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METHODS Patients ( n = 451 ) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double-blind trial . |
METHODS The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods . |
METHODS Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries . |
RESULTS Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing ( P < 0.0025 ) . |
RESULTS Maintenance rates were 87 % and 82 % for the 60 and 90 mg doses , respectively , vs. 26 % for placebo ( life table ) , and 66 % and 65 % vs. 14 % , respectively ( crude rate ) . |
RESULTS Both doses were superior to placebo for the percentage of 24-h heartburn-free days ( 60 mg , 96 % ; 90 mg , 94 % ; placebo , 19 % ) and nights ( 98 % , 97 % , and 50 % , respectively ) . |
RESULTS Diarrhoea , flatulence , gastritis ( symptoms ) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo , but were not dose-related . |
CONCLUSIONS Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo , and was well tolerated . |
###16087986 |
BACKGROUND The pathophysiology of anemia in coastal East Africa is complex . |
BACKGROUND Impaired erythropoietin production is one possible mechanism . |
BACKGROUND Plasmodium falciparum malaria has been found to blunt erythropoietin production , whereas vitamin A stimulates erythropoietin production in vitro . |
OBJECTIVE We investigated the 72-h effects of vitamin A and the antimalarial drug sulfadoxine pyramethamine ( SP ) on erythropoietin production in severely anemic ( hemoglobin < or = 70 g/L ) preschool children in Zanzibar , a region of known vitamin A deficiency . |
OBJECTIVE We hypothesized that both treatments would stimulate erythropoietin production directly , within 72 h , before a change in hemoglobin would occur . |
METHODS One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity substudy of a community-based micronutrient supplementation trial . |
METHODS All severely anemic children were randomly assigned to receive either vitamin A ( 100,000 or 200,000 IU depending on age ) or SP at baseline ; 72 h later they received the opposite treatment plus daily hematinic syrup for 90 d. Erythropoietic and parasitic indicators were assessed at baseline and again after 72 h. |
RESULTS After 72 h , SP reduced the malaria parasite density ( by 5029 parasites/microL ; P < 0.001 ) , CRP concentrations ( by 10.6 mg/L ; P = 0.001 ) , and the proportion of children infected with malaria ( by 32.4 % ; P < 0.001 ) . |
RESULTS Vitamin A reduced CRP ( by 9.6 mg/L ; P = 0.011 ) , serum ferritin ( by 18.1 microg/L ; P = 0.042 ) , and erythropoietin ( by 194.7 mIU/mL ; P = 0.011 ) concentrations and increased the reticulocyte production index ( by 0.40 ; P = 0.041 ) . |
CONCLUSIONS Contrary to our hypothesis , vitamin A significantly decreased erythropoietin concentration . |
CONCLUSIONS The most important effect of both vitamin A and SP was the rapid reduction of inflammation . |
CONCLUSIONS Vitamin A also mobilized iron from stores and stimulated the production of new erythrocytes . |
###10805853 |
BACKGROUND An external straightener for colonoscopy which enables proper compression of the abdomen during the entire examination has been developed . |
METHODS Beginning January 1 , 1997 , patients undergoing outpatient colonoscopy were subjected to either manual abdominal compression or compression with an external straightener . |
METHODS Two hundred patients were divided into two groups of 100 patients each : group A ( colonoscopy using traditional methods ; 38 men , 62 women , mean age 59.6 years , range 18 to 80 ) and group B ( colonoscopy with the help of the external straightener ; 40 men , 60 women , mean age 59.8 years , range 16 to 75 ) . |
METHODS Fifteen minutes after the examination , each patient completed a form that assessed the degree of pain during the procedure ( no pain , mild , moderate , severe ) . |
RESULTS The ileocecal valve was reached in 89 cases in group A and 94 cases in group B. |
RESULTS The average time required to reach the valve was 9.34 + / -4 minutes ( range 4 to 25 ) in group A and 6.97 + / -3.37 minutes ( range 2 to 21 ) in group B ( p < 0.001 ) . |
RESULTS With regard to the degree of pain , the results for groups A and B were , respectively : no pain = 25 % and 40 % , mild = 29 % and 34 % , moderate = 30 % and 20 % , severe = 16 % and 6 % ( p < 0.001 ) . |
CONCLUSIONS The external straightener reduced examination time and decreased the degree of patient pain compared with traditional methods . |
###15791113 |
BACKGROUND Intravenous acetaminophen injection ( paracetamol ) is marketed in Europe for the management of acute pain . |
BACKGROUND A repeated-dose , randomized , double-blind , placebo-controlled , three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug ( propacetamol ) and placebo . |
BACKGROUND Propacetamol has been available in many European countries for more than 20 yr . |
METHODS After orthopedic surgery , patients reporting moderate to severe pain received either 1 g intravenous acetaminophen , 2 g propacetamol , or placebo at 6-h intervals over 24 h. Patients were allowed `` rescue '' intravenous patient-controlled analgesia morphine . |
METHODS Pain intensity , pain relief , and morphine use were measured at selected intervals . |
METHODS Safety was monitored through adverse event reporting , clinical examination , and laboratory testing . |
RESULTS One hundred fifty-one patients ( intravenous acetaminophen : 49 ; propacetamol : 50 ; placebo : 52 ) received at least one dose of study medication . |
RESULTS The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h ( P < 0.05 ) and median time to morphine rescue ( intravenous acetaminophen : 3 h ; propacetamol : 2.6 h ; placebo : 0.8 h ) . |
RESULTS Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period : The total morphine doses received over 24 h were 38.3 + / - 35.1 mg for intravenous acetaminophen , 40.8 + / - 30.2 mg for propacetamol , and 57.4 + / - 52.3 mg for placebo , corresponding to decreases of -33 % ( 19 mg ) and -29 % ( 17 mg ) for intravenous acetaminophen and propacetamol , respectively . |
RESULTS Drug-related adverse events were reported in 8.2 % , 50 % ( most of them local ) , and 17.3 % of patients treated with intravenous acetaminophen , propacetamol , and placebo , respectively . |
CONCLUSIONS Intravenous acetaminophen , 1 g , administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated . |
###10569171 |
OBJECTIVE To assess whether heat trapped under ophthalmic drapes is responsible for patient reports of being hot during cataract surgery using local anesthesia . |
METHODS Departments of Anaesthesia and Intensive Care Medicine and of Ophthalmology and Optometry , Innsbruck University Hospital , Innsbruck , Austria . |
METHODS In a prospective , randomized , single-blind study , the temperature in the ambient air under 2 types of paper drapes ( Group A : Barrier Ophthalmology Drape , Johnson & Johnson ; Group B : Steri Drape 1062 , 3M ) and a plastic drape ( Group C : cotton drape + Steri Drape 1024 , 3M ) was measured for 25 minutes in 60 patients having cataract surgery under local anesthesia . |
RESULTS Three minutes after the patient 's head was draped , the mean temperature under the drape began to increase significantly : Group A , 25.7 degrees C + / - 0.3 degree C ( SD ) to 29.17 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group B , 25.87 degrees C + / - 0.4 degree C to 29.41 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group C , 25.8 degrees C + / - 0.35 degree C to 29.4 degrees C + / - 0.6 degree C ( P < or = .001 ) . |
RESULTS It continued to increase in all groups as the operation continued . |
RESULTS No significant differences in temperature were observed among the 3 drape types studied . |
RESULTS Subjective thermal discomfort was reported by 35 % to 40 % of patients . |
CONCLUSIONS Paper drapes did not cause less heat from being trapped than the plastic drape . |
CONCLUSIONS Trapped heat may impair the comfort of patients having eye surgery under local anesthesia . |
###21664867 |
BACKGROUND Combining targeted treatments for renal cell carcinoma has been suggested as a possible method to improve treatment efficacy . |
BACKGROUND We aimed to assess the potential synergistic or additive effect of the combination of bevacizumab , directed against the VEGF receptor , and temsirolimus , an mTOR inhibitor , in metastatic renal cell carcinoma . |
METHODS TORAVA was an open-label , multicentre randomised phase 2 study undertaken in 24 centres in France . |
METHODS Patients aged 18 years or older who had untreated metastatic renal cell carcinoma were randomly assigned ( 2:1:1 ) to receive the combination of bevacizumab ( 10 mg/kg every 2 weeks ) and temsirolimus ( 25 mg weekly ; group A ) , or one of the standard treatments : sunitinib ( 50 mg/day for 4 weeks followed by 2 weeks off ; group B ) , or the combination of interferon alfa ( 9 mIU three times per week ) and bevacizumab ( 10 mg/kg every 2 weeks ; group C ) . |
METHODS Randomisation was done centrally and independently from other study procedures with computer-generated permuted blocks of four and eight patients stratified by participating centre and Eastern Cooperative Oncology Group performance status . |
METHODS The primary endpoint was progression-free survival ( PFS ) at 48 weeks ( four follow-up CT scans ) , which was expected to be above 50 % in group A. Analysis was by intention to treat . |
METHODS The study is ongoing for long-term overall survival . |
METHODS This study is registered with ClinicalTrials.gov , number NCT00619268 . |
RESULTS Between March 3 , 2008 and May 6 , 2009 , 171 patients were randomly assigned : 88 to the experimental group ( group A ) , 42 to group B , and 41 to group C. PFS at 48 weeks was 29.5 % ( 26 of 88 patients , 95 % CI 20.0-39 .1 ) in group A , 35.7 % ( 15 of 42 , 21.2-50 .2 ) in group B , and 61.0 % ( 25 of 41 , 46.0-75 .9 ) in group C. Median PFS was 8.2 months ( 95 % CI 7.0-9 .6 ) in group A , 8.2 months ( 5.5-11 .7 ) in group B , and 16.8 months ( 6.0-26 .0 ) in group C. 45 ( 51 % ) of 88 patients in group A stopped treatment for reasons other than progression compared with five ( 12 % ) of 42 in group B and 15 ( 38 % ) of 40 in group C. Grade 3 or worse adverse events were reported in 68 ( 77 % ) of 88 patients in group A versus 25 ( 60 % ) of 42 in group B and 28 ( 70 % ) of 40 in group C. Serious adverse events were reported in 39 ( 44 % ) of 88 , 13 ( 31 % ) of 42 , and 18 ( 45 % ) of 40 patients in groups A , B , and C , respectively . |
CONCLUSIONS The toxicity of the temsirolimus and bevacizumab combination was much higher than anticipated and limited treatment continuation over time . |
CONCLUSIONS Clinical activity was low compared with the benefit expected from sequential use of each targeted therapy . |
CONCLUSIONS This combination can not be recommended for first-line treatment in patients with metastatic renal cell carcinoma . |
BACKGROUND French Ministry of Health and Wyeth Pharmaceuticals . |
###18622878 |
BACKGROUND Wound pain is a serious problem for people with chronic wounds . |
BACKGROUND The aim of this real-life study was to compare the effect of a foam dressing that releases ibuprofen ( Biatain Ibu ) with local best practice on the treatment of painful exuding wounds . |
METHODS A total of 185 patients with painful exuding wounds were randomized to either ibuprofen foam treatment ( n = 98 ) or local best practice ( n = 87 ) . |
METHODS The primary endpoint was pain relief over 7 days of treatment , assessed daily using a 5-point verbal rating scale ( no relief , slight relief , moderate relief , lots of relief , and complete relief ) . |
METHODS Secondary endpoints included a total reduction in pain intensity for the whole study period ( using an 11-point Numeric Box Scale : 0 = no pain to 10 = worst possible pain ) and incidence of adverse events ( AEs ) . |
RESULTS More patients in the ibuprofen foam treatment group reported wound pain relief and lower wound pain intensity values after 7 days ( p < 0.0001 for both variables ) . |
RESULTS Within the four most common ulcer aetiolgies , patients reported significantly more effective pain relief with ibuprofen foam treatment ( venous : p = 0.009 , mixed arterial venous : p < 0.0001 , arterial : p = 0.0009 , and vasculitis : p = 0.009 ) . |
RESULTS In all groups , patients from the ibuprofen foam group reported lower pain intensities . |
RESULTS The results were significant for patients with venous ( p < 0.002 ) and arterial ( p < 0.0001 ) leg ulcers . |
RESULTS Two AEs were reported . |
CONCLUSIONS The ibuprofen foam represents an effective and safe alternative to local best practice in the management of painful exuding wounds . |
###1676251 |
OBJECTIVE To determine if a 6-month course of therapy with IMREG-1 , a leukocyte-derived immunomodulator , slows disease progression in patients with AIDS-related complex . |
METHODS Randomized , double-blind trial . |
METHODS Five academic - and three community-based clinics . |
METHODS Immunocompromised patients ( 143 ) with HIV . |
METHODS IMREG-1 or placebo every 2 weeks ( 13 doses ) . |
RESULTS Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events ( AIDS-defining opportunistic infection or neoplasm , wasting syndrome , HIV-associated encephalopathy , or peripheral sensory neuropathy ) . |
RESULTS Based on an intention-to-treat analysis , Kaplan-Meier event probabilities were 26 % for the placebo group and 6 % for the IMREG-1 group ( P less than 0.001 ) ; based on the Cox proportional hazards model , the relative risk for patients on placebo compared with patients on IMREG-1 was 5.1 ( 95 % CI , 1.8 to 14.8 ) . |
RESULTS The frequency of symptoms significantly increased from baseline in patients receiving placebo . |
RESULTS The mean decrease in CD4 + cells from baseline was 80 x 10 ( 6 ) cells/L in the placebo group and 29 x 10 ( 6 ) cells/L in patients on IMREG-1 , with 20 % ( 8 ) and 38 % ( 32 ) of patients , respectively , showing a trend toward an increase ( P = 0.04 ) . |
RESULTS In patients receiving IMREG-1 , the size and rate of delayed hypersensitivity responses were larger than in the placebo group . |
CONCLUSIONS Patients with AIDS-related complex experienced fewer adverse events and constitutional symptoms after IMREG-1 treatment . |
CONCLUSIONS The slower loss of CD4 + cells and increased size and rate of delayed hypersensitivity responses most likely reflect the effect of IMREG-1 on the immune system . |
CONCLUSIONS No toxicity related to IMREG-1 administration was observed . |