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[ { "id": "NCT01313676_exc_text", "type": "exclusion", "text": [ "Pregnancy: Women who are pregnant or lactating. \nAsthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD). \nalpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD. \nOther respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. \nLung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant. \nA moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable). \nCurrent severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD). \nOther diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study. \nEnd stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal). \nDrug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded. \nDrug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years. \nOxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary. \nQuestionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures. \nAffiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. \nAdditional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified): \nMedication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day Any other investigational drug 30 days or 5 half lives whichever is longer. \n \n" ], "offsets": [ [ 0, 3742 ] ] } ]

[ { "id": "NCT01313676_exc_T2", "type": "Condition", "text": [ "Asthma" ], "offsets": [ [ 49, 55 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T3", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T4", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 73, 80 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T5", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 119, 124 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T7", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 136, 142 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T8", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 197, 201 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T9", "type": "Condition", "text": [ "alpha 1-antitrypsin deficiency" ], "offsets": [ [ 205, 235 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T10", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 315, 319 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T11", "type": "Condition", "text": [ "alpha-1 antitrypsin deficiency" ], "offsets": [ [ 257, 287 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T12", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 372, 384 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T13", "type": "Condition", "text": [ "Other respiratory disorders" ], "offsets": [ [ 322, 349 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T15", "type": "Condition", "text": [ "lung cancer" ], "offsets": [ [ 386, 397 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T16", "type": "Condition", "text": [ "bronchiectasis" ], "offsets": [ [ 399, 413 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T17", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 415, 426 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T18", "type": "Condition", "text": [ "pulmonary fibrosis" ], "offsets": [ [ 428, 446 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T19", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 448, 470 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T20", "type": "Condition", "text": [ "interstitial lung diseases" ], "offsets": [ [ 472, 498 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T21", "type": "Condition", "text": [ "active pulmonary diseases" ], "offsets": [ [ 508, 533 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T22", "type": "Scope", "text": [ "tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases" ], "offsets": [ [ 372, 533 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T23", "type": "Procedure", "text": [ "Lung resection" ], "offsets": [ [ 536, 550 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T24", "type": "Procedure", "text": [ "transplantation" ], "offsets": [ [ 554, 569 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T25", "type": "Procedure", "text": [ "lung volume reduction surgery" ], "offsets": [ [ 585, 614 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T26", "type": "Temporal", "text": [ "within the 12 months prior to Screening" ], "offsets": [ [ 615, 654 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T27", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 645, 654 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T28", "type": "Procedure", "text": [ "lung transplant" ], "offsets": [ [ 671, 686 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T29", "type": "Condition", "text": [ "having had a lung transplant" ], "offsets": [ [ 658, 686 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T30", "type": "Condition", "text": [ "with lung volume reduction surgery" ], "offsets": [ [ 580, 614 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T31", "type": "Scope", "text": [ "with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant" ], "offsets": [ [ 580, 686 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T32", "type": "Scope", "text": [ "Lung resection or transplantation" ], "offsets": [ [ 536, 569 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T33", "type": "Condition", "text": [ "COPD exacerbation" ], "offsets": [ [ 707, 724 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T34", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 691, 699 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T35", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 700, 706 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T36", "type": "Scope", "text": [ "moderate/severe" ], "offsets": [ [ 691, 706 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T38", "type": "Temporal", "text": [ "at least 14 days prior to Visit 1" ], "offsets": [ [ 747, 780 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T37", "type": "Observation", "text": [ "resolved" ], "offsets": [ [ 738, 746 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T39", "type": "Negation", "text": [ "not" ], "offsets": [ [ 734, 737 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T40", "type": "Temporal", "text": [ "at least 30 days following the last dose of oral corticosteroids" ], "offsets": [ [ 785, 849 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T41", "type": "Reference_point", "text": [ "the last dose of oral corticosteroids" ], "offsets": [ [ 812, 849 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T42", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 883, 896 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T43", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 876, 882 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T44", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 898, 924 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T45", "type": "Value", "text": [ "class IV" ], "offsets": [ [ 925, 933 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T46", "type": "Measurement", "text": [ "ejection fraction" ], "offsets": [ [ 988, 1005 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T47", "type": "Value", "text": [ "<30%" ], "offsets": [ [ 1009, 1013 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T48", "type": "Device", "text": [ "implantable cardioverter defibrillator (ICD)" ], "offsets": [ [ 1033, 1077 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T49", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 1146, 1161 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T50", "type": "Value", "text": [ "<3 years" ], "offsets": [ [ 1162, 1170 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T51", "type": "Condition", "text": [ "life-threatening condition" ], "offsets": [ [ 1114, 1140 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T52", "type": "Condition", "text": [ "vascular disease" ], "offsets": [ [ 1183, 1199 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T53", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 1203, 1207 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T55", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1172, 1182 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T56", "type": "Scope", "text": [ "vascular disease or COPD" ], "offsets": [ [ 1183, 1207 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T57", "type": "Condition", "text": [ "End stage chronic renal disease" ], "offsets": [ [ 1268, 1299 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T58", "type": "Procedure", "text": [ "renal replacement therapy" ], "offsets": [ [ 1333, 1358 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T59", "type": "Procedure", "text": [ "hemodialysis" ], "offsets": [ [ 1360, 1372 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T60", "type": "Qualifier", "text": [ "peritoneal" ], "offsets": [ [ 1376, 1386 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T61", "type": "Scope", "text": [ "hemodialysis or peritoneal" ], "offsets": [ [ 1360, 1386 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T62", "type": "Condition", "text": [ "Drug", "allergy" ], "offsets": [ [ 1390, 1394 ], [ 1400, 1407 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T63", "type": "Condition", "text": [ "food allergy" ], "offsets": [ [ 1395, 1407 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T64", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1436, 1452 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T65", "type": "Drug", "text": [ "beta-agonists" ], "offsets": [ [ 1491, 1504 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T66", "type": "Drug", "text": [ "corticosteroid" ], "offsets": [ [ 1506, 1520 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T67", "type": "Drug", "text": [ "study medications" ], "offsets": [ [ 1467, 1484 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T69", "type": "Scope", "text": [ "beta-agonists, corticosteroid" ], "offsets": [ [ 1491, 1520 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T70", "type": "Drug", "text": [ "components of the inhalation powder" ], "offsets": [ [ 1525, 1560 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T71", "type": "Drug", "text": [ "lactose" ], "offsets": [ [ 1567, 1574 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T72", "type": "Drug", "text": [ "magnesium stearate" ], "offsets": [ [ 1576, 1594 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T73", "type": "Scope", "text": [ "lactose, magnesium stearate" ], "offsets": [ [ 1567, 1594 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T74", "type": "Scope", "text": [ "study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate)" ], "offsets": [ [ 1467, 1595 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T75", "type": "Condition", "text": [ "milk protein allergy" ], "offsets": [ [ 1644, 1664 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T76", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1637, 1643 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T77", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1626, 1633 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T79", "type": "Drug", "text": [ "alcohol abuse" ], "offsets": [ [ 1783, 1796 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T80", "type": "Drug", "text": [ "Drug", "abuse" ], "offsets": [ [ 1778, 1782 ], [ 1791, 1796 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T81", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1833, 1840 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T82", "type": "Drug", "text": [ "drug abuse" ], "offsets": [ [ 1855, 1865 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T83", "type": "Drug", "text": [ "alcohol", "abuse" ], "offsets": [ [ 1844, 1851 ], [ 1860, 1865 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T84", "type": "Temporal", "text": [ "within the last 2 years" ], "offsets": [ [ 1866, 1889 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T85", "type": "Scope", "text": [ "alcohol or drug abuse" ], "offsets": [ [ 1844, 1865 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T86", "type": "Procedure", "text": [ "long-term oxygen therapy (LTOT)" ], "offsets": [ [ 1942, 1973 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T87", "type": "Procedure", "text": [ "nocturnal oxygen therapy" ], "offsets": [ [ 1977, 2001 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T88", "type": "Multiplier", "text": [ "greater than 12 hours a day" ], "offsets": [ [ 2015, 2042 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T89", "type": "Scope", "text": [ "long-term oxygen therapy (LTOT) or nocturnal oxygen therapy" ], "offsets": [ [ 1942, 2001 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T94", "type": "Drug", "text": [ "Inhaled Long acting beta-agonists (LABA)" ], "offsets": [ [ 2918, 2958 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T95", "type": "Temporal", "text": [ "48 hours" ], "offsets": [ [ 2959, 2967 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T96", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 2836, 2845 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T97", "type": "Drug", "text": [ "ICS/LABA combination products" ], "offsets": [ [ 2968, 2997 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T98", "type": "Temporal", "text": [ "48 hours" ], "offsets": [ [ 2998, 3006 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T99", "type": "Drug", "text": [ "Inhaled corticosteroids" ], "offsets": [ [ 3007, 3030 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T100", "type": "Temporal", "text": [ "48 hours" ], "offsets": [ [ 3031, 3039 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T101", "type": "Drug", "text": [ "Tiotropium" ], "offsets": [ [ 3040, 3050 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T102", "type": "Temporal", "text": [ "1 week" ], "offsets": [ [ 3051, 3057 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T103", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 3102, 3117 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T104", "type": "Qualifier", "text": [ "Systemic" ], "offsets": [ [ 3058, 3066 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T105", "type": "Qualifier", "text": [ "Oral" ], "offsets": [ [ 3068, 3072 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T106", "type": "Qualifier", "text": [ "parenteral" ], "offsets": [ [ 3074, 3084 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T107", "type": "Qualifier", "text": [ "intra-articular" ], "offsets": [ [ 3086, 3101 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T108", "type": "Scope", "text": [ "Systemic, Oral, parenteral, intra-articular" ], "offsets": [ [ 3058, 3101 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T109", "type": "Temporal", "text": [ "30 days" ], "offsets": [ [ 3118, 3125 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T110", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 3145, 3160 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T111", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 3127, 3131 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T112", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 3136, 3144 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T113", "type": "Scope", "text": [ "oral and systemic" ], "offsets": [ [ 3127, 3144 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T114", "type": "Condition", "text": [ "COPD exacerbations" ], "offsets": [ [ 3182, 3200 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T115", "type": "Procedure", "text": [ "treat COPD exacerbations" ], "offsets": [ [ 3176, 3200 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T116", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 3201, 3217 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T117", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 3208, 3217 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T119", "type": "Drug", "text": [ "Cytochrome P450 3A4 strong inhibitors" ], "offsets": [ [ 3219, 3256 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T120", "type": "Drug", "text": [ "Itraconazole" ], "offsets": [ [ 3432, 3444 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T121", "type": "Drug", "text": [ "Clarithromycin" ], "offsets": [ [ 3447, 3461 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T122", "type": "Drug", "text": [ "Telithromycin" ], "offsets": [ [ 3463, 3476 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T123", "type": "Drug", "text": [ "Amiodarone" ], "offsets": [ [ 3478, 3488 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T124", "type": "Drug", "text": [ "Nefazodone" ], "offsets": [ [ 3494, 3504 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T125", "type": "Temporal", "text": [ "6 weeks" ], "offsets": [ [ 3505, 3512 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T126", "type": "Drug", "text": [ "Grapefruit" ], "offsets": [ [ 3513, 3523 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T128", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 3664, 3684 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T130", "type": "Temporal", "text": [ "30 days" ], "offsets": [ [ 3685, 3692 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T131", "type": "Temporal", "text": [ "5 half lives" ], "offsets": [ [ 3696, 3708 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T132", "type": "Scope", "text": [ "30 days or 5 half lives" ], "offsets": [ [ 3685, 3708 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T133", "type": "Drug", "text": [ "antiretrovirals" ], "offsets": [ [ 3286, 3301 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T134", "type": "Drug", "text": [ "protease inhibitors" ], "offsets": [ [ 3303, 3322 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T135", "type": "Drug", "text": [ "Indinavir" ], "offsets": [ [ 3329, 3338 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T136", "type": "Drug", "text": [ "Nelfinavir" ], "offsets": [ [ 3340, 3350 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T137", "type": "Drug", "text": [ "Ritonavir" ], "offsets": [ [ 3352, 3361 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T138", "type": "Drug", "text": [ "Saquinavir" ], "offsets": [ [ 3363, 3373 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T139", "type": "Scope", "text": [ "Indinavir, Nelfinavir, Ritonavir, Saquinavir" ], "offsets": [ [ 3329, 3373 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T140", "type": "Drug", "text": [ "Imidazole", "anti-fungals" ], "offsets": [ [ 3376, 3385 ], [ 3399, 3411 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T141", "type": "Drug", "text": [ "Triazole anti-fungals" ], "offsets": [ [ 3390, 3411 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T142", "type": "Drug", "text": [ "Ketaconazole" ], "offsets": [ [ 3418, 3430 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T143", "type": "Scope", "text": [ "Imidazole and Triazole anti-fungals" ], "offsets": [ [ 3376, 3411 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T144", "type": "Scope", "text": [ "Ketaconazole, Itraconazole" ], "offsets": [ [ 3418, 3444 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T145", "type": "Scope", "text": [ "antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone" ], "offsets": [ [ 3286, 3504 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T146", "type": "Negation", "text": [ "No" ], "offsets": [ [ 2784, 2786 ] ], "normalized": [] }, { "id": "NCT01313676_exc_T147", "type": "Reference_point", "text": [ "any time during the study" ], "offsets": [ [ 2863, 2888 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01313676_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T3", "arg2_id": "NCT01313676_exc_T4", "normalized": [] }, { "id": "NCT01313676_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T2", "arg2_id": "NCT01313676_exc_T4", "normalized": [] }, { "id": "NCT01313676_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T7", "arg2_id": "NCT01313676_exc_T6", "normalized": [] }, { "id": "NCT01313676_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T7", "arg2_id": "NCT01313676_exc_T5", "normalized": [] }, { "id": "NCT01313676_exc_R5", "type": "AND", "arg1_id": "NCT01313676_exc_T10", "arg2_id": "NCT01313676_exc_T11", "normalized": [] }, { "id": "NCT01313676_exc_R6", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T9", "arg2_id": "NCT01313676_exc_T10", "normalized": [] }, { "id": "NCT01313676_exc_R7", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T13", "arg2_id": "NCT01313676_exc_T22", "normalized": [] }, { "id": "NCT01313676_exc_R8", "type": "Has_index", "arg1_id": "NCT01313676_exc_T26", "arg2_id": "NCT01313676_exc_T27", "normalized": [] }, { "id": "NCT01313676_exc_R9", "type": "AND", "arg1_id": "NCT01313676_exc_T29", "arg2_id": "NCT01313676_exc_T28", "normalized": [] }, { "id": "NCT01313676_exc_R10", "type": "AND", "arg1_id": "NCT01313676_exc_T30", "arg2_id": "NCT01313676_exc_T25", "normalized": [] }, { "id": "NCT01313676_exc_R11", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T32", "arg2_id": "NCT01313676_exc_T31", "normalized": [] }, { "id": "NCT01313676_exc_R12", "type": "Has_negation", "arg1_id": "NCT01313676_exc_T37", "arg2_id": "NCT01313676_exc_T39", "normalized": [] }, { "id": "NCT01313676_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T37", "arg2_id": "NCT01313676_exc_T38", "normalized": [] }, { "id": "NCT01313676_exc_R15", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T33", "arg2_id": "NCT01313676_exc_T36", "normalized": [] }, { "id": "NCT01313676_exc_R16", "type": "Has_index", "arg1_id": "NCT01313676_exc_T40", "arg2_id": "NCT01313676_exc_T41", "normalized": [] }, { "id": "NCT01313676_exc_R17", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T37", "arg2_id": "NCT01313676_exc_T40", "normalized": [] }, { "id": "NCT01313676_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT01313676_exc_T42", "arg2_id": "NCT01313676_exc_T43", "normalized": [] }, { "id": "NCT01313676_exc_R19", "type": "Has_value", "arg1_id": "NCT01313676_exc_T44", "arg2_id": "NCT01313676_exc_T45", "normalized": [] }, { "id": "NCT01313676_exc_R20", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T43", "arg2_id": "NCT01313676_exc_T44", "normalized": [] }, { "id": "NCT01313676_exc_R21", "type": "Has_value", "arg1_id": "NCT01313676_exc_T46", "arg2_id": "NCT01313676_exc_T47", "normalized": [] }, { "id": "NCT01313676_exc_R22", "type": "Has_value", "arg1_id": "NCT01313676_exc_T49", "arg2_id": "NCT01313676_exc_T50", "normalized": [] }, { "id": "NCT01313676_exc_R24", "type": "Has_negation", "arg1_id": "NCT01313676_exc_T56", "arg2_id": "NCT01313676_exc_T55", "normalized": [] }, { "id": "NCT01313676_exc_R25", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T51", "arg2_id": "NCT01313676_exc_T56", "normalized": [] }, { "id": "NCT01313676_exc_R26", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T58", "arg2_id": "NCT01313676_exc_T61", "normalized": [] }, { "id": "NCT01313676_exc_R27", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T57", "arg2_id": "NCT01313676_exc_T58", "normalized": [] }, { "id": "NCT01313676_exc_R28", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T67", "arg2_id": "NCT01313676_exc_T69", "normalized": [] }, { "id": "NCT01313676_exc_R29", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T70", "arg2_id": "NCT01313676_exc_T73", "normalized": [] }, { "id": "NCT01313676_exc_R30", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T64", "arg2_id": "NCT01313676_exc_T74", "normalized": [] }, { "id": "NCT01313676_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT01313676_exc_T75", "arg2_id": "NCT01313676_exc_T76", "normalized": [] }, { "id": "NCT01313676_exc_R32", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T75", "arg2_id": "NCT01313676_exc_T77", "normalized": [] }, { "id": "NCT01313676_exc_R33", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T85", "arg2_id": "NCT01313676_exc_T81", "normalized": [] }, { "id": "NCT01313676_exc_R34", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T85", "arg2_id": "NCT01313676_exc_T84", "normalized": [] }, { "id": "NCT01313676_exc_R35", "type": "Has_multiplier", "arg1_id": "NCT01313676_exc_T89", "arg2_id": "NCT01313676_exc_T88", "normalized": [] }, { "id": "NCT01313676_exc_R36", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T94", "arg2_id": "NCT01313676_exc_T95", "normalized": [] }, { "id": "NCT01313676_exc_R37", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T97", "arg2_id": "NCT01313676_exc_T98", "normalized": [] }, { "id": "NCT01313676_exc_R38", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T99", "arg2_id": "NCT01313676_exc_T100", "normalized": [] }, { "id": "NCT01313676_exc_R39", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T103", "arg2_id": "NCT01313676_exc_T108", "normalized": [] }, { "id": "NCT01313676_exc_R40", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T103", "arg2_id": "NCT01313676_exc_T109", "normalized": [] }, { "id": "NCT01313676_exc_R41", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T110", "arg2_id": "NCT01313676_exc_T113", "normalized": [] }, { "id": "NCT01313676_exc_R42", "type": "AND", "arg1_id": "NCT01313676_exc_T115", "arg2_id": "NCT01313676_exc_T114", "normalized": [] }, { "id": "NCT01313676_exc_R43", "type": "Has_index", "arg1_id": "NCT01313676_exc_T116", "arg2_id": "NCT01313676_exc_T117", "normalized": [] }, { "id": "NCT01313676_exc_R44", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T115", "arg2_id": "NCT01313676_exc_T116", "normalized": [] }, { "id": "NCT01313676_exc_R45", "type": "Has_scope", "arg1_id": "NCT01313676_exc_T128", "arg2_id": "NCT01313676_exc_T132", "normalized": [] }, { "id": "NCT01313676_exc_R46", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T134", "arg2_id": "NCT01313676_exc_T139", "normalized": [] }, { "id": "NCT01313676_exc_R47", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T133", "arg2_id": "NCT01313676_exc_T134", "normalized": [] }, { "id": "NCT01313676_exc_R48", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T143", "arg2_id": "NCT01313676_exc_T144", "normalized": [] }, { "id": "NCT01313676_exc_R49", "type": "Subsumes", "arg1_id": "NCT01313676_exc_T119", "arg2_id": "NCT01313676_exc_T145", "normalized": [] }, { "id": "NCT01313676_exc_R50", "type": "Has_temporal", "arg1_id": "NCT01313676_exc_T119", "arg2_id": "NCT01313676_exc_T125", "normalized": [] } ]

[ { "id": "NCT01313676_inc_text", "type": "inclusion", "text": [ "Type of subject: outpatient. \nInformed consent: Subjects must give their signed and dated written informed consent to participate. \nGender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception. \nAge: >=40 and <=80 years of age at Screening (Visit 1). \nTobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. \nAirflow Obstruction: \nSubjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1). \nSubjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1). \nPost-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated. \nSymptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) \nCardiovascular disease: \nFor patients >= 40 years of age: any one of the following: \nEstablished (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR \nFor patients >=60 years of age: any 2 of the following: \nBeing treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease \n" ], "offsets": [ [ 0, 2094 ] ] } ]

[ { "id": "NCT01313676_inc_T1", "type": "Visit", "text": [ "outpatient" ], "offsets": [ [ 17, 27 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T3", "type": "Person", "text": [ "Male" ], "offsets": [ [ 140, 144 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T4", "type": "Person", "text": [ "female" ], "offsets": [ [ 148, 154 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T6", "type": "Person", "text": [ "Age" ], "offsets": [ [ 450, 453 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T7", "type": "Value", "text": [ ">=40 and <=80 years" ], "offsets": [ [ 455, 474 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T8", "type": "Person", "text": [ "age" ], "offsets": [ [ 478, 481 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T9", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 482, 494 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T10", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 485, 494 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T11", "type": "Multiplier", "text": [ ">=10 pack-years" ], "offsets": [ [ 564, 579 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T12", "type": "Observation", "text": [ "cigarette smoking" ], "offsets": [ [ 583, 600 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T13", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 601, 613 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T14", "type": "Observation", "text": [ "history" ], "offsets": [ [ 553, 560 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T15", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 547, 552 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T16", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 536, 543 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T17", "type": "Scope", "text": [ "current or prior" ], "offsets": [ [ 536, 552 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T18", "type": "Condition", "text": [ "Previous smokers" ], "offsets": [ [ 625, 641 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T19", "type": "Observation", "text": [ "stopped smoking" ], "offsets": [ [ 672, 687 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T20", "type": "Temporal", "text": [ "for at least 6 months prior to Visit 1" ], "offsets": [ [ 688, 726 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T21", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 719, 726 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T22", "type": "Scope", "text": [ "stopped smoking for at least 6 months prior to Visit 1" ], "offsets": [ [ 672, 726 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T24", "type": "Drug", "text": [ "albuterol" ], "offsets": [ [ 781, 790 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T25", "type": "Drug", "text": [ "salbutamol" ], "offsets": [ [ 791, 801 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T26", "type": "Temporal", "text": [ "post-albuterol/salbutamol" ], "offsets": [ [ 776, 801 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T27", "type": "Measurement", "text": [ "forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio" ], "offsets": [ [ 802, 878 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T28", "type": "Value", "text": [ "<=0.70" ], "offsets": [ [ 882, 888 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T29", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 889, 901 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T30", "type": "Qualifier", "text": [ "post-albuterol/salbutamol" ], "offsets": [ [ 776, 801 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T31", "type": "Reference_point", "text": [ "albuterol/salbutamol" ], "offsets": [ [ 781, 801 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T32", "type": "Qualifier", "text": [ "post-albuterol/salbutamol" ], "offsets": [ [ 939, 964 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T33", "type": "Temporal", "text": [ "post-albuterol/salbutamol" ], "offsets": [ [ 939, 964 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T34", "type": "Drug", "text": [ "albuterol" ], "offsets": [ [ 944, 953 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T35", "type": "Drug", "text": [ "salbutamol" ], "offsets": [ [ 954, 964 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T36", "type": "Reference_point", "text": [ "albuterol/salbutamol" ], "offsets": [ [ 944, 964 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T37", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 965, 969 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T38", "type": "Value", "text": [ ">=50 and <=70% of predicted normal values" ], "offsets": [ [ 970, 1011 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T39", "type": "Qualifier", "text": [ "using NHANES III reference equations" ], "offsets": [ [ 1023, 1059 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T40", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 1095, 1107 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T41", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 1098, 1107 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T42", "type": "Qualifier", "text": [ "Post-bronchodilator" ], "offsets": [ [ 1120, 1139 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T43", "type": "Temporal", "text": [ "Post-bronchodilator" ], "offsets": [ [ 1120, 1139 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T44", "type": "Drug", "text": [ "bronchodilator" ], "offsets": [ [ 1125, 1139 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T45", "type": "Reference_point", "text": [ "bronchodilator" ], "offsets": [ [ 1125, 1139 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T46", "type": "Procedure", "text": [ "spirometry" ], "offsets": [ [ 1140, 1150 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T47", "type": "Temporal", "text": [ "approximately 15 minutes after" ], "offsets": [ [ 1169, 1199 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T48", "type": "Multiplier", "text": [ "4" ], "offsets": [ [ 1234, 1235 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T49", "type": "Procedure", "text": [ "inhalations" ], "offsets": [ [ 1236, 1247 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T50", "type": "Qualifier", "text": [ "self-administered" ], "offsets": [ [ 1216, 1233 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T51", "type": "Multiplier", "text": [ "400mcg" ], "offsets": [ [ 1261, 1267 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T52", "type": "Drug", "text": [ "albuterol" ], "offsets": [ [ 1272, 1281 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T53", "type": "Drug", "text": [ "salbutamol" ], "offsets": [ [ 1282, 1292 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T54", "type": "Scope", "text": [ "albuterol/salbutamol" ], "offsets": [ [ 1272, 1292 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T55", "type": "Procedure", "text": [ "metered dose inhaler (MDI )" ], "offsets": [ [ 1299, 1326 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T56", "type": "Qualifier", "text": [ "with a valved-holding chamber" ], "offsets": [ [ 1326, 1355 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T57", "type": "Condition", "text": [ "Symptoms of COPD" ], "offsets": [ [ 1431, 1447 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T58", "type": "Value", "text": [ "score 2 or higher" ], "offsets": [ [ 1463, 1480 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T59", "type": "Measurement", "text": [ "modified Medical Research Council Dyspnea scale" ], "offsets": [ [ 1488, 1535 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T61", "type": "Value", "text": [ ">= 40 years" ], "offsets": [ [ 1585, 1596 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T62", "type": "Person", "text": [ "age" ], "offsets": [ [ 1600, 1603 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T63", "type": "Condition", "text": [ "coronary artery disease (CAD)" ], "offsets": [ [ 1688, 1717 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T64", "type": "Condition", "text": [ "peripheral vascular disease (PVD)" ], "offsets": [ [ 1774, 1807 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T65", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 1817, 1823 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T66", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 1808, 1816 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T67", "type": "Observation", "text": [ "Established" ], "offsets": [ [ 1718, 1729 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T68", "type": "Observation", "text": [ "clinical signs" ], "offsets": [ [ 1739, 1753 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T69", "type": "Procedure", "text": [ "imaging studies" ], "offsets": [ [ 1757, 1772 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T70", "type": "Condition", "text": [ "MI" ], "offsets": [ [ 1833, 1835 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T71", "type": "Condition", "text": [ "Diabetes mellitus" ], "offsets": [ [ 1836, 1853 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T72", "type": "Condition", "text": [ "target organ disease" ], "offsets": [ [ 1859, 1879 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T74", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 1824, 1832 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T75", "type": "Scope", "text": [ "clinical signs or imaging studies" ], "offsets": [ [ 1739, 1772 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T76", "type": "Observation", "text": [ "Established" ], "offsets": [ [ 1632, 1643 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T77", "type": "Observation", "text": [ "clinical signs" ], "offsets": [ [ 1653, 1667 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T78", "type": "Procedure", "text": [ "imaging studies" ], "offsets": [ [ 1671, 1686 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T79", "type": "Scope", "text": [ "clinical signs or imaging studies" ], "offsets": [ [ 1653, 1686 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T80", "type": "Value", "text": [ ">=60 years" ], "offsets": [ [ 1897, 1907 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T81", "type": "Person", "text": [ "age" ], "offsets": [ [ 1911, 1914 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T82", "type": "Condition", "text": [ "hypercholesterolemia" ], "offsets": [ [ 1959, 1979 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T83", "type": "Procedure", "text": [ "treated for hypercholesterolemia" ], "offsets": [ [ 1947, 1979 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T84", "type": "Procedure", "text": [ "treated for hypertension" ], "offsets": [ [ 1986, 2010 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T85", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 1998, 2010 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T86", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 2029, 2046 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T87", "type": "Procedure", "text": [ "treated for diabetes mellitus" ], "offsets": [ [ 2017, 2046 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T88", "type": "Procedure", "text": [ "treated for peripheral vascular disease" ], "offsets": [ [ 2053, 2092 ] ], "normalized": [] }, { "id": "NCT01313676_inc_T89", "type": "Condition", "text": [ "peripheral vascular disease" ], "offsets": [ [ 2065, 2092 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01313676_inc_R1", "type": "Has_value", "arg1_id": "NCT01313676_inc_T8", "arg2_id": "NCT01313676_inc_T7", "normalized": [] }, { "id": "NCT01313676_inc_R2", "type": "Has_value", "arg1_id": "NCT01313676_inc_T6", "arg2_id": "NCT01313676_inc_T7", "normalized": [] }, { "id": "NCT01313676_inc_R3", "type": "Has_index", "arg1_id": "NCT01313676_inc_T9", "arg2_id": "NCT01313676_inc_T10", "normalized": [] }, { "id": "NCT01313676_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T8", "arg2_id": "NCT01313676_inc_T9", "normalized": [] }, { "id": "NCT01313676_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T6", "arg2_id": "NCT01313676_inc_T9", "normalized": [] }, { "id": "NCT01313676_inc_R6", "type": "Has_multiplier", "arg1_id": "NCT01313676_inc_T12", "arg2_id": "NCT01313676_inc_T11", "normalized": [] }, { "id": "NCT01313676_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T12", "arg2_id": "NCT01313676_inc_T13", "normalized": [] }, { "id": "NCT01313676_inc_R8", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T12", "arg2_id": "NCT01313676_inc_T14", "normalized": [] }, { "id": "NCT01313676_inc_R9", "type": "Has_scope", "arg1_id": "NCT01313676_inc_T12", "arg2_id": "NCT01313676_inc_T17", "normalized": [] }, { "id": "NCT01313676_inc_R10", "type": "Has_index", "arg1_id": "NCT01313676_inc_T20", "arg2_id": "NCT01313676_inc_T21", "normalized": [] }, { "id": "NCT01313676_inc_R11", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T19", "arg2_id": "NCT01313676_inc_T20", "normalized": [] }, { "id": "NCT01313676_inc_R12", "type": "Subsumes", "arg1_id": "NCT01313676_inc_T18", "arg2_id": "NCT01313676_inc_T22", "normalized": [] }, { "id": "NCT01313676_inc_R13", "type": "Has_value", "arg1_id": "NCT01313676_inc_T27", "arg2_id": "NCT01313676_inc_T28", "normalized": [] }, { "id": "NCT01313676_inc_R14", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T27", "arg2_id": "NCT01313676_inc_T29", "normalized": [] }, { "id": "NCT01313676_inc_R15", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T30", "arg2_id": "NCT01313676_inc_T26", "normalized": [] }, { "id": "NCT01313676_inc_R16", "type": "Has_index", "arg1_id": "NCT01313676_inc_T26", "arg2_id": "NCT01313676_inc_T31", "normalized": [] }, { "id": "NCT01313676_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T27", "arg2_id": "NCT01313676_inc_T30", "normalized": [] }, { "id": "NCT01313676_inc_R18", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T32", "arg2_id": "NCT01313676_inc_T33", "normalized": [] }, { "id": "NCT01313676_inc_R19", "type": "Has_index", "arg1_id": "NCT01313676_inc_T33", "arg2_id": "NCT01313676_inc_T36", "normalized": [] }, { "id": "NCT01313676_inc_R20", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T37", "arg2_id": "NCT01313676_inc_T32", "normalized": [] }, { "id": "NCT01313676_inc_R21", "type": "Has_value", "arg1_id": "NCT01313676_inc_T37", "arg2_id": "NCT01313676_inc_T38", "normalized": [] }, { "id": "NCT01313676_inc_R22", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T38", "arg2_id": "NCT01313676_inc_T39", "normalized": [] }, { "id": "NCT01313676_inc_R23", "type": "Has_index", "arg1_id": "NCT01313676_inc_T40", "arg2_id": "NCT01313676_inc_T41", "normalized": [] }, { "id": "NCT01313676_inc_R24", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T37", "arg2_id": "NCT01313676_inc_T40", "normalized": [] }, { "id": "NCT01313676_inc_R25", "type": "Has_index", "arg1_id": "NCT01313676_inc_T43", "arg2_id": "NCT01313676_inc_T45", "normalized": [] }, { "id": "NCT01313676_inc_R26", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T42", "arg2_id": "NCT01313676_inc_T43", "normalized": [] }, { "id": "NCT01313676_inc_R27", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T46", "arg2_id": "NCT01313676_inc_T42", "normalized": [] }, { "id": "NCT01313676_inc_R28", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T46", "arg2_id": "NCT01313676_inc_T47", "normalized": [] }, { "id": "NCT01313676_inc_R29", "type": "Has_multiplier", "arg1_id": "NCT01313676_inc_T49", "arg2_id": "NCT01313676_inc_T48", "normalized": [] }, { "id": "NCT01313676_inc_R30", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T49", "arg2_id": "NCT01313676_inc_T50", "normalized": [] }, { "id": "NCT01313676_inc_R31", "type": "Subsumes", "arg1_id": "NCT01313676_inc_T48", "arg2_id": "NCT01313676_inc_T51", "normalized": [] }, { "id": "NCT01313676_inc_R32", "type": "Has_scope", "arg1_id": "NCT01313676_inc_T49", "arg2_id": "NCT01313676_inc_T54", "normalized": [] }, { "id": "NCT01313676_inc_R33", "type": "Has_qualifier", "arg1_id": "NCT01313676_inc_T55", "arg2_id": "NCT01313676_inc_T56", "normalized": [] }, { "id": "NCT01313676_inc_R34", "type": "AND", "arg1_id": "NCT01313676_inc_T49", "arg2_id": "NCT01313676_inc_T55", "normalized": [] }, { "id": "NCT01313676_inc_R35", "type": "Has_value", "arg1_id": "NCT01313676_inc_T59", "arg2_id": "NCT01313676_inc_T58", "normalized": [] }, { "id": "NCT01313676_inc_R36", "type": "Subsumes", "arg1_id": "NCT01313676_inc_T57", "arg2_id": "NCT01313676_inc_T59", "normalized": [] }, { "id": "NCT01313676_inc_R37", "type": "Has_value", "arg1_id": "NCT01313676_inc_T62", "arg2_id": "NCT01313676_inc_T61", "normalized": [] }, { "id": "NCT01313676_inc_R38", "type": "AND", "arg1_id": "NCT01313676_inc_T71", "arg2_id": "NCT01313676_inc_T72", "normalized": [] }, { "id": "NCT01313676_inc_R39", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T70", "arg2_id": "NCT01313676_inc_T74", "normalized": [] }, { "id": "NCT01313676_inc_R40", "type": "Has_temporal", "arg1_id": "NCT01313676_inc_T65", "arg2_id": "NCT01313676_inc_T66", "normalized": [] }, { "id": "NCT01313676_inc_R41", "type": "Subsumes", "arg1_id": "NCT01313676_inc_T67", "arg2_id": "NCT01313676_inc_T75", "normalized": [] }, { "id": "NCT01313676_inc_R43", "type": "Subsumes", "arg1_id": "NCT01313676_inc_T76", "arg2_id": "NCT01313676_inc_T79", "normalized": [] }, { "id": "NCT01313676_inc_R45", "type": "Has_value", "arg1_id": "NCT01313676_inc_T81", "arg2_id": "NCT01313676_inc_T80", "normalized": [] }, { "id": "NCT01313676_inc_R46", "type": "AND", "arg1_id": "NCT01313676_inc_T83", "arg2_id": "NCT01313676_inc_T82", "normalized": [] }, { "id": "NCT01313676_inc_R47", "type": "AND", "arg1_id": "NCT01313676_inc_T84", "arg2_id": "NCT01313676_inc_T85", "normalized": [] }, { "id": "NCT01313676_inc_R48", "type": "AND", "arg1_id": "NCT01313676_inc_T87", "arg2_id": "NCT01313676_inc_T86", "normalized": [] }, { "id": "NCT01313676_inc_R49", "type": "AND", "arg1_id": "NCT01313676_inc_T88", "arg2_id": "NCT01313676_inc_T89", "normalized": [] } ]

[ { "id": "NCT01314898_exc_text", "type": "exclusion", "text": [ "Subjects with a supine BP >140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic based on the average of the triplicate \nSerum potassium >=5.1 mmol/L or <3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary. \nEstimated GFR <60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening. \n \n" ], "offsets": [ [ 0, 435 ] ] } ]

[ { "id": "NCT01314898_exc_T1", "type": "Measurement", "text": [ "supine BP" ], "offsets": [ [ 16, 25 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T2", "type": "Value", "text": [ ">140 mm Hg systolic" ], "offsets": [ [ 26, 45 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T3", "type": "Value", "text": [ ">90 mm Hg diastolic" ], "offsets": [ [ 49, 68 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T4", "type": "Value", "text": [ "<100 mm Hg systolic" ], "offsets": [ [ 72, 91 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T5", "type": "Value", "text": [ "<60 mm Hg diastolic" ], "offsets": [ [ 95, 114 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T6", "type": "Scope", "text": [ ">140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic" ], "offsets": [ [ 26, 114 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T7", "type": "Measurement", "text": [ "Serum potassium" ], "offsets": [ [ 155, 170 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T8", "type": "Value", "text": [ ">=5.1 mmol/L" ], "offsets": [ [ 171, 183 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T9", "type": "Value", "text": [ "<3.5 mmol/L" ], "offsets": [ [ 187, 198 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T10", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 199, 211 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T11", "type": "Scope", "text": [ ">=5.1 mmol/L or <3.5 mmol/L" ], "offsets": [ [ 171, 198 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T12", "type": "Measurement", "text": [ "Estimated GFR" ], "offsets": [ [ 264, 277 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T13", "type": "Value", "text": [ "<60 mL/min/1.73 m2" ], "offsets": [ [ 278, 296 ] ], "normalized": [] }, { "id": "NCT01314898_exc_T14", "type": "Observation", "text": [ "Cockcroft-Gault formula" ], "offsets": [ [ 307, 330 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01314898_exc_R1", "type": "Has_scope", "arg1_id": "NCT01314898_exc_T1", "arg2_id": "NCT01314898_exc_T6", "normalized": [] }, { "id": "NCT01314898_exc_R2", "type": "Has_scope", "arg1_id": "NCT01314898_exc_T7", "arg2_id": "NCT01314898_exc_T11", "normalized": [] }, { "id": "NCT01314898_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01314898_exc_T7", "arg2_id": "NCT01314898_exc_T10", "normalized": [] }, { "id": "NCT01314898_exc_R4", "type": "Has_value", "arg1_id": "NCT01314898_exc_T12", "arg2_id": "NCT01314898_exc_T13", "normalized": [] } ]

[ { "id": "NCT01314898_inc_text", "type": "inclusion", "text": [ "Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential. \nBody Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). \nSubjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures. \n" ], "offsets": [ [ 0, 343 ] ] } ]

[ { "id": "NCT01314898_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T3", "type": "Condition", "text": [ "healthy" ], "offsets": [ [ 19, 26 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 39, 42 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T5", "type": "Value", "text": [ "18 to 55 years" ], "offsets": [ [ 43, 57 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T6", "type": "Person", "text": [ "Females" ], "offsets": [ [ 59, 66 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T7", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 82, 104 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T8", "type": "Negation", "text": [ "non" ], "offsets": [ [ 78, 81 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T9", "type": "Measurement", "text": [ "Body Mass Index (BMI)" ], "offsets": [ [ 107, 128 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T10", "type": "Value", "text": [ "17.5 to 30.5 kg/m2" ], "offsets": [ [ 132, 150 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T11", "type": "Measurement", "text": [ "total body weight" ], "offsets": [ [ 158, 175 ] ], "normalized": [] }, { "id": "NCT01314898_inc_T12", "type": "Value", "text": [ ">50 kg (110 lbs)" ], "offsets": [ [ 176, 192 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01314898_inc_R1", "type": "Has_value", "arg1_id": "NCT01314898_inc_T4", "arg2_id": "NCT01314898_inc_T5", "normalized": [] }, { "id": "NCT01314898_inc_R2", "type": "Has_negation", "arg1_id": "NCT01314898_inc_T7", "arg2_id": "NCT01314898_inc_T8", "normalized": [] }, { "id": "NCT01314898_inc_R3", "type": "Has_value", "arg1_id": "NCT01314898_inc_T9", "arg2_id": "NCT01314898_inc_T10", "normalized": [] }, { "id": "NCT01314898_inc_R4", "type": "Has_value", "arg1_id": "NCT01314898_inc_T11", "arg2_id": "NCT01314898_inc_T12", "normalized": [] } ]

[ { "id": "NCT01320579_exc_text", "type": "exclusion", "text": [ "History of other significant skin disease, or skin manifestations of allergic illness or other dermatologic condition, except chronic moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient's safety according to the opinion of the Investigator \nPresent symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin \nCurrent use of any active systemic medication for chronic atopic dermatitis within one month \nCurrent use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks \nHistory of a sunny holiday, UV-light therapy or solarium use within one month before beginning of study treatments, or planning such during the study or within 7 days after the study \nAllergy to cis-UCA, or any constituents of the placebo emulsion cream or any constituents of Protopic® ointment \nHistory of any skin-related cancer \nCongenital or acquired immunodeficiency or ongoing therapy that cause immunosuppression \nEarlier participation in a clinical study performed with cis-UCA \nAny clinically significant laboratory test result \nSuspected current drug or alcohol abuse \nClinically significant illness during the 4 weeks prior to the first dose administration \nAny other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the patient \nUnwillingness or doubtful capacity to comply with the protocol \nDoubtful availability to complete the study \n \n" ], "offsets": [ [ 0, 1617 ] ] } ]

[ { "id": "NCT01320579_exc_T1", "type": "Condition", "text": [ "skin disease" ], "offsets": [ [ 29, 41 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T2", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 17, 28 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T3", "type": "Observation", "text": [ "History" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T4", "type": "Condition", "text": [ "allergic illness" ], "offsets": [ [ 69, 85 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T5", "type": "Condition", "text": [ "dermatologic condition" ], "offsets": [ [ 95, 117 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T6", "type": "Condition", "text": [ "skin manifestations" ], "offsets": [ [ 46, 65 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T7", "type": "Scope", "text": [ "allergic illness or other dermatologic condition" ], "offsets": [ [ 69, 117 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T8", "type": "Condition", "text": [ "atopic dermatitis" ], "offsets": [ [ 153, 170 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 146, 152 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T10", "type": "Qualifier", "text": [ "chronic moderate" ], "offsets": [ [ 126, 142 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T11", "type": "Scope", "text": [ "chronic moderate or severe" ], "offsets": [ [ 126, 152 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T13", "type": "Negation", "text": [ "except" ], "offsets": [ [ 119, 125 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T14", "type": "Condition", "text": [ "skin diseases" ], "offsets": [ [ 327, 340 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T15", "type": "Condition", "text": [ "chronic atopic dermatitis" ], "offsets": [ [ 349, 374 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T16", "type": "Negation", "text": [ "except" ], "offsets": [ [ 342, 348 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T17", "type": "Qualifier", "text": [ "could disturb the study assessment and evaluation of the skin" ], "offsets": [ [ 381, 442 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T19", "type": "Condition", "text": [ "chronic atopic dermatitis" ], "offsets": [ [ 494, 519 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T20", "type": "Temporal", "text": [ "within one month" ], "offsets": [ [ 520, 536 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T21", "type": "Drug", "text": [ "systemic medication" ], "offsets": [ [ 470, 489 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T22", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 463, 469 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T23", "type": "Condition", "text": [ "chronic atopic dermatitis" ], "offsets": [ [ 619, 644 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T24", "type": "Temporal", "text": [ "within two weeks" ], "offsets": [ [ 645, 661 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T25", "type": "Drug", "text": [ "topical medication" ], "offsets": [ [ 560, 578 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T26", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 553, 559 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T27", "type": "Observation", "text": [ "sunny holiday" ], "offsets": [ [ 676, 689 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T28", "type": "Procedure", "text": [ "UV-light therapy" ], "offsets": [ [ 691, 707 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T29", "type": "Observation", "text": [ "solarium use" ], "offsets": [ [ 711, 723 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T30", "type": "Temporal", "text": [ "within one month before beginning of study treatments" ], "offsets": [ [ 724, 777 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T31", "type": "Reference_point", "text": [ "beginning of study treatments" ], "offsets": [ [ 748, 777 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T32", "type": "Observation", "text": [ "planning" ], "offsets": [ [ 782, 790 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T33", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 796, 812 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T34", "type": "Temporal", "text": [ "within 7 days after the study" ], "offsets": [ [ 816, 845 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T35", "type": "Scope", "text": [ "during the study or within 7 days after the study" ], "offsets": [ [ 796, 845 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T36", "type": "Scope", "text": [ "sunny holiday, UV-light therapy or solarium use" ], "offsets": [ [ 676, 723 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T37", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 847, 854 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T38", "type": "Drug", "text": [ "Protopic® ointment" ], "offsets": [ [ 940, 958 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T39", "type": "Drug", "text": [ "cis-UCA" ], "offsets": [ [ 858, 865 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T40", "type": "Drug", "text": [ "placebo emulsion cream" ], "offsets": [ [ 894, 916 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T41", "type": "Scope", "text": [ "cis-UCA, or any constituents of the placebo emulsion cream or any constituents of Protopic® ointment" ], "offsets": [ [ 858, 958 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T42", "type": "Condition", "text": [ "skin-related cancer" ], "offsets": [ [ 975, 994 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T43", "type": "Observation", "text": [ "History" ], "offsets": [ [ 960, 967 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T44", "type": "Condition", "text": [ "acquired immunodeficiency" ], "offsets": [ [ 1010, 1035 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T45", "type": "Condition", "text": [ "immunodeficiency", "Congenital" ], "offsets": [ [ 1019, 1035 ], [ 996, 1006 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T46", "type": "Procedure", "text": [ "therapy that cause immunosuppression" ], "offsets": [ [ 1047, 1083 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T47", "type": "Qualifier", "text": [ "that cause immunosuppression" ], "offsets": [ [ 1055, 1083 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T48", "type": "Condition", "text": [ "immunosuppression" ], "offsets": [ [ 1066, 1083 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T49", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 1039, 1046 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T51", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1155, 1177 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T52", "type": "Procedure", "text": [ "laboratory test" ], "offsets": [ [ 1178, 1193 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T55", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 1228, 1241 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T56", "type": "Condition", "text": [ "drug", "abuse" ], "offsets": [ [ 1220, 1224 ], [ 1236, 1241 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T57", "type": "Observation", "text": [ "Suspected" ], "offsets": [ [ 1202, 1211 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T58", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1212, 1219 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T59", "type": "Scope", "text": [ "drug or alcohol abuse" ], "offsets": [ [ 1220, 1241 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T60", "type": "Temporal", "text": [ "during the 4 weeks prior to the first dose administration" ], "offsets": [ [ 1274, 1331 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T61", "type": "Reference_point", "text": [ "the first dose administration" ], "offsets": [ [ 1302, 1331 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T62", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 1266, 1273 ] ], "normalized": [] }, { "id": "NCT01320579_exc_T63", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 1243, 1265 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01320579_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01320579_exc_T1", "arg2_id": "NCT01320579_exc_T2", "normalized": [] }, { "id": "NCT01320579_exc_R3", "type": "Has_scope", "arg1_id": "NCT01320579_exc_T6", "arg2_id": "NCT01320579_exc_T7", "normalized": [] }, { "id": "NCT01320579_exc_R4", "type": "Has_scope", "arg1_id": "NCT01320579_exc_T8", "arg2_id": "NCT01320579_exc_T11", "normalized": [] }, { "id": "NCT01320579_exc_R2", "type": "Has_negation", "arg1_id": "NCT01320579_exc_T8", "arg2_id": "NCT01320579_exc_T13", "normalized": [] }, { "id": "NCT01320579_exc_R5", "type": "AND", "arg1_id": "NCT01320579_exc_T6", "arg2_id": "NCT01320579_exc_T8", "normalized": [] }, { "id": "NCT01320579_exc_R6", "type": "Has_negation", "arg1_id": "NCT01320579_exc_T15", "arg2_id": "NCT01320579_exc_T16", "normalized": [] }, { "id": "NCT01320579_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01320579_exc_T14", "arg2_id": "NCT01320579_exc_T17", "normalized": [] }, { "id": "NCT01320579_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T19", "arg2_id": "NCT01320579_exc_T20", "normalized": [] }, { "id": "NCT01320579_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T21", "arg2_id": "NCT01320579_exc_T22", "normalized": [] }, { "id": "NCT01320579_exc_R10", "type": "AND", "arg1_id": "NCT01320579_exc_T21", "arg2_id": "NCT01320579_exc_T19", "normalized": [] }, { "id": "NCT01320579_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T23", "arg2_id": "NCT01320579_exc_T24", "normalized": [] }, { "id": "NCT01320579_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T25", "arg2_id": "NCT01320579_exc_T26", "normalized": [] }, { "id": "NCT01320579_exc_R13", "type": "AND", "arg1_id": "NCT01320579_exc_T25", "arg2_id": "NCT01320579_exc_T23", "normalized": [] }, { "id": "NCT01320579_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T36", "arg2_id": "NCT01320579_exc_T30", "normalized": [] }, { "id": "NCT01320579_exc_R15", "type": "Has_mood", "arg1_id": "NCT01320579_exc_T36", "arg2_id": "NCT01320579_exc_T32", "normalized": [] }, { "id": "NCT01320579_exc_R16", "type": "Has_scope", "arg1_id": "NCT01320579_exc_T32", "arg2_id": "NCT01320579_exc_T35", "normalized": [] }, { "id": "NCT01320579_exc_R17", "type": "Has_scope", "arg1_id": "NCT01320579_exc_T37", "arg2_id": "NCT01320579_exc_T41", "normalized": [] }, { "id": "NCT01320579_exc_R18", "type": "AND", "arg1_id": "NCT01320579_exc_T47", "arg2_id": "NCT01320579_exc_T48", "normalized": [] }, { "id": "NCT01320579_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT01320579_exc_T46", "arg2_id": "NCT01320579_exc_T47", "normalized": [] }, { "id": "NCT01320579_exc_R20", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T46", "arg2_id": "NCT01320579_exc_T49", "normalized": [] }, { "id": "NCT01320579_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT01320579_exc_T52", "arg2_id": "NCT01320579_exc_T51", "normalized": [] }, { "id": "NCT01320579_exc_R23", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T59", "arg2_id": "NCT01320579_exc_T58", "normalized": [] }, { "id": "NCT01320579_exc_R24", "type": "Has_index", "arg1_id": "NCT01320579_exc_T60", "arg2_id": "NCT01320579_exc_T61", "normalized": [] }, { "id": "NCT01320579_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT01320579_exc_T62", "arg2_id": "NCT01320579_exc_T63", "normalized": [] }, { "id": "NCT01320579_exc_R26", "type": "Has_temporal", "arg1_id": "NCT01320579_exc_T62", "arg2_id": "NCT01320579_exc_T60", "normalized": [] } ]

[ { "id": "NCT01320579_inc_text", "type": "inclusion", "text": [ "Informed consent obtained prior to any screening procedure \nCaucasian male or female patient \nAt least 18 years of age \nWeight at least 45 kg \nPatient with moderate or severe chronic atopic dermatitis \nGood general health ascertained by medical history, physical examination and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis \nNegative pregnancy test (premenopausal female patient) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the last cis-UCA dose \n" ], "offsets": [ [ 0, 598 ] ] } ]

[ { "id": "NCT01320579_inc_T2", "type": "Person", "text": [ "Caucasian" ], "offsets": [ [ 60, 69 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T3", "type": "Person", "text": [ "male" ], "offsets": [ [ 70, 74 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T4", "type": "Person", "text": [ "female" ], "offsets": [ [ 78, 84 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T5", "type": "Value", "text": [ "At least 18 years" ], "offsets": [ [ 94, 111 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 115, 118 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T7", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 120, 126 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T8", "type": "Value", "text": [ "at least 45 kg" ], "offsets": [ [ 127, 141 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T9", "type": "Condition", "text": [ "chronic atopic dermatitis" ], "offsets": [ [ 175, 200 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T10", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 168, 174 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T11", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 156, 164 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T12", "type": "Scope", "text": [ "moderate or severe" ], "offsets": [ [ 156, 174 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T13", "type": "Condition", "text": [ "Good general health" ], "offsets": [ [ 202, 221 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T14", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 237, 252 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T15", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 254, 274 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T16", "type": "Procedure", "text": [ "laboratory determinations" ], "offsets": [ [ 279, 304 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T17", "type": "Negation", "text": [ "no" ], "offsets": [ [ 314, 316 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T18", "type": "Observation", "text": [ "signs of clinically significant findings" ], "offsets": [ [ 317, 357 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T19", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 326, 348 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T21", "type": "Condition", "text": [ "chronic atopic dermatitis" ], "offsets": [ [ 366, 391 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T22", "type": "Negation", "text": [ "except" ], "offsets": [ [ 359, 365 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T23", "type": "Qualifier", "text": [ "ascertained by medical history, physical examination and laboratory determinations" ], "offsets": [ [ 222, 304 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T24", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 402, 416 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T25", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 393, 401 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T26", "type": "Condition", "text": [ "premenopausal" ], "offsets": [ [ 418, 431 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T27", "type": "Person", "text": [ "female" ], "offsets": [ [ 432, 438 ] ], "normalized": [] }, { "id": "NCT01320579_inc_T28", "type": "Scope", "text": [ "premenopausal female" ], "offsets": [ [ 418, 438 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01320579_inc_R1", "type": "Has_value", "arg1_id": "NCT01320579_inc_T6", "arg2_id": "NCT01320579_inc_T5", "normalized": [] }, { "id": "NCT01320579_inc_R2", "type": "Has_value", "arg1_id": "NCT01320579_inc_T7", "arg2_id": "NCT01320579_inc_T8", "normalized": [] }, { "id": "NCT01320579_inc_R3", "type": "Has_scope", "arg1_id": "NCT01320579_inc_T9", "arg2_id": "NCT01320579_inc_T12", "normalized": [] }, { "id": "NCT01320579_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01320579_inc_T18", "arg2_id": "NCT01320579_inc_T19", "normalized": [] }, { "id": "NCT01320579_inc_R5", "type": "Has_negation", "arg1_id": "NCT01320579_inc_T18", "arg2_id": "NCT01320579_inc_T17", "normalized": [] }, { "id": "NCT01320579_inc_R6", "type": "Has_negation", "arg1_id": "NCT01320579_inc_T21", "arg2_id": "NCT01320579_inc_T22", "normalized": [] }, { "id": "NCT01320579_inc_R7", "type": "AND", "arg1_id": "NCT01320579_inc_T17", "arg2_id": "NCT01320579_inc_T21", "normalized": [] }, { "id": "NCT01320579_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT01320579_inc_T13", "arg2_id": "NCT01320579_inc_T23", "normalized": [] }, { "id": "NCT01320579_inc_R9", "type": "Has_value", "arg1_id": "NCT01320579_inc_T24", "arg2_id": "NCT01320579_inc_T25", "normalized": [] }, { "id": "NCT01320579_inc_R10", "type": "AND", "arg1_id": "NCT01320579_inc_T28", "arg2_id": "NCT01320579_inc_T24", "normalized": [] } ]

[ { "id": "NCT01322464_exc_text", "type": "exclusion", "text": [ "Subjects were not to have a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. \nSubjects were not to have any history or presence or family history of schizophrenia, other psychotic illness, severe personality disorder, depression, or other significant psychiatric disorder. \nSubjects were not to have a postural drop of 20 mmHg or more in systolic blood pressure at screening. \nSubjects were not to have participated in a previous clinical trial within 90 days prior to study initiation. \nSubjects were not to have donated plasma within 90 days prior to study initiation. \nSubjects were not to have donated blood within 90 days prior to study initiation. \nSubjects were not to have had an abnormal diet or substantial changes in eating habits within 30 days prior to study initiation. \nSubjects were not to have had treatment with any known enzyme-altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study. \nSubjects were to have no history of known hypersensitivity or idiosyncratic reaction to the study drug or related compounds. \nSubjects were not to use any prescription medication within 14 days prior to or during the study. \nSubjects were not to use any over-the-counter medication within 7 days prior to or during the study. \nSubjects were not to have a history of alcohol or drug abuse within 2 years prior to the study (subjects with a history of previous use of cannabis were not excluded unless they had used cannabis or cannabinoid based medicine within 30 days prior to study drug administration or were unwilling to abstain for the duration of the study). \n \n" ], "offsets": [ [ 0, 1768 ] ] } ]

[ { "id": "NCT01322464_exc_T2", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 284, 297 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T3", "type": "Condition", "text": [ "psychotic illness" ], "offsets": [ [ 305, 322 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T4", "type": "Condition", "text": [ "severe personality disorder" ], "offsets": [ [ 324, 351 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T6", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 353, 363 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T7", "type": "Condition", "text": [ "psychiatric disorder" ], "offsets": [ [ 386, 406 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T8", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 374, 385 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T10", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 266, 280 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T11", "type": "Observation", "text": [ "history" ], "offsets": [ [ 243, 250 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T12", "type": "Observation", "text": [ "presence" ], "offsets": [ [ 254, 262 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T13", "type": "Scope", "text": [ "history or presence or family history" ], "offsets": [ [ 243, 280 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T14", "type": "Scope", "text": [ "schizophrenia, other psychotic illness, severe personality disorder, depression, or other significant psychiatric disorder" ], "offsets": [ [ 284, 406 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T15", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 473, 496 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T16", "type": "Value", "text": [ "postural drop of 20 mmHg" ], "offsets": [ [ 437, 461 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T17", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 497, 509 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T18", "type": "Temporal", "text": [ "90 days prior to study initiation" ], "offsets": [ [ 587, 620 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T19", "type": "Observation", "text": [ "participated in a previous clinical trial" ], "offsets": [ [ 538, 579 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T21", "type": "Procedure", "text": [ "donated plasma" ], "offsets": [ [ 649, 663 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T22", "type": "Temporal", "text": [ "within 90 days prior to study initiation" ], "offsets": [ [ 664, 704 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T23", "type": "Reference_point", "text": [ "study initiation" ], "offsets": [ [ 688, 704 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T24", "type": "Negation", "text": [ "not" ], "offsets": [ [ 637, 640 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T25", "type": "Negation", "text": [ "not" ], "offsets": [ [ 423, 426 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T26", "type": "Procedure", "text": [ "donated blood" ], "offsets": [ [ 733, 746 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T27", "type": "Negation", "text": [ "not" ], "offsets": [ [ 721, 724 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T28", "type": "Temporal", "text": [ "within 90 days prior to study initiation" ], "offsets": [ [ 747, 787 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T29", "type": "Reference_point", "text": [ "study initiation" ], "offsets": [ [ 771, 787 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T30", "type": "Observation", "text": [ "abnormal diet" ], "offsets": [ [ 823, 836 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T31", "type": "Observation", "text": [ "changes in eating habits" ], "offsets": [ [ 852, 876 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T32", "type": "Qualifier", "text": [ "substantial" ], "offsets": [ [ 840, 851 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T33", "type": "Temporal", "text": [ "within 30 days prior to study initiation" ], "offsets": [ [ 877, 917 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T34", "type": "Reference_point", "text": [ "study initiation" ], "offsets": [ [ 901, 917 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T35", "type": "Scope", "text": [ "abnormal diet or substantial changes in eating habits" ], "offsets": [ [ 823, 876 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T36", "type": "Negation", "text": [ "not" ], "offsets": [ [ 804, 807 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T37", "type": "Drug", "text": [ "enzyme-altering agents" ], "offsets": [ [ 975, 997 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T38", "type": "Drug", "text": [ "barbiturates" ], "offsets": [ [ 999, 1011 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T39", "type": "Drug", "text": [ "phenothiazines" ], "offsets": [ [ 1013, 1027 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T40", "type": "Drug", "text": [ "cimetidine" ], "offsets": [ [ 1029, 1039 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T41", "type": "Temporal", "text": [ "within 30 days prior to or during the study" ], "offsets": [ [ 1046, 1089 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T42", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1134, 1150 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T43", "type": "Condition", "text": [ "idiosyncratic reaction" ], "offsets": [ [ 1154, 1176 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T44", "type": "Drug", "text": [ "study drug" ], "offsets": [ [ 1184, 1194 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T45", "type": "Negation", "text": [ "no" ], "offsets": [ [ 1114, 1116 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T46", "type": "Drug", "text": [ "prescription medication" ], "offsets": [ [ 1247, 1270 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T47", "type": "Temporal", "text": [ "within 14 days prior to", "the study" ], "offsets": [ [ 1271, 1294 ], [ 1305, 1314 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T48", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 1298, 1314 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T49", "type": "Scope", "text": [ "within 14 days prior to or during the study" ], "offsets": [ [ 1271, 1314 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T50", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1232, 1235 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T51", "type": "Temporal", "text": [ "within 7 days prior to", "the study" ], "offsets": [ [ 1374, 1396 ], [ 1407, 1416 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T52", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 1400, 1416 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T53", "type": "Scope", "text": [ "within 7 days prior to or during the study" ], "offsets": [ [ 1374, 1416 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T54", "type": "Drug", "text": [ "over-the-counter medication" ], "offsets": [ [ 1346, 1373 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T55", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1331, 1334 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T56", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 1469, 1479 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T57", "type": "Condition", "text": [ "alcohol", "abuse" ], "offsets": [ [ 1458, 1465 ], [ 1474, 1479 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T58", "type": "Temporal", "text": [ "within 2 years prior to the study" ], "offsets": [ [ 1480, 1513 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T59", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 1504, 1513 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T60", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 1407, 1416 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T61", "type": "Scope", "text": [ "alcohol or drug abuse" ], "offsets": [ [ 1458, 1479 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T62", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1447, 1454 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T63", "type": "Condition", "text": [ "use of cannabis" ], "offsets": [ [ 1551, 1566 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T64", "type": "Negation", "text": [ "not excluded" ], "offsets": [ [ 1572, 1584 ] ], "normalized": [] }, { "id": "NCT01322464_exc_T66", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1433, 1436 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01322464_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01322464_exc_T7", "arg2_id": "NCT01322464_exc_T8", "normalized": [] }, { "id": "NCT01322464_exc_R2", "type": "Has_scope", "arg1_id": "NCT01322464_exc_T14", "arg2_id": "NCT01322464_exc_T13", "normalized": [] }, { "id": "NCT01322464_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T15", "arg2_id": "NCT01322464_exc_T17", "normalized": [] }, { "id": "NCT01322464_exc_R4", "type": "Has_value", "arg1_id": "NCT01322464_exc_T15", "arg2_id": "NCT01322464_exc_T16", "normalized": [] }, { "id": "NCT01322464_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T19", "arg2_id": "NCT01322464_exc_T18", "normalized": [] }, { "id": "NCT01322464_exc_R6", "type": "Has_index", "arg1_id": "NCT01322464_exc_T22", "arg2_id": "NCT01322464_exc_T23", "normalized": [] }, { "id": "NCT01322464_exc_R7", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T21", "arg2_id": "NCT01322464_exc_T24", "normalized": [] }, { "id": "NCT01322464_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T21", "arg2_id": "NCT01322464_exc_T22", "normalized": [] }, { "id": "NCT01322464_exc_R9", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T16", "arg2_id": "NCT01322464_exc_T25", "normalized": [] }, { "id": "NCT01322464_exc_R10", "type": "Has_index", "arg1_id": "NCT01322464_exc_T28", "arg2_id": "NCT01322464_exc_T29", "normalized": [] }, { "id": "NCT01322464_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T26", "arg2_id": "NCT01322464_exc_T28", "normalized": [] }, { "id": "NCT01322464_exc_R12", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T26", "arg2_id": "NCT01322464_exc_T27", "normalized": [] }, { "id": "NCT01322464_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01322464_exc_T31", "arg2_id": "NCT01322464_exc_T32", "normalized": [] }, { "id": "NCT01322464_exc_R14", "type": "Has_index", "arg1_id": "NCT01322464_exc_T33", "arg2_id": "NCT01322464_exc_T34", "normalized": [] }, { "id": "NCT01322464_exc_R15", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T35", "arg2_id": "NCT01322464_exc_T36", "normalized": [] }, { "id": "NCT01322464_exc_R16", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T35", "arg2_id": "NCT01322464_exc_T33", "normalized": [] }, { "id": "NCT01322464_exc_R17", "type": "AND", "arg1_id": "NCT01322464_exc_T43", "arg2_id": "NCT01322464_exc_T44", "normalized": [] }, { "id": "NCT01322464_exc_R18", "type": "AND", "arg1_id": "NCT01322464_exc_T42", "arg2_id": "NCT01322464_exc_T44", "normalized": [] }, { "id": "NCT01322464_exc_R19", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T42", "arg2_id": "NCT01322464_exc_T45", "normalized": [] }, { "id": "NCT01322464_exc_R20", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T43", "arg2_id": "NCT01322464_exc_T45", "normalized": [] }, { "id": "NCT01322464_exc_R21", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T46", "arg2_id": "NCT01322464_exc_T50", "normalized": [] }, { "id": "NCT01322464_exc_R22", "type": "Has_scope", "arg1_id": "NCT01322464_exc_T46", "arg2_id": "NCT01322464_exc_T49", "normalized": [] }, { "id": "NCT01322464_exc_R23", "type": "Has_scope", "arg1_id": "NCT01322464_exc_T54", "arg2_id": "NCT01322464_exc_T53", "normalized": [] }, { "id": "NCT01322464_exc_R24", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T54", "arg2_id": "NCT01322464_exc_T55", "normalized": [] }, { "id": "NCT01322464_exc_R25", "type": "Has_index", "arg1_id": "NCT01322464_exc_T58", "arg2_id": "NCT01322464_exc_T59", "normalized": [] }, { "id": "NCT01322464_exc_R26", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T61", "arg2_id": "NCT01322464_exc_T58", "normalized": [] }, { "id": "NCT01322464_exc_R27", "type": "Has_temporal", "arg1_id": "NCT01322464_exc_T61", "arg2_id": "NCT01322464_exc_T62", "normalized": [] }, { "id": "NCT01322464_exc_R28", "type": "Has_negation", "arg1_id": "NCT01322464_exc_T61", "arg2_id": "NCT01322464_exc_T66", "normalized": [] } ]

[ { "id": "NCT01322464_inc_text", "type": "inclusion", "text": [ "Healthy males between 18 and 45 years of age (inclusive). \nBody mass index to be between 18 to 30 kg/m2 (inclusive) as calculated by weight(Kg)/height(m2). \nSubjects were to have no clinically significant abnormal findings on physical examination, ECG, medical history, or clinical laboratory results during screening. \nSubjects were to, in the opinion of the investigator, have no clinically significant abnormal findings of renal and hepatic function as determined by serum creatinine, total bilirubin, and transaminase levels. \nSubjects were to be non-users of tobacco products (minimum of 6 months prior to the start of the study). \nSubjects were to have a negative screen for HIV I and II, HBsAg, and antibody to Hepatitis C virus. \nSubjects were to have a negative urine screen for alcohol, drugs of abuse (screening only), and cotinine. \nSubjects were to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g.female condom or occlusive cap with spermicide) during the study and for 3 months following administration of the study drug. \nSubjects were able to comply with the protocol and the restrictions and assessments therein. \nSubjects were to give voluntary written informed consent to participate in the trial. \n" ], "offsets": [ [ 0, 1335 ] ] } ]

[ { "id": "NCT01322464_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T2", "type": "Value", "text": [ "between 18 and 45 years" ], "offsets": [ [ 14, 37 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 41, 44 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T4", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 59, 74 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T5", "type": "Value", "text": [ "between 18 to 30 kg/m2" ], "offsets": [ [ 81, 103 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T6", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 182, 204 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T8", "type": "Condition", "text": [ "abnormal findings" ], "offsets": [ [ 205, 222 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T9", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 226, 246 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T10", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 248, 251 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T11", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 253, 268 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T12", "type": "Procedure", "text": [ "clinical laboratory" ], "offsets": [ [ 273, 292 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T13", "type": "Temporal", "text": [ "during screening" ], "offsets": [ [ 301, 317 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T14", "type": "Negation", "text": [ "no" ], "offsets": [ [ 179, 181 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T15", "type": "Scope", "text": [ "physical examination, ECG, medical history, or clinical laboratory" ], "offsets": [ [ 226, 292 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T17", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 470, 486 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T18", "type": "Measurement", "text": [ "total bilirubin" ], "offsets": [ [ 488, 503 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T19", "type": "Measurement", "text": [ "transaminase levels" ], "offsets": [ [ 509, 528 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T20", "type": "Measurement", "text": [ "hepatic function" ], "offsets": [ [ 436, 452 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T21", "type": "Measurement", "text": [ "renal", "function" ], "offsets": [ [ 426, 431 ], [ 444, 452 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T22", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 382, 404 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T23", "type": "Condition", "text": [ "abnormal findings" ], "offsets": [ [ 405, 422 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T24", "type": "Scope", "text": [ "renal and hepatic function" ], "offsets": [ [ 426, 452 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T25", "type": "Scope", "text": [ "serum creatinine, total bilirubin, and transaminase levels" ], "offsets": [ [ 470, 528 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T26", "type": "Negation", "text": [ "no" ], "offsets": [ [ 379, 381 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T27", "type": "Condition", "text": [ "users of tobacco products" ], "offsets": [ [ 555, 580 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T28", "type": "Negation", "text": [ "non" ], "offsets": [ [ 551, 554 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T29", "type": "Temporal", "text": [ "minimum of 6 months prior to the start of the study" ], "offsets": [ [ 582, 633 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T30", "type": "Reference_point", "text": [ "the start of the study" ], "offsets": [ [ 611, 633 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T31", "type": "Measurement", "text": [ "screen for HIV I" ], "offsets": [ [ 670, 686 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T32", "type": "Measurement", "text": [ "screen for HIV", "II" ], "offsets": [ [ 670, 684 ], [ 691, 693 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T33", "type": "Value", "text": [ "negative" ], "offsets": [ [ 661, 669 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T34", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 695, 700 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T35", "type": "Measurement", "text": [ "antibody to Hepatitis C virus" ], "offsets": [ [ 706, 735 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T36", "type": "Measurement", "text": [ "urine screen for alcohol" ], "offsets": [ [ 771, 795 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T37", "type": "Measurement", "text": [ "urine screen for", "drugs of abuse" ], "offsets": [ [ 771, 787 ], [ 797, 811 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T38", "type": "Measurement", "text": [ "urine screen for", "cotinine" ], "offsets": [ [ 771, 787 ], [ 834, 842 ] ], "normalized": [] }, { "id": "NCT01322464_inc_T39", "type": "Value", "text": [ "negative" ], "offsets": [ [ 762, 770 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01322464_inc_R1", "type": "Has_value", "arg1_id": "NCT01322464_inc_T3", "arg2_id": "NCT01322464_inc_T2", "normalized": [] }, { "id": "NCT01322464_inc_R2", "type": "Has_value", "arg1_id": "NCT01322464_inc_T4", "arg2_id": "NCT01322464_inc_T5", "normalized": [] }, { "id": "NCT01322464_inc_R3", "type": "Has_negation", "arg1_id": "NCT01322464_inc_T8", "arg2_id": "NCT01322464_inc_T14", "normalized": [] }, { "id": "NCT01322464_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01322464_inc_T8", "arg2_id": "NCT01322464_inc_T6", "normalized": [] }, { "id": "NCT01322464_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01322464_inc_T8", "arg2_id": "NCT01322464_inc_T13", "normalized": [] }, { "id": "NCT01322464_inc_R6", "type": "Has_scope", "arg1_id": "NCT01322464_inc_T8", "arg2_id": "NCT01322464_inc_T15", "normalized": [] }, { "id": "NCT01322464_inc_R7", "type": "Has_scope", "arg1_id": "NCT01322464_inc_T23", "arg2_id": "NCT01322464_inc_T24", "normalized": [] }, { "id": "NCT01322464_inc_R8", "type": "Subsumes", "arg1_id": "NCT01322464_inc_T24", "arg2_id": "NCT01322464_inc_T25", "normalized": [] }, { "id": "NCT01322464_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT01322464_inc_T23", "arg2_id": "NCT01322464_inc_T22", "normalized": [] }, { "id": "NCT01322464_inc_R10", "type": "Has_negation", "arg1_id": "NCT01322464_inc_T23", "arg2_id": "NCT01322464_inc_T26", "normalized": [] }, { "id": "NCT01322464_inc_R11", "type": "Has_negation", "arg1_id": "NCT01322464_inc_T27", "arg2_id": "NCT01322464_inc_T28", "normalized": [] }, { "id": "NCT01322464_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01322464_inc_T27", "arg2_id": "NCT01322464_inc_T29", "normalized": [] }, { "id": "NCT01322464_inc_R13", "type": "Has_value", "arg1_id": "NCT01322464_inc_T32", "arg2_id": "NCT01322464_inc_T33", "normalized": [] }, { "id": "NCT01322464_inc_R14", "type": "Has_value", "arg1_id": "NCT01322464_inc_T31", "arg2_id": "NCT01322464_inc_T33", "normalized": [] }, { "id": "NCT01322464_inc_R15", "type": "Has_value", "arg1_id": "NCT01322464_inc_T34", "arg2_id": "NCT01322464_inc_T33", "normalized": [] }, { "id": "NCT01322464_inc_R16", "type": "Has_value", "arg1_id": "NCT01322464_inc_T35", "arg2_id": "NCT01322464_inc_T33", "normalized": [] }, { "id": "NCT01322464_inc_R17", "type": "Has_value", "arg1_id": "NCT01322464_inc_T38", "arg2_id": "NCT01322464_inc_T39", "normalized": [] }, { "id": "NCT01322464_inc_R18", "type": "Has_value", "arg1_id": "NCT01322464_inc_T37", "arg2_id": "NCT01322464_inc_T39", "normalized": [] }, { "id": "NCT01322464_inc_R19", "type": "Has_value", "arg1_id": "NCT01322464_inc_T36", "arg2_id": "NCT01322464_inc_T39", "normalized": [] } ]

[ { "id": "NCT01346436_exc_text", "type": "exclusion", "text": [ "Age <18 years old\nPatient unable to communicate or to understand the study\nPatient refusing to participate to the study\ncontraindication to laparoscopy\n" ], "offsets": [ [ 0, 152 ] ] } ]

[ { "id": "NCT01346436_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01346436_exc_T2", "type": "Value", "text": [ "<18 years old" ], "offsets": [ [ 4, 17 ] ], "normalized": [] }, { "id": "NCT01346436_exc_T5", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 120, 136 ] ], "normalized": [] }, { "id": "NCT01346436_exc_T6", "type": "Procedure", "text": [ "laparoscopy" ], "offsets": [ [ 140, 151 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01346436_exc_R1", "type": "Has_value", "arg1_id": "NCT01346436_exc_T1", "arg2_id": "NCT01346436_exc_T2", "normalized": [] }, { "id": "NCT01346436_exc_R2", "type": "AND", "arg1_id": "NCT01346436_exc_T5", "arg2_id": "NCT01346436_exc_T6", "normalized": [] } ]

[ { "id": "NCT01346436_inc_text", "type": "inclusion", "text": [ "women\nproven pelvic floor dysfunction\ninformed consent\n" ], "offsets": [ [ 0, 55 ] ] } ]

[ { "id": "NCT01346436_inc_T1", "type": "Person", "text": [ "women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01346436_inc_T2", "type": "Condition", "text": [ "pelvic floor dysfunction" ], "offsets": [ [ 13, 37 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT01349413_exc_text", "type": "exclusion", "text": [ "Presence of organic pathology identified by upper endoscopy or other investigations\nPresence of sliding hiatus hernia as defined by flap valve grade IV disruption of morphology at gastro-esophageal junction\nConcurrent medications that affect gastrointestinal motility\nPresence of acid reflux or heartburn symptoms of more than twice a month\nHistory of gastric surgery\nH. pylori infection\nUse of PPI or NSAID in the past 4 weeks\nPregnancy\nKnown hypersensitivity to PPI\n" ], "offsets": [ [ 0, 468 ] ] } ]

[ { "id": "NCT01349413_exc_T1", "type": "Procedure", "text": [ "upper endoscopy" ], "offsets": [ [ 44, 59 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T2", "type": "Condition", "text": [ "organic pathology" ], "offsets": [ [ 12, 29 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T3", "type": "Procedure", "text": [ "investigations" ], "offsets": [ [ 69, 83 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T4", "type": "Scope", "text": [ "upper endoscopy or other investigations" ], "offsets": [ [ 44, 83 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T5", "type": "Condition", "text": [ "hiatus hernia" ], "offsets": [ [ 104, 117 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T6", "type": "Qualifier", "text": [ "sliding" ], "offsets": [ [ 96, 103 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T7", "type": "Measurement", "text": [ "lap valve", "isruption of morphology" ], "offsets": [ [ 133, 142 ], [ 153, 176 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T8", "type": "Value", "text": [ "grade IV" ], "offsets": [ [ 143, 151 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T9", "type": "Qualifier", "text": [ "at gastro-esophageal junction" ], "offsets": [ [ 177, 206 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T10", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 218, 229 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T11", "type": "Condition", "text": [ "gastrointestinal motility" ], "offsets": [ [ 242, 267 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T12", "type": "Condition", "text": [ "acid reflux" ], "offsets": [ [ 280, 291 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T13", "type": "Condition", "text": [ "heartburn symptoms" ], "offsets": [ [ 295, 313 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T14", "type": "Temporal", "text": [ "more than twice a month" ], "offsets": [ [ 317, 340 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T15", "type": "Scope", "text": [ "acid reflux or heartburn symptoms" ], "offsets": [ [ 280, 313 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T16", "type": "Procedure", "text": [ "gastric surgery" ], "offsets": [ [ 352, 367 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T17", "type": "Condition", "text": [ "H. pylori infection" ], "offsets": [ [ 368, 387 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T18", "type": "Drug", "text": [ "PPI" ], "offsets": [ [ 395, 398 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T19", "type": "Drug", "text": [ "NSAID" ], "offsets": [ [ 402, 407 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T20", "type": "Temporal", "text": [ "in the past 4 weeks" ], "offsets": [ [ 408, 427 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T21", "type": "Scope", "text": [ "PPI or NSAID" ], "offsets": [ [ 395, 407 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T22", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 428, 437 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T23", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 444, 460 ] ], "normalized": [] }, { "id": "NCT01349413_exc_T24", "type": "Drug", "text": [ "PPI" ], "offsets": [ [ 464, 467 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01349413_exc_R1", "type": "AND", "arg1_id": "NCT01349413_exc_T4", "arg2_id": "NCT01349413_exc_T2", "normalized": [] }, { "id": "NCT01349413_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01349413_exc_T5", "arg2_id": "NCT01349413_exc_T6", "normalized": [] }, { "id": "NCT01349413_exc_R3", "type": "Has_value", "arg1_id": "NCT01349413_exc_T7", "arg2_id": "NCT01349413_exc_T8", "normalized": [] }, { "id": "NCT01349413_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01349413_exc_T5", "arg2_id": "NCT01349413_exc_T9", "normalized": [] }, { "id": "NCT01349413_exc_R5", "type": "AND", "arg1_id": "NCT01349413_exc_T7", "arg2_id": "NCT01349413_exc_T5", "normalized": [] }, { "id": "NCT01349413_exc_R6", "type": "AND", "arg1_id": "NCT01349413_exc_T10", "arg2_id": "NCT01349413_exc_T11", "normalized": [] }, { "id": "NCT01349413_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01349413_exc_T15", "arg2_id": "NCT01349413_exc_T14", "normalized": [] }, { "id": "NCT01349413_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01349413_exc_T21", "arg2_id": "NCT01349413_exc_T20", "normalized": [] }, { "id": "NCT01349413_exc_R9", "type": "AND", "arg1_id": "NCT01349413_exc_T23", "arg2_id": "NCT01349413_exc_T24", "normalized": [] } ]

[ { "id": "NCT01349413_inc_text", "type": "inclusion", "text": [ "Patients with functional dyspepsia that fulfill Rome III criteria with inadequate relief of dyspeptic symptoms\nAge >18\nProvision of written consent\n" ], "offsets": [ [ 0, 148 ] ] } ]

[ { "id": "NCT01349413_inc_T1", "type": "Condition", "text": [ "functional dyspepsia" ], "offsets": [ [ 14, 34 ] ], "normalized": [] }, { "id": "NCT01349413_inc_T2", "type": "Qualifier", "text": [ "Rome III criteria" ], "offsets": [ [ 48, 65 ] ], "normalized": [] }, { "id": "NCT01349413_inc_T3", "type": "Qualifier", "text": [ "inadequate relief" ], "offsets": [ [ 71, 88 ] ], "normalized": [] }, { "id": "NCT01349413_inc_T4", "type": "Condition", "text": [ "dyspeptic symptoms" ], "offsets": [ [ 92, 110 ] ], "normalized": [] }, { "id": "NCT01349413_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 111, 114 ] ], "normalized": [] }, { "id": "NCT01349413_inc_T6", "type": "Value", "text": [ ">18" ], "offsets": [ [ 115, 118 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01349413_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01349413_inc_T4", "arg2_id": "NCT01349413_inc_T3", "normalized": [] }, { "id": "NCT01349413_inc_R2", "type": "AND", "arg1_id": "NCT01349413_inc_T1", "arg2_id": "NCT01349413_inc_T4", "normalized": [] }, { "id": "NCT01349413_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01349413_inc_T1", "arg2_id": "NCT01349413_inc_T2", "normalized": [] } ]

[ { "id": "NCT01352598_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01352598_inc_text", "type": "inclusion", "text": [ "Patient age >= 18 years\nZubrod performance status of 0-3\nT1-3 N0 M0 adenocarcinoma of the prostate\nProstate volume = 100 cc\nSigned study-specific consent form\nExtension of local tumor to involve adjacent organs other than seminal vesicles (T4)\nProstate volume > 100 cc\nNodal involvement\nMetastatic disease\nPrior pelvic radiotherapy except as part of combination therapy for prostate cancer\nHistory of scleroderma\nPatients with psychiatric or addictive disorder that would preclude obtaining informed consent\n" ], "offsets": [ [ 0, 508 ] ] } ]

[ { "id": "NCT01352598_inc_T1", "type": "Person", "text": [ "Patient age" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T2", "type": "Value", "text": [ ">= 18 years" ], "offsets": [ [ 12, 23 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T3", "type": "Measurement", "text": [ "Zubrod performance status" ], "offsets": [ [ 24, 49 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T4", "type": "Value", "text": [ "0-3" ], "offsets": [ [ 53, 56 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T5", "type": "Measurement", "text": [ "T" ], "offsets": [ [ 57, 58 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T6", "type": "Value", "text": [ "1-3" ], "offsets": [ [ 58, 61 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T7", "type": "Measurement", "text": [ "N" ], "offsets": [ [ 62, 63 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T8", "type": "Measurement", "text": [ "M" ], "offsets": [ [ 65, 66 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T9", "type": "Value", "text": [ "0" ], "offsets": [ [ 66, 67 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T10", "type": "Value", "text": [ "0" ], "offsets": [ [ 66, 67 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T11", "type": "Scope", "text": [ "T1-3 N0 M0" ], "offsets": [ [ 57, 67 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T12", "type": "Condition", "text": [ "adenocarcinoma" ], "offsets": [ [ 68, 82 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T13", "type": "Qualifier", "text": [ "prostate" ], "offsets": [ [ 90, 98 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T14", "type": "Measurement", "text": [ "Prostate volume" ], "offsets": [ [ 99, 114 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T15", "type": "Value", "text": [ "= 100 cc" ], "offsets": [ [ 115, 123 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T17", "type": "Condition", "text": [ "Extension of local tumor" ], "offsets": [ [ 159, 183 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T18", "type": "Qualifier", "text": [ "adjacent organs" ], "offsets": [ [ 195, 210 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T19", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 211, 221 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T20", "type": "Qualifier", "text": [ "seminal vesicles" ], "offsets": [ [ 222, 238 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T21", "type": "Scope", "text": [ "adjacent organs other than seminal vesicles" ], "offsets": [ [ 195, 238 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T22", "type": "Measurement", "text": [ "Prostate volume" ], "offsets": [ [ 244, 259 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T23", "type": "Value", "text": [ "> 100 cc" ], "offsets": [ [ 260, 268 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T24", "type": "Condition", "text": [ "Nodal involvement" ], "offsets": [ [ 269, 286 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T25", "type": "Condition", "text": [ "Metastatic disease" ], "offsets": [ [ 287, 305 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T26", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 306, 311 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T27", "type": "Qualifier", "text": [ "pelvic" ], "offsets": [ [ 312, 318 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T28", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 319, 331 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T29", "type": "Negation", "text": [ "except" ], "offsets": [ [ 332, 338 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T30", "type": "Procedure", "text": [ "combination therapy" ], "offsets": [ [ 350, 369 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T31", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 374, 389 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T32", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 374, 389 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T33", "type": "Observation", "text": [ "History" ], "offsets": [ [ 390, 397 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T34", "type": "Condition", "text": [ "scleroderma" ], "offsets": [ [ 401, 412 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T35", "type": "Condition", "text": [ " or addict", "at would" ], "offsets": [ [ 438, 448 ], [ 463, 471 ] ], "normalized": [] }, { "id": "NCT01352598_inc_T36", "type": "Condition", "text": [ "addictive disorder" ], "offsets": [ [ 442, 460 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01352598_inc_R1", "type": "Has_value", "arg1_id": "NCT01352598_inc_T1", "arg2_id": "NCT01352598_inc_T2", "normalized": [] }, { "id": "NCT01352598_inc_R2", "type": "Has_value", "arg1_id": "NCT01352598_inc_T3", "arg2_id": "NCT01352598_inc_T4", "normalized": [] }, { "id": "NCT01352598_inc_R3", "type": "Has_value", "arg1_id": "NCT01352598_inc_T7", "arg2_id": "NCT01352598_inc_T9", "normalized": [] }, { "id": "NCT01352598_inc_R4", "type": "Has_value", "arg1_id": "NCT01352598_inc_T8", "arg2_id": "NCT01352598_inc_T10", "normalized": [] }, { "id": "NCT01352598_inc_R5", "type": "Has_value", "arg1_id": "NCT01352598_inc_T5", "arg2_id": "NCT01352598_inc_T6", "normalized": [] }, { "id": "NCT01352598_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01352598_inc_T12", "arg2_id": "NCT01352598_inc_T13", "normalized": [] }, { "id": "NCT01352598_inc_R7", "type": "Has_scope", "arg1_id": "NCT01352598_inc_T12", "arg2_id": "NCT01352598_inc_T11", "normalized": [] }, { "id": "NCT01352598_inc_R8", "type": "Has_value", "arg1_id": "NCT01352598_inc_T14", "arg2_id": "NCT01352598_inc_T15", "normalized": [] }, { "id": "NCT01352598_inc_R9", "type": "Has_negation", "arg1_id": "NCT01352598_inc_T20", "arg2_id": "NCT01352598_inc_T19", "normalized": [] }, { "id": "NCT01352598_inc_R10", "type": "Has_scope", "arg1_id": "NCT01352598_inc_T17", "arg2_id": "NCT01352598_inc_T21", "normalized": [] }, { "id": "NCT01352598_inc_R11", "type": "Has_value", "arg1_id": "NCT01352598_inc_T22", "arg2_id": "NCT01352598_inc_T23", "normalized": [] }, { "id": "NCT01352598_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT01352598_inc_T28", "arg2_id": "NCT01352598_inc_T27", "normalized": [] }, { "id": "NCT01352598_inc_R13", "type": "Has_temporal", "arg1_id": "NCT01352598_inc_T28", "arg2_id": "NCT01352598_inc_T26", "normalized": [] }, { "id": "NCT01352598_inc_R14", "type": "AND", "arg1_id": "NCT01352598_inc_T30", "arg2_id": "NCT01352598_inc_T31", "normalized": [] }, { "id": "NCT01352598_inc_R15", "type": "AND", "arg1_id": "NCT01352598_inc_T30", "arg2_id": "NCT01352598_inc_T32", "normalized": [] }, { "id": "NCT01352598_inc_R16", "type": "Has_negation", "arg1_id": "NCT01352598_inc_T30", "arg2_id": "NCT01352598_inc_T29", "normalized": [] }, { "id": "NCT01352598_inc_R17", "type": "AND", "arg1_id": "NCT01352598_inc_T28", "arg2_id": "NCT01352598_inc_T30", "normalized": [] }, { "id": "NCT01352598_inc_R18", "type": "Has_temporal", "arg1_id": "NCT01352598_inc_T34", "arg2_id": "NCT01352598_inc_T33", "normalized": [] } ]

[ { "id": "NCT01373684_exc_text", "type": "exclusion", "text": [ "Treatment with any investigational drug within 30 days of entry to this protocol\nCurrent treatment with Telbivudine\nSevere hepatitis activity as documented by ALT>10 x ULN\nHistory of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)\nPre-existent neutropenia (neutrophils <1,500/mm3) or thrombocytopenia (platelets < 90,000/mm3)\nCo-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)\nOther acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency\nAlpha fetoprotein > 50 ng/ml\nHyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)\nImmune suppressive treatment within the previous 6 months\nContra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.\nPregnancy, breast-feeding\nOther significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)\nAny medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study\nSubstance abuse, such as alcohol (>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.\nAny other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study\n" ], "offsets": [ [ 0, 2003 ] ] } ]

[ { "id": "NCT01373684_exc_T2", "type": "Drug", "text": [ "Telbivudine" ], "offsets": [ [ 104, 115 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T3", "type": "Condition", "text": [ "hepatitis" ], "offsets": [ [ 123, 132 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T4", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 116, 122 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T5", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 159, 162 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T6", "type": "Value", "text": [ ">10 x ULN" ], "offsets": [ [ 162, 171 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T7", "type": "Condition", "text": [ "cirrhosis" ], "offsets": [ [ 197, 206 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T8", "type": "Qualifier", "text": [ "decompensated" ], "offsets": [ [ 183, 196 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T9", "type": "Condition", "text": [ "jaundice" ], "offsets": [ [ 219, 227 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T10", "type": "Condition", "text": [ "cirrhosis" ], "offsets": [ [ 247, 256 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T11", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 258, 265 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T12", "type": "Condition", "text": [ "bleeding gastric" ], "offsets": [ [ 267, 283 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T13", "type": "Condition", "text": [ "esophageal varices" ], "offsets": [ [ 287, 305 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T14", "type": "Condition", "text": [ "encephalopathy" ], "offsets": [ [ 309, 323 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T15", "type": "Scope", "text": [ "defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy" ], "offsets": [ [ 208, 323 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T16", "type": "Condition", "text": [ "neutropenia" ], "offsets": [ [ 338, 349 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T17", "type": "Qualifier", "text": [ "Pre-existent" ], "offsets": [ [ 325, 337 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T18", "type": "Measurement", "text": [ "neutrophils" ], "offsets": [ [ 351, 362 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T19", "type": "Value", "text": [ "<1,500/mm3" ], "offsets": [ [ 363, 373 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T20", "type": "Condition", "text": [ "thrombocytopenia" ], "offsets": [ [ 378, 394 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T21", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 396, 405 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T22", "type": "Value", "text": [ "< 90,000/mm3" ], "offsets": [ [ 406, 418 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T23", "type": "Qualifier", "text": [ "hepatitis C virus" ], "offsets": [ [ 438, 455 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T24", "type": "Qualifier", "text": [ "hepatitis D virus" ], "offsets": [ [ 457, 474 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T25", "type": "Qualifier", "text": [ "human immunodeficiency virus" ], "offsets": [ [ 478, 506 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T26", "type": "Qualifier", "text": [ "HIV" ], "offsets": [ [ 508, 511 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T27", "type": "Condition", "text": [ "Co-infection" ], "offsets": [ [ 420, 432 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T28", "type": "Scope", "text": [ "hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV" ], "offsets": [ [ 438, 511 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T29", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 551, 564 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T30", "type": "Qualifier", "text": [ "inherited" ], "offsets": [ [ 531, 540 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T31", "type": "Qualifier", "text": [ "acquired" ], "offsets": [ [ 519, 527 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T32", "type": "Scope", "text": [ "acquired or inherited" ], "offsets": [ [ 519, 540 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T33", "type": "Condition", "text": [ "alcoholic liver disease" ], "offsets": [ [ 566, 589 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T34", "type": "Condition", "text": [ "obesity induced liver disease" ], "offsets": [ [ 591, 620 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T35", "type": "Condition", "text": [ "drug related liver disease" ], "offsets": [ [ 622, 648 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T36", "type": "Condition", "text": [ "auto-immune hepatitis" ], "offsets": [ [ 650, 671 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T37", "type": "Condition", "text": [ "hemochromatosis" ], "offsets": [ [ 673, 688 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T38", "type": "Condition", "text": [ "Wilson's disease" ], "offsets": [ [ 690, 706 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T39", "type": "Condition", "text": [ "alpha-1 antitrypsin deficiency" ], "offsets": [ [ 710, 740 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T40", "type": "Scope", "text": [ "alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficienc" ], "offsets": [ [ 566, 739 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T41", "type": "Measurement", "text": [ "Alpha fetoprotein" ], "offsets": [ [ 741, 758 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T42", "type": "Value", "text": [ "> 50 ng/ml" ], "offsets": [ [ 759, 769 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T43", "type": "Condition", "text": [ "hypothyroidism" ], "offsets": [ [ 780, 794 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T44", "type": "Condition", "text": [ "r hyp", "sm (subjec" ], "offsets": [ [ 778, 783 ], [ 792, 802 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T45", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 815, 825 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T47", "type": "Procedure", "text": [ "Immune suppressive treatment" ], "offsets": [ [ 933, 961 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T48", "type": "Temporal", "text": [ "within the previous 6 months" ], "offsets": [ [ 962, 990 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T49", "type": "Condition", "text": [ "Contra-indications" ], "offsets": [ [ 991, 1009 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T50", "type": "Drug", "text": [ "alfa-interferon therapy" ], "offsets": [ [ 1014, 1037 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T51", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1053, 1069 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T52", "type": "Drug", "text": [ "interferon" ], "offsets": [ [ 1090, 1100 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T53", "type": "Drug", "text": [ "Peginterferon" ], "offsets": [ [ 1087, 1100 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T55", "type": "Scope", "text": [ "interferon or Peginterferon" ], "offsets": [ [ 1073, 1100 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T57", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1263, 1274 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T58", "type": "Condition", "text": [ "medical illness" ], "offsets": [ [ 1275, 1290 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T59", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1329, 1340 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T60", "type": "Condition", "text": [ "pulmonary dysfunction" ], "offsets": [ [ 1341, 1362 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T61", "type": "Temporal", "text": [ "in the previous 6 months" ], "offsets": [ [ 1363, 1387 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T62", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1389, 1399 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T63", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1400, 1410 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T64", "type": "Condition", "text": [ "skin basocellular carcinoma" ], "offsets": [ [ 1411, 1438 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T65", "type": "Temporal", "text": [ "in previous 5 years" ], "offsets": [ [ 1439, 1458 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T66", "type": "Condition", "text": [ "immunodeficiency syndromes" ], "offsets": [ [ 1460, 1486 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T67", "type": "Condition", "text": [ "HIV positivity" ], "offsets": [ [ 1493, 1507 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T68", "type": "Condition", "text": [ "auto-immune diseases" ], "offsets": [ [ 1509, 1529 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T69", "type": "Procedure", "text": [ "organ transplants" ], "offsets": [ [ 1531, 1548 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T70", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1549, 1559 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T71", "type": "Procedure", "text": [ "air tr", "Any medica" ], "offsets": [ [ 1572, 1578 ], [ 1588, 1598 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T72", "type": "Procedure", "text": [ "hair transplant" ], "offsets": [ [ 1571, 1586 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T73", "type": "Scope", "text": [ "cornea and hair transplant" ], "offsets": [ [ 1560, 1586 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T74", "type": "Scope", "text": [ "organ transplants other than cornea and hair transplant" ], "offsets": [ [ 1531, 1586 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T75", "type": "Scope", "text": [ "HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant" ], "offsets": [ [ 1493, 1586 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T76", "type": "Scope", "text": [ "malignancy other than skin basocellular carcinoma in previous 5 years" ], "offsets": [ [ 1389, 1458 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T77", "type": "Scope", "text": [ "significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant" ], "offsets": [ [ 1329, 1586 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T78", "type": "Drug", "text": [ "nistrati", "ing the" ], "offsets": [ [ 1663, 1671 ], [ 1690, 1697 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T79", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 1642, 1649 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T80", "type": "Temporal", "text": [ "during the course of the study" ], "offsets": [ [ 1687, 1717 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T81", "type": "Reference_point", "text": [ "course of the study" ], "offsets": [ [ 1698, 1717 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T82", "type": "Condition", "text": [ "Substance abuse" ], "offsets": [ [ 1718, 1733 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T83", "type": "Qualifier", "text": [ "alcohol" ], "offsets": [ [ 1743, 1750 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T84", "type": "Qualifier", "text": [ "I.V. drugs" ], "offsets": [ [ 1764, 1774 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T85", "type": "Qualifier", "text": [ "inhaled drugs" ], "offsets": [ [ 1779, 1792 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T86", "type": "Temporal", "text": [ "in the past 2 years." ], "offsets": [ [ 1793, 1813 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T87", "type": "Multiplier", "text": [ ">80 g/day" ], "offsets": [ [ 1752, 1761 ] ], "normalized": [] }, { "id": "NCT01373684_exc_T88", "type": "Scope", "text": [ "alcohol (>80 g/day), I.V. drugs and inhaled drugs" ], "offsets": [ [ 1743, 1792 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01373684_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T3", "arg2_id": "NCT01373684_exc_T4", "normalized": [] }, { "id": "NCT01373684_exc_R2", "type": "Has_value", "arg1_id": "NCT01373684_exc_T5", "arg2_id": "NCT01373684_exc_T6", "normalized": [] }, { "id": "NCT01373684_exc_R3", "type": "AND", "arg1_id": "NCT01373684_exc_T3", "arg2_id": "NCT01373684_exc_T5", "normalized": [] }, { "id": "NCT01373684_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T7", "arg2_id": "NCT01373684_exc_T8", "normalized": [] }, { "id": "NCT01373684_exc_R5", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T7", "arg2_id": "NCT01373684_exc_T15", "normalized": [] }, { "id": "NCT01373684_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T16", "arg2_id": "NCT01373684_exc_T17", "normalized": [] }, { "id": "NCT01373684_exc_R7", "type": "Has_value", "arg1_id": "NCT01373684_exc_T18", "arg2_id": "NCT01373684_exc_T19", "normalized": [] }, { "id": "NCT01373684_exc_R8", "type": "Has_value", "arg1_id": "NCT01373684_exc_T21", "arg2_id": "NCT01373684_exc_T22", "normalized": [] }, { "id": "NCT01373684_exc_R9", "type": "AND", "arg1_id": "NCT01373684_exc_T20", "arg2_id": "NCT01373684_exc_T21", "normalized": [] }, { "id": "NCT01373684_exc_R10", "type": "AND", "arg1_id": "NCT01373684_exc_T16", "arg2_id": "NCT01373684_exc_T18", "normalized": [] }, { "id": "NCT01373684_exc_R11", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T25", "arg2_id": "NCT01373684_exc_T26", "normalized": [] }, { "id": "NCT01373684_exc_R12", "type": "Has_scope", "arg1_id": "NCT01373684_exc_T27", "arg2_id": "NCT01373684_exc_T28", "normalized": [] }, { "id": "NCT01373684_exc_R13", "type": "Has_scope", "arg1_id": "NCT01373684_exc_T29", "arg2_id": "NCT01373684_exc_T32", "normalized": [] }, { "id": "NCT01373684_exc_R14", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T29", "arg2_id": "NCT01373684_exc_T40", "normalized": [] }, { "id": "NCT01373684_exc_R15", "type": "Has_value", "arg1_id": "NCT01373684_exc_T41", "arg2_id": "NCT01373684_exc_T42", "normalized": [] }, { "id": "NCT01373684_exc_R16", "type": "Has_temporal", "arg1_id": "NCT01373684_exc_T47", "arg2_id": "NCT01373684_exc_T48", "normalized": [] }, { "id": "NCT01373684_exc_R17", "type": "Has_scope", "arg1_id": "NCT01373684_exc_T51", "arg2_id": "NCT01373684_exc_T55", "normalized": [] }, { "id": "NCT01373684_exc_R18", "type": "AND", "arg1_id": "NCT01373684_exc_T49", "arg2_id": "NCT01373684_exc_T50", "normalized": [] }, { "id": "NCT01373684_exc_R19", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T49", "arg2_id": "NCT01373684_exc_T51", "normalized": [] }, { "id": "NCT01373684_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T58", "arg2_id": "NCT01373684_exc_T57", "normalized": [] }, { "id": "NCT01373684_exc_R21", "type": "Has_negation", "arg1_id": "NCT01373684_exc_T73", "arg2_id": "NCT01373684_exc_T70", "normalized": [] }, { "id": "NCT01373684_exc_R22", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T66", "arg2_id": "NCT01373684_exc_T75", "normalized": [] }, { "id": "NCT01373684_exc_R23", "type": "Has_negation", "arg1_id": "NCT01373684_exc_T64", "arg2_id": "NCT01373684_exc_T63", "normalized": [] }, { "id": "NCT01373684_exc_R24", "type": "Has_temporal", "arg1_id": "NCT01373684_exc_T76", "arg2_id": "NCT01373684_exc_T65", "normalized": [] }, { "id": "NCT01373684_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T60", "arg2_id": "NCT01373684_exc_T59", "normalized": [] }, { "id": "NCT01373684_exc_R26", "type": "Has_temporal", "arg1_id": "NCT01373684_exc_T60", "arg2_id": "NCT01373684_exc_T61", "normalized": [] }, { "id": "NCT01373684_exc_R27", "type": "Subsumes", "arg1_id": "NCT01373684_exc_T58", "arg2_id": "NCT01373684_exc_T77", "normalized": [] }, { "id": "NCT01373684_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT01373684_exc_T78", "arg2_id": "NCT01373684_exc_T79", "normalized": [] }, { "id": "NCT01373684_exc_R29", "type": "Has_temporal", "arg1_id": "NCT01373684_exc_T78", "arg2_id": "NCT01373684_exc_T80", "normalized": [] }, { "id": "NCT01373684_exc_R30", "type": "Has_index", "arg1_id": "NCT01373684_exc_T80", "arg2_id": "NCT01373684_exc_T81", "normalized": [] }, { "id": "NCT01373684_exc_R31", "type": "Has_multiplier", "arg1_id": "NCT01373684_exc_T83", "arg2_id": "NCT01373684_exc_T87", "normalized": [] }, { "id": "NCT01373684_exc_R32", "type": "Has_scope", "arg1_id": "NCT01373684_exc_T82", "arg2_id": "NCT01373684_exc_T88", "normalized": [] }, { "id": "NCT01373684_exc_R33", "type": "Has_temporal", "arg1_id": "NCT01373684_exc_T82", "arg2_id": "NCT01373684_exc_T86", "normalized": [] } ]

[ { "id": "NCT01373684_inc_text", "type": "inclusion", "text": [ "Chronic hepatitis B (HBsAg positive > 6 months)\nHBeAg negative within six months prior to initiation of peginterferon alfa-2a\nHBV DNA < 200 IU/ml during nucleos(t)ide analogue (except Telbivudine) treatment within one month prior to initiation of peginterferon alfa-2a\nCompensated liver disease\nAge > 18 years\nWritten informed consent\n" ], "offsets": [ [ 0, 335 ] ] } ]

[ { "id": "NCT01373684_inc_T1", "type": "Condition", "text": [ "Chronic hepatitis B" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T2", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 21, 26 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T3", "type": "Value", "text": [ "positive" ], "offsets": [ [ 27, 35 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T4", "type": "Temporal", "text": [ "> 6 months" ], "offsets": [ [ 36, 46 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T5", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 48, 53 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T6", "type": "Value", "text": [ "negative" ], "offsets": [ [ 54, 62 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T7", "type": "Temporal", "text": [ "within six months prior to initiation of peginterferon alfa-2a" ], "offsets": [ [ 63, 125 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T9", "type": "Reference_point", "text": [ "initiation of peginterferon alfa-2a" ], "offsets": [ [ 90, 125 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T10", "type": "Drug", "text": [ "peginterferon alfa-2a" ], "offsets": [ [ 104, 125 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T8", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 126, 133 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T11", "type": "Value", "text": [ "< 200 IU/ml" ], "offsets": [ [ 134, 145 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T12", "type": "Temporal", "text": [ "within one month prior to initiation of peginterferon alfa-2a" ], "offsets": [ [ 207, 268 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T13", "type": "Reference_point", "text": [ "initiation of peginterferon alfa-2a" ], "offsets": [ [ 233, 268 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T14", "type": "Drug", "text": [ "peginterferon alfa-2a" ], "offsets": [ [ 247, 268 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T15", "type": "Drug", "text": [ "nucleos(t)ide analogue" ], "offsets": [ [ 153, 175 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T16", "type": "Drug", "text": [ "Telbivudine" ], "offsets": [ [ 184, 195 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T17", "type": "Negation", "text": [ "except" ], "offsets": [ [ 177, 183 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T18", "type": "Temporal", "text": [ "during nucleos(t)ide analogue (except Telbivudine) treatment" ], "offsets": [ [ 146, 206 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T19", "type": "Reference_point", "text": [ "nucleos(t)ide analogue (except Telbivudine) treatment" ], "offsets": [ [ 153, 206 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T20", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 281, 294 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T21", "type": "Qualifier", "text": [ "Compensated" ], "offsets": [ [ 269, 280 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T22", "type": "Person", "text": [ "Age" ], "offsets": [ [ 295, 298 ] ], "normalized": [] }, { "id": "NCT01373684_inc_T23", "type": "Value", "text": [ "> 18 years" ], "offsets": [ [ 299, 309 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01373684_inc_R1", "type": "Has_value", "arg1_id": "NCT01373684_inc_T2", "arg2_id": "NCT01373684_inc_T3", "normalized": [] }, { "id": "NCT01373684_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01373684_inc_T2", "arg2_id": "NCT01373684_inc_T4", "normalized": [] }, { "id": "NCT01373684_inc_R3", "type": "AND", "arg1_id": "NCT01373684_inc_T1", "arg2_id": "NCT01373684_inc_T2", "normalized": [] }, { "id": "NCT01373684_inc_R5", "type": "Has_index", "arg1_id": "NCT01373684_inc_T7", "arg2_id": "NCT01373684_inc_T9", "normalized": [] }, { "id": "NCT01373684_inc_R6", "type": "Has_value", "arg1_id": "NCT01373684_inc_T5", "arg2_id": "NCT01373684_inc_T6", "normalized": [] }, { "id": "NCT01373684_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01373684_inc_T5", "arg2_id": "NCT01373684_inc_T7", "normalized": [] }, { "id": "NCT01373684_inc_R8", "type": "Has_index", "arg1_id": "NCT01373684_inc_T12", "arg2_id": "NCT01373684_inc_T13", "normalized": [] }, { "id": "NCT01373684_inc_R9", "type": "AND", "arg1_id": "NCT01373684_inc_T13", "arg2_id": "NCT01373684_inc_T14", "normalized": [] }, { "id": "NCT01373684_inc_R10", "type": "Has_negation", "arg1_id": "NCT01373684_inc_T16", "arg2_id": "NCT01373684_inc_T17", "normalized": [] }, { "id": "NCT01373684_inc_R11", "type": "Has_value", "arg1_id": "NCT01373684_inc_T8", "arg2_id": "NCT01373684_inc_T11", "normalized": [] }, { "id": "NCT01373684_inc_R12", "type": "Has_index", "arg1_id": "NCT01373684_inc_T18", "arg2_id": "NCT01373684_inc_T19", "normalized": [] }, { "id": "NCT01373684_inc_R13", "type": "Has_temporal", "arg1_id": "NCT01373684_inc_T8", "arg2_id": "NCT01373684_inc_T18", "normalized": [] }, { "id": "NCT01373684_inc_R14", "type": "Has_temporal", "arg1_id": "NCT01373684_inc_T8", "arg2_id": "NCT01373684_inc_T12", "normalized": [] }, { "id": "NCT01373684_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT01373684_inc_T20", "arg2_id": "NCT01373684_inc_T21", "normalized": [] } ]

[ { "id": "NCT01391780_exc_text", "type": "exclusion", "text": [ "neurological diseases \nprevious pelvic surgeries \ndiabetes \ncognitive difficulties \nvaginal and urinary infection \n \n" ], "offsets": [ [ 0, 126 ] ] } ]

[ { "id": "NCT01391780_exc_T1", "type": "Condition", "text": [ "neurological diseases" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T2", "type": "Procedure", "text": [ "pelvic surgeries" ], "offsets": [ [ 32, 48 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T3", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 23, 31 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T4", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 50, 58 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T5", "type": "Condition", "text": [ "cognitive difficulties" ], "offsets": [ [ 60, 82 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T6", "type": "Condition", "text": [ "urinary infection" ], "offsets": [ [ 96, 113 ] ], "normalized": [] }, { "id": "NCT01391780_exc_T8", "type": "Condition", "text": [ "infection", "vaginal" ], "offsets": [ [ 104, 113 ], [ 84, 91 ] ], "normalized": [] } ]

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[ { "id": "NCT01391780_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01391780_exc_T2", "arg2_id": "NCT01391780_exc_T3", "normalized": [] } ]

[ { "id": "NCT01391780_inc_text", "type": "inclusion", "text": [ "presence of stress urinary or urgency incontinence \n" ], "offsets": [ [ 0, 52 ] ] } ]

[ { "id": "NCT01391780_inc_T1", "type": "Condition", "text": [ "urgency incontinence" ], "offsets": [ [ 30, 50 ] ], "normalized": [] }, { "id": "NCT01391780_inc_T2", "type": "Condition", "text": [ "stress urinary", "incontinence" ], "offsets": [ [ 12, 26 ], [ 38, 50 ] ], "normalized": [] } ]

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[ { "id": "NCT01401335_exc_text", "type": "exclusion", "text": [ "Age less than 15 or greater than 25 and not participating in the day care center \n \n" ], "offsets": [ [ 0, 93 ] ] } ]

[ { "id": "NCT01401335_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01401335_exc_T2", "type": "Value", "text": [ "less than 15" ], "offsets": [ [ 4, 16 ] ], "normalized": [] }, { "id": "NCT01401335_exc_T3", "type": "Value", "text": [ "greater than 25" ], "offsets": [ [ 20, 35 ] ], "normalized": [] }, { "id": "NCT01401335_exc_T4", "type": "Scope", "text": [ "less than 15 or greater than 25" ], "offsets": [ [ 4, 35 ] ], "normalized": [] }, { "id": "NCT01401335_exc_T5", "type": "Observation", "text": [ "participating in the day care center" ], "offsets": [ [ 44, 80 ] ], "normalized": [] }, { "id": "NCT01401335_exc_T6", "type": "Negation", "text": [ "not" ], "offsets": [ [ 40, 43 ] ], "normalized": [] } ]

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[ { "id": "NCT01401335_exc_R1", "type": "Has_scope", "arg1_id": "NCT01401335_exc_T1", "arg2_id": "NCT01401335_exc_T4", "normalized": [] }, { "id": "NCT01401335_exc_R2", "type": "Has_negation", "arg1_id": "NCT01401335_exc_T5", "arg2_id": "NCT01401335_exc_T6", "normalized": [] } ]

[ { "id": "NCT01401335_inc_text", "type": "inclusion", "text": [ "100 orphans/vulnerable youth aged 15 to 25 will be recruited through their participation at the day care center, on a voluntary basis. \n" ], "offsets": [ [ 0, 136 ] ] } ]

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[ { "id": "NCT01410890_exc_text", "type": "exclusion", "text": [ "The patient is participating in another clinical study using an investigational product.\nThe patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.\n" ], "offsets": [ [ 0, 192 ] ] } ]

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[ { "id": "NCT01410890_inc_text", "type": "inclusion", "text": [ "The patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent.\nThe patient has a confirmed GAA enzyme deficiency from skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.\nInfant and toddler Pompe disease patients can be included in the study only under condition (minimal body weight) that the trial-related blood loss (including any losses in the maneuver) will not exceed 3 percent of the total blood volume during a period of 4 weeks and will not exceed 1 percent at any single time.\nThe patient, if female and of childbearing potential, must have a negative pregnancy test (urine beta-human chorionic gonadotropin) at screening. Note: All female patients of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.\nFor patients previously treated with alglucosidase alfa the patient has received alglucosidase alfa for at least 6 months.\n" ], "offsets": [ [ 0, 983 ] ] } ]

[ { "id": "NCT01410890_inc_T2", "type": "Condition", "text": [ "GAA enzyme deficiency" ], "offsets": [ [ 139, 160 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T3", "type": "Qualifier", "text": [ "skin" ], "offsets": [ [ 166, 170 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T4", "type": "Qualifier", "text": [ "blood" ], "offsets": [ [ 172, 177 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T5", "type": "Qualifier", "text": [ "muscle tissue" ], "offsets": [ [ 182, 195 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T6", "type": "Multiplier", "text": [ "2" ], "offsets": [ [ 203, 204 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T7", "type": "Observation", "text": [ "GAA gene mutations" ], "offsets": [ [ 215, 233 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T8", "type": "Scope", "text": [ "skin, blood, or muscle tissue" ], "offsets": [ [ 166, 195 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T9", "type": "Condition", "text": [ "Pompe disease" ], "offsets": [ [ 254, 267 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T10", "type": "Person", "text": [ "Infant" ], "offsets": [ [ 235, 241 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T11", "type": "Person", "text": [ "toddler" ], "offsets": [ [ 246, 253 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T15", "type": "Drug", "text": [ "alglucosidase alfa" ], "offsets": [ [ 941, 959 ] ], "normalized": [] }, { "id": "NCT01410890_inc_T16", "type": "Temporal", "text": [ "for at least 6 months" ], "offsets": [ [ 960, 981 ] ], "normalized": [] } ]

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[ { "id": "NCT01410890_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT01410890_inc_T7", "arg2_id": "NCT01410890_inc_T6", "normalized": [] }, { "id": "NCT01410890_inc_R2", "type": "Has_scope", "arg1_id": "NCT01410890_inc_T2", "arg2_id": "NCT01410890_inc_T8", "normalized": [] }, { "id": "NCT01410890_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01410890_inc_T15", "arg2_id": "NCT01410890_inc_T16", "normalized": [] } ]

[ { "id": "NCT01424020_exc_text", "type": "exclusion", "text": [ "Unable to participate for administrative reasons\nPsychiatric troubles\nPain at rest or critical limb ischemia\nUnable to walk (ex: wheelchair subjects)\n" ], "offsets": [ [ 0, 150 ] ] } ]

[ { "id": "NCT01424020_exc_T1", "type": "Observation", "text": [ "Unable to participate" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T2", "type": "Qualifier", "text": [ "administrative reasons" ], "offsets": [ [ 26, 48 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T3", "type": "Condition", "text": [ "Psychiatric troubles" ], "offsets": [ [ 49, 69 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T4", "type": "Condition", "text": [ "Pain at rest" ], "offsets": [ [ 70, 82 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T5", "type": "Condition", "text": [ "critical limb ischemia" ], "offsets": [ [ 86, 108 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T6", "type": "Condition", "text": [ "Unable to walk" ], "offsets": [ [ 109, 123 ] ], "normalized": [] }, { "id": "NCT01424020_exc_T7", "type": "Observation", "text": [ "wheelchair subjects" ], "offsets": [ [ 129, 148 ] ], "normalized": [] } ]

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[ { "id": "NCT01424020_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01424020_exc_T1", "arg2_id": "NCT01424020_exc_T2", "normalized": [] }, { "id": "NCT01424020_exc_R2", "type": "Subsumes", "arg1_id": "NCT01424020_exc_T6", "arg2_id": "NCT01424020_exc_T7", "normalized": [] } ]

[ { "id": "NCT01424020_inc_text", "type": "inclusion", "text": [ "French Native language\n18 years old or older\nSigned consent\nCovered by the French social care system\n" ], "offsets": [ [ 0, 101 ] ] } ]

[ { "id": "NCT01424020_inc_T1", "type": "Observation", "text": [ "French Native language" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01424020_inc_T2", "type": "Value", "text": [ "8 years", "r older" ], "offsets": [ [ 24, 31 ], [ 37, 44 ] ], "normalized": [] }, { "id": "NCT01424020_inc_T3", "type": "Person", "text": [ "old" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT01424020_inc_T5", "type": "Observation", "text": [ "Covered by the French social care system" ], "offsets": [ [ 60, 100 ] ], "normalized": [] } ]

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[ { "id": "NCT01424020_inc_R1", "type": "Has_value", "arg1_id": "NCT01424020_inc_T3", "arg2_id": "NCT01424020_inc_T2", "normalized": [] } ]

[ { "id": "NCT01440296_exc_text", "type": "exclusion", "text": [ "any condition that would contra-indicate Magnetic Resonance Imaging or administration of contrast agent \n \n" ], "offsets": [ [ 0, 116 ] ] } ]

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[ { "id": "NCT01440296_inc_text", "type": "inclusion", "text": [ "male and female patients over the age of 18 years. \nwritten informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific procedures. \npatient with mild to severe carotid artery disease \n" ], "offsets": [ [ 0, 265 ] ] } ]

[ { "id": "NCT01440296_inc_T1", "type": "Person", "text": [ "male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 9, 15 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T3", "type": "Value", "text": [ "over", "18 years" ], "offsets": [ [ 25, 29 ], [ 41, 49 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 34, 37 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T6", "type": "Condition", "text": [ "carotid artery disease" ], "offsets": [ [ 241, 263 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T7", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 234, 240 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T8", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 226, 230 ] ], "normalized": [] }, { "id": "NCT01440296_inc_T9", "type": "Scope", "text": [ "mild to severe" ], "offsets": [ [ 226, 240 ] ], "normalized": [] } ]

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[ { "id": "NCT01440296_inc_R1", "type": "Has_value", "arg1_id": "NCT01440296_inc_T4", "arg2_id": "NCT01440296_inc_T3", "normalized": [] }, { "id": "NCT01440296_inc_R2", "type": "Has_scope", "arg1_id": "NCT01440296_inc_T6", "arg2_id": "NCT01440296_inc_T9", "normalized": [] } ]

[ { "id": "NCT01446094_exc_text", "type": "exclusion", "text": [ "Inability to give informed consent\nPossible pregnancy (confirmed by urine test)\nWomen who are breastfeeding\nSevere claustrophobia\nInability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)\nIndividuals with cochlear implants\nIndividuals with non-MRI compatible aneurysm clips\nPotential contraindications to regadenoson use due to:\nContraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):\n" ], "offsets": [ [ 0, 458 ] ] } ]

[ { "id": "NCT01446094_exc_T2", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T3", "type": "Mood", "text": [ "Possible" ], "offsets": [ [ 35, 43 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T4", "type": "Procedure", "text": [ "urine test" ], "offsets": [ [ 68, 78 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T5", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 55, 64 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T6", "type": "Person", "text": [ "Women" ], "offsets": [ [ 80, 85 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T7", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 94, 107 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T8", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 108, 114 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T9", "type": "Condition", "text": [ "claustrophobia" ], "offsets": [ [ 115, 129 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T10", "type": "Condition", "text": [ "Inability to lie flat" ], "offsets": [ [ 130, 151 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T11", "type": "Qualifier", "text": [ "20-30 minutes" ], "offsets": [ [ 156, 169 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T12", "type": "Qualifier", "text": [ "amount of time to complete the MRI procedure" ], "offsets": [ [ 187, 231 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T13", "type": "Device", "text": [ "cochlear implants" ], "offsets": [ [ 250, 267 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T14", "type": "Device", "text": [ "aneurysm clips" ], "offsets": [ [ 304, 318 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T15", "type": "Qualifier", "text": [ "MRI compatible" ], "offsets": [ [ 289, 303 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T16", "type": "Negation", "text": [ "non" ], "offsets": [ [ 285, 288 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T18", "type": "Drug", "text": [ "Gadolinium (Gd) based contrast agents (GBCA)" ], "offsets": [ [ 412, 456 ] ], "normalized": [] }, { "id": "NCT01446094_exc_T19", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 374, 390 ] ], "normalized": [] } ]

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[ { "id": "NCT01446094_exc_R1", "type": "Has_mood", "arg1_id": "NCT01446094_exc_T2", "arg2_id": "NCT01446094_exc_T3", "normalized": [] }, { "id": "NCT01446094_exc_R2", "type": "Has_value", "arg1_id": "NCT01446094_exc_T4", "arg2_id": "NCT01446094_exc_T5", "normalized": [] }, { "id": "NCT01446094_exc_R3", "type": "AND", "arg1_id": "NCT01446094_exc_T2", "arg2_id": "NCT01446094_exc_T4", "normalized": [] }, { "id": "NCT01446094_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01446094_exc_T9", "arg2_id": "NCT01446094_exc_T8", "normalized": [] }, { "id": "NCT01446094_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01446094_exc_T10", "arg2_id": "NCT01446094_exc_T11", "normalized": [] }, { "id": "NCT01446094_exc_R6", "type": "Subsumes", "arg1_id": "NCT01446094_exc_T11", "arg2_id": "NCT01446094_exc_T12", "normalized": [] }, { "id": "NCT01446094_exc_R7", "type": "Has_negation", "arg1_id": "NCT01446094_exc_T15", "arg2_id": "NCT01446094_exc_T16", "normalized": [] }, { "id": "NCT01446094_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT01446094_exc_T14", "arg2_id": "NCT01446094_exc_T15", "normalized": [] }, { "id": "NCT01446094_exc_R9", "type": "AND", "arg1_id": "NCT01446094_exc_T19", "arg2_id": "NCT01446094_exc_T18", "normalized": [] } ]

[ { "id": "NCT01446094_inc_text", "type": "inclusion", "text": [ "Aged 18 years or older\nScheduled for invasive coronary angiography\n" ], "offsets": [ [ 0, 67 ] ] } ]

[ { "id": "NCT01446094_inc_T1", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01446094_inc_T2", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT01446094_inc_T3", "type": "Procedure", "text": [ "invasive coronary angiography" ], "offsets": [ [ 37, 66 ] ], "normalized": [] }, { "id": "NCT01446094_inc_T4", "type": "Mood", "text": [ "Scheduled" ], "offsets": [ [ 23, 32 ] ], "normalized": [] } ]

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[ { "id": "NCT01446094_inc_R1", "type": "Has_value", "arg1_id": "NCT01446094_inc_T1", "arg2_id": "NCT01446094_inc_T2", "normalized": [] }, { "id": "NCT01446094_inc_R2", "type": "Has_mood", "arg1_id": "NCT01446094_inc_T3", "arg2_id": "NCT01446094_inc_T4", "normalized": [] } ]

[ { "id": "NCT01483118_exc_text", "type": "exclusion", "text": [ "Current pregnancy or lactation \nLiver disease or elevated liver enzymes \nEstablished diagnosis of diabetes mellitus \nAbnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association. \nInsulin sensitizing treatment within 3 months prior to or during the eight week study period. \nHormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding. \nSystemic or inhaled corticosteroids. \nKnown hypersensitive reaction to cinnamon. \nPatients with seizure disorders, known cardiovascular disease, or cerebrovascular disease. \nBody mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50). \n \n" ], "offsets": [ [ 0, 858 ] ] } ]

[ { "id": "NCT01483118_exc_T1", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 8, 17 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T2", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 21, 30 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T3", "type": "Condition", "text": [ "Liver disease" ], "offsets": [ [ 32, 45 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T4", "type": "Condition", "text": [ "elevated liver enzymes" ], "offsets": [ [ 49, 71 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T5", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 98, 115 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T6", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 117, 125 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T7", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 58, 71 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T8", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 49, 57 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T9", "type": "Measurement", "text": [ "serum glucose levels" ], "offsets": [ [ 126, 146 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T10", "type": "Condition", "text": [ "Abnormal serum glucose levels" ], "offsets": [ [ 117, 146 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T11", "type": "Temporal", "text": [ "at fasting" ], "offsets": [ [ 154, 164 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T12", "type": "Temporal", "text": [ "after the 2-hr oral glucose tolerance test" ], "offsets": [ [ 168, 210 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T13", "type": "Reference_point", "text": [ "the 2-hr oral glucose tolerance test" ], "offsets": [ [ 174, 210 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T14", "type": "Procedure", "text": [ "2-hr oral glucose tolerance test" ], "offsets": [ [ 178, 210 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T15", "type": "Scope", "text": [ "at fasting or after the 2-hr oral glucose tolerance test" ], "offsets": [ [ 154, 210 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T16", "type": "Reference_point", "text": [ "fasting" ], "offsets": [ [ 157, 164 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T17", "type": "Measurement", "text": [ "criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association" ], "offsets": [ [ 219, 313 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T18", "type": "Value", "text": [ "meeting" ], "offsets": [ [ 211, 218 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T19", "type": "Qualifier", "text": [ "meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association" ], "offsets": [ [ 211, 313 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T20", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 249, 266 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T21", "type": "Procedure", "text": [ "Insulin sensitizing treatment" ], "offsets": [ [ 316, 345 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T22", "type": "Temporal", "text": [ "within 3 months prior to", "eight week study period" ], "offsets": [ [ 346, 370 ], [ 385, 408 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T23", "type": "Temporal", "text": [ "during the eight week study period" ], "offsets": [ [ 374, 408 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T24", "type": "Scope", "text": [ "within 3 months prior to or during the eight week study period" ], "offsets": [ [ 346, 408 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T25", "type": "Drug", "text": [ "estrogen" ], "offsets": [ [ 440, 448 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T26", "type": "Drug", "text": [ "progesterone" ], "offsets": [ [ 452, 464 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T27", "type": "Temporal", "text": [ "3 months prior to", "the study period" ], "offsets": [ [ 465, 482 ], [ 493, 509 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T28", "type": "Temporal", "text": [ "during the study period" ], "offsets": [ [ 486, 509 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T29", "type": "Drug", "text": [ "medroxyprogesterone acetate" ], "offsets": [ [ 533, 560 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T30", "type": "Condition", "text": [ "withdrawal bleeding" ], "offsets": [ [ 565, 584 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T31", "type": "Negation", "text": [ "exception" ], "offsets": [ [ 520, 529 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T32", "type": "Drug", "text": [ "inhaled corticosteroids" ], "offsets": [ [ 599, 622 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T33", "type": "Drug", "text": [ "Systemic", "corticosteroids" ], "offsets": [ [ 587, 595 ], [ 607, 622 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T34", "type": "Qualifier", "text": [ "Systemic" ], "offsets": [ [ 587, 595 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T35", "type": "Qualifier", "text": [ "inhaled" ], "offsets": [ [ 599, 606 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T36", "type": "Condition", "text": [ "hypersensitive reaction to cinnamon" ], "offsets": [ [ 631, 666 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T37", "type": "Observation", "text": [ "cinnamon" ], "offsets": [ [ 658, 666 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T38", "type": "Condition", "text": [ "seizure disorders" ], "offsets": [ [ 683, 700 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T39", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 708, 730 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T40", "type": "Condition", "text": [ "cerebrovascular disease" ], "offsets": [ [ 735, 758 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T41", "type": "Measurement", "text": [ "Body mass index (BMI)" ], "offsets": [ [ 761, 782 ] ], "normalized": [] }, { "id": "NCT01483118_exc_T42", "type": "Value", "text": [ "range 20-50" ], "offsets": [ [ 782, 793 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01483118_exc_R1", "type": "Has_value", "arg1_id": "NCT01483118_exc_T7", "arg2_id": "NCT01483118_exc_T8", "normalized": [] }, { "id": "NCT01483118_exc_R2", "type": "Has_value", "arg1_id": "NCT01483118_exc_T9", "arg2_id": "NCT01483118_exc_T6", "normalized": [] }, { "id": "NCT01483118_exc_R3", "type": "Has_scope", "arg1_id": "NCT01483118_exc_T10", "arg2_id": "NCT01483118_exc_T15", "normalized": [] }, { "id": "NCT01483118_exc_R4", "type": "Has_value", "arg1_id": "NCT01483118_exc_T17", "arg2_id": "NCT01483118_exc_T18", "normalized": [] }, { "id": "NCT01483118_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01483118_exc_T10", "arg2_id": "NCT01483118_exc_T19", "normalized": [] }, { "id": "NCT01483118_exc_R6", "type": "Has_scope", "arg1_id": "NCT01483118_exc_T21", "arg2_id": "NCT01483118_exc_T24", "normalized": [] }, { "id": "NCT01483118_exc_R7", "type": "AND", "arg1_id": "NCT01483118_exc_T29", "arg2_id": "NCT01483118_exc_T30", "normalized": [] }, { "id": "NCT01483118_exc_R8", "type": "Has_negation", "arg1_id": "NCT01483118_exc_T29", "arg2_id": "NCT01483118_exc_T31", "normalized": [] }, { "id": "NCT01483118_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01483118_exc_T33", "arg2_id": "NCT01483118_exc_T34", "normalized": [] }, { "id": "NCT01483118_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01483118_exc_T32", "arg2_id": "NCT01483118_exc_T35", "normalized": [] }, { "id": "NCT01483118_exc_R11", "type": "Has_value", "arg1_id": "NCT01483118_exc_T41", "arg2_id": "NCT01483118_exc_T42", "normalized": [] } ]

[ { "id": "NCT01483118_inc_text", "type": "inclusion", "text": [ "Patients aged greater than 18 years of age \nAbility to understand and willingness to comply with the study protocol \nWritten informed consent \nPatients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries. \n" ], "offsets": [ [ 0, 422 ] ] } ]

[ { "id": "NCT01483118_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T2", "type": "Value", "text": [ "greater than 18 years" ], "offsets": [ [ 14, 35 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 39, 42 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T8", "type": "Measurement", "text": [ "Rotterdam PCOS workshop criteria for polycystic ovary syndrome" ], "offsets": [ [ 164, 226 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T9", "type": "Value", "text": [ "meeting" ], "offsets": [ [ 152, 159 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T10", "type": "Condition", "text": [ "oligomenorrhea" ], "offsets": [ [ 239, 253 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T11", "type": "Condition", "text": [ "amenorrhea" ], "offsets": [ [ 257, 267 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T12", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 272, 284 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T13", "type": "Condition", "text": [ "hyperandrogenism" ], "offsets": [ [ 349, 365 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T14", "type": "Condition", "text": [ "polycystic", "ovaries" ], "offsets": [ [ 391, 401 ], [ 412, 419 ] ], "normalized": [] }, { "id": "NCT01483118_inc_T15", "type": "Procedure", "text": [ "ultrasound" ], "offsets": [ [ 369, 379 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01483118_inc_R1", "type": "Has_value", "arg1_id": "NCT01483118_inc_T3", "arg2_id": "NCT01483118_inc_T2", "normalized": [] }, { "id": "NCT01483118_inc_R2", "type": "Has_value", "arg1_id": "NCT01483118_inc_T1", "arg2_id": "NCT01483118_inc_T2", "normalized": [] }, { "id": "NCT01483118_inc_R3", "type": "Has_value", "arg1_id": "NCT01483118_inc_T8", "arg2_id": "NCT01483118_inc_T9", "normalized": [] }, { "id": "NCT01483118_inc_R4", "type": "AND", "arg1_id": "NCT01483118_inc_T15", "arg2_id": "NCT01483118_inc_T14", "normalized": [] } ]

[ { "id": "NCT01490034_exc_text", "type": "exclusion", "text": [ " \n" ], "offsets": [ [ 0, 5 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01490034_inc_text", "type": "inclusion", "text": [ "Weight stable (<3 kg weight change within last 3 months) \nConstant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months) \nConstant habitual diet patterns within last 3 months \nWillingness to eat a chocolate-flavored snack at test sessions and two week training period \nNo allergies to any test foods \nNot planning to change use of medications known to influence appetite or metabolism \nNot diabetic \nNo history of GI pathology \nNon-smoker for one year or more \n" ], "offsets": [ [ 0, 496 ] ] } ]

[ { "id": "NCT01490034_inc_T1", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T2", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 7, 13 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T3", "type": "Value", "text": [ "<3 kg weight change" ], "offsets": [ [ 15, 34 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T4", "type": "Temporal", "text": [ "within last 3 months" ], "offsets": [ [ 35, 55 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T5", "type": "Condition", "text": [ "Constant habitual activity patterns" ], "offsets": [ [ 58, 93 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T6", "type": "Observation", "text": [ "no deviation > 1x/wk at 30 min/session within last 3 months" ], "offsets": [ [ 95, 154 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T7", "type": "Condition", "text": [ "Constant habitual diet patterns" ], "offsets": [ [ 157, 188 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T8", "type": "Temporal", "text": [ "within last 3 months" ], "offsets": [ [ 189, 209 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T9", "type": "Observation", "text": [ "Willingness to eat a chocolate-flavored snack" ], "offsets": [ [ 211, 256 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T10", "type": "Temporal", "text": [ "at test sessions" ], "offsets": [ [ 257, 273 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T11", "type": "Temporal", "text": [ "at", "two week training period" ], "offsets": [ [ 257, 259 ], [ 278, 302 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T12", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 307, 316 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T13", "type": "Negation", "text": [ "No" ], "offsets": [ [ 304, 306 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T14", "type": "Observation", "text": [ "test foods" ], "offsets": [ [ 324, 334 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T15", "type": "Observation", "text": [ "planning to change" ], "offsets": [ [ 340, 358 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T16", "type": "Drug", "text": [ "medications known to influence appetite" ], "offsets": [ [ 366, 405 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T17", "type": "Drug", "text": [ "medications known to influence", "metabolism" ], "offsets": [ [ 366, 396 ], [ 409, 419 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T18", "type": "Scope", "text": [ "medications known to influence appetite or metabolism" ], "offsets": [ [ 366, 419 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T19", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 336, 339 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T20", "type": "Condition", "text": [ "diabetic" ], "offsets": [ [ 425, 433 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T21", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 421, 424 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T22", "type": "Condition", "text": [ "GI pathology" ], "offsets": [ [ 449, 461 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T23", "type": "Observation", "text": [ "history" ], "offsets": [ [ 438, 445 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T24", "type": "Negation", "text": [ "No" ], "offsets": [ [ 435, 437 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T25", "type": "Condition", "text": [ "smoker" ], "offsets": [ [ 467, 473 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T26", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 463, 466 ] ], "normalized": [] }, { "id": "NCT01490034_inc_T27", "type": "Temporal", "text": [ "for one year or more" ], "offsets": [ [ 474, 494 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01490034_inc_R1", "type": "Subsumes", "arg1_id": "NCT01490034_inc_T2", "arg2_id": "NCT01490034_inc_T3", "normalized": [] }, { "id": "NCT01490034_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01490034_inc_T1", "arg2_id": "NCT01490034_inc_T2", "normalized": [] }, { "id": "NCT01490034_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T1", "arg2_id": "NCT01490034_inc_T4", "normalized": [] }, { "id": "NCT01490034_inc_R4", "type": "Subsumes", "arg1_id": "NCT01490034_inc_T5", "arg2_id": "NCT01490034_inc_T6", "normalized": [] }, { "id": "NCT01490034_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T7", "arg2_id": "NCT01490034_inc_T8", "normalized": [] }, { "id": "NCT01490034_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T9", "arg2_id": "NCT01490034_inc_T11", "normalized": [] }, { "id": "NCT01490034_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T9", "arg2_id": "NCT01490034_inc_T10", "normalized": [] }, { "id": "NCT01490034_inc_R8", "type": "Has_negation", "arg1_id": "NCT01490034_inc_T12", "arg2_id": "NCT01490034_inc_T13", "normalized": [] }, { "id": "NCT01490034_inc_R10", "type": "Has_mood", "arg1_id": "NCT01490034_inc_T18", "arg2_id": "NCT01490034_inc_T15", "normalized": [] }, { "id": "NCT01490034_inc_R12", "type": "Has_negation", "arg1_id": "NCT01490034_inc_T20", "arg2_id": "NCT01490034_inc_T21", "normalized": [] }, { "id": "NCT01490034_inc_R13", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T22", "arg2_id": "NCT01490034_inc_T23", "normalized": [] }, { "id": "NCT01490034_inc_R14", "type": "Has_negation", "arg1_id": "NCT01490034_inc_T22", "arg2_id": "NCT01490034_inc_T24", "normalized": [] }, { "id": "NCT01490034_inc_R11", "type": "Has_negation", "arg1_id": "NCT01490034_inc_T18", "arg2_id": "NCT01490034_inc_T19", "normalized": [] }, { "id": "NCT01490034_inc_R15", "type": "Has_negation", "arg1_id": "NCT01490034_inc_T25", "arg2_id": "NCT01490034_inc_T26", "normalized": [] }, { "id": "NCT01490034_inc_R16", "type": "Has_temporal", "arg1_id": "NCT01490034_inc_T25", "arg2_id": "NCT01490034_inc_T27", "normalized": [] } ]

[ { "id": "NCT01491295_exc_text", "type": "exclusion", "text": [ "HCV, HIV, HDV coinfection.\nUncontrolled HCC, malignancy or decompensated liver cirrhosis (CTP score = 7).\nUremia patients or Creatinine = 2 mg/dl.\n" ], "offsets": [ [ 0, 147 ] ] } ]

[ { "id": "NCT01491295_exc_T1", "type": "Condition", "text": [ "HCV", "coinfection" ], "offsets": [ [ 0, 3 ], [ 14, 25 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T2", "type": "Condition", "text": [ "coinfection", "HIV" ], "offsets": [ [ 14, 25 ], [ 5, 8 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T3", "type": "Condition", "text": [ "HDV coinfection" ], "offsets": [ [ 10, 25 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T4", "type": "Condition", "text": [ "HCC" ], "offsets": [ [ 40, 43 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T5", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 45, 55 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T6", "type": "Condition", "text": [ "liver cirrhosis" ], "offsets": [ [ 73, 88 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T7", "type": "Qualifier", "text": [ "decompensated" ], "offsets": [ [ 59, 72 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T8", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 27, 39 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T9", "type": "Measurement", "text": [ "CTP score" ], "offsets": [ [ 90, 99 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T10", "type": "Value", "text": [ "= 7" ], "offsets": [ [ 100, 103 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T11", "type": "Condition", "text": [ "Uremia" ], "offsets": [ [ 106, 112 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T12", "type": "Measurement", "text": [ "Creatinine" ], "offsets": [ [ 125, 135 ] ], "normalized": [] }, { "id": "NCT01491295_exc_T13", "type": "Value", "text": [ "= 2 mg/dl" ], "offsets": [ [ 136, 145 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01491295_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01491295_exc_T6", "arg2_id": "NCT01491295_exc_T7", "normalized": [] }, { "id": "NCT01491295_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01491295_exc_T4", "arg2_id": "NCT01491295_exc_T8", "normalized": [] }, { "id": "NCT01491295_exc_R3", "type": "Has_value", "arg1_id": "NCT01491295_exc_T9", "arg2_id": "NCT01491295_exc_T10", "normalized": [] }, { "id": "NCT01491295_exc_R4", "type": "Has_value", "arg1_id": "NCT01491295_exc_T12", "arg2_id": "NCT01491295_exc_T13", "normalized": [] } ]

[ { "id": "NCT01491295_inc_text", "type": "inclusion", "text": [ "HBsAg-positive for more than 6 months (HBeAg-positive or HBeAg-negative).\nAge > 20 y/o.\nUnder lamivudine/adefovir treatment for more than 1 year due to previous lamivudine resistance (LAM-R), current HBV DNA is undetectable (< 20 IU/ml) during enrollment.\n" ], "offsets": [ [ 0, 256 ] ] } ]

[ { "id": "NCT01491295_inc_T1", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T2", "type": "Value", "text": [ "positive" ], "offsets": [ [ 6, 14 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T3", "type": "Temporal", "text": [ "more than 6 months" ], "offsets": [ [ 19, 37 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T4", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 39, 44 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T5", "type": "Value", "text": [ "positive" ], "offsets": [ [ 45, 53 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T6", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 57, 62 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T7", "type": "Value", "text": [ "negative" ], "offsets": [ [ 63, 71 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T8", "type": "Scope", "text": [ "HBeAg-positive or HBeAg-negative" ], "offsets": [ [ 39, 71 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T9", "type": "Person", "text": [ "Age" ], "offsets": [ [ 74, 77 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T10", "type": "Value", "text": [ "> 20 y/o" ], "offsets": [ [ 78, 86 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T11", "type": "Drug", "text": [ "lamivudine" ], "offsets": [ [ 94, 104 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T12", "type": "Drug", "text": [ "adefovir" ], "offsets": [ [ 105, 113 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T13", "type": "Temporal", "text": [ "more than 1 year" ], "offsets": [ [ 128, 144 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T14", "type": "Observation", "text": [ "lamivudine resistance" ], "offsets": [ [ 161, 182 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T15", "type": "Observation", "text": [ "LAM-R" ], "offsets": [ [ 184, 189 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T16", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 200, 207 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T17", "type": "Value", "text": [ "undetectable" ], "offsets": [ [ 211, 223 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T18", "type": "Value", "text": [ "< 20 IU/ml" ], "offsets": [ [ 225, 235 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T19", "type": "Temporal", "text": [ "during enrollment" ], "offsets": [ [ 237, 254 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T20", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 244, 254 ] ], "normalized": [] }, { "id": "NCT01491295_inc_T21", "type": "Scope", "text": [ "lamivudine/adefovir" ], "offsets": [ [ 94, 113 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01491295_inc_R1", "type": "Has_value", "arg1_id": "NCT01491295_inc_T1", "arg2_id": "NCT01491295_inc_T2", "normalized": [] }, { "id": "NCT01491295_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01491295_inc_T1", "arg2_id": "NCT01491295_inc_T3", "normalized": [] }, { "id": "NCT01491295_inc_R3", "type": "Has_value", "arg1_id": "NCT01491295_inc_T4", "arg2_id": "NCT01491295_inc_T5", "normalized": [] }, { "id": "NCT01491295_inc_R4", "type": "Has_value", "arg1_id": "NCT01491295_inc_T6", "arg2_id": "NCT01491295_inc_T7", "normalized": [] }, { "id": "NCT01491295_inc_R6", "type": "Has_value", "arg1_id": "NCT01491295_inc_T9", "arg2_id": "NCT01491295_inc_T10", "normalized": [] }, { "id": "NCT01491295_inc_R5", "type": "Has_index", "arg1_id": "NCT01491295_inc_T19", "arg2_id": "NCT01491295_inc_T20", "normalized": [] }, { "id": "NCT01491295_inc_R7", "type": "Has_value", "arg1_id": "NCT01491295_inc_T16", "arg2_id": "NCT01491295_inc_T17", "normalized": [] }, { "id": "NCT01491295_inc_R8", "type": "Subsumes", "arg1_id": "NCT01491295_inc_T17", "arg2_id": "NCT01491295_inc_T18", "normalized": [] }, { "id": "NCT01491295_inc_R9", "type": "Subsumes", "arg1_id": "NCT01491295_inc_T14", "arg2_id": "NCT01491295_inc_T15", "normalized": [] }, { "id": "NCT01491295_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01491295_inc_T21", "arg2_id": "NCT01491295_inc_T13", "normalized": [] } ]

[ { "id": "NCT01491763_exc_text", "type": "exclusion", "text": [ "Any other variety of LAL\nPatients with a history of coronary artery disease, valvular or hypertensive heart disease\nPatients with chronic liver disease\nPatients with chronic respiratory failure\nRenal failure not due to LAL\nPatients with positive HIV status\nNo serious neurological abnormalities due to LAL\nImpact on overall severe (grade 3 or 4 of the WHO scale) not attributable to the LAL\nPregnant or breastfeeding\ninitial blast crisis CML\n" ], "offsets": [ [ 0, 442 ] ] } ]

[ { "id": "NCT01491763_exc_T1", "type": "Qualifier", "text": [ "other variety" ], "offsets": [ [ 4, 17 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T2", "type": "Condition", "text": [ "LAL" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 41, 48 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T4", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 52, 75 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T5", "type": "Condition", "text": [ "hypertensive heart disease" ], "offsets": [ [ 89, 115 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T6", "type": "Condition", "text": [ "eart disease", "alvular" ], "offsets": [ [ 103, 115 ], [ 78, 85 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T7", "type": "Scope", "text": [ "coronary artery disease, valvular or hypertensive heart disease" ], "offsets": [ [ 52, 115 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T8", "type": "Condition", "text": [ "chronic liver disease" ], "offsets": [ [ 130, 151 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T9", "type": "Condition", "text": [ "chronic respiratory failure" ], "offsets": [ [ 166, 193 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T10", "type": "Condition", "text": [ "Renal failure" ], "offsets": [ [ 194, 207 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T11", "type": "Condition", "text": [ "LAL" ], "offsets": [ [ 219, 222 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T12", "type": "Negation", "text": [ "not" ], "offsets": [ [ 208, 211 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T13", "type": "Mood", "text": [ "due to" ], "offsets": [ [ 212, 218 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T14", "type": "Value", "text": [ "positive" ], "offsets": [ [ 237, 245 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T15", "type": "Measurement", "text": [ "HIV status" ], "offsets": [ [ 246, 256 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T16", "type": "Negation", "text": [ "No" ], "offsets": [ [ 257, 259 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T17", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 260, 267 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T18", "type": "Condition", "text": [ "neurological abnormalities" ], "offsets": [ [ 268, 294 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T19", "type": "Mood", "text": [ "due to" ], "offsets": [ [ 295, 301 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T20", "type": "Condition", "text": [ "LAL" ], "offsets": [ [ 302, 305 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T22", "type": "Observation", "text": [ "Pregnant" ], "offsets": [ [ 391, 399 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T23", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 403, 416 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T24", "type": "Qualifier", "text": [ "blast crisis" ], "offsets": [ [ 425, 437 ] ], "normalized": [] }, { "id": "NCT01491763_exc_T25", "type": "Condition", "text": [ "CML" ], "offsets": [ [ 438, 441 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01491763_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01491763_exc_T2", "arg2_id": "NCT01491763_exc_T1", "normalized": [] }, { "id": "NCT01491763_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01491763_exc_T7", "arg2_id": "NCT01491763_exc_T3", "normalized": [] }, { "id": "NCT01491763_exc_R3", "type": "Has_negation", "arg1_id": "NCT01491763_exc_T11", "arg2_id": "NCT01491763_exc_T12", "normalized": [] }, { "id": "NCT01491763_exc_R4", "type": "Has_mood", "arg1_id": "NCT01491763_exc_T11", "arg2_id": "NCT01491763_exc_T13", "normalized": [] }, { "id": "NCT01491763_exc_R5", "type": "AND", "arg1_id": "NCT01491763_exc_T11", "arg2_id": "NCT01491763_exc_T10", "normalized": [] }, { "id": "NCT01491763_exc_R6", "type": "Has_value", "arg1_id": "NCT01491763_exc_T15", "arg2_id": "NCT01491763_exc_T14", "normalized": [] }, { "id": "NCT01491763_exc_R7", "type": "Has_mood", "arg1_id": "NCT01491763_exc_T20", "arg2_id": "NCT01491763_exc_T19", "normalized": [] }, { "id": "NCT01491763_exc_R8", "type": "AND", "arg1_id": "NCT01491763_exc_T18", "arg2_id": "NCT01491763_exc_T20", "normalized": [] }, { "id": "NCT01491763_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01491763_exc_T18", "arg2_id": "NCT01491763_exc_T17", "normalized": [] }, { "id": "NCT01491763_exc_R10", "type": "Has_negation", "arg1_id": "NCT01491763_exc_T18", "arg2_id": "NCT01491763_exc_T16", "normalized": [] }, { "id": "NCT01491763_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT01491763_exc_T25", "arg2_id": "NCT01491763_exc_T24", "normalized": [] } ]

[ { "id": "NCT01491763_inc_text", "type": "inclusion", "text": [ "Patients with Ph (BCR/ABL) positive de novo < 55 years old (it is advisable to include patients over 55 years LAL07OPH protocol).\nPerformance status 0-2 (Appendix B) may include patients with performance status > 2 attributable to LAL.\nPatients without functional impairment of organs: liver function: total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine > 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF > 50%, absence of severe chronic respiratory disease. In the event that alterations are secondary to the disease is at the discretion of the investigator to determine if the patient can be included in the trial.\n" ], "offsets": [ [ 0, 805 ] ] } ]

[ { "id": "NCT01491763_inc_T1", "type": "Measurement", "text": [ "Ph (BCR/ABL)" ], "offsets": [ [ 14, 26 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T2", "type": "Value", "text": [ "positive" ], "offsets": [ [ 27, 35 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T3", "type": "Qualifier", "text": [ "de novo" ], "offsets": [ [ 36, 43 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T4", "type": "Value", "text": [ "< 55 years" ], "offsets": [ [ 44, 54 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T5", "type": "Person", "text": [ "old" ], "offsets": [ [ 55, 58 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T7", "type": "Measurement", "text": [ "Performance status" ], "offsets": [ [ 130, 148 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T8", "type": "Value", "text": [ "0-2" ], "offsets": [ [ 149, 152 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T10", "type": "Condition", "text": [ "functional impairment of organs" ], "offsets": [ [ 253, 284 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T11", "type": "Negation", "text": [ "without" ], "offsets": [ [ 245, 252 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T12", "type": "Measurement", "text": [ "total bilirubin" ], "offsets": [ [ 302, 317 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T13", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 319, 322 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T14", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 324, 327 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T15", "type": "Measurement", "text": [ "alfa-GT" ], "offsets": [ [ 329, 336 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T16", "type": "Measurement", "text": [ "alkaline phosphatase" ], "offsets": [ [ 341, 361 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T17", "type": "Value", "text": [ "less than 3 times the upper limit of normal" ], "offsets": [ [ 362, 405 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T18", "type": "Scope", "text": [ "total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase" ], "offsets": [ [ 302, 361 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T19", "type": "Scope", "text": [ "total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal" ], "offsets": [ [ 302, 405 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T20", "type": "Scope", "text": [ "without functional impairment of organs" ], "offsets": [ [ 245, 284 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T21", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 433, 449 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T22", "type": "Value", "text": [ "< 2 mg/dL" ], "offsets": [ [ 450, 459 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T23", "type": "Measurement", "text": [ "clearance creatinine" ], "offsets": [ [ 463, 483 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T24", "type": "Value", "text": [ "> 30 ml/min" ], "offsets": [ [ 484, 495 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T26", "type": "Measurement", "text": [ "cardiac function" ], "offsets": [ [ 540, 556 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T27", "type": "Value", "text": [ "normal" ], "offsets": [ [ 570, 576 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T28", "type": "Measurement", "text": [ "ventricular EF" ], "offsets": [ [ 578, 592 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T29", "type": "Value", "text": [ "> 50%" ], "offsets": [ [ 593, 598 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T30", "type": "Negation", "text": [ "absence of" ], "offsets": [ [ 600, 610 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T31", "type": "Condition", "text": [ "severe chronic respiratory disease" ], "offsets": [ [ 611, 645 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T32", "type": "Scope", "text": [ "cardiac function (Appendix B) normal" ], "offsets": [ [ 540, 576 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T33", "type": "Scope", "text": [ "ventricular EF > 50%" ], "offsets": [ [ 578, 598 ] ], "normalized": [] }, { "id": "NCT01491763_inc_T35", "type": "Scope", "text": [ "total bilirubin, AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine > 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B) normal: ventricular EF > 50%, absence of severe chronic respiratory disease." ], "offsets": [ [ 302, 646 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01491763_inc_R1", "type": "Has_value", "arg1_id": "NCT01491763_inc_T1", "arg2_id": "NCT01491763_inc_T2", "normalized": [] }, { "id": "NCT01491763_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01491763_inc_T1", "arg2_id": "NCT01491763_inc_T3", "normalized": [] }, { "id": "NCT01491763_inc_R3", "type": "Has_value", "arg1_id": "NCT01491763_inc_T5", "arg2_id": "NCT01491763_inc_T4", "normalized": [] }, { "id": "NCT01491763_inc_R4", "type": "Has_value", "arg1_id": "NCT01491763_inc_T7", "arg2_id": "NCT01491763_inc_T8", "normalized": [] }, { "id": "NCT01491763_inc_R5", "type": "Has_negation", "arg1_id": "NCT01491763_inc_T10", "arg2_id": "NCT01491763_inc_T11", "normalized": [] }, { "id": "NCT01491763_inc_R6", "type": "Has_value", "arg1_id": "NCT01491763_inc_T18", "arg2_id": "NCT01491763_inc_T17", "normalized": [] }, { "id": "NCT01491763_inc_R8", "type": "Has_value", "arg1_id": "NCT01491763_inc_T26", "arg2_id": "NCT01491763_inc_T27", "normalized": [] }, { "id": "NCT01491763_inc_R9", "type": "Has_value", "arg1_id": "NCT01491763_inc_T23", "arg2_id": "NCT01491763_inc_T24", "normalized": [] }, { "id": "NCT01491763_inc_R10", "type": "Has_value", "arg1_id": "NCT01491763_inc_T21", "arg2_id": "NCT01491763_inc_T22", "normalized": [] }, { "id": "NCT01491763_inc_R7", "type": "Has_value", "arg1_id": "NCT01491763_inc_T28", "arg2_id": "NCT01491763_inc_T29", "normalized": [] }, { "id": "NCT01491763_inc_R11", "type": "Has_negation", "arg1_id": "NCT01491763_inc_T31", "arg2_id": "NCT01491763_inc_T30", "normalized": [] }, { "id": "NCT01491763_inc_R12", "type": "Subsumes", "arg1_id": "NCT01491763_inc_T32", "arg2_id": "NCT01491763_inc_T33", "normalized": [] }, { "id": "NCT01491763_inc_R13", "type": "Subsumes", "arg1_id": "NCT01491763_inc_T20", "arg2_id": "NCT01491763_inc_T35", "normalized": [] } ]

[ { "id": "NCT01497639_exc_text", "type": "exclusion", "text": [ "previous brain surgery;\ncognitive impairment (< 120 points on the Mattis Dementia Rating Scale)\nmoderate-to-severe depression (> 25 points on the Beck Depression Inventory)\nmarked brain atrophy as detected by magnetic resonance imaging\nother medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial\n" ], "offsets": [ [ 0, 366 ] ] } ]

[ { "id": "NCT01497639_exc_T1", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T2", "type": "Procedure", "text": [ "brain surgery" ], "offsets": [ [ 9, 22 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T3", "type": "Condition", "text": [ "cognitive impairment" ], "offsets": [ [ 24, 44 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T4", "type": "Value", "text": [ "< 120 points" ], "offsets": [ [ 46, 58 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T5", "type": "Measurement", "text": [ "Mattis Dementia Rating Scale" ], "offsets": [ [ 66, 94 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T6", "type": "Qualifier", "text": [ "moderate-to-severe" ], "offsets": [ [ 96, 114 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T7", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 115, 125 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T8", "type": "Value", "text": [ "> 25 points" ], "offsets": [ [ 127, 138 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T9", "type": "Measurement", "text": [ "Beck Depression Inventory" ], "offsets": [ [ 146, 171 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T10", "type": "Condition", "text": [ "brain atrophy" ], "offsets": [ [ 180, 193 ] ], "normalized": [] }, { "id": "NCT01497639_exc_T11", "type": "Procedure", "text": [ "magnetic resonance imaging" ], "offsets": [ [ 209, 235 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01497639_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01497639_exc_T2", "arg2_id": "NCT01497639_exc_T1", "normalized": [] }, { "id": "NCT01497639_exc_R2", "type": "Has_value", "arg1_id": "NCT01497639_exc_T5", "arg2_id": "NCT01497639_exc_T4", "normalized": [] }, { "id": "NCT01497639_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01497639_exc_T7", "arg2_id": "NCT01497639_exc_T6", "normalized": [] }, { "id": "NCT01497639_exc_R4", "type": "Has_value", "arg1_id": "NCT01497639_exc_T9", "arg2_id": "NCT01497639_exc_T8", "normalized": [] }, { "id": "NCT01497639_exc_R5", "type": "AND", "arg1_id": "NCT01497639_exc_T10", "arg2_id": "NCT01497639_exc_T11", "normalized": [] } ]

[ { "id": "NCT01497639_inc_text", "type": "inclusion", "text": [ "ages of 7 and 75 years\nmarked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment\ndisease duration of at least 5 years.\n" ], "offsets": [ [ 0, 171 ] ] } ]

[ { "id": "NCT01497639_inc_T1", "type": "Person", "text": [ "ages" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T2", "type": "Value", "text": [ "7 and 75 years" ], "offsets": [ [ 8, 22 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T3", "type": "Condition", "text": [ "disability" ], "offsets": [ [ 30, 40 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T4", "type": "Condition", "text": [ "dystonia" ], "offsets": [ [ 83, 91 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T5", "type": "Qualifier", "text": [ "segmental" ], "offsets": [ [ 73, 82 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T6", "type": "Qualifier", "text": [ "generalized" ], "offsets": [ [ 58, 69 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T7", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 50, 57 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T8", "type": "Scope", "text": [ "generalized or segmental" ], "offsets": [ [ 58, 82 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T9", "type": "Qualifier", "text": [ "optimal" ], "offsets": [ [ 101, 108 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T10", "type": "Procedure", "text": [ "pharmacologic treatment" ], "offsets": [ [ 109, 132 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T11", "type": "Measurement", "text": [ "disease duration" ], "offsets": [ [ 133, 149 ] ], "normalized": [] }, { "id": "NCT01497639_inc_T12", "type": "Value", "text": [ "at least 5 years" ], "offsets": [ [ 153, 169 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01497639_inc_R1", "type": "Has_value", "arg1_id": "NCT01497639_inc_T1", "arg2_id": "NCT01497639_inc_T2", "normalized": [] }, { "id": "NCT01497639_inc_R2", "type": "Has_scope", "arg1_id": "NCT01497639_inc_T4", "arg2_id": "NCT01497639_inc_T8", "normalized": [] }, { "id": "NCT01497639_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01497639_inc_T4", "arg2_id": "NCT01497639_inc_T7", "normalized": [] }, { "id": "NCT01497639_inc_R4", "type": "AND", "arg1_id": "NCT01497639_inc_T3", "arg2_id": "NCT01497639_inc_T4", "normalized": [] }, { "id": "NCT01497639_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01497639_inc_T10", "arg2_id": "NCT01497639_inc_T9", "normalized": [] }, { "id": "NCT01497639_inc_R6", "type": "AND", "arg1_id": "NCT01497639_inc_T3", "arg2_id": "NCT01497639_inc_T10", "normalized": [] }, { "id": "NCT01497639_inc_R7", "type": "Has_value", "arg1_id": "NCT01497639_inc_T11", "arg2_id": "NCT01497639_inc_T12", "normalized": [] } ]

[ { "id": "NCT01501201_exc_text", "type": "exclusion", "text": [ "Contraindication to bariatric surgery\nPregnancy\nAffiliation of health care assurance\nPsychiatric disorders\n" ], "offsets": [ [ 0, 107 ] ] } ]

[ { "id": "NCT01501201_exc_T1", "type": "Procedure", "text": [ "bariatric surgery" ], "offsets": [ [ 20, 37 ] ], "normalized": [] }, { "id": "NCT01501201_exc_T2", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT01501201_exc_T3", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 38, 47 ] ], "normalized": [] }, { "id": "NCT01501201_exc_T4", "type": "Observation", "text": [ "Affiliation of health care assurance" ], "offsets": [ [ 48, 84 ] ], "normalized": [] }, { "id": "NCT01501201_exc_T5", "type": "Condition", "text": [ "Psychiatric disorders" ], "offsets": [ [ 85, 106 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01501201_exc_R1", "type": "AND", "arg1_id": "NCT01501201_exc_T2", "arg2_id": "NCT01501201_exc_T1", "normalized": [] } ]

[ { "id": "NCT01501201_inc_text", "type": "inclusion", "text": [ "Type 2 diabetes mellitus with HbA1c > 7.5 %\nBody mass index > 35 and < 50 kg/m2\nCandidate for Gastric By-Pass\nTreatment with GLP1 (glucagon-like peptide) analogue or insulin\n" ], "offsets": [ [ 0, 174 ] ] } ]

[ { "id": "NCT01501201_inc_T1", "type": "Condition", "text": [ "Type 2 diabetes mellitus" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T2", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 30, 35 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T3", "type": "Value", "text": [ "> 7.5 %" ], "offsets": [ [ 36, 43 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T4", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 44, 59 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T5", "type": "Value", "text": [ "> 35 and < 50 kg/m2" ], "offsets": [ [ 60, 79 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T6", "type": "Procedure", "text": [ "Gastric By-Pass" ], "offsets": [ [ 94, 109 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T7", "type": "Mood", "text": [ "Candidate" ], "offsets": [ [ 80, 89 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T8", "type": "Drug", "text": [ "GLP1 (glucagon-like peptide) analogue" ], "offsets": [ [ 125, 162 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T9", "type": "Drug", "text": [ "insulin" ], "offsets": [ [ 166, 173 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T10", "type": "Procedure", "text": [ "Treatment" ], "offsets": [ [ 110, 119 ] ], "normalized": [] }, { "id": "NCT01501201_inc_T11", "type": "Scope", "text": [ "GLP1 (glucagon-like peptide) analogue or insulin" ], "offsets": [ [ 125, 173 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01501201_inc_R1", "type": "Has_value", "arg1_id": "NCT01501201_inc_T2", "arg2_id": "NCT01501201_inc_T3", "normalized": [] }, { "id": "NCT01501201_inc_R2", "type": "Has_value", "arg1_id": "NCT01501201_inc_T4", "arg2_id": "NCT01501201_inc_T5", "normalized": [] }, { "id": "NCT01501201_inc_R3", "type": "Has_mood", "arg1_id": "NCT01501201_inc_T6", "arg2_id": "NCT01501201_inc_T7", "normalized": [] }, { "id": "NCT01501201_inc_R4", "type": "Has_scope", "arg1_id": "NCT01501201_inc_T10", "arg2_id": "NCT01501201_inc_T11", "normalized": [] } ]

[ { "id": "NCT01518946_exc_text", "type": "exclusion", "text": [ "1. The subject is a pregnant or lactating female. \n2. The subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes. \n3. Subjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study. \n4. The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant \n5. The subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406). \n6. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures. \n7. The subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram [ECG] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject. \n8. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients. \n9. Prior enrollment failure or randomization in this study. \n10. History of alcohol abuse or other substance abuse within the last year. \n \n" ], "offsets": [ [ 0, 2004 ] ] } ]

[ { "id": "NCT01518946_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 20, 28 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T2", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 32, 41 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T3", "type": "Person", "text": [ "female" ], "offsets": [ [ 42, 48 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T4", "type": "Condition", "text": [ "supine hypertension" ], "offsets": [ [ 93, 112 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T5", "type": "Value", "text": [ "greater than 180mmHg systolic" ], "offsets": [ [ 113, 142 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T6", "type": "Value", "text": [ "110mmHg diastolic" ], "offsets": [ [ 147, 164 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T7", "type": "Measurement", "text": [ "BP" ], "offsets": [ [ 165, 167 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T8", "type": "Temporal", "text": [ "at the Screening Visit" ], "offsets": [ [ 194, 216 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T9", "type": "Reference_point", "text": [ "Screening Visit" ], "offsets": [ [ 201, 216 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T10", "type": "Temporal", "text": [ "pre-existing" ], "offsets": [ [ 70, 82 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T11", "type": "Temporal", "text": [ "sustained" ], "offsets": [ [ 83, 92 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T12", "type": "Scope", "text": [ "or", "at the Screening Visit", "sustained" ], "offsets": [ [ 168, 170 ], [ 194, 216 ], [ 83, 92 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T13", "type": "Temporal", "text": [ "persistently" ], "offsets": [ [ 242, 254 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T14", "type": "Value", "text": [ "greater" ], "offsets": [ [ 255, 262 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T15", "type": "Multiplier", "text": [ "2 separate", "at least 5 minutes apart" ], "offsets": [ [ 266, 276 ], [ 290, 314 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T16", "type": "Measurement", "text": [ "measurements" ], "offsets": [ [ 277, 289 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T17", "type": "Drug", "text": [ "medications of interest" ], "offsets": [ [ 402, 425 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T18", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 390, 401 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T23", "type": "Condition", "text": [ "chronic", "illness" ], "offsets": [ [ 1417, 1424 ], [ 1434, 1441 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T24", "type": "Condition", "text": [ "acute illness" ], "offsets": [ [ 1428, 1441 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T25", "type": "Condition", "text": [ "disability" ], "offsets": [ [ 1443, 1453 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T26", "type": "Condition", "text": [ "other condition" ], "offsets": [ [ 1458, 1473 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T28", "type": "Procedure", "text": [ "electrocardiogram [ECG]" ], "offsets": [ [ 1522, 1545 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T29", "type": "Condition", "text": [ "laboratory", "findings" ], "offsets": [ [ 1508, 1518 ], [ 1546, 1554 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T30", "type": "Condition", "text": [ "electrocardiogram [ECG] findings" ], "offsets": [ [ 1522, 1554 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T32", "type": "Condition", "text": [ "enrollment failure" ], "offsets": [ [ 1864, 1882 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T34", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 1931, 1944 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T35", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 1954, 1969 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T36", "type": "Temporal", "text": [ "within the last year" ], "offsets": [ [ 1970, 1990 ] ], "normalized": [] }, { "id": "NCT01518946_exc_T37", "type": "Scope", "text": [ "alcohol abuse or other substance abuse" ], "offsets": [ [ 1931, 1969 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01518946_exc_R1", "type": "Has_value", "arg1_id": "NCT01518946_exc_T7", "arg2_id": "NCT01518946_exc_T6", "normalized": [] }, { "id": "NCT01518946_exc_R2", "type": "Has_value", "arg1_id": "NCT01518946_exc_T7", "arg2_id": "NCT01518946_exc_T5", "normalized": [] }, { "id": "NCT01518946_exc_R3", "type": "Has_index", "arg1_id": "NCT01518946_exc_T8", "arg2_id": "NCT01518946_exc_T9", "normalized": [] }, { "id": "NCT01518946_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01518946_exc_T4", "arg2_id": "NCT01518946_exc_T10", "normalized": [] }, { "id": "NCT01518946_exc_R5", "type": "AND", "arg1_id": "NCT01518946_exc_T4", "arg2_id": "NCT01518946_exc_T7", "normalized": [] }, { "id": "NCT01518946_exc_R6", "type": "Has_scope", "arg1_id": "NCT01518946_exc_T4", "arg2_id": "NCT01518946_exc_T12", "normalized": [] }, { "id": "NCT01518946_exc_R7", "type": "Has_multiplier", "arg1_id": "NCT01518946_exc_T16", "arg2_id": "NCT01518946_exc_T15", "normalized": [] }, { "id": "NCT01518946_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01518946_exc_T17", "arg2_id": "NCT01518946_exc_T18", "normalized": [] }, { "id": "NCT01518946_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01518946_exc_T37", "arg2_id": "NCT01518946_exc_T36", "normalized": [] } ]

[ { "id": "NCT01518946_inc_text", "type": "inclusion", "text": [ "1. Male and female subjects must be 18 years of age or older and ambulatory. \n2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test. \n3. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl , and has been at a stable dose for at least 3 months. \n4. The subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out. \n" ], "offsets": [ [ 0, 692 ] ] } ]

[ { "id": "NCT01518946_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 3, 7 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T3", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 36, 44 ], [ 52, 60 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 48, 51 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T5", "type": "Visit", "text": [ "ambulatory" ], "offsets": [ [ 65, 75 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T6", "type": "Person", "text": [ "Females" ], "offsets": [ [ 81, 88 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T7", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 92, 115 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T8", "type": "Measurement", "text": [ "serum beta human chorionic gonadotropin (HCG) pregnancy test" ], "offsets": [ [ 144, 204 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T9", "type": "Value", "text": [ "negative" ], "offsets": [ [ 135, 143 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T10", "type": "Scope", "text": [ "Females of child-bearing potential" ], "offsets": [ [ 81, 115 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T11", "type": "Condition", "text": [ "Symptomatic Orthostatic Hypotension (SOH)" ], "offsets": [ [ 241, 282 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T12", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 234, 240 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T13", "type": "Drug", "text": [ "midodrine HCl" ], "offsets": [ [ 360, 373 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T14", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 394, 405 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T15", "type": "Temporal", "text": [ "for at least 3 months" ], "offsets": [ [ 406, 427 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T16", "type": "Multiplier", "text": [ "at least 1" ], "offsets": [ [ 460, 470 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T17", "type": "Condition", "text": [ "dizziness" ], "offsets": [ [ 610, 619 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T18", "type": "Condition", "text": [ "lightheadedness" ], "offsets": [ [ 621, 636 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T19", "type": "Condition", "text": [ "feeling faint" ], "offsets": [ [ 638, 651 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T20", "type": "Condition", "text": [ "feeling like they might black out" ], "offsets": [ [ 656, 689 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T21", "type": "Condition", "text": [ "orthostatic hypotension (OH)" ], "offsets": [ [ 580, 608 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T22", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 568, 575 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T23", "type": "Negation", "text": [ "not" ], "offsets": [ [ 564, 567 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T24", "type": "Multiplier", "text": [ "1" ], "offsets": [ [ 540, 541 ] ], "normalized": [] }, { "id": "NCT01518946_inc_T25", "type": "Scope", "text": [ "dizziness, lightheadedness, feeling faint, or feeling like they might black out" ], "offsets": [ [ 610, 689 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01518946_inc_R1", "type": "Has_value", "arg1_id": "NCT01518946_inc_T4", "arg2_id": "NCT01518946_inc_T3", "normalized": [] }, { "id": "NCT01518946_inc_R2", "type": "Has_value", "arg1_id": "NCT01518946_inc_T8", "arg2_id": "NCT01518946_inc_T9", "normalized": [] }, { "id": "NCT01518946_inc_R3", "type": "AND", "arg1_id": "NCT01518946_inc_T10", "arg2_id": "NCT01518946_inc_T8", "normalized": [] }, { "id": "NCT01518946_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01518946_inc_T14", "arg2_id": "NCT01518946_inc_T15", "normalized": [] }, { "id": "NCT01518946_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01518946_inc_T11", "arg2_id": "NCT01518946_inc_T12", "normalized": [] }, { "id": "NCT01518946_inc_R6", "type": "AND", "arg1_id": "NCT01518946_inc_T22", "arg2_id": "NCT01518946_inc_T21", "normalized": [] }, { "id": "NCT01518946_inc_R7", "type": "Has_negation", "arg1_id": "NCT01518946_inc_T22", "arg2_id": "NCT01518946_inc_T23", "normalized": [] }, { "id": "NCT01518946_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01518946_inc_T25", "arg2_id": "NCT01518946_inc_T24", "normalized": [] }, { "id": "NCT01518946_inc_R9", "type": "Has_scope", "arg1_id": "NCT01518946_inc_T22", "arg2_id": "NCT01518946_inc_T25", "normalized": [] } ]

[ { "id": "NCT01531257_exc_text", "type": "exclusion", "text": [ "1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. \n2. Recipients of previous non-renal solid organ and/or islet cell transplantation. \n3. Infection with HIV. \n4. Inability or unwillingness of a participant and/or guardian to provide informed consent \n \n" ], "offsets": [ [ 0, 311 ] ] } ]

[ { "id": "NCT01531257_exc_T1", "type": "Procedure", "text": [ "combined organ transplantation" ], "offsets": [ [ 12, 42 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T2", "type": "Qualifier", "text": [ "extra-renal organ" ], "offsets": [ [ 51, 68 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T3", "type": "Procedure", "text": [ "islet cell transplant" ], "offsets": [ [ 76, 97 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T4", "type": "Scope", "text": [ "extra-renal organ and/or islet cell transplant" ], "offsets": [ [ 51, 97 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T5", "type": "Procedure", "text": [ "non-renal solid organ", "transplantation" ], "offsets": [ [ 126, 147 ], [ 166, 181 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T6", "type": "Procedure", "text": [ "islet cell transplantation" ], "offsets": [ [ 155, 181 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T7", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 117, 125 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T8", "type": "Scope", "text": [ "non-renal solid organ and/or islet cell transplantation" ], "offsets": [ [ 126, 181 ] ], "normalized": [] }, { "id": "NCT01531257_exc_T9", "type": "Condition", "text": [ "Infection with HIV" ], "offsets": [ [ 187, 205 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01531257_exc_R1", "type": "Has_scope", "arg1_id": "NCT01531257_exc_T1", "arg2_id": "NCT01531257_exc_T4", "normalized": [] }, { "id": "NCT01531257_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01531257_exc_T8", "arg2_id": "NCT01531257_exc_T7", "normalized": [] } ]

[ { "id": "NCT01531257_inc_text", "type": "inclusion", "text": [ "1. Male and female recipients of all races, ≥18 years of age. \n2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation. \n3. Subject and/or guardian must be able to provide informed consent. \n4. Subject and/or guardian must be able to comply with the study protocol. \n" ], "offsets": [ [ 0, 310 ] ] } ]

[ { "id": "NCT01531257_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 3, 7 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T3", "type": "Value", "text": [ "≥18 years" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 57, 60 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T5", "type": "Multiplier", "text": [ "primary" ], "offsets": [ [ 86, 93 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T6", "type": "Multiplier", "text": [ "subsequent" ], "offsets": [ [ 97, 107 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T7", "type": "Procedure", "text": [ "living donor kidney transplantation" ], "offsets": [ [ 126, 161 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T8", "type": "Procedure", "text": [ "deceased-donor", "kidney transplantation" ], "offsets": [ [ 108, 122 ], [ 139, 161 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T9", "type": "Scope", "text": [ "deceased-donor or living donor kidney transplantation" ], "offsets": [ [ 108, 161 ] ], "normalized": [] }, { "id": "NCT01531257_inc_T10", "type": "Scope", "text": [ "primary or subsequent" ], "offsets": [ [ 86, 107 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01531257_inc_R1", "type": "Has_value", "arg1_id": "NCT01531257_inc_T4", "arg2_id": "NCT01531257_inc_T3", "normalized": [] }, { "id": "NCT01531257_inc_R2", "type": "Has_scope", "arg1_id": "NCT01531257_inc_T9", "arg2_id": "NCT01531257_inc_T10", "normalized": [] } ]

[ { "id": "NCT01567605_exc_text", "type": "exclusion", "text": [ "cauda equina or conus lesion\ncurrently use ventilator\ncolostomy, or do not perform regular bowel care for any reason\nany skin breakdown (pressure sores)\ndo not speak English\nare under 19 years old\nare pregnant or think you might be pregnant\nmedical/psychiatric condition or substance abuse that is likely to affect your ability to complete this study\ncurrently using medications containing lidocaine\nallergy to lidocaine\n" ], "offsets": [ [ 0, 421 ] ] } ]

[ { "id": "NCT01567605_exc_T1", "type": "Qualifier", "text": [ "cauda equina" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T2", "type": "Qualifier", "text": [ "conus" ], "offsets": [ [ 16, 21 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T3", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 22, 28 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T4", "type": "Scope", "text": [ "cauda equina or conus" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T5", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T6", "type": "Procedure", "text": [ "ventilator" ], "offsets": [ [ 43, 53 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T7", "type": "Procedure", "text": [ "colostomy" ], "offsets": [ [ 54, 63 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T8", "type": "Procedure", "text": [ "regular bowel care" ], "offsets": [ [ 83, 101 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T9", "type": "Negation", "text": [ "do not perform" ], "offsets": [ [ 68, 82 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T10", "type": "Condition", "text": [ "skin breakdown" ], "offsets": [ [ 121, 135 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T11", "type": "Condition", "text": [ "pressure sores" ], "offsets": [ [ 137, 151 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T12", "type": "Negation", "text": [ "not" ], "offsets": [ [ 156, 159 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T13", "type": "Observation", "text": [ "speak English" ], "offsets": [ [ 160, 173 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T14", "type": "Value", "text": [ "under 19 years" ], "offsets": [ [ 178, 192 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T15", "type": "Person", "text": [ "old" ], "offsets": [ [ 193, 196 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T16", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 201, 209 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T17", "type": "Mood", "text": [ "think you might be" ], "offsets": [ [ 213, 231 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T18", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 232, 240 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T19", "type": "Condition", "text": [ "/psychi", "on or sub" ], "offsets": [ [ 248, 255 ], [ 268, 277 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T20", "type": "Condition", "text": [ "psychiatric condition" ], "offsets": [ [ 249, 270 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T21", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 274, 289 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T22", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 351, 360 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T24", "type": "Drug", "text": [ "medications containing lidocaine" ], "offsets": [ [ 367, 399 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T23", "type": "Drug", "text": [ "lidocaine" ], "offsets": [ [ 411, 420 ] ], "normalized": [] }, { "id": "NCT01567605_exc_T25", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 400, 407 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01567605_exc_R1", "type": "Has_scope", "arg1_id": "NCT01567605_exc_T3", "arg2_id": "NCT01567605_exc_T4", "normalized": [] }, { "id": "NCT01567605_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01567605_exc_T6", "arg2_id": "NCT01567605_exc_T5", "normalized": [] }, { "id": "NCT01567605_exc_R3", "type": "Has_negation", "arg1_id": "NCT01567605_exc_T8", "arg2_id": "NCT01567605_exc_T9", "normalized": [] }, { "id": "NCT01567605_exc_R4", "type": "Subsumes", "arg1_id": "NCT01567605_exc_T10", "arg2_id": "NCT01567605_exc_T11", "normalized": [] }, { "id": "NCT01567605_exc_R5", "type": "Has_negation", "arg1_id": "NCT01567605_exc_T13", "arg2_id": "NCT01567605_exc_T12", "normalized": [] }, { "id": "NCT01567605_exc_R6", "type": "Has_value", "arg1_id": "NCT01567605_exc_T15", "arg2_id": "NCT01567605_exc_T14", "normalized": [] }, { "id": "NCT01567605_exc_R7", "type": "Has_mood", "arg1_id": "NCT01567605_exc_T18", "arg2_id": "NCT01567605_exc_T17", "normalized": [] }, { "id": "NCT01567605_exc_R8", "type": "AND", "arg1_id": "NCT01567605_exc_T25", "arg2_id": "NCT01567605_exc_T23", "normalized": [] } ]

[ { "id": "NCT01567605_inc_text", "type": "inclusion", "text": [ "traumatic spinal cord injury at least one year ago\nregular bowel care routine (at least four weeks)\n" ], "offsets": [ [ 0, 100 ] ] } ]

[ { "id": "NCT01567605_inc_T1", "type": "Condition", "text": [ "traumatic spinal cord injury" ], "offsets": [ [ 0, 28 ] ], "normalized": [] }, { "id": "NCT01567605_inc_T2", "type": "Temporal", "text": [ "at least one year ago" ], "offsets": [ [ 29, 50 ] ], "normalized": [] }, { "id": "NCT01567605_inc_T3", "type": "Observation", "text": [ "regular bowel care routine" ], "offsets": [ [ 51, 77 ] ], "normalized": [] }, { "id": "NCT01567605_inc_T4", "type": "Temporal", "text": [ "at least four weeks" ], "offsets": [ [ 79, 98 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01567605_inc_R1", "type": "Has_temporal", "arg1_id": "NCT01567605_inc_T1", "arg2_id": "NCT01567605_inc_T2", "normalized": [] }, { "id": "NCT01567605_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01567605_inc_T3", "arg2_id": "NCT01567605_inc_T4", "normalized": [] } ]

[ { "id": "NCT01579604_exc_text", "type": "exclusion", "text": [ "Unstable patient\nJoint contracture\nSpasticity\nLoss of function is expected to be improved by reliable tendon transfer, tenodesis or arthrodesis that is available\nEvidence of recovering finger/thumb extension at 4-6 months\nGreater than 12 months from spinal cord injury\nSubject not fluent in English or an appropriate translator not available\n" ], "offsets": [ [ 0, 342 ] ] } ]

[ { "id": "NCT01579604_exc_T1", "type": "Person", "text": [ "patient" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T2", "type": "Qualifier", "text": [ "Unstable" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T3", "type": "Condition", "text": [ "Joint contracture" ], "offsets": [ [ 17, 34 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T4", "type": "Condition", "text": [ "Spasticity" ], "offsets": [ [ 35, 45 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T5", "type": "Observation", "text": [ "Loss of function" ], "offsets": [ [ 46, 62 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T6", "type": "Mood", "text": [ "improved by" ], "offsets": [ [ 81, 92 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T7", "type": "Procedure", "text": [ "tendon transfer" ], "offsets": [ [ 102, 117 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T8", "type": "Procedure", "text": [ "tenodesis" ], "offsets": [ [ 119, 128 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T9", "type": "Procedure", "text": [ "arthrodesis" ], "offsets": [ [ 132, 143 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T10", "type": "Scope", "text": [ "tendon transfer, tenodesis or arthrodesis" ], "offsets": [ [ 102, 143 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T11", "type": "Observation", "text": [ "vering fin", "nsion at" ], "offsets": [ [ 178, 188 ], [ 202, 210 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T12", "type": "Qualifier", "text": [ "finger" ], "offsets": [ [ 185, 191 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T13", "type": "Qualifier", "text": [ "thumb" ], "offsets": [ [ 192, 197 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T14", "type": "Scope", "text": [ "finger/thumb" ], "offsets": [ [ 185, 197 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T15", "type": "Temporal", "text": [ "at 4-6 months" ], "offsets": [ [ 208, 221 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T16", "type": "Condition", "text": [ "spinal cord injury" ], "offsets": [ [ 250, 268 ] ], "normalized": [] }, { "id": "NCT01579604_exc_T17", "type": "Temporal", "text": [ "Greater than 12 months" ], "offsets": [ [ 222, 244 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01579604_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01579604_exc_T1", "arg2_id": "NCT01579604_exc_T2", "normalized": [] }, { "id": "NCT01579604_exc_R2", "type": "Has_mood", "arg1_id": "NCT01579604_exc_T10", "arg2_id": "NCT01579604_exc_T6", "normalized": [] }, { "id": "NCT01579604_exc_R3", "type": "Has_scope", "arg1_id": "NCT01579604_exc_T5", "arg2_id": "NCT01579604_exc_T10", "normalized": [] }, { "id": "NCT01579604_exc_R4", "type": "Has_scope", "arg1_id": "NCT01579604_exc_T11", "arg2_id": "NCT01579604_exc_T14", "normalized": [] }, { "id": "NCT01579604_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01579604_exc_T11", "arg2_id": "NCT01579604_exc_T15", "normalized": [] }, { "id": "NCT01579604_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01579604_exc_T16", "arg2_id": "NCT01579604_exc_T17", "normalized": [] } ]

[ { "id": "NCT01579604_inc_text", "type": "inclusion", "text": [ "Cervical spine injury with functional loss in the upper extremity\nGreater than 4 months out from C-spine injury\nStable motor recovery\nMedically stable\nInternational Classification for Surgery of the Hand in Tetraplegia of 0-5 at 6 months\nGrade 0 finger/thumb extension at 6 months\nSubjects fluent in English or when not fluent, an appropriate translator is present\n" ], "offsets": [ [ 0, 365 ] ] } ]

[ { "id": "NCT01579604_inc_T1", "type": "Condition", "text": [ "Cervical spine injury" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T2", "type": "Observation", "text": [ "functional loss" ], "offsets": [ [ 27, 42 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T3", "type": "Qualifier", "text": [ "upper extremity" ], "offsets": [ [ 50, 65 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T4", "type": "Condition", "text": [ "C-spine injury" ], "offsets": [ [ 97, 111 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T5", "type": "Temporal", "text": [ "Greater than 4 month" ], "offsets": [ [ 66, 86 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T6", "type": "Observation", "text": [ "motor recovery" ], "offsets": [ [ 119, 133 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T7", "type": "Qualifier", "text": [ "Stable" ], "offsets": [ [ 112, 118 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T8", "type": "Condition", "text": [ "stable" ], "offsets": [ [ 144, 150 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T9", "type": "Qualifier", "text": [ "Medically" ], "offsets": [ [ 134, 143 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T10", "type": "Measurement", "text": [ "International Classification for Surgery of the Hand in Tetraplegia" ], "offsets": [ [ 151, 218 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T11", "type": "Value", "text": [ "0-5" ], "offsets": [ [ 222, 225 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T12", "type": "Temporal", "text": [ "at 6 months" ], "offsets": [ [ 226, 237 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T13", "type": "Measurement", "text": [ "extension" ], "offsets": [ [ 259, 268 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T14", "type": "Qualifier", "text": [ "thumb" ], "offsets": [ [ 253, 258 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T15", "type": "Qualifier", "text": [ "finger" ], "offsets": [ [ 246, 252 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T16", "type": "Value", "text": [ "Grade 0" ], "offsets": [ [ 238, 245 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T17", "type": "Scope", "text": [ "finger/thumb" ], "offsets": [ [ 246, 258 ] ], "normalized": [] }, { "id": "NCT01579604_inc_T18", "type": "Temporal", "text": [ "at 6 months" ], "offsets": [ [ 269, 280 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01579604_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01579604_inc_T2", "arg2_id": "NCT01579604_inc_T3", "normalized": [] }, { "id": "NCT01579604_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01579604_inc_T4", "arg2_id": "NCT01579604_inc_T5", "normalized": [] }, { "id": "NCT01579604_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01579604_inc_T6", "arg2_id": "NCT01579604_inc_T7", "normalized": [] }, { "id": "NCT01579604_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01579604_inc_T8", "arg2_id": "NCT01579604_inc_T9", "normalized": [] }, { "id": "NCT01579604_inc_R6", "type": "Has_value", "arg1_id": "NCT01579604_inc_T10", "arg2_id": "NCT01579604_inc_T11", "normalized": [] }, { "id": "NCT01579604_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01579604_inc_T10", "arg2_id": "NCT01579604_inc_T12", "normalized": [] }, { "id": "NCT01579604_inc_R8", "type": "Has_scope", "arg1_id": "NCT01579604_inc_T13", "arg2_id": "NCT01579604_inc_T17", "normalized": [] }, { "id": "NCT01579604_inc_R9", "type": "Has_value", "arg1_id": "NCT01579604_inc_T13", "arg2_id": "NCT01579604_inc_T16", "normalized": [] }, { "id": "NCT01579604_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01579604_inc_T13", "arg2_id": "NCT01579604_inc_T18", "normalized": [] } ]

[ { "id": "NCT01581749_exc_text", "type": "exclusion", "text": [ "implanted hardware or other material that would prohibit treatment planning or delivery\nchemotherapy for a malignancy within the previous 5 years\nhistory of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years\nhormone ablation for 2 months prior to treatment or during treatment\n" ], "offsets": [ [ 0, 338 ] ] } ]

[ { "id": "NCT01581749_exc_T2", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 88, 100 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T3", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 107, 117 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T4", "type": "Temporal", "text": [ "within the previous 5 years" ], "offsets": [ [ 118, 145 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T5", "type": "Condition", "text": [ "invasive malignancy" ], "offsets": [ [ 160, 179 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T6", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 181, 191 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T7", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 197, 212 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T8", "type": "Condition", "text": [ "squamous skin cancers" ], "offsets": [ [ 225, 246 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T9", "type": "Condition", "text": [ "sal o", "in cancers)" ], "offsets": [ [ 218, 223 ], [ 236, 247 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T10", "type": "Scope", "text": [ "prostate cancer,or basal or squamous skin cancers" ], "offsets": [ [ 197, 246 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T11", "type": "Temporal", "text": [ "within prior 5 years" ], "offsets": [ [ 248, 268 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T12", "type": "Scope", "text": [ "invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers" ], "offsets": [ [ 160, 246 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T13", "type": "Procedure", "text": [ "hormone ablation" ], "offsets": [ [ 269, 285 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T14", "type": "Temporal", "text": [ "for 2 months prior to treatment" ], "offsets": [ [ 286, 317 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T15", "type": "Reference_point", "text": [ "treatment" ], "offsets": [ [ 308, 317 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T16", "type": "Temporal", "text": [ "during treatment" ], "offsets": [ [ 321, 337 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T17", "type": "Reference_point", "text": [ "treatment" ], "offsets": [ [ 328, 337 ] ], "normalized": [] }, { "id": "NCT01581749_exc_T18", "type": "Scope", "text": [ "for 2 months prior to treatment or during treatment" ], "offsets": [ [ 286, 337 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01581749_exc_R1", "type": "AND", "arg1_id": "NCT01581749_exc_T2", "arg2_id": "NCT01581749_exc_T3", "normalized": [] }, { "id": "NCT01581749_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01581749_exc_T2", "arg2_id": "NCT01581749_exc_T4", "normalized": [] }, { "id": "NCT01581749_exc_R3", "type": "Has_negation", "arg1_id": "NCT01581749_exc_T10", "arg2_id": "NCT01581749_exc_T6", "normalized": [] }, { "id": "NCT01581749_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01581749_exc_T12", "arg2_id": "NCT01581749_exc_T11", "normalized": [] }, { "id": "NCT01581749_exc_R5", "type": "Has_index", "arg1_id": "NCT01581749_exc_T14", "arg2_id": "NCT01581749_exc_T15", "normalized": [] }, { "id": "NCT01581749_exc_R6", "type": "Has_index", "arg1_id": "NCT01581749_exc_T16", "arg2_id": "NCT01581749_exc_T17", "normalized": [] }, { "id": "NCT01581749_exc_R7", "type": "Has_scope", "arg1_id": "NCT01581749_exc_T13", "arg2_id": "NCT01581749_exc_T18", "normalized": [] } ]

[ { "id": "NCT01581749_inc_text", "type": "inclusion", "text": [ "histologically proven prostate adenocarcinoma within 1 year of enrollment\nLow risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0\nIntermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0\nECOG Performance Status 0-1\nNo prior prostate radiation or other definitive therapy\n" ], "offsets": [ [ 0, 439 ] ] } ]

[ { "id": "NCT01581749_inc_T1", "type": "Condition", "text": [ "prostate adenocarcinoma" ], "offsets": [ [ 22, 45 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T2", "type": "Qualifier", "text": [ "histologically proven" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T3", "type": "Temporal", "text": [ "within 1 year of enrollment" ], "offsets": [ [ 46, 73 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T4", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 63, 73 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T5", "type": "Measurement", "text": [ "Gleason" ], "offsets": [ [ 84, 91 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T6", "type": "Observation", "text": [ "Low risk" ], "offsets": [ [ 74, 82 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T7", "type": "Value", "text": [ "<or=6" ], "offsets": [ [ 92, 97 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T8", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 100, 103 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T9", "type": "Value", "text": [ "<or=10" ], "offsets": [ [ 104, 110 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T10", "type": "Measurement", "text": [ "Clinical Stage" ], "offsets": [ [ 113, 127 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T12", "type": "Value", "text": [ "T1b-T2a" ], "offsets": [ [ 128, 135 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T13", "type": "Value", "text": [ "Mx" ], "offsets": [ [ 146, 148 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T14", "type": "Value", "text": [ "M0" ], "offsets": [ [ 152, 154 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T11", "type": "Value", "text": [ "Nx" ], "offsets": [ [ 136, 138 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T15", "type": "Value", "text": [ "N0" ], "offsets": [ [ 142, 144 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T16", "type": "Scope", "text": [ "T1b-T2a,Nx or N0, Mx or M0" ], "offsets": [ [ 128, 154 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T17", "type": "Scope", "text": [ "Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0" ], "offsets": [ [ 84, 154 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T18", "type": "Observation", "text": [ "Intermediate risk" ], "offsets": [ [ 155, 172 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T19", "type": "Measurement", "text": [ "Gleason" ], "offsets": [ [ 173, 180 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T20", "type": "Value", "text": [ "<or=6" ], "offsets": [ [ 181, 186 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T21", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 189, 192 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T22", "type": "Value", "text": [ "<or=10" ], "offsets": [ [ 192, 198 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T23", "type": "Measurement", "text": [ "Clinical Stage" ], "offsets": [ [ 201, 215 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T24", "type": "Value", "text": [ "T2b" ], "offsets": [ [ 216, 219 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T25", "type": "Measurement", "text": [ "Gleason" ], "offsets": [ [ 223, 230 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T26", "type": "Value", "text": [ "=7" ], "offsets": [ [ 230, 232 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T27", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 235, 238 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T28", "type": "Value", "text": [ "<or=10" ], "offsets": [ [ 238, 244 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T29", "type": "Measurement", "text": [ "Clinical Stage" ], "offsets": [ [ 247, 261 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T30", "type": "Value", "text": [ "T1b-T2b" ], "offsets": [ [ 262, 269 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T31", "type": "Measurement", "text": [ "Gleason" ], "offsets": [ [ 273, 280 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T32", "type": "Value", "text": [ "<or=6" ], "offsets": [ [ 281, 286 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T33", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 289, 292 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T34", "type": "Value", "text": [ "> 10 & < or =20" ], "offsets": [ [ 293, 308 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T35", "type": "Measurement", "text": [ "Clinical Stage" ], "offsets": [ [ 311, 325 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T36", "type": "Value", "text": [ "T1b- T2b" ], "offsets": [ [ 326, 334 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T37", "type": "Value", "text": [ "Nx" ], "offsets": [ [ 336, 338 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T38", "type": "Value", "text": [ "NO" ], "offsets": [ [ 342, 344 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T39", "type": "Value", "text": [ "Mx" ], "offsets": [ [ 346, 348 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T40", "type": "Value", "text": [ "M0" ], "offsets": [ [ 352, 354 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T41", "type": "Scope", "text": [ "T1b- T2b, Nx or NO, Mx or M0" ], "offsets": [ [ 326, 354 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T42", "type": "Scope", "text": [ "Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0" ], "offsets": [ [ 273, 354 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T43", "type": "Scope", "text": [ "Gleason <or=6 & PSA<or=10 & Clinical Stage T2b" ], "offsets": [ [ 173, 219 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T44", "type": "Scope", "text": [ "Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b" ], "offsets": [ [ 223, 269 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T45", "type": "Scope", "text": [ "Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0" ], "offsets": [ [ 173, 354 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T46", "type": "Measurement", "text": [ "ECOG Performance Status" ], "offsets": [ [ 355, 378 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T47", "type": "Value", "text": [ "0-1" ], "offsets": [ [ 379, 382 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T48", "type": "Procedure", "text": [ "prostate radiation" ], "offsets": [ [ 392, 410 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T49", "type": "Negation", "text": [ "No" ], "offsets": [ [ 383, 385 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T50", "type": "Procedure", "text": [ "definitive therapy" ], "offsets": [ [ 420, 438 ] ], "normalized": [] }, { "id": "NCT01581749_inc_T51", "type": "Scope", "text": [ "prostate radiation or other definitive therapy" ], "offsets": [ [ 392, 438 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01581749_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01581749_inc_T1", "arg2_id": "NCT01581749_inc_T2", "normalized": [] }, { "id": "NCT01581749_inc_R2", "type": "Has_index", "arg1_id": "NCT01581749_inc_T3", "arg2_id": "NCT01581749_inc_T4", "normalized": [] }, { "id": "NCT01581749_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01581749_inc_T1", "arg2_id": "NCT01581749_inc_T3", "normalized": [] }, { "id": "NCT01581749_inc_R4", "type": "Has_scope", "arg1_id": "NCT01581749_inc_T10", "arg2_id": "NCT01581749_inc_T16", "normalized": [] }, { "id": "NCT01581749_inc_R5", "type": "Has_value", "arg1_id": "NCT01581749_inc_T8", "arg2_id": "NCT01581749_inc_T9", "normalized": [] }, { "id": "NCT01581749_inc_R6", "type": "Has_value", "arg1_id": "NCT01581749_inc_T5", "arg2_id": "NCT01581749_inc_T7", "normalized": [] }, { "id": "NCT01581749_inc_R7", "type": "Subsumes", "arg1_id": "NCT01581749_inc_T6", "arg2_id": "NCT01581749_inc_T17", "normalized": [] }, { "id": "NCT01581749_inc_R8", "type": "Has_scope", "arg1_id": "NCT01581749_inc_T35", "arg2_id": "NCT01581749_inc_T41", "normalized": [] }, { "id": "NCT01581749_inc_R9", "type": "Has_value", "arg1_id": "NCT01581749_inc_T33", "arg2_id": "NCT01581749_inc_T34", "normalized": [] }, { "id": "NCT01581749_inc_R10", "type": "Has_value", "arg1_id": "NCT01581749_inc_T31", "arg2_id": "NCT01581749_inc_T32", "normalized": [] }, { "id": "NCT01581749_inc_R11", "type": "Has_value", "arg1_id": "NCT01581749_inc_T29", "arg2_id": "NCT01581749_inc_T30", "normalized": [] }, { "id": "NCT01581749_inc_R12", "type": "Has_value", "arg1_id": "NCT01581749_inc_T27", "arg2_id": "NCT01581749_inc_T28", "normalized": [] }, { "id": "NCT01581749_inc_R13", "type": "Has_value", "arg1_id": "NCT01581749_inc_T25", "arg2_id": "NCT01581749_inc_T26", "normalized": [] }, { "id": "NCT01581749_inc_R14", "type": "Has_value", "arg1_id": "NCT01581749_inc_T23", "arg2_id": "NCT01581749_inc_T24", "normalized": [] }, { "id": "NCT01581749_inc_R15", "type": "Has_value", "arg1_id": "NCT01581749_inc_T21", "arg2_id": "NCT01581749_inc_T22", "normalized": [] }, { "id": "NCT01581749_inc_R16", "type": "Has_value", "arg1_id": "NCT01581749_inc_T19", "arg2_id": "NCT01581749_inc_T20", "normalized": [] }, { "id": "NCT01581749_inc_R17", "type": "Subsumes", "arg1_id": "NCT01581749_inc_T18", "arg2_id": "NCT01581749_inc_T45", "normalized": [] }, { "id": "NCT01581749_inc_R18", "type": "Has_value", "arg1_id": "NCT01581749_inc_T46", "arg2_id": "NCT01581749_inc_T47", "normalized": [] }, { "id": "NCT01581749_inc_R19", "type": "Has_negation", "arg1_id": "NCT01581749_inc_T51", "arg2_id": "NCT01581749_inc_T49", "normalized": [] } ]

[ { "id": "NCT01602081_exc_text", "type": "exclusion", "text": [ "Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure \nFistula with multiple tracts \nRecto-vaginal fistula \nActive infection in the anal fistula \nPhysical allergies or cultural objections to porcine products \nPatient is not medically fit to undergo the LIFT procedure as judged by the treating physician \nPrevious diagnosis of collagen disorder \nHistory of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region \n \n" ], "offsets": [ [ 0, 497 ] ] } ]

[ { "id": "NCT01602081_exc_T1", "type": "Procedure", "text": [ "fistulotomy" ], "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T2", "type": "Procedure", "text": [ "fistulectomy" ], "offsets": [ [ 33, 45 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T3", "type": "Procedure", "text": [ "LIFT" ], "offsets": [ [ 47, 51 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T4", "type": "Procedure", "text": [ "cutting seton" ], "offsets": [ [ 53, 66 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T5", "type": "Procedure", "text": [ "advancement flap procedure" ], "offsets": [ [ 70, 96 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T6", "type": "Condition", "text": [ "Fistula" ], "offsets": [ [ 98, 105 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T7", "type": "Qualifier", "text": [ "multiple tracts" ], "offsets": [ [ 111, 126 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T8", "type": "Condition", "text": [ "Recto-vaginal fistula" ], "offsets": [ [ 128, 149 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T9", "type": "Condition", "text": [ "anal fistula" ], "offsets": [ [ 175, 187 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T10", "type": "Condition", "text": [ "infection in the anal fistula" ], "offsets": [ [ 158, 187 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T14", "type": "Condition", "text": [ "collagen disorder" ], "offsets": [ [ 370, 387 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T15", "type": "Condition", "text": [ "Crohn's Disease" ], "offsets": [ [ 400, 415 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T16", "type": "Condition", "text": [ "Irritable Bowel Syndrome" ], "offsets": [ [ 417, 441 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T17", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 443, 460 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T18", "type": "Qualifier", "text": [ "rectoanal region" ], "offsets": [ [ 468, 484 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T19", "type": "Observation", "text": [ "History" ], "offsets": [ [ 389, 396 ] ], "normalized": [] }, { "id": "NCT01602081_exc_T20", "type": "Scope", "text": [ "Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region" ], "offsets": [ [ 400, 484 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01602081_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01602081_exc_T6", "arg2_id": "NCT01602081_exc_T7", "normalized": [] }, { "id": "NCT01602081_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01602081_exc_T17", "arg2_id": "NCT01602081_exc_T18", "normalized": [] }, { "id": "NCT01602081_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01602081_exc_T20", "arg2_id": "NCT01602081_exc_T19", "normalized": [] } ]

[ { "id": "NCT01602081_inc_text", "type": "inclusion", "text": [ "Persistent primary or recurrent trans-sphincteric anal fistula \n" ], "offsets": [ [ 0, 64 ] ] } ]

[ { "id": "NCT01602081_inc_T1", "type": "Condition", "text": [ "trans-sphincteric anal fistula" ], "offsets": [ [ 32, 62 ] ], "normalized": [] }, { "id": "NCT01602081_inc_T2", "type": "Multiplier", "text": [ "recurrent" ], "offsets": [ [ 22, 31 ] ], "normalized": [] }, { "id": "NCT01602081_inc_T3", "type": "Multiplier", "text": [ "primary" ], "offsets": [ [ 11, 18 ] ], "normalized": [] }, { "id": "NCT01602081_inc_T4", "type": "Scope", "text": [ "primary or recurrent" ], "offsets": [ [ 11, 31 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01602081_inc_R1", "type": "Has_scope", "arg1_id": "NCT01602081_inc_T1", "arg2_id": "NCT01602081_inc_T4", "normalized": [] } ]

[ { "id": "NCT01604187_exc_text", "type": "exclusion", "text": [ "A previous history of intolerance to the study drug or related compounds and additives\nHistory of alcoholism, drug abuse, psychiatric, psychological or other emotional problems that are likely to invalidate informed consent\nSleep apnoea\nChronic obstructive pulmonary disease\nBMI = 35 or weight < 50 kg\nSpO2 < 90 %\nConcomitant drug therapy known to cause significant enzyme induction or inhibition of CYP 3A4.\nPregnancy or nursing.\n" ], "offsets": [ [ 0, 431 ] ] } ]

[ { "id": "NCT01604187_exc_T1", "type": "Observation", "text": [ "previous history" ], "offsets": [ [ 2, 18 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T2", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 22, 33 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T3", "type": "Drug", "text": [ "study drug" ], "offsets": [ [ 41, 51 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T4", "type": "Drug", "text": [ "related compounds" ], "offsets": [ [ 55, 72 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T5", "type": "Scope", "text": [ "study drug or related compounds" ], "offsets": [ [ 41, 72 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T6", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 98, 108 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T7", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 110, 120 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T8", "type": "Condition", "text": [ "sychiatric,", "roblems" ], "offsets": [ [ 123, 134 ], [ 169, 176 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T9", "type": "Condition", "text": [ "sychological", "roblems" ], "offsets": [ [ 136, 148 ], [ 169, 176 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T10", "type": "Condition", "text": [ "emotional problems" ], "offsets": [ [ 158, 176 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T11", "type": "Condition", "text": [ "Sleep apnoea" ], "offsets": [ [ 224, 236 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T12", "type": "Condition", "text": [ "Chronic obstructive pulmonary disease" ], "offsets": [ [ 237, 274 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T13", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 275, 278 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T14", "type": "Value", "text": [ "= 35" ], "offsets": [ [ 279, 283 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T15", "type": "Measurement", "text": [ "weight" ], "offsets": [ [ 287, 293 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T16", "type": "Value", "text": [ "< 50 kg" ], "offsets": [ [ 294, 301 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T17", "type": "Measurement", "text": [ "SpO2" ], "offsets": [ [ 302, 306 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T18", "type": "Value", "text": [ "< 90 %" ], "offsets": [ [ 307, 313 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T19", "type": "Measurement", "text": [ "drug therapy" ], "offsets": [ [ 326, 338 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T20", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 314, 325 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T21", "type": "Observation", "text": [ " induction or i", " 3A4.\nPre" ], "offsets": [ [ 372, 387 ], [ 403, 412 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T22", "type": "Observation", "text": [ " indu", "tion of CYP 3A4.\nPreg" ], "offsets": [ [ 372, 377 ], [ 392, 413 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T23", "type": "Scope", "text": [ "enzyme induction or inhibition of CYP 3A4" ], "offsets": [ [ 366, 407 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T24", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 409, 418 ] ], "normalized": [] }, { "id": "NCT01604187_exc_T25", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 422, 429 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01604187_exc_R1", "type": "Has_scope", "arg1_id": "NCT01604187_exc_T2", "arg2_id": "NCT01604187_exc_T5", "normalized": [] }, { "id": "NCT01604187_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01604187_exc_T2", "arg2_id": "NCT01604187_exc_T1", "normalized": [] }, { "id": "NCT01604187_exc_R3", "type": "Has_value", "arg1_id": "NCT01604187_exc_T13", "arg2_id": "NCT01604187_exc_T14", "normalized": [] }, { "id": "NCT01604187_exc_R4", "type": "Has_value", "arg1_id": "NCT01604187_exc_T15", "arg2_id": "NCT01604187_exc_T16", "normalized": [] }, { "id": "NCT01604187_exc_R5", "type": "Has_value", "arg1_id": "NCT01604187_exc_T17", "arg2_id": "NCT01604187_exc_T18", "normalized": [] }, { "id": "NCT01604187_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01604187_exc_T19", "arg2_id": "NCT01604187_exc_T20", "normalized": [] }, { "id": "NCT01604187_exc_R7", "type": "Has_scope", "arg1_id": "NCT01604187_exc_T19", "arg2_id": "NCT01604187_exc_T23", "normalized": [] } ]

[ { "id": "NCT01604187_inc_text", "type": "inclusion", "text": [ "ASA I-III\nColonoscopy\nWritten informed consent from participating subject\n" ], "offsets": [ [ 0, 74 ] ] } ]

[ { "id": "NCT01604187_inc_T1", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01604187_inc_T2", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 4, 9 ] ], "normalized": [] }, { "id": "NCT01604187_inc_T3", "type": "Procedure", "text": [ "Colonoscopy" ], "offsets": [ [ 10, 21 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01604187_inc_R1", "type": "Has_value", "arg1_id": "NCT01604187_inc_T1", "arg2_id": "NCT01604187_inc_T2", "normalized": [] } ]

[ { "id": "NCT01614041_exc_text", "type": "exclusion", "text": [ "Serious suicidal tendency\nThe score of the sixth item of HAMA =3\nThe score of HAMD =21\nPregnant or lactating women\nHistory of allergic or hypersensitivity to tandospirone\nSerious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease\nSecondary anxiety disorders\nDrug or alcohol dependence within 1 year\nPatients currently taking benzodiazepine drugs\nDrivers and dangerous machine operators\nParticipated in other clinical studies in the last 30 days\nPatients with clinically significant ECG or laboratory abnormalities\nPatients with a history of epilepsy\nPatients with abnormal TSH concentration\n" ], "offsets": [ [ 0, 629 ] ] } ]

[ { "id": "NCT01614041_exc_T1", "type": "Condition", "text": [ "suicidal tendency" ], "offsets": [ [ 8, 25 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T2", "type": "Measurement", "text": [ "score of the sixth item of HAMA" ], "offsets": [ [ 30, 61 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T3", "type": "Value", "text": [ "=3" ], "offsets": [ [ 62, 64 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T4", "type": "Measurement", "text": [ "score of HAMD" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T5", "type": "Value", "text": [ "=21" ], "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T6", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 87, 95 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T7", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 99, 108 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T8", "type": "Person", "text": [ "women" ], "offsets": [ [ 109, 114 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T9", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 138, 154 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T10", "type": "Drug", "text": [ "tandospirone" ], "offsets": [ [ 158, 170 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T11", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 126, 134 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T12", "type": "Qualifier", "text": [ "tandospirone" ], "offsets": [ [ 158, 170 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T13", "type": "Scope", "text": [ "allergic or hypersensitivity" ], "offsets": [ [ 126, 154 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T14", "type": "Condition", "text": [ "ac, ren", "se\nSeco" ], "offsets": [ [ 196, 203 ], [ 265, 272 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T15", "type": "Condition", "text": [ ", neu", "se\nSeco" ], "offsets": [ [ 205, 210 ], [ 265, 272 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T16", "type": "Condition", "text": [ "logic, cer", "se\nSeco" ], "offsets": [ [ 212, 222 ], [ 265, 272 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T17", "type": "Condition", "text": [ "rovascular, met", "se\nSeco" ], "offsets": [ [ 224, 239 ], [ 265, 272 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T18", "type": "Condition", "text": [ "olic, or", "se\nSeco" ], "offsets": [ [ 241, 249 ], [ 265, 272 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T19", "type": "Condition", "text": [ "pulmonary disease" ], "offsets": [ [ 250, 267 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T20", "type": "Scope", "text": [ "cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease" ], "offsets": [ [ 191, 267 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T21", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 182, 190 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T22", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 171, 178 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T23", "type": "Scope", "text": [ "Serious or unstable" ], "offsets": [ [ 171, 190 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T24", "type": "Condition", "text": [ "Secondary anxiety disorders" ], "offsets": [ [ 268, 295 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T25", "type": "Condition", "text": [ "alcohol dependence" ], "offsets": [ [ 304, 322 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T26", "type": "Condition", "text": [ " al", "nce within" ], "offsets": [ [ 303, 306 ], [ 319, 329 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T27", "type": "Scope", "text": [ "Drug or alcohol dependence" ], "offsets": [ [ 296, 322 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T28", "type": "Temporal", "text": [ "within 1 year" ], "offsets": [ [ 323, 336 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T29", "type": "Procedure", "text": [ "benzodiazepine drugs" ], "offsets": [ [ 363, 383 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T31", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 346, 355 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T32", "type": "Person", "text": [ "Drivers" ], "offsets": [ [ 384, 391 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T33", "type": "Person", "text": [ "dangerous machine operators" ], "offsets": [ [ 396, 423 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T35", "type": "Observation", "text": [ "Participated in other clinical studies" ], "offsets": [ [ 424, 462 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T36", "type": "Temporal", "text": [ "the last 30 days" ], "offsets": [ [ 466, 482 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T37", "type": "Condition", "text": [ "laboratory abnormalities" ], "offsets": [ [ 527, 551 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T38", "type": "Condition", "text": [ "rat", "es\nPatients w" ], "offsets": [ [ 531, 534 ], [ 549, 562 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T39", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 527, 537 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T40", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 520, 523 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T41", "type": "Scope", "text": [ "ECG or laboratory abnormalities" ], "offsets": [ [ 520, 551 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T42", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 497, 519 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T43", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 579, 587 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T44", "type": "Measurement", "text": [ "TSH" ], "offsets": [ [ 611, 614 ] ], "normalized": [] }, { "id": "NCT01614041_exc_T45", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 602, 610 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01614041_exc_R1", "type": "Has_value", "arg1_id": "NCT01614041_exc_T2", "arg2_id": "NCT01614041_exc_T3", "normalized": [] }, { "id": "NCT01614041_exc_R2", "type": "Has_value", "arg1_id": "NCT01614041_exc_T4", "arg2_id": "NCT01614041_exc_T5", "normalized": [] }, { "id": "NCT01614041_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01614041_exc_T13", "arg2_id": "NCT01614041_exc_T12", "normalized": [] }, { "id": "NCT01614041_exc_R5", "type": "Has_scope", "arg1_id": "NCT01614041_exc_T20", "arg2_id": "NCT01614041_exc_T23", "normalized": [] }, { "id": "NCT01614041_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01614041_exc_T27", "arg2_id": "NCT01614041_exc_T28", "normalized": [] }, { "id": "NCT01614041_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01614041_exc_T35", "arg2_id": "NCT01614041_exc_T36", "normalized": [] }, { "id": "NCT01614041_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT01614041_exc_T41", "arg2_id": "NCT01614041_exc_T42", "normalized": [] }, { "id": "NCT01614041_exc_R13", "type": "Has_value", "arg1_id": "NCT01614041_exc_T44", "arg2_id": "NCT01614041_exc_T45", "normalized": [] }, { "id": "NCT01614041_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01614041_exc_T29", "arg2_id": "NCT01614041_exc_T31", "normalized": [] } ]

[ { "id": "NCT01614041_inc_text", "type": "inclusion", "text": [ "18-65 years old\nMale or female\nDiagnosed with GAD according to DSM-IV\nHAMA score=17\nProvide with written informed consent\nAgree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.\n" ], "offsets": [ [ 0, 192 ] ] } ]

[ { "id": "NCT01614041_inc_T1", "type": "Person", "text": [ "years old" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T2", "type": "Value", "text": [ "18-65" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T3", "type": "Person", "text": [ "Male" ], "offsets": [ [ 16, 20 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T4", "type": "Person", "text": [ "female" ], "offsets": [ [ 24, 30 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T5", "type": "Condition", "text": [ "GAD" ], "offsets": [ [ 46, 49 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T6", "type": "Measurement", "text": [ "DSM-IV" ], "offsets": [ [ 63, 69 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T7", "type": "Measurement", "text": [ "HAMA score" ], "offsets": [ [ 70, 80 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T8", "type": "Value", "text": [ "=17" ], "offsets": [ [ 80, 83 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T10", "type": "Procedure", "text": [ "SSRI" ], "offsets": [ [ 172, 176 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T11", "type": "Procedure", "text": [ "SNRI" ], "offsets": [ [ 178, 182 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T12", "type": "Procedure", "text": [ "NASA" ], "offsets": [ [ 186, 190 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T13", "type": "Temporal", "text": [ "for two weeks" ], "offsets": [ [ 145, 158 ] ], "normalized": [] }, { "id": "NCT01614041_inc_T14", "type": "Procedure", "text": [ "washed-out" ], "offsets": [ [ 134, 144 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01614041_inc_R1", "type": "Has_value", "arg1_id": "NCT01614041_inc_T1", "arg2_id": "NCT01614041_inc_T2", "normalized": [] }, { "id": "NCT01614041_inc_R2", "type": "AND", "arg1_id": "NCT01614041_inc_T5", "arg2_id": "NCT01614041_inc_T6", "normalized": [] }, { "id": "NCT01614041_inc_R3", "type": "Has_value", "arg1_id": "NCT01614041_inc_T7", "arg2_id": "NCT01614041_inc_T8", "normalized": [] }, { "id": "NCT01614041_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01614041_inc_T14", "arg2_id": "NCT01614041_inc_T13", "normalized": [] } ]

[ { "id": "NCT01630954_exc_text", "type": "exclusion", "text": [ "Partial mole\nHistory of treatment for molar pregnancy like prior evacuation or chemotherapy\nWomen requiring hysterectomy for treatment of H Mole\n" ], "offsets": [ [ 0, 145 ] ] } ]

[ { "id": "NCT01630954_exc_T1", "type": "Condition", "text": [ "Partial mole" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T2", "type": "Condition", "text": [ "molar pregnancy" ], "offsets": [ [ 38, 53 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T3", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 24, 33 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T4", "type": "Procedure", "text": [ "evacuation" ], "offsets": [ [ 65, 75 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T5", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 79, 91 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T6", "type": "Scope", "text": [ "evacuation or chemotherapy" ], "offsets": [ [ 65, 91 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T7", "type": "Person", "text": [ "Women" ], "offsets": [ [ 92, 97 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T8", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 108, 120 ] ], "normalized": [] }, { "id": "NCT01630954_exc_T9", "type": "Condition", "text": [ "H Mole" ], "offsets": [ [ 138, 144 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01630954_exc_R1", "type": "AND", "arg1_id": "NCT01630954_exc_T3", "arg2_id": "NCT01630954_exc_T2", "normalized": [] }, { "id": "NCT01630954_exc_R2", "type": "Subsumes", "arg1_id": "NCT01630954_exc_T3", "arg2_id": "NCT01630954_exc_T6", "normalized": [] }, { "id": "NCT01630954_exc_R3", "type": "AND", "arg1_id": "NCT01630954_exc_T8", "arg2_id": "NCT01630954_exc_T9", "normalized": [] } ]

[ { "id": "NCT01630954_inc_text", "type": "inclusion", "text": [ "Ultrasound confirmed complete mole\n" ], "offsets": [ [ 0, 35 ] ] } ]

[ { "id": "NCT01630954_inc_T1", "type": "Procedure", "text": [ "Ultrasound" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01630954_inc_T2", "type": "Condition", "text": [ "complete mole" ], "offsets": [ [ 21, 34 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01630954_inc_R1", "type": "AND", "arg1_id": "NCT01630954_inc_T1", "arg2_id": "NCT01630954_inc_T2", "normalized": [] } ]

[ { "id": "NCT01631058_exc_text", "type": "exclusion", "text": [ "Allergy to any of proposed medications\nPatients with any active infection including HBV, HCV and HIV.\n" ], "offsets": [ [ 0, 102 ] ] } ]

[ { "id": "NCT01631058_exc_T1", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T2", "type": "Drug", "text": [ "proposed medications" ], "offsets": [ [ 18, 38 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T3", "type": "Condition", "text": [ "active infection" ], "offsets": [ [ 57, 73 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T4", "type": "Condition", "text": [ "HBV" ], "offsets": [ [ 84, 87 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T5", "type": "Condition", "text": [ "HCV" ], "offsets": [ [ 89, 92 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T6", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 97, 100 ] ], "normalized": [] }, { "id": "NCT01631058_exc_T7", "type": "Scope", "text": [ "HBV, HCV and HIV" ], "offsets": [ [ 84, 100 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01631058_exc_R1", "type": "AND", "arg1_id": "NCT01631058_exc_T1", "arg2_id": "NCT01631058_exc_T2", "normalized": [] }, { "id": "NCT01631058_exc_R2", "type": "Subsumes", "arg1_id": "NCT01631058_exc_T3", "arg2_id": "NCT01631058_exc_T7", "normalized": [] } ]

[ { "id": "NCT01631058_inc_text", "type": "inclusion", "text": [ "All renal (only) male and female recipients aged = 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).\nPanel Reactive Antibody (PRA) < 30%.\nPatients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).\n" ], "offsets": [ [ 0, 357 ] ] } ]

[ { "id": "NCT01631058_inc_T1", "type": "Person", "text": [ "male" ], "offsets": [ [ 17, 21 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 26, 32 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T3", "type": "Measurement", "text": [ "aged" ], "offsets": [ [ 44, 48 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T4", "type": "Value", "text": [ "= 60" ], "offsets": [ [ 49, 53 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T5", "type": "Condition", "text": [ "recipients", "renal" ], "offsets": [ [ 33, 43 ], [ 4, 9 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T6", "type": "Procedure", "text": [ "kidney transplantation" ], "offsets": [ [ 72, 94 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T7", "type": "Qualifier", "text": [ "living", "donor" ], "offsets": [ [ 102, 108 ], [ 121, 126 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T8", "type": "Qualifier", "text": [ "deceased donor" ], "offsets": [ [ 112, 126 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T9", "type": "Qualifier", "text": [ "Expanded Criteria Donors (ECD)" ], "offsets": [ [ 138, 168 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T10", "type": "Scope", "text": [ "living or deceased donor," ], "offsets": [ [ 102, 127 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T11", "type": "Measurement", "text": [ "Panel Reactive Antibody (PRA)" ], "offsets": [ [ 170, 199 ] ], "normalized": [] }, { "id": "NCT01631058_inc_T12", "type": "Value", "text": [ "< 30%" ], "offsets": [ [ 200, 205 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01631058_inc_R1", "type": "Has_value", "arg1_id": "NCT01631058_inc_T3", "arg2_id": "NCT01631058_inc_T4", "normalized": [] }, { "id": "NCT01631058_inc_R2", "type": "Subsumes", "arg1_id": "NCT01631058_inc_T10", "arg2_id": "NCT01631058_inc_T9", "normalized": [] }, { "id": "NCT01631058_inc_R3", "type": "Has_value", "arg1_id": "NCT01631058_inc_T11", "arg2_id": "NCT01631058_inc_T12", "normalized": [] } ]

[ { "id": "NCT01639664_exc_text", "type": "exclusion", "text": [ "Age less than 14 years\nPregnancy\nEstimated life expectancy (due to comorbidities) less than 90 days\nPresence of relative or absolute contraindications to CPFA\nAdmission from an other ICU where the patient remained for more than 24 hours\nAbsence of informed consent\n" ], "offsets": [ [ 0, 265 ] ] } ]

[ { "id": "NCT01639664_exc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T3", "type": "Value", "text": [ "less than 14 years" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 23, 32 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T4", "type": "Person", "text": [ "Estimated life expectancy" ], "offsets": [ [ 33, 58 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T5", "type": "Value", "text": [ "less than 90 days" ], "offsets": [ [ 82, 99 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T6", "type": "Condition", "text": [ "ative or", "traindications to" ], "offsets": [ [ 115, 123 ], [ 136, 153 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T7", "type": "Condition", "text": [ "absolute contraindications" ], "offsets": [ [ 124, 150 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T8", "type": "Procedure", "text": [ "CPFA" ], "offsets": [ [ 154, 158 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T9", "type": "Scope", "text": [ "relative or absolute contraindications" ], "offsets": [ [ 112, 150 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T10", "type": "Procedure", "text": [ "Admission" ], "offsets": [ [ 159, 168 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T11", "type": "Visit", "text": [ "an other ICU" ], "offsets": [ [ 174, 186 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T12", "type": "Observation", "text": [ "patient remained" ], "offsets": [ [ 197, 213 ] ], "normalized": [] }, { "id": "NCT01639664_exc_T13", "type": "Multiplier", "text": [ "for more than 24 hours" ], "offsets": [ [ 214, 236 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01639664_exc_R1", "type": "Has_value", "arg1_id": "NCT01639664_exc_T2", "arg2_id": "NCT01639664_exc_T3", "normalized": [] }, { "id": "NCT01639664_exc_R2", "type": "Has_value", "arg1_id": "NCT01639664_exc_T4", "arg2_id": "NCT01639664_exc_T5", "normalized": [] }, { "id": "NCT01639664_exc_R3", "type": "AND", "arg1_id": "NCT01639664_exc_T9", "arg2_id": "NCT01639664_exc_T8", "normalized": [] }, { "id": "NCT01639664_exc_R4", "type": "Has_multiplier", "arg1_id": "NCT01639664_exc_T12", "arg2_id": "NCT01639664_exc_T13", "normalized": [] }, { "id": "NCT01639664_exc_R5", "type": "AND", "arg1_id": "NCT01639664_exc_T10", "arg2_id": "NCT01639664_exc_T11", "normalized": [] } ]

[ { "id": "NCT01639664_inc_text", "type": "inclusion", "text": [ "All patients admitted to the ICU in septic shock\nAll patients that develop septic shock while in the ICU\n" ], "offsets": [ [ 0, 105 ] ] } ]

[ { "id": "NCT01639664_inc_T1", "type": "Procedure", "text": [ "admitted" ], "offsets": [ [ 13, 21 ] ], "normalized": [] }, { "id": "NCT01639664_inc_T2", "type": "Visit", "text": [ "ICU" ], "offsets": [ [ 29, 32 ] ], "normalized": [] }, { "id": "NCT01639664_inc_T3", "type": "Condition", "text": [ "septic shock" ], "offsets": [ [ 36, 48 ] ], "normalized": [] }, { "id": "NCT01639664_inc_T4", "type": "Condition", "text": [ "septic shock" ], "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT01639664_inc_T5", "type": "Temporal", "text": [ "while in the ICU" ], "offsets": [ [ 88, 104 ] ], "normalized": [] }, { "id": "NCT01639664_inc_T6", "type": "Reference_point", "text": [ "in the ICU" ], "offsets": [ [ 94, 104 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01639664_inc_R1", "type": "AND", "arg1_id": "NCT01639664_inc_T1", "arg2_id": "NCT01639664_inc_T2", "normalized": [] }, { "id": "NCT01639664_inc_R2", "type": "Has_index", "arg1_id": "NCT01639664_inc_T5", "arg2_id": "NCT01639664_inc_T6", "normalized": [] }, { "id": "NCT01639664_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01639664_inc_T4", "arg2_id": "NCT01639664_inc_T5", "normalized": [] } ]

[ { "id": "NCT01642875_exc_text", "type": "exclusion", "text": [ "Metastatic tumor\nLocally unresectable tumor\nPrevious gastric resection\nASA IV-V\nAge under 18 years\nPreoperative complete parenteral or enteral feeding\nImmunosuppressive therapy before operation\nSevere malnutrition\nLack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia\n" ], "offsets": [ [ 0, 318 ] ] } ]

[ { "id": "NCT01642875_exc_T1", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 11, 16 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T2", "type": "Qualifier", "text": [ "Locally unresectable" ], "offsets": [ [ 17, 37 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T3", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 38, 43 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T4", "type": "Qualifier", "text": [ "Metastatic" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T5", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 44, 52 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T6", "type": "Procedure", "text": [ "gastric resection" ], "offsets": [ [ 53, 70 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T7", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 71, 74 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T8", "type": "Value", "text": [ "IV-V" ], "offsets": [ [ 75, 79 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T9", "type": "Person", "text": [ "Age" ], "offsets": [ [ 80, 83 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T10", "type": "Value", "text": [ "under 18 years" ], "offsets": [ [ 84, 98 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T11", "type": "Temporal", "text": [ "Preoperative" ], "offsets": [ [ 99, 111 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T12", "type": "Condition", "text": [ "ete parenteral or e", "ng\nImmu" ], "offsets": [ [ 117, 136 ], [ 148, 155 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T13", "type": "Condition", "text": [ "ete pare", "al feeding\nImmu" ], "offsets": [ [ 117, 125 ], [ 140, 155 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T14", "type": "Scope", "text": [ "complete parenteral or enteral feeding" ], "offsets": [ [ 112, 150 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T15", "type": "Procedure", "text": [ "Immunosuppressive therapy" ], "offsets": [ [ 151, 176 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T16", "type": "Temporal", "text": [ "before operation" ], "offsets": [ [ 177, 193 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T17", "type": "Procedure", "text": [ "operation" ], "offsets": [ [ 184, 193 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T18", "type": "Reference_point", "text": [ "operation" ], "offsets": [ [ 184, 193 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T19", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 194, 200 ] ], "normalized": [] }, { "id": "NCT01642875_exc_T20", "type": "Condition", "text": [ "malnutrition" ], "offsets": [ [ 201, 213 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01642875_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01642875_exc_T1", "arg2_id": "NCT01642875_exc_T4", "normalized": [] }, { "id": "NCT01642875_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01642875_exc_T6", "arg2_id": "NCT01642875_exc_T5", "normalized": [] }, { "id": "NCT01642875_exc_R3", "type": "Has_value", "arg1_id": "NCT01642875_exc_T7", "arg2_id": "NCT01642875_exc_T8", "normalized": [] }, { "id": "NCT01642875_exc_R4", "type": "Has_value", "arg1_id": "NCT01642875_exc_T9", "arg2_id": "NCT01642875_exc_T10", "normalized": [] }, { "id": "NCT01642875_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01642875_exc_T14", "arg2_id": "NCT01642875_exc_T11", "normalized": [] }, { "id": "NCT01642875_exc_R6", "type": "Has_index", "arg1_id": "NCT01642875_exc_T16", "arg2_id": "NCT01642875_exc_T18", "normalized": [] }, { "id": "NCT01642875_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01642875_exc_T15", "arg2_id": "NCT01642875_exc_T16", "normalized": [] }, { "id": "NCT01642875_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01642875_exc_T20", "arg2_id": "NCT01642875_exc_T19", "normalized": [] } ]

[ { "id": "NCT01642875_inc_text", "type": "inclusion", "text": [ "Primary periampullary tumor\nR0, R1 resection\nChronic pancreatitis requiring pancreatoduodenectomy\n" ], "offsets": [ [ 0, 98 ] ] } ]

[ { "id": "NCT01642875_inc_T1", "type": "Qualifier", "text": [ "Primary" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T2", "type": "Condition", "text": [ "periampullary tumor" ], "offsets": [ [ 8, 27 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T3", "type": "Procedure", "text": [ "R1 resection" ], "offsets": [ [ 32, 44 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T4", "type": "Procedure", "text": [ "0,", "esection" ], "offsets": [ [ 29, 31 ], [ 36, 44 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T5", "type": "Condition", "text": [ "Chronic pancreatitis" ], "offsets": [ [ 45, 65 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T6", "type": "Observation", "text": [ "requiring" ], "offsets": [ [ 66, 75 ] ], "normalized": [] }, { "id": "NCT01642875_inc_T7", "type": "Procedure", "text": [ "pancreatoduodenectomy" ], "offsets": [ [ 76, 97 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01642875_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01642875_inc_T2", "arg2_id": "NCT01642875_inc_T1", "normalized": [] }, { "id": "NCT01642875_inc_R2", "type": "AND", "arg1_id": "NCT01642875_inc_T6", "arg2_id": "NCT01642875_inc_T7", "normalized": [] } ]

[ { "id": "NCT01650792_exc_text", "type": "exclusion", "text": [ "Patients with a history of an untreated malignancy (except local skin cancers)\nIschemic stroke (determined using the Questionnaire for Verifying Stroke-Free Status (QVSFS)\nPatients on renal dialysis or with end-stage hepatic dysfunction\nAcute infection/inflammation (Temperature > 101.5 F, and/or WBC> 15, 000)\nInability to obtain informed consent from patient or next of kin\nAnticoagulant use (warfarin or heparin)\n" ], "offsets": [ [ 0, 416 ] ] } ]

[ { "id": "NCT01650792_exc_T1", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 30, 39 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T2", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 40, 50 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T3", "type": "Condition", "text": [ "local skin cancers" ], "offsets": [ [ 59, 77 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T4", "type": "Negation", "text": [ "except" ], "offsets": [ [ 52, 58 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T5", "type": "Condition", "text": [ "Ischemic stroke" ], "offsets": [ [ 79, 94 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T6", "type": "Qualifier", "text": [ "Questionnaire for Verifying Stroke-Free Status (QVSFS)" ], "offsets": [ [ 117, 171 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T7", "type": "Procedure", "text": [ "renal dialysis" ], "offsets": [ [ 184, 198 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T8", "type": "Condition", "text": [ "end-stage hepatic dysfunction" ], "offsets": [ [ 207, 236 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T9", "type": "Qualifier", "text": [ "Acute" ], "offsets": [ [ 237, 242 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T10", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 243, 252 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T11", "type": "Condition", "text": [ "inflammation" ], "offsets": [ [ 253, 265 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T12", "type": "Scope", "text": [ "infection/inflammation" ], "offsets": [ [ 243, 265 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T13", "type": "Measurement", "text": [ "Temperature" ], "offsets": [ [ 267, 278 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T14", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 297, 300 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T15", "type": "Value", "text": [ "> 101.5 F" ], "offsets": [ [ 279, 288 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T16", "type": "Value", "text": [ "> 15, 000" ], "offsets": [ [ 300, 309 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T18", "type": "Drug", "text": [ "Anticoagulant" ], "offsets": [ [ 376, 389 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T19", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 395, 403 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T20", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 407, 414 ] ], "normalized": [] }, { "id": "NCT01650792_exc_T21", "type": "Scope", "text": [ "warfarin or heparin" ], "offsets": [ [ 395, 414 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01650792_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01650792_exc_T2", "arg2_id": "NCT01650792_exc_T1", "normalized": [] }, { "id": "NCT01650792_exc_R2", "type": "Has_negation", "arg1_id": "NCT01650792_exc_T3", "arg2_id": "NCT01650792_exc_T4", "normalized": [] }, { "id": "NCT01650792_exc_R3", "type": "AND", "arg1_id": "NCT01650792_exc_T2", "arg2_id": "NCT01650792_exc_T3", "normalized": [] }, { "id": "NCT01650792_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01650792_exc_T5", "arg2_id": "NCT01650792_exc_T6", "normalized": [] }, { "id": "NCT01650792_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01650792_exc_T12", "arg2_id": "NCT01650792_exc_T9", "normalized": [] }, { "id": "NCT01650792_exc_R6", "type": "Has_value", "arg1_id": "NCT01650792_exc_T13", "arg2_id": "NCT01650792_exc_T15", "normalized": [] }, { "id": "NCT01650792_exc_R7", "type": "Has_value", "arg1_id": "NCT01650792_exc_T14", "arg2_id": "NCT01650792_exc_T16", "normalized": [] }, { "id": "NCT01650792_exc_R8", "type": "Subsumes", "arg1_id": "NCT01650792_exc_T18", "arg2_id": "NCT01650792_exc_T21", "normalized": [] } ]

[ { "id": "NCT01650792_inc_text", "type": "inclusion", "text": [ "Diagnosis of heart failure according to Framingham criteria\nInformed consent\nAge 18 years or above\n" ], "offsets": [ [ 0, 99 ] ] } ]

[ { "id": "NCT01650792_inc_T1", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 13, 26 ] ], "normalized": [] }, { "id": "NCT01650792_inc_T2", "type": "Qualifier", "text": [ "Framingham criteria" ], "offsets": [ [ 40, 59 ] ], "normalized": [] }, { "id": "NCT01650792_inc_T4", "type": "Person", "text": [ "Age" ], "offsets": [ [ 77, 80 ] ], "normalized": [] }, { "id": "NCT01650792_inc_T5", "type": "Value", "text": [ "18 years or above" ], "offsets": [ [ 81, 98 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01650792_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01650792_inc_T1", "arg2_id": "NCT01650792_inc_T2", "normalized": [] }, { "id": "NCT01650792_inc_R2", "type": "Has_value", "arg1_id": "NCT01650792_inc_T4", "arg2_id": "NCT01650792_inc_T5", "normalized": [] } ]

[ { "id": "NCT01664507_exc_text", "type": "exclusion", "text": [ "underlying lung or heart disase\ncontra indication to dexamethasone\nimmune deficient state\npreterm birth\nprevious intubation or apnea history\n" ], "offsets": [ [ 0, 141 ] ] } ]

[ { "id": "NCT01664507_exc_T1", "type": "Condition", "text": [ "heart disase" ], "offsets": [ [ 19, 31 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T2", "type": "Condition", "text": [ "lung", "disase" ], "offsets": [ [ 11, 15 ], [ 25, 31 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T3", "type": "Drug", "text": [ "dexamethasone" ], "offsets": [ [ 53, 66 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T4", "type": "Condition", "text": [ "contra indication" ], "offsets": [ [ 32, 49 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T5", "type": "Condition", "text": [ "immune deficient state" ], "offsets": [ [ 67, 89 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T6", "type": "Condition", "text": [ "preterm birth" ], "offsets": [ [ 90, 103 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T7", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 113, 123 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T8", "type": "Condition", "text": [ "apnea" ], "offsets": [ [ 127, 132 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T9", "type": "Observation", "text": [ "history" ], "offsets": [ [ 133, 140 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T10", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 104, 112 ] ], "normalized": [] }, { "id": "NCT01664507_exc_T11", "type": "Scope", "text": [ "intubation or apnea" ], "offsets": [ [ 113, 132 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01664507_exc_R1", "type": "AND", "arg1_id": "NCT01664507_exc_T4", "arg2_id": "NCT01664507_exc_T3", "normalized": [] }, { "id": "NCT01664507_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01664507_exc_T11", "arg2_id": "NCT01664507_exc_T10", "normalized": [] }, { "id": "NCT01664507_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01664507_exc_T11", "arg2_id": "NCT01664507_exc_T9", "normalized": [] } ]

[ { "id": "NCT01664507_inc_text", "type": "inclusion", "text": [ "croup children between 6 month and 5 years old\nWestley croup score between 3 and 11\n" ], "offsets": [ [ 0, 84 ] ] } ]

[ { "id": "NCT01664507_inc_T1", "type": "Value", "text": [ "between 6 month and 5 years" ], "offsets": [ [ 15, 42 ] ], "normalized": [] }, { "id": "NCT01664507_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 43, 46 ] ], "normalized": [] }, { "id": "NCT01664507_inc_T3", "type": "Person", "text": [ "children" ], "offsets": [ [ 6, 14 ] ], "normalized": [] }, { "id": "NCT01664507_inc_T4", "type": "Measurement", "text": [ "Westley croup score" ], "offsets": [ [ 47, 66 ] ], "normalized": [] }, { "id": "NCT01664507_inc_T5", "type": "Value", "text": [ "between 3 and 11" ], "offsets": [ [ 67, 83 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01664507_inc_R1", "type": "Has_value", "arg1_id": "NCT01664507_inc_T2", "arg2_id": "NCT01664507_inc_T1", "normalized": [] }, { "id": "NCT01664507_inc_R2", "type": "Has_value", "arg1_id": "NCT01664507_inc_T4", "arg2_id": "NCT01664507_inc_T5", "normalized": [] } ]

[ { "id": "NCT01665417_exc_text", "type": "exclusion", "text": [ "Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease\n" ], "offsets": [ [ 0, 200 ] ] } ]

[ { "id": "NCT01665417_exc_T1", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 6, 18 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T2", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T4", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T5", "type": "Drug", "text": [ "gefitinib" ], "offsets": [ [ 40, 49 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T6", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 19, 24 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T8", "type": "Drug", "text": [ "erlotinib" ], "offsets": [ [ 51, 60 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T7", "type": "Drug", "text": [ "drugs that target EGFR" ], "offsets": [ [ 71, 93 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T9", "type": "Scope", "text": [ "gefitinib, erlotinib, or other drugs that target EGFR" ], "offsets": [ [ 40, 93 ] ], "normalized": [] }, { "id": "NCT01665417_exc_T12", "type": "Condition", "text": [ "interstitial lung disease" ], "offsets": [ [ 174, 199 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01665417_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01665417_exc_T4", "arg2_id": "NCT01665417_exc_T6", "normalized": [] }, { "id": "NCT01665417_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01665417_exc_T1", "arg2_id": "NCT01665417_exc_T2", "normalized": [] }, { "id": "NCT01665417_exc_R1", "type": "Has_scope", "arg1_id": "NCT01665417_exc_T4", "arg2_id": "NCT01665417_exc_T9", "normalized": [] } ]

[ { "id": "NCT01665417_inc_text", "type": "inclusion", "text": [ "Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).\n" ], "offsets": [ [ 0, 381 ] ] } ]

[ { "id": "NCT01665417_inc_T1", "type": "Condition", "text": [ "lung adenocarcinoma" ], "offsets": [ [ 27, 46 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T2", "type": "Procedure", "text": [ "Pathologic" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T3", "type": "Value", "text": [ "confirmation" ], "offsets": [ [ 11, 23 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T4", "type": "Qualifier", "text": [ "with measurable disease" ], "offsets": [ [ 47, 70 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T5", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 83, 95 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T6", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 96, 102 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T7", "type": "Qualifier", "text": [ "can be accurately measured in at least one dimension" ], "offsets": [ [ 108, 160 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T8", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 232, 241 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T9", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 242, 258 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T10", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 262, 272 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T11", "type": "Condition", "text": [ "NSCLC" ], "offsets": [ [ 273, 278 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T12", "type": "Scope", "text": [ "locally advanced or metastatic" ], "offsets": [ [ 242, 272 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T13", "type": "Condition", "text": [ "lung cancer" ], "offsets": [ [ 299, 310 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T14", "type": "Qualifier", "text": [ "with", "EGFR activating mutation" ], "offsets": [ [ 311, 315 ], [ 329, 353 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T15", "type": "Condition", "text": [ "exon 19 deletion" ], "offsets": [ [ 355, 371 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T16", "type": "Condition", "text": [ "L858R" ], "offsets": [ [ 373, 378 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T17", "type": "Scope", "text": [ "exon 19 deletion, L858R" ], "offsets": [ [ 355, 378 ] ], "normalized": [] }, { "id": "NCT01665417_inc_T18", "type": "Scope", "text": [ "lung adenocarcinoma with measurable disease" ], "offsets": [ [ 27, 70 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01665417_inc_R1", "type": "Has_value", "arg1_id": "NCT01665417_inc_T2", "arg2_id": "NCT01665417_inc_T3", "normalized": [] }, { "id": "NCT01665417_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01665417_inc_T1", "arg2_id": "NCT01665417_inc_T4", "normalized": [] }, { "id": "NCT01665417_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT01665417_inc_T6", "arg2_id": "NCT01665417_inc_T5", "normalized": [] }, { "id": "NCT01665417_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01665417_inc_T6", "arg2_id": "NCT01665417_inc_T7", "normalized": [] }, { "id": "NCT01665417_inc_R6", "type": "Has_scope", "arg1_id": "NCT01665417_inc_T11", "arg2_id": "NCT01665417_inc_T12", "normalized": [] }, { "id": "NCT01665417_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT01665417_inc_T11", "arg2_id": "NCT01665417_inc_T8", "normalized": [] }, { "id": "NCT01665417_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT01665417_inc_T13", "arg2_id": "NCT01665417_inc_T14", "normalized": [] }, { "id": "NCT01665417_inc_R9", "type": "Subsumes", "arg1_id": "NCT01665417_inc_T14", "arg2_id": "NCT01665417_inc_T17", "normalized": [] }, { "id": "NCT01665417_inc_R2", "type": "AND", "arg1_id": "NCT01665417_inc_T18", "arg2_id": "NCT01665417_inc_T2", "normalized": [] }, { "id": "NCT01665417_inc_R10", "type": "Subsumes", "arg1_id": "NCT01665417_inc_T18", "arg2_id": "NCT01665417_inc_T6", "normalized": [] } ]

[ { "id": "NCT01669369_exc_text", "type": "exclusion", "text": [ "a history of non-standard treatment(chemotherapy or surgery)\nsecondary osteosarcoma or well-differentiated parosteal osteosarcoma\nevident dysfunction of cardia,liver and kidney, or pregnant women or women during lactation\n" ], "offsets": [ [ 0, 222 ] ] } ]

[ { "id": "NCT01669369_exc_T1", "type": "Procedure", "text": [ "non-standard treatment" ], "offsets": [ [ 13, 35 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T2", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 36, 48 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T3", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 52, 59 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T4", "type": "Scope", "text": [ "chemotherapy or surgery" ], "offsets": [ [ 36, 59 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T5", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2, 9 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T6", "type": "Condition", "text": [ "secondary osteosarcoma" ], "offsets": [ [ 61, 83 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T7", "type": "Condition", "text": [ "parosteal osteosarcoma" ], "offsets": [ [ 107, 129 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T8", "type": "Qualifier", "text": [ "well-differentiated" ], "offsets": [ [ 87, 106 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T9", "type": "Condition", "text": [ "dysfunction of cardia" ], "offsets": [ [ 138, 159 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T10", "type": "Condition", "text": [ "sfunction of c", "dney," ], "offsets": [ [ 140, 154 ], [ 172, 177 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T11", "type": "Condition", "text": [ "sfunction of c", "ver a" ], "offsets": [ [ 140, 154 ], [ 162, 167 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T12", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 181, 189 ] ], "normalized": [] }, { "id": "NCT01669369_exc_T13", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 212, 221 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01669369_exc_R1", "type": "Subsumes", "arg1_id": "NCT01669369_exc_T1", "arg2_id": "NCT01669369_exc_T4", "normalized": [] }, { "id": "NCT01669369_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01669369_exc_T7", "arg2_id": "NCT01669369_exc_T8", "normalized": [] } ]

[ { "id": "NCT01669369_inc_text", "type": "inclusion", "text": [ "histologically diagnosed primary classical osteosarcoma in extremities\nstaging IIB\nMRI showing no skip lesion\nreceive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard surgical treatment\n" ], "offsets": [ [ 0, 208 ] ] } ]

[ { "id": "NCT01669369_inc_T1", "type": "Procedure", "text": [ "histologically" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T2", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 25, 32 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T3", "type": "Condition", "text": [ "classical osteosarcoma" ], "offsets": [ [ 33, 55 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T4", "type": "Qualifier", "text": [ "in extremities" ], "offsets": [ [ 56, 70 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T5", "type": "Qualifier", "text": [ "staging IIB" ], "offsets": [ [ 71, 82 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T6", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T7", "type": "Negation", "text": [ "no" ], "offsets": [ [ 95, 97 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T8", "type": "Observation", "text": [ "skip lesion" ], "offsets": [ [ 98, 109 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T9", "type": "Procedure", "text": [ "standard neo-adjuvant chemotherapy" ], "offsets": [ [ 118, 152 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T10", "type": "Procedure", "text": [ "adjuvant chemotherapy" ], "offsets": [ [ 154, 175 ] ], "normalized": [] }, { "id": "NCT01669369_inc_T11", "type": "Procedure", "text": [ "standard surgical treatment" ], "offsets": [ [ 180, 207 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01669369_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01669369_inc_T3", "arg2_id": "NCT01669369_inc_T4", "normalized": [] }, { "id": "NCT01669369_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01669369_inc_T3", "arg2_id": "NCT01669369_inc_T2", "normalized": [] }, { "id": "NCT01669369_inc_R3", "type": "AND", "arg1_id": "NCT01669369_inc_T1", "arg2_id": "NCT01669369_inc_T3", "normalized": [] }, { "id": "NCT01669369_inc_R4", "type": "Has_negation", "arg1_id": "NCT01669369_inc_T8", "arg2_id": "NCT01669369_inc_T7", "normalized": [] } ]

[ { "id": "NCT01680081_exc_text", "type": "exclusion", "text": [ "Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)\nContraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min\nUnstable or uncooperative patients\nLimited life expectancy due to cancer or end-stage renal or liver disease\nEvidence of severe symptomatic heart failure (NYHA Class III or IV)\nPrevious myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery\n" ], "offsets": [ [ 0, 736 ] ] } ]

[ { "id": "NCT01680081_exc_T1", "type": "Condition", "text": [ "Contraindication of CT" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T2", "type": "Condition", "text": [ "Known allergy" ], "offsets": [ [ 23, 36 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T3", "type": "Drug", "text": [ "iodinated contrast media" ], "offsets": [ [ 40, 64 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T4", "type": "Condition", "text": [ "contrast-induced nephropathy" ], "offsets": [ [ 79, 107 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T5", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 118, 132 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T6", "type": "Value", "text": [ "Decreased" ], "offsets": [ [ 108, 117 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T7", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 134, 142 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T8", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 143, 159 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T9", "type": "Value", "text": [ ">1.5mg/dl" ], "offsets": [ [ 160, 169 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T10", "type": "Drug", "text": [ "beta-blockers" ], "offsets": [ [ 191, 204 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T11", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 171, 187 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T12", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 212, 222 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T13", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 205, 211 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T14", "type": "Condition", "text": [ "arterial fibrillation" ], "offsets": [ [ 224, 245 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T15", "type": "Condition", "text": [ "uncontrolled tachyarrhythmia" ], "offsets": [ [ 249, 277 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T16", "type": "Condition", "text": [ "advanced atrioventricular block" ], "offsets": [ [ 282, 313 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T17", "type": "Condition", "text": [ "third degree heart block" ], "offsets": [ [ 325, 349 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T18", "type": "Condition", "text": [ "second", "degree heart block" ], "offsets": [ [ 315, 321 ], [ 331, 349 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T19", "type": "Scope", "text": [ "second or third degree heart block" ], "offsets": [ [ 315, 349 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T25", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 351, 367 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T26", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 371, 374 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T27", "type": "Condition", "text": [ "Claustrophobia" ], "offsets": [ [ 375, 389 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T28", "type": "Condition", "text": [ "Metallic hazards" ], "offsets": [ [ 390, 406 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T29", "type": "Device", "text": [ "Pacemaker implant" ], "offsets": [ [ 407, 424 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T30", "type": "Measurement", "text": [ "eGFR" ], "offsets": [ [ 425, 429 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T31", "type": "Value", "text": [ "<30 ml/min" ], "offsets": [ [ 429, 439 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T32", "type": "Scope", "text": [ "Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min" ], "offsets": [ [ 375, 439 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T33", "type": "Condition", "text": [ "uncooperative patients" ], "offsets": [ [ 452, 474 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T34", "type": "Condition", "text": [ "stable o", "tients\nL" ], "offsets": [ [ 442, 450 ], [ 468, 476 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T35", "type": "Person", "text": [ "life expectancy" ], "offsets": [ [ 483, 498 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T36", "type": "Value", "text": [ "Limited" ], "offsets": [ [ 475, 482 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T37", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 506, 512 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T38", "type": "Condition", "text": [ "-stage renal or", "ease\nEv" ], "offsets": [ [ 519, 534 ], [ 544, 551 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T39", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 535, 548 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T40", "type": "Scope", "text": [ "cancer or end-stage renal or liver disease" ], "offsets": [ [ 506, 548 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T41", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 561, 567 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T42", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 568, 579 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T43", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 580, 593 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T44", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 595, 599 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T45", "type": "Value", "text": [ "Class III or IV" ], "offsets": [ [ 600, 615 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T46", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 626, 647 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T47", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 617, 625 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T48", "type": "Procedure", "text": [ "coronary artery intervention" ], "offsets": [ [ 649, 677 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T49", "type": "Procedure", "text": [ "coronary artery bypass surgery" ], "offsets": [ [ 679, 709 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T50", "type": "Procedure", "text": [ "other cardiac surgery" ], "offsets": [ [ 714, 735 ] ], "normalized": [] }, { "id": "NCT01680081_exc_T51", "type": "Scope", "text": [ "myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery" ], "offsets": [ [ 626, 735 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01680081_exc_R1", "type": "AND", "arg1_id": "NCT01680081_exc_T2", "arg2_id": "NCT01680081_exc_T3", "normalized": [] }, { "id": "NCT01680081_exc_R2", "type": "Has_value", "arg1_id": "NCT01680081_exc_T5", "arg2_id": "NCT01680081_exc_T6", "normalized": [] }, { "id": "NCT01680081_exc_R3", "type": "Subsumes", "arg1_id": "NCT01680081_exc_T7", "arg2_id": "NCT01680081_exc_T9", "normalized": [] }, { "id": "NCT01680081_exc_R4", "type": "Has_value", "arg1_id": "NCT01680081_exc_T8", "arg2_id": "NCT01680081_exc_T7", "normalized": [] }, { "id": "NCT01680081_exc_R5", "type": "AND", "arg1_id": "NCT01680081_exc_T11", "arg2_id": "NCT01680081_exc_T10", "normalized": [] }, { "id": "NCT01680081_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01680081_exc_T12", "arg2_id": "NCT01680081_exc_T13", "normalized": [] }, { "id": "NCT01680081_exc_R7", "type": "Subsumes", "arg1_id": "NCT01680081_exc_T16", "arg2_id": "NCT01680081_exc_T19", "normalized": [] }, { "id": "NCT01680081_exc_R8", "type": "AND", "arg1_id": "NCT01680081_exc_T25", "arg2_id": "NCT01680081_exc_T26", "normalized": [] }, { "id": "NCT01680081_exc_R11", "type": "Has_value", "arg1_id": "NCT01680081_exc_T30", "arg2_id": "NCT01680081_exc_T31", "normalized": [] }, { "id": "NCT01680081_exc_R12", "type": "Subsumes", "arg1_id": "NCT01680081_exc_T25", "arg2_id": "NCT01680081_exc_T32", "normalized": [] }, { "id": "NCT01680081_exc_R13", "type": "Has_value", "arg1_id": "NCT01680081_exc_T35", "arg2_id": "NCT01680081_exc_T36", "normalized": [] }, { "id": "NCT01680081_exc_R14", "type": "Has_scope", "arg1_id": "NCT01680081_exc_T35", "arg2_id": "NCT01680081_exc_T40", "normalized": [] }, { "id": "NCT01680081_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT01680081_exc_T43", "arg2_id": "NCT01680081_exc_T42", "normalized": [] }, { "id": "NCT01680081_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT01680081_exc_T43", "arg2_id": "NCT01680081_exc_T41", "normalized": [] }, { "id": "NCT01680081_exc_R17", "type": "Has_value", "arg1_id": "NCT01680081_exc_T44", "arg2_id": "NCT01680081_exc_T45", "normalized": [] }, { "id": "NCT01680081_exc_R18", "type": "Has_temporal", "arg1_id": "NCT01680081_exc_T51", "arg2_id": "NCT01680081_exc_T47", "normalized": [] } ]

[ { "id": "NCT01680081_inc_text", "type": "inclusion", "text": [ "Men and women patients, with age ranging 40-80.\nSuspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications\nPatients who are willing to sign the informed consent form\n" ], "offsets": [ [ 0, 237 ] ] } ]

[ { "id": "NCT01680081_inc_T1", "type": "Person", "text": [ "women" ], "offsets": [ [ 8, 13 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T2", "type": "Person", "text": [ "Men" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 29, 32 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T4", "type": "Value", "text": [ "ranging 40-80" ], "offsets": [ [ 33, 46 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T5", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 58, 81 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T6", "type": "Mood", "text": [ "Suspected" ], "offsets": [ [ 48, 57 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T7", "type": "Procedure", "text": [ "invasive coronary angiography" ], "offsets": [ [ 110, 139 ] ], "normalized": [] }, { "id": "NCT01680081_inc_T8", "type": "Mood", "text": [ "supposed to undergo" ], "offsets": [ [ 90, 109 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01680081_inc_R1", "type": "Has_value", "arg1_id": "NCT01680081_inc_T3", "arg2_id": "NCT01680081_inc_T4", "normalized": [] }, { "id": "NCT01680081_inc_R2", "type": "Has_mood", "arg1_id": "NCT01680081_inc_T5", "arg2_id": "NCT01680081_inc_T6", "normalized": [] }, { "id": "NCT01680081_inc_R3", "type": "Has_mood", "arg1_id": "NCT01680081_inc_T7", "arg2_id": "NCT01680081_inc_T8", "normalized": [] } ]

[ { "id": "NCT01684501_exc_text", "type": "exclusion", "text": [ "score level D on the SIGAM mobility grade \nhave experienced 1 or more falls in the last month before the study \nhave a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot \nthe residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function \nthe sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity \nAny diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation \n \n" ], "offsets": [ [ 0, 648 ] ] } ]

[ { "id": "NCT01684501_exc_T1", "type": "Measurement", "text": [ "SIGAM mobility grade" ], "offsets": [ [ 21, 41 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T2", "type": "Value", "text": [ "level D" ], "offsets": [ [ 6, 13 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T3", "type": "Multiplier", "text": [ "1 or more" ], "offsets": [ [ 60, 69 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T4", "type": "Observation", "text": [ "falls" ], "offsets": [ [ 70, 75 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T5", "type": "Temporal", "text": [ "in the last month before the study" ], "offsets": [ [ 76, 110 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T6", "type": "Reference_point", "text": [ "last month before the study" ], "offsets": [ [ 83, 110 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T7", "type": "Measurement", "text": [ "residual limb length" ], "offsets": [ [ 119, 139 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T8", "type": "Value", "text": [ "does not allow for seven inches clearance of bracket attachment" ], "offsets": [ [ 146, 209 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T9", "type": "Negation", "text": [ "does not" ], "offsets": [ [ 146, 154 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T11", "type": "Condition", "text": [ "impediments that affect gait" ], "offsets": [ [ 431, 459 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T12", "type": "Condition", "text": [ "impediments that affect", "range of motion" ], "offsets": [ [ 431, 454 ], [ 461, 476 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T13", "type": "Condition", "text": [ "impediments that affect", "limb muscle activity" ], "offsets": [ [ 431, 454 ], [ 481, 501 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T14", "type": "Observation", "text": [ "lower extremity" ], "offsets": [ [ 399, 414 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T15", "type": "Scope", "text": [ "impediments that affect gait, range of motion, or limb muscle activity" ], "offsets": [ [ 431, 501 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T16", "type": "Negation", "text": [ "free" ], "offsets": [ [ 423, 427 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T17", "type": "Condition", "text": [ "cardiovascular", "conditions" ], "offsets": [ [ 517, 531 ], [ 577, 587 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T18", "type": "Condition", "text": [ "pulmonary", "conditions" ], "offsets": [ [ 533, 542 ], [ 577, 587 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T19", "type": "Condition", "text": [ "neurological", "conditions" ], "offsets": [ [ 544, 556 ], [ 577, 587 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T20", "type": "Condition", "text": [ "orthopedic conditions" ], "offsets": [ [ 566, 587 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T21", "type": "Scope", "text": [ "cardiovascular, pulmonary, neurological, and/ or orthopedic conditions" ], "offsets": [ [ 517, 587 ] ], "normalized": [] }, { "id": "NCT01684501_exc_T22", "type": "Qualifier", "text": [ "interfere with subject participation" ], "offsets": [ [ 599, 635 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01684501_exc_R1", "type": "Has_value", "arg1_id": "NCT01684501_exc_T1", "arg2_id": "NCT01684501_exc_T2", "normalized": [] }, { "id": "NCT01684501_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT01684501_exc_T4", "arg2_id": "NCT01684501_exc_T3", "normalized": [] }, { "id": "NCT01684501_exc_R3", "type": "Has_index", "arg1_id": "NCT01684501_exc_T5", "arg2_id": "NCT01684501_exc_T6", "normalized": [] }, { "id": "NCT01684501_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01684501_exc_T4", "arg2_id": "NCT01684501_exc_T5", "normalized": [] }, { "id": "NCT01684501_exc_R5", "type": "Has_value", "arg1_id": "NCT01684501_exc_T7", "arg2_id": "NCT01684501_exc_T8", "normalized": [] }, { "id": "NCT01684501_exc_R6", "type": "Has_negation", "arg1_id": "NCT01684501_exc_T15", "arg2_id": "NCT01684501_exc_T16", "normalized": [] }, { "id": "NCT01684501_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT01684501_exc_T21", "arg2_id": "NCT01684501_exc_T22", "normalized": [] } ]

[ { "id": "NCT01684501_inc_text", "type": "inclusion", "text": [ "weigh more than 200 lbs \nare high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade \nhave the ability to follow multi-step commands. \n" ], "offsets": [ [ 0, 205 ] ] } ]

[ { "id": "NCT01684501_inc_T1", "type": "Measurement", "text": [ "weigh" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01684501_inc_T2", "type": "Value", "text": [ "more than 200 lbs" ], "offsets": [ [ 6, 23 ] ], "normalized": [] }, { "id": "NCT01684501_inc_T3", "type": "Condition", "text": [ "high level ambulators" ], "offsets": [ [ 29, 50 ] ], "normalized": [] }, { "id": "NCT01684501_inc_T4", "type": "Measurement", "text": [ "Special Interest Group of Amputee Medicine (SIGAM) mobility grade" ], "offsets": [ [ 89, 154 ] ], "normalized": [] }, { "id": "NCT01684501_inc_T5", "type": "Value", "text": [ "levels E to F" ], "offsets": [ [ 68, 81 ] ], "normalized": [] }, { "id": "NCT01684501_inc_T6", "type": "Condition", "text": [ "ability to follow multi-step commands" ], "offsets": [ [ 165, 202 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01684501_inc_R1", "type": "Has_value", "arg1_id": "NCT01684501_inc_T1", "arg2_id": "NCT01684501_inc_T2", "normalized": [] }, { "id": "NCT01684501_inc_R2", "type": "Has_value", "arg1_id": "NCT01684501_inc_T4", "arg2_id": "NCT01684501_inc_T5", "normalized": [] }, { "id": "NCT01684501_inc_R3", "type": "AND", "arg1_id": "NCT01684501_inc_T3", "arg2_id": "NCT01684501_inc_T4", "normalized": [] } ]

[ { "id": "NCT01696617_exc_text", "type": "exclusion", "text": [ "Past history of hypersensitivity to aripiprazole\nPrimary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia\nClinically significant current Axis II (DSM-IV-TR) diagnosis\nA significant risk of suicide corroborated by a score of =5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator\nPregnancy or in breast-feeding\nPresence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function\nPatients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics\nPatients with past treatment failures of aripiprazole\n" ], "offsets": [ [ 0, 968 ] ] } ]

[ { "id": "NCT01696617_exc_T1", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 16, 32 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T2", "type": "Drug", "text": [ "aripiprazole" ], "offsets": [ [ 36, 48 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T3", "type": "Condition", "text": [ "MDD" ], "offsets": [ [ 70, 73 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T4", "type": "Condition", "text": [ "psychotic feature" ], "offsets": [ [ 79, 96 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T5", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 98, 114 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T6", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 116, 129 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T7", "type": "Condition", "text": [ "schizoaffective disorder" ], "offsets": [ [ 131, 155 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T8", "type": "Condition", "text": [ "psychotic disorder" ], "offsets": [ [ 163, 181 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T9", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 157, 162 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T10", "type": "Condition", "text": [ "anxiety disorder," ], "offsets": [ [ 185, 202 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T11", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 225, 235 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T12", "type": "Condition", "text": [ "lcohol/", "buse" ], "offsets": [ [ 217, 224 ], [ 231, 235 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T13", "type": "Temporal", "text": [ "within the past 12 months" ], "offsets": [ [ 236, 261 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T14", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 281, 289 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T15", "type": "Scope", "text": [ "alcohol/ drug abuse" ], "offsets": [ [ 216, 235 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T16", "type": "Scope", "text": [ "psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder" ], "offsets": [ [ 79, 201 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T17", "type": "Qualifier", "text": [ "Axis II" ], "offsets": [ [ 321, 328 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T18", "type": "Condition", "text": [ "diagnosis" ], "offsets": [ [ 341, 350 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T19", "type": "Qualifier", "text": [ "DSM-IV-TR" ], "offsets": [ [ 330, 339 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T20", "type": "Observation", "text": [ "risk of suicide" ], "offsets": [ [ 365, 380 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T21", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 353, 364 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T22", "type": "Measurement", "text": [ "MADRS scale" ], "offsets": [ [ 448, 459 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T23", "type": "Value", "text": [ "score of =5 on item 10" ], "offsets": [ [ 399, 421 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T26", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 549, 556 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T28", "type": "Condition", "text": [ "medical illness" ], "offsets": [ [ 557, 572 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T27", "type": "Condition", "text": [ "cardiac" ], "offsets": [ [ 583, 590 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T29", "type": "Condition", "text": [ "hepatic" ], "offsets": [ [ 592, 599 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T30", "type": "Condition", "text": [ "renal" ], "offsets": [ [ 601, 606 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T31", "type": "Condition", "text": [ "respiratory" ], "offsets": [ [ 608, 619 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T32", "type": "Condition", "text": [ "endocrinologic" ], "offsets": [ [ 621, 635 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T33", "type": "Condition", "text": [ "neurologic" ], "offsets": [ [ 637, 647 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T34", "type": "Condition", "text": [ "hematologic disease" ], "offsets": [ [ 652, 671 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T35", "type": "Condition", "text": [ "physical disorder" ], "offsets": [ [ 675, 692 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T37", "type": "Drug", "text": [ "antipsychotics" ], "offsets": [ [ 772, 786 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T38", "type": "Drug", "text": [ "mood stabilizer" ], "offsets": [ [ 788, 803 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T39", "type": "Drug", "text": [ "psychotropic medications" ], "offsets": [ [ 811, 835 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T40", "type": "Negation", "text": [ "besides" ], "offsets": [ [ 836, 843 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T41", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 844, 859 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T42", "type": "Negation", "text": [ "except" ], "offsets": [ [ 861, 867 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T43", "type": "Drug", "text": [ "benzodiazepines" ], "offsets": [ [ 868, 883 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T44", "type": "Drug", "text": [ "beta blockers" ], "offsets": [ [ 887, 900 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T45", "type": "Drug", "text": [ "hypnotics" ], "offsets": [ [ 904, 913 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T46", "type": "Scope", "text": [ "benzodiazepines or beta blockers or hypnotics" ], "offsets": [ [ 868, 913 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T47", "type": "Scope", "text": [ "psychotropic medications besides antidepressants" ], "offsets": [ [ 811, 859 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T48", "type": "Drug", "text": [ "aripiprazole" ], "offsets": [ [ 955, 967 ] ], "normalized": [] }, { "id": "NCT01696617_exc_T49", "type": "Observation", "text": [ "treatment failures" ], "offsets": [ [ 933, 951 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01696617_exc_R1", "type": "AND", "arg1_id": "NCT01696617_exc_T1", "arg2_id": "NCT01696617_exc_T2", "normalized": [] }, { "id": "NCT01696617_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01696617_exc_T8", "arg2_id": "NCT01696617_exc_T9", "normalized": [] }, { "id": "NCT01696617_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01696617_exc_T15", "arg2_id": "NCT01696617_exc_T13", "normalized": [] }, { "id": "NCT01696617_exc_R4", "type": "Has_scope", "arg1_id": "NCT01696617_exc_T3", "arg2_id": "NCT01696617_exc_T16", "normalized": [] }, { "id": "NCT01696617_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01696617_exc_T18", "arg2_id": "NCT01696617_exc_T17", "normalized": [] }, { "id": "NCT01696617_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01696617_exc_T18", "arg2_id": "NCT01696617_exc_T19", "normalized": [] }, { "id": "NCT01696617_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01696617_exc_T20", "arg2_id": "NCT01696617_exc_T21", "normalized": [] }, { "id": "NCT01696617_exc_R8", "type": "Has_value", "arg1_id": "NCT01696617_exc_T22", "arg2_id": "NCT01696617_exc_T23", "normalized": [] }, { "id": "NCT01696617_exc_R9", "type": "AND", "arg1_id": "NCT01696617_exc_T20", "arg2_id": "NCT01696617_exc_T22", "normalized": [] }, { "id": "NCT01696617_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01696617_exc_T28", "arg2_id": "NCT01696617_exc_T26", "normalized": [] }, { "id": "NCT01696617_exc_R11", "type": "Has_negation", "arg1_id": "NCT01696617_exc_T46", "arg2_id": "NCT01696617_exc_T42", "normalized": [] }, { "id": "NCT01696617_exc_R12", "type": "Has_negation", "arg1_id": "NCT01696617_exc_T41", "arg2_id": "NCT01696617_exc_T40", "normalized": [] } ]

[ { "id": "NCT01696617_inc_text", "type": "inclusion", "text": [ "Age : 18-65\nPatients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks\nMADRS total score of 18 or higher\nPatients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration\nCurrent use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)\n" ], "offsets": [ [ 0, 558 ] ] } ]

[ { "id": "NCT01696617_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T2", "type": "Value", "text": [ "18-65" ], "offsets": [ [ 6, 11 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T3", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 26, 51 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T4", "type": "Measurement", "text": [ "DSM-IV criteria" ], "offsets": [ [ 65, 80 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T5", "type": "Temporal", "text": [ "lasted >8 weeks" ], "offsets": [ [ 91, 106 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T6", "type": "Measurement", "text": [ "MADRS" ], "offsets": [ [ 107, 112 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T7", "type": "Value", "text": [ "score of 18 or higher" ], "offsets": [ [ 119, 140 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T8", "type": "Measurement", "text": [ "MADRS" ], "offsets": [ [ 200, 205 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T9", "type": "Value", "text": [ "score of >18" ], "offsets": [ [ 180, 192 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T10", "type": "Qualifier", "text": [ "first-line" ], "offsets": [ [ 210, 220 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T11", "type": "Drug", "text": [ "antidepressant" ], "offsets": [ [ 221, 235 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T12", "type": "Temporal", "text": [ "of 4 week" ], "offsets": [ [ 246, 255 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T13", "type": "Observation", "text": [ "responded inadequately" ], "offsets": [ [ 154, 176 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T14", "type": "Qualifier", "text": [ "standard" ], "offsets": [ [ 280, 288 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T15", "type": "Drug", "text": [ "antidepressant" ], "offsets": [ [ 289, 303 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T16", "type": "Qualifier", "text": [ "monotherapy" ], "offsets": [ [ 317, 328 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T17", "type": "Multiplier", "text": [ "2" ], "offsets": [ [ 347, 348 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T18", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 349, 364 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T19", "type": "Drug", "text": [ "escitalopram" ], "offsets": [ [ 367, 379 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T20", "type": "Drug", "text": [ "fluoxetine" ], "offsets": [ [ 395, 405 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T21", "type": "Drug", "text": [ "paroxetine CR" ], "offsets": [ [ 420, 433 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T22", "type": "Drug", "text": [ "sertraline" ], "offsets": [ [ 448, 458 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T23", "type": "Drug", "text": [ "mirtazapine" ], "offsets": [ [ 475, 486 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T24", "type": "Drug", "text": [ "duloxetine" ], "offsets": [ [ 502, 512 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T25", "type": "Multiplier", "text": [ "10 - 20mg/d" ], "offsets": [ [ 381, 392 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T26", "type": "Multiplier", "text": [ "20 - 40mg/d" ], "offsets": [ [ 406, 417 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T27", "type": "Multiplier", "text": [ "25 - 50mg/d" ], "offsets": [ [ 434, 445 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T28", "type": "Multiplier", "text": [ "100 - 150mg/d" ], "offsets": [ [ 459, 472 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T29", "type": "Multiplier", "text": [ "15 - 45mg/d" ], "offsets": [ [ 488, 499 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T30", "type": "Multiplier", "text": [ "30 - 60mg/d" ], "offsets": [ [ 514, 525 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T31", "type": "Drug", "text": [ "venlafaxine ER" ], "offsets": [ [ 530, 544 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T32", "type": "Multiplier", "text": [ "150-225mg/d" ], "offsets": [ [ 545, 556 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T33", "type": "Scope", "text": [ "escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)" ], "offsets": [ [ 367, 557 ] ], "normalized": [] }, { "id": "NCT01696617_inc_T34", "type": "Scope", "text": [ "standard antidepressant treatment in monotherapy or combination of 2 antidepressants" ], "offsets": [ [ 280, 364 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01696617_inc_R1", "type": "Has_value", "arg1_id": "NCT01696617_inc_T1", "arg2_id": "NCT01696617_inc_T2", "normalized": [] }, { "id": "NCT01696617_inc_R2", "type": "AND", "arg1_id": "NCT01696617_inc_T4", "arg2_id": "NCT01696617_inc_T3", "normalized": [] }, { "id": "NCT01696617_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01696617_inc_T3", "arg2_id": "NCT01696617_inc_T5", "normalized": [] }, { "id": "NCT01696617_inc_R4", "type": "Has_value", "arg1_id": "NCT01696617_inc_T6", "arg2_id": "NCT01696617_inc_T7", "normalized": [] }, { "id": "NCT01696617_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01696617_inc_T11", "arg2_id": "NCT01696617_inc_T10", "normalized": [] }, { "id": "NCT01696617_inc_R6", "type": "Has_value", "arg1_id": "NCT01696617_inc_T8", "arg2_id": "NCT01696617_inc_T9", "normalized": [] }, { "id": "NCT01696617_inc_R7", "type": "AND", "arg1_id": "NCT01696617_inc_T13", "arg2_id": "NCT01696617_inc_T8", "normalized": [] }, { "id": "NCT01696617_inc_R8", "type": "AND", "arg1_id": "NCT01696617_inc_T13", "arg2_id": "NCT01696617_inc_T11", "normalized": [] }, { "id": "NCT01696617_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01696617_inc_T11", "arg2_id": "NCT01696617_inc_T12", "normalized": [] }, { "id": "NCT01696617_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT01696617_inc_T15", "arg2_id": "NCT01696617_inc_T14", "normalized": [] }, { "id": "NCT01696617_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT01696617_inc_T15", "arg2_id": "NCT01696617_inc_T16", "normalized": [] }, { "id": "NCT01696617_inc_R12", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T18", "arg2_id": "NCT01696617_inc_T17", "normalized": [] }, { "id": "NCT01696617_inc_R13", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T19", "arg2_id": "NCT01696617_inc_T25", "normalized": [] }, { "id": "NCT01696617_inc_R14", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T20", "arg2_id": "NCT01696617_inc_T26", "normalized": [] }, { "id": "NCT01696617_inc_R15", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T21", "arg2_id": "NCT01696617_inc_T27", "normalized": [] }, { "id": "NCT01696617_inc_R16", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T22", "arg2_id": "NCT01696617_inc_T28", "normalized": [] }, { "id": "NCT01696617_inc_R17", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T23", "arg2_id": "NCT01696617_inc_T29", "normalized": [] }, { "id": "NCT01696617_inc_R18", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T24", "arg2_id": "NCT01696617_inc_T30", "normalized": [] }, { "id": "NCT01696617_inc_R19", "type": "Has_multiplier", "arg1_id": "NCT01696617_inc_T31", "arg2_id": "NCT01696617_inc_T32", "normalized": [] }, { "id": "NCT01696617_inc_R20", "type": "Subsumes", "arg1_id": "NCT01696617_inc_T34", "arg2_id": "NCT01696617_inc_T33", "normalized": [] } ]

[ { "id": "NCT01700790_exc_text", "type": "exclusion", "text": [ "Non-compliance with DOTPlus. Alternatively DOT can be done by telephoning patient on a daily basis 5 times a week and having patient annotate taking drug in a log which would be reviewed by clinic staff\nHistory of being treated for tuberculosis in the prior 2 years unless there is DST, including PCR testing, showing sensitivity to rifamycin.\nKnown hypersensitivity to rifampin or rifabutin.\nLiver enzymes greater than 2 times ULN.\nBilirubin greater than 2 times ULN.\nSerum creatinine greater than 3 times ULN.\nHemoglobin less than 7.0 gms even if receiving erythropoietin.\nAbsolute neutrophil count less than 750 cells/mm3 even if receiving G-CSF.\nFasting triglycerides greater than 400 mg/dL.\nFasting cholesterol > 1.6 upper limits of normal.\nGI intolerance of tuberculosis medications requiring discontinuation of tuberculosis medications.\nFasting glucose greater 150 mg/dL.\nPregnant women.\nUse of one of the prohibited medications\nAny condition that the investigators feel could compromise the use of the current medication.\nHave a CD4 cell count of 50 cells/mm3or less\nHepatitis B or C infection\nAlcohol or illicit drug use, which in the investigators opinion may affect participation in study.\n" ], "offsets": [ [ 0, 1201 ] ] } ]

[ { "id": "NCT01700790_exc_T1", "type": "Condition", "text": [ "Non-compliance" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T2", "type": "Procedure", "text": [ "DOTPlus" ], "offsets": [ [ 20, 27 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T4", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 220, 227 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T5", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 232, 244 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T6", "type": "Temporal", "text": [ "in the prior 2 years" ], "offsets": [ [ 245, 265 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T7", "type": "Procedure", "text": [ "PCR testing" ], "offsets": [ [ 297, 308 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T8", "type": "Condition", "text": [ "sensitivity" ], "offsets": [ [ 318, 329 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T9", "type": "Drug", "text": [ "rifamycin" ], "offsets": [ [ 333, 342 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T10", "type": "Condition", "text": [ "DST" ], "offsets": [ [ 282, 285 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T11", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 350, 366 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T12", "type": "Drug", "text": [ "rifampin" ], "offsets": [ [ 370, 378 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T13", "type": "Drug", "text": [ "rifabutin" ], "offsets": [ [ 382, 391 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T14", "type": "Scope", "text": [ "rifampin or rifabutin" ], "offsets": [ [ 370, 391 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T15", "type": "Measurement", "text": [ "Liver enzymes" ], "offsets": [ [ 393, 406 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T16", "type": "Value", "text": [ "greater than 2 times ULN" ], "offsets": [ [ 407, 431 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T17", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 433, 442 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T18", "type": "Value", "text": [ "greater than 2 times ULN" ], "offsets": [ [ 443, 467 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T19", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 469, 485 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T20", "type": "Value", "text": [ "greater than 3 times ULN" ], "offsets": [ [ 486, 510 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T21", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 512, 522 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T22", "type": "Value", "text": [ "less than 7.0 gms" ], "offsets": [ [ 523, 540 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T23", "type": "Qualifier", "text": [ "even if receiving erythropoietin" ], "offsets": [ [ 541, 573 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T24", "type": "Measurement", "text": [ "Absolute neutrophil count" ], "offsets": [ [ 575, 600 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T25", "type": "Value", "text": [ "less than 750 cells/mm3" ], "offsets": [ [ 601, 624 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T26", "type": "Qualifier", "text": [ "even if receiving G-CSF" ], "offsets": [ [ 625, 648 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T27", "type": "Measurement", "text": [ "Fasting triglycerides" ], "offsets": [ [ 650, 671 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T28", "type": "Value", "text": [ "greater than 400 mg/dL" ], "offsets": [ [ 672, 694 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T29", "type": "Measurement", "text": [ "Fasting cholesterol" ], "offsets": [ [ 696, 715 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T30", "type": "Value", "text": [ "> 1.6 upper limits of normal" ], "offsets": [ [ 716, 744 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T31", "type": "Condition", "text": [ "GI intolerance" ], "offsets": [ [ 746, 760 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T32", "type": "Drug", "text": [ "tuberculosis medications" ], "offsets": [ [ 764, 788 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T33", "type": "Drug", "text": [ "tuberculosis medications" ], "offsets": [ [ 818, 842 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T34", "type": "Procedure", "text": [ "discontinuation" ], "offsets": [ [ 799, 814 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T35", "type": "Measurement", "text": [ "Fasting glucose" ], "offsets": [ [ 844, 859 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T36", "type": "Value", "text": [ "greater 150 mg/dL" ], "offsets": [ [ 860, 877 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T37", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 879, 887 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T38", "type": "Person", "text": [ "women" ], "offsets": [ [ 888, 893 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T41", "type": "Measurement", "text": [ "CD4 cell count" ], "offsets": [ [ 1037, 1051 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T42", "type": "Value", "text": [ "50 cells/mm3or less" ], "offsets": [ [ 1055, 1074 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T43", "type": "Condition", "text": [ "Hepatitis B" ], "offsets": [ [ 1075, 1086 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T44", "type": "Condition", "text": [ " infecti", "h" ], "offsets": [ [ 1091, 1099 ], [ 1106, 1107 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T45", "type": "Observation", "text": [ "t drug", " i" ], "offsets": [ [ 1119, 1125 ], [ 1143, 1145 ] ], "normalized": [] }, { "id": "NCT01700790_exc_T46", "type": "Observation", "text": [ "illicit drug use" ], "offsets": [ [ 1113, 1129 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01700790_exc_R1", "type": "AND", "arg1_id": "NCT01700790_exc_T1", "arg2_id": "NCT01700790_exc_T2", "normalized": [] }, { "id": "NCT01700790_exc_R2", "type": "AND", "arg1_id": "NCT01700790_exc_T4", "arg2_id": "NCT01700790_exc_T5", "normalized": [] }, { "id": "NCT01700790_exc_R3", "type": "AND", "arg1_id": "NCT01700790_exc_T8", "arg2_id": "NCT01700790_exc_T9", "normalized": [] }, { "id": "NCT01700790_exc_R4", "type": "AND", "arg1_id": "NCT01700790_exc_T7", "arg2_id": "NCT01700790_exc_T8", "normalized": [] }, { "id": "NCT01700790_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01700790_exc_T4", "arg2_id": "NCT01700790_exc_T6", "normalized": [] }, { "id": "NCT01700790_exc_R6", "type": "Subsumes", "arg1_id": "NCT01700790_exc_T10", "arg2_id": "NCT01700790_exc_T7", "normalized": [] }, { "id": "NCT01700790_exc_R7", "type": "Has_scope", "arg1_id": "NCT01700790_exc_T11", "arg2_id": "NCT01700790_exc_T14", "normalized": [] }, { "id": "NCT01700790_exc_R8", "type": "Has_value", "arg1_id": "NCT01700790_exc_T15", "arg2_id": "NCT01700790_exc_T16", "normalized": [] }, { "id": "NCT01700790_exc_R9", "type": "Has_value", "arg1_id": "NCT01700790_exc_T19", "arg2_id": "NCT01700790_exc_T20", "normalized": [] }, { "id": "NCT01700790_exc_R10", "type": "Has_value", "arg1_id": "NCT01700790_exc_T17", "arg2_id": "NCT01700790_exc_T18", "normalized": [] }, { "id": "NCT01700790_exc_R11", "type": "Has_value", "arg1_id": "NCT01700790_exc_T21", "arg2_id": "NCT01700790_exc_T22", "normalized": [] }, { "id": "NCT01700790_exc_R12", "type": "Has_value", "arg1_id": "NCT01700790_exc_T24", "arg2_id": "NCT01700790_exc_T25", "normalized": [] }, { "id": "NCT01700790_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01700790_exc_T22", "arg2_id": "NCT01700790_exc_T23", "normalized": [] }, { "id": "NCT01700790_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT01700790_exc_T25", "arg2_id": "NCT01700790_exc_T26", "normalized": [] }, { "id": "NCT01700790_exc_R15", "type": "Has_value", "arg1_id": "NCT01700790_exc_T27", "arg2_id": "NCT01700790_exc_T28", "normalized": [] }, { "id": "NCT01700790_exc_R16", "type": "Has_value", "arg1_id": "NCT01700790_exc_T29", "arg2_id": "NCT01700790_exc_T30", "normalized": [] }, { "id": "NCT01700790_exc_R17", "type": "AND", "arg1_id": "NCT01700790_exc_T31", "arg2_id": "NCT01700790_exc_T32", "normalized": [] }, { "id": "NCT01700790_exc_R18", "type": "AND", "arg1_id": "NCT01700790_exc_T31", "arg2_id": "NCT01700790_exc_T34", "normalized": [] }, { "id": "NCT01700790_exc_R19", "type": "AND", "arg1_id": "NCT01700790_exc_T34", "arg2_id": "NCT01700790_exc_T33", "normalized": [] }, { "id": "NCT01700790_exc_R20", "type": "Has_value", "arg1_id": "NCT01700790_exc_T35", "arg2_id": "NCT01700790_exc_T36", "normalized": [] }, { "id": "NCT01700790_exc_R21", "type": "Has_value", "arg1_id": "NCT01700790_exc_T41", "arg2_id": "NCT01700790_exc_T42", "normalized": [] } ]

[ { "id": "NCT01700790_inc_text", "type": "inclusion", "text": [ "Antiretroviral naive\nTaking Kaletra containing regimen with suppressed viral load.\nTaking an NNRTI or integrase containing regimen without prior history of use of PI for more than 2 weeks\nTaking an NNRTI or integrase containing regimen with prior exposure to PI greater than 2 weeks. It must be clearly stated in the source document that PI was switched to another agent for convenience.\nTaking another PI containing regimens with suppressed viral load. It must be clearly stated in source document that if another PI was used for greater than 2 weeks the regimen was switched to another agent for convenience. Subjects with prior history of PI use may be enrolled, if there is a genotype showing no resistance to Kaletra Other Inclusion criteria\nBe at least 18 years of age and able to give informed consent.\nDiagnosed with TB by criteria per Brazilian Ministry of Health\nHave a good clinical response to TB.\nTolerating tuberculosis therapy containing rifampin for the 2 weeks prior to screening,except for persons taking protease inhibitors at time of diagnosis of TB.,. Subjects taking protease inhibitors will be screened and initiate visit 1 within 3 days of starting TB medication\nHIV positive with documentation present in source document.\nHave a CD4 cell count greater than 50 cells/mm3if not taking ART. Persons with cd4 < 50 may be enrolled, if it is felt that in the best interest of the patient, that enrollment in the study will allow for quicker initiation of antiretroviral therapy than referral to another treatment center.\n" ], "offsets": [ [ 0, 1540 ] ] } ]

[ { "id": "NCT01700790_inc_T1", "type": "Condition", "text": [ "naive" ], "offsets": [ [ 15, 20 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T2", "type": "Drug", "text": [ "Antiretroviral" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T3", "type": "Drug", "text": [ "Kaletra" ], "offsets": [ [ 28, 35 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T4", "type": "Measurement", "text": [ "viral load" ], "offsets": [ [ 71, 81 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T5", "type": "Value", "text": [ "suppressed" ], "offsets": [ [ 60, 70 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T6", "type": "Drug", "text": [ "NNRTI" ], "offsets": [ [ 93, 98 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T7", "type": "Drug", "text": [ "integrase" ], "offsets": [ [ 102, 111 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T8", "type": "Negation", "text": [ "without" ], "offsets": [ [ 131, 138 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T9", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 139, 144 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T10", "type": "Drug", "text": [ "PI" ], "offsets": [ [ 163, 165 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T11", "type": "Value", "text": [ "for more than 2 weeks" ], "offsets": [ [ 166, 187 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T12", "type": "Procedure", "text": [ "regimen" ], "offsets": [ [ 47, 54 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T13", "type": "Procedure", "text": [ "regimen" ], "offsets": [ [ 123, 130 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T14", "type": "Scope", "text": [ "NNRTI or integrase" ], "offsets": [ [ 93, 111 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T15", "type": "Drug", "text": [ "NNRTI" ], "offsets": [ [ 198, 203 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T16", "type": "Drug", "text": [ "integrase" ], "offsets": [ [ 207, 216 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T17", "type": "Procedure", "text": [ "regimen" ], "offsets": [ [ 228, 235 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T18", "type": "Scope", "text": [ "NNRTI or integrase" ], "offsets": [ [ 198, 216 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T19", "type": "Drug", "text": [ "PI" ], "offsets": [ [ 259, 261 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T20", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 241, 246 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T21", "type": "Temporal", "text": [ "greater than 2 weeks" ], "offsets": [ [ 262, 282 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T22", "type": "Drug", "text": [ "PI" ], "offsets": [ [ 403, 405 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T23", "type": "Procedure", "text": [ "regimens" ], "offsets": [ [ 417, 425 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T24", "type": "Measurement", "text": [ "viral load" ], "offsets": [ [ 442, 452 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T25", "type": "Value", "text": [ "suppressed" ], "offsets": [ [ 431, 441 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T26", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 750, 767 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T27", "type": "Person", "text": [ "age" ], "offsets": [ [ 771, 774 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T30", "type": "Condition", "text": [ "TB" ], "offsets": [ [ 825, 827 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T31", "type": "Qualifier", "text": [ "criteria per Brazilian Ministry of Health" ], "offsets": [ [ 831, 872 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T32", "type": "Condition", "text": [ "good clinical response" ], "offsets": [ [ 880, 902 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T33", "type": "Condition", "text": [ "TB" ], "offsets": [ [ 906, 908 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T34", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 921, 933 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T35", "type": "Procedure", "text": [ "tuberculosis therapy" ], "offsets": [ [ 921, 941 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T36", "type": "Drug", "text": [ "rifampin" ], "offsets": [ [ 953, 961 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T37", "type": "Temporal", "text": [ "for the 2 weeks prior to screening" ], "offsets": [ [ 962, 996 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T38", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 987, 996 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T39", "type": "Drug", "text": [ "protease inhibitors" ], "offsets": [ [ 1023, 1042 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T40", "type": "Negation", "text": [ "except" ], "offsets": [ [ 997, 1003 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T41", "type": "Temporal", "text": [ "at time of diagnosis of TB" ], "offsets": [ [ 1043, 1069 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T42", "type": "Reference_point", "text": [ "time of diagnosis of TB" ], "offsets": [ [ 1046, 1069 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T43", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 1187, 1190 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T44", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1191, 1199 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T45", "type": "Condition", "text": [ "HIV positive" ], "offsets": [ [ 1187, 1199 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T46", "type": "Measurement", "text": [ "CD4 cell count" ], "offsets": [ [ 1254, 1268 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T47", "type": "Value", "text": [ "greater than 50 cells/mm3" ], "offsets": [ [ 1269, 1294 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T48", "type": "Procedure", "text": [ "ART" ], "offsets": [ [ 1308, 1311 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T49", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1297, 1300 ] ], "normalized": [] }, { "id": "NCT01700790_inc_T50", "type": "Scope", "text": [ "not taking ART" ], "offsets": [ [ 1297, 1311 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01700790_inc_R1", "type": "AND", "arg1_id": "NCT01700790_inc_T1", "arg2_id": "NCT01700790_inc_T2", "normalized": [] }, { "id": "NCT01700790_inc_R2", "type": "Has_value", "arg1_id": "NCT01700790_inc_T4", "arg2_id": "NCT01700790_inc_T5", "normalized": [] }, { "id": "NCT01700790_inc_R3", "type": "Has_value", "arg1_id": "NCT01700790_inc_T10", "arg2_id": "NCT01700790_inc_T11", "normalized": [] }, { "id": "NCT01700790_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01700790_inc_T10", "arg2_id": "NCT01700790_inc_T9", "normalized": [] }, { "id": "NCT01700790_inc_R5", "type": "Has_negation", "arg1_id": "NCT01700790_inc_T10", "arg2_id": "NCT01700790_inc_T8", "normalized": [] }, { "id": "NCT01700790_inc_R6", "type": "AND", "arg1_id": "NCT01700790_inc_T12", "arg2_id": "NCT01700790_inc_T3", "normalized": [] }, { "id": "NCT01700790_inc_R7", "type": "Has_scope", "arg1_id": "NCT01700790_inc_T13", "arg2_id": "NCT01700790_inc_T14", "normalized": [] }, { "id": "NCT01700790_inc_R8", "type": "Has_scope", "arg1_id": "NCT01700790_inc_T17", "arg2_id": "NCT01700790_inc_T18", "normalized": [] }, { "id": "NCT01700790_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01700790_inc_T19", "arg2_id": "NCT01700790_inc_T20", "normalized": [] }, { "id": "NCT01700790_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01700790_inc_T19", "arg2_id": "NCT01700790_inc_T21", "normalized": [] }, { "id": "NCT01700790_inc_R11", "type": "AND", "arg1_id": "NCT01700790_inc_T23", "arg2_id": "NCT01700790_inc_T22", "normalized": [] }, { "id": "NCT01700790_inc_R12", "type": "Has_value", "arg1_id": "NCT01700790_inc_T24", "arg2_id": "NCT01700790_inc_T25", "normalized": [] }, { "id": "NCT01700790_inc_R13", "type": "Has_value", "arg1_id": "NCT01700790_inc_T27", "arg2_id": "NCT01700790_inc_T26", "normalized": [] }, { "id": "NCT01700790_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT01700790_inc_T30", "arg2_id": "NCT01700790_inc_T31", "normalized": [] }, { "id": "NCT01700790_inc_R15", "type": "AND", "arg1_id": "NCT01700790_inc_T32", "arg2_id": "NCT01700790_inc_T33", "normalized": [] }, { "id": "NCT01700790_inc_R16", "type": "Has_index", "arg1_id": "NCT01700790_inc_T37", "arg2_id": "NCT01700790_inc_T38", "normalized": [] }, { "id": "NCT01700790_inc_R17", "type": "AND", "arg1_id": "NCT01700790_inc_T35", "arg2_id": "NCT01700790_inc_T36", "normalized": [] }, { "id": "NCT01700790_inc_R18", "type": "Has_temporal", "arg1_id": "NCT01700790_inc_T35", "arg2_id": "NCT01700790_inc_T37", "normalized": [] }, { "id": "NCT01700790_inc_R19", "type": "Has_index", "arg1_id": "NCT01700790_inc_T41", "arg2_id": "NCT01700790_inc_T42", "normalized": [] }, { "id": "NCT01700790_inc_R20", "type": "Has_temporal", "arg1_id": "NCT01700790_inc_T39", "arg2_id": "NCT01700790_inc_T41", "normalized": [] }, { "id": "NCT01700790_inc_R21", "type": "Has_negation", "arg1_id": "NCT01700790_inc_T39", "arg2_id": "NCT01700790_inc_T40", "normalized": [] }, { "id": "NCT01700790_inc_R22", "type": "AND", "arg1_id": "NCT01700790_inc_T35", "arg2_id": "NCT01700790_inc_T39", "normalized": [] }, { "id": "NCT01700790_inc_R23", "type": "Has_value", "arg1_id": "NCT01700790_inc_T43", "arg2_id": "NCT01700790_inc_T44", "normalized": [] }, { "id": "NCT01700790_inc_R24", "type": "Has_negation", "arg1_id": "NCT01700790_inc_T48", "arg2_id": "NCT01700790_inc_T49", "normalized": [] }, { "id": "NCT01700790_inc_R25", "type": "Has_value", "arg1_id": "NCT01700790_inc_T46", "arg2_id": "NCT01700790_inc_T47", "normalized": [] }, { "id": "NCT01700790_inc_R26", "type": "AND", "arg1_id": "NCT01700790_inc_T50", "arg2_id": "NCT01700790_inc_T46", "normalized": [] } ]

[ { "id": "NCT01701219_exc_text", "type": "exclusion", "text": [ "1. For subjects in Cohort A: previous therapy for more than 48 hours with any parenteral antibiotic with activity against S. aureus within 72 hours of positive blood culture results. \n2. For subjects in Cohort B: previous therapy for more than 48 hours with any parenteral antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence. \n3. Previous episode of S. aureus bacteremia within 3 months. \n4. Known left-sided endocarditis or prosthetic heart valve. \n5. Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis. \n6. History of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent. \n7. Evidence of significant hepatic, hematologic, or immunologic impairment. \n8. Pregnant or nursing females. \n \n" ], "offsets": [ [ 0, 875 ] ] } ]

[ { "id": "NCT01701219_exc_T1", "type": "Observation", "text": [ "Cohort A" ], "offsets": [ [ 19, 27 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T3", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 38, 45 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T5", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 29, 37 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T6", "type": "Temporal", "text": [ "for more than 48 hours" ], "offsets": [ [ 46, 68 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T7", "type": "Drug", "text": [ "parenteral antibiotic with activity against S. aureus" ], "offsets": [ [ 78, 131 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T8", "type": "Qualifier", "text": [ "with activity against S. aureus" ], "offsets": [ [ 100, 131 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T9", "type": "Observation", "text": [ "S. aureus" ], "offsets": [ [ 122, 131 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T10", "type": "Temporal", "text": [ "within 72 hours of positive blood culture results" ], "offsets": [ [ 132, 181 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T11", "type": "Reference_point", "text": [ "positive blood culture results" ], "offsets": [ [ 151, 181 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T12", "type": "Procedure", "text": [ "blood culture" ], "offsets": [ [ 160, 173 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T13", "type": "Value", "text": [ "positive", "results" ], "offsets": [ [ 151, 159 ], [ 174, 181 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T14", "type": "Observation", "text": [ "Cohort B" ], "offsets": [ [ 203, 211 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T16", "type": "Scope", "text": [ "previous therapy for more than 48 hours with any parenteral antibiotic with activity against S. aureus within 72 hours of positive blood culture results." ], "offsets": [ [ 29, 182 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T17", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 213, 221 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T18", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 222, 229 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T20", "type": "Temporal", "text": [ "for more than 48 hours" ], "offsets": [ [ 230, 252 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T21", "type": "Drug", "text": [ "parenteral antibiotic with activity against MRSA" ], "offsets": [ [ 262, 310 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T22", "type": "Qualifier", "text": [ "parenteral" ], "offsets": [ [ 78, 88 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T23", "type": "Qualifier", "text": [ "parenteral" ], "offsets": [ [ 262, 272 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T24", "type": "Qualifier", "text": [ "with activity against MRSA" ], "offsets": [ [ 284, 310 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T25", "type": "Observation", "text": [ "MRSA" ], "offsets": [ [ 306, 310 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T26", "type": "Drug", "text": [ "vancomycin" ], "offsets": [ [ 319, 329 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T27", "type": "Negation", "text": [ "except" ], "offsets": [ [ 312, 318 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T28", "type": "Drug", "text": [ "daptomycin" ], "offsets": [ [ 337, 347 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T29", "type": "Temporal", "text": [ "within 72 hours of positive blood culture results" ], "offsets": [ [ 349, 398 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T30", "type": "Reference_point", "text": [ "positive blood culture results" ], "offsets": [ [ 368, 398 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T31", "type": "Value", "text": [ "positive", "results" ], "offsets": [ [ 368, 376 ], [ 391, 398 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T32", "type": "Procedure", "text": [ "blood culture" ], "offsets": [ [ 377, 390 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T33", "type": "Scope", "text": [ "except vancomycin and/or daptomycin" ], "offsets": [ [ 312, 347 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T34", "type": "Condition", "text": [ "S. aureus bacteremia" ], "offsets": [ [ 447, 467 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T35", "type": "Observation", "text": [ "S. aureus" ], "offsets": [ [ 447, 456 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T36", "type": "Qualifier", "text": [ "S. aureus" ], "offsets": [ [ 447, 456 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T37", "type": "Temporal", "text": [ "within 3 months" ], "offsets": [ [ 468, 483 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T38", "type": "Condition", "text": [ "left-sided endocarditis" ], "offsets": [ [ 495, 518 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T39", "type": "Qualifier", "text": [ "left-sided" ], "offsets": [ [ 495, 505 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T40", "type": "Device", "text": [ "prosthetic heart valve" ], "offsets": [ [ 522, 544 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T41", "type": "Condition", "text": [ "Osteomyelitis" ], "offsets": [ [ 550, 563 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T42", "type": "Condition", "text": [ "prosthetic joint infection" ], "offsets": [ [ 567, 593 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T43", "type": "Temporal", "text": [ "new onset" ], "offsets": [ [ 601, 610 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T44", "type": "Qualifier", "text": [ "nonhardware-associated" ], "offsets": [ [ 611, 633 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T45", "type": "Condition", "text": [ "vertebral osteomyelitis" ], "offsets": [ [ 634, 657 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T46", "type": "Negation", "text": [ "except" ], "offsets": [ [ 594, 600 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T47", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 678, 694 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T48", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 698, 715 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T49", "type": "Drug", "text": [ "β-lactam antibacterial agent" ], "offsets": [ [ 723, 751 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T50", "type": "Scope", "text": [ "hypersensitivity or allergic reaction" ], "offsets": [ [ 678, 715 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T51", "type": "Observation", "text": [ "History" ], "offsets": [ [ 663, 670 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T52", "type": "Condition", "text": [ "hepatic", "impairment" ], "offsets": [ [ 781, 788 ], [ 818, 828 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T53", "type": "Condition", "text": [ "immunologic impairment" ], "offsets": [ [ 806, 828 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T54", "type": "Condition", "text": [ "hematologic", "impairment" ], "offsets": [ [ 790, 801 ], [ 818, 828 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T55", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 834, 842 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T56", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 846, 853 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T57", "type": "Person", "text": [ "females" ], "offsets": [ [ 854, 861 ] ], "normalized": [] }, { "id": "NCT01701219_exc_T58", "type": "Scope", "text": [ "previous therapy for more than 48 hours with any parenteral antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence" ], "offsets": [ [ 213, 421 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01701219_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T3", "arg2_id": "NCT01701219_exc_T5", "normalized": [] }, { "id": "NCT01701219_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T3", "arg2_id": "NCT01701219_exc_T6", "normalized": [] }, { "id": "NCT01701219_exc_R3", "type": "Has_value", "arg1_id": "NCT01701219_exc_T12", "arg2_id": "NCT01701219_exc_T13", "normalized": [] }, { "id": "NCT01701219_exc_R4", "type": "Has_index", "arg1_id": "NCT01701219_exc_T10", "arg2_id": "NCT01701219_exc_T11", "normalized": [] }, { "id": "NCT01701219_exc_R5", "type": "Has_scope", "arg1_id": "NCT01701219_exc_T1", "arg2_id": "NCT01701219_exc_T16", "normalized": [] }, { "id": "NCT01701219_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T18", "arg2_id": "NCT01701219_exc_T17", "normalized": [] }, { "id": "NCT01701219_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T18", "arg2_id": "NCT01701219_exc_T20", "normalized": [] }, { "id": "NCT01701219_exc_R8", "type": "Has_negation", "arg1_id": "NCT01701219_exc_T26", "arg2_id": "NCT01701219_exc_T27", "normalized": [] }, { "id": "NCT01701219_exc_R9", "type": "Has_negation", "arg1_id": "NCT01701219_exc_T28", "arg2_id": "NCT01701219_exc_T27", "normalized": [] }, { "id": "NCT01701219_exc_R10", "type": "Has_value", "arg1_id": "NCT01701219_exc_T32", "arg2_id": "NCT01701219_exc_T31", "normalized": [] }, { "id": "NCT01701219_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T33", "arg2_id": "NCT01701219_exc_T29", "normalized": [] }, { "id": "NCT01701219_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T34", "arg2_id": "NCT01701219_exc_T37", "normalized": [] }, { "id": "NCT01701219_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01701219_exc_T45", "arg2_id": "NCT01701219_exc_T44", "normalized": [] }, { "id": "NCT01701219_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T45", "arg2_id": "NCT01701219_exc_T43", "normalized": [] }, { "id": "NCT01701219_exc_R15", "type": "Has_negation", "arg1_id": "NCT01701219_exc_T45", "arg2_id": "NCT01701219_exc_T46", "normalized": [] }, { "id": "NCT01701219_exc_R16", "type": "AND", "arg1_id": "NCT01701219_exc_T50", "arg2_id": "NCT01701219_exc_T49", "normalized": [] }, { "id": "NCT01701219_exc_R17", "type": "Has_temporal", "arg1_id": "NCT01701219_exc_T50", "arg2_id": "NCT01701219_exc_T51", "normalized": [] }, { "id": "NCT01701219_exc_R18", "type": "Has_scope", "arg1_id": "NCT01701219_exc_T14", "arg2_id": "NCT01701219_exc_T58", "normalized": [] } ]

[ { "id": "NCT01701219_inc_text", "type": "inclusion", "text": [ "1. Presence of bacteremia due solely to: \nS. aureus on at least 1 blood culture within 72 hours of beginning study drug (Cohort A) OR \nMRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment (Cohort B). \n2. Male or female ≥ 18 years of age. \n3. If female of childbearing potential must be willing to practice sexual abstinence or dual methods of contraception during treatment and for at least 30 days after the last dose of study drug. \n4. Expectation of survival for at least 2 months. \n" ], "offsets": [ [ 0, 575 ] ] } ]

[ { "id": "NCT01701219_inc_T1", "type": "Condition", "text": [ "bacteremia" ], "offsets": [ [ 15, 25 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T3", "type": "Procedure", "text": [ "blood culture" ], "offsets": [ [ 66, 79 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T4", "type": "Multiplier", "text": [ "at least 1" ], "offsets": [ [ 55, 65 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T5", "type": "Observation", "text": [ "S. aureus" ], "offsets": [ [ 42, 51 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T6", "type": "Temporal", "text": [ "within 72 hours of beginning study drug" ], "offsets": [ [ 80, 119 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T7", "type": "Reference_point", "text": [ "beginning study drug" ], "offsets": [ [ 99, 119 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T8", "type": "Observation", "text": [ "MRSA" ], "offsets": [ [ 135, 139 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T9", "type": "Procedure", "text": [ "blood culture" ], "offsets": [ [ 154, 167 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T10", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 145, 153 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T11", "type": "Multiplier", "text": [ "at least 1 additional" ], "offsets": [ [ 175, 196 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T12", "type": "Procedure", "text": [ "blood culture" ], "offsets": [ [ 197, 210 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T13", "type": "Temporal", "text": [ "after at least 72 hours of vancomycin and/or daptomycin treatment" ], "offsets": [ [ 211, 276 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T14", "type": "Reference_point", "text": [ "vancomycin and/or daptomycin treatment" ], "offsets": [ [ 238, 276 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T15", "type": "Drug", "text": [ "vancomycin" ], "offsets": [ [ 238, 248 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T16", "type": "Drug", "text": [ "daptomycin" ], "offsets": [ [ 256, 266 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T17", "type": "Procedure", "text": [ "daptomycin treatment" ], "offsets": [ [ 256, 276 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T18", "type": "Procedure", "text": [ "vancomycin", "treatment" ], "offsets": [ [ 238, 248 ], [ 267, 276 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T19", "type": "Person", "text": [ "Male" ], "offsets": [ [ 293, 297 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T20", "type": "Person", "text": [ "female" ], "offsets": [ [ 301, 307 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T21", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 308, 318 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T22", "type": "Person", "text": [ "age" ], "offsets": [ [ 322, 325 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T23", "type": "Person", "text": [ "female" ], "offsets": [ [ 334, 340 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T24", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 344, 366 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T25", "type": "Observation", "text": [ "willing" ], "offsets": [ [ 375, 382 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T26", "type": "Procedure", "text": [ "practice sexual abstinence" ], "offsets": [ [ 386, 412 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T27", "type": "Multiplier", "text": [ "dual" ], "offsets": [ [ 416, 420 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T28", "type": "Procedure", "text": [ "methods of contraception" ], "offsets": [ [ 421, 445 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T29", "type": "Temporal", "text": [ "during treatment" ], "offsets": [ [ 446, 462 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T30", "type": "Temporal", "text": [ "for at least 30 days after the last dose of study drug" ], "offsets": [ [ 467, 521 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T31", "type": "Reference_point", "text": [ "the last dose of study drug" ], "offsets": [ [ 494, 521 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T32", "type": "Scope", "text": [ "practice sexual abstinence or dual methods of contraception" ], "offsets": [ [ 386, 445 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T33", "type": "Scope", "text": [ "female of childbearing potential" ], "offsets": [ [ 334, 366 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T34", "type": "Observation", "text": [ "Expectation" ], "offsets": [ [ 527, 538 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T35", "type": "Condition", "text": [ "survival" ], "offsets": [ [ 542, 550 ] ], "normalized": [] }, { "id": "NCT01701219_inc_T36", "type": "Temporal", "text": [ "for at least 2 months" ], "offsets": [ [ 551, 572 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01701219_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT01701219_inc_T3", "arg2_id": "NCT01701219_inc_T4", "normalized": [] }, { "id": "NCT01701219_inc_R3", "type": "Has_index", "arg1_id": "NCT01701219_inc_T6", "arg2_id": "NCT01701219_inc_T7", "normalized": [] }, { "id": "NCT01701219_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T9", "arg2_id": "NCT01701219_inc_T10", "normalized": [] }, { "id": "NCT01701219_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T3", "arg2_id": "NCT01701219_inc_T6", "normalized": [] }, { "id": "NCT01701219_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T12", "arg2_id": "NCT01701219_inc_T13", "normalized": [] }, { "id": "NCT01701219_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT01701219_inc_T12", "arg2_id": "NCT01701219_inc_T11", "normalized": [] }, { "id": "NCT01701219_inc_R9", "type": "Has_value", "arg1_id": "NCT01701219_inc_T22", "arg2_id": "NCT01701219_inc_T21", "normalized": [] }, { "id": "NCT01701219_inc_R11", "type": "Has_multiplier", "arg1_id": "NCT01701219_inc_T28", "arg2_id": "NCT01701219_inc_T27", "normalized": [] }, { "id": "NCT01701219_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T32", "arg2_id": "NCT01701219_inc_T29", "normalized": [] }, { "id": "NCT01701219_inc_R13", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T32", "arg2_id": "NCT01701219_inc_T30", "normalized": [] }, { "id": "NCT01701219_inc_R14", "type": "Has_scope", "arg1_id": "NCT01701219_inc_T33", "arg2_id": "NCT01701219_inc_T32", "normalized": [] }, { "id": "NCT01701219_inc_R15", "type": "Has_temporal", "arg1_id": "NCT01701219_inc_T35", "arg2_id": "NCT01701219_inc_T36", "normalized": [] } ]

[ { "id": "NCT01709981_exc_text", "type": "exclusion", "text": [ "Plan for diagnostic-only coronary angiography\nOn colchicine chronically\nHistory of intolerance to colchicine\nGlomerular filtration rate <30mL/minute or on dialysis\nActive malignancy or infection\nHistory of myelodysplasia\nHigh-dose statin load <24 hours prior to procedure\nUse of oral steroids or non-steroidal anti-inflammatory agents other than aspirin within 72 hours or 3 times the agent's half-life (whichever is longer)\nUse of strong CYP3A4/P-glycoprotein inhibitors (specifically ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil)\nUnable to consent\nParticipating in a competing study\n" ], "offsets": [ [ 0, 619 ] ] } ]

[ { "id": "NCT01709981_exc_T1", "type": "Procedure", "text": [ "coronary angiography" ], "offsets": [ [ 25, 45 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T2", "type": "Qualifier", "text": [ "diagnostic-only" ], "offsets": [ [ 9, 24 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T3", "type": "Drug", "text": [ "colchicine" ], "offsets": [ [ 49, 59 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T4", "type": "Multiplier", "text": [ "chronically" ], "offsets": [ [ 60, 71 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T5", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 83, 94 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T6", "type": "Drug", "text": [ "colchicine" ], "offsets": [ [ 98, 108 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T7", "type": "Measurement", "text": [ "Glomerular filtration rate" ], "offsets": [ [ 109, 135 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T8", "type": "Value", "text": [ "<30mL/minute" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T9", "type": "Procedure", "text": [ "dialysis" ], "offsets": [ [ 155, 163 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T10", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 171, 181 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T11", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 164, 170 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T12", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 185, 194 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T13", "type": "Condition", "text": [ "myelodysplasia" ], "offsets": [ [ 206, 220 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T14", "type": "Drug", "text": [ "High-dose statin" ], "offsets": [ [ 221, 237 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T15", "type": "Temporal", "text": [ "<24 hours prior to procedure" ], "offsets": [ [ 243, 271 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T16", "type": "Reference_point", "text": [ "procedure" ], "offsets": [ [ 262, 271 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T17", "type": "Drug", "text": [ "oral steroids" ], "offsets": [ [ 279, 292 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T18", "type": "Drug", "text": [ "non-steroidal anti-inflammatory agents" ], "offsets": [ [ 296, 334 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T19", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 346, 353 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T20", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 335, 345 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T21", "type": "Temporal", "text": [ "within 72 hours" ], "offsets": [ [ 354, 369 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T22", "type": "Temporal", "text": [ "72 hou", " the agent's half-life (whic" ], "offsets": [ [ 361, 367 ], [ 380, 408 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T23", "type": "Reference_point", "text": [ "3 times the agent's half-life" ], "offsets": [ [ 373, 402 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T24", "type": "Reference_point", "text": [ "72 hours" ], "offsets": [ [ 361, 369 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T25", "type": "Scope", "text": [ "oral steroids or non-steroidal anti-inflammatory agents other than aspirin" ], "offsets": [ [ 279, 353 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T26", "type": "Scope", "text": [ "within 72 hours or 3 times the agent's half-life" ], "offsets": [ [ 354, 402 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T27", "type": "Drug", "text": [ "strong CYP3A4/P-glycoprotein inhibitors" ], "offsets": [ [ 432, 471 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T28", "type": "Drug", "text": [ "ritonavir" ], "offsets": [ [ 486, 495 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T29", "type": "Drug", "text": [ "ketoconazole" ], "offsets": [ [ 497, 509 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T30", "type": "Drug", "text": [ "clarithromycin" ], "offsets": [ [ 511, 525 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T31", "type": "Drug", "text": [ "cyclosporine" ], "offsets": [ [ 527, 539 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T32", "type": "Drug", "text": [ "diltiazem" ], "offsets": [ [ 541, 550 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T33", "type": "Drug", "text": [ "verapamil" ], "offsets": [ [ 555, 564 ] ], "normalized": [] }, { "id": "NCT01709981_exc_T34", "type": "Scope", "text": [ "ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil" ], "offsets": [ [ 486, 564 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01709981_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01709981_exc_T1", "arg2_id": "NCT01709981_exc_T2", "normalized": [] }, { "id": "NCT01709981_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT01709981_exc_T3", "arg2_id": "NCT01709981_exc_T4", "normalized": [] }, { "id": "NCT01709981_exc_R3", "type": "AND", "arg1_id": "NCT01709981_exc_T5", "arg2_id": "NCT01709981_exc_T6", "normalized": [] }, { "id": "NCT01709981_exc_R4", "type": "Has_value", "arg1_id": "NCT01709981_exc_T7", "arg2_id": "NCT01709981_exc_T8", "normalized": [] }, { "id": "NCT01709981_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01709981_exc_T10", "arg2_id": "NCT01709981_exc_T11", "normalized": [] }, { "id": "NCT01709981_exc_R6", "type": "Has_index", "arg1_id": "NCT01709981_exc_T15", "arg2_id": "NCT01709981_exc_T16", "normalized": [] }, { "id": "NCT01709981_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01709981_exc_T14", "arg2_id": "NCT01709981_exc_T15", "normalized": [] }, { "id": "NCT01709981_exc_R8", "type": "Has_negation", "arg1_id": "NCT01709981_exc_T19", "arg2_id": "NCT01709981_exc_T20", "normalized": [] }, { "id": "NCT01709981_exc_R9", "type": "AND", "arg1_id": "NCT01709981_exc_T18", "arg2_id": "NCT01709981_exc_T19", "normalized": [] }, { "id": "NCT01709981_exc_R10", "type": "Has_index", "arg1_id": "NCT01709981_exc_T21", "arg2_id": "NCT01709981_exc_T24", "normalized": [] }, { "id": "NCT01709981_exc_R11", "type": "Has_index", "arg1_id": "NCT01709981_exc_T22", "arg2_id": "NCT01709981_exc_T23", "normalized": [] }, { "id": "NCT01709981_exc_R12", "type": "Has_scope", "arg1_id": "NCT01709981_exc_T25", "arg2_id": "NCT01709981_exc_T26", "normalized": [] }, { "id": "NCT01709981_exc_R13", "type": "Subsumes", "arg1_id": "NCT01709981_exc_T27", "arg2_id": "NCT01709981_exc_T34", "normalized": [] } ]

[ { "id": "NCT01709981_inc_text", "type": "inclusion", "text": [ "Patients must be more than 18 years of age and referred for coronary angiography\n" ], "offsets": [ [ 0, 81 ] ] } ]

[ { "id": "NCT01709981_inc_T1", "type": "Value", "text": [ "more than 18 years" ], "offsets": [ [ 17, 35 ] ], "normalized": [] }, { "id": "NCT01709981_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 39, 42 ] ], "normalized": [] }, { "id": "NCT01709981_inc_T3", "type": "Procedure", "text": [ "coronary angiography" ], "offsets": [ [ 60, 80 ] ], "normalized": [] }, { "id": "NCT01709981_inc_T4", "type": "Mood", "text": [ "referred for" ], "offsets": [ [ 47, 59 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01709981_inc_R1", "type": "Has_value", "arg1_id": "NCT01709981_inc_T2", "arg2_id": "NCT01709981_inc_T1", "normalized": [] }, { "id": "NCT01709981_inc_R2", "type": "Has_mood", "arg1_id": "NCT01709981_inc_T3", "arg2_id": "NCT01709981_inc_T4", "normalized": [] } ]

[ { "id": "NCT01711801_exc_text", "type": "exclusion", "text": [ "History or presence of any clinically significant disease or disorder \nAny condition or disease that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator \nHistory of clinically significant hypersensitivity or allergic drug reactions \nAny suspicion or history of alcohol abuse and/or consumption of other drugs of abuse \nRegular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day) \nPositive for hepatitis B, hepatitis C or HIV infection \nDietary restrictions that would prohibit the consumption of standardized meals \nParticipation in an investigational drug or device study within 90 days prior to screening, as calculated from the follow-up from the previous study \n \n" ], "offsets": [ [ 0, 816 ] ] } ]

[ { "id": "NCT01711801_exc_T1", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 27, 49 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T2", "type": "Condition", "text": [ "clinically significant disease" ], "offsets": [ [ 27, 57 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T3", "type": "Condition", "text": [ "clinically significant", "disorder" ], "offsets": [ [ 27, 49 ], [ 61, 69 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T6", "type": "Observation", "text": [ "History" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T9", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 298, 320 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T11", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 321, 337 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T12", "type": "Condition", "text": [ "allergic drug reactions" ], "offsets": [ [ 341, 364 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T13", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 394, 407 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T14", "type": "Observation", "text": [ "suspicion" ], "offsets": [ [ 370, 379 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T15", "type": "Observation", "text": [ "history" ], "offsets": [ [ 383, 390 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T16", "type": "Scope", "text": [ "suspicion or history" ], "offsets": [ [ 370, 390 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T17", "type": "Condition", "text": [ "consumption of other drugs of abuse" ], "offsets": [ [ 415, 450 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T18", "type": "Scope", "text": [ "alcohol abuse and/or consumption of other drugs of abuse" ], "offsets": [ [ 394, 450 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T19", "type": "Condition", "text": [ "Regular smoker" ], "offsets": [ [ 452, 466 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T20", "type": "Multiplier", "text": [ "> 5" ], "offsets": [ [ 468, 471 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T21", "type": "Observation", "text": [ "cigarettes" ], "offsets": [ [ 472, 482 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T23", "type": "Multiplier", "text": [ "> 1", "per day" ], "offsets": [ [ 499, 502 ], [ 509, 516 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T24", "type": "Observation", "text": [ "cigar" ], "offsets": [ [ 503, 508 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T22", "type": "Multiplier", "text": [ "> 1" ], "offsets": [ [ 484, 487 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T25", "type": "Observation", "text": [ "pipeful" ], "offsets": [ [ 488, 495 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T26", "type": "Scope", "text": [ "> 5 cigarettes, > 1 pipeful or > 1 cigar per day" ], "offsets": [ [ 468, 516 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T27", "type": "Measurement", "text": [ "hepatitis B" ], "offsets": [ [ 532, 543 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T28", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 519, 527 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T29", "type": "Measurement", "text": [ "hepatitis C" ], "offsets": [ [ 545, 556 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T30", "type": "Condition", "text": [ "HIV infection" ], "offsets": [ [ 560, 573 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T31", "type": "Condition", "text": [ "Dietary restrictions" ], "offsets": [ [ 575, 595 ] ], "normalized": [] }, { "id": "NCT01711801_exc_T32", "type": "Qualifier", "text": [ "would prohibit the consumption of standardized meals" ], "offsets": [ [ 601, 653 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01711801_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01711801_exc_T3", "arg2_id": "NCT01711801_exc_T1", "normalized": [] }, { "id": "NCT01711801_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01711801_exc_T2", "arg2_id": "NCT01711801_exc_T1", "normalized": [] }, { "id": "NCT01711801_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01711801_exc_T3", "arg2_id": "NCT01711801_exc_T6", "normalized": [] }, { "id": "NCT01711801_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01711801_exc_T2", "arg2_id": "NCT01711801_exc_T6", "normalized": [] }, { "id": "NCT01711801_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01711801_exc_T11", "arg2_id": "NCT01711801_exc_T9", "normalized": [] }, { "id": "NCT01711801_exc_R7", "type": "Has_scope", "arg1_id": "NCT01711801_exc_T18", "arg2_id": "NCT01711801_exc_T16", "normalized": [] }, { "id": "NCT01711801_exc_R8", "type": "Has_multiplier", "arg1_id": "NCT01711801_exc_T25", "arg2_id": "NCT01711801_exc_T22", "normalized": [] }, { "id": "NCT01711801_exc_R9", "type": "Has_multiplier", "arg1_id": "NCT01711801_exc_T21", "arg2_id": "NCT01711801_exc_T20", "normalized": [] }, { "id": "NCT01711801_exc_R10", "type": "Has_multiplier", "arg1_id": "NCT01711801_exc_T24", "arg2_id": "NCT01711801_exc_T23", "normalized": [] }, { "id": "NCT01711801_exc_R11", "type": "Subsumes", "arg1_id": "NCT01711801_exc_T19", "arg2_id": "NCT01711801_exc_T26", "normalized": [] }, { "id": "NCT01711801_exc_R12", "type": "Has_value", "arg1_id": "NCT01711801_exc_T27", "arg2_id": "NCT01711801_exc_T28", "normalized": [] }, { "id": "NCT01711801_exc_R13", "type": "Has_value", "arg1_id": "NCT01711801_exc_T29", "arg2_id": "NCT01711801_exc_T28", "normalized": [] }, { "id": "NCT01711801_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT01711801_exc_T31", "arg2_id": "NCT01711801_exc_T32", "normalized": [] } ]

[ { "id": "NCT01711801_inc_text", "type": "inclusion", "text": [ "Healthy male volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis \nBody mass index (BMI) 18 to 30 kg/m2 inclusive \nMale subjects (whether surgically sterilized or not) with female partners of child-bearing potential must use two forms of contraception, one of which must be a barrier method, for the duration of the study and for 77 days after the last dose \n" ], "offsets": [ [ 0, 606 ] ] } ]

[ { "id": "NCT01711801_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T2", "type": "Person", "text": [ "male" ], "offsets": [ [ 8, 12 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T3", "type": "Value", "text": [ "18 to 45 years", ", inclusive" ], "offsets": [ [ 25, 39 ], [ 46, 57 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 43, 46 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T5", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 88, 95 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T6", "type": "Observation", "text": [ "evidence of any active or chronic disease" ], "offsets": [ [ 99, 140 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T7", "type": "Observation", "text": [ "medical", "history" ], "offsets": [ [ 162, 169 ], [ 183, 190 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T8", "type": "Observation", "text": [ "surgical history" ], "offsets": [ [ 174, 190 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T9", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 203, 223 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T10", "type": "Procedure", "text": [ "vital signs" ], "offsets": [ [ 234, 245 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T11", "type": "Procedure", "text": [ "12-lead ECG" ], "offsets": [ [ 247, 258 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T12", "type": "Procedure", "text": [ "hematology" ], "offsets": [ [ 260, 270 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T13", "type": "Procedure", "text": [ "blood chemistry" ], "offsets": [ [ 272, 287 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T14", "type": "Procedure", "text": [ "serology" ], "offsets": [ [ 289, 297 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T15", "type": "Procedure", "text": [ "urinalysis" ], "offsets": [ [ 302, 312 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T16", "type": "Scope", "text": [ "absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis" ], "offsets": [ [ 88, 312 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T17", "type": "Measurement", "text": [ "Body mass index (BMI)" ], "offsets": [ [ 314, 335 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T18", "type": "Value", "text": [ "18 to 30 kg/m2 inclusive" ], "offsets": [ [ 336, 360 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T19", "type": "Person", "text": [ "Male" ], "offsets": [ [ 362, 366 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T20", "type": "Condition", "text": [ "surgically sterilized" ], "offsets": [ [ 385, 406 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T21", "type": "Condition", "text": [ "surgically sterilized" ], "offsets": [ [ 385, 406 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T22", "type": "Negation", "text": [ "not" ], "offsets": [ [ 410, 413 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T23", "type": "Person", "text": [ "female" ], "offsets": [ [ 420, 426 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T24", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 439, 462 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T25", "type": "Multiplier", "text": [ "two" ], "offsets": [ [ 472, 475 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T26", "type": "Device", "text": [ "forms of contraception" ], "offsets": [ [ 476, 498 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T28", "type": "Device", "text": [ "barrier method" ], "offsets": [ [ 523, 537 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T29", "type": "Temporal", "text": [ "for the duration of the study" ], "offsets": [ [ 539, 568 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T30", "type": "Temporal", "text": [ "for 77 days after the last dose" ], "offsets": [ [ 573, 604 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T31", "type": "Reference_point", "text": [ "the last dose" ], "offsets": [ [ 591, 604 ] ], "normalized": [] }, { "id": "NCT01711801_inc_T32", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 559, 568 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01711801_inc_R1", "type": "Has_value", "arg1_id": "NCT01711801_inc_T4", "arg2_id": "NCT01711801_inc_T3", "normalized": [] }, { "id": "NCT01711801_inc_R2", "type": "Has_negation", "arg1_id": "NCT01711801_inc_T6", "arg2_id": "NCT01711801_inc_T5", "normalized": [] }, { "id": "NCT01711801_inc_R3", "type": "Subsumes", "arg1_id": "NCT01711801_inc_T1", "arg2_id": "NCT01711801_inc_T16", "normalized": [] }, { "id": "NCT01711801_inc_R4", "type": "Has_value", "arg1_id": "NCT01711801_inc_T17", "arg2_id": "NCT01711801_inc_T18", "normalized": [] }, { "id": "NCT01711801_inc_R5", "type": "Has_negation", "arg1_id": "NCT01711801_inc_T20", "arg2_id": "NCT01711801_inc_T22", "normalized": [] }, { "id": "NCT01711801_inc_R6", "type": "AND", "arg1_id": "NCT01711801_inc_T19", "arg2_id": "NCT01711801_inc_T23", "normalized": [] }, { "id": "NCT01711801_inc_R7", "type": "AND", "arg1_id": "NCT01711801_inc_T23", "arg2_id": "NCT01711801_inc_T24", "normalized": [] }, { "id": "NCT01711801_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01711801_inc_T26", "arg2_id": "NCT01711801_inc_T25", "normalized": [] }, { "id": "NCT01711801_inc_R9", "type": "Subsumes", "arg1_id": "NCT01711801_inc_T26", "arg2_id": "NCT01711801_inc_T28", "normalized": [] }, { "id": "NCT01711801_inc_R10", "type": "Has_index", "arg1_id": "NCT01711801_inc_T29", "arg2_id": "NCT01711801_inc_T32", "normalized": [] }, { "id": "NCT01711801_inc_R11", "type": "Has_index", "arg1_id": "NCT01711801_inc_T30", "arg2_id": "NCT01711801_inc_T31", "normalized": [] }, { "id": "NCT01711801_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01711801_inc_T26", "arg2_id": "NCT01711801_inc_T29", "normalized": [] }, { "id": "NCT01711801_inc_R13", "type": "Has_temporal", "arg1_id": "NCT01711801_inc_T26", "arg2_id": "NCT01711801_inc_T30", "normalized": [] } ]

[ { "id": "NCT01715584_exc_text", "type": "exclusion", "text": [ "patient refusal\nage less than 40 or over 80 years\ncombined surgical procedures\nemergency surgery\nLeft ventricular ejection fraction less than 50 per cent\ncalculated creatinine clearance less than 60 mL per minute\n" ], "offsets": [ [ 0, 213 ] ] } ]

[ { "id": "NCT01715584_exc_T1", "type": "Observation", "text": [ "patient refusal" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T3", "type": "Value", "text": [ "less than 40" ], "offsets": [ [ 20, 32 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T4", "type": "Value", "text": [ "over 80 years" ], "offsets": [ [ 36, 49 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T5", "type": "Scope", "text": [ "less than 40 or over 80 years" ], "offsets": [ [ 20, 49 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T6", "type": "Procedure", "text": [ "combined surgical procedures" ], "offsets": [ [ 50, 78 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T7", "type": "Procedure", "text": [ "emergency surgery" ], "offsets": [ [ 79, 96 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T8", "type": "Measurement", "text": [ "Left ventricular ejection fraction" ], "offsets": [ [ 97, 131 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T9", "type": "Value", "text": [ "less than 50 per cent" ], "offsets": [ [ 132, 153 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T10", "type": "Measurement", "text": [ "calculated creatinine clearance" ], "offsets": [ [ 154, 185 ] ], "normalized": [] }, { "id": "NCT01715584_exc_T11", "type": "Value", "text": [ "less than 60 mL per minute" ], "offsets": [ [ 186, 212 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01715584_exc_R1", "type": "Has_scope", "arg1_id": "NCT01715584_exc_T2", "arg2_id": "NCT01715584_exc_T5", "normalized": [] }, { "id": "NCT01715584_exc_R2", "type": "Has_value", "arg1_id": "NCT01715584_exc_T8", "arg2_id": "NCT01715584_exc_T9", "normalized": [] }, { "id": "NCT01715584_exc_R3", "type": "Has_value", "arg1_id": "NCT01715584_exc_T10", "arg2_id": "NCT01715584_exc_T11", "normalized": [] } ]

[ { "id": "NCT01715584_inc_text", "type": "inclusion", "text": [ "age over 40\ncomposite head and neck tumor resection\ntreated hypertension\nhypertension medications taken on morning of surgery (except diuretics)\n" ], "offsets": [ [ 0, 145 ] ] } ]

[ { "id": "NCT01715584_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T2", "type": "Value", "text": [ "over 40" ], "offsets": [ [ 4, 11 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T3", "type": "Procedure", "text": [ "composite head and neck tumor resection" ], "offsets": [ [ 12, 51 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T4", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 60, 72 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T5", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 52, 59 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T6", "type": "Drug", "text": [ "hypertension medications" ], "offsets": [ [ 73, 97 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T7", "type": "Temporal", "text": [ "on morning of surgery" ], "offsets": [ [ 104, 125 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T8", "type": "Drug", "text": [ "diuretics" ], "offsets": [ [ 134, 143 ] ], "normalized": [] }, { "id": "NCT01715584_inc_T9", "type": "Negation", "text": [ "except" ], "offsets": [ [ 127, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01715584_inc_R1", "type": "Has_value", "arg1_id": "NCT01715584_inc_T1", "arg2_id": "NCT01715584_inc_T2", "normalized": [] }, { "id": "NCT01715584_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01715584_inc_T4", "arg2_id": "NCT01715584_inc_T5", "normalized": [] }, { "id": "NCT01715584_inc_R3", "type": "Has_negation", "arg1_id": "NCT01715584_inc_T8", "arg2_id": "NCT01715584_inc_T9", "normalized": [] }, { "id": "NCT01715584_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01715584_inc_T6", "arg2_id": "NCT01715584_inc_T7", "normalized": [] }, { "id": "NCT01715584_inc_R5", "type": "AND", "arg1_id": "NCT01715584_inc_T6", "arg2_id": "NCT01715584_inc_T8", "normalized": [] } ]

[ { "id": "NCT01715714_exc_text", "type": "exclusion", "text": [ "Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)\nAcute ST-segment-elevation myocardial infarction (STEMI)\nNSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission\nHistory of atrial fibrillation or muscle disease (myopathy)\nCurrent renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)\nInability of oral drug intake\n" ], "offsets": [ [ 0, 499 ] ] } ]

[ { "id": "NCT01715714_exc_T1", "type": "Procedure", "text": [ "cardiovascular procedure" ], "offsets": [ [ 16, 40 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T2", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 44, 48 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T3", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T4", "type": "Procedure", "text": [ "carotid surgery" ], "offsets": [ [ 72, 87 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T5", "type": "Procedure", "text": [ "aortic", "surgery" ], "offsets": [ [ 62, 68 ], [ 80, 87 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T6", "type": "Procedure", "text": [ "valve", "surgery" ], "offsets": [ [ 55, 60 ], [ 80, 87 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T7", "type": "Scope", "text": [ "valve, aortic or carotid surgery" ], "offsets": [ [ 55, 87 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T8", "type": "Condition", "text": [ "Acute ST-segment-elevation myocardial infarction" ], "offsets": [ [ 89, 137 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T9", "type": "Condition", "text": [ "STEMI" ], "offsets": [ [ 139, 144 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T10", "type": "Condition", "text": [ "NSTE-ACS" ], "offsets": [ [ 146, 154 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T11", "type": "Condition", "text": [ "cardiogenic shock" ], "offsets": [ [ 160, 177 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T12", "type": "Procedure", "text": [ "salvage surgery" ], "offsets": [ [ 198, 213 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T13", "type": "Mood", "text": [ "warranting" ], "offsets": [ [ 178, 188 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T14", "type": "Temporal", "text": [ "within 12 hrs from hospital admission" ], "offsets": [ [ 214, 251 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T15", "type": "Reference_point", "text": [ "hospital admission" ], "offsets": [ [ 233, 251 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T16", "type": "Scope", "text": [ "NSTE-ACS with cardiogenic shock" ], "offsets": [ [ 146, 177 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T17", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 263, 282 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T18", "type": "Condition", "text": [ "muscle disease" ], "offsets": [ [ 286, 300 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T19", "type": "Condition", "text": [ "myopathy" ], "offsets": [ [ 302, 310 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T20", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 327, 337 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T21", "type": "Value", "text": [ ">2x upper limit of normal (ULN)" ], "offsets": [ [ 337, 368 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T22", "type": "Procedure", "text": [ "dialysis" ], "offsets": [ [ 370, 378 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T23", "type": "Procedure", "text": [ "kidney transplant" ], "offsets": [ [ 380, 397 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T24", "type": "Scope", "text": [ "creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant" ], "offsets": [ [ 327, 397 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T25", "type": "Condition", "text": [ "l (cr", "unction (AS" ], "offsets": [ [ 324, 329 ], [ 414, 425 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T26", "type": "Condition", "text": [ "hepatic dysfunction" ], "offsets": [ [ 402, 421 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T27", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 423, 426 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T28", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 427, 430 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T29", "type": "Value", "text": [ ">2x ULN" ], "offsets": [ [ 430, 437 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T30", "type": "Procedure", "text": [ "liver transplant" ], "offsets": [ [ 439, 455 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T31", "type": "Condition", "text": [ "neoplasm" ], "offsets": [ [ 459, 467 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T32", "type": "Scope", "text": [ "AST/ALT>2x ULN" ], "offsets": [ [ 423, 437 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T33", "type": "Scope", "text": [ "AST/ALT>2x ULN, liver transplant or neoplasm" ], "offsets": [ [ 423, 467 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T34", "type": "Mood", "text": [ "Inability of" ], "offsets": [ [ 469, 481 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T35", "type": "Drug", "text": [ "oral drug" ], "offsets": [ [ 482, 491 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T36", "type": "Observation", "text": [ "oral drug intake" ], "offsets": [ [ 482, 498 ] ], "normalized": [] }, { "id": "NCT01715714_exc_T37", "type": "Negation", "text": [ "Inability" ], "offsets": [ [ 469, 478 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01715714_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01715714_exc_T1", "arg2_id": "NCT01715714_exc_T3", "normalized": [] }, { "id": "NCT01715714_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01715714_exc_T2", "arg2_id": "NCT01715714_exc_T3", "normalized": [] }, { "id": "NCT01715714_exc_R3", "type": "Subsumes", "arg1_id": "NCT01715714_exc_T1", "arg2_id": "NCT01715714_exc_T7", "normalized": [] }, { "id": "NCT01715714_exc_R4", "type": "Subsumes", "arg1_id": "NCT01715714_exc_T8", "arg2_id": "NCT01715714_exc_T9", "normalized": [] }, { "id": "NCT01715714_exc_R5", "type": "Has_mood", "arg1_id": "NCT01715714_exc_T12", "arg2_id": "NCT01715714_exc_T13", "normalized": [] }, { "id": "NCT01715714_exc_R6", "type": "Has_index", "arg1_id": "NCT01715714_exc_T14", "arg2_id": "NCT01715714_exc_T15", "normalized": [] }, { "id": "NCT01715714_exc_R7", "type": "AND", "arg1_id": "NCT01715714_exc_T16", "arg2_id": "NCT01715714_exc_T12", "normalized": [] }, { "id": "NCT01715714_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01715714_exc_T16", "arg2_id": "NCT01715714_exc_T14", "normalized": [] }, { "id": "NCT01715714_exc_R9", "type": "Subsumes", "arg1_id": "NCT01715714_exc_T18", "arg2_id": "NCT01715714_exc_T19", "normalized": [] }, { "id": "NCT01715714_exc_R10", "type": "Has_value", "arg1_id": "NCT01715714_exc_T20", "arg2_id": "NCT01715714_exc_T21", "normalized": [] }, { "id": "NCT01715714_exc_R11", "type": "Has_value", "arg1_id": "NCT01715714_exc_T28", "arg2_id": "NCT01715714_exc_T29", "normalized": [] }, { "id": "NCT01715714_exc_R12", "type": "Has_value", "arg1_id": "NCT01715714_exc_T27", "arg2_id": "NCT01715714_exc_T29", "normalized": [] }, { "id": "NCT01715714_exc_R13", "type": "Subsumes", "arg1_id": "NCT01715714_exc_T26", "arg2_id": "NCT01715714_exc_T33", "normalized": [] }, { "id": "NCT01715714_exc_R14", "type": "Subsumes", "arg1_id": "NCT01715714_exc_T25", "arg2_id": "NCT01715714_exc_T24", "normalized": [] }, { "id": "NCT01715714_exc_R17", "type": "Has_mood", "arg1_id": "NCT01715714_exc_T36", "arg2_id": "NCT01715714_exc_T34", "normalized": [] } ]

[ { "id": "NCT01715714_inc_text", "type": "inclusion", "text": [ "Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures\nStable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)\nAge = 18 years\nWritten informed consent\n" ], "offsets": [ [ 0, 288 ] ] } ]

[ { "id": "NCT01715714_inc_T1", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 12, 19 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T2", "type": "Drug", "text": [ "statin" ], "offsets": [ [ 20, 26 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T3", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 27, 36 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T4", "type": "Value", "text": [ ">30 days" ], "offsets": [ [ 38, 46 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T5", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 71, 75 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T6", "type": "Qualifier", "text": [ "isolated" ], "offsets": [ [ 62, 70 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T7", "type": "Mood", "text": [ "scheduled" ], "offsets": [ [ 48, 57 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T8", "type": "Procedure", "text": [ "revascularisation procedures" ], "offsets": [ [ 122, 150 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T9", "type": "Qualifier", "text": [ "on- or off-pump or repeat" ], "offsets": [ [ 87, 112 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T10", "type": "Qualifier", "text": [ "redo's" ], "offsets": [ [ 114, 120 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T11", "type": "Condition", "text": [ "table", "ngina," ], "offsets": [ [ 152, 157 ], [ 171, 177 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T12", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 161, 176 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T13", "type": "Condition", "text": [ "non ST-segment-elevation acute coronary syndrome" ], "offsets": [ [ 188, 236 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T14", "type": "Condition", "text": [ "NSTE-ACS" ], "offsets": [ [ 238, 246 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T15", "type": "Person", "text": [ "Age" ], "offsets": [ [ 248, 251 ] ], "normalized": [] }, { "id": "NCT01715714_inc_T16", "type": "Value", "text": [ "= 18 years" ], "offsets": [ [ 252, 262 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01715714_inc_R1", "type": "AND", "arg1_id": "NCT01715714_inc_T3", "arg2_id": "NCT01715714_inc_T2", "normalized": [] }, { "id": "NCT01715714_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT01715714_inc_T3", "arg2_id": "NCT01715714_inc_T1", "normalized": [] }, { "id": "NCT01715714_inc_R3", "type": "Has_value", "arg1_id": "NCT01715714_inc_T3", "arg2_id": "NCT01715714_inc_T4", "normalized": [] }, { "id": "NCT01715714_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01715714_inc_T5", "arg2_id": "NCT01715714_inc_T6", "normalized": [] }, { "id": "NCT01715714_inc_R5", "type": "Has_mood", "arg1_id": "NCT01715714_inc_T5", "arg2_id": "NCT01715714_inc_T7", "normalized": [] }, { "id": "NCT01715714_inc_R6", "type": "Subsumes", "arg1_id": "NCT01715714_inc_T9", "arg2_id": "NCT01715714_inc_T10", "normalized": [] }, { "id": "NCT01715714_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT01715714_inc_T8", "arg2_id": "NCT01715714_inc_T9", "normalized": [] }, { "id": "NCT01715714_inc_R8", "type": "Subsumes", "arg1_id": "NCT01715714_inc_T5", "arg2_id": "NCT01715714_inc_T8", "normalized": [] }, { "id": "NCT01715714_inc_R9", "type": "Subsumes", "arg1_id": "NCT01715714_inc_T13", "arg2_id": "NCT01715714_inc_T14", "normalized": [] }, { "id": "NCT01715714_inc_R10", "type": "Subsumes", "arg1_id": "NCT01715714_inc_T12", "arg2_id": "NCT01715714_inc_T13", "normalized": [] }, { "id": "NCT01715714_inc_R11", "type": "Has_value", "arg1_id": "NCT01715714_inc_T15", "arg2_id": "NCT01715714_inc_T16", "normalized": [] } ]

[ { "id": "NCT01717911_exc_text", "type": "exclusion", "text": [ "Previous treated with anti-diabetic medication\nPregnant or nursing women.\nImpaired liver function (ALT > 120 U/L)\nImpaired renal function (Serum creatinine >1.5 mg/dL in male, >1.4 mg/dL in female )\nRecently suffered from MI or CVA.\nPatients are acute intercurrent illness.\n2-hour C-peptide level < 1.8 ng/mL.\n" ], "offsets": [ [ 0, 310 ] ] } ]

[ { "id": "NCT01717911_exc_T1", "type": "Drug", "text": [ "anti-diabetic medication" ], "offsets": [ [ 22, 46 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T2", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T3", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T4", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 47, 55 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T5", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 59, 66 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T6", "type": "Person", "text": [ "women" ], "offsets": [ [ 67, 72 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T7", "type": "Condition", "text": [ "Impaired liver function" ], "offsets": [ [ 74, 97 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T8", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 99, 102 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T9", "type": "Value", "text": [ "> 120 U/L" ], "offsets": [ [ 103, 112 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T10", "type": "Scope", "text": [ "ALT > 120 U/L" ], "offsets": [ [ 99, 112 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T11", "type": "Condition", "text": [ "Impaired renal function" ], "offsets": [ [ 114, 137 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T12", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 139, 155 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T13", "type": "Value", "text": [ ">1.5 mg/dL" ], "offsets": [ [ 156, 166 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T14", "type": "Person", "text": [ "male" ], "offsets": [ [ 170, 174 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T15", "type": "Person", "text": [ "female" ], "offsets": [ [ 190, 196 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T16", "type": "Value", "text": [ ">1.4 mg/dL" ], "offsets": [ [ 176, 186 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T17", "type": "Scope", "text": [ ">1.5 mg/dL in male, >1.4 mg/dL in female" ], "offsets": [ [ 156, 196 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T18", "type": "Condition", "text": [ "MI" ], "offsets": [ [ 222, 224 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T19", "type": "Condition", "text": [ "CVA" ], "offsets": [ [ 228, 231 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T20", "type": "Temporal", "text": [ "Recently" ], "offsets": [ [ 199, 207 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T21", "type": "Scope", "text": [ "MI or CVA" ], "offsets": [ [ 222, 231 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T22", "type": "Condition", "text": [ "acute intercurrent illness" ], "offsets": [ [ 246, 272 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T23", "type": "Measurement", "text": [ "2-hour C-peptide level" ], "offsets": [ [ 274, 296 ] ], "normalized": [] }, { "id": "NCT01717911_exc_T24", "type": "Value", "text": [ "< 1.8 ng/mL" ], "offsets": [ [ 297, 308 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01717911_exc_R1", "type": "AND", "arg1_id": "NCT01717911_exc_T3", "arg2_id": "NCT01717911_exc_T1", "normalized": [] }, { "id": "NCT01717911_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01717911_exc_T3", "arg2_id": "NCT01717911_exc_T2", "normalized": [] }, { "id": "NCT01717911_exc_R3", "type": "Has_value", "arg1_id": "NCT01717911_exc_T8", "arg2_id": "NCT01717911_exc_T9", "normalized": [] }, { "id": "NCT01717911_exc_R4", "type": "Subsumes", "arg1_id": "NCT01717911_exc_T7", "arg2_id": "NCT01717911_exc_T10", "normalized": [] }, { "id": "NCT01717911_exc_R5", "type": "Has_value", "arg1_id": "NCT01717911_exc_T14", "arg2_id": "NCT01717911_exc_T13", "normalized": [] }, { "id": "NCT01717911_exc_R6", "type": "Has_value", "arg1_id": "NCT01717911_exc_T15", "arg2_id": "NCT01717911_exc_T16", "normalized": [] }, { "id": "NCT01717911_exc_R7", "type": "Has_scope", "arg1_id": "NCT01717911_exc_T12", "arg2_id": "NCT01717911_exc_T17", "normalized": [] }, { "id": "NCT01717911_exc_R8", "type": "AND", "arg1_id": "NCT01717911_exc_T11", "arg2_id": "NCT01717911_exc_T12", "normalized": [] }, { "id": "NCT01717911_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01717911_exc_T21", "arg2_id": "NCT01717911_exc_T20", "normalized": [] }, { "id": "NCT01717911_exc_R10", "type": "Has_value", "arg1_id": "NCT01717911_exc_T23", "arg2_id": "NCT01717911_exc_T24", "normalized": [] } ]

[ { "id": "NCT01717911_inc_text", "type": "inclusion", "text": [ "Recently diagnosed type 2 diabetic patients.\nFasting plasma glucose between 200-300 mg/dl (A1C level between 7% and 10%).\nThose who age between 30 and 80 years old and can inject insulin by themselves.\n" ], "offsets": [ [ 0, 202 ] ] } ]

[ { "id": "NCT01717911_inc_T1", "type": "Condition", "text": [ "type 2 diabetic" ], "offsets": [ [ 19, 34 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T2", "type": "Temporal", "text": [ "Recently diagnosed" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T3", "type": "Measurement", "text": [ "Fasting plasma glucose" ], "offsets": [ [ 45, 67 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T4", "type": "Value", "text": [ "between 200-300 mg/dl" ], "offsets": [ [ 68, 89 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T5", "type": "Measurement", "text": [ "A1C level" ], "offsets": [ [ 91, 100 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T6", "type": "Value", "text": [ "between 7% and 10%" ], "offsets": [ [ 101, 119 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T7", "type": "Scope", "text": [ "A1C level between 7% and 10%" ], "offsets": [ [ 91, 119 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T8", "type": "Scope", "text": [ "Fasting plasma glucose between 200-300 mg/dl" ], "offsets": [ [ 45, 89 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T9", "type": "Value", "text": [ "between 30 and 80 years old" ], "offsets": [ [ 136, 163 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T10", "type": "Person", "text": [ "age" ], "offsets": [ [ 132, 135 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T11", "type": "Observation", "text": [ "can" ], "offsets": [ [ 168, 171 ] ], "normalized": [] }, { "id": "NCT01717911_inc_T12", "type": "Procedure", "text": [ "inject insulin" ], "offsets": [ [ 172, 186 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01717911_inc_R1", "type": "Has_temporal", "arg1_id": "NCT01717911_inc_T1", "arg2_id": "NCT01717911_inc_T2", "normalized": [] }, { "id": "NCT01717911_inc_R2", "type": "Has_value", "arg1_id": "NCT01717911_inc_T5", "arg2_id": "NCT01717911_inc_T6", "normalized": [] }, { "id": "NCT01717911_inc_R3", "type": "Has_value", "arg1_id": "NCT01717911_inc_T3", "arg2_id": "NCT01717911_inc_T4", "normalized": [] }, { "id": "NCT01717911_inc_R4", "type": "Subsumes", "arg1_id": "NCT01717911_inc_T8", "arg2_id": "NCT01717911_inc_T7", "normalized": [] }, { "id": "NCT01717911_inc_R5", "type": "Has_value", "arg1_id": "NCT01717911_inc_T10", "arg2_id": "NCT01717911_inc_T9", "normalized": [] } ]

[ { "id": "NCT01720394_exc_text", "type": "exclusion", "text": [ "fetal anomalies\ncontra-indications for medical induction of labor\nplacental pathologies\nSt.p. surgery with opening the uterine cavity (incl. caesarean section)\nPROM\nmultiple gestations\n< 37-0 weeks of gestation\nSt.p. cervical tear\n" ], "offsets": [ [ 0, 231 ] ] } ]

[ { "id": "NCT01720394_exc_T1", "type": "Condition", "text": [ "fetal anomalies" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T2", "type": "Condition", "text": [ "contra-indications" ], "offsets": [ [ 16, 34 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T3", "type": "Procedure", "text": [ "medical induction of labor" ], "offsets": [ [ 39, 65 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T4", "type": "Condition", "text": [ "placental pathologies" ], "offsets": [ [ 66, 87 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T5", "type": "Condition", "text": [ "St.p." ], "offsets": [ [ 88, 93 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T6", "type": "Procedure", "text": [ "surgery with opening the uterine cavity" ], "offsets": [ [ 94, 133 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T7", "type": "Procedure", "text": [ "caesarean section" ], "offsets": [ [ 141, 158 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T8", "type": "Condition", "text": [ "PROM" ], "offsets": [ [ 160, 164 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T9", "type": "Condition", "text": [ "multiple gestations" ], "offsets": [ [ 165, 184 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T10", "type": "Value", "text": [ "< 37-0 weeks" ], "offsets": [ [ 185, 197 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T11", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 201, 210 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T12", "type": "Condition", "text": [ "St.p." ], "offsets": [ [ 211, 216 ] ], "normalized": [] }, { "id": "NCT01720394_exc_T13", "type": "Procedure", "text": [ "cervical tear" ], "offsets": [ [ 217, 230 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01720394_exc_R1", "type": "AND", "arg1_id": "NCT01720394_exc_T2", "arg2_id": "NCT01720394_exc_T3", "normalized": [] }, { "id": "NCT01720394_exc_R2", "type": "AND", "arg1_id": "NCT01720394_exc_T5", "arg2_id": "NCT01720394_exc_T6", "normalized": [] }, { "id": "NCT01720394_exc_R3", "type": "Subsumes", "arg1_id": "NCT01720394_exc_T6", "arg2_id": "NCT01720394_exc_T7", "normalized": [] }, { "id": "NCT01720394_exc_R4", "type": "Has_value", "arg1_id": "NCT01720394_exc_T11", "arg2_id": "NCT01720394_exc_T10", "normalized": [] }, { "id": "NCT01720394_exc_R5", "type": "AND", "arg1_id": "NCT01720394_exc_T12", "arg2_id": "NCT01720394_exc_T13", "normalized": [] } ]

[ { "id": "NCT01720394_inc_text", "type": "inclusion", "text": [ "medical indication for induction of labor\n18 years of age\nsigned informed consent\ncephalic presentation\nno PROM\n37+0 - 42+0 weeks of gestation\nBishop-Score = 6\nno contra-indication for medical induction of labor\nno clinical signs of infection\n" ], "offsets": [ [ 0, 243 ] ] } ]

[ { "id": "NCT01720394_inc_T1", "type": "Condition", "text": [ "medical indication" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T2", "type": "Procedure", "text": [ "induction of labor" ], "offsets": [ [ 23, 41 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T3", "type": "Value", "text": [ "18 years" ], "offsets": [ [ 42, 50 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 54, 57 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T6", "type": "Condition", "text": [ "cephalic presentation" ], "offsets": [ [ 82, 103 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T7", "type": "Condition", "text": [ "PROM" ], "offsets": [ [ 107, 111 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T8", "type": "Negation", "text": [ "no" ], "offsets": [ [ 104, 106 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T9", "type": "Value", "text": [ "37+0" ], "offsets": [ [ 112, 116 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T10", "type": "Value", "text": [ "42+0" ], "offsets": [ [ 119, 123 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T11", "type": "Measurement", "text": [ "weeks of gestation" ], "offsets": [ [ 124, 142 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T12", "type": "Scope", "text": [ "37+0 - 42+0" ], "offsets": [ [ 112, 123 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T13", "type": "Measurement", "text": [ "Bishop-Score" ], "offsets": [ [ 143, 155 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T14", "type": "Value", "text": [ "= 6" ], "offsets": [ [ 156, 159 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T15", "type": "Condition", "text": [ "contra-indication" ], "offsets": [ [ 163, 180 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T16", "type": "Negation", "text": [ "no" ], "offsets": [ [ 160, 162 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T17", "type": "Procedure", "text": [ "medical induction of labor" ], "offsets": [ [ 185, 211 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T18", "type": "Negation", "text": [ "no" ], "offsets": [ [ 212, 214 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T19", "type": "Mood", "text": [ "clinical signs of" ], "offsets": [ [ 215, 232 ] ], "normalized": [] }, { "id": "NCT01720394_inc_T20", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 233, 242 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01720394_inc_R1", "type": "AND", "arg1_id": "NCT01720394_inc_T1", "arg2_id": "NCT01720394_inc_T2", "normalized": [] }, { "id": "NCT01720394_inc_R2", "type": "Has_value", "arg1_id": "NCT01720394_inc_T4", "arg2_id": "NCT01720394_inc_T3", "normalized": [] }, { "id": "NCT01720394_inc_R3", "type": "Has_negation", "arg1_id": "NCT01720394_inc_T7", "arg2_id": "NCT01720394_inc_T8", "normalized": [] }, { "id": "NCT01720394_inc_R4", "type": "Has_scope", "arg1_id": "NCT01720394_inc_T11", "arg2_id": "NCT01720394_inc_T12", "normalized": [] }, { "id": "NCT01720394_inc_R5", "type": "Has_value", "arg1_id": "NCT01720394_inc_T13", "arg2_id": "NCT01720394_inc_T14", "normalized": [] }, { "id": "NCT01720394_inc_R6", "type": "Has_negation", "arg1_id": "NCT01720394_inc_T15", "arg2_id": "NCT01720394_inc_T16", "normalized": [] }, { "id": "NCT01720394_inc_R7", "type": "AND", "arg1_id": "NCT01720394_inc_T15", "arg2_id": "NCT01720394_inc_T17", "normalized": [] }, { "id": "NCT01720394_inc_R8", "type": "Has_negation", "arg1_id": "NCT01720394_inc_T20", "arg2_id": "NCT01720394_inc_T18", "normalized": [] }, { "id": "NCT01720394_inc_R9", "type": "Has_mood", "arg1_id": "NCT01720394_inc_T20", "arg2_id": "NCT01720394_inc_T19", "normalized": [] } ]

[ { "id": "NCT01728194_exc_text", "type": "exclusion", "text": [ "Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher than 2;\nHigh suicide risk, i.e. intent or plan to attempt suicide in near future;\nPresence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse;\nHistory of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);\nDementia: Diagnosis of dementia by DSM-IV;\nMild Cognitive Impairment (MCI);\nAcute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or use of drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;\nNeurological brain disease and/or history of electroconvulsive therapy;\nHistory of any use of citalopram or escitalopram during the current episode or need for drugs that may interact with these agents, i.e. drug metabolized by the 2D6 P450 isoenzyme system;\nCurrent involvement in psychotherapy;\nContraindications to MRI scanning including cardiac pacemaker, metallic objects and metallic implants contraindicating MRI, cardiac stent, claustrophobia;\nInability to speak English;\nCorrected visual acuity < 20/70; Color blindness.\n" ], "offsets": [ [ 0, 1370 ] ] } ]

[ { "id": "NCT01728194_exc_T1", "type": "Condition", "text": [ "Psychotic depression" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T2", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 24, 30 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T3", "type": "Condition", "text": [ "delusions" ], "offsets": [ [ 50, 59 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T4", "type": "Measurement", "text": [ "SCID-R score" ], "offsets": [ [ 67, 79 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T5", "type": "Value", "text": [ "higher than 2" ], "offsets": [ [ 80, 93 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T6", "type": "Observation", "text": [ "suicide risk" ], "offsets": [ [ 100, 112 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T7", "type": "Qualifier", "text": [ "High" ], "offsets": [ [ 95, 99 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T8", "type": "Mood", "text": [ "intent" ], "offsets": [ [ 119, 125 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T9", "type": "Mood", "text": [ "plan to" ], "offsets": [ [ 129, 136 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T10", "type": "Observation", "text": [ "attempt suicide" ], "offsets": [ [ 137, 152 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T11", "type": "Temporal", "text": [ "in near future" ], "offsets": [ [ 153, 167 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T12", "type": "Scope", "text": [ "intent or plan to" ], "offsets": [ [ 119, 136 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T13", "type": "Condition", "text": [ "psychiatric disorder" ], "offsets": [ [ 192, 212 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T14", "type": "Qualifier", "text": [ "Axis I" ], "offsets": [ [ 185, 191 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T15", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 214, 224 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T16", "type": "Condition", "text": [ "unipolar major depression" ], "offsets": [ [ 225, 250 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T17", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 255, 270 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T18", "type": "Scope", "text": [ "Axis I psychiatric disorder (other than unipolar major depression" ], "offsets": [ [ 185, 250 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T19", "type": "Condition", "text": [ "psychiatric disorders" ], "offsets": [ [ 283, 304 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T20", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 305, 315 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T21", "type": "Condition", "text": [ "unipolar major depression" ], "offsets": [ [ 316, 341 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T22", "type": "Condition", "text": [ "generalized anxiety disorder" ], "offsets": [ [ 345, 373 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T23", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 375, 391 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T24", "type": "Condition", "text": [ "hypomania" ], "offsets": [ [ 393, 402 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T25", "type": "Condition", "text": [ "dysthymia" ], "offsets": [ [ 408, 417 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T27", "type": "Scope", "text": [ "unipolar major depression or generalized anxiety disorder" ], "offsets": [ [ 316, 373 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T26", "type": "Scope", "text": [ "bipolar disorder, hypomania, and dysthymia" ], "offsets": [ [ 375, 417 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T28", "type": "Condition", "text": [ "Dementia" ], "offsets": [ [ 443, 451 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T29", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 478, 484 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T30", "type": "Condition", "text": [ "Mild Cognitive Impairment" ], "offsets": [ [ 486, 511 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T31", "type": "Condition", "text": [ "MCI" ], "offsets": [ [ 513, 516 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T32", "type": "Condition", "text": [ "medical illness" ], "offsets": [ [ 535, 550 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T33", "type": "Qualifier", "text": [ "Acute" ], "offsets": [ [ 519, 524 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T34", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 528, 534 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T35", "type": "Condition", "text": [ "delirium" ], "offsets": [ [ 558, 566 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T36", "type": "Condition", "text": [ "metastatic cancer" ], "offsets": [ [ 568, 585 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T37", "type": "Qualifier", "text": [ "decompensated" ], "offsets": [ [ 587, 600 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T38", "type": "Condition", "text": [ "c, live", "e, majo" ], "offsets": [ [ 607, 614 ], [ 632, 639 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T39", "type": "Condition", "text": [ "or ki", "e, majo" ], "offsets": [ [ 616, 621 ], [ 632, 639 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T40", "type": "Condition", "text": [ "kidney failure" ], "offsets": [ [ 619, 633 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T41", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 635, 648 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T42", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 650, 656 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T43", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 660, 681 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T44", "type": "Temporal", "text": [ "three months prior to entry" ], "offsets": [ [ 693, 720 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T45", "type": "Reference_point", "text": [ "entry" ], "offsets": [ [ 715, 720 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T46", "type": "Drug", "text": [ "drugs" ], "offsets": [ [ 732, 737 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T47", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 753, 763 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T48", "type": "Drug", "text": [ "reserpine" ], "offsets": [ [ 771, 780 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T49", "type": "Drug", "text": [ "alpha-methyl-dopa" ], "offsets": [ [ 782, 799 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T50", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 801, 809 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T51", "type": "Condition", "text": [ "sympathomimetics withdrawal" ], "offsets": [ [ 811, 838 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T52", "type": "Scope", "text": [ "Acute or severe" ], "offsets": [ [ 519, 534 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T53", "type": "Scope", "text": [ "delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction" ], "offsets": [ [ 558, 681 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T54", "type": "Scope", "text": [ "cardiac, liver or kidney failure" ], "offsets": [ [ 601, 633 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T55", "type": "Scope", "text": [ "reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal" ], "offsets": [ [ 771, 838 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T56", "type": "Condition", "text": [ "brain disease" ], "offsets": [ [ 853, 866 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T57", "type": "Qualifier", "text": [ "Neurological" ], "offsets": [ [ 840, 852 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T58", "type": "Procedure", "text": [ "electroconvulsive therapy" ], "offsets": [ [ 885, 910 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T59", "type": "Drug", "text": [ "citalopram" ], "offsets": [ [ 934, 944 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T60", "type": "Drug", "text": [ "escitalopram" ], "offsets": [ [ 948, 960 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T61", "type": "Qualifier", "text": [ "current" ], "offsets": [ [ 972, 979 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T62", "type": "Condition", "text": [ "episode" ], "offsets": [ [ 980, 987 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T63", "type": "Scope", "text": [ "citalopram or escitalopram" ], "offsets": [ [ 934, 960 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T64", "type": "Drug", "text": [ "drugs" ], "offsets": [ [ 1000, 1005 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T65", "type": "Drug", "text": [ "agents" ], "offsets": [ [ 1035, 1041 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T67", "type": "Procedure", "text": [ "psychotherapy" ], "offsets": [ [ 1122, 1135 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T68", "type": "Condition", "text": [ "Contraindications" ], "offsets": [ [ 1137, 1154 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T69", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 1158, 1161 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T70", "type": "Device", "text": [ "cardiac pacemaker" ], "offsets": [ [ 1181, 1198 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T71", "type": "Device", "text": [ "metallic objects" ], "offsets": [ [ 1200, 1216 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T72", "type": "Device", "text": [ "metallic implants" ], "offsets": [ [ 1221, 1238 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T73", "type": "Device", "text": [ "cardiac stent" ], "offsets": [ [ 1261, 1274 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T74", "type": "Condition", "text": [ "claustrophobia" ], "offsets": [ [ 1276, 1290 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T75", "type": "Scope", "text": [ "cardiac pacemaker, metallic objects and metallic implants contraindicating MRI, cardiac stent, claustrophobia" ], "offsets": [ [ 1181, 1290 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T77", "type": "Measurement", "text": [ "visual acuity" ], "offsets": [ [ 1330, 1343 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T78", "type": "Qualifier", "text": [ "Corrected" ], "offsets": [ [ 1320, 1329 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T79", "type": "Value", "text": [ "< 20/70;" ], "offsets": [ [ 1344, 1352 ] ], "normalized": [] }, { "id": "NCT01728194_exc_T80", "type": "Condition", "text": [ "Color blindness" ], "offsets": [ [ 1353, 1368 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01728194_exc_R1", "type": "Has_value", "arg1_id": "NCT01728194_exc_T4", "arg2_id": "NCT01728194_exc_T5", "normalized": [] }, { "id": "NCT01728194_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T1", "arg2_id": "NCT01728194_exc_T2", "normalized": [] }, { "id": "NCT01728194_exc_R3", "type": "AND", "arg1_id": "NCT01728194_exc_T1", "arg2_id": "NCT01728194_exc_T3", "normalized": [] }, { "id": "NCT01728194_exc_R4", "type": "AND", "arg1_id": "NCT01728194_exc_T1", "arg2_id": "NCT01728194_exc_T4", "normalized": [] }, { "id": "NCT01728194_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T6", "arg2_id": "NCT01728194_exc_T7", "normalized": [] }, { "id": "NCT01728194_exc_R6", "type": "Has_scope", "arg1_id": "NCT01728194_exc_T10", "arg2_id": "NCT01728194_exc_T12", "normalized": [] }, { "id": "NCT01728194_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01728194_exc_T10", "arg2_id": "NCT01728194_exc_T11", "normalized": [] }, { "id": "NCT01728194_exc_R8", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T6", "arg2_id": "NCT01728194_exc_T10", "normalized": [] }, { "id": "NCT01728194_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T13", "arg2_id": "NCT01728194_exc_T14", "normalized": [] }, { "id": "NCT01728194_exc_R10", "type": "Has_negation", "arg1_id": "NCT01728194_exc_T16", "arg2_id": "NCT01728194_exc_T15", "normalized": [] }, { "id": "NCT01728194_exc_R11", "type": "Has_negation", "arg1_id": "NCT01728194_exc_T27", "arg2_id": "NCT01728194_exc_T20", "normalized": [] }, { "id": "NCT01728194_exc_R12", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T19", "arg2_id": "NCT01728194_exc_T26", "normalized": [] }, { "id": "NCT01728194_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T28", "arg2_id": "NCT01728194_exc_T29", "normalized": [] }, { "id": "NCT01728194_exc_R14", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T30", "arg2_id": "NCT01728194_exc_T31", "normalized": [] }, { "id": "NCT01728194_exc_R15", "type": "Has_scope", "arg1_id": "NCT01728194_exc_T32", "arg2_id": "NCT01728194_exc_T52", "normalized": [] }, { "id": "NCT01728194_exc_R16", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T32", "arg2_id": "NCT01728194_exc_T53", "normalized": [] }, { "id": "NCT01728194_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T54", "arg2_id": "NCT01728194_exc_T37", "normalized": [] }, { "id": "NCT01728194_exc_R18", "type": "Has_temporal", "arg1_id": "NCT01728194_exc_T32", "arg2_id": "NCT01728194_exc_T44", "normalized": [] }, { "id": "NCT01728194_exc_R19", "type": "AND", "arg1_id": "NCT01728194_exc_T46", "arg2_id": "NCT01728194_exc_T47", "normalized": [] }, { "id": "NCT01728194_exc_R20", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T46", "arg2_id": "NCT01728194_exc_T55", "normalized": [] }, { "id": "NCT01728194_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T56", "arg2_id": "NCT01728194_exc_T57", "normalized": [] }, { "id": "NCT01728194_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T62", "arg2_id": "NCT01728194_exc_T61", "normalized": [] }, { "id": "NCT01728194_exc_R23", "type": "AND", "arg1_id": "NCT01728194_exc_T63", "arg2_id": "NCT01728194_exc_T62", "normalized": [] }, { "id": "NCT01728194_exc_R24", "type": "AND", "arg1_id": "NCT01728194_exc_T64", "arg2_id": "NCT01728194_exc_T65", "normalized": [] }, { "id": "NCT01728194_exc_R25", "type": "AND", "arg1_id": "NCT01728194_exc_T68", "arg2_id": "NCT01728194_exc_T69", "normalized": [] }, { "id": "NCT01728194_exc_R26", "type": "Subsumes", "arg1_id": "NCT01728194_exc_T68", "arg2_id": "NCT01728194_exc_T75", "normalized": [] }, { "id": "NCT01728194_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT01728194_exc_T77", "arg2_id": "NCT01728194_exc_T78", "normalized": [] }, { "id": "NCT01728194_exc_R28", "type": "Has_value", "arg1_id": "NCT01728194_exc_T77", "arg2_id": "NCT01728194_exc_T79", "normalized": [] } ]

[ { "id": "NCT01728194_inc_text", "type": "inclusion", "text": [ "Age: 60-85 years, right-handed;\nDiagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);\nAge of onset of first episode = 50 years with up to three depressive episodes;\nSeverity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) = 20.\n" ], "offsets": [ [ 0, 340 ] ] } ]

[ { "id": "NCT01728194_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T2", "type": "Value", "text": [ "60-85 years" ], "offsets": [ [ 5, 16 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T3", "type": "Observation", "text": [ "right-handed" ], "offsets": [ [ 18, 30 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T4", "type": "Condition", "text": [ "Major depression" ], "offsets": [ [ 43, 59 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T5", "type": "Qualifier", "text": [ "unipolar" ], "offsets": [ [ 61, 69 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T6", "type": "Measurement", "text": [ "V", "tructured Clinical Interview for Diagnostic and Statistical Manual" ], "offsets": [ [ 148, 149 ], [ 75, 141 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T7", "type": "Measurement", "text": [ "DSM-IV criteria)" ], "offsets": [ [ 163, 179 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T8", "type": "Measurement", "text": [ "DSM" ], "offsets": [ [ 143, 146 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T9", "type": "Measurement", "text": [ "SCID" ], "offsets": [ [ 151, 155 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T10", "type": "Scope", "text": [ "Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria" ], "offsets": [ [ 74, 178 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T11", "type": "Condition", "text": [ "onset of first episode" ], "offsets": [ [ 188, 210 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T12", "type": "Person", "text": [ "Age" ], "offsets": [ [ 181, 184 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T13", "type": "Value", "text": [ "= 50 years" ], "offsets": [ [ 211, 221 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T14", "type": "Multiplier", "text": [ "three" ], "offsets": [ [ 233, 238 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T15", "type": "Condition", "text": [ "depressive episodes" ], "offsets": [ [ 239, 258 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T16", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 272, 282 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T17", "type": "Measurement", "text": [ "24-Item Hamilton Depression Rating Scale" ], "offsets": [ [ 286, 326 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T18", "type": "Measurement", "text": [ "HDRS" ], "offsets": [ [ 328, 332 ] ], "normalized": [] }, { "id": "NCT01728194_inc_T19", "type": "Value", "text": [ "= 20" ], "offsets": [ [ 334, 338 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01728194_inc_R1", "type": "Has_value", "arg1_id": "NCT01728194_inc_T1", "arg2_id": "NCT01728194_inc_T2", "normalized": [] }, { "id": "NCT01728194_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01728194_inc_T4", "arg2_id": "NCT01728194_inc_T5", "normalized": [] }, { "id": "NCT01728194_inc_R4", "type": "Subsumes", "arg1_id": "NCT01728194_inc_T6", "arg2_id": "NCT01728194_inc_T8", "normalized": [] }, { "id": "NCT01728194_inc_R3", "type": "AND", "arg1_id": "NCT01728194_inc_T10", "arg2_id": "NCT01728194_inc_T4", "normalized": [] }, { "id": "NCT01728194_inc_R5", "type": "Has_value", "arg1_id": "NCT01728194_inc_T12", "arg2_id": "NCT01728194_inc_T13", "normalized": [] }, { "id": "NCT01728194_inc_R6", "type": "AND", "arg1_id": "NCT01728194_inc_T11", "arg2_id": "NCT01728194_inc_T12", "normalized": [] }, { "id": "NCT01728194_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT01728194_inc_T15", "arg2_id": "NCT01728194_inc_T14", "normalized": [] }, { "id": "NCT01728194_inc_R8", "type": "Has_value", "arg1_id": "NCT01728194_inc_T17", "arg2_id": "NCT01728194_inc_T19", "normalized": [] }, { "id": "NCT01728194_inc_R9", "type": "Subsumes", "arg1_id": "NCT01728194_inc_T17", "arg2_id": "NCT01728194_inc_T18", "normalized": [] }, { "id": "NCT01728194_inc_R10", "type": "AND", "arg1_id": "NCT01728194_inc_T16", "arg2_id": "NCT01728194_inc_T17", "normalized": [] } ]

[ { "id": "NCT01735955_exc_text", "type": "exclusion", "text": [ "Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason\nPatient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy\nPatients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study\nPregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.\nWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib." ], "offsets": [ [ 0, 1175 ] ] } ]

[ { "id": "NCT01735955_exc_T1", "type": "Negation", "text": [ "discontinued" ], "offsets": [ [ 29, 41 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T2", "type": "Multiplier", "text": [ "permanently" ], "offsets": [ [ 17, 28 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T3", "type": "Drug", "text": [ "nilotinib" ], "offsets": [ [ 47, 56 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T4", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 57, 66 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T5", "type": "Condition", "text": [ "unacceptable toxicity" ], "offsets": [ [ 94, 115 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T6", "type": "Observation", "text": [ "non-compliance" ], "offsets": [ [ 117, 131 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T7", "type": "Procedure", "text": [ "study procedures" ], "offsets": [ [ 135, 151 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T8", "type": "Negation", "text": [ "withdrawal" ], "offsets": [ [ 153, 163 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T9", "type": "Observation", "text": [ "consent" ], "offsets": [ [ 167, 174 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T10", "type": "Observation", "text": [ "any other reason" ], "offsets": [ [ 178, 194 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T11", "type": "Scope", "text": [ "unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason" ], "offsets": [ [ 94, 194 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T12", "type": "Qualifier", "text": [ "Novartis sponsored" ], "offsets": [ [ 225, 243 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T13", "type": "Observation", "text": [ "participated in a", "combination trial" ], "offsets": [ [ 207, 224 ], [ 244, 261 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T15", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 425, 434 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T16", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 405, 414 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T17", "type": "Drug", "text": [ "any medications" ], "offsets": [ [ 440, 455 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T18", "type": "Qualifier", "text": [ "have the potential to prolong the QT interval" ], "offsets": [ [ 461, 506 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T19", "type": "Qualifier", "text": [ "inducing Torsade de Pointes" ], "offsets": [ [ 510, 537 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T20", "type": "Scope", "text": [ "have the potential to prolong the QT interval or inducing Torsade de Pointes" ], "offsets": [ [ 461, 537 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T22", "type": "Observation", "text": [ "Pregnant" ], "offsets": [ [ 750, 758 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T23", "type": "Observation", "text": [ "nursing" ], "offsets": [ [ 762, 769 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T24", "type": "Person", "text": [ "women" ], "offsets": [ [ 782, 787 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T25", "type": "Observation", "text": [ "lactating" ], "offsets": [ [ 771, 780 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T26", "type": "Observation", "text": [ "hcG laboratory test" ], "offsets": [ [ 922, 941 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T27", "type": "Value", "text": [ "positive" ], "offsets": [ [ 913, 921 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T28", "type": "Person", "text": [ "Women" ], "offsets": [ [ 943, 948 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T29", "type": "Observation", "text": [ "child-bearing potential" ], "offsets": [ [ 952, 975 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T30", "type": "Observation", "text": [ "physiologically capable of becoming pregnant" ], "offsets": [ [ 998, 1042 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T31", "type": "Person", "text": [ "women" ], "offsets": [ [ 992, 997 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T32", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 1044, 1050 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T33", "type": "Qualifier", "text": [ "highly effective methods" ], "offsets": [ [ 1066, 1090 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T34", "type": "Observation", "text": [ "contraception" ], "offsets": [ [ 1094, 1107 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T35", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 1108, 1124 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T36", "type": "Temporal", "text": [ "for 30 days after the final dose of nilotinib" ], "offsets": [ [ 1129, 1174 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T37", "type": "Reference_point", "text": [ "the final dose of nilotinib" ], "offsets": [ [ 1147, 1174 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T38", "type": "Scope", "text": [ "during the study and for 30 days after the final dose of nilotinib" ], "offsets": [ [ 1108, 1174 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T39", "type": "Scope", "text": [ "women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib" ], "offsets": [ [ 992, 1174 ] ], "normalized": [] }, { "id": "NCT01735955_exc_T40", "type": "Scope", "text": [ "Women of child-bearing potential" ], "offsets": [ [ 943, 975 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01735955_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT01735955_exc_T1", "arg2_id": "NCT01735955_exc_T2", "normalized": [] }, { "id": "NCT01735955_exc_R2", "type": "AND", "arg1_id": "NCT01735955_exc_T4", "arg2_id": "NCT01735955_exc_T3", "normalized": [] }, { "id": "NCT01735955_exc_R3", "type": "Has_negation", "arg1_id": "NCT01735955_exc_T4", "arg2_id": "NCT01735955_exc_T1", "normalized": [] }, { "id": "NCT01735955_exc_R4", "type": "AND", "arg1_id": "NCT01735955_exc_T6", "arg2_id": "NCT01735955_exc_T7", "normalized": [] }, { "id": "NCT01735955_exc_R5", "type": "Has_negation", "arg1_id": "NCT01735955_exc_T9", "arg2_id": "NCT01735955_exc_T8", "normalized": [] }, { "id": "NCT01735955_exc_R6", "type": "Has_scope", "arg1_id": "NCT01735955_exc_T4", "arg2_id": "NCT01735955_exc_T11", "normalized": [] }, { "id": "NCT01735955_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01735955_exc_T15", "arg2_id": "NCT01735955_exc_T16", "normalized": [] }, { "id": "NCT01735955_exc_R8", "type": "Has_scope", "arg1_id": "NCT01735955_exc_T17", "arg2_id": "NCT01735955_exc_T20", "normalized": [] }, { "id": "NCT01735955_exc_R9", "type": "AND", "arg1_id": "NCT01735955_exc_T15", "arg2_id": "NCT01735955_exc_T17", "normalized": [] }, { "id": "NCT01735955_exc_R10", "type": "Subsumes", "arg1_id": "NCT01735955_exc_T23", "arg2_id": "NCT01735955_exc_T25", "normalized": [] }, { "id": "NCT01735955_exc_R11", "type": "Has_value", "arg1_id": "NCT01735955_exc_T26", "arg2_id": "NCT01735955_exc_T27", "normalized": [] }, { "id": "NCT01735955_exc_R13", "type": "Has_index", "arg1_id": "NCT01735955_exc_T36", "arg2_id": "NCT01735955_exc_T37", "normalized": [] }, { "id": "NCT01735955_exc_R14", "type": "Has_scope", "arg1_id": "NCT01735955_exc_T34", "arg2_id": "NCT01735955_exc_T38", "normalized": [] }, { "id": "NCT01735955_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT01735955_exc_T34", "arg2_id": "NCT01735955_exc_T33", "normalized": [] }, { "id": "NCT01735955_exc_R16", "type": "Has_negation", "arg1_id": "NCT01735955_exc_T34", "arg2_id": "NCT01735955_exc_T32", "normalized": [] }, { "id": "NCT01735955_exc_R17", "type": "Subsumes", "arg1_id": "NCT01735955_exc_T40", "arg2_id": "NCT01735955_exc_T39", "normalized": [] } ]

[ { "id": "NCT01735955_inc_text", "type": "inclusion", "text": [ "Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study\nPatient is currently benefiting from the treatment with nilotinib, as determined by the investigator\nPatient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements\nWillingness and ability to comply with scheduled visits, treatment plans and any other study procedures\nWritten informed consent obtained prior to enrolling in roll-over study" ], "offsets": [ [ 0, 580 ] ] } ]

[ { "id": "NCT01735955_inc_T1", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 11, 20 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T3", "type": "Qualifier", "text": [ "Novartis-sponsored" ], "offsets": [ [ 35, 53 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T4", "type": "Observation", "text": [ "enrolled in a", "Oncology Clinical Development & Medical Affairs study" ], "offsets": [ [ 21, 34 ], [ 55, 108 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T2", "type": "Drug", "text": [ "nilotinib" ], "offsets": [ [ 119, 128 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T6", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 231, 240 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T7", "type": "Drug", "text": [ "nilotinib" ], "offsets": [ [ 246, 255 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T9", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 201, 210 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T10", "type": "Observation", "text": [ "mpliance,", "th the parent study protocol requirements\nW" ], "offsets": [ [ 318, 327 ], [ 363, 406 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T12", "type": "Observation", "text": [ "lingness an", "comply with scheduled visits, t" ], "offsets": [ [ 408, 419 ], [ 432, 463 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T13", "type": "Observation", "text": [ "ability to comply with scheduled visits" ], "offsets": [ [ 421, 460 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T14", "type": "Observation", "text": [ "lingness an", "comply with sc", "atment plans an" ], "offsets": [ [ 408, 419 ], [ 432, 446 ], [ 465, 480 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T15", "type": "Observation", "text": [ "Written informed consent" ], "offsets": [ [ 509, 533 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T16", "type": "Temporal", "text": [ "prior to enrolling in roll-over study" ], "offsets": [ [ 543, 580 ] ], "normalized": [] }, { "id": "NCT01735955_inc_T17", "type": "Reference_point", "text": [ "enrolling in roll-over study" ], "offsets": [ [ 552, 580 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01735955_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01735955_inc_T4", "arg2_id": "NCT01735955_inc_T3", "normalized": [] }, { "id": "NCT01735955_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01735955_inc_T4", "arg2_id": "NCT01735955_inc_T1", "normalized": [] }, { "id": "NCT01735955_inc_R3", "type": "AND", "arg1_id": "NCT01735955_inc_T6", "arg2_id": "NCT01735955_inc_T7", "normalized": [] }, { "id": "NCT01735955_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01735955_inc_T6", "arg2_id": "NCT01735955_inc_T9", "normalized": [] }, { "id": "NCT01735955_inc_R5", "type": "Has_index", "arg1_id": "NCT01735955_inc_T16", "arg2_id": "NCT01735955_inc_T17", "normalized": [] }, { "id": "NCT01735955_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01735955_inc_T15", "arg2_id": "NCT01735955_inc_T16", "normalized": [] } ]

[ { "id": "NCT01742117_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01742117_inc_text", "type": "inclusion", "text": [ "Patient >18 years of age\nPatient presents with acute coronary syndrome (ACS) or stable coronary artery disease (CAD)\nPatient is eligible for PCI\nPatient is willing and able to provide informed written consent\nPatient not able to receive 12 months of dual anti-platelet therapy\nFailure of index PCI\nPatient or physician refusal to enroll in the study\nPatient with known CYP2C19 genotype prior to randomization\nPlanned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure\nAnticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery\nSerum creatinine >2.5 mg/dL within 7 days of index procedure\nPlatelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 if persistent (at least 2 abnormal values) within 7 days prior to index procedure.\nHistory of intracranial hemorrhage\nKnown hypersensitivity to clopidogrel or ticagrelor or any of its components\nPatient is participating in an investigational drug or device clinical trial that has not reached its primary endpoint\nPatient previously enrolled in this study\nPatient is pregnant, lactating, or planning to become pregnant within 12 months\nPatient has received an organ transplant or is on a waiting list for an organ transplant\nPatient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedure\nPatient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)\nPatient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)\nConcomitant use of simvastatin/lovastatin > 40 mg qd\nConcomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine)\nNon-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)\nKnown history of severe hepatic impairment\nPatient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions\nPatient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding\nInability to take aspirin at a dosage of 100 mg or less\nCurrent substance abuse (e.g., alcohol, cocaine, heroin, etc.)\n" ], "offsets": [ [ 0, 2551 ] ] } ]

[ { "id": "NCT01742117_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T2", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 8, 17 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T3", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 47, 70 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T4", "type": "Condition", "text": [ "ACS" ], "offsets": [ [ 72, 75 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T5", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 87, 110 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T6", "type": "Condition", "text": [ "CAD" ], "offsets": [ [ 112, 115 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T7", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 80, 86 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T8", "type": "Procedure", "text": [ "PCI" ], "offsets": [ [ 141, 144 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T9", "type": "Mood", "text": [ "eligible" ], "offsets": [ [ 128, 136 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T11", "type": "Condition", "text": [ "able to receive" ], "offsets": [ [ 221, 236 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T12", "type": "Procedure", "text": [ "dual anti-platelet therapy" ], "offsets": [ [ 250, 276 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T13", "type": "Temporal", "text": [ "12 months" ], "offsets": [ [ 237, 246 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T14", "type": "Procedure", "text": [ "PCI" ], "offsets": [ [ 294, 297 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T15", "type": "Temporal", "text": [ "index" ], "offsets": [ [ 288, 293 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T16", "type": "Observation", "text": [ "Failure" ], "offsets": [ [ 277, 284 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T18", "type": "Condition", "text": [ "CYP2C19 genotype" ], "offsets": [ [ 369, 385 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T19", "type": "Temporal", "text": [ "prior to randomization" ], "offsets": [ [ 386, 408 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T20", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 395, 408 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T21", "type": "Procedure", "text": [ "revascularization" ], "offsets": [ [ 417, 434 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T22", "type": "Mood", "text": [ "Planned" ], "offsets": [ [ 409, 416 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T23", "type": "Qualifier", "text": [ "any vessel" ], "offsets": [ [ 438, 448 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T24", "type": "Temporal", "text": [ "within 30 days post-index procedure" ], "offsets": [ [ 449, 484 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T25", "type": "Reference_point", "text": [ "index procedure" ], "offsets": [ [ 469, 484 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T26", "type": "Temporal", "text": [ "within 12 months post-procedure" ], "offsets": [ [ 516, 547 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T27", "type": "Reference_point", "text": [ "procedure" ], "offsets": [ [ 538, 547 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T28", "type": "Qualifier", "text": [ "of the target vessel(s)" ], "offsets": [ [ 492, 515 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T29", "type": "Scope", "text": [ "any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure" ], "offsets": [ [ 438, 547 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T30", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 579, 590 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T31", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 594, 604 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T32", "type": "Temporal", "text": [ "within the 12 month follow up period" ], "offsets": [ [ 605, 641 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T33", "type": "Procedure", "text": [ "elective surgery" ], "offsets": [ [ 655, 671 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T34", "type": "Mood", "text": [ "example for" ], "offsets": [ [ 643, 654 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T35", "type": "Scope", "text": [ "clopidogrel or ticagrelo" ], "offsets": [ [ 579, 603 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T36", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 672, 688 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T37", "type": "Value", "text": [ ">2.5 mg/dL" ], "offsets": [ [ 689, 699 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T38", "type": "Temporal", "text": [ "within 7 days of index procedure" ], "offsets": [ [ 700, 732 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T39", "type": "Reference_point", "text": [ "index procedure" ], "offsets": [ [ 717, 732 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T40", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 733, 747 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T42", "type": "Value", "text": [ "<80,000 or >700,000 cells/mm3" ], "offsets": [ [ 748, 777 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T41", "type": "Measurement", "text": [ "white blood cell count" ], "offsets": [ [ 782, 804 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T43", "type": "Value", "text": [ "<3,000 cells/mm3" ], "offsets": [ [ 805, 821 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T44", "type": "Temporal", "text": [ "within 7 days prior to index procedure" ], "offsets": [ [ 865, 903 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T45", "type": "Reference_point", "text": [ "index procedure" ], "offsets": [ [ 888, 903 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T46", "type": "Scope", "text": [ "Platelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3" ], "offsets": [ [ 733, 821 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T47", "type": "Condition", "text": [ "intracranial hemorrhage" ], "offsets": [ [ 916, 939 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T48", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 946, 962 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T49", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 966, 977 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T50", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 981, 991 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T51", "type": "Drug", "text": [ "any of its components" ], "offsets": [ [ 995, 1016 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T52", "type": "Scope", "text": [ "clopidogrel or ticagrelor" ], "offsets": [ [ 966, 991 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T55", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1189, 1197 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T56", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1199, 1208 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T57", "type": "Mood", "text": [ "planning to become" ], "offsets": [ [ 1213, 1231 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T58", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1232, 1240 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T59", "type": "Temporal", "text": [ "within 12 months" ], "offsets": [ [ 1241, 1257 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T60", "type": "Procedure", "text": [ "organ transplant" ], "offsets": [ [ 1282, 1298 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T61", "type": "Mood", "text": [ "is on a waiting list" ], "offsets": [ [ 1302, 1322 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T62", "type": "Procedure", "text": [ "organ transplant" ], "offsets": [ [ 1330, 1346 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T63", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 1392, 1404 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T64", "type": "Mood", "text": [ "is receiving" ], "offsets": [ [ 1355, 1367 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T65", "type": "Mood", "text": [ "scheduled to receive" ], "offsets": [ [ 1371, 1391 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T66", "type": "Scope", "text": [ "is receiving or scheduled to receive" ], "offsets": [ [ 1355, 1391 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T67", "type": "Temporal", "text": [ "within 30 days before or after the procedure" ], "offsets": [ [ 1405, 1449 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T68", "type": "Reference_point", "text": [ "the procedure" ], "offsets": [ [ 1436, 1449 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T69", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 1471, 1496 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T70", "type": "Condition", "text": [ "r autoimmune dise", "n immun" ], "offsets": [ [ 1529, 1546 ], [ 1561, 1568 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T71", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1531, 1549 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T72", "type": "Condition", "text": [ "human immunodeficiency virus" ], "offsets": [ [ 1557, 1585 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T73", "type": "Condition", "text": [ "systemic lupus erythematous" ], "offsets": [ [ 1587, 1614 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T74", "type": "Scope", "text": [ "human immunodeficiency virus, systemic lupus erythematous" ], "offsets": [ [ 1557, 1614 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T75", "type": "Procedure", "text": [ "oral anticoagulation therapy" ], "offsets": [ [ 1651, 1679 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T76", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 1643, 1650 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T77", "type": "Drug", "text": [ "vitamin K antagonist" ], "offsets": [ [ 1687, 1707 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T78", "type": "Drug", "text": [ "direct thrombin inhibitor" ], "offsets": [ [ 1709, 1734 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T79", "type": "Drug", "text": [ "Factor Xa inhibitor" ], "offsets": [ [ 1736, 1755 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T80", "type": "Scope", "text": [ "vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor" ], "offsets": [ [ 1687, 1755 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T81", "type": "Drug", "text": [ "simvastatin" ], "offsets": [ [ 1776, 1787 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T82", "type": "Drug", "text": [ "lovastatin" ], "offsets": [ [ 1788, 1798 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T83", "type": "Multiplier", "text": [ "> 40 mg qd" ], "offsets": [ [ 1799, 1809 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T84", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 1757, 1768 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T85", "type": "Drug", "text": [ "potent CYP3A4 inhibitors" ], "offsets": [ [ 1829, 1853 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T86", "type": "Drug", "text": [ "atazanavir" ], "offsets": [ [ 1855, 1865 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T87", "type": "Drug", "text": [ "clarithromycin" ], "offsets": [ [ 1867, 1881 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T88", "type": "Drug", "text": [ "indinavir" ], "offsets": [ [ 1883, 1892 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T89", "type": "Drug", "text": [ "itraconazole" ], "offsets": [ [ 1894, 1906 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T90", "type": "Drug", "text": [ "ketoconazole" ], "offsets": [ [ 1908, 1920 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T91", "type": "Drug", "text": [ "nefazodone" ], "offsets": [ [ 1922, 1932 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T92", "type": "Drug", "text": [ "nelfinavir" ], "offsets": [ [ 1934, 1944 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T93", "type": "Drug", "text": [ "ritonavir" ], "offsets": [ [ 1946, 1955 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T94", "type": "Drug", "text": [ "saquinavir" ], "offsets": [ [ 1957, 1967 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T95", "type": "Drug", "text": [ "telithromycin" ], "offsets": [ [ 1969, 1982 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T96", "type": "Drug", "text": [ "voriconazole" ], "offsets": [ [ 1987, 1999 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T97", "type": "Drug", "text": [ "rs (atazanavi", "e, dexam" ], "offsets": [ [ 1851, 1864 ], [ 2026, 2034 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T98", "type": "Drug", "text": [ "carbamazepine" ], "offsets": [ [ 2014, 2027 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T99", "type": "Drug", "text": [ "dexamethasone" ], "offsets": [ [ 2029, 2042 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T100", "type": "Drug", "text": [ "phenobarbital" ], "offsets": [ [ 2044, 2057 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T101", "type": "Drug", "text": [ "phenytoin" ], "offsets": [ [ 2059, 2068 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T102", "type": "Drug", "text": [ "rifampin" ], "offsets": [ [ 2070, 2078 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T103", "type": "Drug", "text": [ "rifapentine" ], "offsets": [ [ 2084, 2095 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T104", "type": "Scope", "text": [ "carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine" ], "offsets": [ [ 2014, 2095 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T105", "type": "Scope", "text": [ "atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole" ], "offsets": [ [ 1855, 1999 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T106", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 1810, 1821 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T107", "type": "Condition", "text": [ "Non-cardiac condition" ], "offsets": [ [ 2097, 2118 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T108", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 2128, 2143 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T109", "type": "Temporal", "text": [ "less than one year" ], "offsets": [ [ 2147, 2165 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T110", "type": "Condition", "text": [ "hepatic impairment" ], "offsets": [ [ 2228, 2246 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T111", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2221, 2227 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T112", "type": "Condition", "text": [ "bleeding diathesis" ], "offsets": [ [ 2272, 2290 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T113", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 2294, 2306 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T114", "type": "Procedure", "text": [ "blood transfusions" ], "offsets": [ [ 2322, 2340 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T115", "type": "Mood", "text": [ "will refuse" ], "offsets": [ [ 2310, 2321 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T116", "type": "Condition", "text": [ "pathological bleeding" ], "offsets": [ [ 2363, 2384 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T117", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 2394, 2400 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T118", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 2394, 2400 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T119", "type": "Condition", "text": [ "gastrointestinal (GI) bleeding" ], "offsets": [ [ 2401, 2431 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T120", "type": "Condition", "text": [ "Inability to take" ], "offsets": [ [ 2432, 2449 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T121", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 2450, 2457 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T122", "type": "Multiplier", "text": [ "100 mg or less" ], "offsets": [ [ 2473, 2487 ] ], "normalized": [] }, { "id": "NCT01742117_inc_T123", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 2496, 2511 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01742117_inc_R1", "type": "Has_value", "arg1_id": "NCT01742117_inc_T1", "arg2_id": "NCT01742117_inc_T2", "normalized": [] }, { "id": "NCT01742117_inc_R2", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T3", "arg2_id": "NCT01742117_inc_T4", "normalized": [] }, { "id": "NCT01742117_inc_R3", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T5", "arg2_id": "NCT01742117_inc_T6", "normalized": [] }, { "id": "NCT01742117_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01742117_inc_T5", "arg2_id": "NCT01742117_inc_T7", "normalized": [] }, { "id": "NCT01742117_inc_R5", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T8", "arg2_id": "NCT01742117_inc_T9", "normalized": [] }, { "id": "NCT01742117_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T12", "arg2_id": "NCT01742117_inc_T13", "normalized": [] }, { "id": "NCT01742117_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T14", "arg2_id": "NCT01742117_inc_T15", "normalized": [] }, { "id": "NCT01742117_inc_R9", "type": "Has_index", "arg1_id": "NCT01742117_inc_T19", "arg2_id": "NCT01742117_inc_T20", "normalized": [] }, { "id": "NCT01742117_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T18", "arg2_id": "NCT01742117_inc_T19", "normalized": [] }, { "id": "NCT01742117_inc_R12", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T21", "arg2_id": "NCT01742117_inc_T22", "normalized": [] }, { "id": "NCT01742117_inc_R13", "type": "Has_index", "arg1_id": "NCT01742117_inc_T24", "arg2_id": "NCT01742117_inc_T25", "normalized": [] }, { "id": "NCT01742117_inc_R15", "type": "Has_index", "arg1_id": "NCT01742117_inc_T26", "arg2_id": "NCT01742117_inc_T27", "normalized": [] }, { "id": "NCT01742117_inc_R16", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T28", "arg2_id": "NCT01742117_inc_T26", "normalized": [] }, { "id": "NCT01742117_inc_R14", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T23", "arg2_id": "NCT01742117_inc_T24", "normalized": [] }, { "id": "NCT01742117_inc_R11", "type": "Has_scope", "arg1_id": "NCT01742117_inc_T21", "arg2_id": "NCT01742117_inc_T29", "normalized": [] }, { "id": "NCT01742117_inc_R17", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T33", "arg2_id": "NCT01742117_inc_T34", "normalized": [] }, { "id": "NCT01742117_inc_R18", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T35", "arg2_id": "NCT01742117_inc_T32", "normalized": [] }, { "id": "NCT01742117_inc_R19", "type": "Has_value", "arg1_id": "NCT01742117_inc_T36", "arg2_id": "NCT01742117_inc_T37", "normalized": [] }, { "id": "NCT01742117_inc_R20", "type": "Has_index", "arg1_id": "NCT01742117_inc_T38", "arg2_id": "NCT01742117_inc_T39", "normalized": [] }, { "id": "NCT01742117_inc_R21", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T36", "arg2_id": "NCT01742117_inc_T38", "normalized": [] }, { "id": "NCT01742117_inc_R22", "type": "Has_value", "arg1_id": "NCT01742117_inc_T41", "arg2_id": "NCT01742117_inc_T43", "normalized": [] }, { "id": "NCT01742117_inc_R23", "type": "Has_value", "arg1_id": "NCT01742117_inc_T40", "arg2_id": "NCT01742117_inc_T42", "normalized": [] }, { "id": "NCT01742117_inc_R24", "type": "Has_index", "arg1_id": "NCT01742117_inc_T44", "arg2_id": "NCT01742117_inc_T45", "normalized": [] }, { "id": "NCT01742117_inc_R25", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T46", "arg2_id": "NCT01742117_inc_T44", "normalized": [] }, { "id": "NCT01742117_inc_R26", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T52", "arg2_id": "NCT01742117_inc_T51", "normalized": [] }, { "id": "NCT01742117_inc_R27", "type": "Has_scope", "arg1_id": "NCT01742117_inc_T48", "arg2_id": "NCT01742117_inc_T52", "normalized": [] }, { "id": "NCT01742117_inc_R28", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T58", "arg2_id": "NCT01742117_inc_T59", "normalized": [] }, { "id": "NCT01742117_inc_R29", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T58", "arg2_id": "NCT01742117_inc_T57", "normalized": [] }, { "id": "NCT01742117_inc_R30", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T62", "arg2_id": "NCT01742117_inc_T61", "normalized": [] }, { "id": "NCT01742117_inc_R31", "type": "Has_scope", "arg1_id": "NCT01742117_inc_T63", "arg2_id": "NCT01742117_inc_T66", "normalized": [] }, { "id": "NCT01742117_inc_R32", "type": "Has_index", "arg1_id": "NCT01742117_inc_T67", "arg2_id": "NCT01742117_inc_T68", "normalized": [] }, { "id": "NCT01742117_inc_R33", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T66", "arg2_id": "NCT01742117_inc_T67", "normalized": [] }, { "id": "NCT01742117_inc_R34", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T71", "arg2_id": "NCT01742117_inc_T74", "normalized": [] }, { "id": "NCT01742117_inc_R35", "type": "Has_multiplier", "arg1_id": "NCT01742117_inc_T75", "arg2_id": "NCT01742117_inc_T76", "normalized": [] }, { "id": "NCT01742117_inc_R36", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T75", "arg2_id": "NCT01742117_inc_T80", "normalized": [] }, { "id": "NCT01742117_inc_R37", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T81", "arg2_id": "NCT01742117_inc_T84", "normalized": [] }, { "id": "NCT01742117_inc_R38", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T82", "arg2_id": "NCT01742117_inc_T84", "normalized": [] }, { "id": "NCT01742117_inc_R39", "type": "Has_multiplier", "arg1_id": "NCT01742117_inc_T82", "arg2_id": "NCT01742117_inc_T83", "normalized": [] }, { "id": "NCT01742117_inc_R40", "type": "Has_multiplier", "arg1_id": "NCT01742117_inc_T81", "arg2_id": "NCT01742117_inc_T83", "normalized": [] }, { "id": "NCT01742117_inc_R41", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T97", "arg2_id": "NCT01742117_inc_T104", "normalized": [] }, { "id": "NCT01742117_inc_R42", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T85", "arg2_id": "NCT01742117_inc_T105", "normalized": [] }, { "id": "NCT01742117_inc_R43", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T97", "arg2_id": "NCT01742117_inc_T106", "normalized": [] }, { "id": "NCT01742117_inc_R44", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T85", "arg2_id": "NCT01742117_inc_T106", "normalized": [] }, { "id": "NCT01742117_inc_R45", "type": "Has_temporal", "arg1_id": "NCT01742117_inc_T108", "arg2_id": "NCT01742117_inc_T109", "normalized": [] }, { "id": "NCT01742117_inc_R47", "type": "Has_qualifier", "arg1_id": "NCT01742117_inc_T110", "arg2_id": "NCT01742117_inc_T111", "normalized": [] }, { "id": "NCT01742117_inc_R48", "type": "Has_mood", "arg1_id": "NCT01742117_inc_T114", "arg2_id": "NCT01742117_inc_T115", "normalized": [] }, { "id": "NCT01742117_inc_R49", "type": "Has_qualifier", "arg1_id": "NCT01742117_inc_T116", "arg2_id": "NCT01742117_inc_T117", "normalized": [] }, { "id": "NCT01742117_inc_R50", "type": "Has_qualifier", "arg1_id": "NCT01742117_inc_T119", "arg2_id": "NCT01742117_inc_T118", "normalized": [] }, { "id": "NCT01742117_inc_R51", "type": "Subsumes", "arg1_id": "NCT01742117_inc_T116", "arg2_id": "NCT01742117_inc_T119", "normalized": [] }, { "id": "NCT01742117_inc_R52", "type": "Has_multiplier", "arg1_id": "NCT01742117_inc_T121", "arg2_id": "NCT01742117_inc_T122", "normalized": [] }, { "id": "NCT01742117_inc_R53", "type": "AND", "arg1_id": "NCT01742117_inc_T120", "arg2_id": "NCT01742117_inc_T121", "normalized": [] } ]