiety level and postoperative pain level. ### Conditions Module **Conditions:** - Anxiety - Children **Keywords:** - children - anxiety - analgesia - pediatric - anaesthesia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Are between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study. Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study. **Intervention Names:** - Other: determining scores with tests **Label:** children group ### Interventions #### Intervention 1 **Arm Group Labels:** - children group **Description:** Parents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves. An anesthesia technician blind to the content of the study will calculate and take notes on the children\&#39;s anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4). FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken. **Name:** determining scores with tests **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms. **Measure:** Anxiety level of parents **Time Frame:** preoperative period **Description:** According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4). **Measure:** Anxiety level of the child undergoing surgery **Time Frame:** preoperative and intraoperative period **Description:** Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes. **Measure:** Pain levels of children undergoing surgery **Time Frame:** postoperative period #### Secondary Outcomes **Description:** beats/min **Measure:** heart rate **Time Frame:** intraoperative period **Description:** beats/min **Measure:** heart rate **Time Frame:** up to 8 hour postoperative **Description:** such as nausea, vomiting and desaturation **Measure:** complication **Time Frame:** up to 24 hour postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The child is between the ages of 2-6 * Patients scheduled for surgery under general anesthesia due to inguinal area pathology * Surgery performed as planned * There is no mental or neurological disorder in both the mother and the child. * There are no vision, hearing or speech problems in both the mother and the child. * Parents and children who volunteer to participate in the research * Children with ASA I Exclusion Criteria: * Not volunteering to participate in the study (those for whom parental consent cannot be obtained) * Those who underwent surgery with a pathology other than the inguinal area * Having emergency surgery * Children at risk with ASA 2 and above * Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem). **Healthy Volunteers:** True **Maximum Age:** 6 Years **Minimum Age:** 2 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Children who are planned to undergo surgery under general anesthesia due to inguinal area pathology ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dgyeniay@gmail.com **Name:** DİLEK YENİAY **Phone:** +905375521553 **Role:** CONTACT #### Locations **Location 1:** **City:** Giresun **Contacts:** ***Contact 1:*** - **Email:** dgyeniay@gmail.com - **Name:** Dilek Giresun Gynecology and Pediatrics Training Research Hospital - **Phone:** +90 454 2163600 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dilek Yeniay - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Giresun Gynecology and Pediatrics Training Research Hospital **State:** Centre **Zip:** 28000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative - ID: D000001008 - Term: Anxiety Disorders ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11595 - Name: Meperidine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05084079 **Brief Title:** Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT **Official Title:** The Impact of Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in Short-term Intensive Insulin Therapy(SIIT) #### Organization Study ID Info **ID:** 2021526 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2022-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2021-10-19 **Type:** ACTUAL **Last Update Submit Date:** 2021-10-08 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-10 **Type:** ESTIMATED #### Start Date **Date:** 2021-11 **Type:** ESTIMATED **Status Verified Date:** 2021-10 #### Study First Post Date **Date:** 2021-10-19 **Type:** ACTUAL **Study First Submit Date:** 2021-09-26 **Study First Submit QC Date:** 2021-10-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Yanbing Li **Investigator Title:** Director of Endocrinology and Metabolism Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen. **Detailed Description:** Diabetes has become one of the major chronic non-communicable diseases. Its prevalence was rising in these years. Short-term intensive insulin therapy can improve the β-cell function and nearly half of the patients can live with long-term glycemic remission. It has therefore become the recommended treatment for the newly diagnosis T2DM patients with high blood glucose. However, due to the glycemic goal for intensive therapy is strict, it's important to find out a suitable initial insulin regimen for continuous subcutaneous insulin infusion(CSII) with which patients can achieve euglycemia safely, stably and rapidly. In previous study, the investigators found out that the total daily insulin dose at the first day when euglycemia was achieved（TDD-1） was associated with weight, waist circumference, triglycerides and fasting blood glucose levels. According to this, the investigators figured out a formula for estimation of insulin dose for the short-term intensive insulin therapy in patients with newly diagnosed T2DM. However, its feasibility needs to be further verified. Therefore, the investigators conducted this prospective randomized controlled study to compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes patients, in order to investigate the rational of formula based initiation regimen. ### Conditions Module **Conditions:** - Diabetes Mellitus - Diabetes Mellitus, Type 2 - Glucose Metabolism Disorders - Metabolic Disease - Endocrine System Diseases **Keywords:** - Short-term intensive insulin therapy - Insulin dose - Time to glycemic goal - Hypoglycemic - Glycemic variability ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Initial insulin regimen was decided according to the formula developed by the investigators previously. **Intervention Names:** - Drug: CSII with formula-based initial insulin regimen **Label:** Formula-based **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Initial insulin regimen was decided according to current guidelines. **Intervention Names:** - Drug: CSII with weight-based initial insulin regimen **Label:** Weight-based **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Formula-based **Description:** Initial total daily insulin dose(TDD) for CSII was calculated with a formula :（estimate TDD-1(eTDD-1) = 0.35× body weight (kg) + 2.05× FPG (mmol/L) + 4.24×triglyceride(mmol/L) + 0.55× waist circumference (cm) - 49.1）, 42% of which was assigned as total basal dose and 58% as total premeal dose, with the pre-meal doses divided into 30:35:35 for breakfast, lunch and dinner. **Name:** CSII with formula-based initial insulin regimen **Other Names:** - Formula-based regimen **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Weight-based **Description:** TDD for CSII was started with 0.5 IU/kg, 50% of which was assigned as total basal dose and 50% as total premeal dose, and the total pre-meal dose was divided equally before each meal. **Name:** CSII with weight-based initial insulin regimen **Other Names:** - Weight-based regimen **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** After CSII begin, the time(days) to reach glycemic goal of each patients. The glycemic goal defined as at least six out of eight-point fingertip blood glucose meet the standard that fasting blood glucose(FBG) or non-postprandial blood glucose is between 4.4-6.0 mmol/L and 2h postprandial blood glucose(PBG) is between 4.4-8.0 mmol/L. **Measure:** The time to glycemic goal **Time Frame:** 1 year #### Secondary Outcomes **Description:** Differences in incidence of hypoglycemia among treatment arms at the end of study. **Measure:** Incidence of hypoglycemia **Time Frame:** 1 year **Description:** Differences in blood glucose fluctuations among treatment arms at the end of study. **Measure:** Change of blood glucose fluctuations **Time Frame:** 1 year **Description:** Differences in β-cell indicators among treatment arms at the end of study. **Measure:** Change of β cell function **Time Frame:** 1 year **Description:** Differences in insulin sensitivity indicators among treatment arms at the end of study. **Measure:** Change of insulin sensitivity **Time Frame:** 1 year **Description:** Differences in insulin dosage among treatment arms at the end of study. **Measure:** Change of insulin dosage **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Newly diagnosed type 2 diabetes (1999 World Health Organization standard); * Type 2 diabetic patients who have never received any hypoglycemic therapy (including oral hypoglycemic agents, Chinese medicine , and insulin); * Body mass index (BMI) between 20-35 kg/m2; * Fasting plasma glucose (FPG) levels between 7.0 -16.7 mmol/L, glycated haemoglobin \>7.0%; * Willing to receive CSII intensive treatment during hospitalization and monitoring blood glucose 8 times per day. Exclusion Criteria: * Type 1 diabetes or special type of diabetes; * Acute complications of diabetes: ketoacidosis, hyperosmolar coma, lactic acidosis, etc.; * Severe macrovascular complications: acute cerebral vascular accidents, acute coronary syndromes, peripheral arterial disease requiring vascular intervention or amputees for hospitalization occur within 12 months before selection; * Severe microvascular complications: proliferative phase retinopathy; urinary albumin excretion rate(AER)\> 300 mg/g or urinary protein Positive, quantitative\> 0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; * Obvious liver and kidney dysfunction: alanine aminotransferase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine greater than 150 umol/L or creatinine clearance less than 50 mL/min; * Significant increase in blood pressure: blood pressure continued to be higher than 180/110 mmHg; * Significant anemia: hemoglobin \<100g /L may require regular blood transfusions; * Use of drugs that may affect blood glucose during 12 weeks, such as oral/intravenous corticosteroids, growth hormone, estrogen/progestogen, high-dose diuretics, antipsychotics, etc. Low-dose diuretics for antihypertensive purposes (hydrochlorothiazide \<25 mg/d, indapamide ≤ 1.5 mg/d), and physiological quantities of thyroid hormones used for replacement therapy are not limited to this; * Effects associated with other underlying diseases influenced the observation of blood glucose, such as systemic infection or severe comorbidity, malignancy or chronic diarrhea, uncontrolled endocrine gland function abnormalities, chronic cardiac insufficiency (grade III and above), psychosis, or pregnant; * The patients does not cooperate, or the investigator judges that it may be difficult to complete the study. **Maximum Age:** 65 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 17301500@qq.com **Name:** Xinwei Huang, MA **Phone:** +8613480264781 **Role:** CONTACT **Contact 2:** **Email:** turkey310@163.com **Name:** Liehua Liu, PhD **Phone:** +8613751748843 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** easd04lyb@126.com - **Name:** Yanbing Li, MD,PhD - **Phone:** 8602087334331 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yanbing Li, MD,PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** endocrinology department of the first affiliated hospital of Sun Yat-sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510080 #### Overall Officials **Official 1:** **Affiliation:** endocrinology department of the first affiliated hospital of Sun Yat-sen University **Name:** Yanbing Li, MD,PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21. **PMID:** 25765670 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: HIGH - As Found: Metabolic Diseases - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: HIGH - As Found: Glucose Metabolism Disorders - ID: M7862 - Name: Endocrine System Diseases - Relevance: HIGH - As Found: Endocrine System Diseases ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000008659 - Term: Metabolic Diseases - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000004700 - Term: Endocrine System Diseases ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: HIGH - As Found: Day 1 - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: C000557859 - Term: Insulin, Globin Zinc ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00981279 **Acronym:** PHSP **Brief Title:** Profile of HIV Seropositive Patients **Official Title:** Profile of HIV Seropositive Patients on Antiretroviral Therapy at the Clinical Hospital of the Federal University of Goiás #### Organization Study ID Info **ID:** 129/2009 #### Organization **Class:** OTHER **Full Name:** Universidade Federal de Goias #### Secondary ID Infos **ID:** CONEP- 129/2009 ### Status Module #### Completion Date **Date:** 2009-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2009-10-29 **Type:** ESTIMATED **Last Update Submit Date:** 2009-10-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-09 **Type:** ACTUAL #### Start Date **Date:** 2009-06 **Status Verified Date:** 2009-09 #### Study First Post Date **Date:** 2009-09-22 **Type:** ESTIMATED **Study First Submit Date:** 2009-09-19 **Study First Submit QC Date:** 2009-09-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal de Goias #### Responsible Party **Old Name Title:** Caroline Nayanna Rodrigues Santos **Old Organization:** Universidade Federal de Goiás ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study was to delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás. **Detailed Description:** Objective: To delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás. Methods: The present study is documental and analitical descriptive and it was conducted at the Clinical Hospital of the Federal University of Goiás, trough data collection of 222 records of individuals in drug therapy. Data were collected regarding the personal aspects, aspects related to the infection and information about the most used therapeutic. ### Conditions Module **Conditions:** - HIV Infection - HIV Infections **Keywords:** - Health Profile - AIDS - Health Promotion - HIV - treatment experienced ### Design Module #### Design Info **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 222 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Seroposite HIV patients that take their treatment at the Clinical Hospital of The Federal University of Goias, and have their records in the hospital. **Label:** HIV seroposite patients ### Outcomes Module #### Primary Outcomes **Measure:** Data regarding the personal aspects, aspects related to the infection and information about the most used therapeutic. **Time Frame:** Since the start of the drug therapy ( means of 36 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All of the patients that had data in the hospital * All with the diagnose of HIV * Using antiretroviral drugs Exclusion Criteria: * Incompleted records * Patients who didn't take their medicines regularly. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Community sample, with HIV, in drug therapy in the Clinical Hospital of UFG. ### Contacts Locations Module #### Locations **Location 1:** **City:** Goiânia **Country:** Brazil **Facility:** Federal University of Goias **State:** GO **Zip:** 74.605-020 #### Overall Officials **Official 1:** **Affiliation:** UFG **Name:** Caroline N Rodrigues, Graduated **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Information about epidemiological datas of HIV patients in Goiás, Brazil **URL:** http://www.saude.go.gov.br/index.php?idMateria=16409 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000086982 - Term: Blood-Borne Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes - ID: D000007154 - Term: Immune System Diseases - ID: D000012897 - Term: Slow Virus Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: HIGH - As Found: HIV Infections - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: HIV Infections - ID: M9742 - Name: HIV Seropositivity - Relevance: HIGH - As Found: HIV Seropositive - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M15700 - Name: Slow Virus Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000015658 - Term: HIV Infections - ID: D000000163 - Term: Acquired Immunodeficiency Syndrome - ID: D000006679 - Term: HIV Seropositivity ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01462279 **Acronym:** VO2 **Brief Title:** Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness **Official Title:** The Effect of Thiamine on VO2 Levels in Critically Ill Patients #### Organization Study ID Info **ID:** 2010P000312 #### Organization **Class:** OTHER **Full Name:** Beth Israel Deaconess Medical Center ### Status Module #### Completion Date **Date:** 2012-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-01-16 **Type:** ACTUAL **Last Update Submit Date:** 2017-12-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2016-11-30 **Type:** ESTIMATED **Results First Submit Date:** 2016-10-07 **Results First Submit QC Date:** 2016-10-07 #### Start Date **Date:** 2011-09 **Status Verified Date:** 2017-12 #### Study First Post Date **Date:** 2011-10-31 **Type:** ESTIMATED **Study First Submit Date:** 2011-10-25 **Study First Submit QC Date:** 2011-10-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** American Medical Association #### Lead Sponsor **Class:** OTHER **Name:** Beth Israel Deaconess Medical Center #### Responsible Party **Investigator Affiliation:** Beth Israel Deaconess Medical Center **Investigator Full Name:** Michael Donnino **Investigator Title:** Associate Professor of Emergency Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this study is to determine the effect of thiamine therapy on oxygen consumption in critically-ill patients. The investigators will evaluate this by measuring VO2 before and after thiamine administration in patients admitted to the ICU and requiring mechanical ventilation. **Detailed Description:** Extensive research has been done over the past two decades looking at the role of oxygen delivery (DO2) and oxygen utilization (VO2) in critical illness. VO2 depends on cardiac output, arterial oxygen content, and the body's ability to extract oxygen effectively from the blood. Oxygen demand rises in critical illness as the body goes into a catabolic state, and lower VO2 has been associated with higher lactate levels and with poorer outcomes. Although increasing DO2 will often raise VO2, Hayes et al found that a subset of critically-ill patients failed to demonstrate a rise in VO2 in spite of achieving supranormal values of cardiac index (CI) and DO2. This group, in contrast to patients whose VO2 rose with the increase in CI and DO2, had exceedingly poor outcomes, suggesting that an inability to extract oxygen from the blood confers a poorer prognosis.(1) Thiamine deficiency can manifest in several ways, but the syndrome of wet beriberi, caused by thiamine deficiency, includes lactic acidosis, cardiac decompensation and vasodilatory shock, similar to sepsis and other forms of critical illness. The mechanism by which thiamine deficiency causes dysfunction rests upon the vitamin's essential role in the Krebs cycle and Pentose Phosphate Pathway. Lack of adequate thiamine results in the failure of pyruvate to enter the Krebs Cycle, thus preventing aerobic metabolism. The resulting decrease in aerobic metabolism and increase in anaerobic metabolism leads to decreased oxygen consumption by the tissues and increased lactic acid production. The investigators group has found previously that upwards of 20% of critically ill patients with sepsis are thiamine deficient within 72 hours of presentation. In a dog model of septic shock, Lindenbaum et al have shown that, regardless of thiamine levels, supplementation with thiamine improved not only lactate clearance and mean arterial pressure, but increased VO2 as well. The effect of thiamine on VO2 in critically ill humans has not yet been reported, but an increase in VO2 max after administration of thiamine to healthy volunteers has been described. VO2 is known to rise in inflammatory states, reflecting increased energy expenditure. Prior studies have shown that VO2 will decrease with interventions such as fever control. In spite of VO2 being higher than normal in critically-ill patients, however, the end-organ damage and lactic acidosis suggest that it is not high enough to meet the metabolic demands of the critically-ill body. If the investigators were able to increase VO2 further in critically-ill patients, the investigators could potentially help maintain aerobic metabolism and decrease tissue hypoxia and the resulting end-organ damage. The investigators hypothesis is that administering thiamine intravenously to critically-ill patients will increase VO2. Multiple methods of measuring VO2 have been used in the ICU, but in the current era where invasive monitoring with routine use of PA catheters is no longer the norm, indirect calorimetry became, for a time, the gold standard for measurement of gas exchange in critically ill, mechanically ventilated patients.(2) The metabolic cart used for indirect calorimetry is cumbersome and requires frequent calibration to maintain accuracy, however, and a newer, more portable method has been designed. The Datex-Ohmeda M-COVX device has been approved for the measurement of VO2 and VCO2 in mechanically ventilated patients. In studies, it has been validated as a method that is as accurate as indirect calorimetry, and perhaps even more accurate at higher FiO2.(3,4) The Datex-Ohmeda M-COVX connects to the Carescape B650 monitor made by GE, and measures VO2 through a single-use spirometer that attaches to the patient's ventilator tubing. In the following proposal, the investigators present a plan to examine the effect of thiamine therapy on VO2 in 30 critically-ill, mechanically ventilated patients, using the Datex-Ohmeda M-COVX module to measure VO2 before and after thiamine administration. ### Conditions Module **Conditions:** - Acute Respiratory Failure **Keywords:** - acute respiratory failure - thiamine - oxygen consumption - VO2 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Open label - 200mg IV **Intervention Names:** - Drug: Thiamine **Label:** Thiamine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Thiamine **Description:** 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once **Name:** Thiamine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken. **Measure:** Improvement in VO2 **Time Frame:** Baseline to 9 Hours #### Secondary Outcomes **Description:** Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error. **Measure:** Improvement in Hemodynamics **Time Frame:** Baseline to Nine Hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (age \> 18 years) admitted to an ICU * Mechanically ventilated Exclusion Criteria: * Unstable ventilator settings during measurement of VO2 * Temp \> 100 at time of VO2 measurement * FIO2 \> 60% * Endotracheal cuff leak, chest tube, or other evident source of air leak * Thiamine supplementation within 24 hours prior to study enrollment **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Beth Israel Deaconess Medical Center (BIDMC) **State:** Massachusetts **Zip:** 02115 #### Overall Officials **Official 1:** **Affiliation:** Beth Israel Deaconess Medical Center **Name:** Katherine M Berg, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Beth Israel Deaconess Medical Center **Name:** Michael W Donnino, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Berg KM, Gautam S, Salciccioli JD, Giberson T, Saindon B, Donnino MW. Intravenous thiamine is associated with increased oxygen consumption in critically ill patients with preserved cardiac index. Ann Am Thorac Soc. 2014 Dec;11(10):1597-601. doi: 10.1513/AnnalsATS.201406-259BC. **PMID:** 25390455 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Respiratory Failure - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Intervention Browse Module - Ancestors - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M16595 - Name: Thiamine - Relevance: HIGH - As Found: Patient-controlled analgesia - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T464 - Name: Thiamin - Relevance: HIGH - As Found: Patient-controlled analgesia - ID: T465 - Name: Thiamine - Relevance: HIGH - As Found: Patient-controlled analgesia - ID: T469 - Name: Vitamin B1 - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013831 - Term: Thiamine ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Thiamine **Description:** Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once **ID:** EG000 **Other Num at Risk:** 17 **Serious Number At Risk:** 17 **Title:** Thiamine **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 17 **Units:** Participants ### Group **ID:** BG000 **Title:** Thiamine **Description:** Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once ### Measure #### Measurement **Group ID:** BG000 **Spread:** 17 **Value:** 66 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 11 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 16 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 15 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 17 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** mdonnino@bidmc.harvard.edu **Organization:** Beth Israel Deaconess Medical Center **Phone:** 6177542341 **Title:** Dr. Michael W. Donnino ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.6 - **Upper Limit:** - **Value:** 16.9 **Title:** #### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline to 9 Hours **Title:** Improvement in VO2 **Type:** PRIMARY **Unit of Measure:** ml/min ##### Group **Description:** Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once **ID:** OG000 **Title:** Thiamine #### Outcome Measure 2 **Description:** Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error. **Population Description:** Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error. **Reporting Status:** POSTED **Time Frame:** Baseline to Nine Hours **Title:** Improvement in Hemodynamics **Type:** SECONDARY ##### Group **Description:** Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once **ID:** OG000 **Title:** Thiamine ### Participant Flow Module #### Group **Description:** Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once **ID:** FG000 **Title:** Thiamine #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 20 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 17 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03447379 **Brief Title:** Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent **Official Title:** Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent #### Organization Study ID Info **ID:** 3-2017-0230 #### Organization **Class:** OTHER **Full Name:** Gangnam Severance Hospital ### Status Module #### Completion Date **Date:** 2022-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2022-08-17 **Type:** ACTUAL #### Start Date **Date:** 2017-12-15 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2018-02-27 **Type:** ACTUAL **Study First Submit Date:** 2017-12-01 **Study First Submit QC Date:** 2018-02-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gangnam Severance Hospital #### Responsible Party **Investigator Affiliation:** Gangnam Severance Hospital **Investigator Full Name:** Bumkee Hong **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®) ### Conditions Module **Conditions:** - Coronary Artery Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1452 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** P2Y12 antagonist monotherapy after 3-month DAPT **Intervention Names:** - Drug: P2Y12 antagonist monotherapy **Label:** P2Y12 antagonist monotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Aspirin + P2Y12 antagonist after 3-month DAPT **Intervention Names:** - Drug: Aspirin plus P2Y12 antagonist **Label:** Aspirin + P2Y12 antagonist **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - P2Y12 antagonist monotherapy **Description:** P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) **Name:** P2Y12 antagonist monotherapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Aspirin + P2Y12 antagonist **Description:** DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year **Name:** Aspirin plus P2Y12 antagonist **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization **Measure:** Major adverse cardiovascular clinical events (MACCE) **Time Frame:** between 3 and 12 month after the procedure **Description:** The Bleeding Academic Research Consortium (BARC) type 3 or 5 **Measure:** Major bleeding **Time Frame:** between 3 and 12 month after the procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 19+ 2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®) 3. Patients who understand the content of the subject description and voluntarily sign the subject Exclusion Criteria: 1. Age 86+ 2. Hemodynamically unstable patient 3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent 4. Patients at high risk of bleeding, anemia, thrombocytopenia 5. Patients requiring oral anticoagulants 6. Pregnant women or women of childbearing age 7. Life expectancy is less than one year 8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir) 9. Patients with a history of intracranial hemorrhage 10. Patients with moderate to severe hepatic impairment 11. Patients underwent coronary intervention with stenting within 1 year 12. Patients with left-main lesions requiring coronary intervention 13. Patients with chronic stricture lesions requiring treatment 14. Patients with in-stent restenosis in a lesion requiring treatment 15. Patients with bifurcation lesions requiring stenting in lateral branches 16. Patients with lesions requiring more than 3 stents **Maximum Age:** 85 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Gangnam Severance Hospital **State:** Souel #### Overall Officials **Official 1:** **Affiliation:** Gangnam Severance Hospital **Name:** Bumkee Hong **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M255 - Name: Everolimus - Relevance: LOW - As Found: Unknown - ID: M1669 - Name: Clopidogrel - Relevance: LOW - As Found: Unknown - ID: M4548 - Name: Aspirin - Relevance: HIGH - As Found: Progression - ID: M1812 - Name: Ticagrelor - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001241 - Term: Aspirin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00947479 **Acronym:** OSA-AKI **Brief Title:** Effect of Obstructive Sleep Apnea on Central Blood Pressure and Kidney and Endothelial Function **Official Title:** Effect of Correction of Obstructive Sleep Apnea With Positive Airway Pressure on Central Blood Pressure and Kidney and Endothelial Function #### Organization Study ID Info **ID:** UMLodz OSA-AKI #### Organization **Class:** OTHER **Full Name:** Medical University of Lodz ### Status Module #### Completion Date **Date:** 2011-07 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2009-07-28 **Type:** ESTIMATED **Last Update Submit Date:** 2009-07-27 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2010-06 **Type:** ESTIMATED #### Start Date **Date:** 2009-02 **Status Verified Date:** 2009-07 #### Study First Post Date **Date:** 2009-07-28 **Type:** ESTIMATED **Study First Submit Date:** 2009-07-27 **Study First Submit QC Date:** 2009-07-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of Lodz #### Responsible Party **Old Name Title:** Professor Michał Nowicki **Old Organization:** Department of Nephrology, Hypertension and Kidney Transplantation ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms responsible for AKI might be endothelial injury followed by an increase of central aortic pressure. **Detailed Description:** Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. Its prevalence may reach 25% in middle-aged men and 11% in women. The most important risk factor for OSA is obesity - every 10% weight gain increases the incidence of the disease 6 times. OSA usually occurs in middle age males and is characterized by history of snoring, daytime somnolence and nocturnal choking or gasping. The underlying cause is transient cessation of airflow due to occlusion of the oropharyngeal tract. Episodes of apnea are considered important if they persist for longer than 10 seconds, but in some cases they may last as long as 2 minutes. The airway occlusion results in recurrent hypoxia, hypercapnia, arousals from sleep, compensatory hyperventilation leading to secondary hypocapnia and generation of exaggerated negative intrathoracic pressure that all can either directly or indirectly be harmful to the cardiovascular system through several pathways like sympathetic activation, inflammation, oxidative stress and endothelial dysfunction. Recurrent episodes of apnea/hypoxia may negatively affect the function of many organs, e.g. they induce (cyclical bradycardia during the apneic episodes, followed by tachycardia during the ensuing ventilatory phases) or rise blood pressure. Moreover, OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The mechanisms responsible for this phenomenon are complex because the direct effects of apnea (hypoxemia and low intrathoracic pressure) are modified by cardiopulmonary reflexes. Undoubtedly, the rapid increase in arterial pressure that occurs at the end of an apneic episode is mainly mediated by surges in sympathetic function during the arousal reaction. Hypertension has emerged as a second, after diabetes mellitus, most frequent cause of chronic kidney disease (CKD). The rise of arterial blood pressure and endothelial damage due to ischaemia during apneic episodes may contribute to CKD. According to the recent findings OSA patients are much more frequently diagnosed with chronic kidney disease. The high frequency of OSA in patients with renal function impairment could be explained by the fact that the most common comorbid conditions of CKD, namely atherosclerosis and diabetes, are also independently associated with his syndrome. The detailed pathogenesis of the strong relation between OSA and CKD has not been investigated so far. OSA patients are characterized by arterial stiffness, evaluated by pulse-wave velocity (PWV). PWV is a sensitive and validated marker of cardiovascular risk, including premature coronary artery disease, atherosclerosis, stroke and cardiovascular mortality. The diagnosis of acute kidney injury (AKI) is routinely based on changes in serum creatinine, but its measurements are a poor indicator of acute deterioration in kidney function. First, serum creatinine concentrations might not change until about 50% of kidney function has already been lost. Second, serum creatinine levels can vary widely with age, sex, muscle mass, muscle metabolism, medications and hydration status. Novel, more specific and sensitive biomarkers of AKI are neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, kidney injury molecule 1 (KIM-1), liver-type fatty acid-binding protein (L-FABP), which concentrations in both urine or serum rise significantly in patients with AKI and correlate with severity of kidney injury. CKD is a devastating illness that has reached epidemic proportions worldwide. CKD is characterized by a progressive decline in kidney function that is associated with excess morbidity and mortality. The deterioration of kidney function can be delayed and patient outcome favorably affected if kidney disease is recognized and treated in a timely manner. In our study we would like to prove that apneic episodes during sleep can cause repeated renal ischaemia-reperfusion injuries, which may lead to repeated acute subclinical kidney injuries (AKI) contributing to the development of chronic kidney disease. The aim of this project is to study the influence of sleep apnea syndrome on the markers of acute kidney injury, endothelial function, arterial stiffness and central aortic pressure. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea - Acute Kidney Failure - Chronic Kidney Disease **Keywords:** - obstructive sleep apnea - pulse-wave velocity, - acute kidney injury - biomarkers of acute kidney injury ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CPAP will be applied in all patients **Intervention Names:** - Other: continuous positive airway pressure (CPAP) **Label:** continuous positive airway pressure (CPAP) **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - continuous positive airway pressure (CPAP) **Description:** After being qualified into the study according to the aforementioned inclusion criteria and after giving an informed consent the polysomnography will be performed in all patients during night rest.In all patients eligible to sleep apnea treatment according to apnea/hypopnea index (AHI, number of apneic/hypopneic episodes per 1 h of effective sleep) from diagnostic polysomnography, CPAP treatment will be introduced under polysomnographic surveillance and the same panel of clinical and biochemical parameters will be evaluated. **Name:** continuous positive airway pressure (CPAP) **Other Names:** - Epworth sleepiness scale (ESS) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** presence of acute kidney injury **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males with high risk of obstructive sleep apnea syndrome as clinically assessed by coincidence of typical symptoms (e.g. daily somnolence, witnessed apnea, non-refreshing sleep), obesity and high score on Epworth sleepiness scale (ESS) with age range from 18 to 70 years 2. Glomerular filtration rate (MDRD formula-based) \> 60 ml/min 3. Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines. Exclusion Criteria: 1. Mental illness 2. Proteinuria \>2 g/24h 3. Acute and chronic inflammation 4. Heart failure III or IV grade 5. Uncontrolled diabetes mellitus 6. Severe lipid disturbances (triglyceride and/or total cholesterol concentration \> 300 mg/dl) 7. Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics 8. Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nefro@wp.pl **Name:** Michał Nowicki, MD, PhD **Phone:** (+48)426776709 **Role:** CONTACT **Contact 2:** **Email:** ania_zawiasa@go2.pl **Name:** Anna Zawiasa-Bryszewska, MD **Phone:** (+48)426776709 **Role:** CONTACT #### Locations **Location 1:** **City:** Lodz **Contacts:** ***Contact 1:*** - **Email:** ania_zawiasa@go2.pl - **Name:** Anna Zawiasa-Bryszewska, MD - **Phone:** (+48)426776709 - **Role:** CONTACT ***Contact 2:*** - **Email:** niedobrus@o2.pl - **Name:** Małgorzata Kołodziejska, MD - **Phone:** (+48)426776709 - **Role:** CONTACT ***Contact 3:*** - **Name:** Piotr Białasiewicz, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Dariusz Nowak, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Maciej Banasiak, MD - **Role:** SUB_INVESTIGATOR **Country:** Poland **Facility:** Medical University **State:** Lodzkie **Status:** RECRUITING **Zip:** 90-153 #### Overall Officials **Official 1:** **Affiliation:** Medical University of Lodz, Poland **Name:** Michał Nowicki, MD, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Failure - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Kidney Failure - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000058186 - Term: Acute Kidney Injury ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05787379 **Brief Title:** Care for Veterans Post-COVID-19 **Official Title:** Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans Post-COVID #### Organization Study ID Info **ID:** SDR 23-001 #### Organization **Class:** FED **Full Name:** VA Office of Research and Development ### Status Module #### Completion Date **Date:** 2027-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-06 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-05 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2023-03-28 **Type:** ACTUAL **Study First Submit Date:** 2023-03-23 **Study First Submit QC Date:** 2023-03-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** VA Office of Research and Development #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, \& disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm. **Detailed Description:** This is a two-part study. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. Concordant Care will be adapted through interviews and focus groups with Veterans with Long-COVID (estimated n=9) and primary care providers (estimated n=21). Feedback from the participants will help refine and test Concordant Care training. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, \& disability for Veterans with Long-COVID. Part 2 will be a randomized parallel cluster trial with primary care clinicians (n=60) separated into a Concordant Care training group and an education packet control group. Veterans (n=240) who have an upcoming appointment with their primary care provider who is a participant in the study will be recruited. The Veterans will be assessed at baseline before their appointment and approximately 3-months later after their appointment. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm. ### Conditions Module **Conditions:** - Post-Acute COVID-19 Syndrome **Keywords:** - training - COVID-19 - post-acute sequelae of COVID infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. The training involves four components: completion of approx. 3 hours of online, asynchronous training; attendance to at least two tele-mentoring sessions to review specific cases, didactics, role-play exercises, and session recordings; obtaining a clinician pocket care with reminders of Concordant Care process; and being prompted by a Veteran patient to talk about their concerns with Long-COVID. ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 348 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Providers randomized to this arm will receive concordant care training. **Intervention Names:** - Behavioral: Concordant Care Training **Label:** Providers receiving Long-COVID Concordant Care Training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Providers randomized to this arm will receive education packet training **Intervention Names:** - Behavioral: Education Packet Training **Label:** Providers receiving Education Packet Training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Providers receiving Long-COVID Concordant Care Training **Description:** Concordant Care training has four components. 1. Clinicians will complete \~3 hours of online, asynchronous training that will teach them practices including validate Veterans' experiences with Long-COVID, develop shared understanding with patients about Long-COVID, and develop patient-centered action plans. Clinicians will be provided with handouts, case examples, video demonstrations, and practice exercises to help them integrate these practices into care. 2. Tele-mentoring groups will be offered \~bi-weekly and be open to all clinician participant in the Concordant Training arm. Content will include review of specific cases, didactics on specific Concordant Care practices, role-play exercises, and review of session recordings. At least two sessions are required. 3. Clinician Pocket Card that serves as a reminder of the Concordant Care process. 4. An electronic prompt will be sent to enrolled Veterans encouraging them to speak with their clinician about their Long-COVID concerns. **Name:** Concordant Care Training **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Providers receiving Education Packet Training **Description:** Clinicians randomized to the control arm will receive a comprehensive information packet with the latest understanding of Long-COVID. Clinicians will also be provided a packet directing them to relevant VA trainings for Long-COVID. Whole Health trainings which focus on wholistic integrated approaches to care will be highlighted. Whole Health is important for all Veterans, and it is thought to be particularly relevant for poorly understood conditions that don't easily fit in traditional medical model. **Name:** Education Packet Training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Concordant Care practices will be measured with the 11-item measure that asks the patient if the clinician talked with them about multiple dimensions of their understanding of the health condition (i.e., cause, consequence, treatment). Participants answer yes or no to each question. Scores range from 0 to 11 with a higher score = more Concordant Care practices. **Measure:** Concordant Care Practice Change **Time Frame:** Baseline and 3-months **Description:** Shared Understanding will be captured with the concordance of illness perceptions questionnaire, a 6-item validated measure of shared understanding of the 5 components of illness perception between patients and clinicians. Veterans respond on a 5-point Likert scale. Scores range from 6 to 30 with higher scores = greater concordant understanding. **Measure:** Concordance of Illness Perceptions Questionnaire Change **Time Frame:** Baseline and 3-months #### Secondary Outcomes **Description:** The 18-item PSQ measures patient satisfaction in health care services and has been used specifically to assess patient satisfaction of VA healthcare services. Response options are 1-5 with 1=strongly agree and 5=strongly disagree. Scores range from 18 to 90 with higher scores = greater satisfaction with medical care. **Measure:** Patient Satisfaction Questionnaire (PSQ-III) **Time Frame:** Baseline and 3-months **Description:** The Medical Outcomes Survey Adherence 5-item scale captures Veterans adherence to primary care clinician's recommendations. Scores range from 6 to 30 with greater scores = better adherence. **Measure:** Medical Outcomes Survey Adherence Scale **Time Frame:** Baseline and 3-months **Description:** Veterans Rand 12-item Health Survey (VR-12). The VR-12 is a well-validated quality of life measure that assesses multiple domains of physical and mental health functioning. Scores range from 0 to 100 with higher scores = less disability. **Measure:** Veterans Rand (VR-12) **Time Frame:** Baseline and 3-months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Part 1 and Part 2, English-speaking VA primary care providers will be included. * Part 1, Veterans who self-identify as having Long-COVID will be included. * Part 2, Veterans who meet criteria for Long-COVID assessed with modified DePaul Symptom Questionnaire version 2 will be included; --Part 2, Veterans must also have a scheduled appointment with one of the participating clinicians within one to six months of the clinician being consented. Exclusion Criteria: * Part 1 and Part 2, clinicians who have already taken Concordant Care training will be excluded. * Part 1, Veterans will be excluded if they are not receiving care in the VA. * Part 2, Veterans will be excluded if they were in the Intensive Care Unit (ICU) for COVID-19. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Lisa.Mcandrew@va.gov **Name:** Lisa M McAndrew, PhD **Phone:** (862) 400-3317 **Role:** CONTACT **Contact 2:** **Email:** shannon.nugent@va.gov **Name:** Shannon Nugent, PhD **Phone:** (503) 220-8262 **Phone Ext:** 51721 **Role:** CONTACT #### Locations **Location 1:** **City:** East Orange **Contacts:** ***Contact 1:*** - **Email:** amanda.matteson@va.gov - **Name:** Amanda L Matteson - **Phone:** (973) 676-1000 - **Phone Ext:** 203580 - **Role:** CONTACT ***Contact 2:*** - **Email:** nicole.whittaker2@va.gov - **Name:** Nicole Whittaker, MSW - **Phone:** (973) 676-1000 - **Phone Ext:** 201167 - **Role:** CONTACT ***Contact 3:*** - **Name:** Lisa Marie McAndrew, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ **State:** New Jersey **Zip:** 07018 #### Overall Officials **Official 1:** **Affiliation:** East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ **Name:** Lisa Marie McAndrew, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000094025 - Term: Post-Infectious Disorders - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: HIGH - As Found: Post-Acute COVID-19 Syndrome - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3014 - Name: Post-Infectious Disorders - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000094024 - Term: Post-Acute COVID-19 Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03084679 **Brief Title:** Characterization of Myocardial Interstitial Fibrosis and Cardiomyocyte Hypertrophy by Cardiac MRI in Heart Failure **Official Title:** Characterization of Myocardial Interstitial Fibrosis and Cardiomyocyte Hypertrophy by Cardiac MRI In Heart Failure: Implication on Early Remodeling and on the Transition to Heart Failure #### Organization Study ID Info **ID:** HF-CMR-53967215800005404 #### Organization **Class:** OTHER **Full Name:** University of Campinas, Brazil #### Secondary ID Infos **Domain:** São Paulo Research Foundation **ID:** FAPESP 2015/15402-2 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2020-07 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2019-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-03 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2017-11-01 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2017-03-21 **Type:** ACTUAL **Study First Submit Date:** 2016-12-25 **Study First Submit QC Date:** 2017-03-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Campinas, Brazil #### Responsible Party **Investigator Affiliation:** University of Campinas, Brazil **Investigator Full Name:** Otavio Rizzi Coelho Filho **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The investigators hypothesised that novel MRI metrics derived from myocardium post-gadolinium T1 mapping analysis will improve the current knowledge about the role interstitial fibrosis and cardiomyocyte hypertrophy in the development of left ventricular (LV) remodelling and clinical Heart Failure (HF). The investigators believe that these recently described variables will be associated with prognostically important indices in HF development. **Detailed Description:** Cardiac hypertrophy is one of the earliest manifestations of myocardial disease, representing a modifiable, prognostic response to hemodynamic stimuli across physiologic (e.g., exercise) and pathologic states (e.g., hypertension, aortic stenosis). The extent of myocardial hypertrophy is determined by a combination of cardiomyocyte size and extracellular volume (ECV) expansion/interstitial fibrosis: while physiologic (exercise-induced) hypertrophy reflects mostly reversible cardiomyocyte hypertrophy, pathologic hypertrophy (e.g., in heart failure) is a combination of both interstitial fibrosis (potentially irreversible) and cardiomyocyte hypertrophy (reversible). Current methods to delineate the potential for LV reverse remodeling (e.g., natriuretic peptides and echocardiographic or clinical markers) detect primarily advanced disease, missing a critical opportunity to intervene and follow patients at an early disease phase where myocardial pathology may be reversible. Therefore, establishing novel, quantitative metrics of myocardial tissue phenotype that define a transition from hypertrophy to fibrosis, and then to irreversible LV remodeling/dysfunction may facilitate targeting therapies at a modifiable stage of disease in HF. The investigator's group has recently extended cardiac T1 mapping MRI techniques to quantify the intracellular lifetime of water (τic) serially as an index of cardiomyocyte diameter, validating this technique histologically in mouse models of pressure overload. ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - Heart Failure - Hypertrophy - Fibrosis - Magnetic Resonance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized trial in a 2:1 (intervention:control) proportion and in blocks of 6 participants. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Heart Failure patients with preserved ejection fraction (HFpEF) randomized to this arm will keep receiving their conventional clinical care, being instructed to continue and maintain their usual daily activities. **Label:** Conventional Clinical Care - HFpEF **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Heart Failure patients with preserved ejection fraction (HFpEF) randomized to this arm will keep receiving their conventional clinical care and participate in a supervised, facility based training program consisting of stretching exercises and aerobic exercise in treadmill. **Intervention Names:** - Other: Aerobic exercise in treadmill - Other: Local strengthening exercises - Other: Stretching exercises **Label:** Supervised Exercise Training- HFpEF **Type:** OTHER #### Arm Group 3 **Description:** Heart Failure patients with reduced ejection fraction (HFrEF) randomized to this arm will keep receiving their conventional clinical care, being instructed to continue and maintain their usual daily activities. **Label:** Conventional Clinical Care - HFrEF **Type:** NO_INTERVENTION #### Arm Group 4 **Description:** Heart Failure patients with reduced ejection fraction (HFrEF) randomized to this arm will keep receiving their conventional clinical care and participate in a supervised, facility based training program consisting of stretching exercises and aerobic exercise in treadmill. **Intervention Names:** - Other: Aerobic exercise in treadmill - Other: Local strengthening exercises - Other: Stretching exercises **Label:** Supervised Exercise Training - HFrEF **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised Exercise Training - HFrEF - Supervised Exercise Training- HFpEF **Description:** 30-40min of aerobic exercise in treadmill. The aerobic intensity will be established by heart rate levels that corresponded to anaerobic threshold up to 10% below the respiratory compensation point obtained in the cardiopulmonary exercise test. This intensity corresponded to 60-72% peak V̇o2. During the exercise sessions, when a training effect will be observed, as indicated by a decrease by 8 to 10% in heart rate, the treadmill velocity or inclination will be increased to return to the target heart rate levels. **Name:** Aerobic exercise in treadmill **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Supervised Exercise Training - HFrEF - Supervised Exercise Training- HFpEF **Description:** 15 min of local strengthening exercises will be performed in major muscle groups (legs, arms and trunk muscles): three series of each exercise, 12-15 repetitions. **Name:** Local strengthening exercises **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Supervised Exercise Training - HFrEF - Supervised Exercise Training- HFpEF **Description:** 5-min stretching exercises will be performed in major muscle groups (legs, arms and trunk muscles) **Name:** Stretching exercises **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Investigate whether rehabilitation compared to usual care is associated with significant favorable myocardial remodeling assessed by CMR determination of ECV. **Measure:** Myocardial remodeling assessed by CMR in rehabilitation vs usual care. **Time Frame:** 4 months #### Secondary Outcomes **Description:** Left Ventricular ejection fraction (%) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in left ventricular ejection fraction **Time Frame:** 4 months **Description:** Right Ventricular ejection fraction (%) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in right ventricular ejection fraction **Time Frame:** 4 months **Description:** Left ventricular mass absolute (g) and index (g/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in left ventricular mass (absolute/index) **Time Frame:** 4 months **Description:** Left ventricular diastolic volume absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in left ventricular diastolic volume (absolute/index) **Time Frame:** 4 months **Description:** Right ventricular diastolic volume absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in right ventricular diastolic volume (absolute/index) **Time Frame:** 4 months **Description:** Left ventricular systolic volume absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in left ventricular systolic volume (absolute/index) **Time Frame:** 4 months **Description:** Right ventricular systolic volume absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in right ventricular systolic volume (absolute/index) **Time Frame:** 4 months **Description:** Left ventricular stroke volume absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in left ventricular stroke volume (absolute/index) **Time Frame:** 4 months **Description:** Right ventricular stroke volume (absolute (ml) and index (ml/m2) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in right ventricular stroke volume (absolute/index) **Time Frame:** 4 months **Description:** Late gadolinium enhancement (LGE) will be determined by cardiac magnetic resonance using a previously describe inversion recovery sequence after 10-15 minutes of a cumulative dose of 0,2 mmol/kg of gadolinium diethylenetriamine pentaacetic acid. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in late gadolinium enhancement **Time Frame:** 4 months **Description:** LV mass/volume ratio (g/mL) will be determined by cardiac magnetic resonance using a previously described cine steady-state free precession imaging. All patients will be imaged with ECG gating and breath holding in a supine position. Patients will be imaged at baseline and after 4 months of the intervention. **Measure:** Change in LV mass/volume ratio **Time Frame:** 4 months **Description:** VO2max will be evaluated by cardiopulmonary test. Patients will performed the cardiopulmonary test at baseline and after 4 months of the intervention. **Measure:** Change in functional capacity **Time Frame:** 4 months **Description:** Quality of life will be evaluated by numerical score of Minnesota Questionnaire. Patients will performed the Minnesota Questionnaire at baseline and after 4 months of the intervention. **Measure:** Change in quality of life **Time Frame:** 4 months **Description:** Change in NT-proBNP with the intervention. **Measure:** Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) **Time Frame:** 4 months **Description:** Change in parameters of diastolic dysfunction assessed before and after the intervention. **Measure:** Change in diastolic dysfunction assessed by transthoracic echocardiogram **Time Frame:** 4 months **Description:** Change in cardiac sympathetic function assessed by cardiac uptake of metaiodobenzylguanidine (MIBG) labeled with I-123. Patients will performed the MIBG study at baseline and after 4 months of the intervention. **Measure:** Change in cardiac sympathetic function **Time Frame:** 4 months **Description:** τic will be determined by cardiac magnetic resonance T1 measurements acquired before and after administration of gadolinium diethylenetriamine pentaacetic acid (0,2mmol/kg), at 2 different time points (baseline and 4-moths after the intervention) **Measure:** Change in intracellular lifetime of water (τic - a marker of cardiomyocyte hypertrophy) **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age\> 18 years * Functional limitation (New York Heart Association Class II or worse) * No contraindication to exercise (American College of Cardiology / American Heart Association criteria) * Eligibility to take MRI (absence of metallic devices, and glomerular filtration rate \> 40ml / min / 1.73m2, etc.) * Prior diagnosis of Heart Failure (by the Framingham criterion) * Therapy with diuretic and euvolemia state (evaluated by cardiologist and cardiopulmonary exercise testing) * Transthoracic echocardiogram Exclusion Criteria: * Severe ischemia in any stress test * Hypertrophic cardiomyopathy or any infiltrative heart disease * Chronic obstructive pulmonary disease , pulmonary hypertension (Pulmonary artery pressure\> 60mmHg) * Severe left or right valve disease. * Pacemaker or implantable cardioverter defibrillator * Myocardial infarction or revascularization in 3 months * Anemia (hemoglobin \<10 grams / dl) until 1 month before cardiopulmonary exercise testing **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tavicocoelho@gmail.com **Name:** OTAVIO R COELHO-FILHO, MD, MPH, PhD **Phone:** 996038484 **Phone Ext:** +5519 **Role:** CONTACT **Contact 2:** **Email:** fermedesportiva@yahoo.com.br **Name:** FERNANDO B CARDOSO, MD **Phone:** 999203131 **Phone Ext:** +5519 **Role:** CONTACT #### Locations **Location 1:** **City:** Campinas **Contacts:** ***Contact 1:*** - **Email:** tavicocoelho@gmail.com - **Name:** Otavio R Coelho Filho, MD, PhD - **Phone:** +5519996038484 - **Role:** CONTACT ***Contact 2:*** - **Email:** fermedesportiva@yahoo.com.br - **Name:** Fernando B Cardoso, MD - **Phone:** +5519999203131 - **Role:** CONTACT **Country:** Brazil **Facility:** University of Campinas **State:** São Paulo **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Campinas, Brazil **Name:** OTAVIO R COELHO-FILHO, MD, MPH, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No plan to Share individual participant data. **IPD Sharing:** NO ### References Module #### References **Citation:** Dorn GW 2nd, Robbins J, Sugden PH. 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Epub 2008 Dec 17. **PMID:** 19091900 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophy - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000005355 - Term: Fibrosis - ID: D000006984 - Term: Hypertrophy ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00099879 **Brief Title:** Study of BMS-275183 in Patients With Pre-treated Non-small Cell Lung Cancer **Official Title:** A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer #### Organization Study ID Info **ID:** CA165-020 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Disp First Post Date **Date:** 2010-03-02 **Type:** ESTIMATED **Disp First Submit Date:** 2010-02-27 **Disp First Submit QC Date:** 2010-02-27 #### Last Update Post Date **Date:** 2010-03-02 **Type:** ESTIMATED **Last Update Submit Date:** 2010-02-27 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2006-03 **Type:** ACTUAL **Status Verified Date:** 2007-08 #### Study First Post Date **Date:** 2004-12-22 **Type:** ESTIMATED **Study First Submit Date:** 2004-12-21 **Study First Submit QC Date:** 2004-12-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb ### Description Module **Brief Summary:** The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied. ### Conditions Module **Conditions:** - Non-small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Primary Purpose:** TREATMENT **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** BMS-275183 **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Advanced or metastatic pretreated NSCLC * Measurable disease * Adequate hematologic, hepatic and renal functions * ECOG Performance Status of 0-2 Exclusion Criteria: * Inability to swallow capsules * Recent significant cardiovascular disease * Woman who are pregnant or breastfeeding **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sacramento **Country:** United States **Facility:** Local Institution **State:** California **Location 2:** **City:** New Haven **Country:** United States **Facility:** Local Institution **State:** Connecticut **Location 3:** **City:** Atlanta **Country:** United States **Facility:** Local Institution **State:** Georgia **Location 4:** **City:** Maywood **Country:** United States **Facility:** Local Institution **State:** Illinois **Location 5:** **City:** Detroit **Country:** United States **Facility:** Local Institution **State:** Michigan **Location 6:** **City:** Pittsburgh **Country:** United States **Facility:** Local Institution **State:** Pennsylvania **Location 7:** **City:** Nashville **Country:** United States **Facility:** Local Institution **State:** Tennessee **Location 8:** **City:** Brussels **Country:** Belgium **Facility:** Local Institution **Location 9:** **City:** Leuven **Country:** Belgium **Facility:** Local Institution **Location 10:** **City:** Besancon **Country:** France **Facility:** Local Institution **State:** Cedex **Location 11:** **City:** Saint-Herblain **Country:** France **Facility:** Local Institution **State:** Cedex **Location 12:** **City:** Belfort **Country:** France **Facility:** Local Institution **Location 13:** **City:** Parma **Country:** Italy **Facility:** Local Institution **Location 14:** **City:** Roma **Country:** Italy **Facility:** Local Institution **Location 15:** **City:** Amsterdam **Country:** Netherlands **Facility:** Local Institution **Location 16:** **City:** Groningen **Country:** Netherlands **Facility:** Local Insitution **Location 17:** **City:** Barcelona **Country:** Spain **Facility:** Local Institution **Location 18:** **City:** Madrid **Country:** Spain **Facility:** Local Institution **Location 19:** **City:** Shefield **Country:** United Kingdom **Facility:** Local Institution **State:** Yorkshire **Location 20:** **City:** Manchester **Country:** United Kingdom **Facility:** Local Institution ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00515879 **Brief Title:** Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia **Official Title:** D-cycloserine Enhancement of Exposure in Social Phobia #### Organization Study ID Info **ID:** R01MH078308 **Link:** https://reporter.nih.gov/quickSearch/R01MH078308 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Boston University Charles River Campus #### Secondary ID Infos **ID:** R01MH078308 **Link:** https://reporter.nih.gov/quickSearch/R01MH078308 **Type:** NIH **ID:** R01MH075889 **Link:** https://reporter.nih.gov/quickSearch/R01MH075889 **Type:** NIH ### Status Module #### Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-02-26 **Type:** ACTUAL **Last Update Submit Date:** 2019-02-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-07-23 **Type:** ESTIMATED **Results First Submit Date:** 2013-08-02 **Results First Submit QC Date:** 2015-07-20 #### Start Date **Date:** 2007-12 **Status Verified Date:** 2019-02 #### Study First Post Date **Date:** 2007-08-14 **Type:** ESTIMATED **Study First Submit Date:** 2007-08-10 **Study First Submit QC Date:** 2007-08-10 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Lead Sponsor **Class:** OTHER **Name:** Boston University Charles River Campus #### Responsible Party **Investigator Affiliation:** Boston University Charles River Campus **Investigator Full Name:** Stefan G. Hofmann **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder. **Detailed Description:** Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD. Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment. ### Conditions Module **Conditions:** - Social Anxiety Disorder **Keywords:** - Generalized subtype ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 169 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive cognitive behavioral therapy plus D-cycloserine **Intervention Names:** - Drug: D-cycloserine - Behavioral: Cognitive behavioral therapy (CBT) **Label:** CBT plus d-cycloserine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive cognitive behavioral therapy plus pill placebo **Intervention Names:** - Behavioral: Cognitive behavioral therapy (CBT) - Drug: Placebo **Label:** CBT plus placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CBT plus d-cycloserine **Description:** 50 mg **Name:** D-cycloserine **Other Names:** - Seromycin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - CBT plus d-cycloserine - CBT plus placebo **Description:** CBT sessions aim to help participants become more comfortable with social situations. **Name:** Cognitive behavioral therapy (CBT) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - CBT plus placebo **Description:** Same dosage as active pill **Name:** Placebo **Other Names:** - Sugar pill **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration). **Measure:** Social Phobic Disorders Severity and Change Form **Time Frame:** Measured at Months 3 (immediately after treatment) **Description:** The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum). **Measure:** Liebowitz Social Anxiety Scale (LSAS) **Time Frame:** Measured at Months 3 #### Secondary Outcomes **Description:** The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety. **Measure:** Social Phobia and Anxiety Inventory **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Description:** The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100). **Measure:** Quality of Life Enjoyment and Satisfaction Questionnaire **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Description:** Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment). **Measure:** Liebowitz Self-Rated Disability Scale **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Description:** The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment). **Measure:** Range of Impaired Functioning Tool **Time Frame:** Measured at Months 3, 6, and 9 post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Meets DSM-IV criteria for generalized social anxiety disorder (GSAD) * Total score of greater than or equal to 60 on the LSAS * Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities Exclusion Criteria: * Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder * Eating disorder within the 6 months prior to study entry * History of organic brain syndrome, mental retardation, or other cognitive dysfunction * Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation * Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder * Suicidal thoughts * Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry * Significant personality dysfunction * Serious medical illness or instability for which hospitalization may be likely within the next year **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Boston University **State:** Massachusetts **Zip:** 02215 #### Overall Officials **Official 1:** **Affiliation:** Boston University **Name:** Stefan G. Hofmann, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Massachusetts General Hospital **Name:** Mark H. Pollack, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Southern Methodist University **Name:** Jasper A. Smits, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Hofmann SG, Pollack MH, Otto MW. Augmentation treatment of psychotherapy for anxiety disorders with D-cycloserine. CNS Drug Rev. 2006 Fall-Winter;12(3-4):208-17. doi: 10.1111/j.1527-3458.2006.00208.x. **PMID:** 17227287 **Citation:** Otto MW, Basden SL, Leyro TM, McHugh RK, Hofmann SG. Clinical perspectives on the combination of D-cycloserine and cognitive-behavioral therapy for the treatment of anxiety disorders. CNS Spectr. 2007 Jan;12(1):51-6, 59-61. doi: 10.1017/s1092852900020526. **PMID:** 17192764 **Citation:** Hofmann SG, Meuret AE, Smits JA, Simon NM, Pollack MH, Eisenmenger K, Shiekh M, Otto MW. Augmentation of exposure therapy with D-cycloserine for social anxiety disorder. Arch Gen Psychiatry. 2006 Mar;63(3):298-304. doi: 10.1001/archpsyc.63.3.298. **PMID:** 16520435 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000010698 - Term: Phobic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety Disorder - ID: M1117 - Name: Phobia, Social - Relevance: HIGH - As Found: Social Anxiety Disorder - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders - ID: D000072861 - Term: Phobia, Social ### Intervention Browse Module - Ancestors - ID: D000000892 - Term: Anti-Infective Agents, Urinary - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6729 - Name: Cycloserine - Relevance: HIGH - As Found: Single Arm Study - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003523 - Term: Cycloserine ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** D-cycloserine-augmented CBT **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** EG000 **Other Num at Risk:** 87 **Serious Number At Risk:** 87 **Title:** D-cycloserine-augmented CBT **Group ID:** EG001 **Title:** Placebo-augmented CBT **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** EG001 **Other Num at Risk:** 82 **Serious Number At Risk:** 82 **Title:** Placebo-augmented CBT **Frequency Threshold:** 5 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 87 **Group ID:** BG001 **Value:** 82 **Group ID:** BG002 **Value:** 169 **Units:** Participants ### Group **ID:** BG000 **Title:** D-cycloserine-augmented CBT **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy ### Group **ID:** BG001 **Title:** Placebo-augmented CBT **Description:** Participants will receive placebo augmented cognitive behavioral therapy ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 82 #### Measurement **Group ID:** BG002 **Value:** 169 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.89 **Value:** 34.6 #### Measurement **Group ID:** BG001 **Spread:** 8.9 **Value:** 30.5 #### Measurement **Group ID:** BG002 **Spread:** 8.41 **Value:** 32.55 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 44 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 74 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 43 #### Measurement **Group ID:** BG001 **Value:** 52 #### Measurement **Group ID:** BG002 **Value:** 95 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 82 #### Measurement **Group ID:** BG002 **Value:** 169 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** shofmann@bu.edu **Organization:** Boston University **Phone:** 617 353 9233 **Title:** Dr. Stefan G. Hofmann, Ph.D., Professor of Psychology ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.38 - **Spread:** - **Upper Limit:** 2.98 - **Value:** 2.68 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2.64 - **Spread:** - **Upper Limit:** 3.27 - **Value:** 2.95 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 34.79 - **Spread:** - **Upper Limit:** 43.59 - **Value:** 39.19 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 37.94 - **Spread:** - **Upper Limit:** 47.03 - **Value:** 42.44 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 28.585 - **Upper Limit:** - **Value:** 71.08 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 30.311 - **Upper Limit:** - **Value:** 73.74 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 75 - **Group ID:** OG001 - **Value:** 64 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 32.188 - **Upper Limit:** - **Value:** 69.64 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 30.566 - **Upper Limit:** - **Value:** 71.97 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 66 - **Group ID:** OG001 - **Value:** 58 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 31.847 - **Upper Limit:** - **Value:** 67.67 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 33.289 - **Upper Limit:** - **Value:** 67.74 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 69 - **Group ID:** OG001 - **Value:** 54 **Units:** Participants #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 14.075 - **Upper Limit:** - **Value:** 67.77 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 14.00 - **Upper Limit:** - **Value:** 67.44 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 76 - **Group ID:** OG001 - **Value:** 66 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.066 - **Upper Limit:** - **Value:** 66.32 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 14.872 - **Upper Limit:** - **Value:** 67.44 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 68 - **Group ID:** OG001 - **Value:** 60 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.063 - **Upper Limit:** - **Value:** 67.08 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 11.761 - **Upper Limit:** - **Value:** 69.58 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 67 - **Group ID:** OG001 - **Value:** 54 **Units:** Participants #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.25681 - **Upper Limit:** - **Value:** 15.6117 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.79688 - **Upper Limit:** - **Value:** 14.0303 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 78 - **Group ID:** OG001 - **Value:** 66 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.03686 - **Upper Limit:** - **Value:** 15.5283 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.98470 - **Upper Limit:** - **Value:** 14.4977 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 70 - **Group ID:** OG001 - **Value:** 62 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.72461 - **Upper Limit:** - **Value:** 15.3269 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.62630 - **Upper Limit:** - **Value:** 14.3130 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 69 - **Group ID:** OG001 - **Value:** 59 **Units:** Participants #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.780 - **Upper Limit:** - **Value:** 8.5256 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.80841 - **Upper Limit:** - **Value:** 8.6667 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 78 - **Group ID:** OG001 - **Value:** 82 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.67730 - **Upper Limit:** - **Value:** 8.6143 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.82987 - **Upper Limit:** - **Value:** 8.5430 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 70 - **Group ID:** OG001 - **Value:** 82 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.80284 - **Upper Limit:** - **Value:** 8.6232 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.43957 - **Upper Limit:** - **Value:** 7.7458 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 69 - **Group ID:** OG001 - **Value:** 82 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Measured at Months 3 (immediately after treatment) **Title:** Social Phobic Disorders Severity and Change Form **Type:** PRIMARY **Unit of Measure:** Units on a scale ##### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** OG000 **Title:** D-cycloserine-augmented CBT ##### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** OG001 **Title:** Placebo-augmented CBT #### Outcome Measure 2 **Description:** The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Measured at Months 3 **Title:** Liebowitz Social Anxiety Scale (LSAS) **Type:** PRIMARY **Unit of Measure:** LSAS scores ##### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** OG000 **Title:** D-cycloserine-augmented CBT ##### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** OG001 **Title:** Placebo-augmented CBT #### Outcome Measure 3 **Description:** The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. **Reporting Status:** POSTED **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Title:** Social Phobia and Anxiety Inventory **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** OG000 **Title:** D-cycloserine-augmented CBT ##### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** OG001 **Title:** Placebo-augmented CBT #### Outcome Measure 4 **Description:** The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. **Reporting Status:** POSTED **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Title:** Quality of Life Enjoyment and Satisfaction Questionnaire **Type:** SECONDARY **Unit of Measure:** percentage of maximum ##### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** OG000 **Title:** D-cycloserine-augmented CBT ##### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** OG001 **Title:** Placebo-augmented CBT #### Outcome Measure 5 **Description:** Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. **Reporting Status:** POSTED **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Title:** Liebowitz Self-Rated Disability Scale **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants will receive cognitive behavioral therapy plus D-cycloserine D-cycloserine: 50 mg Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations. **ID:** OG000 **Title:** CBT Plus D-cycloserine ##### Group **Description:** Participants will receive cognitive behavioral therapy plus pill placebo Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations. Placebo: Same dosage as active pill **ID:** OG001 **Title:** CBT Plus Placebo #### Outcome Measure 6 **Description:** The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. **Reporting Status:** POSTED **Time Frame:** Measured at Months 3, 6, and 9 post-treatment **Title:** Range of Impaired Functioning Tool **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** OG000 **Title:** D-cycloserine-augmented CBT ##### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** OG001 **Title:** Placebo-augmented CBT ### Participant Flow Module #### Group **Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy **ID:** FG000 **Title:** D-cycloserine-augmented CBT #### Group **Description:** Participants will receive placebo augmented cognitive behavioral therapy **ID:** FG001 **Title:** Placebo-augmented CBT #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 87 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 82 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 62 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 62 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 25 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 20 **Pre-Assignment Details:** Study participants underwent a two-step screening evaluation, consisting of 1) telephone screening, and 2) psychiatric assessment and medical history taking with physical examination. **Recruitment Details:** Prospective participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University \[BU\], Massachusetts General Hospital \[MGH\], and Southern Methodist University \[SMU\]), from other area clinical facilities and programs, and from advertisements. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01941979 **Brief Title:** A Study Comparing Adjuvant Chemotherapy Versus Observation for Patients With Rectal Adenocarcinoma After Neoadjuvant Chemo-Radiotherapy Treatment. **Official Title:** A Phase III, Randomized Study of Adjuvant Chemotherapy for Patients With Rectal Adenocarcinoma Who Achieved Suboptimal Response After Neoadjuvant Chemo-radiotherapy. #### Organization Study ID Info **ID:** NP-113/2011 #### Organization **Class:** OTHER **Full Name:** Instituto do Cancer do Estado de São Paulo ### Status Module #### Completion Date **Date:** 2016-09 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2014-10-30 **Type:** ESTIMATED **Last Update Submit Date:** 2014-10-29 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-09 **Type:** ESTIMATED #### Start Date **Date:** 2011-09 **Status Verified Date:** 2014-10 #### Study First Post Date **Date:** 2013-09-13 **Type:** ESTIMATED **Study First Submit Date:** 2013-09-04 **Study First Submit QC Date:** 2013-09-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto do Cancer do Estado de São Paulo #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed early, however local recurrence risk increases when the disease is diagnosed at advanced stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35% and positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data indicate that patient who have a high risk of tumor recurrence should receive an adjuvant therapy treatment. It is possible that adjuvant chemotherapy has a positive impact on survival of patients already treated with neoadjuvant combination therapy. However it is necessary to identify those patients that might have this benefit. An exploratory analysis of the European Organization for Research and Treatment of Cancer (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response to neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer remains controversial. Therefore, a randomized trial is needed to answer this question. Based on these data the investigators proposed a phase III study, randomized, unblinded, adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant chemoradiotherapy and who did not presented complete response. The investigator believes that this subgroup of patients, who have not achieved complete response, will be benefit from adjuvant therapy. Study objective: The main objective of this study is verify if adjuvant chemotherapy with 5-FU and oxaliplatin, for 4 months, increases recurrence-free survival versus the observation. Secondary objectives include the evaluation of toxicity, overall survival and assessment of biomarkers (study protocol separately). The study's primary endpoint is disease-free survival (DFS) to be defined as time from randomization to radiological detection of distant disease and / or locoregional recurrence. Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a new measurable lesion be found. NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary tumors formed by the spread of cancer cells to other parts of the body. ### Conditions Module **Conditions:** - Rectal Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 309 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 5-FU, Leucovorin and Oxaliplatine (FLOX) OR Capecitabine and Oxaliplatin (CAPOX) NOTE: If the patient was randomized for the arm experimental, the investigator can choose between intravenous (IV) treatment or oral treatment (PO). Both are considered equal by the principal investigator. **Intervention Names:** - Drug: 5-FU, Capecitabine, Oxaliplatin, Leucovorin. **Label:** Adjuvant therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Observation **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Adjuvant therapy **Name:** 5-FU, Capecitabine, Oxaliplatin, Leucovorin. **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To evaluate the toxicity of treatment. **Measure:** Incidence of Adverse Event **Time Frame:** 36 month #### Primary Outcomes **Measure:** Disease free survival **Time Frame:** Thorax, abdome, and pelvis tomography Every 6 month up to 3 years and anualy up to 5 years. #### Secondary Outcomes **Measure:** Overall survival **Time Frame:** 36 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of adenocarcinoma rectal stages T3 - 4, N0-1 and M0 - according to TNM staging system (primary tumor, regional nodes, metastasis), previously treated with neoadjuvant chemo-radiotherapy according to institutional routine. * Tumor with clinical end radiological incomplete response after neoadjuvant therapy, according to institutional routine, and completely resection by mesorectal excision with clear margins technique. * No more than 8 weeks after the surgery. * Normal result of CEA in compared to the pre randomization results (28 days of window) * Age ≥ 18 years and ≤ 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Adequate organ function during screening (28 days of window) , defined as: 1. Serum aspartate aminotransferase (AST) and amino alanine transferase (ALT) ≤ 2.5 × Upper Limit of Normal(ULN) 2. Serum total bilirubin ≤ 2.0 × ULN 3. Absolute neutrophil count ≥ 1500 /mm3 4. Platelet count ≥ 100000 /mm3 5. Hemoglobin ≥ 8.0 g/dL 6. Serum creatinine ≥ 1.5 × ULN * Signed written informed consent Exclusion Criteria: * Patients who presented unacceptable toxicity or intolerance to neoadjuvant combination therapy. * Patients with surgical complications that prevent them from receiving adjuvant therapy for up to 8 weeks after surgery; * Compromised surgical margins. * Confirmation or strong suspicion of Lynch syndrome. * History of serious illness or psychiatric clinic. * Patients who participate in other protocols with experimental drugs. * For female patients, current pregnancy and/or lactation. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** pesquisa.clinica@icesp.org.br **Name:** Rachel S.P. Riechelmann, MD **Phone:** 55 11 38932000 **Role:** CONTACT #### Locations **Location 1:** **City:** Sao Paulo **Contacts:** ***Contact 1:*** - **Email:** pesquisa.clinica@icesp.org.br - **Name:** Rachel SP Riechelmann, MD - **Phone:** 55 11 38932000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Rachel SP Riechemann, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Brazil **Facility:** ICESP **State:** SP **Status:** RECRUITING **Zip:** 01246000 ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.icesp.org.br/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000931 - Term: Antidotes - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M6191 - Name: Leucovorin - Relevance: HIGH - As Found: Stem Cell - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Function - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Outcomes - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M4250 - Name: Antidotes - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002955 - Term: Leucovorin - ID: D000069287 - Term: Capecitabine - ID: D000077150 - Term: Oxaliplatin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04344379 **Acronym:** PREP-COVID **Brief Title:** Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus **Official Title:** Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus #### Organization Study ID Info **ID:** APHP200386 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **ID:** 2020-001273-73 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2020-06-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-03 **Type:** ACTUAL **Last Update Submit Date:** 2021-07-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-06-18 **Type:** ACTUAL #### Start Date **Date:** 2020-04-17 **Type:** ACTUAL **Status Verified Date:** 2021-07 #### Study First Post Date **Date:** 2020-04-14 **Type:** ACTUAL **Study First Submit Date:** 2020-03-27 **Study First Submit QC Date:** 2020-04-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo **Detailed Description:** Randomized clinical trial with 3 arms : hydroxychloroquine group, 300 subjects/azithromycin group, 300 subjects/ placebo of hydroxychloroquine group, 300 subjects. Hospital workers workers will be invited to participate in the study in each hospital and they will be included after giving their consent, assessment of their eligibility criteria, endonasal PCR and serolology at baseline. They will be randomized in one of the 3 arms, receive their treatment and will be followed by physical visit (at Day 2, Day 5, Day 15, Day 28) and by phone (at Day) 40 days with clinical data collection (tolerance and clinical signs of infection). At the end of treatment, another serology will be collected. ### Conditions Module **Conditions:** - SARS-CoV-2 Infection **Keywords:** - COVID-19 - SARS-CoV-2 - hydroxychloroquine - azithromycin - caregivers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 122 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: hydroxychloroquine **Label:** Arm Title : hydroxychloroquine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: hydroxychloroquine placebo **Label:** Placebo of hydroxychloroquine **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: azithromycin **Label:** azythromycin **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm Title : hydroxychloroquine **Description:** 200 mg BID per day **Name:** hydroxychloroquine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - azythromycin **Description:** 250 mg per day **Name:** azithromycin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo of hydroxychloroquine **Description:** 200 mg BID per day **Name:** hydroxychloroquine placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up. **Measure:** To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment. **Time Frame:** 3 months #### Secondary Outcomes **Description:** Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR **Measure:** Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR **Time Frame:** 40 days **Description:** number of seroconversion by serology between Day 0 and Day 40. **Measure:** Reducing seroconversion for SARS-CoV-2 without any clinical sign **Time Frame:** 3 months **Description:** number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths **Measure:** Evaluation of drug tolerance in the study **Time Frame:** 40 days **Description:** Number of work stoppages over the period **Measure:** Evaluation on work stopping of hospital workers **Time Frame:** 40 days **Description:** Plasmatic concentrations of treatments **Measure:** Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine **Time Frame:** 40 days **Description:** number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments **Measure:** Incidence of cardiologic events **Time Frame:** 40 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Hospital workers working at AP-HP hospitals over the age of 18 * Hospital workers who have signed consent * No signs of COVID-19 infection * Women who are likely to procreate should have a negative pregnancy test on inclusion day. In addition, they should use at least one effective contraceptive method before starting treatment, during treatment and up to 8 months after the last drug tested during the trial. Sexually active men should also have effective contraception during treatment and for at least 8 months after the last drug tested during the trial. * Affiliated or beneficiary of Social Security Exclusion Criteria: * History of SARS-CoV-2 infection confirmed by PCR or serology is available at inclusion * A history of clinical episode suspecting a PCR-confirmed or unconfirmed COVID-19 infection. * Pregnancy and breastfeeding * Allergy or contraindications to one of the 2 drugs in the study * Known retinopathy * Long congenital QT syndrome (or known in the family) * QTc or 450 ms in men, or 460 ms in women, if Fc 55/mn (except in case of intense sport practice), if ESV on baseline ECG, if QRS - or 120 ms, if AC/FA, if the PR or BAV lengthening * History of severe ischemic heart disease or unbalanced heart failure. * Clinically significant bradycardia known * Known kidney or liver failure * Known G6PD deficit * Subject who received antiviral treatment in the 14 days prior to inclusion * Subject who had treatment with azithromycin or hydroxychloroquine, in the 14 days prior to inclusion * Hypokaliemia (\<= 3.5 mmol/L), Increase in creatinine (\>=120 micromol/Ll, Increase in transaminases at baseline (\>=2N) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bobigny **Country:** France **Facility:** Hopial Avicenne **Zip:** 93000 **Location 2:** **City:** Le Kremlin-Bicêtre **Country:** France **Facility:** Hôpital GHU Paris Saclay **Zip:** 92100 **Location 3:** **City:** Paris **Country:** France **Facility:** Hôpital Saint Antoine **Zip:** 75012 **Location 4:** **City:** Paris **Country:** France **Facility:** Hôpital Broca **Zip:** 75013 **Location 5:** **City:** Paris **Country:** France **Facility:** Hôpital La Pitié-Salpétrière **Zip:** 75013 **Location 6:** **City:** Paris **Country:** France **Facility:** Hôpital Cochin **Zip:** 75014 **Location 7:** **City:** Paris **Country:** France **Facility:** Hôpital européen Georges Pompidou **Zip:** 75015 **Location 8:** **City:** Paris **Country:** France **Facility:** Hôpital Necker **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assitance publique - Hôpitaux de Paris. **Name:** Jean Ma Treluyer, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: SARS-CoV-2 Infection - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M20132 - Name: Azithromycin - Relevance: HIGH - As Found: 20 minutes - ID: M9940 - Name: Hydroxychloroquine - Relevance: HIGH - As Found: Bone marrow - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017963 - Term: Azithromycin - ID: D000006886 - Term: Hydroxychloroquine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06423079 **Brief Title:** Scleral Fixation for Intraocular Lens-Bag Dislocation **Official Title:** Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots #### Organization Study ID Info **ID:** Siep_001 #### Organization **Class:** OTHER **Full Name:** University of Naples ### Status Module #### Completion Date **Date:** 2022-05-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-10 **Type:** ACTUAL #### Start Date **Date:** 2017-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Naples #### Responsible Party **Investigator Affiliation:** University of Naples **Investigator Full Name:** Luca D'Andrea **Investigator Title:** Prinicipal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome. **Detailed Description:** To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up. ### Conditions Module **Conditions:** - Pseudoexfoliation Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 36 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex. **Intervention Names:** - Procedure: Siepser knots **Label:** IOL-Bag Dislocation patients ### Interventions #### Intervention 1 **Arm Group Labels:** - IOL-Bag Dislocation patients **Description:** Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation **Name:** Siepser knots **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** to evaluate the best corrected visual acuity after the surgery **Measure:** Best corrected visual acuity **Time Frame:** 1 year #### Secondary Outcomes **Description:** to evaluate the Endothelial cells count after the surgery **Measure:** Endothelial cells count **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex Exclusion Criteria: * patients who underwent intraoperative complications, * dislocation in the vitreous chamber of the bag-IOL complex, * patients who had already undergone posterior capsule Nd-YAG laser **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery. ### Contacts Locations Module #### Locations **Location 1:** **City:** NAples **Country:** Italy **Facility:** University of Naples Federico II **Zip:** 80131 ### IPD Sharing Statement Module **Access Criteria:** available on request **Description:** all collected IPD **IPD Sharing:** YES **Time Frame:** 5 years **URL:** https://guides.lib.umich.edu/datamanagement/clinicaltrials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007499 - Term: Iris Diseases - ID: D000014603 - Term: Uveal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20069 - Name: Exfoliation Syndrome - Relevance: HIGH - As Found: Pseudoexfoliation Syndrome - ID: M7385 - Name: Joint Dislocations - Relevance: LOW - As Found: Unknown - ID: M10531 - Name: Iris Diseases - Relevance: LOW - As Found: Unknown - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017889 - Term: Exfoliation Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05497479 **Acronym:** MTP **Brief Title:** Study Evaluating Techniques for Measuring Tear Production **Official Title:** A Phase 1 Study Evaluating Techniques for Measuring Tear Production #### Organization Study ID Info **ID:** 21-110-A #### Organization **Class:** INDUSTRY **Full Name:** Aerie Pharmaceuticals ### Status Module #### Completion Date **Date:** 2021-12-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-08-11 **Type:** ACTUAL **Last Update Submit Date:** 2022-08-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-12-10 **Type:** ACTUAL #### Start Date **Date:** 2021-12-09 **Type:** ACTUAL **Status Verified Date:** 2022-08 #### Study First Post Date **Date:** 2022-08-11 **Type:** ACTUAL **Study First Submit Date:** 2022-07-26 **Study First Submit QC Date:** 2022-08-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Aerie Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test. ### Conditions Module **Conditions:** - Dry Eye Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test. ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Both eyes will be treated. **Intervention Names:** - Drug: 0.003% AR-15512 to be administered in both eyes - Drug: Vehicle to be administered in both eyes **Label:** Treatment with Schirmer test with no anesthetic **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Both eyes will be treated. **Intervention Names:** - Drug: 0.003% AR-15512 to be administered in both eyes - Drug: Vehicle to be administered in both eyes **Label:** Treatment with Schirmer test with anesthetic **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment with Schirmer test with no anesthetic **Description:** Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512 **Name:** 0.003% AR-15512 to be administered in both eyes **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment with Schirmer test with no anesthetic **Description:** Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle **Name:** Vehicle to be administered in both eyes **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Treatment with Schirmer test with anesthetic **Description:** Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512 **Name:** 0.003% AR-15512 to be administered in both eyes **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Treatment with Schirmer test with anesthetic **Description:** Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle **Name:** Vehicle to be administered in both eyes **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome. **Measure:** Unanesthetized Schirmer test **Time Frame:** Day 1 **Description:** Mean change in Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome. **Measure:** Unanesthetized Schirmer test **Time Frame:** Day 1 **Description:** Mean Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome. **Measure:** Unanesthetized Schirmer test **Time Frame:** Day 1 **Description:** Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome. **Measure:** Anesthetized Schirmer test **Time Frame:** Day 1 **Description:** Mean change in anesthetized Schirmer score. Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome. **Measure:** Anesthetized Schirmer test **Time Frame:** Day 1 **Description:** Mean anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome. **Measure:** Anesthetized Schirmer test **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1 * Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min * Within the last year from Visit 1, have documented symptoms of DED * Corrected Visual Acuity (Snellen) 20/200 or better in both Exclusion Criteria: * Use of artificial tears within 2 hours prior to Visit 1 * Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period. * Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1 * Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study * Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Newport Beach **Country:** United States **Facility:** Eye Research Foundation **State:** California **Zip:** 92663 #### Overall Officials **Official 1:** **Affiliation:** Aerie Pharmaceuticals **Name:** Michelle S Senchyna, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007766 - Term: Lacrimal Apparatus Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M18040 - Name: Dry Eye Syndromes - Relevance: HIGH - As Found: Dry Eye Disease - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Eye Disease - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000005128 - Term: Eye Diseases ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06410079 **Acronym:** PTH-50 **Brief Title:** Difference in Return to Sports Activity After Hip Arthroplasty by THR or Resurfacing **Official Title:** Do Patients Under the Age of 50 Resume Equivalent Physical Activity Levels After Conventional Total Hip Replacement or Hip Resurfacing? #### Organization Study ID Info **ID:** 2023 A02666 #### Organization **Class:** OTHER **Full Name:** Société Française de chirurgie de la Hanche et du Genou ### Status Module #### Completion Date **Date:** 2026-09-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-10 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-10 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Elsan #### Lead Sponsor **Class:** OTHER **Name:** Société Française de chirurgie de la Hanche et du Genou #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate the return to activity in younger patients under 50 years old after undergoing either total hip replacement (THR) or hip resurfacing, as performed in everyday practice. This research will be observational, meaning patients will not be randomly assigned to different treatment groups. To objectively assess participents; return to everyday, professional, and sports activities, validated questionnaires will be sent to participents in addition to routine clinical practice. The study will be prospective and comparative based on the type of prostheses used. In order to capture the current practices of surgeons performing THR in participents under 50 years old in France, the study will be conducted at multiple centers across the country. Since hip resurfacing is performed only in certain centers, approximately half of the participating centers are experienced in this technique. Participents typically resume activity between 3 and 6 months after THR. One year of post-operative follow-up allows for an accurate assessment of participents; recovery, unaffected by the surgery. Participents ; physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty. **Detailed Description:** The literature is very scarce on Total Hip Arthroplasty(THA) in young patients. To date, there is no comparison on activity resumption based on prosthesis type on a national scale. Total Hip Arthrosplaty (THA) has been subject to a French registry since 2015 for patients operated by resurfacing , but no analysis of prosthesis wear has been conducted. A retrospective study with a follow-up exceeding 10 years is required to address this point and is the subject of another ongoing research. Resurfacing allows the preservation of anatomical elements but remains limited in France. The primary cause of THA revision identified is periprosthetic fracture. After resurfacing, a THA is performed, while after THA, only revision THA is possible but entails a longer operative time with a significant financial impact. The aim of the research is to compare the level of physical activity at 1 year follow-up, according to the type of prostheses in adult patients under 50. It is part of presenting the practices of THA in young individuals in France during a symposium organized by the SFHG for 2025. Research Hypothesis Regardless of the type of implants used, total hip arthroplasty yields excellent results in young patients with early resumption of activities, including sports. A meta-analysis of 11 studies comprising 2297 patients shows that 70%-90% of patients resumed sports activities within 6-12 months post-THA . A more recent systematic literature review confirms that 82% of patients have resumed sports activity on average at 6 months . The research hypothesis is that there is no difference in physical activity at 1 year between patients operated with different types of prostheses, including dual mobility. Justification of Methodological Choices Given the number of young patients undergoing THA per year in France , and considering a 5% margin of error and a 95% confidence interval, the sample size to be included is 500 patients. A retrospective monocentric study is proposed given the scarcity of data in this young population. It will include adult patients under 50 operated on from 2015 to 2020. Participants will be divided into three groups according to the type of prosthesis: hip resurfacing, ;soft-hard THA, and hard-hard THA. A comprehensive review of the medical records will be conducted to collect data. Physical activity will be assessed at 1 year post-surgery using the International Physical Activity Questionnaire (IPAQ), a reliable and validated tool . The primary outcome is the level of physical activity at 1 year, and secondary outcomes include functional scores (HHS, WOMAC), complications, and prosthesis survival rate. Ethical Considerations This study complies with the ethical principles outlined in the Declaration of Helsinki. Participant data will be anonymized to ensure confidentiality. Informed consent will be obtained from all participants. Expected Results It is expected that there will be no significant difference in physical activity level at 1 year between patients operated with different types of prostheses. The results will provide valuable information on the optimal type of prosthesis for young patients undergoing THA and contribute to improving patient outcomes and satisfaction. Primary objective The primary objective of the research is to compare the level of physical activity of participants at 1 year between those operated by resurfacing and those operated for a THA, taking into account their usual level. Secondary objectives The secondary objectives of the study are to: 1. Compare physical and professional activity: * Compare the level of physical activity of patients at 1 year between the 4 studied prosthesis groups, taking into account their usual level. * Compare the level of physical activity at 1 year to the preoperative level between the 2 groups and then between the 4 prosthesis groups. * Compare the change in physical activity level between the 2 groups and then between the 4 prosthesis groups in relation to usual level and preoperative level * Compare the time to return to physical and sporting activity in the year following hip arthroplasty. * Compare the time to return to usual professional activity. * Evaluate the quality of return to activity. * Evaluate early complications after total hip arthroplasty. * Compare the participants postoperative experience. * Analyze the factors influencing the return to physical activity. * Describe the type of implant, surgical approach and clinical parameters in each group Evaluation criteria Main evaluation criterion The main evaluation criterion is the 1-year difference in the UCLA score measuring participants physical activity in relation to their usual level for the resurfacing group and for all THAs. Secondary evaluation criteria The secondary evaluation criteria corresponding to the secondary objectives are: 1. For each prosthesis group: * The 1-year difference in the UCLA score measuring the participants physical activity in relation to their usual level * The 1-year difference in the UCLA score measuring physical activity in relation to the preoperative level * The UCLA score at different times (usual level, preoperative, 6 weeks, 3 months, 6 months, 12 months). * The time to return to activities and sports * The time to return to usual professional activity * The quality of return to activity is evaluated by the Oxford hip functional scores. * Complications and the rate of revision surgery (if applicable) .Participants experience is measured by the SHV (Subjective Hip Value) Score and the Forgotten Hip Score (/100, 100=normal) at all study visits compared to the preoperative value. * The factors influencing the time to return to physical activity at the usual level in the year following prosthetic surgery taken into account for the analysis are patient-related parameters (rehabilitation or not, age, physical activity, medical history including inflammatory diseases), surgery-related parameters (type of implant, surgical approach and length of hospitalization) * The type of implant, surgical approach and clinical outcomes Research design Research scheme Observational, non-inferiority, non-randomized, prospective, multicenter, national study. Patients operated on the hip will be classified into 4 groups according to the type of prosthesis: * The resurfacing group * The THA group (hard-soft) * The THA group (dual mobility) * The THA group (hard-hard) Methods to limit bias Choice of centers Inclusion control Research Procedure The research procedure consists of collecting data from the medical records of patients followed in the context of current practice (demographics, anthropometry, comorbidities, medical history, etiology, surgery-related data, first mobilization, length of stay, discharge, type and duration of rehabilitation). In addition to current practice, patients will be asked to complete questionnaires on their return to activity (daily, professional and sports) with a systematic collection of postoperative events and any complications. No medical procedures or visits have been added in the context of this research. Questionnaires Assessing Physical Activity The patients; level of activity is assessed by the Devane score: it assesses work-related and/or sports activities. It is a score that gives an overall assessment of the participants level of activity or sedentary lifestyle rather than their actual sports practice. The score ranges from 1 to 5 depending on the participants answers, with 5 corresponding to the most intense activities . The participants pre-operative sports profile is assessed by 3 questions asked to the participant. Post-operative return to sports activity is assessed by 1 question (yes/no with 4 modalities to explain the reason for no). If the participant has resumed sports activity, 4 additional questions are asked about the frequency per week, whether it is the same activity, whether it is at the same level as before the intervention and the type of activity. The participant level of physical activity is assessed by the UCLA score, from the University of California, Los Angeles . This scale was originally developed by surgeons to assess the physical activity levels of patients who had undergone hip and knee arthroplasty . It is a 10-level, single-item scale, ranging from 10, for a patient who regularly participates in impact sports, to 1, for a patient who is completely inactive, dependent on others and unable to leave their home. Questionnaires Assessing Hip Function The functional results of the hip are assessed by the participant with the following questionnaires: . The Oxford Hip Score; (OHS-12 Delaunay et al, 2009) questionnaire is composed of 12 questions. It measures pain (on 6 items) and hip function (on 6 items) in relation to activities of daily living such as walking, the ability to dress, and sleep disturbances. Each question has 5 possible answers. Each corresponds to a value of 0 (= highest severity) to 4 (= total or almost total absence of symptoms). The sum of the answers to the questions is normalized on a scale between 0 and 100. The SHV (Subjective Hip Value) questionnaire is an analog evaluation scale coded from 0 to 100 (= Normal hip) The FJS (Forgotten Joint Score) HIP or Forgotten Hip Score is set at 100, with 100 corresponding to a normal hip . Other Questions Asked of the Patient Patients will be asked questions about bleeding, swelling, and wound healing in the days and weeks after surgery. Immediate complications and reoperation, if applicable, will be collected. In addition, patients will be asked about the duration of work stoppage and sports cessation before and after surgery. Treatments and Associated Procedures Authorized Associated Treatments/Procedures Any treatment necessary for the routine care of the participant is authorized. Prohibited Associated Treatments/Procedures No associated treatment or procedure is prohibited during the study. Conduct of the Research Research Schedule Duration of the inclusion period: 6 months Duration of participation for each participant: maximum 15 months Total duration of the research: 21 months Visit 1 Visit 1 is the inclusion visit, corresponding to the pre-operative visit with the surgeon. It is conducted by the investigator physician and usually takes place between 3 and 1 month before the surgical procedure (D0). This visit includes: Providing the information sheet and explaining the research Verifying all eligibility criteria Obtaining the participants non-opposition by the physician Collecting demographic and anthropometric data (age, sex, height, weight) Collecting comorbidities and history of the hip and spine, etiology Visit 2 Visit 2 corresponds to the sending of questionnaires by email to the participant 14 days before the surgical procedure D0 (Visit 3): Description of profession and activities (5 min) Degree of activity (Devane score) (1 min) Patients sport profile (1 min) Usual UCLA activity level and preoperative UCLA activity level (3 min) Self-questionnaires: Oxford questionnaire (20 min) Participant feelings by SHV and hip awareness FJS HIP (3 min) Collection of the duration of sports and professional cessation before surgery (2 min) A reminder for the primary endpoint is planned until the day before the procedure. Visit 3 Visit 3 corresponds to the hip surgery by resurfacing or total prosthesis placement according to the surgeons current practice. Surgical data will be collected such as the operated side, surgical approach, type of anesthesia, duration of the procedure, type of prosthesis and friction couple, surgical procedure and any immediate complications. Visit 4 Visit 4 corresponds to the collection of postoperative data from the participant during the postoperative period between the surgical procedure D0 (Visit 3) and the postoperative visit at 3 months (Visit 5). The following data will be collected during his/her hospital stay and then by email upon discharge: The first day of postoperative mobilization, discharge location, prescription of rehabilitation sessions Bleeding at D1 D3, D7 Edema at D21 and D42 Healing at D21 and D42 Participant feelings by the SHV at D28, D42, D70 UCLA physical activity level questionnaire at D42 Return to work at D28, D35, D42, D70 Surgical complications and any reoperation throughout follow-up Visit 5 Visit 5 corresponds to the collection of data at the 3-month postoperative visit: Postoperative UCLA activity level Oxford questionnaire (sent 5 days before at D85-10min) Participants feelings SHV and hip awareness FJS Hip Edema Surgical complications and any reoperation Return to work and sports activities Collection of SAEs Visit 6 Visit 6 corresponds to the collection of data at the 6-month postoperative visit: Postoperative UCLA activity level Oxford questionnaire (sent 5 days before Visit 6, at D175-10min) Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities. End-of-Study Visit or Visit 7 Visit 7 corresponds to the collection of data at the 12-month postoperative visit: Postoperative UCLA activity level Oxford questionnaire (sent 5 days before Visit 7, at D356-10min) Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities, Postoperative duration of sports and professional cessation Collection of SAEs Study Termination Rules and Protocol Deviations Withdrawal, Consent Withdrawal and Lost to Follow-up A participant who no longer wishes to participate in this research, particularly in case of withdrawal or consent withdrawal, may do so at any time for any reason. He/she will no longer be followed up in the context of this protocol but will continue to receive the best possible care given his/her state of health and the current state of knowledge. Withdrawal is a decision by an included participant to exercise his/her right to discontinue his/her participation in a research study, at any time during the follow-up, without incurring any prejudice as a result and without having to justify himself/herself. Consent withdrawal is a decision by a participant to withdraw his/her participation in a research study and to exercise his/her right to revoke his/her informed consent, at any time during the follow-up and without incurring any prejudice as a result and without having to justify himself/herself. The investigator must assess whether it is possible to collect the variable on which the primary endpoint is based at the time of withdrawal/withdrawal. Withdrawals/withdrawals must be promptly notified to the coordinating investigator center, the sponsor and the data management and methodology center. The reasons, if known, and the date of withdrawal/withdrawal must be documented in the observation notebook and in the participants medical record. A participant is considered lost to follow-up when he/she stops the follow-up planned in the protocol for no reason known to the investigator, so that the data collection cannot be carried out as planned. In case of a lost-to-follow-up subject, the investigator will make every effort to get back in touch with the person. The observation notebook will be completed until the end of the study by documenting the reason for leaving. Research Termination Rules End of research or planned termination of research: end of participation of the last person who lends himself/herself to the research, also called last visit of the last participant included in the research. When the research has reached its planned term (planned termination), the end of the research must be declared to the ANSM and the CPP within 90 days. Early termination of research: the clinical research is stopped (definitively) in advance. This is the case, in particular, when the sponsor decides: Not to start the research despite the favorable opinion of a CPP Not to resume the research after having temporarily interrupted it or after its suspension by the ANSM. When the research is stopped (definitively) in advance, the end of the research must be declared to the ANSM within 15 days, indicating the reasons for this stop. Temporary suspension of research: the temporary suspension of a clinical research consists of: The cessation of the inclusion of new persons in this research. And/or the cessation of the administration of the tested product, if applicable, to all or part of the persons already included in the research. And/or the cessation of the acts provided for in the research protocol. Any decision by the sponsor to temporarily suspend the research must be immediately informed to the ANSM and the CPP concerned and, in a second step and within a maximum of 15 calendar days following the date of this suspension, a request for authorization for a substantial modification concerning this temporary suspension submitted to the ANSM and a request for an opinion to the CPP concerned. 1.2.3. Premature Terminations The investigator may temporarily or permanently discontinue a participants contribution to the study for any reason that would best serve the participants interests, particularly in the event of an SAE. These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge. The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination. The study provides for early exit of participants who are in either of these situations. These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current Premature Terminations The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination. The study provides for early exit of participants who are in either of these situations. These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge. For all premature study withdrawals, the investigator must document the reasons as completely as possible. The observation notebook will be completed until the end of the study. The study may be interrupted prematurely in the event of unexpected adverse events, SAEs, requiring a review of the medical strategies profile. Similarly, unforeseen events or new information relating to medical strategies may lead the sponsor to prematurely interrupt the study. Participants Included in Error A participant is considered to be included in error when he/she has actually been included in the research even though he/she did not meet all the eligibility criteria. Participants included in error must be discussed. They must continue to be followed up as planned by the protocol until a decision has been made by the sponsor in agreement with the study coordinating investigator. Protocol Deviations Deviations must be documented by the investigator. A protocol deviation may be discussed between the investigator and the sponsor. Even in the event of a protocol deviation, the participants follow-up must be conducted until the end of the protocol. Definitions Adverse Event (Article R.1123-46 of the Public Health Code) Any harmful manifestation occurring in a person who lends himself/herself to research involving the human person, whether or not this manifestation is related to the research or the product on which the research is carried out. Serious Adverse Event or Effect (Article R.1123-46 of the Public Health Code and ICH E2B Guide) Any adverse event that: Certain circumstances requiring hospitalization do not fall under the severity criterion of ;hospitalization such as: admission for social or administrative reasons, hospitalization predefined by the protocol, hospitalization for medical or surgical treatment scheduled before the research, day hospital stay. Adverse events likely to be related to a drug or product mentioned in Article R. 5121-150 to be declared to the Regional Pharmacovigilance Center (CRPV) on which it depends. Incidents or risks of incidents resulting from the use of a medical device to be reported to the local Matériovigilance correspondent. Monitoring and Reporting of Serious Adverse Events The study was non-interventional, no serious adverse events are expected related to this study. ### Conditions Module **Conditions:** - Hip Arthrosis - Femur Head Necrosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 12 Months ### Arms Interventions Module #### Arm Group 1 **Description:** involves removing damaged cartilage and bone from the hip joint, half of the femoral head is cut, the neck and the other half are preserved, the acetabulum is covered by a metal cup **Intervention Names:** - Procedure: total hip replacement **Label:** resurfacing #### Arm Group 2 **Description:** dual mobility total hip prosthesis in polyethylene, ceramic hip prosthesis, total hip prosthesis in ceramic or metal and polyethylene **Intervention Names:** - Procedure: total hip replacement **Label:** total hip prosthesis ### Interventions #### Intervention 1 **Arm Group Labels:** - resurfacing - total hip prosthesis **Description:** Replacement of the hip joint with a total prosthesis, a femoral stem, an acetabular cup, a joint head, in metal, ceramic, dual mobility or polyethylene **Name:** total hip replacement **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The UCLA Hip Score is a validated measurement tool used to assess the level of physical activity in patients undergoing hip arthroplasty. It consists of a single-item scale ranging from 10 to 1. A score of 10 indicates regular participation in impact sports, while a score of 1 indicates complete inactivity and dependency on others. This score is utilized to evaluate the patient's functional outcome and activity level following hip surgery. **Measure:** UCLA hip score **Time Frame:** Day 0, and 3 ,6,12 mounths #### Secondary Outcomes **Description:** evaluate patients' subjective perception of their hip function following hip surgery. It's typically assessed on a scale from 0 to 100, where 100 represents a fully functional, pain-free hip similar to its pre-surgery state. Patients rate their hip function based on their comfort, mobility, and overall satisfaction with the outcome of the surgery. This assessment provides valuable insight into the patient's experience and satisfaction with their hip replacement procedure **Measure:** Subjective Hip Value (SHV) Score **Time Frame:** Days 14 and 3,6, 12 mounths **Description:** It measures how "forgotten" the joint feels, with higher scores indicating that patients are less aware of the replaced joint during daily activities. The score typically ranges from 0 to 100, with 100 indicating that the joint feels completely forgotten or normal. This assessment provides valuable information on the patient's perception of their hip replacement and its impact on their quality of life **Measure:** The Forgotten Joint Score (FJS) **Time Frame:** Day 0, and 3 ,6,12 mounths **Description:** 12 questions used to assess the functional status and pain level of patients following hip replacement surgery. The questions cover activities of daily living such as walking, dressing, and sleeping, and patients rate their difficulty or pain level on a scale from 0 to 4 for each question. The total score ranges from 0 to 48, with lower scores indicating greater pain and functional limitation. **Measure:** Oxford Hip Score (OHS) **Time Frame:** Day 0, and 3 ,6,12 mounths **Description:** tool used to evaluate the level of activity or sedentariness in patients. It assesses both professional and recreational activities, providing an overall assessment of the patient's activity level rather than focusing solely on their athletic pursuits. The score ranges from 1 to 5 based on the patient's responses, with 5 indicating the most intense level of activity. **Measure:** The DEVANE Score **Time Frame:** Day 0, 12 mounths **Description:** Years **Measure:** Age **Time Frame:** Day 0 **Description:** Male, female **Measure:** Gendre **Time Frame:** Day 0 **Description:** implant type, resurfacing, dual mobility, ceramic, ceramic or polyethylene metal **Measure:** Implant type **Time Frame:** Day 0 **Description:** choice of surgical approach, anterior, posterior **Measure:** Surgical approach **Time Frame:** Day 0 **Description:** rehabilitation, in a center, at home with a physiotherapist or without **Measure:** Rehabilitation **Time Frame:** 12 mounths **Description:** nflammatory disease, polyarthritis, previous surgical procedures on the hip, spine **Measure:** medical and surgical history **Time Frame:** Day 0 ### Eligibility Module **Eligibility Criteria:** * Inclusion Criteria: * Participant is male or female, aged 50 or under * Participant is indicated for a primary THA or resurfacing procedure * Participant agrees to complete and receive questionnaires by email * Participant has been informed and has not objected to the collection and use of their data * Exclusion Criteria: * Participant is aged under 18 or over 50 years * Participant has had a previous THA or resurfacing procedure * Participant is scheduled for a THA on the other hip within the year * Participant has severe physical and/or psychological health problems that, in the investigators opinion, may affect the participant\&#39;s compliance with the study * Participant is participating in another research study * Participant is in the exclusion period of another research study that is still ongoing at the time of inclusion * Participant is a protected person: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Participant is pregnant, breastfeeding or giving birth * Participant is hospitalized without consent **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Patients will be recruited by surgeons during orthopedic surgery consultations at each of the participating centers in the study. These consultations will take place between 3 and 1 month before the intervention. The purpose of the research will be explained to all patients who meet the eligibility criteria by the surgeon and an information sheet will be given to them. The physician will obtain the patients consent to participate in the research and their non-opposition to the collection and use of their data at least 14 days before the intervention, allowing sufficient time for the participant to reflect. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jmphilippeau@hotmail.com **Name:** Jean Marie PHILIPPEAU, MD **Phone:** 024-012-7701 **Role:** CONTACT **Contact 2:** **Email:** docteurmiri@hotmail.fr **Name:** Nacim MIRI, CTM **Phone:** 076-447-5298 **Role:** CONTACT #### Locations **Location 1:** **City:** Saint Herblain **Contacts:** ***Contact 1:*** - **Email:** jmphilippeau@hotmail.com - **Name:** Jean Marie Dr Philippeau, PI - **Phone:** 0240127701 - **Role:** CONTACT **Country:** France **Facility:** Santé Atlantique **State:** Nantes **Zip:** 44800 #### Overall Officials **Official 1:** **Affiliation:** SFHG **Name:** Ronald Isida, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** the sponsor has not yet decided on the sharing, a meeting of all members of the association must take place soon to decide **IPD Sharing:** NO ### References Module #### See Also Links **Label:** official page of Société Française de chirurgie de la Hanche et du Genou **URL:** https://sfhg.fr/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000010020 - Term: Osteonecrosis - ID: D000001847 - Term: Bone Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Arthrosis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M8409 - Name: Femur Head Necrosis - Relevance: HIGH - As Found: Femur Head Necrosis - ID: M17912 - Name: Osteoarthritis, Hip - Relevance: HIGH - As Found: Hip Arthrosis - ID: M12284 - Name: Necrosis - Relevance: HIGH - As Found: Necrosis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12943 - Name: Osteonecrosis - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000005271 - Term: Femur Head Necrosis - ID: D000015207 - Term: Osteoarthritis, Hip - ID: D000009336 - Term: Necrosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00869479 **Brief Title:** Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis **Official Title:** Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis #### Organization Study ID Info **ID:** 2008P002371 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2010-12-15 **Type:** ESTIMATED **Last Update Submit Date:** 2010-12-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Start Date **Date:** 2009-03 **Status Verified Date:** 2010-12 #### Study First Post Date **Date:** 2009-03-26 **Type:** ESTIMATED **Study First Submit Date:** 2009-03-17 **Study First Submit QC Date:** 2009-03-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Old Name Title:** Alexandra Kimball, MD **Old Organization:** Massachusetts General Hospital ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin. ### Conditions Module **Conditions:** - Nephrogenic Systemic Fibrosis **Keywords:** - Nephrogenic Systemic Fibrosis - Screening ### Design Module #### Design Info **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** subjects with a histologically-proven diagnosis of NSF **Label:** 1 #### Arm Group 2 **Description:** subjects with other fibrosing skin diseases **Label:** 2 #### Arm Group 3 **Description:** subjects with non-fibrosing skin diseases **Label:** 3 #### Arm Group 4 **Description:** subjects without skin diseases **Label:** 4 ### Outcomes Module #### Primary Outcomes **Measure:** Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases. **Time Frame:** 1 day #### Secondary Outcomes **Measure:** Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. **Time Frame:** 1 day **Measure:** Sensitivity of the questionnaire when applied to NSF subjects. **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female subjects 18 years of age or older. 2. Willing and able to understand and provide oral informed consent. 3. Able to complete study and comply with study procedures. Exclusion Criteria: 1. Subject is unable to provide oral consent. 2. Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Massachusetts General Hospital Dermatology and Rheumatology clinics ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02114 #### Overall Officials **Official 1:** **Affiliation:** Massachusetts General Hospital **Name:** Jonathan Kay, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. doi: 10.1007/s11926-008-0033-6. **PMID:** 18638427 **Citation:** Todd DJ, Kagan A, Chibnik LB, Kay J. Cutaneous changes of nephrogenic systemic fibrosis: predictor of early mortality and association with gadolinium exposure. Arthritis Rheum. 2007 Oct;56(10):3433-41. doi: 10.1002/art.22925. **PMID:** 17907148 **Citation:** Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877. **PMID:** 23097320 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M27988 - Name: Nephrogenic Fibrosing Dermopathy - Relevance: HIGH - As Found: Nephrogenic Systemic Fibrosis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4073 - Name: Nephrogenic Systemic Fibrosis - Relevance: HIGH - As Found: Nephrogenic Systemic Fibrosis ### Condition Browse Module - Meshes - ID: D000054989 - Term: Nephrogenic Fibrosing Dermopathy - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01835379 **Brief Title:** Study of Oasis Ultra in Diabetic Foot Ulcers **Official Title:** A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers #### Organization Study ID Info **ID:** 815-999-09-010 #### Organization **Class:** INDUSTRY **Full Name:** Healthpoint ### Status Module #### Completion Date **Date:** 2014-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-01-22 **Type:** ESTIMATED **Last Update Submit Date:** 2015-01-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-09 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-01-22 **Type:** ESTIMATED **Results First Submit Date:** 2015-01-05 **Results First Submit QC Date:** 2015-01-20 #### Start Date **Date:** 2013-05 **Status Verified Date:** 2015-01 #### Study First Post Date **Date:** 2013-04-18 **Type:** ESTIMATED **Study First Submit Date:** 2013-04-16 **Study First Submit QC Date:** 2013-04-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Healthpoint #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care . ### Conditions Module **Conditions:** - Diabetic Foot Ulcer **Keywords:** - Diabetes - Diabetic Foot Ulcer - Diabetic Foot Wound - Non-healing foot wound - Oasis - Diabetic neuropathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 82 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oasis **Intervention Names:** - Device: Oasis **Label:** Oasis **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard Care **Intervention Names:** - Other: Standard **Label:** Standard **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Oasis **Description:** Oasis Ultra will be applied once per week for up to 12 weeks. **Name:** Oasis **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Standard **Name:** Standard **Other Names:** - Standard Care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of Wounds Closed **Time Frame:** At the end of 12 Weeks #### Secondary Outcomes **Description:** Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure. **Measure:** Time to Wound Closure **Time Frame:** During the 12 Week treatment period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. * Subjects 18 years of age or older of either sex with a history of diabetes mellitus (Type 1 or 2) requiring medication (insulin and/or oral/injectable) to control blood glucose levels. * A non-healing, Wagner grade 1 or 2, neuropathic diabetic foot ulcer. * Willing and able to make all required study visits. * Able to follow instructions. * An ulcer present on any part of the plantar surface of the foot, which is 0.5 cm2 to 10 cm2 (inclusive), as measured at the Screening Visit prior to debridement, with a duration ≥ 6 weeks (documented in the patient's history or by patient report of onset) but not more than 12 months. * Separation of at least 5 cm (wound edge to wound edge) if ≥ 2 wounds are present. * Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of \> 40 mmHg OR a transcutaneous oxygen pressure (TcPO2) ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable in lieu of ABI, but if both are obtained, each must meet its respective cutoff. Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable (test result must be included in the source document). * Target ulcer is not infected based on clinical assessment. * Able to perform any required dressing changes at home or have a caregiver who can perform the dressing changes. * Willing to use an appropriate off-loading device to keep weight off of foot ulcers. * Blood counts and blood chemistry values as follows: * Alanine aminotransferase (ALT) ≤ 3x upper limit of normal * Aspartate aminotransferase (AST) ≤ 3x upper limit of normal * Serum albumin ≥ 2.0 g/dL •Pre-albumin levels of ≥ 10 mg/dL * Alkaline phosphatase ≤ 500 U/L •Serum total bilirubin ≤ 3.0 mg/dL * Serum BUN \< 75 mg/dL •Serum creatinine ≤ 4.5 mg/dL * HbA1c ≤ 12% •Hemoglobin (Hgb) \> 8.0 g/dL * WBC \> 2.0 x 109/L •Absolute neutrophil count \> 1.0 x 109/L * Platelet count \> 50 x 109/L Exclusion Criteria: * Contraindications or hypersensitivity to the use of the study device or its components (e.g., porcine sensitivity). * Participation in another investigational study within thirty (30) days of Visit 1 or planned participation overlapping with this study. * Subjects with evidence of gangrene on either lower limb. * Ulcers that require negative pressure or hyperbaric oxygen therapy. * The Medical Monitor may declare any subject ineligible for a valid medical reason. * Current treatment with disallowed medications or therapies. Subjects may not be enrolled into the study while using systemic antibiotics. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Little Rock **Country:** United States **State:** Arkansas **Zip:** 72205 **Location 2:** **City:** Carlsbad **Country:** United States **State:** California **Zip:** 92009 **Location 3:** **City:** Fair Oaks **Country:** United States **State:** California **Zip:** 95628 **Location 4:** **City:** Fresno **Country:** United States **State:** California **Zip:** 93720 **Location 5:** **City:** San Diego **Country:** United States **State:** California **Zip:** 92103 **Location 6:** **City:** Evansville **Country:** United States **State:** Indiana **Zip:** 47713 **Location 7:** **City:** Madisonville **Country:** United States **State:** Kentucky **Zip:** 42431 **Location 8:** **City:** Shreveport **Country:** United States **State:** Louisiana **Zip:** 71101 **Location 9:** **City:** Saginaw **Country:** United States **State:** Michigan **Zip:** 48602 **Location 10:** **City:** Bayonne **Country:** United States **State:** New Jersey **Zip:** 07002 **Location 11:** **City:** Dallas **Country:** United States **State:** Texas **Zip:** 75224 **Location 12:** **City:** Dallas **Country:** United States **State:** Texas **Zip:** 75243 **Location 13:** **City:** Fort Worth **Country:** United States **State:** Texas **Zip:** 76104 **Location 14:** **City:** Houston **Country:** United States **State:** Texas **Zip:** 77036 **Location 15:** **City:** McAllen **Country:** United States **State:** Texas **Zip:** 78501 **Location 16:** **City:** Virginia Beach **Country:** United States **State:** Virginia **Zip:** 23464 #### Overall Officials **Official 1:** **Affiliation:** Healthpoint **Name:** Herbert B Slade, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007871 - Term: Leg Ulcer - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M7124 - Name: Diabetic Neuropathies - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M19933 - Name: Diabetic Foot - Relevance: HIGH - As Found: Diabetic Foot - ID: M18919 - Name: Foot Ulcer - Relevance: HIGH - As Found: Foot Ulcer - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M10883 - Name: Leg Ulcer - Relevance: LOW - As Found: Unknown - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017719 - Term: Diabetic Foot - ID: D000016523 - Term: Foot Ulcer - ID: D000014456 - Term: Ulcer ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Oasis **Description:** Oasis Oasis Ultra applied once per week for up to 12 weeks. **ID:** EG000 **Other Num at Risk:** 41 **Serious Number Affected:** 10 **Serious Number At Risk:** 41 **Title:** Oasis **Group ID:** EG001 **Title:** Standard **Description:** Standard Care Standard Care as chosen by the Investigator **ID:** EG001 **Other Num at Risk:** 41 **Serious Number Affected:** 10 **Serious Number At Risk:** 41 **Title:** Standard **Frequency Threshold:** 3 #### Serious Events **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Renal Failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Cardiac Failure Congestive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Osteomyelitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 41 **Num Events:** 5 **Term:** Gangrene **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Deep vein thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Pulmonary oedema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 41 **Term:** Cellulitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Term:** Anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Lower GI hermorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** GERD **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Transient ischemic attack (TIA) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA (15.1) ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Time Frame:** Adverse event data was collected during the 12-week treatment period. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 41 **Group ID:** BG001 **Value:** 41 **Group ID:** BG002 **Value:** 82 **Units:** Participants ### Group **ID:** BG000 **Title:** Oasis **Description:** Oasis Oasis Ultra applied once per week for up to 12 weeks. ### Group **ID:** BG001 **Title:** Standard **Description:** Standard Care Standard Care as chosen by the Investigator ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 10.9 **Value:** 57.1 #### Measurement **Group ID:** BG001 **Spread:** 10.8 **Value:** 56.6 #### Measurement **Group ID:** BG002 **Spread:** 10.8 **Value:** 56.9 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 11 #### Measurement **Group ID:** BG002 **Value:** 20 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 32 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 62 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 26 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 31 #### Measurement **Group ID:** BG001 **Value:** 25 #### Measurement **Group ID:** BG002 **Value:** 56 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 12 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 33 #### Measurement **Group ID:** BG001 **Value:** 33 #### Measurement **Group ID:** BG002 **Value:** 66 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 41 #### Measurement **Group ID:** BG001 **Value:** 41 #### Measurement **Group ID:** BG002 **Value:** 82 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.9 **Value:** 32.9 #### Measurement **Group ID:** BG001 **Spread:** 6.1 **Value:** 33.6 #### Measurement **Group ID:** BG002 **Spread:** 7.6 **Value:** 33.3 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 6 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Body Mass Index (BMI) **Unit of Measure:** kg/m2 ## Results Section - More Information Module ### Certain Agreement **Other Details:** The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** jaime.dickerson@smith-nephew.com **Organization:** Smith & Nephew, Inc. **Phone:** 817-302-3914 **Title:** Vice President, Medical & Clinical Affairs ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 54 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1.0 - **Spread:** - **Upper Limit:** 12.0 - **Value:** 9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 1.0 - **Spread:** - **Upper Limit:** 12.0 - **Value:** 11 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** At the end of 12 Weeks **Title:** Percentage of Wounds Closed **Type:** PRIMARY **Unit of Measure:** percentage of wounds closed ##### Group **Description:** Oasis Oasis Ultra applied once per week for up to 12 weeks. **ID:** OG000 **Title:** Oasis ##### Group **Description:** Standard Care Standard Care as chosen by the Investigator **ID:** OG001 **Title:** Standard #### Outcome Measure 2 **Description:** Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** During the 12 Week treatment period **Title:** Time to Wound Closure **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Oasis Oasis Ultra applied once per week for up to 12 weeks. **ID:** OG000 **Title:** Oasis ##### Group **Description:** Standard Care Standard Care as chosen by the Investigator **ID:** OG001 **Title:** Standard ### Participant Flow Module #### Group **Description:** Oasis Oasis Ultra applied once per week for up to 12 weeks. **ID:** FG000 **Title:** Oasis #### Group **Description:** Standard Care Standard Care as chosen by the Investigator **ID:** FG001 **Title:** Standard #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 41 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 41 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01970579 **Acronym:** ConSeQuent **Brief Title:** Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter **Official Title:** Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter #### Organization Study ID Info **ID:** AAG-G-H-1214 #### Organization **Class:** INDUSTRY **Full Name:** B. Braun Melsungen AG ### Status Module #### Completion Date **Date:** 2019-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-03-30 **Type:** ACTUAL **Last Update Submit Date:** 2020-03-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-12 **Type:** ACTUAL #### Start Date **Date:** 2013-10 **Status Verified Date:** 2020-03 #### Study First Post Date **Date:** 2013-10-28 **Type:** ESTIMATED **Study First Submit Date:** 2013-10-23 **Study First Submit QC Date:** 2013-10-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** B. Braun Melsungen AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only. ### Conditions Module **Conditions:** - Stenosis - Restenosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 153 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Paclitaxel coated balloon **Label:** Paclitaxel coated balloon **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Device: uncoated PTA catheter **Label:** uncoated PTA catheter **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Paclitaxel coated balloon **Description:** * Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting **Name:** Paclitaxel coated balloon **Other Names:** - SeQuent® Please P - Drug coated balloon **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - uncoated PTA catheter **Description:** * Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting. **Name:** uncoated PTA catheter **Other Names:** - POBA **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Late Lumen Loss **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Willingness to treat the target lesion according to the DCB only concept * Patients in Rutherford classes 2 through 4 (corresponding to Fontaine stage IIb to III) * Patients eligible for peripheral revascularization by means of PTA * Patients must be ≥ 18 years of age * Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol * Patients must agree to undergo the 6-month angiographic and clinical follow-up * Patients must agree to undergo the 1 and 2 year clinical follow-up * Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. * Peripheral lesions in the native SFA or popliteal artery with reference vessel diameters between ≥ 4.0 and ≤ 7.0 mm, lesions lengths ≥ 4 cm and ≤ 27 cm as angiographically documented * Diameter stenosis pre-procedure must be ≥ 70% * Target lesion in the SFA or popliteal artery (first two proximal segments)\*. \* as far as applicable distance of the target lesion to a previously implanted stent should be about 1cm * Vessels must have adequate runoff with at least one vessel to the foot. * Treatment of max. two lesions is permitted. Exclusion Criteria: * Patients with Rutherford class 5 or 6 * Women who are known or suspected to be pregnant. Hence, patients will be advised to use an adequate birth control method up to and including the 6-month follow-up. * Patients with an expected life span of less than 24 months * Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated * Patients who had a cerebral stroke \< 6 months prior to the procedure * Patients with unstable angina pectoris * Patients with acute myocardial infarction within the past 2 weeks * Patient participates in other clinical trials involving any investigational device or drug that interfere with the effects to be studied in this trial. * Interventional treatment at the contralateral leg within 2 weeks prior to or after the study intervention * Untreated hyperthyroidism * Patient has presence or history of severe renal failure (GFR \< 30ml/min) and is therefore not eligible for angiography. * Post transplantation of any organ or immune suppressive medication * Other disease to jeopardize follow-up (e.g. malignoma) * Addiction to any drug or to alcohol (WHO definition) * Patients with clinically significant aneurysmal disease of the popliteal, femoral or iliac artery and patients with history of clinically significant abdominal aortic aneurysm * Patients with any type of surgical/interventional procedures within 4 weeks prior to or planned after study intervention (if those may interfere with the peripheral study intervention and/or patient's ability to perform the follow up examinations) * Conditions which prevent the intake of the double anti-platelet therapy for two months * Patients with contraindication for drug-eluting balloon angioplasty given in the instruction for use * Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany) * Strongly calcified lesions with circumferential presence of calcifications and a lesion length of \> 4 cm * Chronic total occlusions longer than 10 cm * Lesion below the knee requiring treatment * Target lesion within a bypass graft * In-stent restenosis * Lesions treated with DCB * Concomitant use of atherectomy, cryoplasty or laser therapy * Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bad Krozingen **Country:** Germany **Facility:** Universitäts-Herzzentrum Freiburg Bad Krozingen **Zip:** 79189 **Location 2:** **City:** Berlin **Country:** Germany **Facility:** Vivantes Klinikum Neukölln **Zip:** 12351 **Location 3:** **City:** Berlin **Country:** Germany **Facility:** Ev. Krankenhaus Hubertus **Zip:** 14129 **Location 4:** **City:** Magdeburg **Country:** Germany **Facility:** Klinikum der Otto-von-Guericke-Universität Magdeburg **Zip:** 39120 **Location 5:** **City:** Magdeburg **Country:** Germany **Facility:** Klinikum Magdeburg **Zip:** 39130 **Location 6:** **City:** München **Country:** Germany **Facility:** Deutsches Herzzentrum München **Zip:** 80636 **Location 7:** **City:** Rosenheim **Country:** Germany **Facility:** RoMed Klinikum Rosenheim **Zip:** 83022 #### Overall Officials **Official 1:** **Affiliation:** Vivantes Klinikum Neukölln, Berlin, Germany **Name:** Thomas Albrecht, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Albrecht T, Waliszewski M, Roca C, Redlich U, Tautenhahn J, Pech M, Halloul Z, Gogebakan O, Meyer DR, Gemeinhardt I, Zeller T, Muller-Hulsbeck S, Ott I, Tepe G. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014. doi: 10.1007/s00270-018-1940-1. Epub 2018 Mar 27. **PMID:** 29589098 **Citation:** Tepe G, Gogebakan O, Redlich U, Tautenhahn J, Ricke J, Halloul Z, Meyer DR, Waliszewski M, Schnorr B, Zeller T, Muller-Hulsbeck S, Ott I, Albrecht T. Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-1544. doi: 10.1007/s00270-017-1713-2. Epub 2017 Jun 28. **PMID:** 28660441 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02880579 **Acronym:** NTF **Brief Title:** Neurothrombectomy France **Official Title:** Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke #### Organization Study ID Info **ID:** RC11_0097 #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-08-26 **Type:** ESTIMATED **Last Update Submit Date:** 2016-08-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-03 **Type:** ACTUAL #### Start Date **Date:** 2013-05 **Status Verified Date:** 2016-08 #### Study First Post Date **Date:** 2016-08-26 **Type:** ESTIMATED **Study First Submit Date:** 2016-08-05 **Study First Submit QC Date:** 2016-08-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nantes University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible. NTF The protocol is part of the evaluation process of our clinical practices recommended by the National Health Authority (HAS), in the specific context of mechanical thrombectomy performed in French centers of interventional neuroradiology working with neurovascular units (A V). ### Conditions Module **Conditions:** - Cerebral Artery Occlusion ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 230 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** clinical score for handicap (mRS) **Time Frame:** at 3 months #### Secondary Outcomes **Measure:** hemorrhagic complications on postoperative imaging **Time Frame:** baseline **Measure:** hemorrhagic complications on postoperative imaging **Time Frame:** at 1 day **Description:** Factors of good clinical prognosis **Measure:** physiological parameter : age **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of coronary artery disease **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of arterial hypertension **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of diabetes **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of hypercholesterolemia **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of intracranial stenosis **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of occlusive arterial disease **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of haematological disorders **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** presence of neoplasia **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** NIHSS score **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** ASPECTS score **Time Frame:** baseline **Description:** Factors of good clinical prognosis **Measure:** MRI imaging of stroke **Time Frame:** baseline **Measure:** unblocking rate based on the score TICI **Time Frame:** at 3 months **Measure:** NIHSS evaluation **Time Frame:** at 24h **Measure:** Influence of collaterality score on the NIHSS **Time Frame:** at 24h **Measure:** Influence ASPECTS score on the NIHSS **Time Frame:** at 24h **Measure:** Influence ASPECTS score on the NIHSS **Time Frame:** at 3months **Measure:** influence of anesthesia on the NIHSS **Time Frame:** at 24h **Measure:** hemorrhagic complications **Time Frame:** at 24h **Measure:** Influence of hemorrhagic complications on NIHSS **Time Frame:** at 24h **Measure:** Influence of hemorrhagic complications on NIHSS **Time Frame:** at 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signature of the information notice by the patient or his legal representative * Age\> 18 years * Clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h * Thrombosis (TICI 0 or 1) of the carotid T, M1, M1-M2 bifurcation of the basilar artery occlusion in TANDEM ACI / M1. Exclusion Criteria: * Pregnant or lactating women * Rapid improvement of NIHSS (gain of more than 4 points) between two pre-treatment assessments. * ASPECT score \<7 on the scanner or \<5 on the diffusion-weighted imaging (DWI) * Intracranial hemorrhage on imaging * Inability of clinical evaluations at 3 months * extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000) * 0 Refusal to participate in the study **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 200 consecutive patients admitted to a stroke unit for cerebral infarction treated by thrombectomy included (with or without fibrinolysis by intra venous) prospectively over a period of 1 year and 3 months followed for clinical neurological assessment (primary endpoint) . ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Nantes University Hospital **Name:** Hubert DESAL, PU-PH **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: HIGH - As Found: Artery Occlusion - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001157 - Term: Arterial Occlusive Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01824979 **Brief Title:** Pilairo Lab Market Research **Official Title:** Pilairo Lab Market Research #### Organization Study ID Info **ID:** CIA76 #### Organization **Class:** INDUSTRY **Full Name:** Fisher and Paykel Healthcare ### Status Module #### Completion Date **Date:** 2013-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-03-09 **Type:** ACTUAL **Last Update Submit Date:** 2018-02-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2018-03-09 **Type:** ACTUAL **Results First Submit Date:** 2017-08-02 **Results First Submit QC Date:** 2018-02-08 #### Start Date **Date:** 2012-12 **Status Verified Date:** 2018-02 #### Study First Post Date **Date:** 2013-04-05 **Type:** ESTIMATED **Study First Submit Date:** 2013-04-02 **Study First Submit QC Date:** 2013-04-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Fisher and Paykel Healthcare #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to observe the Pilairo mask in a lab setting. **Detailed Description:** The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pilairo nasal pillows mask during CPAP titration **Intervention Names:** - Device: CPAP mask ( Pilairo) **Label:** Pilairo mask **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Other CPAP mask during CPAP titration **Intervention Names:** - Procedure: Other CPAP mask **Label:** Other CPAP mask **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Pilairo mask **Name:** CPAP mask ( Pilairo) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Other CPAP mask **Name:** Other CPAP mask **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. **Measure:** Technician Experience With Mask **Time Frame:** One night #### Secondary Outcomes **Description:** Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. **Measure:** Number of Mask Interventions During the Night **Time Frame:** One night ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Apnea Hypopnea Indea \>15 from diagnostic study * Minimum 18 years of age Exclusion Criteria: * Inability ot give informed consent * History of intolerance to CPAP * Anatomical or physiological conditions making CPAP therapy inappropriate **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Burlingame **Country:** United States **Facility:** Peninsula Sleep Center Inc **State:** California **Zip:** 94010 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000001049 - Term: Apnea - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: LOW - As Found: Unknown - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020181 - Term: Sleep Apnea, Obstructive ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Pilairo **Deaths Num At Risk:** 50 **Description:** Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) **ID:** EG000 **Other Num at Risk:** 50 **Serious Number At Risk:** 50 **Title:** Pilairo **Group ID:** EG001 **Title:** Other CPAP Mask **Deaths Num At Risk:** 50 **Description:** Other CPAP mask during CPAP titration Other CPAP mask **ID:** EG001 **Other Num at Risk:** 50 **Serious Number At Risk:** 50 **Title:** Other CPAP Mask **Frequency Threshold:** 0 **Time Frame:** 1 night in lab ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 50 **Group ID:** BG001 **Value:** 50 **Group ID:** BG002 **Value:** 100 **Units:** Participants ### Group **ID:** BG000 **Title:** Pilairo **Description:** Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) ### Group **ID:** BG001 **Title:** Other CPAP Mask **Description:** Other CPAP mask during CPAP titration Other CPAP mask ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 50 #### Measurement **Group ID:** BG001 **Value:** 50 #### Measurement **Group ID:** BG002 **Value:** 100 **Class Title:** ≥ 18 years ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 19 #### Measurement **Group ID:** BG002 **Value:** 29 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 31 #### Measurement **Group ID:** BG002 **Value:** 71 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 50 #### Measurement **Group ID:** BG001 **Value:** 50 #### Measurement **Group ID:** BG002 **Value:** 100 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Description:** Inclusion criteria only confirmed participants were over the age of 18. Full date of birth was not recorded on the case report form. Therefore, the exact breakdown of participants in each age bracket is unable to be provided as is required in the non-customized Baseline measure. **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Region of Enrollment **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** CPAPtrial@fphcare.co.nz **Organization:** Fisher and Paykel Healthcare **Phone:** + 64 09 574 0100 **Title:** Clinical Research Scientist ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 10 - **Value:** 8.46 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 10 - **Value:** 8.24 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 5 - **Value:** 1.29 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 5 - **Value:** 2.20 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. **Dispersion Type:** Full Range **Parameter Type:** MEAN **Population Description:** While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure. **Reporting Status:** POSTED **Time Frame:** One night **Title:** Technician Experience With Mask **Type:** PRIMARY **Unit of Measure:** Units on a Scale ##### Group **Description:** Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) **ID:** OG000 **Title:** Pilairo ##### Group **Description:** Other CPAP mask during CPAP titration Other CPAP mask **ID:** OG001 **Title:** Other CPAP Mask #### Outcome Measure 2 **Description:** Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. **Dispersion Type:** Full Range **Parameter Type:** MEAN **Population Description:** While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure. **Reporting Status:** POSTED **Time Frame:** One night **Title:** Number of Mask Interventions During the Night **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) **ID:** OG000 **Title:** Pilairo ##### Group **Description:** Other CPAP mask during CPAP titration Other CPAP mask **ID:** OG001 **Title:** Other CPAP Mask ### Participant Flow Module #### Group **Description:** Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) **ID:** FG000 **Title:** Pilairo #### Group **Description:** Other CPAP mask during CPAP titration Other CPAP mask **ID:** FG001 **Title:** Other CPAP Mask #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ###### Reason **Group ID:** FG001 **Number of Subjects:** 13 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 50 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 50 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 37 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 13 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 13 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01301079 **Brief Title:** Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia **Official Title:** Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Using Filaments, an Algometer, and Interleukins: a Double-blind, Randomized Study #### Organization Study ID Info **ID:** anaana #### Organization **Class:** OTHER **Full Name:** Federal University of São Paulo ### Status Module #### Completion Date **Date:** 2012-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-11-10 **Type:** ESTIMATED **Last Update Submit Date:** 2014-11-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-09 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-11-10 **Type:** ESTIMATED **Results First Submit Date:** 2013-11-10 **Results First Submit QC Date:** 2014-11-06 #### Start Date **Date:** 2010-09 **Status Verified Date:** 2014-10 #### Study First Post Date **Date:** 2011-02-23 **Type:** ESTIMATED **Study First Submit Date:** 2011-02-22 **Study First Submit QC Date:** 2011-02-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Fundação de Amparo à Pesquisa do Estado de São Paulo #### Lead Sponsor **Class:** OTHER **Name:** Federal University of São Paulo #### Responsible Party **Investigator Affiliation:** Federal University of São Paulo **Investigator Full Name:** Plínio da Cunha Leal **Investigator Title:** Master's degree **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study was to determine if the addition of ketamine reduces remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6 and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine). **Detailed Description:** Opioids are very effective in pain relief, but they might lower pain threshold, making the patient more sensitive to a pain stimulus, a condition known as hyperalgesia \[Angst; Clarck, 2006\]. Opioid-induced hyperalgesia (OIH) is usually defined as a reduction in nociceptive thresholds in the peripheral field of the sensitized fibers \[Koppert et al., 2003\], and it is associated with increased pain and higher demand for postoperative analgesia \[Guignard et al., 2000\]. This phenomenon adversely impacts pain control, and has been suggested to occur in the peri-operative context, especially associated with the use of remifentanil, a short-acting opioid \[Guignard et al., 2000\]. Several mechanisms have been proposed to explain the hyperalgesia phenomenon, but the most important seems to be the activation of N-methyl-D-aspartate (NMDA) receptors \[Célèrier et al., 2000\]. Ketamine is a NMDA receptor antagonist that has been shown to reduce postoperative pain and the need for postoperative anesthetics and analgesics. Therefore, it is proposed that ketamine could prevent hyperalgesia, resulting in more effective and long-lasting postsurgical analgesia \[Célèrier et al. 2000\]. The results of studies of low dose of ketamine in the prevention of remifentanil-induced hyperalgesia are controversial. Joly et al. \[2005\] demonstrated a reduction in the consumption of opioids and in hyperalgesia assessed with monofilaments. However, Engelhardt et al \[2008\] showed no differences in pain scores or in postoperative opioid consumption. In addition, some authors observed higher levels of proinflammatory cytokines, associated with increased pain in mice receiving chronic opioid (morphine) infusion \[Johnston et al., 2004; Liang et al., 2008\]. Also, administration of proinflammatory cytokine inhibitors reduced phosphorylation of NMDA receptors \[Zhang et al., 2008\]. However, no study has examined the relationship between the use of remifentanil, the most frequently implicated opioid in OIH \[Guignard et al., 2000\], ketamine (drug capable of inhibiting NMDA-receptors and cytokines) \[Dale et al., 2012\], and the inflammatory response. The aim of this study was to determine if the addition of ketamine reduces remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL-6 and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine) in patients submitted to laparoscopic cholecystectomy, a procedure with an usually neglected potential for postoperative pain and that has been poorly investigated in association with OIH. ### Conditions Module **Conditions:** - Pain - Hyperalgesia - Inflammatory Response **Keywords:** - Remifentanil - Hyperalgesia - Ketamine - Von Frey's filament - Algometer - Interleukines - Opioid-induced hyperalgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), remifentanil (1 μg/kg), and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **Intervention Names:** - Drug: Ketamine **Label:** Ketamine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **Intervention Names:** - Drug: Saline **Label:** Saline **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ketamine **Description:** Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery. **Name:** Ketamine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Saline **Description:** Patients in group N (placebo) was administrated saline during surgery. **Name:** Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 30 Minutes **Time Frame:** 30 minutes **Description:** The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 60 Minutes **Time Frame:** 60 minutes **Description:** The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 90 Minutes **Time Frame:** 90 minutes **Description:** The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 120 Minutes **Time Frame:** 120 minutes **Description:** The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 150 Minutes **Time Frame:** 150 minutes **Description:** The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 180 Minutes **Time Frame:** 180 minutes **Description:** The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 210 Minutes **Time Frame:** 210 minutes **Description:** The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 240 Minutes **Time Frame:** 240 minutes **Description:** The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 6 Hours **Time Frame:** 6 hours **Description:** The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 12 Hours **Time Frame:** 12 hours **Description:** The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 18 Hours **Time Frame:** 18 hours **Description:** The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Measure:** Pain 24 Hours **Time Frame:** 24 hours #### Secondary Outcomes **Measure:** Time to First Morphine Supplementation **Time Frame:** 24 hours **Measure:** Morphine Consumption Within 24 h **Time Frame:** 24 hours **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Measure:** Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence **Time Frame:** Before the procedure (Baseline) **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Measure:** Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence **Time Frame:** 24 hours after procedure **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Measure:** Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region **Time Frame:** Before the procedure (Baseline) **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Measure:** Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region **Time Frame:** 24h after the procedure **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Measure:** Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence **Time Frame:** Baseline (before the procedure) **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Measure:** Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence **Time Frame:** 24 h after the procedure **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Measure:** Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region **Time Frame:** Baseline (before the surgery) **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Measure:** Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region **Time Frame:** 24 h after the procedure **Description:** The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined. **Measure:** Extension of Hyperalgesia **Time Frame:** 24 hours after the procedure **Description:** The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure **Measure:** Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure **Time Frame:** Before the procedure (Baseline) **Description:** The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure **Measure:** Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure **Time Frame:** 24 h after the procedure **Description:** The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure **Measure:** Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure **Time Frame:** Before the procedure (Baseline) **Description:** The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure **Measure:** Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure **Time Frame:** 24 h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-6 Before the Procedure **Time Frame:** Baseline (Before the procedure) **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-6 5 h After the Procedure **Time Frame:** 5 h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-6 24 h After the Procedure **Time Frame:** 24 h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-8 Before the Procedure **Time Frame:** Baseline (Before the procedure) **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-8 5 h After the Procedure **Time Frame:** 5 h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-8 24 h After the Procedure **Time Frame:** 24 h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-10 Before the Procedure **Time Frame:** Baseline (Before the procedure) **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-10 5h After the Procedure **Time Frame:** 5h after the procedure **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Measure:** Serum Level of Interleukin (IL)-10 24 h After the Procedure **Time Frame:** 24 h after the procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥ 18 years old * both sexes * ASA physical status I or II * undergoing laparoscopic cholecystectomy Exclusion Criteria: * chronic users of analgesics or had used opioids within 12 h of surgery * history of drug or alcohol abuse or psychiatric disorder * contraindications to self-administration of opioids (ie, unable to understand the patient-controlled analgesia \[PCA\] device) * contraindication for the use of ketamine, such as a psychiatric disorder, acute cardiovascular disorder, or unstable hypertension **Maximum Age:** 78 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** São Paulo **Country:** Brazil **Facility:** Federal University of São Paulo #### Overall Officials **Official 1:** **Affiliation:** Federal University of São Paulo **Name:** Plínio da Cunha Leal, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Liang D, Shi X, Qiao Y, Angst MS, Yeomans DC, Clark JD. Chronic morphine administration enhances nociceptive sensitivity and local cytokine production after incision. Mol Pain. 2008 Feb 22;4:7. doi: 10.1186/1744-8069-4-7. **PMID:** 18294378 **Citation:** Zhang RX, Li A, Liu B, Wang L, Ren K, Zhang H, Berman BM, Lao L. IL-1ra alleviates inflammatory hyperalgesia through preventing phosphorylation of NMDA receptor NR-1 subunit in rats. Pain. 2008 Apr;135(3):232-239. doi: 10.1016/j.pain.2007.05.023. Epub 2007 Aug 6. **PMID:** 17689191 **Citation:** Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23. **PMID:** 22826531 **Citation:** Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025. **PMID:** 16508405 **Citation:** Koppert W, Sittl R, Scheuber K, Alsheimer M, Schmelz M, Schuttler J. Differential modulation of remifentanil-induced analgesia and postinfusion hyperalgesia by S-ketamine and clonidine in humans. Anesthesiology. 2003 Jul;99(1):152-9. doi: 10.1097/00000542-200307000-00025. **PMID:** 12826855 **Citation:** Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019. **PMID:** 10910490 **Citation:** Celerier E, Rivat C, Jun Y, Laulin JP, Larcher A, Reynier P, Simonnet G. Long-lasting hyperalgesia induced by fentanyl in rats: preventive effect of ketamine. Anesthesiology. 2000 Feb;92(2):465-72. doi: 10.1097/00000542-200002000-00029. **PMID:** 10691234 **Citation:** Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022. **PMID:** 15983467 **Citation:** Engelhardt T, Zaarour C, Naser B, Pehora C, de Ruiter J, Howard A, Crawford MW. Intraoperative low-dose ketamine does not prevent a remifentanil-induced increase in morphine requirement after pediatric scoliosis surgery. Anesth Analg. 2008 Oct;107(4):1170-5. doi: 10.1213/ane.0b013e318183919e. **PMID:** 18806023 **Citation:** Johnston IN, Milligan ED, Wieseler-Frank J, Frank MG, Zapata V, Campisi J, Langer S, Martin D, Green P, Fleshner M, Leinwand L, Maier SF, Watkins LR. A role for proinflammatory cytokines and fractalkine in analgesia, tolerance, and subsequent pain facilitation induced by chronic intrathecal morphine. J Neurosci. 2004 Aug 18;24(33):7353-65. doi: 10.1523/JNEUROSCI.1850-04.2004. **PMID:** 15317861 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020886 - Term: Somatosensory Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M9981 - Name: Hyperalgesia - Relevance: HIGH - As Found: Hyperalgesia - ID: M22625 - Name: Somatosensory Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006930 - Term: Hyperalgesia ### Intervention Browse Module - Ancestors - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000778 - Term: Anesthetics, Dissociative - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Provided - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M10562 - Name: Isoflurane - Relevance: LOW - As Found: Unknown - ID: M4584 - Name: Atracurium - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M12333 - Name: Neostigmine - Relevance: LOW - As Found: Unknown - ID: M12546 - Name: Nitrous Oxide - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4108 - Name: Anesthetics, Dissociative - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007649 - Term: Ketamine ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Ketamine **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** EG000 **Other Num Affected:** 16 **Other Num at Risk:** 28 **Serious Number At Risk:** 28 **Title:** Ketamine **Group ID:** EG001 **Title:** Saline **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** EG001 **Other Num Affected:** 8 **Other Num at Risk:** 28 **Serious Number At Risk:** 28 **Title:** Saline **Frequency Threshold:** 5 #### Other Events **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Diplopia/nystagmus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** **Time Frame:** 24 hours ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 30 **Group ID:** BG001 **Value:** 30 **Group ID:** BG002 **Value:** 60 **Units:** Participants ### Group **ID:** BG000 **Title:** Ketamine **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery. ### Group **ID:** BG001 **Title:** Saline **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution. Saline : Patients in group N (placebo)will receive saline during surgery. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 29 #### Measurement **Group ID:** BG001 **Value:** 28 #### Measurement **Group ID:** BG002 **Value:** 57 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 13.10 **Value:** 45.80 #### Measurement **Group ID:** BG001 **Spread:** 15.90 **Value:** 43.40 #### Measurement **Group ID:** BG002 **Spread:** 14.50 **Value:** 44.60 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 25 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 49 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 30 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 60 **Class Title:** Brazil **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** pliniocunhaleal@hotmail.com **Organization:** Federal University of Sao Paulo **Phone:** 55-98-8852-2021 **Title:** Plínio da Cunha Leal ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.113 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Mann-Whitney **Tested Non-Inferiority:** False ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.946 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.999 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.019 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.652 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 6 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.221 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 7 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.325 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 8 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.386 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 9 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.499 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 1 sided **Tested Non-Inferiority:** False ### Outcome Measure 10 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.909 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 11 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.737 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 12 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** <0.872 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 13 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.598 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 14 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.485 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 2.0 **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 15 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.744 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 16 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.540 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 17 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.673 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 18 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.586 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 19 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.077 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 20 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.677 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 21 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.545 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 22 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.650 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 23 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.593 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 24 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.313 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 25 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.313 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 26 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.313 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 27 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.611 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** False ### Outcome Measure 28 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.312 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 29 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.676 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 30 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.938 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 31 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.385 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 32 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.422 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 33 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.500 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 34 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.435 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 35 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.745 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ### Outcome Measure 36 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.557 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 600 - **Value:** 18 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 2 - **Spread:** - **Upper Limit:** 130 - **Value:** 15 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.30 - **Upper Limit:** - **Value:** 27.40 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 12.90 - **Upper Limit:** - **Value:** 27.70 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0 - **Upper Limit:** - **Value:** 300 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0 - **Upper Limit:** - **Value:** 300 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 54.8 - **Upper Limit:** - **Value:** 290 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 115 - **Upper Limit:** - **Value:** 247 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 77.1 - **Upper Limit:** - **Value:** 279 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 92 - **Upper Limit:** - **Value:** 269 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 114 - **Upper Limit:** - **Value:** 248 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 140 - **Upper Limit:** - **Value:** 205 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.43 - **Upper Limit:** - **Value:** 2.51 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.92 - **Upper Limit:** - **Value:** 2.19 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.5 - **Upper Limit:** - **Value:** 5.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.6 - **Upper Limit:** - **Value:** 6.2 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.0 - **Upper Limit:** - **Value:** 4.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.5 - **Upper Limit:** - **Value:** 5.1 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.4 - **Upper Limit:** - **Value:** 3.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.3 - **Upper Limit:** - **Value:** 3.4 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.1 - **Upper Limit:** - **Value:** 2.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 2.0 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.7 - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.6 - **Upper Limit:** - **Value:** 1.4 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 1.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 1.3 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.6 - **Upper Limit:** - **Value:** 0.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 1.2 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.7 - **Upper Limit:** - **Value:** 1.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 1.1 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.2 - **Upper Limit:** - **Value:** 0.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.0 - **Upper Limit:** - **Value:** 0.7 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 1.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.0 - **Upper Limit:** - **Value:** 1.4 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 1.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.6 - **Upper Limit:** - **Value:** 1.3 **Title:** #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 1.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.0 - **Upper Limit:** - **Value:** 0.8 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.44 - **Upper Limit:** - **Value:** 0.56 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.44 - **Upper Limit:** - **Value:** 0.51 **Title:** #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 3.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.4 - **Upper Limit:** - **Value:** 3.9 **Title:** #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.6 - **Upper Limit:** - **Value:** 3.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.7 - **Upper Limit:** - **Value:** 3.7 **Title:** #### Outcome Measure 23 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.63 - **Upper Limit:** - **Value:** 10.61 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8.36 - **Upper Limit:** - **Value:** 11.82 **Title:** #### Outcome Measure 24 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 25 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 26 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 27 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** #### Outcome Measure 28 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.5 - **Upper Limit:** - **Value:** 3.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.4 - **Upper Limit:** - **Value:** 2.1 **Title:** #### Outcome Measure 29 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 23.6 - **Upper Limit:** - **Value:** 29.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 48.7 - **Upper Limit:** - **Value:** 34.8 **Title:** #### Outcome Measure 30 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.3 - **Upper Limit:** - **Value:** 24.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 31.5 - **Upper Limit:** - **Value:** 24.8 **Title:** #### Outcome Measure 31 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.1 - **Upper Limit:** - **Value:** 3.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.2 - **Upper Limit:** - **Value:** 2.2 **Title:** #### Outcome Measure 32 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.8 - **Upper Limit:** - **Value:** 8.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 15.1 - **Upper Limit:** - **Value:** 11.3 **Title:** #### Outcome Measure 33 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.2 - **Upper Limit:** - **Value:** 6.0 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 6.1 - **Upper Limit:** - **Value:** 4.5 **Title:** #### Outcome Measure 34 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 20 - **Upper Limit:** - **Value:** 7.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 3.3 - **Upper Limit:** - **Value:** 1.9 **Title:** #### Outcome Measure 35 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 19.1 - **Upper Limit:** - **Value:** 9.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.9 - **Upper Limit:** - **Value:** 5.5 **Title:** #### Outcome Measure 36 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.5 - **Upper Limit:** - **Value:** 8.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 5.5 - **Upper Limit:** - **Value:** 5.0 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 24 hours **Title:** Time to First Morphine Supplementation **Type:** SECONDARY **Unit of Measure:** minutes ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 2 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 hours **Title:** Morphine Consumption Within 24 h **Type:** SECONDARY **Unit of Measure:** milligram ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 3 **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Before the procedure (Baseline) **Title:** Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence **Type:** SECONDARY **Unit of Measure:** gram ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 4 **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 hours after procedure **Title:** Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence **Type:** SECONDARY **Unit of Measure:** gram ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. Saline: Patients in group N (placebo) was administrated saline during surgery. **ID:** OG001 **Title:** Saline #### Outcome Measure 5 **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Before the procedure (Baseline) **Title:** Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region **Type:** SECONDARY **Unit of Measure:** gram ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 6 **Description:** The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24h after the procedure **Title:** Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region **Type:** SECONDARY **Unit of Measure:** gram ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 7 **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline (before the procedure) **Title:** Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence **Type:** SECONDARY **Unit of Measure:** kilogram force/second ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 8 **Description:** The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 30 minutes **Title:** Pain 30 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 9 **Description:** The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 60 minutes **Title:** Pain 60 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 10 **Description:** The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 90 minutes **Title:** Pain 90 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 11 **Description:** The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 120 minutes **Title:** Pain 120 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 12 **Description:** The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 150 minutes **Title:** Pain 150 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 13 **Description:** The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 180 minutes **Title:** Pain 180 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 14 **Description:** The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 210 minutes **Title:** Pain 210 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 15 **Description:** The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 240 minutes **Title:** Pain 240 Minutes **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 16 **Description:** The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 6 hours **Title:** Pain 6 Hours **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 17 **Description:** The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 12 hours **Title:** Pain 12 Hours **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 18 **Description:** The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 18 hours **Title:** Pain 18 Hours **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 19 **Description:** The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 hours **Title:** Pain 24 Hours **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 20 **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence **Type:** SECONDARY **Unit of Measure:** kilogram force/second ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 21 **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline (before the surgery) **Title:** Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region **Type:** SECONDARY **Unit of Measure:** kilogram force/second ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 22 **Description:** The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region **Type:** SECONDARY **Unit of Measure:** kilogram force/second ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 23 **Description:** The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 hours after the procedure **Title:** Extension of Hyperalgesia **Type:** SECONDARY **Unit of Measure:** centimeter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 24 **Description:** The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Before the procedure (Baseline) **Title:** Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 25 **Description:** The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 26 **Description:** The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Before the procedure (Baseline) **Title:** Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 27 **Description:** The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 28 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline (Before the procedure) **Title:** Serum Level of Interleukin (IL)-6 Before the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 29 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 5 h after the procedure **Title:** Serum Level of Interleukin (IL)-6 5 h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 30 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Serum Level of Interleukin (IL)-6 24 h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 31 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline (Before the procedure) **Title:** Serum Level of Interleukin (IL)-8 Before the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 32 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 5 h after the procedure **Title:** Serum Level of Interleukin (IL)-8 5 h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 33 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Serum Level of Interleukin (IL)-8 24 h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 34 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Baseline (Before the procedure) **Title:** Serum Level of Interleukin (IL)-10 Before the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 35 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 5h after the procedure **Title:** Serum Level of Interleukin (IL)-10 5h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline #### Outcome Measure 36 **Description:** Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24 h after the procedure **Title:** Serum Level of Interleukin (IL)-10 24 h After the Procedure **Type:** SECONDARY **Unit of Measure:** picogram/milliliter ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG000 **Title:** Ketamine ##### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** OG001 **Title:** Saline ### Participant Flow Module #### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block. **ID:** FG000 **Title:** Ketamine #### Group **Description:** A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block. **ID:** FG001 **Title:** Saline #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 30 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 30 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 28 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 28 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 2 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 **Recruitment Details:** Inclusion criteria were: ≥18 years of age, any gender, classified as American Society of Anesthesiologists (ASA) Physical Status I or II, and undergoing laparoscopic cholecystectomy at Hospital São Paulo/Federal University of São Paulo, from September 2010 to September 2012. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01125579 **Brief Title:** Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness **Official Title:** NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression #### Organization Study ID Info **ID:** 162A07NPB #### Organization **Class:** INDUSTRY **Full Name:** Pascoe Pharmazeutische Praeparate GmbH ### Status Module #### Completion Date **Date:** 2008-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-21 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-11 **Type:** ACTUAL #### Start Date **Date:** 2008-03 **Status Verified Date:** 2010-05 #### Study First Post Date **Date:** 2010-05-18 **Type:** ESTIMATED **Study First Submit Date:** 2010-05-14 **Study First Submit QC Date:** 2010-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pascoe Pharmazeutische Praeparate GmbH #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks. **Detailed Description:** Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks. ### Conditions Module **Conditions:** - Nervousness - Restlessness - Depression (Agitated) - Affective Disorders **Keywords:** - nervousness - restlessness - depression - affective disorder ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 115 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV "affective disorders"), aged 6-12 years **Label:** Children aged 6-12 ### Outcomes Module #### Primary Outcomes **Description:** Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire **Measure:** Change in Parent Child Behaviour Checklist (CBCL/4-18) **Time Frame:** after 2 + 4 weeks´ treatment #### Secondary Outcomes **Description:** kind, frequency, duration, outcome of ADR **Measure:** Tolerability of NEURAPAS balance **Time Frame:** after 2 + 4 weeks **Description:** Questionnaire on 13 common symptoms of nervous restlessness in children **Measure:** Change of 13 common symptoms of nervous restlessness **Time Frame:** after 2 + 4 weeks **Description:** Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life **Measure:** Change of the impact of the child´s complaints on daily family life (VAS) **Time Frame:** after 2 + 4 weeks ### Eligibility Module **Eligibility Criteria:** Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group". Observational Criteria: * age 6 - 11 (extremes included) * nervous restlessness and/or * agitated depression and/or * affective disorders Exclusion Criteria: * patients \<6 and \>12 years of age **Maximum Age:** 11 Years **Minimum Age:** 6 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Children aged 6 - 11 (extremes included) suffering from nervous restlessness and/or agitated depression according to ICD-10 F3 and DSM-IV "affective disorders" ### Contacts Locations Module #### Locations **Location 1:** **City:** Giessen **Country:** Germany **Facility:** multiple German Paediatric Practices **State:** Hessen **Zip:** 35394 #### Overall Officials **Official 1:** **Affiliation:** Pascoe Pharmazeutische Praeparate GmbH **Name:** Anja Braschoss, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000001523 - Term: Mental Disorders - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000011596 - Term: Psychomotor Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000096762 - Term: Aberrant Motor Behavior in Dementia ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M21835 - Name: Mood Disorders - Relevance: HIGH - As Found: Affective Disorder - ID: M14452 - Name: Psychomotor Agitation - Relevance: HIGH - As Found: Restlessness - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M14453 - Name: Psychomotor Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M3259 - Name: Aberrant Motor Behavior in Dementia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011595 - Term: Psychomotor Agitation - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000019964 - Term: Mood Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04467879 **Brief Title:** A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients **Official Title:** A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients #### Organization Study ID Info **ID:** 001 #### Organization **Class:** INDUSTRY **Full Name:** Zona Health, Inc ### Status Module #### Completion Date **Date:** 2022-09-14 **Type:** ACTUAL #### Last Update Post Date **Date:** 2022-09-22 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-19 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2022-09-13 **Type:** ACTUAL #### Start Date **Date:** 2020-06-01 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2020-07-13 **Type:** ACTUAL **Study First Submit Date:** 2020-07-08 **Study First Submit QC Date:** 2020-07-08 **Why Stopped:** New Protocol and Outcome Measures in Review ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Research & Development Concierge Company #### Lead Sponsor **Class:** INDUSTRY **Name:** Zona Health, Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a double-blind, sham-controlled clinical trial assessing the effectiveness of personalized isometric handgrip device therapy. Approximately 230 patients who present with a Systolic Blood Pressure reading of ≤ 149mmHg and who have not taken any antihypertensive medication for more than 30 days will be enrolled. **Detailed Description:** This study is designed to examine the effectiveness of individualized isometric handgrip device therapy in prehypertension or hypertension patient subjects who are not at target BP and who are naive to anti-hypertensive medication for at least 30 days before screening. The investigational plan examines changes in blood pressure (BP) in up to 230 patient subjects who are randomized to either the "active" (i.e., the Zona Plus device proposed for marketing), or to a "sham" device (which is intentionally calibrated for a "weaker grip"). ### Conditions Module **Conditions:** - Hypertension, Systolic **Keywords:** - Diastolic Hypertension - HandGrip Therapy - Pre-Hypertension - Isometric Exercise - Vascular Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Prospective, double-blinded, randomized, sham-controlled study ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double Blinded **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 146 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. **Intervention Names:** - Device: Zona Plus Device **Label:** Zona Plus - Active - "Normal Grip" **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. **Intervention Names:** - Device: Control Device **Label:** Control Device - Sham - "Weaker Grip" **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Zona Plus - Active - "Normal Grip" **Description:** Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device **Name:** Zona Plus Device **Other Names:** - Zona Plus 3.0 **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control Device - Sham - "Weaker Grip" **Description:** Zona Plus control sham device, with a nominal weaker grip **Name:** Control Device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Comparative assessment in the change from Baseline in seated cuff Systolic Blood Pressure after ten(10) weeks of treatment between patients treated with the Zona Plus nominal device ("stronger grip") and patients treated with the Placebo control device ("weaker grip"). A reduction in Systolic Blood ≥ 5 Preassure after 10 weeks of treatment is considered to be a better outcome. **Measure:** Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days **Time Frame:** Change from Baseline to Day 70 ±2 Days #### Secondary Outcomes **Description:** Comparative assessment of the change from Baseline in seated cuff Diastolic Blood Pressure after 10 weeks of treatment between patients treated with the Zona Plus nominal device ("stronger grip") and patients treated with the Placebo control device ("weaker grip"). **Measure:** Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days **Time Frame:** Change from Baseline to Day 70 ±2 Days **Description:** Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) at Day 70 ± 2 Days. **Measure:** Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days **Time Frame:** Change from Baseline to Day 70 ± 2 Days **Description:** Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction (defined as ≥3 mmHg) at Day 70 ± 2 Days. **Measure:** Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days **Time Frame:** Change from Baseline to Day 70 ± 2 Days **Description:** Comparative assessment in change from Baseline in the seated cuff Systolic Blood Pressure after 6 months Day 160 ± 4 of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device. **Measure:** Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days **Time Frame:** Change from Baseline to Day 160 ± 4 Days **Description:** Comparative assessment in change from Baseline in the seated cuff Diastolic Blood Pressure after 6 months Day 160 ± 4 Days of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device. **Measure:** Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days **Time Frame:** Change from Baseline to Day 160 ± 4 Days **Description:** Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) at Day 160 ± 4 Days **Measure:** Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days **Time Frame:** Change from Baseline to Day 160 ± 4 Days **Description:** Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction defined as ≥3 mmHg at Day 160 ± 4 Days **Measure:** Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days **Time Frame:** Change from Baseline to Day 160 ± 4 Days **Description:** The Heart Rate (HR) will be recorded and compared between the Zona Plus nominal device and the Placebo control device treatment groups. **Measure:** Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device **Time Frame:** Change from Baseline to Day 160 ± 4 Days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Male or female of any ethnicity between 18 and 80 years of age * Diagnosed with prehypertension or hypertension and verified during the Baseline visit * Non-use of antihypertensive medication for ≥30 prior to screening * Currently not taking any antihypertensive medications or decline to take any antihypertensive medications(e.g., diuretic, angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), \] beta-blocker (BB), renin inhibitor (RI), calcium channel blocker (CCB) or alpha-adrenergic agonist (clonidine)) * Sufficient vision with the patient able to see the screen prompts on the device, sufficient hearing with the patient able to hear the device audio prompts, sufficient hand strength (demonstrated by a maximum voluntary contraction equaling 35 units of force in both hands measured by the device) * Baseline Blood Pressure measurements collected and study device training completed during the Baseline visit * Non-use of medications and over the counter (OTC)supplement regimen related to hypertension throughout the study duration * Only one patient per household can participate in the study, eliminating the potential of unblinding * Able to comply with study procedures and agrees to complete all required study visits and associated activities * Ability to give written informed consent in either English, Spanish or French •≤149 mmHg, Systolic Blood Pressure wherein patients who present with Systolic Blood Pressure readings ≥140 mmHg will receive heightened monitoring throughout the first month of the study Exclusion Criteria * Pregnant or not using adequate contraception * Blood Pressure ≥150 mmHg (systolic) and/or \>90 mmHg (diastolic) * History of heart failure * Hospitalization due to a hypertensive emergency, with impending or progressive target organ dysfunction (i.e., renal dysfunction, left ventricular hypertrophy or CNS involvement) within the past six (6) months •\>10 mmHg difference in Systolic Blood Pressure between the right and left arms collected during screening * Unstable Blood Pressure, defined as \>5 mmHg variance between any two (2) consecutive weekly readings (with a maximum of four (4) attempts) to determine a baseline BP measurement * Arm circumference greater than 45cm * Acute illness, infection, or inflammation * Unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA within the last six (6)months, or other serious comorbidity impacting life expectancy to \< than a 1 year * Rest or exertional angina pectoris in the previous six (6) months * History of solid organ transplant * Secondary form of hypertension (HTN) etiology, including but not limited to primary aldosteronism, chronic steroid therapy and Cushing syndrome, pheochromocytoma, aorta coarctation or untreated thyroid or parathyroid disease * Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next six(6) months * Any condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study * Currently own or have owned another Zona Plus device and are,or have been,voluntarily performing the isometric handgrip activities. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Saint Louis **Country:** United States **Facility:** Saint Louis Heart & Vascular, P.C. **State:** Missouri **Zip:** 63044 **Location 2:** **City:** Charlotte **Country:** United States **Facility:** Carolinas Research Center LLC **State:** North Carolina **Zip:** 28215 **Location 3:** **City:** Goldsboro **Country:** United States **Facility:** Goldsboro Medical Center **State:** North Carolina **Zip:** 27534 **Location 4:** **City:** Kerrville **Country:** United States **Facility:** Sante Clinical Research **State:** Texas **Zip:** 78028 **Location 5:** **City:** San Antonio **Country:** United States **Facility:** Sun Research Institute **State:** Texas **Zip:** 78215 #### Overall Officials **Official 1:** **Affiliation:** Zona Health, Inc **Name:** Mark Young **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** If in the future Investigators want to access the data for secondary analysis they can submit a request from the Sponsor or R\&D Data Management Contact. Individual patient data will not be shared by the sponsor directly and will be aggregated, monitored, and de-identified (APD) via 1) final approved clinical study report 2) any manuscripts or summary results report via an email request to the central contact once database lock has occurred and reports are generated. **IPD Sharing:** NO ### References Module #### References **Citation:** Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum In: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426. **PMID:** 21160056 **Citation:** Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. **PMID:** 23851406 **Citation:** Al-Khatib SM, Califf RM, Hasselblad V, Alexander JH, McCrory DC, Sugarman J. Medicine. Placebo-controls in short-term clinical trials of hypertension. Science. 2001 Jun 15;292(5524):2013-5. doi: 10.1126/science.1057783. 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Effect of labetalol in hypertension during exercise and postural changes. Br J Clin Pharmacol. 1979 Apr;8 Suppl 2:95S-100S. doi: 10.1111/j.1365-2125.1979.tb04761.x. **PMID:** 26635176 **Citation:** Black HR, Elliott WJ, Neaton JD, Grandits G, Grambsch P, Grimm RH Jr, Hansson L, Lacouciere Y, Muller J, Sleight P, Weber MA, White WB, Williams G, Wittes J, Zanchetti A, Fakouhi TD, Anders RJ. Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial. Hypertension. 2001 Jan;37(1):12-18. doi: 10.1161/01.hyp.37.1.12. **PMID:** 11208750 **Citation:** Boutcher SH, Stocker D. Cardiovascular responses to light isometric and aerobic exercise in 21- and 59-year-old males. Eur J Appl Physiol Occup Physiol. 1999 Aug;80(3):220-6. doi: 10.1007/s004210050585. **PMID:** 10453924 **Citation:** Buck C, Donner AP. Isometric occupational exercise and the incidence of hypertension. 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Myocardial ischemic effects of isometric, dynamic and combined exercise in coronary artery disease. Chest. 1975 Apr;67(4):388-94. doi: 10.1378/chest.67.4.388. **PMID:** 1122766 **Citation:** Lewis SF, Taylor WF, Bastian BC, Graham RM, Pettinger WA, Blomqvist CG. Haemodynamic responses to static and dynamic handgrip before and after autonomic blockade. Clin Sci (Lond). 1983 Jun;64(6):593-9. doi: 10.1042/cs0640593. **PMID:** 6839666 **Citation:** McGowan CL, Levy AS, Millar PJ, Guzman JC, Morillo CA, McCartney N, Macdonald MJ. Acute vascular responses to isometric handgrip exercise and effects of training in persons medicated for hypertension. Am J Physiol Heart Circ Physiol. 2006 Oct;291(4):H1797-802. doi: 10.1152/ajpheart.01113.2005. Epub 2006 Apr 28. **PMID:** 16648182 **Citation:** McGowan CL, Visocchi A, Faulkner M, Verduyn R, Rakobowchuk M, Levy AS, McCartney N, MacDonald MJ. Isometric handgrip training improves local flow-mediated dilation in medicated hypertensives. Eur J Appl Physiol. 2007 Feb;99(3):227-34. doi: 10.1007/s00421-006-0337-z. Epub 2006 Nov 15. Erratum In: Eur J Appl Physiol. 2008 May;103(2):251. **PMID:** 17106718 **Citation:** Millar PJ, Bray SR, McGowan CL, MacDonald MJ, McCartney N. Effects of isometric handgrip training among people medicated for hypertension: a multilevel analysis. Blood Press Monit. 2007 Oct;12(5):307-14. doi: 10.1097/MBP.0b013e3282cb05db. **PMID:** 17890969 **Citation:** Millar PJ, Bray SR, MacDonald MJ, McCartney N. The hypotensive effects of isometric handgrip training using an inexpensive spring handgrip training device. J Cardiopulm Rehabil Prev. 2008 May-Jun;28(3):203-7. doi: 10.1097/01.HCR.0000320073.66223.a7. **PMID:** 18496321 **Citation:** Millar PJ, MacDonald MJ, Bray SR, McCartney N. Isometric handgrip exercise improves acute neurocardiac regulation. Eur J Appl Physiol. 2009 Nov;107(5):509-15. doi: 10.1007/s00421-009-1142-2. Epub 2009 Aug 13. **PMID:** 19680681 **Citation:** Millar PJ, MacDonald MJ, McCartney N. Effects of isometric handgrip protocol on blood pressure and neurocardiac modulation. Int J Sports Med. 2011 Mar;32(3):174-80. doi: 10.1055/s-0030-1268473. Epub 2010 Dec 16. **PMID:** 21165806 **Citation:** Murakami E, Matsuzaki K, Sumimoto T, Mukai M, Kazatani Y, Kodama K. Clinical significance of pressor responses to laboratory stressor testing in hypertension. Hypertens Res. 1996 Jun;19(2):133-7. doi: 10.1291/hypres.19.133. **PMID:** 10968206 **Citation:** Owen A, Wiles J, Swaine I. Effect of isometric exercise on resting blood pressure: a meta analysis. J Hum Hypertens. 2010 Dec;24(12):796-800. doi: 10.1038/jhh.2010.13. Epub 2010 Feb 25. **PMID:** 20182455 **Citation:** Peters PG, Alessio HM, Hagerman AE, Ashton T, Nagy S, Wiley RL. Short-term isometric exercise reduces systolic blood pressure in hypertensive adults: possible role of reactive oxygen species. Int J Cardiol. 2006 Jun 16;110(2):199-205. doi: 10.1016/j.ijcard.2005.07.035. Epub 2005 Oct 18. **PMID:** 16239039 **Citation:** Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6. **PMID:** 15699287 **Citation:** Ray CA, Carrasco DI. Isometric handgrip training reduces arterial pressure at rest without changes in sympathetic nerve activity. Am J Physiol Heart Circ Physiol. 2000 Jul;279(1):H245-9. doi: 10.1152/ajpheart.2000.279.1.H245. **PMID:** 10899063 **Citation:** Rosenthal T, Oparil S. Hypertension in women. J Hum Hypertens. 2000 Oct-Nov;14(10-11):691-704. doi: 10.1038/sj.jhh.1001095. **PMID:** 11095160 **Citation:** Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101. **PMID:** 11136953 **Citation:** Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA. 1991 Jun 26;265(24):3255-64. **PMID:** 2046107 **Citation:** Taylor AC, McCartney N, Kamath MV, Wiley RL. Isometric training lowers resting blood pressure and modulates autonomic control. Med Sci Sports Exerc. 2003 Feb;35(2):251-6. doi: 10.1249/01.MSS.0000048725.15026.B5. **PMID:** 12569213 **Citation:** Whelton PK, He J, Appel LJ, Cutler JA, Havas S, Kotchen TA, Roccella EJ, Stout R, Vallbona C, Winston MC, Karimbakas J; National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA. 2002 Oct 16;288(15):1882-8. doi: 10.1001/jama.288.15.1882. **PMID:** 12377087 **Citation:** Badrov MB, Freeman SR, Zokvic MA, Millar PJ, McGowan CL. Isometric exercise training lowers resting blood pressure and improves local brachial artery flow-mediated dilation equally in men and women. Eur J Appl Physiol. 2016 Jul;116(7):1289-96. doi: 10.1007/s00421-016-3366-2. Epub 2016 May 2. **PMID:** 27137950 **Citation:** Wiley RL, Dunn CL, Cox RH, Hueppchen NA, Scott MS. Isometric exercise training lowers resting blood pressure. Med Sci Sports Exerc. 1992 Jul;24(7):749-54. **PMID:** 1501558 **Citation:** Division of Cardiovascular and Renal Drug Products, Center for Drug Evaluation andResearch (CDER), Food,and Drug Administration. Guidance forIndustry.Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims. 2008.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatorylnformation/Guidances/ucm075072.pdf **Citation:** Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. doi: 10.1161/01.cir.0000034670.06526.15. No abstract available. **PMID:** 12356646 **Citation:** Hicks KA, Hung HMJ, Mahaffey KW, et al. **Citation:** ICH Steering Committee. Draft ICH Consensus Principle:Principles for ClinicalEvaluation ofNew Antihypertensive Drugs. International Conference onHarmonisation ofTechnical Requirements for Registration of Pharmaceuticals forHuman Use. 2000.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073147.pdf **Citation:** Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1. **PMID:** 14656957 **Citation:** Kiveloff B, Huber O. Brief maximal isometric exercise in hypertension. J Am Geriatr Soc. 1971 Dec;19(12):1006-12. doi: 10.1111/j.1532-5415.1971.tb02221.x. No abstract available. **PMID:** 5153689 **Citation:** Millar, PJ. Isometric handgrip training: a natural hypertensive therapy. TownsendLetter: The Examiner of Alternative Medicine 2008. **Citation:** Millar PJ, Paashuis A, McCartney. Isometric Handgrip Effects on Hypertension. CurrHypertens Rev 2009;5:54-60 #### See Also Links **Label:** Drug Labeling for Cardiovascular Outcome Claims **URL:** http://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims **Label:** Principles for ClinicalEvaluation ofNew Antihypertensive Drugs. **URL:** http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073147.pdf **Label:** The Seventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure **URL:** http://www.nhlbi.nih.gov/files/docs/guidelines/jnc7full.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000075222 - Term: Essential Hypertension ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M29007 - Name: Prehypertension - Relevance: LOW - As Found: Unknown - ID: M27583 - Name: Systolic Murmurs - Relevance: LOW - As Found: Unknown - ID: M2913 - Name: Isolated Systolic Hypertension - Relevance: HIGH - As Found: Hypertension, Systolic - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M1470 - Name: Essential Hypertension - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000092244 - Term: Isolated Systolic Hypertension ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05813379 **Brief Title:** Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation **Official Title:** Application of Mesenchymal Stem Cells Derived Exosomes in Skin Rejuvenation #### Organization Study ID Info **ID:** Islamic Azad University #### Organization **Class:** OTHER **Full Name:** Isfahan University of Medical Sciences ### Status Module #### Completion Date **Date:** 2023-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-04-14 **Type:** ACTUAL **Last Update Submit Date:** 2023-04-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-07-29 **Type:** ESTIMATED #### Start Date **Date:** 2022-02-01 **Type:** ACTUAL **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2023-04-14 **Type:** ACTUAL **Study First Submit Date:** 2022-12-26 **Study First Submit QC Date:** 2023-04-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Isfahan University of Medical Sciences #### Responsible Party **Investigator Affiliation:** Isfahan University of Medical Sciences **Investigator Full Name:** Leila Dehghani **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Aging is a natural and complex process. The effect of environmental factors, genetics on the body eventually leads to damage in different ways. Exosomes are present in almost all body fluids, such as synovial fluid and blood. Exosomes and microvesicles are very efficient mediators of cell-to-cell communication by transferring their specific cargo to recipient cells; for example, exosomes are involved in the delivery of genetic materials, causing epigenetic modifications in the target cells .The applications of MSC-derived exosomes have more effect in cutaneous regeneration by collagen stimulation.The basic biology of exosomes indicates that MSC-exosomes may contain MSC-specific components to exert specific effects on recipient cells, which are somewhat equivalent to the regenerative effects of MSCs. This study aims to slow down the aging process of the skin by using exosome. **Detailed Description:** Skin aging is a complex biological process that can be classified into extrinsic or intrinsic aging. Intrinsic aging is an intrinsic degradation process that is caused by a decrease in the proliferation capacity leading to cell senescence. Angiogenesis is essential in various physiological processes, including wound healing and skin tissue regeneration. Literature reviews show that exosomes derived from human umbilical cord blood mesenchymal stem cells can cause Collagen stimulation and reduction of oxidative stress, WNT/βcatenin pathway signaling in the initial stages of causes the regeneration of skin damage . This study aims to slow down the aging process of the skin by using exosome. ### Conditions Module **Conditions:** - Anti Aging **Keywords:** - Anti aging - Rejuvenation - Repair - Regeneration ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Exosome will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing **Intervention Names:** - Combination Product: exosime injection **Label:** exosome injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - exosome injection **Description:** Treatment- exosome injection **Name:** exosime injection **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face **Measure:** Proportion of re-epithelialization **Time Frame:** 1 month **Description:** In order to evaluate the treatment effect, to evaluate wrinkles and collagen before the treatment, take a photo/CT of the face **Measure:** Proportion of re-epithelialization **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * females * Ages 35-65 * Patients of all racial and ethnic origins * Patients of all undergoing facial rejuvenation Exclusion Criteria: * Female patients in pregnancy or menstrual period * Patients undergoing facial rejuvenation using other methods including Botox injections, chemical peels, face lifts and others * Patients using blood thinners, aspirin and hormone, that cannot be stopped * Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on * Patients suffering with mental disease, and acute or chronic infectious diseases **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 35 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** l_dehghani2002@yahoo.com **Name:** Leila Dehghani, Dr **Phone:** +983136201250 **Role:** CONTACT #### Locations **Location 1:** **City:** Isfahan **Contacts:** ***Contact 1:*** - **Email:** l_dehghani2002@yahoo.com - **Name:** Leila Dehghani, PhD - **Phone:** +983136202020 - **Phone Ext:** 2146 - **Role:** CONTACT **Country:** Iran, Islamic Republic of **Facility:** Isfahan University of Medical Sciences **Status:** RECRUITING **Zip:** 81745319 #### Overall Officials **Official 1:** **Affiliation:** university of medical sciences **Name:** Leila Dehghani **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01561079 **Brief Title:** Fetal and Infant Effects of Maternal Buprenorphine Treatment **Official Title:** Fetal and Infant Effects of Maternal Buprenorphine Treatment #### Organization Study ID Info **ID:** 00051600 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins University ### Status Module #### Completion Date **Date:** 2016-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-09-26 **Type:** ACTUAL **Last Update Submit Date:** 2017-08-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-06 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-08-28 **Type:** ACTUAL **Results First Submit Date:** 2017-03-08 **Results First Submit QC Date:** 2017-08-25 #### Start Date **Date:** 2012-02 **Status Verified Date:** 2017-08 #### Study First Post Date **Date:** 2012-03-22 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-19 **Study First Submit QC Date:** 2012-03-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth. **Detailed Description:** There is an increase in the prevalence of illicit opiate use among women of childbearing age in many countries today. Methadone is the treatment of choice for opioid dependency during pregnancy in the US because it markedly diminishes withdrawal symptoms and craving and blocks opioid effects, however, in utero exposure results in significant depression of fetal neurobehaviors such as fetal heart rate and heart rate variability and fetal motor activity, and significant neonatal abstinence syndrome (NAS) in the majority of exposed infants. Since its approval in 2002, the prescription of buprenorphine for opioid dependence has increased dramatically but, as with methadone, this mediation is not approved for use during pregnancy. Currently, women treated with buprenorphine prior to pregnancy are transitioned to methadone treatment due to a lack of information regarding the effects of buprenorphine on the developing fetus and infant. Pilot work by this research team suggests that buprenorphine- as compared to methadone-exposed fetuses display more optimal neurobehavioral functioning in the second and third trimesters of pregnancy. Although these results are encouraging, there is a critical need to explore fully the effects of this medication on the fetus and infant to adequately advise care providers and patients regarding its use. This is particularly true given the imminent publication of a pivotal study comparing buprenorphine to methadone treatment during pregnancy which has suggested the optimality of buprenorphine for the treatment of opioid dependence during pregnancy, and is likely to result in increasing numbers of women being treated with off-label buprenorphine during pregnancy. This proposal seeks to explore the effect of buprenorphine on maternal physiology and fetal neurobehavioral functioning longitudinally as a measure of the development of the fetal nervous system. Additionally, the neurobehavioral profile and NAS of the buprenorphine-exposed infant up to one month will be delineated in an effort to provide information necessary to provide optimal pharmacologic and non-pharmacologic treatment of NAS. Furthermore, this group has previously explored similar parameters in methadone-exposed fetuses and infants, and results of this study can be compared to those historical data. These parameters will advance our understanding of the way the investigators view and implement the future pharmacologic treatment of the opiate dependent woman during pregnancy and her infant after birth, and inform clinicians, health insurance companies and regulatory agencies in the provision of optimal care to the opioid dependent pregnant woman and her offspring before and after birth. ### Conditions Module **Conditions:** - Neonatal Abstinence Syndrome **Keywords:** - Buprenorphine - Methadone - Fetal neurobehavior - Infant neurobehavior ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 127 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Buprenorphine maintenance during pregnancy **Intervention Names:** - Drug: Buprenorphine **Label:** Maternal buprenorphine treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Maternal buprenorphine treatment **Description:** Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age. **Name:** Buprenorphine **Other Names:** - Subutex **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels **Measure:** Fetal Heart Rate **Time Frame:** 24, 28, 32 and 36 weeks of gestation **Description:** Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels **Measure:** Fetal Heart Rate Variability **Time Frame:** 24, 28, 32 and 36 weeks of gestation **Description:** Number of accelerations of fetal heart rate exhibited during the 60 minute recordings **Measure:** Accelerations of Fetal Heart Rate **Time Frame:** 24, 28, 32 36 weeks of gestation **Description:** Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels **Measure:** Fetal Movement **Time Frame:** 24, 28, 32, 36 weeks of gestation **Description:** The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system. **Measure:** Fetal Movement - Fetal Heart Rate Coupling **Time Frame:** 24, 28, 32, 36 weeks of gestation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Current opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-R criteria * 18-40 years of age with uncomplicated singleton pregnancies * Accurate gestational age dating verified by ultrasound * Gestation of less than 34 weeks * Stabilization on buprenorphine for one week prior to study procedures Exclusion Criteria: * Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix) * Evidence of fetal malformation detected by prenatal ultrasound * Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension. * Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia) * Alcohol dependency per DSM IV R criteria (see ascertainment methods below) * Women stable on methadone maintenance (defined as more than 3 days of methadone dosing) * Women entering drug treatment reporting using "street" methadone (for more than 3 days) **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Baltimore **Country:** United States **Facility:** Center for Addiction and Pregnancy **State:** Maryland **Zip:** 21224 **Location 2:** **City:** Baltimore **Country:** United States **Facility:** Johns Hopkins Bayview Medical Center **State:** Maryland **Zip:** 21224 #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins University **Name:** Lauren M Jansson, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Jansson LM, Dipietro JA, Velez M, Elko A, Williams E, Milio L, O'Grady K, Jones HE. Fetal neurobehavioral effects of exposure to methadone or buprenorphine. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):240-3. doi: 10.1016/j.ntt.2010.09.003. Epub 2010 Sep 22. **PMID:** 20868741 **Citation:** Velez ML, McConnell K, Spencer N, Montoya L, Tuten M, Jansson LM. Prenatal buprenorphine exposure and neonatal neurobehavioral functioning. Early Hum Dev. 2018 Feb;117:7-14. doi: 10.1016/j.earlhumdev.2017.11.009. Epub 2017 Dec 7. **PMID:** 29223912 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12302 - Name: Neonatal Abstinence Syndrome - Relevance: HIGH - As Found: Neonatal Abstinence Syndrome - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009357 - Term: Neonatal Abstinence Syndrome ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000009292 - Term: Narcotic Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: HIGH - As Found: Aortic - ID: M11671 - Name: Methadone - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002047 - Term: Buprenorphine ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Maternal Buprenorphine Treatment **Deaths Num At Risk:** 49 **Description:** Buprenorphine maintenance during pregnancy Buprenorphine: Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age. Two severe adverse events were reported in the same infant patient. One infant had congenital heart disease and polydactyly **ID:** EG000 **Other Num Affected:** 15 **Other Num at Risk:** 49 **Serious Number Affected:** 1 **Serious Number At Risk:** 49 **Title:** Maternal Buprenorphine Treatment **Frequency Threshold:** 0 #### Other Events **Term:** Cholestasis of pregnancy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Three participants developed cholestasis of pregnancy. All three had concurrent Hepatitis C infection and were therefore at increased risk for this condition. **Organ System:** Hepatobiliary disorders **Source Vocabulary:** **Term:** Bacterial vaginosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One subject developed bacterial vaginosis **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** choroid plexus cysts **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One fetal subject had choroid plexus cysts on fetal sonogram **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** cardiomegaly **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** 2 fetal subjects had mild cardiomegaly on fetal sonogram **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** pneumonia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One infant was born with congenital pneumonia **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** fetal growth restriction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One fetus was diagnosed with fetal growth restriction (but was average for gestational age at delivery) **Organ System:** General disorders **Source Vocabulary:** **Term:** chorioamnionitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Two maternal subjects had chorioamnionitis at delivery **Organ System:** Pregnancy, puerperium and perinatal conditions **Source Vocabulary:** **Term:** Fetal stress at delivery **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Two fetuses exhibited fetal stress at the time of delivery **Organ System:** Pregnancy, puerperium and perinatal conditions **Source Vocabulary:** **Term:** psychiatric concern **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One maternal subject developed a psychiatric concern warranting hospitalization **Organ System:** General disorders **Source Vocabulary:** **Term:** fetal arrythmia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One fetus had a cardiac arrhythmia **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** maternal dehydration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One maternal subject developed decreased fetal HRV and fetal tachycardia, was dx with dehydration **Organ System:** General disorders **Source Vocabulary:** **Term:** nonreactive fetal tracing, fetal hear rate deceleration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Pregnancy, puerperium and perinatal conditions **Source Vocabulary:** #### Serious Events **Term:** Severe adverse event **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One infant born to a buprenorphine maintained mother in the protocol had polydactyly The infant had a family history of polydactyly **Organ System:** Congenital, familial and genetic disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 49 **Num Events:** 1 **Term:** congenital heart disease **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** One infant born to a buprenorphine maintained mother was born with a congenital heart disease. The infant had a family history of congenital heart disease. **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 49 **Num Events:** 1 **Time Frame:** 3 years, 3 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 49 **Units:** Participants ### Group **ID:** BG000 **Title:** Fetal **Description:** Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects completing any maternal-fetal monitoring at any combination of the following gestational ages: 24, 28, 32 36 weeks ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.4 **Value:** 27.6 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 49 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 43 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 1.9 **Value:** 11.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.8 **Value:** 19.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.6 **Value:** 21.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.4 **Value:** 6.5 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.0 **Value:** 21.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 56.7 **Value:** 121.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 7.1 **Value:** 12.0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.0 **Value:** 12.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.3 **Value:** 12.7 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.5 **Value:** 12.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.0 **Value:** 16.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 25.6 **Value:** 19.7 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Education **Unit of Measure:** years ### Measure 5 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age at first substance use **Unit of Measure:** years ### Measure 6 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age at regular substance use **Unit of Measure:** years ### Measure 7 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Duration of regular substance use upon treatment entry **Unit of Measure:** years ### Measure 8 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Gestational age upon treatment entry **Unit of Measure:** weeks ### Measure 9 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Length of time in treatment prior to delivery **Unit of Measure:** days ### Measure 10 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Buprenorphine dose at 24 weeks if gestation **Unit of Measure:** mg ### Measure 11 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Buprenorphine dose at 28 weeks if gestation **Unit of Measure:** mg ### Measure 12 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Buprenorphine dose at 32 weeks if gestation **Unit of Measure:** mg ### Measure 13 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Buprenorphine dose at 36 weeks if gestation **Unit of Measure:** mg ### Measure 14 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Urine toxicology screenings during treatment **Unit of Measure:** number of screenings ### Measure 15 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Positive research urine toxicology screening at delivery **Unit of Measure:** percent positive urine tox. screenings ## Results Section - More Information Module ### Certain Agreement ### Limitations and Caveats **Description:** Small sample size ### Point of Contact **Email:** ljansson@jhmi.edu **Organization:** Johns Hopkins University School of Medicine **Phone:** 410-550-5438 **Title:** Dr. Lauren M Jansson ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.001 **P-Value Comment:** The p values were not adjusted for multiplicity The a priori threshold = .05 **Parameter Type:** **Parameter Value:** **Statistical Comment:** The p-value was calculated **Statistical Method:** Hierarchical Linear Modeling **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** <.002 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Hierarchical Linear Modeling **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0001 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Hierarchical Linear Modeling **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** .008 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** The reported p-value was calculated **Statistical Method:** Hierarchical Linear Modeling **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** .002 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Hierarchical Linear Modeling **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.8 - **Upper Limit:** - **Value:** 145.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 5.4 - **Upper Limit:** - **Value:** 143.3 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 6.0 - **Upper Limit:** - **Value:** 138.6 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 7.1 - **Upper Limit:** - **Value:** 136.3 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 6.4 - **Upper Limit:** - **Value:** 143.9 - **Comment:** - **Group ID:** OG005 - **Lower Limit:** - **Spread:** 4.8 - **Upper Limit:** - **Value:** 141.0 - **Comment:** - **Group ID:** OG006 - **Lower Limit:** - **Spread:** 6.3 - **Upper Limit:** - **Value:** 135.4 - **Comment:** - **Group ID:** OG007 - **Lower Limit:** - **Spread:** 6.1 - **Upper Limit:** - **Value:** 131.3 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.3 - **Upper Limit:** - **Value:** 5.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.9 - **Upper Limit:** - **Value:** 6.7 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 3.0 - **Upper Limit:** - **Value:** 7.5 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 2.1 - **Upper Limit:** - **Value:** 7.9 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 1.5 - **Upper Limit:** - **Value:** 4.9 - **Comment:** - **Group ID:** OG005 - **Lower Limit:** - **Spread:** 1.8 - **Upper Limit:** - **Value:** 7.3 - **Comment:** - **Group ID:** OG006 - **Lower Limit:** - **Spread:** 2.7 - **Upper Limit:** - **Value:** 7.0 - **Comment:** - **Group ID:** OG007 - **Lower Limit:** - **Spread:** 2.1 - **Upper Limit:** - **Value:** 6.3 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 3 - **Value:** 0.52 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 8 - **Value:** 1.59 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 15 - **Value:** 3.57 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 17 - **Value:** 5.28 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 3 - **Value:** 0.43 - **Comment:** - **Group ID:** OG005 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 7 - **Value:** 2.12 - **Comment:** - **Group ID:** OG006 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 9 - **Value:** 2.29 - **Comment:** - **Group ID:** OG007 - **Lower Limit:** 0 - **Spread:** - **Upper Limit:** 9 - **Value:** 2.25 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 752.0 - **Upper Limit:** - **Value:** 1496.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 795.4 - **Upper Limit:** - **Value:** 1390.0 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 674.6 - **Upper Limit:** - **Value:** 1458.7 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 979.5 - **Upper Limit:** - **Value:** 1446.7 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 575.6 - **Upper Limit:** - **Value:** 1613.0 - **Comment:** - **Group ID:** OG005 - **Lower Limit:** - **Spread:** 674.5 - **Upper Limit:** - **Value:** 1385.7 - **Comment:** - **Group ID:** OG006 - **Lower Limit:** - **Spread:** 830.7 - **Upper Limit:** - **Value:** 1381.2 - **Comment:** - **Group ID:** OG007 - **Lower Limit:** - **Spread:** 756.2 - **Upper Limit:** - **Value:** 1038.2 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.06 - **Upper Limit:** - **Value:** 0.13 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** .07 - **Upper Limit:** - **Value:** 0.21 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** 0.10 - **Upper Limit:** - **Value:** 0.23 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** 0.11 - **Upper Limit:** - **Value:** 0.25 - **Comment:** - **Group ID:** OG004 - **Lower Limit:** - **Spread:** 0.06 - **Upper Limit:** - **Value:** 0.09 - **Comment:** - **Group ID:** OG005 - **Lower Limit:** - **Spread:** 0.09 - **Upper Limit:** - **Value:** 0.20 - **Comment:** - **Group ID:** OG006 - **Lower Limit:** - **Spread:** 0.10 - **Upper Limit:** - **Value:** 0.21 - **Comment:** - **Group ID:** OG007 - **Lower Limit:** - **Spread:** 0.10 - **Upper Limit:** - **Value:** 0.20 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Participants active in the protocol at 24, 28, 32 and 36 weeks, respectively **Reporting Status:** POSTED **Time Frame:** 24, 28, 32 and 36 weeks of gestation **Title:** Fetal Heart Rate **Type:** PRIMARY **Unit of Measure:** beats per minute ##### Group **Description:** Fetal heart rate in beats per minute at 24 weeks of gestation at trough **ID:** OG000 **Title:** FHR 24 Weeks Trough ##### Group **Description:** Fetal heart rate in beats per minute at 28 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG001 **Title:** FHR 28 Weeks Trough ##### Group **Description:** Fetal heart rate in beats per minute at 32 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG002 **Title:** FHR 32 Weeks Trough ##### Group **Description:** Fetal heart rate in beats per minute at 36 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG003 **Title:** FHR 36 Weeks Trough ##### Group **Description:** Fetal heart rate in beats per minute at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG004 **Title:** FHR 24 Weeks Peak ##### Group **Description:** Fetal heart rate in beats per minute at 28 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG005 **Title:** FHR 28 Weeks Peak ##### Group **Description:** Fetal heart rate in beats per minute at 32 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG006 **Title:** FHR 32 Peak ##### Group **Description:** Fetal heart rate in beats per minute at 36 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG007 **Title:** FHR 36 Peak #### Outcome Measure 2 **Description:** Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Per protocol **Reporting Status:** POSTED **Time Frame:** 24, 28, 32 and 36 weeks of gestation **Title:** Fetal Heart Rate Variability **Type:** PRIMARY **Unit of Measure:** msec ##### Group **Description:** Fetal heart rate variability at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG000 **Title:** FHRV 24 Trough ##### Group **Description:** Fetal heart rate variability at 28 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG001 **Title:** FHRV 28 Trough ##### Group **Description:** Fetal heart rate variability at 32 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG002 **Title:** FHRV 32 Trough ##### Group **Description:** Fetal heart rate variability at 36 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG003 **Title:** FHRV 36 Trough ##### Group **Description:** Fetal heart rate variability at 24 weeks gestation at the time of peak maternal buprenorphine levels **ID:** OG004 **Title:** FHRV 24 Peak ##### Group **Description:** Fetal heart rate variability at 28 weeks gestation at the time of peak maternal buprenorphine levels **ID:** OG005 **Title:** FHRV 28 Peak ##### Group **Description:** Fetal heart rate variability at 32 weeks gestation at the time of peak maternal buprenorphine levels **ID:** OG006 **Title:** FHRV 32 Peak ##### Group **Description:** Fetal heart rate variability at 36 weeks gestation at the time of peak maternal buprenorphine levels **ID:** OG007 **Title:** FHRV 36 Peak #### Outcome Measure 3 **Description:** Number of accelerations of fetal heart rate exhibited during the 60 minute recordings **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24, 28, 32 36 weeks of gestation **Title:** Accelerations of Fetal Heart Rate **Type:** PRIMARY **Unit of Measure:** accelerations ##### Group **Description:** Accelerations in fetal heart rate at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG000 **Title:** Accelerations 24 Trough ##### Group **Description:** Accelerations in fetal heart rate at 28 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG001 **Title:** Accelerations 28 Trough ##### Group **Description:** Accelerations in fetal heart rate at 32 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG002 **Title:** Accelerations 32 Trough ##### Group **Description:** Accelerations in fetal heart rate at 36 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG003 **Title:** Accelerations 36 Trough ##### Group **Description:** Accelerations in fetal heart rate at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG004 **Title:** Accelerations 24 Peak ##### Group **Description:** Accelerations in fetal heart rate at 28 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG005 **Title:** Accelerations 28 Peak ##### Group **Description:** Accelerations in fetal heart rate at 32 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG006 **Title:** Accelerations 32 Peak ##### Group **Description:** Accelerations in fetal heart rate at 36 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG007 **Title:** Accelerations36 Peak #### Outcome Measure 4 **Description:** Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24, 28, 32, 36 weeks of gestation **Title:** Fetal Movement **Type:** PRIMARY **Unit of Measure:** seconds ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG000 **Title:** Fetal Movement 24 Trough ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG001 **Title:** Fetal Movement 28 Trough ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG002 **Title:** Fetal Movement 32 Trough ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG003 **Title:** Fetal Movement 36 Trough ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG004 **Title:** Fetal Movement 24 Peak ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG005 **Title:** Fetal Movement 28 Peak ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG006 **Title:** Fetal Movement 32 Peak ##### Group **Description:** Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG007 **Title:** Fetal Movement 36 Peak #### Outcome Measure 5 **Description:** The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 24, 28, 32, 36 weeks of gestation **Title:** Fetal Movement - Fetal Heart Rate Coupling **Type:** PRIMARY **Unit of Measure:** percentage of time FM assoc w FHR change ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG000 **Title:** FM-FHR 24 Trough ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG001 **Title:** FM-FHR 28 Trough ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG002 **Title:** FM-FHR 32 Trough ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level **ID:** OG003 **Title:** FM-FHR 36 Trough ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG004 **Title:** FM-FHR 24 Peak ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG005 **Title:** FM-FHR 28 Peak ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG006 **Title:** FM-FHR 32 Peak ##### Group **Description:** Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level **ID:** OG007 **Title:** FM-FHR 36 Peak ### Participant Flow Module #### Group **Description:** Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects undergo maternal-fetal monitoring at any combination of the following gestational time periods: 24, 28,32, 36 weeks of gestation **ID:** FG000 **Title:** Maternal Buprenorphine Treatment #### Period **Title:** Overall Study ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 17 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 59 ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 127 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 49 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 78 **Pre-Assignment Details:** Participants must have an opioid use disorder, a singleton, generally uncomplicated pregnancy, be between 18 and 40 years of age, have accurate gestational age dating of less than 34 weeks, willing to receive obstetric care at the center and deliver their infant at the hospital affiliated with the treatment facility. **Recruitment Details:** Participants were recruited from a comprehensive care treatment facility for pregnant and postpartum women with substance use disorders between Feb 2012 and March 2016 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00181779 **Brief Title:** Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder **Official Title:** Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder #### Organization Study ID Info **ID:** 2003-P-000153 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2006-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-10-22 **Type:** ESTIMATED **Last Update Submit Date:** 2013-10-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2006-12 **Type:** ACTUAL #### Start Date **Date:** 2003-02 **Status Verified Date:** 2013-10 #### Study First Post Date **Date:** 2005-09-16 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-13 **Study First Submit QC Date:** 2005-09-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Joseph Biederman, MD **Investigator Title:** Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power. **Detailed Description:** Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic recently approved by the FDA for the treatment of schizophrenia, and it has a unique pharmacological profile believed to be fundamentally different from other available antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and adolescents, and as such, safety and efficacy has not been established for these populations. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results, gathered from an 8 week open-label treatment period and subsequent 10 month extension period, will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power. ### Conditions Module **Conditions:** - Bipolar Disorder - Mania **Keywords:** - mania - Abilify - children - bipolar disorder ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** aripiprazole (Abilify) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Scores on the Young Mania Rating Scales ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female patients, 6-17 years of age. 2. Patient and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. 3. Patients and their legal representative must be considered reliable. 4. Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document and the patient must sign an informed assent document. 5. Patient must have a diagnosis of bipolar I or bipolar II disorder and currently display an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders). Eligible will also be children with bipolar spectrum disorder (or sub-threshold bipolar disorder) operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability). 6. Patients must have an initial score on the Y-MRS total score of at least 15. 7. Patient must be able to participate in mandatory blood draws. 8. Patient must be able to swallow pills. Exclusion Criteria: 1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. 2. Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 3. Uncorrected hypothyroidism or hyperthyroidism. 4. History of severe allergies or multiple adverse drug reactions. 5. Non-febrile seizures without a clear and resolved etiology. 6. Leukopenia or history of leukopenia without a clear and resolved etiology. 7. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months. 8. Judged clinically to be at serious suicidal risk. 9. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol. 10. History of intolerance or a non-responder to Aripiprazole as determined by the clinician. 11. Treatment with nonreversible monoamine oxidase inhibitors within 2 weeks prior to Visit 2. 12. Current diagnosis of schizophrenia. 13. For concomitant stimulant therapy used to treat ADHD, patients must have been on a stable dose of the medication for 1 month prior to randomization. **Maximum Age:** 17 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cambridge **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02138 #### Overall Officials **Official 1:** **Affiliation:** Massachusetts General Hospital **Name:** Joseph Biederman, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Biederman J, Mick E, Spencer T, Doyle R, Joshi G, Hammerness P, Kotarski M, Aleardi M, Wozniak J. An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder. CNS Spectr. 2007 Sep;12(9):683-9. doi: 10.1017/s1092852900021519. **PMID:** 17805214 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068105 - Term: Bipolar and Related Disorders - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2598 - Name: Mania - Relevance: HIGH - As Found: Mania - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000087122 - Term: Mania - ID: D000001714 - Term: Bipolar Disorder ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018491 - Term: Dopamine Agonists - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058825 - Term: Serotonin 5-HT1 Receptor Agonists - ID: D000017366 - Term: Serotonin Receptor Agonists - ID: D000018490 - Term: Serotonin Agents - ID: D000058830 - Term: Serotonin 5-HT2 Receptor Antagonists - ID: D000012702 - Term: Serotonin Antagonists - ID: D000065127 - Term: Dopamine D2 Receptor Antagonists - ID: D000018492 - Term: Dopamine Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M229 - Name: Aripiprazole - Relevance: HIGH - As Found: Internal - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20595 - Name: Dopamine Agonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M29240 - Name: Serotonin 5-HT1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M19648 - Name: Serotonin Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068180 - Term: Aripiprazole ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03039179 **Acronym:** SCHIUMABIMB **Brief Title:** Polyurethane Foam on the Heel for Prevention in Children **Official Title:** Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial #### Organization Study ID Info **ID:** 0024520 #### Organization **Class:** OTHER **Full Name:** Istituto Ortopedico Rizzoli ### Status Module #### Completion Date **Date:** 2015-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-02-05 **Type:** ACTUAL **Last Update Submit Date:** 2020-01-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-07-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-03-22 **Type:** ACTUAL **Results First Submit Date:** 2017-02-01 **Results First Submit QC Date:** 2017-02-01 #### Start Date **Date:** 2014-07-01 **Type:** ACTUAL **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2017-02-01 **Type:** ESTIMATED **Study First Submit Date:** 2017-01-31 **Study First Submit QC Date:** 2017-01-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istituto Ortopedico Rizzoli #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced. ### Conditions Module **Conditions:** - Flat Foot - Pressure Ulcer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: polyurethane foam dress **Label:** Polyurethane foam **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Only application of the Walker in the immediate postoperative period. **Label:** standard care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Polyurethane foam **Description:** Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker **Name:** polyurethane foam dress **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. **Measure:** Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) **Time Frame:** every day until discharge (expected average of 3 days) #### Secondary Outcomes **Description:** Pain Score on the "Numeric Rating Scale" \> 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain. **Measure:** Pain (Score on the "Numeric Rating Scale") **Time Frame:** up to the first 3 days post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children aged \> 3 years underwent surgery for flat foot * Children with intact skin at the heel Exclusion Criteria: * Caregivers who cannot speak Italian * Those who refuse to give their consent to take part in the study * Patients with lower limb casts after surgery **Maximum Age:** 18 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Istituto Ortopedico Rizzoli **Name:** Caterina Guerra, RN **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000070558 - Term: Talipes - ID: D000005531 - Term: Foot Deformities, Acquired - ID: D000005530 - Term: Foot Deformities - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005532 - Term: Foot Deformities, Congenital - ID: D000038061 - Term: Lower Extremity Deformities, Congenital - ID: D000017880 - Term: Limb Deformities, Congenital - ID: D000009139 - Term: Musculoskeletal Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M6870 - Name: Pressure Ulcer - Relevance: HIGH - As Found: Pressure Ulcer - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M8543 - Name: Flatfoot - Relevance: HIGH - As Found: Flat Foot - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M6255 - Name: Clubfoot - Relevance: LOW - As Found: Unknown - ID: M586 - Name: Talipes - Relevance: LOW - As Found: Unknown - ID: M8017 - Name: Equinus Deformity - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M8654 - Name: Foot Deformities - Relevance: LOW - As Found: Unknown - ID: M8656 - Name: Foot Deformities, Congenital - Relevance: LOW - As Found: Unknown - ID: M8655 - Name: Foot Deformities, Acquired - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M24718 - Name: Lower Extremity Deformities, Congenital - Relevance: LOW - As Found: Unknown - ID: M20062 - Name: Limb Deformities, Congenital - Relevance: LOW - As Found: Unknown - ID: M12096 - Name: Musculoskeletal Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005413 - Term: Flatfoot - ID: D000003668 - Term: Pressure Ulcer ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Polyurethane Foam **Deaths Num At Risk:** 38 **Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker **ID:** EG000 **Other Num at Risk:** 38 **Serious Number At Risk:** 38 **Title:** Polyurethane Foam **Group ID:** EG001 **Title:** Standard Care **Deaths Num At Risk:** 42 **ID:** EG001 **Other Num at Risk:** 42 **Serious Number At Risk:** 42 **Title:** Standard Care **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 38 **Group ID:** BG001 **Value:** 42 **Group ID:** BG002 **Value:** 80 **Units:** Participants ### Group **ID:** BG000 **Title:** Polyurethane Foam **Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker ### Group **ID:** BG001 **Title:** Standard Care ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 1.27 **Value:** 11.79 #### Measurement **Group ID:** BG001 **Spread:** 1.44 **Value:** 11.64 #### Measurement **Group ID:** BG002 **Spread:** 1.35 **Value:** 11.71 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 31 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 23 #### Measurement **Group ID:** BG001 **Value:** 26 #### Measurement **Group ID:** BG002 **Value:** 49 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 37 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 76 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 23 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** type of surgery:Calcaneal Osteotomy **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** type of analgesia:peripheral nerve blocks analgesia **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** cristiana.forni@ior.it **Organization:** Istituto Ortopedico Rizzoli **Phone:** 0516366694 **Phone Extension:** 0039 **Title:** Head of the Research Nursing Unit ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 25 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** every day until discharge (expected average of 3 days) **Title:** Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker **ID:** OG000 **Title:** Polyurethane Foam ##### Group **ID:** OG001 **Title:** Standard Care #### Outcome Measure 2 **Description:** Pain Score on the "Numeric Rating Scale" \> 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** up to the first 3 days post intervention **Title:** Pain (Score on the "Numeric Rating Scale") **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker **ID:** OG000 **Title:** Polyurethane Foam ##### Group **ID:** OG001 **Title:** Standard Care ### Participant Flow Module #### Group **Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker **ID:** FG000 **Title:** Polyurethane Foam #### Group **Description:** Only application of the Walker in the immediate postoperative period. **ID:** FG001 **Title:** Standard Care #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 42 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 38 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 42 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Recruitment Details:** The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05025579 **Brief Title:** What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression? **Official Title:** What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression? #### Organization Study ID Info **ID:** 03/15/2019-74 #### Organization **Class:** OTHER **Full Name:** Ankara Yildirim Beyazıt University ### Status Module #### Completion Date **Date:** 2019-07-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-27 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-06-30 **Type:** ACTUAL #### Start Date **Date:** 2019-04-01 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2021-08-27 **Type:** ACTUAL **Study First Submit Date:** 2021-08-24 **Study First Submit QC Date:** 2021-08-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara Yildirim Beyazıt University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression. **Detailed Description:** In this study 67 ± 5 years of age averaged and by the physician in geriatric depression diagnosis was placed 38 sedentary geriatric subjects were included. Meet the inclusion criteria geriatric individuals information, vital signs (pulse,"beats /min", blood pressure, " mmHg ", respiration number, respiratory rate,) was recorded. Depression levels, Depression Outcome Scale- KOFDSS to and quality of life is Quality of Life Survey -EUROHIS WHO-QOL) were evaluated. 6-week, 4 days a week aerobic exercise program was applied to geriatric individuals. As aerobic exercise which included the heating and cooling cycle was started the first week and 120 minutes, 160 minutes weekend out and gradually the intensity was given as an exercise program to be increasing. Individuals from the 6-week program were re-evaluated. ### Conditions Module **Conditions:** - Aerobic Exercise - Depression - Geriatric - Chronic Illness **Keywords:** - Aerobic Exercise - Depression - Geriatric - Chronic Illness ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The study, 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study. Geriatrics psychiatric disorders other than depression who, for any reason unable to ride a bike, that static man, to exercise contraindications u found my show compliance with the exercise program and to the individuals who were excluded from the study . ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Considering the protocol suggested in the literature and by examining exercise samples for geriatric individuals, an exercise protocol was created. The first week started with aerobic exercises with a total of 120 minutes, and the next week increased to 160 minutes . A 6-week exercise program was planned and applied 4 days a week in which the intensity was increased gradually. People 's heart rate, blood pressure and respiratory frequency exercise program implementation before and after was recorded in the evaluation form. **Intervention Names:** - Other: Aerobic Exercise **Label:** Exercise group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise group **Description:** Since up in 2 min 10 repetitions active joint movement (while seated knee flexion and extension the ankle plantar and dorsal flexion , standing the hip flexion , extension the , abduction and adduction ) , treadmill for 3 minutes, 0.5 m / sec speed walk with and to adapt both warming bike 5 minutes, RPE ( Rating of Perceived exertion discoverable by exertion rate) will be 2/10 in a way was built. As aerobic exercise, the first week will be RPE 4/10 for 10 minutes, the second week with RPE 4/10 12 minutes, the third week with RPE 4/10 14 minutes, the fourth week with RPE 4/10, 16 minutes, the fifth week with RPE 5/ 2 0 will be as 18 minutes sixth week RPA 10.6 will form was done 20 minutes of exercise . Cooling period in the RPE 2.10 will be the 5 minute turning cycling, 5 min active range of motion exercises and stretching was done. **Name:** Aerobic Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change from Clinically useful depression outcome scale score at beginning and 6th. weeks **Measure:** geriatric depression **Time Frame:** before and after treatment (24 sessions, beginning and 6th. weeks) #### Secondary Outcomes **Description:** Change from World Health Organization Quality of Life Questionnaire (EUROHIS-QOL) score at beginning and 6th. weeks **Measure:** Life Quality **Time Frame:** before and after treatment (24 sessions, beginning and 6th. weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study. Exclusion Criteria: * Having geriatric psychiatric disorders other than depression, not being able to ride a bike for any reason, have contraindications for exercise, inability to adapt to exercise, not volunteering to participate **Maximum Age:** 75 Years **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department **Zip:** 06760 **Location 2:** **City:** Ankara **Country:** Turkey **Facility:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department #### Overall Officials **Official 1:** **Affiliation:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department ANKARA, Turkey, 06760 **Name:** Rabia Tugba Kilic **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ankara Yildirim Beyazit University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department **Name:** Bonny Wamukoya Wasıke **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Ankara Health Sciences University Department of Physical Therapy and Rehabilitation **Name:** Necmiye Un Yildirim **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Blumenthal JA, Babyak MA, Moore KA, Craighead WE, Herman S, Khatri P, Waugh R, Napolitano MA, Forman LM, Appelbaum M, Doraiswamy PM, Krishnan KR. Effects of exercise training on older patients with major depression. Arch Intern Med. 1999 Oct 25;159(19):2349-56. doi: 10.1001/archinte.159.19.2349. **PMID:** 10547175 **Citation:** Rinaldi P, Mecocci P, Benedetti C, Ercolani S, Bregnocchi M, Menculini G, Catani M, Senin U, Cherubini A. Validation of the five-item geriatric depression scale in elderly subjects in three different settings. J Am Geriatr Soc. 2003 May;51(5):694-8. doi: 10.1034/j.1600-0579.2003.00216.x. **PMID:** 12752847 **Citation:** Egede LE, Nietert PJ, Zheng D. Depression and all-cause and coronary heart disease mortality among adults with and without diabetes. Diabetes Care. 2005 Jun;28(6):1339-45. doi: 10.2337/diacare.28.6.1339. **PMID:** 15920049 **Citation:** Lieberwirth C, Wang Z. The social environment and neurogenesis in the adult Mammalian brain. Front Hum Neurosci. 2012 May 8;6:118. doi: 10.3389/fnhum.2012.00118. eCollection 2012. **PMID:** 22586385 **Citation:** Babyak M, Blumenthal JA, Herman S, Khatri P, Doraiswamy M, Moore K, Craighead WE, Baldewicz TT, Krishnan KR. Exercise treatment for major depression: maintenance of therapeutic benefit at 10 months. Psychosom Med. 2000 Sep-Oct;62(5):633-8. doi: 10.1097/00006842-200009000-00006. **PMID:** 11020092 **Citation:** Christmas C, Andersen RA. Exercise and older patients: guidelines for the clinician. J Am Geriatr Soc. 2000 Mar;48(3):318-24. doi: 10.1111/j.1532-5415.2000.tb02654.x. **PMID:** 10733061 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Illness - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002908 - Term: Chronic Disease - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03903679 **Acronym:** LMA **Brief Title:** Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? **Official Title:** Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial #### Organization Study ID Info **ID:** erolkaraaslan2 #### Organization **Class:** OTHER **Full Name:** Inonu University ### Status Module #### Completion Date **Date:** 2019-06-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-25 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-06-01 **Type:** ACTUAL #### Start Date **Date:** 2019-04-05 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2019-04-04 **Type:** ACTUAL **Study First Submit Date:** 2019-04-02 **Study First Submit QC Date:** 2019-04-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Inonu University #### Responsible Party **Investigator Affiliation:** Inonu University **Investigator Full Name:** Erol Karaaslan **Investigator Title:** Asst. Prof. Erol Karaaslan **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists. The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated. **Detailed Description:** Airway management is one of the main issue of anesthesia practice. The use of endotracheal tubes has been accepted as the standard method for many years. High pressure and long-term use of cuffed tubes related to mucosal hypoperfusion and submucosal stenosis are important. The laryngeal mask airway is produced in the 1980s and considered as a supraglottic airway used to provide airway clearance in short-term surgical procedures. The laryngeal mask airways have recently found to use in many general anesthesia applications as a minimally invasive airway method and continue to be used increasingly. More appropriate supraglottic airway vehicles with different characteristics in terms of efficacy and side effects are being developed. Laryngeal mask airway-Supreme™ is latex-free, semi-rigid, elliptical and anatomical shape due to the fingers in the mouth of the patient easily and quickly without inserting the new generation laryngeal mask airways. Designed to provide higher sealing pressures than the laryngeal mask airway-classic. In addition, the presence of a gastric canal for gastric tube passage is another important advantage. The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists. The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated. ### Conditions Module **Conditions:** - Airway Aspiration - Airway Complication of Anesthesia **Keywords:** - Airway management - Septal surgery - Laryngeal mask airway - Endotracheal tube - Presence of tracheal blood ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be maintained with laryngeal mask airway supreme during the septal surgery. **Intervention Names:** - Device: Laryngeal mask airway **Label:** Laryngeal mask airway **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients will be maintained with endotracheal tube during the septal surgery. **Intervention Names:** - Device: Endotracheal tube **Label:** Endotracheal tube **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Laryngeal mask airway **Description:** Patients will be maintained with laryngeal mask airway during the septal surgery. **Name:** Laryngeal mask airway **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Endotracheal tube **Description:** Patients will be maintained with endotracheal tube during the septal surgery. **Name:** Endotracheal tube **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe). **Measure:** Presence of blood in trachea **Time Frame:** From the time 2minutes after the septal surgery to the time of extubation #### Secondary Outcomes **Description:** Sore-throat is defined as constant pain felt independently of swallowing. The evaluation was made with 0 ile10 numerical pain rating scale. According to numerical pain rating scale, sore throat score was evaluated as; 0-1 none, 2-4 between mild, 5-7 intermediate and 8-10 severe N **Measure:** Sore-throat **Time Frame:** From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively **Description:** Oropharyngeal leak pressures were measured while the head was in neutral position. The flowmeter oxygen current was set at 3 L/min and the expiratory valve was closed. When an investigator who did not know which type of airway device was placed, another researcher looked at the current pressure value from the aneroid manometer and confirmed that the pressure remained constant (pressure gauge stability test). This value was recorded as the value of Oropharyngeal leakage pressure. To prevent lung exposure to barotrauma, the expiratory valve was opened when the peak inspiratory pressure reached 40 pressure, and the test was terminated. **Measure:** Oropharyngeal leak pressure **Time Frame:** From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years old, * American Society of Anesthesiologists I-II * Patients with elective nasal septum surgery. * Patients who agreed to participate with informed consent form. Exclusion Criteria: * Under 18 years, * Over 65 years, * American Society of Anesthesiologists III-IV, * Patients with severe respiratory, hepatic or renal dysfunction, * Patients with history of allergy to anesthesia medications * Modified mallampati grade 4, * Thyromental distance \<65 mm, **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Malatya **Country:** Turkey **Facility:** Inonu University Medical Faculty **Zip:** 44090 #### Overall Officials **Official 1:** **Affiliation:** Inonu University Medical Faculty **Name:** Erol Karaaslan, Asst. Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Mao S, Du X, Ma J, Zhang G, Cui J. A comparison between laryngeal mask airway and endotracheal intubation for anaesthesia in adult patients undergoing NUSS procedure. J Thorac Dis. 2018 Jun;10(6):3216-3224. doi: 10.21037/jtd.2018.05.74. **PMID:** 30069317 **Citation:** Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4. **PMID:** 33407130 ## Document Section ### Large Document Module #### Large Docs - Date: 2018-11-28 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 206444 - Type Abbrev: Prot_SAP - Upload Date: 2019-04-03T06:14 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00171379 **Brief Title:** Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant **Official Title:** Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant #### Organization Study ID Info **ID:** CERL080AIT01 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Completion Date **Date:** 2005-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-02-02 **Type:** ESTIMATED **Last Update Submit Date:** 2011-02-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-06 **Type:** ACTUAL #### Start Date **Date:** 2004-03 **Status Verified Date:** 2011-02 #### Study First Post Date **Date:** 2005-09-15 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-12 **Study First Submit QC Date:** 2005-09-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis #### Responsible Party **Old Name Title:** Novartis External Affairs **Old Organization:** Novartis Pharmaceuticals ### Description Module **Brief Summary:** The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine. ### Conditions Module **Conditions:** - Prevention of Acute Rejection After Kidney Transplantation **Keywords:** - Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium. ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 162 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Enteric-Coated Mycophenolate Sodium **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula #### Secondary Outcomes **Measure:** Incidence of biopsy proven acute rejection **Measure:** Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) **Measure:** Quality of life related to GI symptoms (GIQLI scale) **Measure:** Full blood count **Measure:** Gastrointestinal Adverse Events (check-list) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * First or second (single or double) deceased or living donor kidney transplant received at least six months previously; * Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF); * Receiving an MMF dose of \<2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF Exclusion Criteria: * • Subjects expected to discontinue cyclosporin therapy; * Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline; * Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Novartis **Name:** Novartis **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12128 - Name: Mycophenolic Acid - Relevance: HIGH - As Found: Exhaled - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009173 - Term: Mycophenolic Acid ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00831779 **Brief Title:** Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes **Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes #### Organization Study ID Info **ID:** MB102-045 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2010-08 **Type:** ACTUAL #### Disp First Post Date **Date:** 2014-06-18 **Type:** ESTIMATED **Disp First Submit Date:** 2012-03-24 **Disp First Submit QC Date:** 2014-06-06 #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-24 **Type:** ACTUAL **Last Update Submit Date:** 2017-03-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-08 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-03-01 **Type:** ACTUAL **Results First Submit Date:** 2016-09-30 **Results First Submit QC Date:** 2017-01-10 #### Start Date **Date:** 2009-04 **Status Verified Date:** 2017-03 #### Study First Post Date **Date:** 2009-01-29 **Type:** ESTIMATED **Study First Submit Date:** 2009-01-28 **Study First Submit QC Date:** 2009-01-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Astra Zeneca, Bristol-Myers Squibb #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 116 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Dapagliflozin **Label:** Dapagliflozin **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dapagliflozin **Description:** Tablets, Oral, 5 mg, once daily, 12 weeks **Name:** Dapagliflozin **Other Names:** - BMS-512148 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Tablets, Oral, 0 mg, Once daily, 12 weeks **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. **Measure:** Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) **Time Frame:** From Baseline to Week 12 #### Secondary Outcomes **Description:** Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. **Measure:** Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]) **Time Frame:** From Baseline to Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit * Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment * C-peptide ≥ 1.0 ng/ml (0.34 nmol/l) * BMI ≤ 45.0 kg/m2 Exclusion Criteria: * Urine albumin to creatinine ratio (UACR) \> 1,800 mg/g (203.4 mg/mmol/Cr) * Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) * Alanine aminotransferase (ALT) \> 3X ULN * Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l) * Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women * Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases **Maximum Age:** 70 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** San Diego **Country:** United States **Facility:** Va San Diego Healthcare System **State:** California **Zip:** 92161 **Location 2:** **City:** Baton Rouge **Country:** United States **Facility:** Pennington Biomedical Research Center **State:** Louisiana **Zip:** 70808 **Location 3:** **City:** Philadelphia **Country:** United States **Facility:** Temple University General Clinical Research Center **State:** Pennsylvania **Zip:** 19140 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006946 - Term: Hyperinsulinism ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - ID: M10370 - Name: Insulin Resistance - Relevance: HIGH - As Found: Insulin Resistance - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000007333 - Term: Insulin Resistance ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: Intramuscular - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Placebo + Background Anti-Diabetes Medication **Description:** Placebo tablets, oral, once daily, 12 weeks **ID:** EG000 **Other Num Affected:** 8 **Other Num at Risk:** 21 **Serious Number At Risk:** 21 **Title:** Placebo + Background Anti-Diabetes Medication **Group ID:** EG001 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication **Description:** Dapagliflozin tablets, oral, once daily, 12 weeks **ID:** EG001 **Other Num Affected:** 9 **Other Num at Risk:** 23 **Serious Number At Risk:** 23 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication **Frequency Threshold:** 5 #### Other Events **Term:** HEADACHE **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** INFUSION SITE PAIN **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** MICTURITION URGENCY **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** POLLAKIURIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** URINARY TRACT INFECTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA Version: 13.0 **Term:** OEDEMA PERIPHERAL **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** SINUS CONGESTION **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA Version: 13.0 **Term:** PYREXIA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA Version: 13.0 **Time Frame:** Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 21 **Group ID:** BG001 **Value:** 23 **Group ID:** BG002 **Value:** 44 **Units:** Participants ### Group **ID:** BG000 **Title:** Placebo + Background Anti-Diabetes Medication **Description:** Placebo tablets, oral, once daily, 12 weeks ### Group **ID:** BG001 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication **Description:** Dapagliflozin tablets, oral, once daily, 12 weeks ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.02 **Value:** 53.3 #### Measurement **Group ID:** BG001 **Spread:** 8.85 **Value:** 56.2 #### Measurement **Group ID:** BG002 **Spread:** 8.49 **Value:** 54.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 18 #### Measurement **Group ID:** BG001 **Value:** 19 #### Measurement **Group ID:** BG002 **Value:** 37 **Class Title:** Younger than 65 years #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 7 **Class Title:** 65-70 years ### Measure #### Measurement **Group ID:** BG000 **Value:** 14 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 29 **Class Title:** Male #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 8 #### Measurement **Group ID:** BG002 **Value:** 15 **Class Title:** Female ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 28 **Class Title:** White #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 15 **Class Title:** Black/African American #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Asian **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** NUMBER **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Sex/Gender, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants **Population Description:** All randomized participants who received at least 1 dose of study medication ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** ClinicalTrialTransparency@astrazeneca.com **Organization:** AstraZeneca **Title:** Anna Maria Langkilde ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 5.75 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 36.10 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 7.4685 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0059 **P-Value Comment:** Primary endpoint was tested at alpha=0.05 **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 19.97 **Statistical Comment:** **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** -1.22 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 57.48 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 14.4984 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.0598 **P-Value Comment:** Secondary endpoint was tested following a sequential testing procedure at alpha=0.05 **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 28.13 **Statistical Comment:** **Statistical Method:** ANOVA **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.0392 - **Upper Limit:** - **Value:** -9.99 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 4.4849 - **Upper Limit:** - **Value:** 7.98 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.7107 - **Upper Limit:** - **Value:** -12.73 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 9.5930 - **Upper Limit:** - **Value:** 15.39 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF) **Reporting Status:** POSTED **Time Frame:** From Baseline to Week 12 **Title:** Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) **Type:** PRIMARY **Unit of Measure:** % Change of Baseline Insulin Sensitivity ##### Group **Description:** Placebo tablets, oral, once daily, 12 weeks **ID:** OG000 **Title:** Placebo + Background Anti-Diabetes Medication ##### Group **Description:** Dapagliflozin tablets, oral, once daily, 12 weeks **ID:** OG001 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication #### Outcome Measure 2 **Description:** Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF) **Reporting Status:** POSTED **Time Frame:** From Baseline to Week 12 **Title:** Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]) **Type:** SECONDARY **Unit of Measure:** mU/L*min ##### Group **Description:** Placebo tablets, oral, once daily, 12 weeks **ID:** OG000 **Title:** Placebo + Background Anti-Diabetes Medication ##### Group **Description:** Dapagliflozin tablets, oral, once daily, 12 weeks **ID:** OG001 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication ### Participant Flow Module #### Group **Description:** Placebo tablets, oral, once daily, 12 weeks **ID:** FG000 **Title:** Placebo + Background Anti-Diabetes Medication #### Group **Description:** Dapagliflozin tablets, oral, once daily, 12 weeks **ID:** FG001 **Title:** Dapagliflozin 5 mg + Background Anti-Diabetes Medication #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** No longer met criteria ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 21 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 23 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 20 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 22 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 **Recruitment Details:** Of 116 participants enrolled, 50 completed a qualification period. Of these 50 participants, 44 were randomized and received treatment. Of these 44 participants, 42 completed double-blind treatment period. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01425879 **Brief Title:** MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery **Official Title:** A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers #### Organization Study ID Info **ID:** NCI-2011-02974 #### Organization **Class:** NIH **Full Name:** National Cancer Institute (NCI) #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2011-02974 **Type:** REGISTRY **ID:** OSU-10104 **ID:** OSU 10104 **ID:** CDR0000698451 **Domain:** Ohio State University Comprehensive Cancer Center **ID:** OSU 10104 **Type:** OTHER **Domain:** CTEP **ID:** 8735 **Type:** OTHER **ID:** N01CM00070 **Link:** https://reporter.nih.gov/quickSearch/N01CM00070 **Type:** NIH **ID:** P30CA016058 **Link:** https://reporter.nih.gov/quickSearch/P30CA016058 **Type:** NIH ### Status Module #### Completion Date **Date:** 2014-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-06-17 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2016-04-15 **Type:** ESTIMATED **Results First Submit Date:** 2016-03-15 **Results First Submit QC Date:** 2016-03-15 #### Start Date **Date:** 2011-04 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2011-08-30 **Type:** ESTIMATED **Study First Submit Date:** 2011-08-27 **Study First Submit QC Date:** 2011-08-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Cancer Institute (NCI) #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery. **Detailed Description:** PRIMARY OBJECTIVES: I. To evaluate the objective response rate (complete and partial response), as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, in patients with advanced refractory biliary cancers (BC) receiving Akt inhibitor MK2206 (MK2206). SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving MK2206. II. To determine the overall and progression-free survival of patients with advanced refractory BC receiving MK2206. III. To determine the presence of genetic mutations of PI3-kinase/ Akt pathway signaling-pathway genes relevant to BC and how these correlate with objective response to treatment with MK2206. IV. To determine the pharmacokinetic and pharmacogenetic profile as a way of assessing inter-individual variability as well as how these relate to clinical outcomes. V. To determine genetic variants and mutations in genes encoding drug-metabolizing enzymes and transporters, and genes involved in tumor biology, and how these may be related to response to treatment. OUTLINE: This is a multicenter study. Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during study for pharmacokinetic, pharmacogenetic, and other correlative studies. Previously collected tumor tissue is also analyzed. After completion of study therapy, patients are followed up for 4 weeks. ### Conditions Module **Conditions:** - Advanced Adult Hepatocellular Carcinoma - Localized Non-Resectable Adult Liver Carcinoma - Recurrent Adult Liver Carcinoma - Recurrent Gallbladder Carcinoma - Stage IV Distal Bile Duct Cancer - Stage IV Gallbladder Cancer - Unresectable Extrahepatic Bile Duct Carcinoma - Unresectable Gallbladder Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 8 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. **Intervention Names:** - Drug: Akt Inhibitor MK2206 - Other: Diagnostic Laboratory Biomarker Analysis - Other: Pharmacological Study **Label:** Treatment (Akt inhibitor MK2206) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (Akt inhibitor MK2206) **Description:** Given PO **Name:** Akt Inhibitor MK2206 **Other Names:** - MK2206 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment (Akt inhibitor MK2206) **Description:** Correlative studies **Name:** Diagnostic Laboratory Biomarker Analysis **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Treatment (Akt inhibitor MK2206) **Description:** Correlative studies **Name:** Pharmacological Study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. **Measure:** Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1 **Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year #### Secondary Outcomes **Description:** Severity of adverse events is graded according to the NCI CTCAE 4.0. **Measure:** Frequency of Adverse Events Related to MK-2206 **Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year **Description:** Analyzed using Kaplan-Meier method. **Measure:** Overall Survival **Time Frame:** From study initiation to time of death, assessed up to 4 weeks after completion of study treatment **Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions **Measure:** Progression-free Survival **Time Frame:** From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients must have histologically confirmed biliary tract carcinoma that is surgically unresectable * Cytological confirmation is not allowed on this study, as tissue is needed for correlative science analysis * Either fresh-frozen tissue (FFT) or paraffin-embedded tissue blocks (PETB) will be required from patients before enrolling on this study * No biopsies will be required unless there is insufficient tissue or if the PETB available is more than 12 months old * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan (CT scan slice thickness no greater than 5 mm) * Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis * Patients must have received one prior therapy for metastatic disease * No prior Akt inhibitors allowed * Patients with known brain metastases should be excluded from this clinical trial * Life expectancy greater than 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\<2 (Karnofsky \>= 60%) * Leukocytes \>= 3,000/mcL * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelet count \>= 100,000/mcL * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\] =\< 2.5 x IULN * Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (measured or calculated using the Cockroft-Gualt formula) * Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Not pregnant or nursing * Able to swallow oral tablets * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Akt Inhibitor MK2206 (MK2206) or other agents used in the study * Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial * Cardiovascular: baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female) will exclude patients from entry on study * Patients with clinically significant bundle branch block or pre-existing clinically significant bradycardia will be excluded from the study * No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements * No concurrent grapefruit or grapefruit juice * For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization (TACE), or photodynamic therapy, the following criteria must be met: * 6 weeks has elapsed since that therapy * Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion * Edges of the indicator lesion are clearly distinct on CT scanning * Prior radiation therapy with or without the use of a fluoropyrimidine as a radiosensitizer in the adjuvant setting will be allowed on study if \> 12 weeks have elapsed since therapy * Prior palliative radiation therapy will allowed as long as \> 4 weeks have elapsed since therapy * No patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not be receiving any other investigational agents * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Patients receiving any medications or substances that are inhibitors or inducers of CYP 450 3A4 are ineligible **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** USC / Norris Comprehensive Cancer Center **State:** California **Zip:** 90033 **Location 2:** **City:** Washington **Country:** United States **Facility:** MedStar Georgetown University Hospital **State:** District of Columbia **Zip:** 20007 **Location 3:** **City:** Atlanta **Country:** United States **Facility:** Emory University/Winship Cancer Institute **State:** Georgia **Zip:** 30322 **Location 4:** **City:** Chapel Hill **Country:** United States **Facility:** University of North Carolina at Chapel Hill **State:** North Carolina **Zip:** 27599 **Location 5:** **City:** Cleveland **Country:** United States **Facility:** Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center **State:** Ohio **Zip:** 44106 **Location 6:** **City:** Cleveland **Country:** United States **Facility:** Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center **State:** Ohio **Zip:** 44195 **Location 7:** **City:** Columbus **Country:** United States **Facility:** Ohio State University Comprehensive Cancer Center **State:** Ohio **Zip:** 43210 **Location 8:** **City:** Houston **Country:** United States **Facility:** M D Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** Ohio State University Comprehensive Cancer Center **Name:** Tanios Bekaii-Saab **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000000230 - Term: Adenocarcinoma - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases - ID: D000001661 - Term: Biliary Tract Neoplasms - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000005705 - Term: Gallbladder Diseases - ID: D000001649 - Term: Bile Duct Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M25356 - Name: Carcinoma, Ductal - Relevance: LOW - As Found: Unknown - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Liver Carcinoma - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M20426 - Name: Cholangiocarcinoma - Relevance: LOW - As Found: Unknown - ID: M8824 - Name: Gallbladder Neoplasms - Relevance: HIGH - As Found: Gallbladder Carcinoma - ID: M4936 - Name: Bile Duct Neoplasms - Relevance: HIGH - As Found: Bile Duct Cancer - ID: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Adult Liver Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8823 - Name: Gallbladder Diseases - Relevance: LOW - As Found: Unknown - ID: M4935 - Name: Bile Duct Diseases - Relevance: LOW - As Found: Unknown - ID: T761 - Name: Biliary Tract Cancer - Relevance: HIGH - As Found: Biliary Cancer - ID: T2425 - Name: Gallbladder Cancer - Relevance: HIGH - As Found: Gallbladder Carcinoma - ID: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Bile Duct Cancer ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular - ID: D000005706 - Term: Gallbladder Neoplasms - ID: D000001650 - Term: Bile Duct Neoplasms - ID: D000008113 - Term: Liver Neoplasms - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting. #### Event Groups **Group ID:** EG000 **Title:** Treatment (Akt Inhibitor MK2206) **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** EG000 **Other Num Affected:** 8 **Other Num at Risk:** 8 **Serious Number At Risk:** 8 **Title:** Treatment (Akt Inhibitor MK2206) **Frequency Threshold:** 5 #### Other Events **Term:** Anemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Thrombocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Dry Mouth **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Dry Skin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Fever **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Hand Foot Syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Hypophosphatemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Leukopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE version 4.0 **Term:** Lymphopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Macular Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Mucositis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE version 4.0 **Term:** Hyponatremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** CTCAE version 4.0 **Time Frame:** All patients were evaluable for toxicity from the time of their first treatment with MK2206 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 8 **Units:** Participants ### Group **ID:** BG000 **Title:** Treatment (Akt Inhibitor MK2206) **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 40 **Upper Limit:** 83 **Value:** 58 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 7 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 8 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 **Class Title:** Intrahepatic #### Measurement **Group ID:** BG000 **Value:** 0 **Class Title:** Gallbladder #### Measurement **Group ID:** BG000 **Value:** 2 **Class Title:** Extrahepatic ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Class Title:** PS 0 #### Measurement **Group ID:** BG000 **Value:** 6 **Class Title:** PS 1 **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** patients ### Measure 5 **Parameter Type:** NUMBER **Title:** Disease site **Unit of Measure:** patients ### Measure 6 **Description:** Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) PS 0 defined as Normal activity. Fully active, able to carry on all pre-disease performance without restriction. PS 1 defined as Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work). **Parameter Type:** NUMBER **Title:** ECOG Performance Status **Unit of Measure:** patients ## Results Section - More Information Module ### Certain Agreement **Restriction Type:** LTE60 **Restrictive Agreement:** True ### Point of Contact **Email:** tanios.bekaii-saab@osumc.edu **Organization:** The Ohio State University **Phone:** 614-293-9863 **Title:** Tanios Bekaii-Saab, MD ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2.2 - **Spread:** - **Upper Limit:** 6.7 - **Value:** 3.5 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 0.5 - **Spread:** - **Upper Limit:** 5.6 - **Value:** 1.7 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year **Title:** Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1 **Type:** PRIMARY **Unit of Measure:** patients ##### Group **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** OG000 **Title:** Treatment (Akt Inhibitor MK2206) #### Outcome Measure 2 **Description:** Severity of adverse events is graded according to the NCI CTCAE 4.0. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year **Title:** Frequency of Adverse Events Related to MK-2206 **Type:** SECONDARY **Unit of Measure:** percentage of patients ##### Group **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** OG000 **Title:** Treatment (Akt Inhibitor MK2206) #### Outcome Measure 3 **Description:** Analyzed using Kaplan-Meier method. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** From study initiation to time of death, assessed up to 4 weeks after completion of study treatment **Title:** Overall Survival **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** OG000 **Title:** Treatment (Akt Inhibitor MK2206) #### Outcome Measure 4 **Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment **Title:** Progression-free Survival **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** OG000 **Title:** Treatment (Akt Inhibitor MK2206) ### Participant Flow Module #### Group **Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Diagnostic Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies **ID:** FG000 **Title:** Treatment (Akt Inhibitor MK2206) #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 8 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 8 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Recruitment Details:** Patients were enrolled between September 2012 and December 2013 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04071379 **Brief Title:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B **Official Title:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants #### Organization Study ID Info **ID:** Penta BS19 #### Organization **Class:** INDUSTRY **Full Name:** PT Bio Farma ### Status Module #### Completion Date **Date:** 2021-12-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-01-18 **Type:** ACTUAL **Last Update Submit Date:** 2022-01-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-04-06 **Type:** ACTUAL #### Start Date **Date:** 2020-10-13 **Type:** ACTUAL **Status Verified Date:** 2022-01 #### Study First Post Date **Date:** 2019-08-28 **Type:** ACTUAL **Study First Submit Date:** 2019-08-26 **Study First Submit QC Date:** 2019-08-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** PT Bio Farma #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B **Detailed Description:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants ### Conditions Module **Conditions:** - Immunogenicity - Safety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study ##### Masking Info **Masking:** DOUBLE **Masking Description:** Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 220 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Recombinant Hepatitis B + DTP-HB-Hib batch 1 **Intervention Names:** - Biological: Recombinant Hepatitis B + DTP-HB-Hib **Label:** HepB + Penta batch 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Recombinant Hepatitis B + Pentabio (registered) **Intervention Names:** - Biological: Hep B + Pentabio (registered) **Label:** Hep B + Pentabio (registered) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HepB + Penta batch 1 **Description:** 1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib **Name:** Recombinant Hepatitis B + DTP-HB-Hib **Other Names:** - Hep B + DTP-HB-Hib **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Hep B + Pentabio (registered) **Description:** 1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered) **Name:** Hep B + Pentabio (registered) **Other Names:** - Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma) **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Percentage of infants with anti-diphtheria titer and anti-tetanus titer \> 0.01 IU/ml, anti HbsAg titer \> 10 mIU/ml, and anti PRP-T titer \> 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group. **Measure:** To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk **Time Frame:** 28 days after immunization #### Secondary Outcomes **Description:** Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer \> 0.01 IU/ml, \> 0.1 IU/ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive **Measure:** Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria **Time Frame:** 28 days after immunization **Description:** Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer \> 40, \> 80, \> 160 and \> 320 (1/dil.), percentage of infants with increasing antibody titer \> 4 times **Measure:** Serological response to the pertussis component (agglutinins) **Time Frame:** 28 days after immunization **Description:** Geometric mean of anti-HbsAg, percentage of infants with titer \> 10mIU/ml, percentage of infants with increasing antibody titer \> 4 times and/ or percentage of infants with transition of seronegative to seropositive **Measure:** Geometric mean of anti-HbsAg **Time Frame:** 28 days after immunization **Description:** Serological response to Hib/PRP: GMT, percentage of infants with titer \>1 ug /ml ; \> 0.15 ug /ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive **Measure:** Serological response to Hib/PRP **Time Frame:** 28 days after immunization **Description:** Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \> 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control. **Measure:** Seroconversion **Time Frame:** 28 days after immunization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy, full term, newborns infants. * Infant born after 37-42 weeks of pregnancy. * Infant weighing 2500 gram or more at birth. * Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial. Exclusion Criteria: * Child concomitantly enrolled or scheduled to be enrolled in another trial. * Mother with HBsAg positive. * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5C on Day 0). * Suspected of allergy to any component of the vaccines (e.g. formaldehyde). * Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * Newborn suspected of congenital or acquired immunodeficiency (including HIV infection). * Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)). * Received other vaccination with the exception of BCG and poliomyelitis. * Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. **Healthy Volunteers:** True **Maximum Age:** 3 Days **Minimum Age:** 0 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Bandung **Country:** Indonesia **Facility:** Garuda Primary Health Centre **State:** West Java **Location 2:** **City:** Bandung **Country:** Indonesia **Facility:** Ibrahim Adjie Primary Health Centre **State:** West Java **Location 3:** **City:** Bandung **Country:** Indonesia **Facility:** Puter Primary Health Care **State:** West Java #### Overall Officials **Official 1:** **Affiliation:** Hasan Sadikin General Hospital **Name:** Eddy Fadliyana **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9284 - Name: Haemophilus Infections - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006509 - Term: Hepatitis B - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: AnCoag - Name: Anticoagulants ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M175476 - Name: PENTA - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04168879 **Brief Title:** Sphenopalatine Ganglion Block for Nasal Surery **Official Title:** Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery #### Organization Study ID Info **ID:** ACCA #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2023-12-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-13 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-10 **Type:** ACTUAL #### Start Date **Date:** 2021-11-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2019-11-19 **Type:** ACTUAL **Study First Submit Date:** 2019-11-16 **Study First Submit QC Date:** 2019-11-16 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** saeid metwaly abouelyazid elsawy #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Rasha Hamed **Investigator Title:** lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge. ### Conditions Module **Conditions:** - Postoperative Delirium ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution **Label:** bupivacaine group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: normal saline **Label:** saline group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - bupivacaine group **Description:** 1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach **Name:** Bupivacaine 0.5% Preservative-Free Injectable Solution **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - saline group **Description:** 1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach **Name:** normal saline **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** suction and weight of surgical gauze used was measured and calculated **Measure:** intraoperative bleeding **Time Frame:** 2 hours #### Primary Outcomes **Description:** ramsy hunt sedation agitation score used during emergence from anesthesia **Measure:** Postoperative emergence agitation **Time Frame:** 2 hour #### Secondary Outcomes **Description:** total amount of opioid analgesia in first 24 hours postoperative **Measure:** postoperative opioid consumption **Time Frame:** 24 hour **Description:** Boezaart score was be used **Measure:** surgical field quality **Time Frame:** 2 hours **Description:** mean anesthesia MAC intraoperative **Measure:** consumed inhalational anesthesia **Time Frame:** 2 hours **Description:** using VAS ; scale from 0 to 10 . where 0 is no pain and 10 is worst pain **Measure:** postoperative pain **Time Frame:** 2 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patient written consent * elective surgery * age 18 - 55 year old Exclusion Criteria: * patient refusal * emergency surgery **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Asyut **Country:** Egypt **Facility:** Faculty of Medicine **Zip:** 71111 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003693 - Term: Delirium - ID: D000003221 - Term: Confusion - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M6894 - Name: Delirium - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M772 - Name: Emergence Delirium - Relevance: HIGH - As Found: Postoperative Delirium - ID: M6446 - Name: Confusion - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000071257 - Term: Emergence Delirium ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: Following - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05882279 **Brief Title:** A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan **Official Title:** Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper Use of NINLARO in Japan #### Organization Study ID Info **ID:** C16065 #### Organization **Class:** INDUSTRY **Full Name:** Takeda ### Status Module #### Completion Date **Date:** 2023-06-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-15 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-09 **Type:** ACTUAL #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2023-05-31 **Type:** ACTUAL **Study First Submit Date:** 2023-05-22 **Study First Submit QC Date:** 2023-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Takeda #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM). The main aims of the study are: * To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients. * To assess the frequency of pharmacists who have obtained the RMP material for patients. * To evaluate the depth of understanding of proper usage of NINLARO among pharmacists. **Detailed Description:** This is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrMM. The study will assess the effectiveness of distributed RMP material in prevention of ixazomib overdose in Japanese clinical practice. The study will enroll approximately 300 pharmacists who belong to hospitals prescribing NINLARO. The data will be collected through a self-administered web-based survey with questionnaires provided in Japanese. This web-based survey will be conducted in Japan. ### Conditions Module **Conditions:** - Multiple Myeloma **Keywords:** - Drug Therapy ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pharmacists included in Nikkei Research Access Panel who are active in clinical practice, with valid contact and who have instructed the dosing of NINLARO IRD therapy to patients with rrMM will self-administer a web-based survey. The questionnaires in the survey will be provided in Japanese. **Intervention Names:** - Other: No Intervention **Label:** Pharmacists in Hospitals Prescribing NINLARO ### Interventions #### Intervention 1 **Arm Group Labels:** - Pharmacists in Hospitals Prescribing NINLARO **Description:** This is a non-interventional study. **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Number of Pharmacists who Have Provided Patients With the Contents of the RMP Material **Time Frame:** 12 days #### Secondary Outcomes **Measure:** Number of Pharmacists who Have Received the RMP Material for Patients **Time Frame:** 12 days **Measure:** Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule **Time Frame:** 12 days **Measure:** Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule **Time Frame:** 12 days ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: 1. Who belong to hospitals prescribing NINLARO. 2. Who have instructed the dosing of NINLARO in IRD therapy to patients. Exclusion criteria: None **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Pharmacists included in Nikkei Research Access Panel, active in clinical practice, and with valid contact details who belong to hospitals prescribing NINLARO and instructed the dosing of NINLARO in IRD therapy to patients with rrMM will be randomly selected to participate in the survey. ### Contacts Locations Module #### Locations **Location 1:** **City:** Tokyo **Country:** Japan **Facility:** Takeda selected site #### Overall Officials **Official 1:** **Affiliation:** Takeda **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. **Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **URL:** https://vivli.org/ourmember/takeda/ ### References Module #### See Also Links **Label:** To obtain more information on the study, click here/on this link **URL:** https://clinicaltrials.takeda.com/study-detail/b6e2fa0988884fc1 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000054219 - Term: Neoplasms, Plasma Cell - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M238820 - Name: Ixazomib - Relevance: LOW - As Found: Unknown ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-05-23 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2024-05-23 - Reset Date: Unknown - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04265079 **Brief Title:** I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke **Official Title:** I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte #### Organization Study ID Info **ID:** I2-CoRT_WTP9_BEMIHOMB #### Organization **Class:** OTHER **Full Name:** Maastricht University ### Status Module #### Completion Date **Date:** 2021-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-05 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2021-06 **Type:** ESTIMATED #### Start Date **Date:** 2021-02 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2020-02-11 **Type:** ACTUAL **Study First Submit Date:** 2020-01-22 **Study First Submit QC Date:** 2020-02-10 **Why Stopped:** The study could not be executed due to COVID-19 regulations. ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Jessa Hospital #### Lead Sponsor **Class:** OTHER **Name:** Maastricht University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool. ### Conditions Module **Conditions:** - Stroke - Upper Extremity Dysfunction ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Masking Description:** Study focusses on within participant comparison and cannot be blinded. **Primary Purpose:** OTHER #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Additional weight at hand **Label:** Added weight to hand **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Added weight to hand **Description:** Added weight of an inactive hand orthosis (300 gram) **Name:** Additional weight at hand **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Score **Measure:** Action Research Arm Test **Time Frame:** 0 weeks **Description:** Score **Measure:** Action Research Arm Test **Time Frame:** 8 weeks **Description:** Score **Measure:** Fugl-Meyer **Time Frame:** 0 weeks **Description:** Score **Measure:** Fugl-Meyer **Time Frame:** 8 weeks **Description:** Score **Measure:** Box and Blocks **Time Frame:** 0 weeks **Description:** Score **Measure:** Box and Blocks **Time Frame:** 8 weeks **Description:** Joint angles **Measure:** Upper extremity kinematics **Time Frame:** 0 weeks **Description:** Joint angles **Measure:** Upper extremity kinematics **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Post-stroke * Receive regular therapy at Jessa hospital * Able to willingly sign informed consent Exclusion Criteria: * Relapse during study * Secundary complications limiting upper extremity performance **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01730079 **Brief Title:** Near Infrared Spectroscopy in Children With Autism and ADHD **Official Title:** Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children #### Organization Study ID Info **ID:** 130007 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 13-M-0007 ### Status Module #### Completion Date **Date:** 2017-04-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-10-18 **Type:** ACTUAL **Last Update Submit Date:** 2019-10-17 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2017-04-11 **Type:** ACTUAL #### Start Date **Date:** 2012-10-23 **Status Verified Date:** 2017-04-11 #### Study First Post Date **Date:** 2012-11-21 **Type:** ESTIMATED **Study First Submit Date:** 2012-11-17 **Study First Submit QC Date:** 2012-11-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** Background: - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light to study brain function while allowing for movement. To look at blood flow in the brain, NIRS uses a low-power light source with detectors that see how the light changes as it passes through brain tissue. Brain blood flow can indicate which parts of the brain are active during different tasks. Researchers want to study children with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to compare the blood flow in the brain of children with ADHD and ASD with that of typically developing children. Objectives: * To see how well NIRS can detect changes in brain blood flow during tests of thinking and memory in children. * To compare blood flow in the brains of typically developing children and those with ADHD or ASD. Eligibility: - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric diagnoses. Design: * Participants will be screened for eligibility. Those who are taking stimulant medication for ADHD or ASD will need to stop taking it for 3 days before the study visit. * After participating in a screening assessment, all participants will have one study visit. At this visit, they will have be asked to complete two tasks during a NIRS scan. For both tasks, they will react to images on a computer screen. This visit will last about 2 hours. * This is a testing study only. No blood or other samples will be needed for this study. **Detailed Description:** Objective: to test whether Near Infra-Red Spectroscopy (NIRS) can be used to monitor cognitive brain function and detect markers for differentiation of Autism Spectrum Disorders (ASD) and Attention Deficit Hyperactivity Disorder (ADHD). Study population: Children with ASD, ADHD, and typically developing children, all between 4 and 8 years of age. Design: The study will investigate NIRS signal changes while children with ASD, ADHD, and typically developing children perform well-known functional tasks. Outcome Measures: Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks. ### Conditions Module **Conditions:** - Attention Deficit Disorder With Hyperactivity - Attention Deficit Disorder - Attention Deficit Hyperactivity Disorder - Autism - Autism Spectrum Disorders **Keywords:** - Attention Deficit Hyperactivity Disorder - Autism - Near Infrared Spectroscopy - Brain Activity ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 42 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks. #### Secondary Outcomes **Measure:** Differential activity according to region of the frontal cortext and task elements. ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA: Children will be between 4 to 8 years of age (4 years, 0 months to 8 years, 11 months). English speakers only will be recruited for the study, because the language measures/tests and stimuli being used are in English and were developed and standardized on English-only samples. Typically Developing Group: -Development in nonverbal and verbal areas within age expectations (per scores onthe Differential Ability Scales, Second Edition or the Wechsler Preschool and Primary Scale of Intelligence Fourth Edition , no more than 1.5 standard deviation below the mean) ASD Group: -Diagnosis of Autistic Disorder, Asperger s disorder, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD NOS), based on diagnostic evaluation conducted through a separate screening protocol ADHD Group: -Diagnosis of ADHD based on diagnostic evaluation conducted through a separate screening protocol Minimum Nonverbal IQ of 80; Minimum Verbal IQ score of 60 EXCLUSION CRITERIA: All children who meet the following criteria: * Primary language spoken at home is other than English * Any skin disease that affects the scalp * Past or present vascular disease, such as lupus, ankylosing spondylitis or scleroderma. * Known adverse reaction to latex * Presence or history of medical conditions known to affect cerebral anatomy, such as known cysts, arterivenous malformations or cortical tubers. * Head trauma with loss of consciousness lasting longer than 5 seconds in the last year or any evidence of functional impairment due to and persisting after head trauma * Motor movement disorder which may cause sudden excessive movement, such as Tourette s disorder * Birth before 32 weeks of gestation. Premature birth can have a profound effect on brain function and structure * A known neurological or neurogenetic condition affecting the central nervous system, such as epilepsy, cerebral palsy, neurofibromatosis, velo-cardiofacial syndrome. * Color blindness Typically Developing Group: * Cognitive impairment, defined as Nonverbal IQ below 80, or signs of ASD or ADHD * Confirmed diagnosis of any DSM-IV-TR Axis I disorder * Taking medications for neuropsychiatric disorders such as antidepressants, antipsychotics, mood stabilizers, anxiolytics or any medication used to treat ADHD (psychostimulants, atomoxetine (Strattera ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ). ASD Group: * Taking medications for neuropsychiatric disorders: such as antidepressants, antipsychotics, mood stabilizers, or anxiolytics. Some medications used to treatment for ADHD are also exclusionary for all children - including atomoxetine (Strattera ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ). Children with ASD who take stimulants (like Ritalin, adderall, concerta and vyvanse) may be able to participate if they are willing and able to stop stimulant medications for 2 days on 1 occasion for the study * A known neurological or neurogenetic condition affecting the central nervous system, such as epilepsy, cerebral palsy, neurofibromatosis, velo-cardiofacial syndrome. ADHD Group: * Taking medications for neuropsychiatric disorders: such as antidepressants, antipsychotics, mood stabilizers, or anxiolytics. Some medications used to treatment for ADHD are also exclusionary for all children - including atomoxetine (Strattera ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ). Children with ASD who take stimulants (like Ritalin, adderall, concerta and vyvanse) may be able to participate if they are willing and able to stop stimulant medications for 2 days on 1 occasion for the study * Other psychiatric diagnoses (including ASD, anxiety and depression), except for comorbid oppostional defiant disorder **Healthy Volunteers:** True **Maximum Age:** 8 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Institutes of Health Clinical Center, 9000 Rockville Pike **State:** Maryland **Zip:** 20892 #### Overall Officials **Official 1:** **Affiliation:** National Institute of Mental Health (NIMH) **Name:** Audrey E Thurm, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Boas DA, Dale AM, Franceschini MA. Diffuse optical imaging of brain activation: approaches to optimizing image sensitivity, resolution, and accuracy. Neuroimage. 2004;23 Suppl 1:S275-88. doi: 10.1016/j.neuroimage.2004.07.011. **PMID:** 15501097 **Citation:** Carlsson J, Lagercrantz H, Olson L, Printz G, Bartocci M. Activation of the right fronto-temporal cortex during maternal facial recognition in young infants. Acta Paediatr. 2008 Sep;97(9):1221-5. doi: 10.1111/j.1651-2227.2008.00886.x. **PMID:** 18627358 **Citation:** Elwell CE, Henty JR, Leung TS, Austin T, Meek JH, Delpy DT, Wyatt JS. Measurement of CMRO2 in neonates undergoing intensive care using near infrared spectroscopy. Adv Exp Med Biol. 2005;566:263-8. doi: 10.1007/0-387-26206-7_35. **PMID:** 16594161 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019958 - Term: Attention Deficit and Disruptive Behavior Disorders - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4594 - Name: Attention Deficit Disorder with Hyperactivity - Relevance: HIGH - As Found: Attention Deficit Disorder - ID: M9999 - Name: Hyperkinesis - Relevance: HIGH - As Found: Hyperactivity - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21830 - Name: Attention Deficit and Disruptive Behavior Disorders - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006948 - Term: Hyperkinesis - ID: D000001321 - Term: Autistic Disorder - ID: D000001289 - Term: Attention Deficit Disorder with Hyperactivity - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03902379 **Brief Title:** Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer **Official Title:** Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study #### Organization Study ID Info **ID:** Pro20160000637 #### Organization **Class:** OTHER **Full Name:** Rutgers, The State University of New Jersey #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2017-02300 **Type:** REGISTRY **ID:** Pro20160000637 **Domain:** Rutgers Cancer Institute of New Jersey **ID:** 131602 **Type:** OTHER **ID:** P30CA072720 **Link:** https://reporter.nih.gov/quickSearch/P30CA072720 **Type:** NIH ### Status Module #### Completion Date **Date:** 2020-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2021-04-19 **Type:** ACTUAL **Last Update Submit Date:** 2021-04-16 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2020-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2016-07-27 **Type:** ACTUAL **Status Verified Date:** 2021-04 #### Study First Post Date **Date:** 2019-04-04 **Type:** ACTUAL **Study First Submit Date:** 2018-07-06 **Study First Submit QC Date:** 2019-04-01 **Why Stopped:** The study was never initiated, no patients were enrolled. It has been closed with the IRB. ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Rutgers, The State University of New Jersey #### Responsible Party **Investigator Affiliation:** Rutgers Cancer Institute of New Jersey **Investigator Full Name:** Sharon Manne, PhD **Investigator Title:** Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience. **Detailed Description:** PRIMARY OBJECTIVES: I. To examine the feasibility and acceptability of an online coping and communication skills intervention (CCI). II. To collect pilot data on the impact of online CCI on global and cancer-specific distress. OUTLINE: Patients complete 3 modules of online CCI intervention. After completion of study, patients are followed up at 2 months. ### Conditions Module **Conditions:** - Endometrial Carcinoma - Stage 0 Fallopian Tube Cancer AJCC v7 - Stage I Fallopian Tube Cancer AJCC v6 and v7 - Stage I Ovarian Cancer AJCC v6 and v7 - Stage IA Fallopian Tube Cancer AJCC v6 and v7 - Stage IA Ovarian Cancer AJCC v6 and v7 - Stage IB Fallopian Tube Cancer AJCC v6 and v7 - Stage IB Ovarian Cancer AJCC v6 and v7 - Stage IC Fallopian Tube Cancer AJCC v6 and v7 - Stage IC Ovarian Cancer AJCC v6 and v7 - Stage II Cervical Cancer AJCC v7 - Stage II Fallopian Tube Cancer AJCC v6 and v7 - Stage II Ovarian Cancer AJCC v6 and v7 - Stage II Uterine Corpus Cancer AJCC v7 - Stage IIA Cervical Cancer AJCC v7 - Stage IIA Fallopian Tube Cancer AJCC v6 and v7 - Stage IIA Ovarian Cancer AJCC V6 and v7 - Stage IIA1 Cervical Cancer AJCC v7 - Stage IIA2 Cervical Cancer AJCC v7 - Stage IIB Cervical Cancer AJCC v6 and v7 - Stage IIB Fallopian Tube Cancer AJCC v6 and v7 - Stage IIB Ovarian Cancer AJCC v6 and v7 - Stage IIC Fallopian Tube Cancer AJCC v6 and v7 - Stage IIC Ovarian Cancer AJCC v6 and v7 - Stage III Cervical Cancer AJCC v6 and v7 - Stage III Fallopian Tube Cancer AJCC v7 - Stage III Ovarian Cancer AJCC v6 and v7 - Stage III Primary Peritoneal Cancer AJCC v7 - Stage III Uterine Corpus Cancer AJCC v7 - Stage IIIA Cervical Cancer AJCC v6 and v7 - Stage IIIA Fallopian Tube Cancer AJCC v7 - Stage IIIA Ovarian Cancer AJCC v6 and v7 - Stage IIIA Primary Peritoneal Cancer AJCC v7 - Stage IIIA Uterine Corpus Cancer AJCC v7 - Stage IIIB Cervical Cancer AJCC v6 and v7 - Stage IIIB Fallopian Tube Cancer AJCC v7 - Stage IIIB Ovarian Cancer AJCC v6 and v7 - Stage IIIB Primary Peritoneal Cancer AJCC v7 - Stage IIIB Uterine Corpus Cancer AJCC v7 - Stage IIIC Fallopian Tube Cancer AJCC v7 - Stage IIIC Ovarian Cancer AJCC v6 and v7 - Stage IIIC Primary Peritoneal Cancer AJCC v7 - Stage IIIC Uterine Corpus Cancer AJCC v7 - Stage IIIC1 Uterine Corpus Cancer AJCC v7 - Stage IIIC2 Uterine Corpus Cancer AJCC v7 - Stage IV Cervical Cancer AJCC v6 and v7 - Stage IV Fallopian Tube Cancer AJCC v6 and v7 - Stage IV Ovarian Cancer AJCC v6 and v7 - Stage IV Primary Peritoneal Cancer AJCC v7 - Stage IV Uterine Corpus Cancer AJCC v7 - Stage IVA Cervical Cancer AJCC v6 and v7 - Stage IVA Uterine Corpus Cancer AJCC v7 - Stage IVB Cervical Cancer AJCC v6 and v7 - Stage IVB Uterine Corpus Cancer AJCC v7 - Uterine Carcinosarcoma - Uterine Corpus Sarcoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients complete 3 modules of online CCI intervention. **Intervention Names:** - Other: Internet-Based Intervention - Other: Quality-of-Life Assessment - Other: Questionnaire Administration - Other: Survey Administration **Label:** Supportive Care (CCI intervention) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Supportive Care (CCI intervention) **Description:** Receive CCI intervention **Name:** Internet-Based Intervention **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Supportive Care (CCI intervention) **Description:** Ancillary studies **Name:** Quality-of-Life Assessment **Other Names:** - Quality of Life Assessment **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Supportive Care (CCI intervention) **Description:** Ancillary studies **Name:** Questionnaire Administration **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Supportive Care (CCI intervention) **Description:** Ancillary studies **Name:** Survey Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Will define feasibility/acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program. **Measure:** Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention **Time Frame:** Up to 2 months #### Secondary Outcomes **Description:** Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63 **Measure:** Changes in psychological adaptation- Beck Depression Inventory (BDI) **Time Frame:** Baseline up to 2 months **Description:** Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used **Measure:** Changes in psychological adaptation-Mental Health Inventory (MHI) **Time Frame:** Baseline up to 2 months **Description:** Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests. **Measure:** Changes in psychological coping **Time Frame:** Baseline up to 2 months **Description:** Will define acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program. **Measure:** Examine acceptability of an online CCI **Time Frame:** Up to 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months * Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months * Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months * Newly diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months * At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery * At the time of recruitment, a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1 * English speaking * Has internet access * Must give informed consent within 6 months of diagnosis **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New Brunswick **Country:** United States **Facility:** Rutgers Cancer Institute of New Jersey **State:** New Jersey **Zip:** 08903 #### Overall Officials **Official 1:** **Affiliation:** Rutgers Cancer Institute of New Jersey **Name:** Sharon Manne **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000012509 - Term: Sarcoma - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000014594 - Term: Uterine Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005184 - Term: Fallopian Tube Diseases - ID: D000000008 - Term: Abdominal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010532 - Term: Peritoneal Diseases - ID: D000018193 - Term: Neoplasms, Complex and Mixed ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Cancer - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Ovarian Cancer - ID: M5552 - Name: Carcinosarcoma - Relevance: HIGH - As Found: Carcinosarcoma - ID: M20346 - Name: Mixed Tumor, Mullerian - Relevance: LOW - As Found: Unknown - ID: M8328 - Name: Fallopian Tube Neoplasms - Relevance: HIGH - As Found: Fallopian Tube Cancer - ID: M13443 - Name: Peritoneal Neoplasms - Relevance: HIGH - As Found: Peritoneal Cancer - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Carcinoma - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8327 - Name: Fallopian Tube Diseases - Relevance: LOW - As Found: Unknown - ID: M7 - Name: Abdominal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M13441 - Name: Peritoneal Diseases - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T2189 - Name: Fallopian Tube Cancer - Relevance: HIGH - As Found: Fallopian Tube Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T3586 - Name: Malignant Mixed Mullerian Tumor - Relevance: LOW - As Found: Unknown - ID: T5821 - Name: Uterine Sarcoma - Relevance: HIGH - As Found: Uterine Corpus Sarcoma - ID: T5820 - Name: Uterine Carcinosarcoma - Relevance: HIGH - As Found: Uterine Carcinosarcoma ### Condition Browse Module - Meshes - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial - ID: D000002583 - Term: Uterine Cervical Neoplasms - ID: D000005185 - Term: Fallopian Tube Neoplasms - ID: D000010534 - Term: Peritoneal Neoplasms - ID: D000016889 - Term: Endometrial Neoplasms - ID: D000002296 - Term: Carcinosarcoma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00826579 **Brief Title:** Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer **Official Title:** Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer #### Organization Study ID Info **ID:** Rhein4031 #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-03-12 **Type:** ESTIMATED **Last Update Submit Date:** 2015-03-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-01 **Type:** ACTUAL #### Start Date **Date:** 2000-05 **Status Verified Date:** 2015-03 #### Study First Post Date **Date:** 2009-01-22 **Type:** ESTIMATED **Study First Submit Date:** 2009-01-13 **Study First Submit QC Date:** 2009-01-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk. Additionally, a search for occult metastatic tumor cells in the bone marrow is performed. ### Conditions Module **Conditions:** - Colonic Neoplasms **Keywords:** - Sentinel lymph node - Lymph node analysis - Bone marrow analysis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 192 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Colon cancer patients of all stages **Intervention Names:** - Procedure: Sentinel lymph node procedure - Procedure: Bone marrow aspiration **Label:** Colon cancer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Colon cancer **Description:** After careful mobilization of the affected colon segment, isosulfan blue 1% is injected in vivo into the subserosa circumferentially around the tumor. Lymph nodes in the mesentery staining blue within the first minutes are marked as SLN. The procedure is followed by a resection of the affected colon segment with standard lymphadenectomy. **Name:** Sentinel lymph node procedure **Other Names:** - Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Colon cancer **Description:** Prior to surgery, bone marrow is aspirated from both iliac crests. Bone marrow aspirates are analyzed for the presence of occult metastatic colon cancer cells. **Name:** Bone marrow aspiration **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** To assess the extent of upstaging due to the SLN procedure for colon cancer. **Time Frame:** 1 month #### Secondary Outcomes **Measure:** To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS. **Time Frame:** 1 month, 3 and 5 years after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology. * Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded). * Patient's informed consent Exclusion Criteria: * Prior intrabdominal tumor surgery * Other preexisting malignancies * Hypersensitivity/allergy to dye (isosulfan blue) * Pregnancy * Breast-feeding * No patient's informed consent **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Basel **Country:** Switzerland **Facility:** Carsten T. Viehl, MD **Zip:** 4031 **Location 2:** **City:** Biel **Country:** Switzerland **Facility:** Urban Laffer, MD **Zip:** 2501 **Location 3:** **City:** Olten **Country:** Switzerland **Facility:** Markus Zuber, MD **Zip:** 4600 #### Overall Officials **Official 1:** **Affiliation:** aktuell: Spitalzentrum Biel-Bienne **Name:** Carsten T. Viehl, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Kantonsspital Olten **Name:** Markus Zuber, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Weixler B, Viehl CT, Warschkow R, Guller U, Ramser M, Sauter G, Zuber M. Comparative Analysis of Tumor Cell Dissemination to the Sentinel Lymph Nodes and to the Bone Marrow in Patients With Nonmetastasized Colon Cancer: A Prospective Multicenter Study. JAMA Surg. 2017 Oct 1;152(10):912-920. doi: 10.1001/jamasurg.2017.1514. **PMID:** 28593306 **Citation:** Viehl CT, Guller U, Langer I, Laffer U, Oertli D, Zuber M. Factors influencing the success of in vivo sentinel lymph node procedure in colon cancer patients: Swiss prospective, multicenter study sentinel lymph node procedure in colon cancer. World J Surg. 2013 Apr;37(4):873-7. doi: 10.1007/s00268-013-1910-3. **PMID:** 23354923 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colonic Neoplasms - ID: M17890 - Name: Colorectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003110 - Term: Colonic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04206579 **Brief Title:** Oral Dextrose Formula in Performance of Soccer Athlete **Official Title:** Oral 10% Dextrose Versus Sodium Dextrose Formula in Performance of Soccer Athlete. A Double-Blind Cross Over Randomized Controlled Trial #### Organization Study ID Info **ID:** 0611192027 #### Organization **Class:** OTHER **Full Name:** Hasanuddin University ### Status Module #### Completion Date **Date:** 2019-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-20 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-28 **Type:** ACTUAL #### Start Date **Date:** 2019-03-25 **Type:** ACTUAL **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2019-12-20 **Type:** ACTUAL **Study First Submit Date:** 2019-12-12 **Study First Submit QC Date:** 2019-12-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hasanuddin University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** I. Title of Proposed Research Project Dextrose 10% Drink Increase Blood Sugar and Sprint Velocity Compared to Sodium Dextrose in Soccer Players II. Specific Aims This study aims to evaluate the ergogenic effect in terms of blood sugar, VO2 max and sprint speed of dextrose 10% compared with sodium dextrose 10% in young male soccer players. III. Background Sports drinks are designed to provide CHO, electrolytes, and fluids to the body, which are absorbed very fast from the small intestine. In other words, the period from ingestion until the CHO, electrolytes, and fluids reach the muscles, brain and so on, should be very short. This is the most important advantage of using sports drinks (Simulescu, Ilia, Macarie, \& Merghes, 2019). Commercial sports drinks generally contain both of CHO and sodium; To the best of the investigator's knowledge, there is no trial in which compare the differential effect of solely dextrose supplementation versus sodium dextrose in soccer players in terms of BG concentration, VO2 max and sprint speed, which may give a new paradigm for the available ergogenic sports drink. **Detailed Description:** Male academy soccer players, included in a trial, received two types of solutions (compound of 150 cc dextrose 10% + 20 mM sodium or single 150 cc dextrose 10%) interchangeably, separated within 120 minutes were completed in a counterbalanced, randomized, double-blind, crossover design. The study was approved by the Faculty of Medicine Hasanuddin University Research Ethics Committee. This trial was conducted at UNM Banta-Bantaeng, Makassar, Indonesia, from April 2019 to May 2019. All participants were within the last meal four hours prior to the test. Exclusion criteria were the use of amylase supplement, suffering from fever and diarrhea, using laxative agents within 24 h, consuming CHO absorption inhibitors, caffeine, creatinine, beta alanine, sodium bicarbonate supplement within 24 h, mean arterial pressure \<65mmHg, knee or muscle injuries, history of diabetes mellitus and heart disease, going through ketogenic diet program, history of gastrointestinal surgery, and total body fat percentages \> 30%. Dietary intake was collected using two days food recall. BG were measured using portable glucometer (Aviva; Accucheck, Roche Diagnostics, Indiana, U.S.A), blood pressure were measured using aneroid sphygmomanometer (R1 shock-proof; Riester, Jungingen, Germany), heart rate were measured with wrist band pulse monitor (Bluetooth 4.0 wireless sport heart rate monitor WP290; Egoman, Shenzen, China), body weight, muscle, fat, water, metabolic rate were measured using body composition analyzer (BC-545N; Tanita, Tokyo, Japan), body height were measured using stadiometer (HR-200, Tanita, Tokyo, Japan), sprint speed were measured using digital stopwatch (S23589 S23589P1; Seiko, Tokyo, Japan) Participants were instructed to refrain from strenuous physical activity in the 2 days preceding trial sessions and recorded all food consumed in the 2 days before the trial. Food records subsequently were analyzed using professional German nutrition software (EBISpro, Nutrisurvey 2007). On arrival at the field, pre supplementation capillary blood samples were collected, and then all players run for 2x100 m and calculated the VO2max using Uth-Sorenen-Overgaard-Pedersen Formula and sprint speed was recorded. After doing the baseline measurement, each player waited for 15 minutes in order to consume either dextrose or sodium dextrose solution, and then waited for 15 minutes to had another subsequent capillary blood samples measurement. After that, the players run for 2x100 m, recorded the VO2max and sprint speed. The players remained in a rested state for 120 minutes as a crossover washed-out period, and then did the same protocol with different solution. All data are expressed as mean ± SD unless otherwise stated, with 95% confidence interval, and significance was accepted at p \< 0.05. Data were checked for normality as indicated by the Shapiro-Wilk test. Paired t tests were used to compare before and after condition in blood sugar, VO2max and sprint speed. Data was analysed using IBM SPSS Statistics software, version 25; IBM Corp., Chicago, IL. To interpret the magnitude of effect, Cohen's d effect sizes (±95% confidence limits) were estimated using a purpose built spreadsheet, with effect size thresholds set at \<0.20, \>0.50, and \>0.80 for small, moderate, large, effects respectively. ### Conditions Module **Conditions:** - Athletes **Keywords:** - Oral Dextrose - Blood Sugar - Sprint Velocity - Athletes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** the study involves two different groups with a cross-over design. Each participant will be given an oral formula according to the group allocation followed by outcome measurement. After the wash-out period, the formula will be switched and given to the participants, followed by outcome measurement ##### Masking Info **Masking:** DOUBLE **Masking Description:** Both packages of intervention have a similar dimension to ensure the participants are not recognizing the formula. The pharmacists are responsible for preparing the formula and given to the nurse prior to the intervention. Investigators are being masked during the whole intervention. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral 10% Dextrose **Intervention Names:** - Drug: 10% Dextrose - Drug: Natrium Dextrose **Label:** 10% Dextrose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Oral Natrium Dextrose **Intervention Names:** - Drug: 10% Dextrose - Drug: Natrium Dextrose **Label:** Natrium Dextrose **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 10% Dextrose - Natrium Dextrose **Description:** A mixture of 150 cc dextrose 10% in oral formulation **Name:** 10% Dextrose **Other Names:** - Unavailable Information **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 10% Dextrose - Natrium Dextrose **Description:** A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation **Name:** Natrium Dextrose **Other Names:** - Unavailable Information **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Blood Glucose measured in capillary blood vessels **Measure:** Blood Glucose **Time Frame:** Blood Glucose Level at 15 minutes after intake #### Secondary Outcomes **Description:** maximum sprint speed **Measure:** Sprint Velocity **Time Frame:** Sprint Velocity 30 minutes after intervention **Description:** Maximum (MAX) volume (V) of oxygen (O2) an individual body in incremental exercise **Measure:** Volume O2 maximum (VO2 Max) **Time Frame:** VO2 10 minutes after sprint ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male 2. Age 18-23 years. 3. Soccer player 4. Last meal a maximum of 4 hours before 5. Willing and signed an agreement to participate in research. Exclusion Criteria: 1. The use of amylase supplement 2. Suffering from fever and diarrhea 3. Using laxative agents within 24 h 4. Consuming CHO absorption inhibitors, Caffeine, creatinine, beta-alanine, sodium bicarbonate supplement within 24 h, 5. Mean arterial pressure \<65mmHg 6. Knee or muscle injuries, 7. History of diabetes mellitus and heart disease 8. Going through the ketogenic diet program. 9. History of gastrointestinal surgery, and total body fat percentages \> 30%. **Gender Based:** True **Gender Description:** Male at birth **Healthy Volunteers:** True **Maximum Age:** 23 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Makasar **Country:** Indonesia **Facility:** Makassar State University **State:** South Sulawesi **Zip:** 90222 #### Overall Officials **Official 1:** **Affiliation:** Hasanuddin University **Name:** Agussalim Bukhari, MD, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No individual participant data (IPD) will be shared **IPD Sharing:** NO ### References Module #### References **Citation:** Achten J, Halson SL, Moseley L, Rayson MP, Casey A, Jeukendrup AE. Higher dietary carbohydrate content during intensified running training results in better maintenance of performance and mood state. 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Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015. **PMID:** 25969700 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03375879 **Brief Title:** Bandage Contact Lens in Post Operative Ptosis Patients **Official Title:** The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair #### Organization Study ID Info **ID:** StJosephharveyj #### Organization **Class:** OTHER **Full Name:** St. Joseph's Healthcare Hamilton ### Status Module #### Completion Date **Date:** 2018-12-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2018-04-23 **Type:** ACTUAL **Last Update Submit Date:** 2018-04-19 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2018-02-21 **Type:** ACTUAL **Status Verified Date:** 2018-04 #### Study First Post Date **Date:** 2017-12-18 **Type:** ACTUAL **Study First Submit Date:** 2017-11-08 **Study First Submit QC Date:** 2017-12-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Robert Adam **Class:** UNKNOWN **Name:** Forough Farrokhyar **Class:** UNKNOWN **Name:** Sivisan Suntheralingam #### Lead Sponsor **Class:** OTHER **Name:** St. Joseph's Healthcare Hamilton #### Responsible Party **Investigator Affiliation:** St. Joseph's Healthcare Hamilton **Investigator Full Name:** John Harvey **Investigator Title:** Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. **Detailed Description:** This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. The investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. This is a randomized control trial in which patients undergoing bilateral ptosis surgery (Fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.In this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. Follow up will occur in one week where the outcomes will be obtained through questionnaires. ### Conditions Module **Conditions:** - Ptosis - Blepharoptosis **Keywords:** - Ptosis - Blepharoptosis - bandage contact lens - fasanella servat procedure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The investigators will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens. ##### Masking Info **Masking:** SINGLE **Masking Description:** The investigator will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Placing a bandage contact lens in one eye. **Intervention Names:** - Device: Bandage contact lens **Label:** Bandage contact lens **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Sham contact lens will be placed on other eye, placing it and immediately removing it so patient does not know which eye will have a bandage contact lens. **Label:** Sham contact lens (immediate removal) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Bandage contact lens **Description:** Bandage contact lens **Name:** Bandage contact lens **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme. **Measure:** Patient's pain/discomfort **Time Frame:** One week post-operation. #### Secondary Outcomes **Description:** This will be measured using one question from the Ocular Surface Disease Index (OSDI), with a scale from 0 (none of the time) to 4 (all of the time). **Measure:** Blurry vision **Time Frame:** One week post-operation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this Exclusion Criteria: * patient having any other eye related pathologies **Healthy Volunteers:** True **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** johntharvey@gmail.com **Name:** John Harvey, M.D. **Phone:** 905-522 1155 **Phone Ext:** 38095 **Role:** CONTACT #### Locations **Location 1:** **City:** Hamilton **Contacts:** ***Contact 1:*** - **Email:** johntharvey@gmail.com - **Name:** John Harvey, M.D. - **Phone:** 905-522 1155 - **Phone Ext:** 38095 - **Role:** CONTACT ***Contact 2:*** - **Name:** John Harvey, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** St. Joseph's Hospital Hamilton **State:** Ontario **Status:** RECRUITING **Zip:** L8G 5E4 ### IPD Sharing Statement Module **Description:** IPD will not be shared with others. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2017-10-17 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 498576 - Type Abbrev: Prot_SAP - Upload Date: 2017-11-23T21:41 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000005141 - Term: Eyelid Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Ptosis - ID: M5044 - Name: Blepharoptosis - Relevance: HIGH - As Found: Blepharoptosis - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M8284 - Name: Eyelid Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001763 - Term: Blepharoptosis - ID: D000011391 - Term: Prolapse ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01648179 **Brief Title:** A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects **Official Title:** A Single Dose, Open Label, Randomized, Balanced, Crossover Study to Assess the Relative Bioavailability of ThreeFormulations and Food Effect on GSK1322322 in Healthy Subjects #### Organization Study ID Info **ID:** 116595 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2012-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2017-03-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-05 **Type:** ACTUAL #### Start Date **Date:** 2012-03 **Status Verified Date:** 2017-03 #### Study First Post Date **Date:** 2012-07-24 **Type:** ESTIMATED **Study First Submit Date:** 2012-06-07 **Study First Submit QC Date:** 2012-07-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects. **Detailed Description:** This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects: * The relative bioavailability of the wet milled GSK1322322 tablet formulation with and without food compared to an oral mesylate salt solution. * The effect of body weight on the pharmacokinetics of GSK1322322 when given either orally or IV. * The absolute bioavailability of the wet milled tablet and the oral mesylate salt solution compared to the IV formulation. ### Conditions Module **Conditions:** - Infections, Bacterial **Keywords:** - GSK1322322, relative bioavailability, healthy subjects, open label, food effect, weight effect ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be randomized in a cross over fashion to receive the GSK1322322 administered via IV formulation **Intervention Names:** - Drug: GSK1322322 (mesylate salt) Powder for Injection **Label:** GSK1322322 IV formulation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will be randomized in a cross over fashion to receive the GSK1322322 administered via Wet milled Tablet (Fasted) **Intervention Names:** - Drug: GSK1322322 (freebase) tablets **Label:** GSK1322322 Wet milled Tablet (Fasted) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Subjects will be randomized in a cross over fashion to receive the GSK1322322 administered via Oral mesylate salt solution **Intervention Names:** - Drug: GSK1322322 (mesylate salt) Powder for Oral Solution **Label:** GSK1322322 Oral mesylate salt solution **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Subjects will be randomized in a cross over fashion to receive the GSK1322322 administered via Wet milled Tablet (Fed) **Intervention Names:** - Drug: GSK1322322 (freebase) tablets FED **Label:** GSK1322322 Wet milled Tablet (Fed) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GSK1322322 IV formulation **Description:** 1500 mg (mesylate salt) as free base, dissolved in sterile water for injection to a concentration of 100 mg/mL free base equivalent and sterilized via filtration. 15 mL of solution, equivalent to 1500 mg GSK 1322322, is the diluted into 0.9% Sodium Chloride Injection prior to infusion **Name:** GSK1322322 (mesylate salt) Powder for Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - GSK1322322 Wet milled Tablet (Fasted) **Description:** 500 mg tablets for a 1500 mg total single dose (3 tablets). Taken with 240 mL of water **Name:** GSK1322322 (freebase) tablets **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - GSK1322322 Oral mesylate salt solution **Description:** 1500 mg as a free base, dissolved in purified water to a concentration of 100 mg/mL free base equivalent. 15 mL of solution, equivalent to1500 mg GSK1322322 is administered orally with 225 mL of water **Name:** GSK1322322 (mesylate salt) Powder for Oral Solution **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - GSK1322322 Wet milled Tablet (Fed) **Description:** Drug 500 mg tablets for a 1500 mg total single dose (3 tablets) (FED moderate fat meal) Taken with 240 mL of water **Name:** GSK1322322 (freebase) tablets FED **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** GSK1322322 AUC(0-∞) and Cmax following wet milled tablet formulation administered with and without moderate fat/calorie meal. GSK1322322 AUC(0-∞) and Cmax following oral mesylate salt solution administration. **Measure:** To estimate the relative bioavailability of wet milled tablet formulations of GSK1322322 with and without food as compared to an oral mesylate salt solution following single doses in healthy subjects. **Time Frame:** 72 Hours **Description:** GSK1322322 AUC(0-∞) and Cmax in each body weight group following IV or oral formulation administration to assess effect of body weight. **Measure:** To estimate the effect of body weight on the pharmacokinetics of GSK1322322 formulations (IV and oral) following single dose administration to healthy subjects. **Time Frame:** 72 Hours #### Secondary Outcomes **Description:** Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs. **Measure:** To evaluate the safety and tolerability of GSK1322322 after single doses of each formulation in healthy subjects. **Time Frame:** 14 Days **Description:** GSK1322322 AUC(0-∞) following different oral formulations (oral mesylate salt solution and wet milled tablet) versus IV formulation to assess absolute bioavailability. GSK1322322 pharmacokinetic parameters will be computed with noncompartmental analysis **Measure:** To estimate the absolute bioavailability of the different oral formulations of GSK1322322 as compared to IV mesylate salt formulation following single doses in healthy subjects. **Time Frame:** 72 Hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * QTcB \< 450 msec; or QTcB \< 480 msec in subjects with Bundle Branch Block. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Male or female (of non childbearing potential) between 18 and 65 years of age inclusive, at the time of signing the informed consent. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample withsimultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \<40 pg/ml (\<147 pmol/L) is confirmatory\]. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the final follow up visit. * Body weight ≥ 40 kg (Refer to Table 3 for weight stratification details). * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: * A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A positive pre-study drug/alcohol screen. * A positive test for HIV antibody. * History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety due to potential drug interaction. * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. * Pregnant females as determined by positive \[serum or urine\] hCG test at screening or prior to dosing. * Lactating females. * Unwillingness or inability to follow the procedures outlined in the protocol. * Subject is mentally or legally incapacitated. * History of sensitivity to heparin or heparin-induced thrombocytopenia. * Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices\] from 7 days prior to the first dose of study medication. * Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Males Females Heart rate \<45 and \>100 bpm \<50 and \>100 bpm PR Interval \<120 and \>220 msec QRS duration \<70 and \>120 msec QTc interval (Bazett) \>450 msec * Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). * Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block \[2nd degree or higher\], Wolf Parkinson White \[WPW\] syndrome), sinus pauses\> 3 seconds, non-sustained or sustained ventricular tachycardia (≥3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety of the individual subject. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Minneapolis **Country:** United States **Facility:** GSK Investigational Site **State:** Minnesota **Zip:** 55404 #### Overall Officials **Official 1:** **Affiliation:** GlaxoSmithKline **Name:** GSK Clinical Trials **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. **IPD Sharing:** YES ### References Module #### Available IPDs **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Annotated Case Report Form **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Clinical Study Report **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Informed Consent Form **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Individual Participant Data Set **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Study Protocol **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Dataset Specification **URL:** https://www.clinicalstudydatarequest.com **Comment:** For additional information about this study please refer to the GSK Clinical Study Register **ID:** 116595 **Type:** Statistical Analysis Plan **URL:** https://www.clinicalstudydatarequest.com #### See Also Links **Label:** Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. **URL:** https://www.clinicalstudydatarequest.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Infection, Bacterial - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001424 - Term: Bacterial Infections ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03695679 **Brief Title:** Interactive Web-based Sexual Health Literacy Program and Safe Sex Practice in University Students **Official Title:** Evaluation of an Interactive Web-based Sexual Health Literacy Program to Safe Sex Practice for Female University Students: A Multicentred Randomized Controlled Trial #### Organization Study ID Info **ID:** 14150971 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2019-10-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-14 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-10-29 **Type:** ACTUAL #### Start Date **Date:** 2017-09-01 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2018-10-04 **Type:** ACTUAL **Study First Submit Date:** 2018-09-16 **Study First Submit QC Date:** 2018-10-02 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Chinese University of Hong Kong **Class:** OTHER **Name:** The Hong Kong Polytechnic University **Class:** UNKNOWN **Name:** Hong Kong Shue Yan University **Class:** OTHER **Name:** City University of Hong Kong #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Investigator Affiliation:** The University of Hong Kong **Investigator Full Name:** Dr. Janet Wong **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective is to evaluate the efficacy of an Interactive web-based sexual health literacy program to enhance safe sex practice among female university students. Based on Health Belief Model, the intervention comprising: (1) personalized perceived susceptibility and perceived severity of STIs and cervical cancer; (2) perceived benefits and perceived barriers of safe sex practice via knowledge- based information; (3) cue to action via the local resources; and (4) self-efficacy via narrative stories, which are tailored for female university students, to communicate safe sex messages. The investigators hypothesised that the intervention will enhance consistency of condom use, knowledge, attitude, norms, self-efficacy towards condom use, sexual consent, sexual communication and reduce sexual coercion and casual sex among participants in intervention group compared to those in control group. A multicentered randomized controlled trial will be conducted in 500 female university students in 5 universities with dormitories. Inclusion criteria are unmarried female university Chinese students aged at least 18-year and not received any sexual health intervention in the past 12 months. The main outcome measures will be self-reported consistency of condom use with every partner in 3-month assessments, sexual coercion, sexual consent, casual sex and sexual communication. The study instruments used will be UCLA Multidimensional Condom Attitudes Scale; Sexual Consent Scale-Revised; Conflict Tactic Scale-Revised; and Sexual Communication Self-Efficacy Scale. The data analysis will be a linear mixed effects model with intervention group and baseline consistency of condom use as the covariates. The investigators expected that the intervention will enhance consistency of condom use with Cohen effect size of 0.3. **Detailed Description:** Subject recruitment procedures: Recruitment of participants will be conducted by using bulk electronic mails, promotional brochures, posters and campus booths. An invitation card with a QR code of the web-based intervention will be used for inviting female university students to enrol the study. Online enrolment will be done for screening participants for eligibility. From the investigators' past experience in recruiting university students, the investigators shall be able to reach over 30,000 female university students in five universities. Participants will be asked to complete the web-based baseline survey at enrolment. The web-based questionnaire will be set up under an online platform. Participants may use their mobile devices including laptop computers and smartphones to complete the questionnaire. Participation is entirely voluntary. Written informed consent will be obtained via the web-based platform before completing the baseline questionnaire. After completion of the questionnaire, the recruited students will then be randomized to either intervention group or control group, according to a list prepared by blocked randomization of a size decided by a randomizer. The block size and order of allocation will be kept securely in the randomizer to avoid selection bias. Allocation concealment will be done at the online platform according to the participants' enrolment sequence. The participants will then be guided to a web-page according to their group allocation. At 3-month and 6-month after the entry of the study, participants will receive a link through their e-mail to complete a follow-up questionnaire (T2). Three months later, another e-mail link will be sent to participants for completing the last follow-up questionnaire (T3). If no response from a participant, a follow-up telephone text-message and/or telephone call will be sent after 1 week as a reminder. Sample size assessment: Female university students (n = 500), across disciplines and year of study, will be recruited from five universities with dormitory or residential halls in Hong Kong. The sample size calculation is based on the primary comparison of behavioural change in consistency of condom use. A previous study showed the mean percentage of condom use was 67.8% (SD 39.3%) in people under an ICBI and 23.5% (SD 35.3%) in those under usual care, corresponding to a moderate to large Cohen effect size of 0.6.(20) To detect a conservative small Cohen effect size of 0.3 with 80% power and maximum 5% false positive error rate by a two-sided two-sample t-test, the investigators need a total of 352 (176 per group) female university students. Assuming 30% attrition based on a previous study using web-based intervention (21), the investigators plan to recruit a total of 500 female university students. Quality assurance plan: The web-based intervention is password-protected and "Pseudo-Codes" will be used to ensure anonymity and confidentiality to minimize social desirability of the responses. By asking the participant to create his/her own "pseudo-code", a code that can be accurately retyped each time the participant completes pre-test and post-test. There will otherwise no other vulnerable subjects involve in the study. Data check and analysis method: To assess the efficacy of ICBI in increasing consistency of condom use, a linear mixed effects model will be adopted with intervention group and baseline consistency of condom use as the covariates. The group by time interaction shall be assessed for changes of ICBI effects over time. When the interaction effect is insignificant, it will be removed from the model and the overall ICBI will be estimated. Otherwise, liner contrasts will be used to assess the ICBI effect at each time epoch. In case of baseline imbalance, additional analysis with adjustment of variables that show imbalance at baseline will be performed. If the data will not normally distributed, the corresponding analyses methods, such as zero/one inflated beta (ZOIB) regression model, will be applied based on the data characteristics. The intention-to-treat principle will be adopted and all study subjects will be included in the analysis. Missing values at 3- and 6-month follow-up will be replaced by the last observed value and multiple imputation. Missing values at baseline will be replaced by values from 3-month or 6-month follow-up. If there will be no value obtained at any of the 3 time points, the participant will be excluded from the analysis. For other outcomes, the t test will be applied for continuous data and the chi-square test will be applied for categorical data. The analysis will be performed by using the R software (version 3.6.1; R Core Team). Each estimated effect will be accompanied by a 95% confidence interval and 5% level of significance. Questions will be downloaded from the inquiry system. Content analysis will be performed to categorise the collected responses. Data collection and management: The investigators and the research assistants of the research team are responsible for data collection and they will be permitted to access to source data and study record. Daily logs will be recorded by the research assistants to monitor the study progress including the number of respondents approached, interviews completed or refused and incomplete interviews. All data entered in the database will be verified and cleaned. After completion of data entry, computer logic checks will be run for consistency of related code. Necessary corrections will be made to the database. ### Conditions Module **Conditions:** - Safe Sex **Keywords:** - computer-assisted instruction/methods - safe sex - students - universities ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 781 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Interactive computer-based intervention **Intervention Names:** - Behavioral: Interactive computer-based intervention **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** An one-page online information about procedures and tips of condom use with minimal intervention **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** There are 4 components of the Interactive computer-based intervention(ICBI) which will be delivered in 3 phases: 1. Perceived Susceptibility and Perceived Severity 2. Perceived Benefits and Perceived Barriers 3. Cue to Action 4. Self-Efficacy In addition, a discussion forum will be created to handle questions from the participants. Also, there will be an email address for enquiries if the participants need any support or if they want to seek further enquiry/ clarification after reading the web-based information. **Name:** Interactive computer-based intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** It will be assessed by using percentage of male condom protected sex with every partner according to the recommended guidelines from the systematic review of 56 studies. Other behavioural items will also be asked, for examples, condom use at last sex and description of sexual partners (dating partner vs casual partner) at last sex. **Measure:** Change from consistency in condom use with every partner at 3 months **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention #### Secondary Outcomes **Description:** It will be assessed by 25-item MCAS which contains assessment on five subscales: reliability and effectiveness of condoms, sexual pleasure associated with condom use, stigma associated with people proposing or using condoms, embarrassment about negotiating and using of condoms, and embarrassment about purchasing condoms. The measurement can be used with participants who do and do not have personal experience with condoms. The items are answered by a 7-point Likert-scale and total scores are ranged from 7 to 175. The higher the score, the more positive is the knowledge, attitude, norms, and self-efficacy of condom use. **Measure:** Knowledge, attitude, norms and self-efficacy of condom use **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention **Description:** It will be assessed by 39-item SCS-R. It contains four attitudinal subscales (positive attitude towards establishing consent, lack of perceived behavioral control, relationship length norms, and (pro) assuming consent) and two behavioral subscales (indirect consent behaviors and awareness of consent). It is suitable for both participants who do and do not have personal experience with sexual consent. The items are answered by a 7-point Likert-scale and total scores are ranged from 39 to 273. The higher the score, the more positive is the attitude, norms, and perceived behavioural control of sexual consent. **Measure:** Knowledge, attitude, norms and self-efficacy of sexual coercion and sexual consent **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention **Description:** It will be measured by 7-item subscale from Revised Conflict Tactic Scale. The responses will be on a dichotomous scale for assessing sexual coercion. All items will be rated on a 7-point Likert scale indicating how often the behaviour occurred. The higher the score, the greater the frequency. **Measure:** Sexual coercion **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention **Description:** It will be assessed by 20-item SCSES. It contains five domains (contraceptive communication, positive sexual messages, negative sexual messages, sexual history, and condom negotiation). The items are answered by a 4-point Likert-scale and total scores are ranged from 20 to 80. The higher the score, the more the self-efficacy in sexual communication. **Measure:** Self-efficacy in sexual communication **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention **Description:** It will be evaluated by recording retention of the participants. **Measure:** Retention of the participant **Time Frame:** 6-month post intervention **Description:** It will be evaluated by recording the total time spent on the website. **Measure:** Engagement time of the participants **Time Frame:** 6-month post intervention **Description:** It will be evaluated by recording the adverse events of the intervention. **Measure:** Incidence of adverse events of the intervention **Time Frame:** 6-month post intervention **Description:** It will be evaluated by recording overall satisfaction of the intervention in a scale of 0-10 and overall perception of the intervention with a 5-Likert-scale. Also, participants will be asked whether they will recommend the intervention to friends and "yes" will be scored 1 point. The higher the score, the higher overall satisfaction of the intervention. **Measure:** Overall satisfaction of the intervention **Time Frame:** 6-month post intervention **Description:** It will be evaluated by recording the total pages of the website each participant visited. **Measure:** Total pages of the website each participant visited **Time Frame:** 6-month post intervention **Description:** It will be evaluated by recording each participant's performance on the interactive tasks. **Measure:** Percentage of performance on the interactive tasks **Time Frame:** 6-month post intervention **Description:** Participants will be asked whether they searched for more information about safe sex practice during the last three months. **Measure:** Incidence of searching more information about safe sex practice **Time Frame:** 3-month post intervention and 6-month post intervention **Description:** It includes items such as gender, age, year of study, and dating relationships status. Also, the participants will be asked for history of childhood sexual coercion. The item is extracted from Adverse Childhood Experiences questionnaire - "Did an adult or person at least 5 years older than you ever touch or fondle you or have you touch their body in a sexual way? Or attempt or actually have oral, anal, or vaginal intercourse with you?" Also, the information regarding individual risks on STIs and cervical cancer will be collected at baseline (including age, age at first sexual intercourse, number of sexual partners during one's lifetime, frequency of condom use, history of ever being diagnosed with an STI, smoking status, history of giving birth, and history of having pap smear test). **Measure:** Demographics **Time Frame:** Baseline, 3-month post intervention and 6-month post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female university students aged at least 18 years * Able to read Chinese or understand Cantonese * Unmarried * Having intimate partners in the past 12 months * Did not receive any sexual health information including formal face-to-face or online education/ training courses related to contraceptives and sexually transmitted diseases from university, hospitals, clinics and non-governmental organizations in the past 12 months Exclusion Criteria: * Unwilling to complete the questionnaires at 3 time points * Pregnant women and postnatal women * With psychiatric illness **Gender Based:** True **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** School of Nursing, LKS Faulty of Medicine, The University of Hong Kong **Zip:** 852 #### Overall Officials **Official 1:** **Affiliation:** The University of Hong Kong **Name:** Janet Yuen Ha Wong, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Wong JY, Zhang W, Wu Y, Choi EPH, Lo HHM, Wong W, Chio JHM, Tam HLC, Ngai FW, Tarrant M, Wang MP, Ngan HY, Fong DY. An Interactive Web-Based Sexual Health Literacy Program for Safe Sex Practice for Female Chinese University Students: Multicenter Randomized Controlled Trial. J Med Internet Res. 2021 Mar 12;23(3):e22564. doi: 10.2196/22564. **PMID:** 33709941 ## Document Section ### Large Document Module #### Large Docs - Date: 2016-12-30 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 251815 - Type Abbrev: ICF - Upload Date: 2018-09-20T00:47 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04599179 **Brief Title:** SEMS and Gastroenterostomy **Official Title:** Stage IV Gastric Cancer: Patient's Quality of Life (QoL) After Surgical or Endoscopic Palliative Treatment. #### Organization Study ID Info **ID:** 14102020 #### Organization **Class:** OTHER **Full Name:** University of Roma La Sapienza ### Status Module #### Completion Date **Date:** 2020-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-10-22 **Type:** ACTUAL **Last Update Submit Date:** 2020-10-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-01-01 **Type:** ACTUAL #### Start Date **Date:** 2010-01-01 **Type:** ACTUAL **Status Verified Date:** 2020-10 #### Study First Post Date **Date:** 2020-10-22 **Type:** ACTUAL **Study First Submit Date:** 2020-10-16 **Study First Submit QC Date:** 2020-10-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Roma La Sapienza #### Responsible Party **Investigator Affiliation:** University of Roma La Sapienza **Investigator Full Name:** ENRICO FIORI **Investigator Title:** Professor of Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** More than 20% of patients with gastric cancer have at presentation a stage IV disease. Advanced adenocarcinoma of the antro-pyloric region often determines a condition of gastric outlet obstruction syndrome (GOOS), which requires a rapid resolution for the severe consequences that will occur if the obstruction is not resolved. GOOS causes malnutrition, fluid and electrolyte imbalances that are difficult to control. Laparoscopic or open gastroenterostomy has been proposed as the treatment of choice in patients with advanced unresectable distal stomach tumor presenting with symptoms of GOOS. Noticeably, laparoscopic gastroenterostomy might be difficult to be performed in a hostile abdomen because of the involvement of the root of the mesentery, infiltration of the surrounding structures and peritoneal carcinosis. Furthermore, laparoscopic or open gastroenterostomy provides suboptimal palliation, because it is associated with postoperative complications ranging from 15% to 50% related to a delayed gastric emptying and a protract postoperative hospital stay. These results negatively affect the quality of life (QoL), and therefore, the efficacy of gastroenterostomy for palliation has been questioned. In 1997, Kaminishi et al. introduced a technique of stomach-partitioning gastrojejunostomy (SPGJ), which divides the lower part of the stomach and connects the jejunum to the proximal part of the stomach while maintaining a tunnel that is 2 to 3 cm in diameter along the lesser curvature. This technique theoretically provides some benefits: endoscopic evaluation of the tumor response to adjuvant chemotherapy and the possibility of repeated endoscopic local treatment on the tumor, prevention of ingested food retention in the distal part of the stomach thus facilitating gastric emptying and improving patient's QoL. A current alternative to laparoscopic or open surgical approach to an advanced gastric tumor is the positioning of a self-expandable metal stent (SEMS) which offers many potential advantages: the avoidance of general anaesthesia for a laparoscopic or open approach, a shorter hospital stay and a minor patient postoperative discomfort. We want to perform a prospective longitudinal cohort trial, comparing the QoL of patients affected with stage IV antropyloric stomach cancer and symptoms of GOOS who underwent endoscopic placement of a SEMS or after open SPGJ. ### Conditions Module **Conditions:** - Stage IV Gastric Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients underwent placement of a self-expandable metal stent (SEMS) **Intervention Names:** - Device: self-expandable metal stent **Label:** Group 1 #### Arm Group 2 **Description:** Patients underwent to stomach-partitioning gastrojejunostomy **Label:** Group 2 ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 **Description:** self-expandable metal stent endoscopic positioning **Name:** self-expandable metal stent **Other Names:** - stomach-partitioning gastrojejunostomy (SPGJ) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Quality of life (QoL) after endoscopic or surgical treatment **Time Frame:** 6-12 months ### Eligibility Module **Eligibility Criteria:** Inclusion criteria are age less than 85 years, pre-treatment histological diagnosis of gastric adenocarcinoma, computed tomographic (CT), adjuvant-neoadjuvant chemotherapy regimen, symptoms of GOOS (symptoms of GOOS include: regular, frequent feeling of bloating or fullness; feeling full after eating less food; nausea and vomiting of undigested food, especially right after eating, abdominal pain) lumen reduction ranging between 70% and 99% at gastroscopy. Criteria for exclusion are a white blood cells count less than 4,000/L, a platelet count less than 70,000/L, patients with renal failure (i.e. albumin to creatinine ratio \> 30 mg/mmol and estimated glomerular filtration rate \< 30-44 mL/min/1.73m2), patients with major alterations of liver function tests (i.e. total bilirubin \> 25.6 μmol/L, AST \> 5 U/L, ALT \>5 U/L, PT-INR \> 1.5). - **Maximum Age:** 85 Years **Minimum Age:** 30 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients presenting with stage IV antropyloric gastric cancer at our Institution are enrolled ### Contacts Locations Module #### Locations **Location 1:** **City:** Roma **Country:** Italy **Facility:** Sapienza University **State:** Lazio **Zip:** 00161 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05622279 **Acronym:** ANTILOPE **Brief Title:** Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance **Official Title:** Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance #### Organization Study ID Info **ID:** RC22_0153 #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-17 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-09 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2022-11-18 **Type:** ACTUAL **Study First Submit Date:** 2022-11-13 **Study First Submit QC Date:** 2022-11-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Regen Lab SA #### Lead Sponsor **Class:** OTHER **Name:** Nantes University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment \[Rompe, Sports Med Arthrosc Rev, 2009\]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis. **Detailed Description:** * Pre-inclusion visit (consultation for scheduling the procedure) After verification of the inclusion criteria, the investigating rheumatologist will inform the patient of the study and give him/her the information note. The patient will be offered a period of reflection before signing the consent form. As the procedure requires prior precautions, this will allow the patient to become aware of them. The patient will be given a prescription for a walking boot and a pair of walking sticks. * Inclusion visit (D0) After verification of all the inclusion and non-inclusion criteria, the following examinations will be performed during the inclusion visit before the procedure: * Signature of the consent by the patient and the investigator * Interrogatory including collection of concomitant treatments, evaluation of the walking perimeter, evaluation of sports activities * Clinical examination of the foot (Heel tenderness index) * Standard X-ray of the foot (if not performed at screening) * Plantar ultrasound = echogenicity of the plantar aponeurosis, measurement of thickness in mm, search for hypervascularization by Doppler * VAS pain during activity * FAAM self-questionnaire * Procedure in 3 steps: 1. Local anesthesia by tibial block 60 minutes before the tenotomy 2. Venous sampling of 10 ml and centrifugation for 5 minutes 3. Needle tenotomy and injection of 1 ml of PRP at the end of the procedure * Prescription of enoxaparin at a preventive dose for 7 days The tolerance of the procedure will be evaluated immediately after the procedure, using a VAS for pain. This will be collected by a nurse. We will also collect the acceptability of the procedure as well as the immediate complications (vagal discomfort, bleeding at the injection site). The patient will then be monitored for two hours (4 times) in order to verify the lifting of the sensory block and the pain during it. At the end of the consultation, the patient will receive a patient logbook to be completed at home in the 7 days following the procedure and at 14 days (collection of pain at the injection site and possible side effects) and a second logbook to be completed 6 weeks after the procedure. -First protocol follow-up at home: D7 The patient will have filled out a daily pain VAS and notified any side effects related to the procedure and the analgesic intake during the first week. A telephone contact will be made at this date by an investigating physician, or a mandated person, in order to ensure that the logbook has been filled out correctly and that there are no complications. The call will also remind the patient to return the questionnaire by mail (stamped and addressed envelope provided). - Second protocol follow-up at home: S6 +/- 3 days Six weeks after the procedure, the patient will complete the patient booklet given at D0 at home: * FAAM self-questionnaire * VAS pain during activity * Occurrence of complications * Gait perimeter * Third protocol follow-up: consultation at M3 +/- 7 days A follow-up consultation is performed 3 months after the procedure. This corresponds to the usual follow-up of the patient. During the consultation, the following examinations will be performed * Clinical examination (HTI) * Ultrasound of the foot * VAS pain during activity * Complications * FAAM self-questionnaire * Gait perimeter * Questions about returning to sport * Fourth protocol follow-up: consultation at M6 +/- 7 days (main objective) During the consultation, the following examinations will be performed * Clinical examination (HTI) * Ultrasound of the foot * VAS pain during activity * Complications * FAAM self-questionnaire * Gait perimeter * Questions about returning to sport ### Conditions Module **Conditions:** - Plantar Fascitis **Keywords:** - Plantar fasciitis, needle tenotomy, ultrasound, platelet rich plasma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The VAS pain data will be compared between before the procedure and 6 months after using a Wilcoxon ranks test for paired data. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 19 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There will be a single arm receiving the treatment being evaluated **Intervention Names:** - Procedure: Percutaneous tenotomy + PRP **Label:** percutaneous tenotomy + PRP **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - percutaneous tenotomy + PRP **Description:** The patients will receive a percutaneous ultrasound-guided treatment including a needle tenotomy followed by a PRP injection in the plantar fasciitis. **Name:** Percutaneous tenotomy + PRP **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** VAS pain at activity **Measure:** To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis. **Time Frame:** 6 months #### Secondary Outcomes **Description:** To evaluate the tolerance of the procedure, a VAS \[0 to 10\] will be filled in by the patient to evaluate the pain felt during the procedure. **Measure:** Evaluate the tolerance of the procedure **Time Frame:** 6 weeks, 3 months, 6 months **Description:** To assess the acceptability of the procedure, the following question will be asked: Would you be willing to repeat this procedure if necessary? **Measure:** Evaluate the acceptability of the procedure **Time Frame:** 6 weeks, 3 months, 6 months **Description:** To evaluate the effect on function, we will use two parameters: the FAAM self-questionnaire and the walking perimeter. The FAAM (Foot and Ankle Ability Measure) self-questionnaire will be completed by the patient before the procedure and then 6 weeks, 3 months and 6 months after the procedure. The score is composed of 21 items evaluating the discomfort in daily activities and 8 in sports activities. The walking perimeter (distance the patient can walk without stopping) will be evaluated at 6 weeks, 3 months and 6 months. It will be assessed by the following scale: Unlimited / More than 1 Km / From 500 to 1000m / From 100 to 500m / Less than 100m / Walking impossible. **Measure:** Evaluate the evolution of the functional discomfort **Time Frame:** 6 weeks, 3 months, 6 months **Description:** To evaluate the return to sport, the following 3 questions will be asked to the patient: Have you resumed your sport activity? If yes, how long after the infiltration? Was it possible to resume the activity at the same level as before? This will be collected at 3 and 6 months. **Measure:** Evaluate the return to sports activities **Time Frame:** 6 weeks, 3 months, 6 months **Description:** The HTI (physician-assessed Heel Tenderness Index) score will be assessed before the procedure and after 3 and 6 months. It is a score ranging from 0 to 3 (0 = no pain; 1 = pain; 2 = pain and grimace; 3 = pain, grimace, and foot removal). **Measure:** Evaluate the evolution of pain when pressing the insertion of the plantar fascia **Time Frame:** 6 weeks, 3 months, 6 months **Description:** Two items will be evaluated before the procedure and after 3 and 6 months: * Thickness of the superficial plantar fascia at the insertion * Doppler hypervascularization **Measure:** Evaluate the evolution of the ultrasound data **Time Frame:** 6 weeks, 3 months, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria : Patient with chronic inferior heel pain diagnosed as plantar fasciitis plantar fasciitis evolving for more than 3 months with a pain VAS at activity ≥ 4/10 * Failure of the initial management including physical therapy, adaptation of footwear and local steroid infiltration * Patient 18 years of age or older * Patient affiliated to a social security plan * Patient able to understand the protocol and having signed an informed informed consent Exclusion Criteria : * Patients on NSAIDs and refusing to discontinue them 1 week and 1 week after the procedure * Corticosteroid infusion at the same lesion site in the last 3 months * History of PRP injection at the same lesion site * Treatment with antiplatelet agents \[Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)\] * Coagulation disorders: thrombocytopenia \< 150,000 platelets/mm3 - Patients on curative anticoagulants * Any medical condition that may interfere with pain assessment * Current hematological disease or in remission for less than 5 years (hematological malignancies, myelodysplasia, autoimmune thrombocytopenia), chemotherapy * Infection at the time of inclusion (bacterial infection and/or presence of fever and/or antibiotic treatment) * Pregnant or breastfeeding women or those refusing effective contraception * Patient deprived of liberty or under legal protection (guardianship or curatorship) * Patients under court protection * Patients participating in another clinical research protocol involving a drug or medical device * Patients unable to follow the protocol, as determined by the investigator * Patient refusing to participate in the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** christelle.darrieutortlaffite@chu-nantes.fr **Name:** Christèlle Darrieutort Laffite, PH **Phone:** 02 40 08 48 25 **Role:** CONTACT #### Locations **Location 1:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Name:** Christelle Darrieutort Laffite, PH - **Role:** CONTACT ***Contact 2:*** - **Name:** Christelle Darrieutort Laffite, PH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de Nantes **Status:** RECRUITING **Zip:** 44000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M8351 - Name: Fasciitis - Relevance: HIGH - As Found: Fasciitis - ID: M24656 - Name: Fasciitis, Plantar - Relevance: HIGH - As Found: Plantar Fasciitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005208 - Term: Fasciitis - ID: D000036981 - Term: Fasciitis, Plantar ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00571779 **Acronym:** RESTORE SR IIB **Brief Title:** AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB **Official Title:** Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation #### Organization Study ID Info **ID:** CP2007-2 #### Organization **Class:** INDUSTRY **Full Name:** AtriCure, Inc. ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2011-02-21 **Type:** ESTIMATED **Last Update Submit Date:** 2011-02-18 **Overall Status:** WITHDRAWN **Status Verified Date:** 2011-02 #### Study First Post Date **Date:** 2007-12-12 **Type:** ESTIMATED **Study First Submit Date:** 2007-12-10 **Study First Submit QC Date:** 2007-12-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AtriCure, Inc. ### Description Module **Brief Summary:** Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF). ### Conditions Module **Conditions:** - Atrial Fibrillation ### Design Module **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** AtriCure Bipolar System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions. **Measure:** The primary safety endpoint will be determined by assessing the rate of serious adverse events. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient between 18 and 80 years of age 2. Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs. * Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically. * Longstanding AF: Persistent AF of 12 months (or longer) duration. * Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted. 3. Patient is willing and able to provide written informed consent. 4. Patient has a life expectancy of at least 2 years. 5. Patient is willing and able to attend the scheduled follow-up visits. Exclusion Criteria: 1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months. 2. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications 3. Myocardial infarction within 8 weeks. 4. Prior cardiac surgery. 5. Patient requires cardiac surgery for treatment other than for AF. 6. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF 7. Cerebrovascular accident within previous 6 months 8. Known carotid artery stenosis greater than 80% 9. Evidence of significant active infection 10. Patient unable to undergo TEE 11. Pregnant woman 12. Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia 13. Presence of thrombus in the left atrium 14. Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery 15. Patient is enrolled in another cardiac clinical trial 16. Left ventricular ejection fraction \< 30% 17. Left atrial transverse diameter \>6.0 18. Patient has undergone previous thoracic targeted radiation **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module #### Removed Countries - Country: United States - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03538379 **Acronym:** TRIAGE **Brief Title:** Tourniquet Training Effectiveness Study **Official Title:** Evaluation of Hemorrhage Control and Tourniquet Training Effectiveness for Laypersons #### Organization Study ID Info **ID:** 2018P000536 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2018-07-15 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ENROLLING_BY_INVITATION #### Last Update Post Date **Date:** 2018-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2018-05-24 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2018-04-04 **Type:** ACTUAL **Status Verified Date:** 2018-05 #### Study First Post Date **Date:** 2018-05-29 **Type:** ACTUAL **Study First Submit Date:** 2018-04-09 **Study First Submit QC Date:** 2018-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** The Gillian Reny Stepping Strong Center for Trauma Innovation #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Eric Goralnick **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Trauma is the leading cause of death for individuals ages 1-45 years old, within this cohort, and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on the battlefield and there is level 4 evidence that EMS application of tourniquets in the civilian sector is effective though not to the same degree as in the military.3,4 Multiple national groups have advocated that to further decrease preventable deaths from hemorrhage, laypersons should apply tourniquets before the arrival of professional first responders. To this aim, the "Stop the Bleed" campaign has trained over 100,000 individuals in the US in hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con) course.5 The "Stop the Bleed" campaign informs course participants all commercial tourniquets are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is not available.6 The investigators are evaluating the ability of the B-Con course participants to apply three different types of commercial tourniquets, the Rapid Application tourniquet (RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well as participants ability to fashion an improvised tourniquet. The investigators hypothesize B-Con in its current form does not enable course participants to apply other commercial tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to apply an improvised tourniquet. **Detailed Description:** Hemorrhage control by rapid application of commercial tourniquets has significantly improved the survival of military personnel injured on the battlefield.7,8 The U.S. civilian population has seen a spike in battlefield like injuries in the recent years, a prime example being the Boston Marathon bombing.9,10 To address this issue, the American College of Surgeons (ACS) formed a committee comprised of individuals from the fields of healthcare, law-enforcement, fire department, pre-hospital care and the military. This committee came up with a set of recommendation regarding first response and capacity building for hemorrhage control, known as the Harford Consensus.11 These recommendations include educational programs for lay-people in hemorrhage control with an emphasis on rapid and early tourniquet application. There is level 4 evidence that after adjustment for covariates, emergency medical providers' application of tourniquets in civilian trauma decreases mortality, though not to the same dramatic degree seen in the military setting.12-14 Researchers are working to show the effect of training of laypersons in hemorrhage control in the real world but no data beyond the simulation setting is currently presented in the literature.15 Various groups have developed training programs for hemorrhage control training, the most notable of which is the ACS "Stop the Bleed" Bleeding Control Basic (B-Con) training.16 B-Con has trained over 100,000 individuals in the US since its implementation.5 Goralnick et. al. have shown that there is moderate retention for the retention of B-Con specifically for application of the Combat Application Tourniquet (CAT), which is also the type of tourniquet with the best evidence for its use as it is the type used by the US military.17 However, the Hartford consensus and the "Stop the Bleed" campaign state that "(1) commercial windlass-type tourniquets should be used in the prehospital setting for the control of significant extremity hemorrhage when direct pressure is ineffective or impractical, (2) improvised tourniquets should be used only if no commercial device is available."5,18 This advocacy for types of commercial tourniquets beyond the CAT and, more significantly, for improvised tourniquets has not been studied in either a simulated or real setting. There are multiple different tourniquet types available for which, while the principle is the same for all, the actual mechanism and steps for application vary. B-Con in its current iteration informs participants the principle is the same for both other commercial tourniquets and improvised tourniquets, which is to be tight enough to occlude arterial bleeding. Other courses which have been widely disseminated have taught how to use tourniquets other than the CAT, such as the Stretch-Wrap-And-Tuck tourniquet (SWAT-T).19 Currently, the courses being offered typically only teach how to use one, and sometimes two, different types of tourniquets. Furthermore, as there is not broad consensus statement about which tourniquet type to use and teach, different groups distribute different types of tourniquets in publicly available bleeding control kits, and professional first responders carry different types of commercial tourniquets. A randomized trial has shown that among some of the available commercial tourniquets, the CAT, ratcheting medical tourniquet (RMT), and SWAT-T, the proportion of application for those without training ranges from 10.6-23.4%. The B-Con course presumption that participants understand tourniquet principles rather than a single technique, which would enable them to apply devices they have not seen before, has not been evaluated. In this context, the investigators would evaluate participants, immediately after completing the full B-Con course, on their ability to apply different commercial tourniquets than what they were trained on and their ability to apply a commercial tourniquet. 1. Study design: a) Prospective open-label trial 2. Consent: a) Verbal consent 3. Protocol: 1. All participants will receive the ACS stop the Bleed training from qualified instructors. This training is 45 to 60 minutes long, consisting of an audio-visual presentation with tourniquet application instructions followed by hands-on training under the supervision of an instructor. The training takes place in groups of 20 to 50 at a time. The audio-visual part of the training takes place in groups of 20, which are then divided in to subgroups of 4-8 for hands-on training with an instructor. There is no compensation for the study participants. 2. The evaluation of hemorrhage control competence will take place individually. A mannequin, the Hapmed tourniquet trainer, with a traumatic amputation of the leg just above the knee will be present. A reviewer will provide instructions, including that the lights on the leg represent continued bleeding and they will have a maximum of 2 minutes to apply the tourniquet. The participant will be provided a tourniquet and told to stop the simulated bleeding. Participants will be tested in all 5 types of tourniquets sequentially using the same method but with the order of testing varying according to the randomization. The reviewer will start timing after telling the participant to begin. This will then be repeated for the other type of tourniquet the individual will need to apply. No feedback will be given to the participant throughout the testing process. i) Supplies for the improvised tourniquet will include a T-shirt, long stretch of gauze, a stick to act as a windlass, and a leather belt c) Parameters measured: i) The participants will be timed until they feel that they have stopped the bleeding or they tell the instructor they are done. The maximum amount of time provided to apply the tourniquet will be 2 minutes based on the results of the investigators prior studies in which the 90th percentile for time to correct application was 117 seconds. ii) Appropriateness of hemorrhage control will be determined by correct placements of tourniquet as defined by at least 2 inches proximal to the amputation site iii) Adequate pressure to stop the bleeding which will be set at 250 mmHg. For unsuccessful hemorrhage control, the reason for failure will be recorded. iv) Correct tourniquet application defined by: (1) Time to application \< 120 seconds (2) Placement of tourniquet a minimum of 2 inches proximal to amputation (3) Tourniquet application pressure \> 250 mmHg d) All the reviewers would be physicians, nurses and EMTs, trained in hemorrhage-control. The complete test for each individual will not take more than 15 mins. 4. Randomization for the order of tourniquet application: a) Permutated block randomization will be used to vary the order for application of the 5 different types of tourniquets (CAT, RAT, SWAT-T, Sof-T, and improvised tourniquet) 5. Pre-trial questionnaire: a) Study subjects will be given a pre-trial questionnaire to gather information regarding age, gender, and level of education. The questionnaire will also include questions to assess their knowledge regarding hemorrhage control and to determine their willingness and self-reported comfort level in acting as a first-responder in a mass causality scenario. Answers will be presented on a Likert-type scale or dichotomous yes-no. 6. Post-trial questionnaire: a) After the hemorrhage control training, all participants will be given a questionnaire to evaluate comfort level, self-efficacy, and other questions relating to hemorrhage control response. 7. Sample size calculation: 1. Sample Size calculation was done for paired comparisons with 80% power and Bonferroni corrected for 4 pairwise comparisons for an alpha level of 0.0125 and correlation of 0.1. The largest difference was then taken as the sample size for each arm. 2. The expected corrected proportions for the different tourniquets are: 1. CAT: 80-90% (Control) 2. RAT: 10-30% 3. SWAT-T: 10-30% 4. Sof-T: 20-40% 5. Improvised: \< 10% ii) The smallest presumed difference in correct application for the CAT (control) at 80% is to the Sof-T at 40%. To attain 80% power with alpha of 0.0125 the required minimum sample size is 34. 3. All sample size calculations performed using Stata v14.1. 8. Statistical Analysis: 1. Paired statistical tests using McNemars test will be used for the univariate analysis of the primary outcome of correct tourniquet application comparing the CAT tourniquet as a control (CAT being type of tourniquet taught in the B-Con course) to each of the other tourniquet types (RAT, SWAT-T, Sof-T, Improvised) for 4 total pairwise comparisons. 2. Descriptive statistical analysis (ANOVA, Kruskal-wallis, Mann Whitney U test, Student T-test) will be used to assess the secondary outcomes of time to tourniquet application, estimated blood loss prior to tourniquet application, and pressure applied by the tourniquet. 3. Multiple Logistic regression will be used to assess for predictors of correct tourniquet application for each of the different tourniquet types. The model will include age, gender, education level, any prior hemorrhage control training, and success in application for each of the other tourniquet types. 4. Descriptive statistics will also be used to assess participants responses on the questionnaires. Non-parametric statistical tests (Wilcoxon signed rank test and generalized estimating equations) will be used to assess 5-point Likert scale questions. 5. P-value for significance will be set at 0.05 after Bonferroni correction. ### Conditions Module **Conditions:** - Trauma Injury - Hemorrhage **Keywords:** - Tourniquets - Bleeding Control Basic (B-Con) Course - Layperson training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Individuals will complete the bleeding control basic (B-Con) course followed by evaluation of individuals ability to apply each of 5 different types of tourniquets. Each individual is evaluated for all 5 types of tourniquets. The order of testing for tourniquets for each individual is randomized. ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The combat application tourniquet (CAT) is the type of commercial tourniquet taught in the B-Con course as administered by the investigators. It will serve as the control group to which all other types of tourniquets, which are not explicitly taught in the course, are compared to. **Intervention Names:** - Behavioral: Bleeding Control Basic (B-Con) Course **Label:** Combat Application Tourniquet (CAT) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The Sof-Tourniquet (Sof-T) is a commercial windlass type tourniquet similar to the CAT tourniquet in that it is based on a windlass mechanism. Its application not explicitly taught in the B-Con course. **Intervention Names:** - Behavioral: Bleeding Control Basic (B-Con) Course **Label:** Sof Tourniquet (Sof-T) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** The Stretch-Wrap-And-Tuck (SWAT) Tourniquet is a commercial elastic tourniquet. Its application not explicitly taught in the B-Con course. **Intervention Names:** - Behavioral: Bleeding Control Basic (B-Con) Course **Label:** Stretch-Wrap-And-Tuck (SWAT) Tourniquet **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** The Rapid Application Tourniquet (RAT) is a commercial elastic tourniquet similar to a bungee cord. Its application not explicitly taught in the B-Con course. **Intervention Names:** - Behavioral: Bleeding Control Basic (B-Con) Course **Label:** Rapid Application Tourniquet (RAT) **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Description:** The improvised tourniquet arm will involve participants being given supplies to enable them to fashion a tourniquet. The supplies will include a leather belt, gauze, shoestring, and a rod to act as a windlass. **Intervention Names:** - Behavioral: Bleeding Control Basic (B-Con) Course **Label:** Improvised Tourniquet **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combat Application Tourniquet (CAT) - Improvised Tourniquet - Rapid Application Tourniquet (RAT) - Sof Tourniquet (Sof-T) - Stretch-Wrap-And-Tuck (SWAT) Tourniquet **Description:** The American College of Surgeons Bleeding Control Basic Course will be provided to participants. This course consists of a 30-minute lecture followed by 30-minutes of hands-on training in hemorrhage control technique application. It teaches how to apply manual pressure and how to apply a Combat Application Tourniquet (CAT). The course will not vary from its typical administration for this study. **Name:** Bleeding Control Basic (B-Con) Course **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Correct tourniquet application for each type of tourniquet tested. Correct application for all arms / types of tourniquets is defined as application pressure \> 250 mmHg, distance above injury of \> 2 inches, and time to application \< 2 minutes. **Measure:** Correct Tourniquet Application **Time Frame:** Within 30 minutes of completing training #### Secondary Outcomes **Description:** Estimate of amount of blood loss prior to tourniquet application in milliliters. **Measure:** Total Blood loss **Time Frame:** Within 30 minutes of completing training **Description:** Time to correct tourniquet application or participant stopping in seconds. **Measure:** Time to Tourniquet Application **Time Frame:** Within 30 minutes of completing training **Description:** Amount of pressure applied by the tourniquet measured in mmHg **Measure:** Pressure Applied by Tourniquet **Time Frame:** Within 30 minutes of completing training **Description:** Demographics (age, gender, education level, prior training) associated with correct tourniquet application as defined as application pressure \> 250 mmHg, distance above injury of \> 2 inches, and time to application \< 2 minutes. **Measure:** Demographic Predictors of Correct Tourniquet Application **Time Frame:** Within 30 minutes of completing training **Description:** Questions regarding willingness to assist in an emergency with responses reported on 5-point Likert Scale. 1 corresponds to very unwilling to assist and 5 corresponds to very willing to assist. **Measure:** Willingness-to-assist in Emergency **Time Frame:** immediately before training and within 30 minutes of completing training **Description:** Questions regarding comfort level controlling hemorrhage with responses reported on 5-point Likert Scale. 1 corresponds to very uncomfortable and 5 corresponds to very comfortable controlling hemorrhage. **Measure:** Comfort level Controlling Hemorrhage **Time Frame:** immediately before training and within 30 minutes of completing training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participation in the Bleeding Control Basic Course Exclusion Criteria: * None **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Brigham and Women's Hospital **State:** Massachusetts **Zip:** 02115 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rhee P, Joseph B, Pandit V, Aziz H, Vercruysse G, Kulvatunyou N, Friese RS. Increasing trauma deaths in the United States. Ann Surg. 2014 Jul;260(1):13-21. doi: 10.1097/SLA.0000000000000600. **PMID:** 24651132 **Citation:** Kwon AM, Garbett NC, Kloecker GH. Pooled preventable death rates in trauma patients : Meta analysis and systematic review since 1990. Eur J Trauma Emerg Surg. 2014 Jun;40(3):279-85. doi: 10.1007/s00068-013-0364-5. Epub 2014 Jan 29. **PMID:** 26816061 **Citation:** Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Survival with emergency tourniquet use to stop bleeding in major limb trauma. Ann Surg. 2009 Jan;249(1):1-7. doi: 10.1097/SLA.0b013e31818842ba. **PMID:** 19106667 **Citation:** Kauvar DS, Dubick MA, Walters TJ, Kragh JF Jr. Systematic review of prehospital tourniquet use in civilian limb trauma. J Trauma Acute Care Surg. 2018 May;84(5):819-825. doi: 10.1097/TA.0000000000001826. **PMID:** 29432381 **Citation:** Joint Committee to Create a National Policy to Enhance Survivability from Mass Casualty Shooting Events; Jacobs LM, Eastman A, Mcswain N, Butler FK, Rotondo M, Sinclair J, Wade DS, Fabbri WR. Improving Survival from Active Shooter Events: The Hartford Consensus. Bull Am Coll Surg. 2015 Sep;100(1 Suppl):32-4. No abstract available. **PMID:** 26477133 **Citation:** Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum In: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S]. **PMID:** 23192066 **Citation:** Kotwal RS, Montgomery HR, Kotwal BM, Champion HR, Butler FK Jr, Mabry RL, Cain JS, Blackbourne LH, Mechler KK, Holcomb JB. Eliminating preventable death on the battlefield. Arch Surg. 2011 Dec;146(12):1350-8. doi: 10.1001/archsurg.2011.213. Epub 2011 Aug 15. **PMID:** 21844425 **Citation:** Biddinger PD, Baggish A, Harrington L, d'Hemecourt P, Hooley J, Jones J, Kue R, Troyanos C, Dyer KS. Be prepared--the Boston Marathon and mass-casualty events. N Engl J Med. 2013 May 23;368(21):1958-60. doi: 10.1056/NEJMp1305480. Epub 2013 May 1. No abstract available. **PMID:** 23635020 **Citation:** Teixeira PGR, Brown CVR, Emigh B, Long M, Foreman M, Eastridge B, Gale S, Truitt MS, Dissanaike S, Duane T, Holcomb J, Eastman A, Regner J; Texas Tourniquet Study Group. Civilian Prehospital Tourniquet Use Is Associated with Improved Survival in Patients with Peripheral Vascular Injury. J Am Coll Surg. 2018 May;226(5):769-776.e1. doi: 10.1016/j.jamcollsurg.2018.01.047. Epub 2018 Mar 29. **PMID:** 29605726 **Citation:** Scerbo MH, Holcomb JB, Taub E, Gates K, Love JD, Wade CE, Cotton BA. The trauma center is too late: Major limb trauma without a pre-hospital tourniquet has increased death from hemorrhagic shock. J Trauma Acute Care Surg. 2017 Dec;83(6):1165-1172. doi: 10.1097/TA.0000000000001666. **PMID:** 29190257 **Citation:** Scerbo MH, Mumm JP, Gates K, Love JD, Wade CE, Holcomb JB, Cotton BA. Safety and Appropriateness of Tourniquets in 105 Civilians. Prehosp Emerg Care. 2016 Nov-Dec;20(6):712-722. doi: 10.1080/10903127.2016.1182606. Epub 2016 May 31. **PMID:** 27245978 **Citation:** Beaucreux C, Vivien B, Miles E, Ausset S, Pasquier P. Application of tourniquet in civilian trauma: Systematic review of the literature. Anaesth Crit Care Pain Med. 2018 Dec;37(6):597-606. doi: 10.1016/j.accpm.2017.11.017. Epub 2018 Jan 5. **PMID:** 29309952 **Citation:** Butler FK Jr, Holcomb JB, Giebner SD, McSwain NE, Bagian J. Tactical combat casualty care 2007: evolving concepts and battlefield experience. Mil Med. 2007 Nov;172(11 Suppl):1-19. doi: 10.7205/milmed.172.supplement_1.1. **PMID:** 18154234 **Citation:** Jacobs LM, Burns KJ, Langer G, Kiewiet de Jonge C. The Hartford Consensus: A National Survey of the Public Regarding Bleeding Control. J Am Coll Surg. 2016 May;222(5):948-55. doi: 10.1016/j.jamcollsurg.2016.02.013. Epub 2016 Mar 31. No abstract available. **PMID:** 27113518 **Citation:** Sidwell RA, Spilman SK, Huntsman RS, Pelaez CA. Efficient Hemorrhage Control Skills Training for Healthcare Employees. J Am Coll Surg. 2018 Feb;226(2):160-164. doi: 10.1016/j.jamcollsurg.2017.11.003. Epub 2017 Nov 16. **PMID:** 29155270 **Citation:** McCarty JC, Hashmi ZG, Herrera-Escobar JP, de Jager E, Chaudhary MA, Lipsitz SR, Jarman M, Caterson EJ, Goralnick E. Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial. JAMA Surg. 2019 Oct 1;154(10):923-929. doi: 10.1001/jamasurg.2019.2275. **PMID:** 31339533 ## Document Section ### Large Document Module #### Large Docs - Date: 2018-04-03 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 146614 - Type Abbrev: Prot_SAP - Upload Date: 2018-04-12T14:41 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2019-01-14 - Date Unknown: Unknown #### Event: RESET - Date: 2019-04-09 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006470 - Term: Hemorrhage ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2019-01-14 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2019-01-14 - Reset Date: 2019-04-09 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00004479 **Brief Title:** Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope #### Organization Study ID Info **ID:** 199/14181 #### Organization **Class:** NIH **Full Name:** Office of Rare Diseases (ORD) #### Secondary ID Infos **ID:** MTS-GCO-97-160NE **ID:** ROBERTS-MTS-GCO-97-160NE ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2005-06-24 **Type:** ESTIMATED **Last Update Submit Date:** 2005-06-23 **Overall Status:** COMPLETED #### Start Date **Date:** 1999-03 **Status Verified Date:** 2004-07 #### Study First Post Date **Date:** 1999-10-19 **Type:** ESTIMATED **Study First Submit Date:** 1999-10-18 **Study First Submit QC Date:** 1999-10-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Icahn School of Medicine at Mount Sinai ### Description Module **Brief Summary:** OBJECTIVES: Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope. **Detailed Description:** PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study. On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug. ### Conditions Module **Conditions:** - Syncope **Keywords:** - neurologic and psychiatric disorders - rare disease - syncope ### Design Module #### Design Info **Allocation:** RANDOMIZED ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** midodrine **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** Mount Sinai School of Medicine **State:** New York **Zip:** 10029 #### Overall Officials **Official 1:** **Affiliation:** Icahn School of Medicine at Mount Sinai **Name:** Horacio Kaufmann **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014474 - Term: Unconsciousness - ID: D000003244 - Term: Consciousness Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M85 - Name: Problem Behavior - Relevance: LOW - As Found: Unknown - ID: M24518 - Name: Rare Diseases - Relevance: LOW - As Found: Unknown - ID: M16353 - Name: Syncope - Relevance: HIGH - As Found: Syncope - ID: M21417 - Name: Syncope, Vasovagal - Relevance: LOW - As Found: Unknown - ID: M17224 - Name: Unconsciousness - Relevance: LOW - As Found: Unknown - ID: M6468 - Name: Consciousness Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013575 - Term: Syncope ### Intervention Browse Module - Ancestors - ID: D000013566 - Term: Sympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000058646 - Term: Adrenergic alpha-1 Receptor Agonists - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11850 - Name: Midodrine - Relevance: HIGH - As Found: Treatment program - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008879 - Term: Midodrine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02837679 **Brief Title:** Oncogeriatric Intervention and Follow-up at Home **Official Title:** Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly #### Organization Study ID Info **ID:** Onkogeriatri randomiseret #### Organization **Class:** OTHER **Full Name:** University of Aarhus ### Status Module #### Completion Date **Date:** 2023-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2020-04-29 **Type:** ACTUAL **Last Update Submit Date:** 2020-04-28 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-09 **Type:** ACTUAL #### Start Date **Date:** 2016-01 **Type:** ACTUAL **Status Verified Date:** 2020-04 #### Study First Post Date **Date:** 2016-07-19 **Type:** ESTIMATED **Study First Submit Date:** 2016-06-27 **Study First Submit QC Date:** 2016-07-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Danish Cancer Society #### Lead Sponsor **Class:** OTHER **Name:** Aarhus University Hospital #### Responsible Party **Investigator Affiliation:** Aarhus University Hospital **Investigator Full Name:** Marianne Ørum **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner. The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,. If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses. **Detailed Description:** Cancer of the head and neck (HNC), lung (LC), upper gastrointestinal channel (CUGI) and colo-rectal cancer (CRC) accounts for approximately 40% of cancer incidence in elderly people (defined as ≥70 years) in Denmark (DK). The four cancers account for more than 50% of the annual cancer-related deaths in DK. Incidence and mortality of cancer increases with age. Comorbidity (simultaneous presence of several medical conditions) are more present in older cancer patients than in younger This means that older cancer patients are more vulnerable by physiological, psychological and social means than younger. Older cancer patients frequent develop side effects of cancer treatment than younger cancer patients. Comprehensive Geriatric Assessment (CGA), is a comprehensive investigation and assessment of various aspects of a person's health, carried out by a multidisciplinary team in order to identify, quantify problems and follow up on the identified problems. CGA comprises collecting information on comorbidity, polypharmacy, physical, psychological and cognitive problems, nutritional status and social support. Problems in these areas implies a worse prognosis in terms of survival, response to treatment and side effects of cancer treatment . CGA have shown to be able to identify novel health problems in about half of elderly patients with cancer. It has previously been shown that the focused palliative care of patients with lung cancer with a focus on optimization of medication and follow up on unresolved problems increases the quality of life, eases depressive symptoms and increases survival. CGA is shown to be an effective base for intervention in order to increase the survival of the elderly in general (with no known cancer), in order to increase the physical and cognitive status, and to reduce the need for changes in housing facilities. Geriatric intervention based on CGA called Comprehensive Geriatric Care (CGC). Frailty is a condition that occurs as a result of declining physiological reserve, causing vulnerability to health stressors. One way of defining frailty is based on CGA, where patients are divided into "frail" "vulnerable/pre-frail" and "fit" by performing CGA : Frail: patients who meet one or more of the following: dependence in Activities of Daily Living (ADL), severe comorbidity, cognitive dysfunction, depression, malnutrition, or more than 7 different fixed daily preparations on time for CGA, (multivitamin not included). Fit patients: independent in ADL and Instrumental Activities of Daily Living (IADL), no or minimal comorbidity, Cognitively intact and no nutritional problems. Vulnerable / pre-frail patients: Neither Fit nor frail. Frailty is a potentially reversible mode. It is known that elderly patients may develop frailty during cancer treatment. From a previously conducted study of 217 elderly patients with HNC, LC, and CRC CUGI, we know that a large part of the patients are frail (52%) or vulnerable (35%). Only 13% are fit . But we do not know the effect of providing geriatric follow-up to this population with regards to complications of cancer treatment, including the ability to be able accomplish cancer treatment as planned and the possibility of reducing hospital stay. A study carried out on patients discharged from the Emergency Department or Geriatric wards, have shown that it is possible to reduce the admission time by offering CGA related to admission and add follow-up with the CGC compared to only providing CGA for patients in the hospital. In the study, hospitalization was reduced by 55% It has not previously been shown if CGA in an outpatient setting and subsequent Geriatric follow up on the problems identified can reduce hospitalization time and increase the proportion who accomplish cancer treatment per protocol in older cancer patients until 1 status examination compared to patients who only get CGA in the outpatient setting, but do not get geriatric follow-up afterwards. It's oncology practice at first outpatient attendance to define what type of cancer a patient must have, this includes both the type of treatment, the aim of treatment (neoadjuvant, adjuvant, curative or palliative (life-prolonging / palliative)), dose of treatment and duration of treatment before status examination. Intervention CGC is an intervention that is tailored to the individual patient based on the problem areas identified by CGA and the problems that occur within 90 days of enrollment. It can include home visits, visits to Aarhus University Hospital (AUH) in outpatient settings, scheduled and on demand and telephone contact. Patients will be followed for 90 days of enrollment or until reference to specialized palliative care treatment or death. The geriatric intervention may consist of liquid treatment, blood transfusion, oral or intravenous antibiotic administration, oxygen therapy, pain management, social intervention, nutritional intervention and lifeline telephone number The geriatric intervention will be different from patient to patient. There may be many or few contacts of various kinds. During the 90 days the number and nature of contacts (telephone / attendance / home visits) will be recorded as the interventions that are performed will be registered (medication changes, social work, nutrition efforts and efforts to optimize Physical functioning) Contact between the oncogeriatric team and the patient can be taken at the initiative of oncogeriatric team, patient or relatives. The oncogeriatric team can initiate treatment or refer to another department, if necessary. Controls For the control group, the result and the recommendations of the CGA, which has been given to patients regarding. for example medication changes, social intervention (eg. adaptation of home care), physical optimization for example. training and nutrition recommendations will be summarized for the patient and with the patient's acceptance sent to the practitioner. Otherwise, no follow-upis performed in the period by oncogeriatric team. After 3 months, the intervention group and control Group are tested by CGA and quality of life questionnaires in order to compare with baseline results and comparing the control group with the intervention group. Blinding It is not possible to blind subjects to randomization. Likewise, it is not possible to blind the geriatric team in charge of the follow-up for the result of the randomization. The person that test subjects after 3 months is blinded to the randomization. Oncologists do not get information about randomization. ### Conditions Module **Conditions:** - Neoplasms - Geriatric Assessment - Lung Neoplasms - Colorectal Neoplasms - Head and Neck Neoplasms - Gastrointestinal Neoplasms - Geriatrics - Polypharmacy - Quality of Life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Geriatric follow up **Intervention Names:** - Other: Geriatric Follow up **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Usual care **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Name:** Geriatric Follow up **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** time to death within 1 year from geriatric contact **Measure:** 1-year mortality **Time Frame:** Within 1 year from first geriatric contact **Description:** time to death within 3 years from geriatric contact **Measure:** 3-year mortality **Time Frame:** Within 3 year from first geriatric contact **Description:** time to death within 5 years from geriatric contact **Measure:** 5-year mortality **Time Frame:** Within 5 year from first geriatric contact **Description:** Costs used per patient at the hospital, in home care, by the GP and the pharmacy within 90 days after Comprehensive Geriatric Assessment **Measure:** Health costs per patient **Time Frame:** Outcome measure will be assessed from time of first geriatric contact and 90 days on (0-90 days) #### Primary Outcomes **Description:** Oncological specialist evaluates if treatment is completed as planned or if eventual deviations are of minor or major character **Measure:** Success rate of admittance to initial planned oncological treatment **Time Frame:** An average of 12 weeks **Description:** Participants with a Mini-Mental State Examination (MMSE)-score of 25 and above are tested using European Organisation of Research and Treatment of Cancer (EORTC) Core Questionnaire (C30) in combination with Elderly questionnaire (ELD14). **Measure:** Change in Quality of life (QoL) **Time Frame:** 90 days **Description:** Participants with a Mini-Mental State Examination (MMSE)-score below 25 are tested using "Depression List" **Measure:** Change in Quality of life **Time Frame:** 90 days #### Secondary Outcomes **Description:** Are patients still alive 90 days after geriatric contact? **Measure:** 90-day survival **Time Frame:** Within 90 days from first geriatric contact **Description:** Physical performance is measured using chair-stand-test **Measure:** Physical performance, chair-stand-test **Time Frame:** Changes in physical performance from first geriatric contact to 90 days after **Description:** Physical performance is measured using Barthel-100 **Measure:** Physical performance, Barthel-100 **Time Frame:** Changes in physical performance from first geriatric contact to 90 days after **Description:** Physical performance is measured using Functional Activities Questionnaire (FAQ)-IADL **Measure:** Physical performance, FAQ-IADL **Time Frame:** Changes in physical performance from first geriatric contact to 90 days after **Description:** Sum of hospital bed days in study period **Measure:** Length of hospital stay **Time Frame:** Within 90 days from first geriatric contact ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 70 years or older with cancer of the head and neck, upper gastro intestinal cancer, colo-rectal cancer or Lung cancer, refered to Aarhus University Hospital for evaluation regarding oncological treatment on the Oncology Department at Aarhus University * Living in following municipalities: Odder (excl. of the island of Thunø), Faurskov, Skanderborg og Aarhus * frail or vulnerable by CGA * Signed informed consent. For incapacitated patients: informed consent by relatives Exclusion Criteria: * evaluated 'fit´ by CGA * Referred to specialized palliative care at time of first visit at the Oncology department * Do not wish to participate **Minimum Age:** 70 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aarhus **Country:** Denmark **Facility:** Aarhus University Hospital **Zip:** 8000 #### Overall Officials **Official 1:** **Affiliation:** Aarhus University Hospital **Name:** Marianne Ørum, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Neoplasms - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Neoplasms - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Neoplasms - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Neoplasms - ID: M7256 - Name: Digestive System Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Neoplasms - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00261079 **Brief Title:** Fexofenadine in Pruritic Skin Disease **Official Title:** The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease #### Organization Study ID Info **ID:** M016455_4125 #### Organization **Class:** INDUSTRY **Full Name:** Handok Inc. ### Status Module #### Completion Date **Date:** 2006-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2007-11-07 **Type:** ESTIMATED **Last Update Submit Date:** 2007-11-05 **Overall Status:** COMPLETED #### Start Date **Date:** 2005-04 **Status Verified Date:** 2007-11 #### Study First Post Date **Date:** 2005-12-02 **Type:** ESTIMATED **Study First Submit Date:** 2005-12-01 **Study First Submit QC Date:** 2005-12-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Handok Inc. ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Primary objective: * To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: * To evaluate patient's satisfaction of Allegra treatment ### Conditions Module **Conditions:** - Pruritus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 435 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Fexofenadine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The change of physician's assessment on pruritic score before and after 7-day treatment. #### Secondary Outcomes **Measure:** Patient visual analogue scale change and Overall satisfaction. ### Eligibility Module **Eligibility Criteria:** The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: Inclusion Criteria: * All patients diagnosed with atopic dermatitis, contact dermatitis Exclusion Criteria: * Other skin disease except atopic dermatitis, contact dermatitis. * Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day. * Pruritus localized only head and face * Subjects with severe hepatic, renal, heart dysfunction. * Subjects with history of alcohol and drug abuse. * Pregnant and lactating women. **Maximum Age:** 70 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Handok #### Overall Officials **Official 1:** **Affiliation:** Handok Inc. **Name:** Hyou-Young Rhim, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012877 - Term: Skin Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15674 - Name: Skin Diseases - Relevance: HIGH - As Found: Skin Diseases - ID: M14396 - Name: Pruritus - Relevance: HIGH - As Found: Pruritus - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011537 - Term: Pruritus - ID: D000012871 - Term: Skin Diseases ### Intervention Browse Module - Ancestors - ID: D000018926 - Term: Anti-Allergic Agents - ID: D000039563 - Term: Histamine H1 Antagonists, Non-Sedating - ID: D000006634 - Term: Histamine H1 Antagonists - ID: D000006633 - Term: Histamine Antagonists - ID: D000018494 - Term: Histamine Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M252074 - Name: Fexofenadine - Relevance: HIGH - As Found: Allogeneic Stem Cell Transplantation - ID: M20962 - Name: Anti-Allergic Agents - Relevance: LOW - As Found: Unknown - ID: M9710 - Name: Histamine H1 Antagonists - Relevance: LOW - As Found: Unknown - ID: M9708 - Name: Histamine - Relevance: LOW - As Found: Unknown - ID: M212144 - Name: Histamine phosphate - Relevance: LOW - As Found: Unknown - ID: M24826 - Name: Histamine H1 Antagonists, Non-Sedating - Relevance: LOW - As Found: Unknown - ID: M9709 - Name: Histamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000093230 - Term: Fexofenadine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00849979 **Brief Title:** Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy **Official Title:** M.D. Anderson Symptom Inventory (MDASI-GI) Validation and Clinical Utility in Patients With Gastrointestinal Cancers Being Treated or Followed by GI Medical Oncology #### Organization Study ID Info **ID:** 2007-0228 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center ### Status Module #### Completion Date **Date:** 2010-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-07-30 **Type:** ESTIMATED **Last Update Submit Date:** 2012-07-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-01 **Type:** ACTUAL #### Start Date **Date:** 2008-07 **Status Verified Date:** 2012-07 #### Study First Post Date **Date:** 2009-02-24 **Type:** ESTIMATED **Study First Submit Date:** 2009-02-23 **Study First Submit QC Date:** 2009-02-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to learn more about the symptoms that may occur in patients with GI cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas, colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire. **Detailed Description:** Questionnaires: If you agree to take part in this study, you will be asked to complete the MDASI-GI questionnaire on Day 1. It asks about any symptoms you may be experiencing, and how those symptoms may be interfering with your daily life. You will also complete two questionnaires that ask about the overall quality of your life. In total, these questionnaires should take about 20 minutes to complete. You will then complete a questionnaire that asks for demographic information such as your age and marital status. It should take about 5 minutes. You will receive another copy of the MDAS-GI questionnaire and the quality-of-life questionnaire to take home and complete 1 week later. The research staff will call you to remind you when it is time to complete this questionnaires. You should mail it back to the study staff in a stamped, pre-addressed envelope that will be provided to you. Evaluation of Questionnaires: Also on Day 1, a small group of participants (25 out of the 185 total participants) will complete an additional questionnaire called a "cognitive debriefing" questionnaire. These 25 participants will be the first 5 participants to join this study who have 1 of the 5 types of cancer being studied. The questionnaire asks questions related to how easy it was for you to answer the questions on the MDASI-GI questionnaire, whether the questions relate to the symptoms you may be experiencing, and whether any other questions should be added. This questionnaire should take about 10 minutes to complete. Interview: Another small group of participants (a different 25 out of the 185 total) will have a one-on-one interview with a member of the study staff. During the interview, you will be asked to further describe the symptoms you may have experienced. This interview will be scheduled for a day when you are going to be at M. D. Anderson for a routine clinic visit. It should take about 30 minutes to complete. You and the interviewer will be the only ones in the room during the interview, and the information collected will be kept confidential. The interview will be tape-recorded. Questionnaire and Interview Content: Your responses will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked about, please contact your doctor. Information Collection: As part of this research study, the research staff will collect information from your medical record one time. This will include data about the cancer, cancer treatment, and routine test results. Length of Study Participation: After you mail back the questionnaire at Week 1 (or complete it by phone interview with research staff), or after the interview if you have one, your active participation in this study will be over. This is an investigational study. Up to 185 patients will take part in this study. All will be enrolled at M. D. Anderson. ### Conditions Module **Conditions:** - Gastrointestinal Cancer **Keywords:** - Colorectal - Gastric - Gastrointestinal - GI - Liver - Pancreas - Gastrointestinal Cancers - Gastro-Intestinal Chemotherapy - M.D. Anderson Symptom Inventory - MDASI-GI - Medical Oncology ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 184 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Questionnaire **Label:** Questionnaire **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Behavioral: Questionnaire - Other: Interview **Label:** Questionnaire + Interview **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Questionnaire - Questionnaire + Interview **Description:** Day 1 MDASI-GI Questionnaire **Name:** Questionnaire **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Questionnaire + Interview **Description:** Open-ended, audiotaped interviews **Name:** Interview **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response) **Time Frame:** 2 Years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients must be out-patients being reviewed or treated in M. D. Anderson's Department of GI Medical Oncology. * Patients will have received a confirmed pathological diagnosis of GI cancer (gastric cancer, liver cancer, pancreatic cancer, colorectal cancer). * Patients will or will not be undergoing chemotherapy or treatment with other agents on the day of enrollment. * Patients must be \> or = 18 years of age. * Patients must be able to speak and read English. Exclusion Criteria: * Patients who, in research staff's estimation, cannot understand the intent of the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** UT MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** UT MD Anderson Cancer Center **Name:** Xin Shelley Wang, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center website **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Cancer - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005770 - Term: Gastrointestinal Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M22554 - Name: Pancrelipase - Relevance: LOW - As Found: Unknown - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02170779 **Brief Title:** Developing and Testing a Comprehensive MS Spasticity Management Program **Official Title:** Developing and Testing a Comprehensive MS Spasticity Management Program #### Organization Study ID Info **ID:** N1401-P #### Organization **Class:** FED **Full Name:** VA Office of Research and Development ### Status Module #### Completion Date **Date:** 2016-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-03-28 **Type:** ACTUAL **Last Update Submit Date:** 2017-02-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-03-28 **Type:** ACTUAL **Results First Submit Date:** 2016-12-12 **Results First Submit QC Date:** 2017-02-07 #### Start Date **Date:** 2015-10 **Status Verified Date:** 2017-02 #### Study First Post Date **Date:** 2014-06-23 **Type:** ESTIMATED **Study First Submit Date:** 2014-06-09 **Study First Submit QC Date:** 2014-06-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Oregon Health and Science University #### Lead Sponsor **Class:** FED **Name:** VA Office of Research and Development #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial. **Detailed Description:** Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation. ### Conditions Module **Conditions:** - Multiple Sclerosis - Spasticity **Keywords:** - multiple sclerosis - spasticity - stretching - exercise - rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **Intervention Names:** - Behavioral: Spasticity: Take Control **Label:** A Spasticity: Take Control **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures **Intervention Names:** - Other: Usual care **Label:** B Usual care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - A Spasticity: Take Control **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **Name:** Spasticity: Take Control **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - B Usual care **Description:** 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **Name:** Usual care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability. **Measure:** MS Walking Scale-12 (MSWS-12) **Time Frame:** at average of 4 months #### Secondary Outcomes **Description:** The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects. The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet. **Measure:** Timed 25 Foot Walk **Time Frame:** at average of 4 months **Description:** The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair. The best score of the two attempts was analyzed. **Measure:** Timed up and go Test **Time Frame:** at average of 4 months **Description:** The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured. **Measure:** 2 Minute Walk Test **Time Frame:** at average of 4 months **Description:** This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue. **Measure:** Modified Fatigue Impact Scale (MFIS) **Time Frame:** at average of 4 months **Description:** The MSIS-29 is designed to measure the physical and psychological impact of MS. Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact. **Measure:** Multiple Sclerosis Impact Scale (MSIS-29) **Time Frame:** at average of 4 months **Description:** The modified Ashworth Scale is a standard clinical and research method to quantify spasticity. Each of the 6 leg groups is given a scale of 0-4. 0 - Normal. No increase in muscle tone. 1. - Mild. Barely increased muscle tone. (catch) 2. - Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance) 3. - Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop) 4. - Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24. **Measure:** Spasticity Measured by the Modified Ashworth Scale **Time Frame:** at average of 4 months **Description:** The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity. The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352. **Measure:** Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) **Time Frame:** at average of 4 months **Description:** The BDI-II is a standardized self-report questionnaire to quantify depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63. **Measure:** Beck Depression Inventory II (BDI II) **Time Frame:** at average of 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosis of definite MS * At least 18 years old * Able to walk 25 feet independently with common assistive devices if needed * Presence of spasticity by self-report interfering with usual daily activities * Have an email account and be familiar with using it * Willing to track daily exercise for 4 weeks * Fluent in English Exclusion Criteria: Other medical or behavioral conditions that would limit participation or completion of the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Portland **Country:** United States **Facility:** VA Portland Health Care System, Portland, OR **State:** Oregon **Zip:** 97239 #### Overall Officials **Official 1:** **Affiliation:** VA Portland Health Care System, Portland, OR **Name:** Lucinda L Hugos, MS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009122 - Term: Muscle Hypertonia - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12085 - Name: Muscle Spasticity - Relevance: HIGH - As Found: Spasticity - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12079 - Name: Muscle Hypertonia - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009128 - Term: Muscle Spasticity - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** A Spasticity: Take Control **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** EG000 **Other Num Affected:** 1 **Other Num at Risk:** 19 **Serious Number At Risk:** 19 **Title:** A Spasticity: Take Control **Group ID:** EG001 **Title:** B Usual Care **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** EG001 **Other Num Affected:** 5 **Other Num at Risk:** 19 **Serious Number At Risk:** 19 **Title:** B Usual Care **Frequency Threshold:** 0 #### Other Events **Term:** Concussion **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Leg spasms **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** UTI **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Broken arm resulting from fall **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** **Term:** Pain and bruising from fall **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** **Term:** Increase in urinary urgency **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Time Frame:** 2 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 20 **Group ID:** BG001 **Value:** 20 **Group ID:** BG002 **Value:** 40 **Units:** Participants ### Group **ID:** BG000 **Title:** A Spasticity: Take Control **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures ### Group **ID:** BG001 **Title:** B Usual Care **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 18 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 36 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 12.79 **Value:** 53.38 #### Measurement **Group ID:** BG001 **Spread:** 12.34 **Value:** 52.83 #### Measurement **Group ID:** BG002 **Spread:** 12.56 **Value:** 53.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 13 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 29 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 40 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** hugosc@ohsu.edu **Organization:** VA Research and Development **Phone:** 503-220-8262 **Phone Extension:** 52338 **Title:** Cinda Hugos, Physical Therapist ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.84 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.738 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.8434 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.638 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.492 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 6 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** This analysis refers to the physical component of the MSIS-29 **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.144 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** This refers to the psychological analysis for the MSIS-29. **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.953 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 7 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.915 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 8 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.023 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ### Outcome Measure 9 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.11 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Wilcoxon (Mann-Whitney) **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 27.3 - **Upper Limit:** - **Value:** 72.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 30.8 - **Upper Limit:** - **Value:** 82.2 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7 - **Upper Limit:** - **Value:** 7.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 10.4 - **Upper Limit:** - **Value:** 9.4 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.69 - **Upper Limit:** - **Value:** 11.23 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 13.51 - **Upper Limit:** - **Value:** 13.82 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 150.5 - **Upper Limit:** - **Value:** 462.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 158.7 - **Upper Limit:** - **Value:** 412.5 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 19.2 - **Upper Limit:** - **Value:** 41.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 20.8 - **Upper Limit:** - **Value:** 43.5 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17.2 - **Upper Limit:** - **Value:** 45.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 19.2 - **Upper Limit:** - **Value:** 52.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.6 - **Upper Limit:** - **Value:** 18.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 7.6 - **Upper Limit:** - **Value:** 20.6 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.5 - **Upper Limit:** - **Value:** 10.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 9.3 - **Upper Limit:** - **Value:** 10.8 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 53.3 - **Upper Limit:** - **Value:** 165.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 58.8 - **Upper Limit:** - **Value:** 192.4 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.5 - **Upper Limit:** - **Value:** 9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 8 - **Upper Limit:** - **Value:** 11.5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** MS Walking Scale-12 (MSWS-12) **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 2 **Description:** The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects. The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** One subject was unable to complete this physical assessment at the visit. **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Timed 25 Foot Walk **Type:** SECONDARY **Unit of Measure:** seconds ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 3 **Description:** The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair. The best score of the two attempts was analyzed. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** One subject was unable to complete this physical assessment at the visit. **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Timed up and go Test **Type:** SECONDARY **Unit of Measure:** seconds ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 4 **Description:** The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** One subject was unable to complete this physical assessment at the visit. **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** 2 Minute Walk Test **Type:** SECONDARY **Unit of Measure:** feet ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 5 **Description:** This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Modified Fatigue Impact Scale (MFIS) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 6 **Description:** The MSIS-29 is designed to measure the physical and psychological impact of MS. Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Multiple Sclerosis Impact Scale (MSIS-29) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 7 **Description:** The modified Ashworth Scale is a standard clinical and research method to quantify spasticity. Each of the 6 leg groups is given a scale of 0-4. 0 - Normal. No increase in muscle tone. 1. - Mild. Barely increased muscle tone. (catch) 2. - Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance) 3. - Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop) 4. - Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Spasticity Measured by the Modified Ashworth Scale **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 8 **Description:** The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity. The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care #### Outcome Measure 9 **Description:** The BDI-II is a standardized self-report questionnaire to quantify depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** at average of 4 months **Title:** Beck Depression Inventory II (BDI II) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** OG000 **Title:** A Spasticity: Take Control ##### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** OG001 **Title:** B Usual Care ### Participant Flow Module #### Group **Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures **ID:** FG000 **Title:** A Spasticity: Take Control #### Group **Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures **ID:** FG001 **Title:** B Usual Care #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 20 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 20 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 19 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 19 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 **Has Results:** True