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[ { "id": "NCT01743755_exc_text", "type": "exclusion", "text": [ "Immunocompromised patients:\nPatients with a known congenital or acquired immunodeficiency.\nPatients who received chemotherapy less than 6 weeks ago.\nPatients who received corticosteroids in the last 6 weeks.\nPatients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).\nPatients with chronic obstructive pulmonary disease who are on systemic corticosteroids.\nPatients who require intensive care unit treatment.\nPatients with tropical worm infection.\nPatients with dexamethasone intolerance.\nPregnant and breastfeeding women.\n" ], "offsets": [ [ 0, 586 ] ] } ]

[ { "id": "NCT01743755_exc_T1", "type": "Condition", "text": [ "Immunocompromised" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T2", "type": "Condition", "text": [ "immunodeficiency" ], "offsets": [ [ 73, 89 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T3", "type": "Qualifier", "text": [ "acquired" ], "offsets": [ [ 64, 72 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T4", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 50, 60 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T5", "type": "Scope", "text": [ "congenital or acquired" ], "offsets": [ [ 50, 72 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T6", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 113, 125 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T7", "type": "Temporal", "text": [ "less than 6 weeks ago" ], "offsets": [ [ 126, 147 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T8", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 171, 186 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T9", "type": "Temporal", "text": [ "in the last 6 weeks" ], "offsets": [ [ 187, 206 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T10", "type": "Procedure", "text": [ "immunosuppressive medication" ], "offsets": [ [ 230, 258 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T11", "type": "Temporal", "text": [ "in the last 6 weeks" ], "offsets": [ [ 259, 278 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T12", "type": "Drug", "text": [ "cyclosporin" ], "offsets": [ [ 285, 296 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T13", "type": "Drug", "text": [ "cyclophosphamide" ], "offsets": [ [ 298, 314 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T14", "type": "Drug", "text": [ "azathioprine" ], "offsets": [ [ 316, 328 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T15", "type": "Scope", "text": [ "cyclosporin, cyclophosphamide, azathioprine" ], "offsets": [ [ 285, 328 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T16", "type": "Condition", "text": [ "chronic obstructive pulmonary disease" ], "offsets": [ [ 345, 382 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T17", "type": "Drug", "text": [ "systemic corticosteroids" ], "offsets": [ [ 394, 418 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T18", "type": "Visit", "text": [ "intensive care unit" ], "offsets": [ [ 441, 460 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T19", "type": "Condition", "text": [ "tropical worm infection" ], "offsets": [ [ 486, 509 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T20", "type": "Drug", "text": [ "dexamethasone" ], "offsets": [ [ 525, 538 ] ], "normalized": [] }, { "id": "NCT01743755_exc_T21", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 539, 550 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01743755_exc_R1", "type": "Has_scope", "arg1_id": "NCT01743755_exc_T2", "arg2_id": "NCT01743755_exc_T5", "normalized": [] }, { "id": "NCT01743755_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01743755_exc_T6", "arg2_id": "NCT01743755_exc_T7", "normalized": [] }, { "id": "NCT01743755_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01743755_exc_T8", "arg2_id": "NCT01743755_exc_T9", "normalized": [] }, { "id": "NCT01743755_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01743755_exc_T10", "arg2_id": "NCT01743755_exc_T11", "normalized": [] }, { "id": "NCT01743755_exc_R5", "type": "Has_scope", "arg1_id": "NCT01743755_exc_T10", "arg2_id": "NCT01743755_exc_T15", "normalized": [] }, { "id": "NCT01743755_exc_R6", "type": "AND", "arg1_id": "NCT01743755_exc_T16", "arg2_id": "NCT01743755_exc_T17", "normalized": [] }, { "id": "NCT01743755_exc_R7", "type": "AND", "arg1_id": "NCT01743755_exc_T21", "arg2_id": "NCT01743755_exc_T20", "normalized": [] } ]

[ { "id": "NCT01743755_inc_text", "type": "inclusion", "text": [ "18 years or older\nChest radiograph showing new opacities.\nCough\nProduction of sputum\nTemp >38,0 °C or <36,0 °C\nAudible abnormalities by chest examination compatible with pneumonia\nLeukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3)\nC-reactive protein > 15 mg/l (three fold higher than the upper limit of normal)\n" ], "offsets": [ [ 0, 348 ] ] } ]

[ { "id": "NCT01743755_inc_T1", "type": "Person", "text": [ "years" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T2", "type": "Value", "text": [ "18", "or older" ], "offsets": [ [ 0, 2 ], [ 9, 17 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T3", "type": "Procedure", "text": [ "Chest radiograph" ], "offsets": [ [ 18, 34 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T4", "type": "Condition", "text": [ "opacities" ], "offsets": [ [ 47, 56 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T5", "type": "Qualifier", "text": [ "new" ], "offsets": [ [ 43, 46 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T6", "type": "Condition", "text": [ "Cough" ], "offsets": [ [ 58, 63 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T7", "type": "Condition", "text": [ "sputum" ], "offsets": [ [ 78, 84 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T8", "type": "Measurement", "text": [ "Temp" ], "offsets": [ [ 85, 89 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T9", "type": "Value", "text": [ ">38,0 °C" ], "offsets": [ [ 90, 98 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T10", "type": "Value", "text": [ "<36,0 °C" ], "offsets": [ [ 102, 110 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T11", "type": "Scope", "text": [ ">38,0 °C or <36,0 °C" ], "offsets": [ [ 90, 110 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T12", "type": "Observation", "text": [ "Audible abnormalities" ], "offsets": [ [ 111, 132 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T13", "type": "Procedure", "text": [ "chest examination" ], "offsets": [ [ 136, 153 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T14", "type": "Condition", "text": [ "pneumonia" ], "offsets": [ [ 170, 179 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T15", "type": "Condition", "text": [ "Leukocytosis" ], "offsets": [ [ 180, 192 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T16", "type": "Multiplier", "text": [ ">10.000 cells/mm3" ], "offsets": [ [ 194, 211 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T17", "type": "Condition", "text": [ "leucopenia" ], "offsets": [ [ 239, 249 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T18", "type": "Multiplier", "text": [ "<4000 cells/mm3" ], "offsets": [ [ 251, 266 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T19", "type": "Multiplier", "text": [ "rd shift (>10%", "or l" ], "offsets": [ [ 220, 234 ], [ 236, 240 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T20", "type": "Scope", "text": [ ">10.000 cells/mm3), leftward shift (>10%)" ], "offsets": [ [ 194, 235 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T21", "type": "Measurement", "text": [ "C-reactive protein" ], "offsets": [ [ 268, 286 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T22", "type": "Value", "text": [ "> 15 mg/l" ], "offsets": [ [ 287, 296 ] ], "normalized": [] }, { "id": "NCT01743755_inc_T23", "type": "Value", "text": [ "three fold higher than the upper limit of normal" ], "offsets": [ [ 298, 346 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01743755_inc_R1", "type": "Has_value", "arg1_id": "NCT01743755_inc_T1", "arg2_id": "NCT01743755_inc_T2", "normalized": [] }, { "id": "NCT01743755_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01743755_inc_T4", "arg2_id": "NCT01743755_inc_T5", "normalized": [] }, { "id": "NCT01743755_inc_R3", "type": "AND", "arg1_id": "NCT01743755_inc_T3", "arg2_id": "NCT01743755_inc_T4", "normalized": [] }, { "id": "NCT01743755_inc_R4", "type": "Has_scope", "arg1_id": "NCT01743755_inc_T8", "arg2_id": "NCT01743755_inc_T11", "normalized": [] }, { "id": "NCT01743755_inc_R6", "type": "AND", "arg1_id": "NCT01743755_inc_T14", "arg2_id": "NCT01743755_inc_T13", "normalized": [] }, { "id": "NCT01743755_inc_R7", "type": "Has_scope", "arg1_id": "NCT01743755_inc_T15", "arg2_id": "NCT01743755_inc_T20", "normalized": [] }, { "id": "NCT01743755_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01743755_inc_T17", "arg2_id": "NCT01743755_inc_T18", "normalized": [] }, { "id": "NCT01743755_inc_R9", "type": "Subsumes", "arg1_id": "NCT01743755_inc_T22", "arg2_id": "NCT01743755_inc_T23", "normalized": [] }, { "id": "NCT01743755_inc_R10", "type": "Has_value", "arg1_id": "NCT01743755_inc_T21", "arg2_id": "NCT01743755_inc_T22", "normalized": [] } ]

[ { "id": "NCT01757717_exc_text", "type": "exclusion", "text": [ "Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria. \nPatients with kyphoplasty cement or hardware that would preclude effective catheter placement. \nPatients with paraspinal extension of disease with visceral involvement. \nAbnormal complete blood count. Any of the following: \nPlatelet count < 75,000/ml \nHb level < 9gm/dl \nWBC < 3.5/ml \nAbnormal coagulation profile: INR > 2.5 and/or PTT > 80 \nPatients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded. \nContraindications to general anesthesia \n \n" ], "offsets": [ [ 0, 804 ] ] } ]

[ { "id": "NCT01757717_exc_T1", "type": "Measurement", "text": [ "MSKCC Radiation Oncology Department dose constraint criteria" ], "offsets": [ [ 129, 189 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T2", "type": "Condition", "text": [ "may receive therapeutically effective doses via an external beam approach to the lesion of interest" ], "offsets": [ [ 13, 112 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T3", "type": "Qualifier", "text": [ "therapeutically effective" ], "offsets": [ [ 25, 50 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T4", "type": "Procedure", "text": [ "doses" ], "offsets": [ [ 51, 56 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T5", "type": "Procedure", "text": [ "external beam" ], "offsets": [ [ 64, 77 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T7", "type": "Device", "text": [ "kyphoplasty cement" ], "offsets": [ [ 206, 224 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T8", "type": "Device", "text": [ "kyphoplasty", "hardware" ], "offsets": [ [ 206, 217 ], [ 228, 236 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T9", "type": "Qualifier", "text": [ "preclude effective catheter placement" ], "offsets": [ [ 248, 285 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T10", "type": "Scope", "text": [ "kyphoplasty cement or hardware" ], "offsets": [ [ 206, 236 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T11", "type": "Condition", "text": [ "paraspinal extension of disease" ], "offsets": [ [ 302, 333 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T12", "type": "Condition", "text": [ "visceral involvement" ], "offsets": [ [ 339, 359 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T13", "type": "Measurement", "text": [ "complete blood count" ], "offsets": [ [ 371, 391 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T14", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 362, 370 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T15", "type": "Condition", "text": [ "Abnormal complete blood count" ], "offsets": [ [ 362, 391 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T18", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 416, 430 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T19", "type": "Value", "text": [ "< 75,000/ml" ], "offsets": [ [ 431, 442 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T20", "type": "Measurement", "text": [ "Hb level" ], "offsets": [ [ 444, 452 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T21", "type": "Value", "text": [ "< 9gm/dl" ], "offsets": [ [ 453, 461 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T22", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 463, 466 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T23", "type": "Value", "text": [ "< 3.5/ml" ], "offsets": [ [ 467, 475 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T24", "type": "Measurement", "text": [ "coagulation profile" ], "offsets": [ [ 486, 505 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T25", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 477, 485 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T26", "type": "Condition", "text": [ "Abnormal coagulation profile" ], "offsets": [ [ 477, 505 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T27", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 507, 510 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T28", "type": "Value", "text": [ "> 2.5" ], "offsets": [ [ 511, 516 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T29", "type": "Measurement", "text": [ "PTT" ], "offsets": [ [ 524, 527 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T30", "type": "Value", "text": [ "> 80" ], "offsets": [ [ 528, 532 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T31", "type": "Scope", "text": [ "INR > 2.5 and/or PTT > 80" ], "offsets": [ [ 507, 532 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T32", "type": "Drug", "text": [ "anticoagulation medication" ], "offsets": [ [ 554, 580 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T34", "type": "Qualifier", "text": [ "may not be safely held for the procedure" ], "offsets": [ [ 586, 626 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T36", "type": "Multiplier", "text": [ "≥ 5 days" ], "offsets": [ [ 628, 636 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T37", "type": "Drug", "text": [ "antiplatelet agents" ], "offsets": [ [ 641, 660 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T38", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 665, 673 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T39", "type": "Multiplier", "text": [ "≥ 24 hours" ], "offsets": [ [ 675, 685 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T40", "type": "Drug", "text": [ "low-molecular weight heparin" ], "offsets": [ [ 690, 718 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T41", "type": "Scope", "text": [ "≥ 5 days for antiplatelet agents and warfarin" ], "offsets": [ [ 628, 673 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T42", "type": "Scope", "text": [ "≥ 24 hours for low-molecular weight heparin" ], "offsets": [ [ 675, 718 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T43", "type": "Scope", "text": [ "≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin" ], "offsets": [ [ 628, 718 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T44", "type": "Scope", "text": [ "anticoagulation medication that may not be safely held for the procedure" ], "offsets": [ [ 554, 626 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T45", "type": "Condition", "text": [ "Contraindications to general anesthesia" ], "offsets": [ [ 752, 791 ] ], "normalized": [] }, { "id": "NCT01757717_exc_T46", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 773, 791 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01757717_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01757717_exc_T10", "arg2_id": "NCT01757717_exc_T9", "normalized": [] }, { "id": "NCT01757717_exc_R2", "type": "AND", "arg1_id": "NCT01757717_exc_T11", "arg2_id": "NCT01757717_exc_T12", "normalized": [] }, { "id": "NCT01757717_exc_R3", "type": "Has_value", "arg1_id": "NCT01757717_exc_T13", "arg2_id": "NCT01757717_exc_T14", "normalized": [] }, { "id": "NCT01757717_exc_R4", "type": "Has_value", "arg1_id": "NCT01757717_exc_T22", "arg2_id": "NCT01757717_exc_T23", "normalized": [] }, { "id": "NCT01757717_exc_R5", "type": "Has_value", "arg1_id": "NCT01757717_exc_T18", "arg2_id": "NCT01757717_exc_T19", "normalized": [] }, { "id": "NCT01757717_exc_R6", "type": "Has_value", "arg1_id": "NCT01757717_exc_T20", "arg2_id": "NCT01757717_exc_T21", "normalized": [] }, { "id": "NCT01757717_exc_R7", "type": "Has_value", "arg1_id": "NCT01757717_exc_T24", "arg2_id": "NCT01757717_exc_T25", "normalized": [] }, { "id": "NCT01757717_exc_R8", "type": "Has_value", "arg1_id": "NCT01757717_exc_T27", "arg2_id": "NCT01757717_exc_T28", "normalized": [] }, { "id": "NCT01757717_exc_R9", "type": "Has_value", "arg1_id": "NCT01757717_exc_T29", "arg2_id": "NCT01757717_exc_T30", "normalized": [] }, { "id": "NCT01757717_exc_R10", "type": "Subsumes", "arg1_id": "NCT01757717_exc_T26", "arg2_id": "NCT01757717_exc_T31", "normalized": [] }, { "id": "NCT01757717_exc_R12", "type": "Has_multiplier", "arg1_id": "NCT01757717_exc_T40", "arg2_id": "NCT01757717_exc_T39", "normalized": [] }, { "id": "NCT01757717_exc_R13", "type": "Has_multiplier", "arg1_id": "NCT01757717_exc_T37", "arg2_id": "NCT01757717_exc_T36", "normalized": [] }, { "id": "NCT01757717_exc_R14", "type": "Has_multiplier", "arg1_id": "NCT01757717_exc_T38", "arg2_id": "NCT01757717_exc_T36", "normalized": [] }, { "id": "NCT01757717_exc_R15", "type": "Subsumes", "arg1_id": "NCT01757717_exc_T44", "arg2_id": "NCT01757717_exc_T43", "normalized": [] }, { "id": "NCT01757717_exc_R16", "type": "AND", "arg1_id": "NCT01757717_exc_T45", "arg2_id": "NCT01757717_exc_T46", "normalized": [] } ]

[ { "id": "NCT01757717_inc_text", "type": "inclusion", "text": [ "Patients must have histologic proof of a malignancy suitable for radiation therapy. \nPatients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration. \nIf repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible. \nIf the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012] \nKPS ≥ 60 \nAge ≥ 18 years old \n" ], "offsets": [ [ 0, 996 ] ] } ]

[ { "id": "NCT01757717_inc_T1", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 41, 51 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T2", "type": "Qualifier", "text": [ "suitable for radiation therapy" ], "offsets": [ [ 52, 82 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T3", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 65, 82 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T4", "type": "Procedure", "text": [ "histologic" ], "offsets": [ [ 19, 29 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T5", "type": "Value", "text": [ "proof" ], "offsets": [ [ 30, 35 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T7", "type": "Procedure", "text": [ "external beam radiation therapy" ], "offsets": [ [ 119, 150 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T8", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 113, 118 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T9", "type": "Procedure", "text": [ "HDR brachytherapy" ], "offsets": [ [ 178, 195 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T11", "type": "Qualifier", "text": [ "to the region proposed for HDR brachytherapy treatment" ], "offsets": [ [ 151, 205 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T12", "type": "Procedure", "text": [ "repeat irradiation" ], "offsets": [ [ 378, 396 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T13", "type": "Value", "text": [ "exceed any normal tissue constraint" ], "offsets": [ [ 403, 438 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T14", "type": "Measurement", "text": [ "MSKCC Radiation Oncology Department dose constraint criteria" ], "offsets": [ [ 446, 506 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T16", "type": "Measurement", "text": [ "KPS" ], "offsets": [ [ 966, 969 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T17", "type": "Value", "text": [ "≥ 60" ], "offsets": [ [ 970, 974 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T18", "type": "Person", "text": [ "Age" ], "offsets": [ [ 976, 979 ] ], "normalized": [] }, { "id": "NCT01757717_inc_T19", "type": "Value", "text": [ "≥ 18 years old" ], "offsets": [ [ 980, 994 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01757717_inc_R1", "type": "AND", "arg1_id": "NCT01757717_inc_T2", "arg2_id": "NCT01757717_inc_T3", "normalized": [] }, { "id": "NCT01757717_inc_R2", "type": "Has_value", "arg1_id": "NCT01757717_inc_T4", "arg2_id": "NCT01757717_inc_T5", "normalized": [] }, { "id": "NCT01757717_inc_R3", "type": "AND", "arg1_id": "NCT01757717_inc_T1", "arg2_id": "NCT01757717_inc_T4", "normalized": [] }, { "id": "NCT01757717_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01757717_inc_T1", "arg2_id": "NCT01757717_inc_T2", "normalized": [] }, { "id": "NCT01757717_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01757717_inc_T7", "arg2_id": "NCT01757717_inc_T8", "normalized": [] }, { "id": "NCT01757717_inc_R6", "type": "AND", "arg1_id": "NCT01757717_inc_T11", "arg2_id": "NCT01757717_inc_T9", "normalized": [] }, { "id": "NCT01757717_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT01757717_inc_T7", "arg2_id": "NCT01757717_inc_T11", "normalized": [] }, { "id": "NCT01757717_inc_R8", "type": "Has_value", "arg1_id": "NCT01757717_inc_T14", "arg2_id": "NCT01757717_inc_T13", "normalized": [] }, { "id": "NCT01757717_inc_R9", "type": "AND", "arg1_id": "NCT01757717_inc_T12", "arg2_id": "NCT01757717_inc_T14", "normalized": [] }, { "id": "NCT01757717_inc_R10", "type": "Has_value", "arg1_id": "NCT01757717_inc_T18", "arg2_id": "NCT01757717_inc_T19", "normalized": [] } ]

[ { "id": "NCT01765231_exc_text", "type": "exclusion", "text": [ "younger than 18 years old\nHBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline\npregnant or lactating women\n" ], "offsets": [ [ 0, 133 ] ] } ]

[ { "id": "NCT01765231_exc_T1", "type": "Value", "text": [ "younger than 18 years" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T3", "type": "Condition", "text": [ "HBsAg positive" ], "offsets": [ [ 26, 40 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T4", "type": "Condition", "text": [ "HBcAb negative" ], "offsets": [ [ 44, 58 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T5", "type": "Condition", "text": [ "hepatitis B virus DNA positive" ], "offsets": [ [ 62, 92 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T6", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 93, 104 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T7", "type": "Scope", "text": [ "HBsAg positive or HBcAb negative or hepatitis B virus DNA positive" ], "offsets": [ [ 26, 92 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T8", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 105, 113 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T9", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 117, 126 ] ], "normalized": [] }, { "id": "NCT01765231_exc_T10", "type": "Person", "text": [ "women" ], "offsets": [ [ 127, 132 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01765231_exc_R1", "type": "Has_value", "arg1_id": "NCT01765231_exc_T2", "arg2_id": "NCT01765231_exc_T1", "normalized": [] }, { "id": "NCT01765231_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01765231_exc_T7", "arg2_id": "NCT01765231_exc_T6", "normalized": [] } ]

[ { "id": "NCT01765231_inc_text", "type": "inclusion", "text": [ "treatment-naive patients with lymphoma\nHBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline\ntreated with chemotherapy and/or immunosuppressive therapy\nlife expectancy of more than 3 months\n" ], "offsets": [ [ 0, 209 ] ] } ]

[ { "id": "NCT01765231_inc_T1", "type": "Observation", "text": [ "treatment-naive" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T2", "type": "Condition", "text": [ "lymphoma" ], "offsets": [ [ 30, 38 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T3", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 39, 44 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T4", "type": "Value", "text": [ "negative" ], "offsets": [ [ 45, 53 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T5", "type": "Measurement", "text": [ "HBcAb" ], "offsets": [ [ 54, 59 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T6", "type": "Value", "text": [ "positive" ], "offsets": [ [ 60, 68 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T7", "type": "Measurement", "text": [ "hepatitis B virus DNA" ], "offsets": [ [ 69, 90 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T8", "type": "Value", "text": [ "negative" ], "offsets": [ [ 91, 99 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T9", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 100, 111 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T10", "type": "Scope", "text": [ "HBsAg negative/HBcAb positive/hepatitis B virus DNA negative" ], "offsets": [ [ 39, 99 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T11", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 125, 137 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T12", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 145, 170 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T13", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 171, 186 ] ], "normalized": [] }, { "id": "NCT01765231_inc_T14", "type": "Temporal", "text": [ "more than 3 months" ], "offsets": [ [ 190, 208 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01765231_inc_R1", "type": "Has_value", "arg1_id": "NCT01765231_inc_T3", "arg2_id": "NCT01765231_inc_T4", "normalized": [] }, { "id": "NCT01765231_inc_R2", "type": "Has_value", "arg1_id": "NCT01765231_inc_T5", "arg2_id": "NCT01765231_inc_T6", "normalized": [] }, { "id": "NCT01765231_inc_R3", "type": "Has_value", "arg1_id": "NCT01765231_inc_T7", "arg2_id": "NCT01765231_inc_T8", "normalized": [] }, { "id": "NCT01765231_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01765231_inc_T10", "arg2_id": "NCT01765231_inc_T9", "normalized": [] }, { "id": "NCT01765231_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01765231_inc_T13", "arg2_id": "NCT01765231_inc_T14", "normalized": [] } ]

[ { "id": "NCT01768195_exc_text", "type": "exclusion", "text": [ "younger than 18 years old\nHBsAg negative at baseline\npregnant or lactating women\n" ], "offsets": [ [ 0, 81 ] ] } ]

[ { "id": "NCT01768195_exc_T1", "type": "Value", "text": [ "younger than 18 years" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T3", "type": "Condition", "text": [ "HBsAg negative" ], "offsets": [ [ 26, 40 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T4", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 41, 52 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T5", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 53, 61 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T6", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 65, 74 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T7", "type": "Person", "text": [ "women" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT01768195_exc_T8", "type": "Scope", "text": [ "pregnant or lactating" ], "offsets": [ [ 53, 74 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01768195_exc_R1", "type": "Has_value", "arg1_id": "NCT01768195_exc_T2", "arg2_id": "NCT01768195_exc_T1", "normalized": [] }, { "id": "NCT01768195_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01768195_exc_T3", "arg2_id": "NCT01768195_exc_T4", "normalized": [] }, { "id": "NCT01768195_exc_R3", "type": "Has_scope", "arg1_id": "NCT01768195_exc_T7", "arg2_id": "NCT01768195_exc_T8", "normalized": [] } ]

[ { "id": "NCT01768195_inc_text", "type": "inclusion", "text": [ "treatment-naive patients with B-cell lymphoma\nHBsAg positive at baseline\ntreated with rituximab-based immunochemotherapy\nlife expectancy of more than 3 months\n" ], "offsets": [ [ 0, 159 ] ] } ]

[ { "id": "NCT01768195_inc_T1", "type": "Condition", "text": [ "treatment" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T2", "type": "Condition", "text": [ "B-cell lymphoma" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T3", "type": "Negation", "text": [ "naive" ], "offsets": [ [ 10, 15 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T4", "type": "Condition", "text": [ "HBsAg positive" ], "offsets": [ [ 46, 60 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T5", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 61, 72 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T6", "type": "Qualifier", "text": [ "rituximab-based" ], "offsets": [ [ 86, 101 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T7", "type": "Drug", "text": [ "rituximab" ], "offsets": [ [ 86, 95 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T8", "type": "Procedure", "text": [ "immunochemotherapy" ], "offsets": [ [ 102, 120 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T9", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 121, 136 ] ], "normalized": [] }, { "id": "NCT01768195_inc_T10", "type": "Value", "text": [ "more than 3 months" ], "offsets": [ [ 140, 158 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01768195_inc_R1", "type": "Has_negation", "arg1_id": "NCT01768195_inc_T1", "arg2_id": "NCT01768195_inc_T3", "normalized": [] }, { "id": "NCT01768195_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01768195_inc_T4", "arg2_id": "NCT01768195_inc_T5", "normalized": [] }, { "id": "NCT01768195_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01768195_inc_T8", "arg2_id": "NCT01768195_inc_T6", "normalized": [] }, { "id": "NCT01768195_inc_R5", "type": "Has_value", "arg1_id": "NCT01768195_inc_T9", "arg2_id": "NCT01768195_inc_T10", "normalized": [] } ]

[ { "id": "NCT01770340_exc_text", "type": "exclusion", "text": [ "IIEF < 21\nOperations in the past 6 months which could limit the erectile function\nErectile dysfunction in the history or current medication for erectile dysfunction\nCurrent involvement in another comparable study.\n" ], "offsets": [ [ 0, 214 ] ] } ]

[ { "id": "NCT01770340_exc_T1", "type": "Measurement", "text": [ "IIEF" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T2", "type": "Value", "text": [ "< 21" ], "offsets": [ [ 5, 9 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T3", "type": "Temporal", "text": [ "in the past 6 months" ], "offsets": [ [ 21, 41 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T4", "type": "Procedure", "text": [ "Operations" ], "offsets": [ [ 10, 20 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T5", "type": "Condition", "text": [ "limit the erectile function" ], "offsets": [ [ 54, 81 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T6", "type": "Condition", "text": [ "Erectile dysfunction" ], "offsets": [ [ 82, 102 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T7", "type": "Observation", "text": [ "history" ], "offsets": [ [ 110, 117 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T8", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 129, 139 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T9", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 121, 128 ] ], "normalized": [] }, { "id": "NCT01770340_exc_T10", "type": "Condition", "text": [ "erectile dysfunction" ], "offsets": [ [ 144, 164 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01770340_exc_R1", "type": "Has_value", "arg1_id": "NCT01770340_exc_T1", "arg2_id": "NCT01770340_exc_T2", "normalized": [] }, { "id": "NCT01770340_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01770340_exc_T4", "arg2_id": "NCT01770340_exc_T3", "normalized": [] }, { "id": "NCT01770340_exc_R3", "type": "AND", "arg1_id": "NCT01770340_exc_T4", "arg2_id": "NCT01770340_exc_T5", "normalized": [] }, { "id": "NCT01770340_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01770340_exc_T6", "arg2_id": "NCT01770340_exc_T7", "normalized": [] }, { "id": "NCT01770340_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01770340_exc_T8", "arg2_id": "NCT01770340_exc_T9", "normalized": [] }, { "id": "NCT01770340_exc_R6", "type": "AND", "arg1_id": "NCT01770340_exc_T8", "arg2_id": "NCT01770340_exc_T10", "normalized": [] } ]

[ { "id": "NCT01770340_inc_text", "type": "inclusion", "text": [ "Localized intermediate-risk or high-risk prostate cancer cT3\nGleason score = 7 (3+4 and/or 4+3) and/or\nPSA = 20 ng/ml\nintact preoperative erectile function with an IIEF = 21 (IIEF-6).\n" ], "offsets": [ [ 0, 184 ] ] } ]

[ { "id": "NCT01770340_inc_T1", "type": "Qualifier", "text": [ "high-risk" ], "offsets": [ [ 31, 40 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T2", "type": "Qualifier", "text": [ "cT3" ], "offsets": [ [ 57, 60 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T3", "type": "Qualifier", "text": [ "intermediate-risk" ], "offsets": [ [ 10, 27 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T4", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 41, 56 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T5", "type": "Scope", "text": [ "intermediate-risk or high-risk" ], "offsets": [ [ 10, 40 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T6", "type": "Measurement", "text": [ "Gleason score" ], "offsets": [ [ 61, 74 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T7", "type": "Value", "text": [ "= 7" ], "offsets": [ [ 75, 78 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T8", "type": "Value", "text": [ "3+4" ], "offsets": [ [ 80, 83 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T9", "type": "Value", "text": [ "4+3" ], "offsets": [ [ 91, 94 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T10", "type": "Scope", "text": [ "3+4 and/or 4+3" ], "offsets": [ [ 80, 94 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T11", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 103, 106 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T12", "type": "Value", "text": [ "= 20 ng/ml" ], "offsets": [ [ 107, 117 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T13", "type": "Condition", "text": [ "act pr", "ctile function wi" ], "offsets": [ [ 121, 127 ], [ 141, 158 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T14", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 125, 137 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T15", "type": "Measurement", "text": [ "IIEF" ], "offsets": [ [ 164, 168 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T16", "type": "Value", "text": [ "= 21" ], "offsets": [ [ 169, 173 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T17", "type": "Observation", "text": [ "IIEF-6" ], "offsets": [ [ 175, 181 ] ], "normalized": [] }, { "id": "NCT01770340_inc_T18", "type": "Scope", "text": [ "IIEF = 21" ], "offsets": [ [ 164, 173 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01770340_inc_R1", "type": "Has_scope", "arg1_id": "NCT01770340_inc_T4", "arg2_id": "NCT01770340_inc_T5", "normalized": [] }, { "id": "NCT01770340_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01770340_inc_T4", "arg2_id": "NCT01770340_inc_T2", "normalized": [] }, { "id": "NCT01770340_inc_R3", "type": "Subsumes", "arg1_id": "NCT01770340_inc_T7", "arg2_id": "NCT01770340_inc_T10", "normalized": [] }, { "id": "NCT01770340_inc_R4", "type": "Has_scope", "arg1_id": "NCT01770340_inc_T6", "arg2_id": "NCT01770340_inc_T10", "normalized": [] }, { "id": "NCT01770340_inc_R5", "type": "Has_value", "arg1_id": "NCT01770340_inc_T11", "arg2_id": "NCT01770340_inc_T12", "normalized": [] }, { "id": "NCT01770340_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01770340_inc_T13", "arg2_id": "NCT01770340_inc_T14", "normalized": [] }, { "id": "NCT01770340_inc_R7", "type": "Has_value", "arg1_id": "NCT01770340_inc_T15", "arg2_id": "NCT01770340_inc_T16", "normalized": [] }, { "id": "NCT01770340_inc_R8", "type": "Subsumes", "arg1_id": "NCT01770340_inc_T18", "arg2_id": "NCT01770340_inc_T17", "normalized": [] }, { "id": "NCT01770340_inc_R9", "type": "Has_scope", "arg1_id": "NCT01770340_inc_T13", "arg2_id": "NCT01770340_inc_T18", "normalized": [] } ]

[ { "id": "NCT01774019_exc_text", "type": "exclusion", "text": [ "Biliary strictures caused by confirmed benign tumors\nBiliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers\nSurgically altered biliary tract anatomy, not including prior cholecystectomy\nNeoadjuvant chemotherapy for current malignancy\nPalliative indication due to reasons other than surgical candidate status\nPrevious biliary drainage by ERCP/PTC\nPatients for whom endoscopic techniques are contraindicated\nParticipation in another investigational trial within 90 days\nPregnancy\n" ], "offsets": [ [ 0, 557 ] ] } ]

[ { "id": "NCT01774019_exc_T1", "type": "Condition", "text": [ "Biliary strictures" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T2", "type": "Condition", "text": [ "benign tumors" ], "offsets": [ [ 39, 52 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T3", "type": "Qualifier", "text": [ "confirmed" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T4", "type": "Condition", "text": [ "Biliary strictures" ], "offsets": [ [ 53, 71 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T5", "type": "Condition", "text": [ "malignancies" ], "offsets": [ [ 82, 94 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T6", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 95, 105 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T7", "type": "Condition", "text": [ "pancreatic cancer" ], "offsets": [ [ 106, 123 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T8", "type": "Condition", "text": [ "distal CBD cholangiocarcinoma" ], "offsets": [ [ 125, 154 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T9", "type": "Condition", "text": [ "other periampullary cancers" ], "offsets": [ [ 159, 186 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T10", "type": "Scope", "text": [ "pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers" ], "offsets": [ [ 106, 186 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T11", "type": "Condition", "text": [ "Surgically altered biliary tract anatomy" ], "offsets": [ [ 187, 227 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T12", "type": "Procedure", "text": [ "cholecystectomy" ], "offsets": [ [ 249, 264 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T13", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 243, 248 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T14", "type": "Negation", "text": [ "not" ], "offsets": [ [ 229, 232 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T15", "type": "Procedure", "text": [ "Neoadjuvant chemotherapy" ], "offsets": [ [ 265, 289 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T16", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 302, 312 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T18", "type": "Procedure", "text": [ "biliary drainage by ERCP/PTC" ], "offsets": [ [ 396, 424 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T19", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 387, 395 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T20", "type": "Condition", "text": [ "contraindicated" ], "offsets": [ [ 469, 484 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T21", "type": "Procedure", "text": [ "endoscopic techniques" ], "offsets": [ [ 443, 464 ] ], "normalized": [] }, { "id": "NCT01774019_exc_T23", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 547, 556 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01774019_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01774019_exc_T2", "arg2_id": "NCT01774019_exc_T3", "normalized": [] }, { "id": "NCT01774019_exc_R2", "type": "AND", "arg1_id": "NCT01774019_exc_T1", "arg2_id": "NCT01774019_exc_T2", "normalized": [] }, { "id": "NCT01774019_exc_R3", "type": "Has_negation", "arg1_id": "NCT01774019_exc_T10", "arg2_id": "NCT01774019_exc_T6", "normalized": [] }, { "id": "NCT01774019_exc_R4", "type": "Has_scope", "arg1_id": "NCT01774019_exc_T5", "arg2_id": "NCT01774019_exc_T10", "normalized": [] }, { "id": "NCT01774019_exc_R5", "type": "AND", "arg1_id": "NCT01774019_exc_T4", "arg2_id": "NCT01774019_exc_T5", "normalized": [] }, { "id": "NCT01774019_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01774019_exc_T12", "arg2_id": "NCT01774019_exc_T13", "normalized": [] }, { "id": "NCT01774019_exc_R7", "type": "Has_negation", "arg1_id": "NCT01774019_exc_T12", "arg2_id": "NCT01774019_exc_T14", "normalized": [] }, { "id": "NCT01774019_exc_R8", "type": "AND", "arg1_id": "NCT01774019_exc_T11", "arg2_id": "NCT01774019_exc_T12", "normalized": [] }, { "id": "NCT01774019_exc_R9", "type": "AND", "arg1_id": "NCT01774019_exc_T15", "arg2_id": "NCT01774019_exc_T16", "normalized": [] }, { "id": "NCT01774019_exc_R10", "type": "Has_temporal", "arg1_id": "NCT01774019_exc_T18", "arg2_id": "NCT01774019_exc_T19", "normalized": [] }, { "id": "NCT01774019_exc_R11", "type": "AND", "arg1_id": "NCT01774019_exc_T20", "arg2_id": "NCT01774019_exc_T21", "normalized": [] } ]

[ { "id": "NCT01774019_inc_text", "type": "inclusion", "text": [ "Age 18 or older\nWilling and able to comply with the study procedures and provide written informed consent to participate in the study\nDiagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)\nBiliary obstructive symptoms or signs\nBilirubin level at/above 100 umol per liter (5.8 mg/dL)\nDistal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy\nLocation of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum\nPatients deemed as resectable by pancreatic protocol CT or MRI\nSurgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion\nSurgery intent within 4 weeks\nEndoscopic and surgical treatment to be provided by same team\n" ], "offsets": [ [ 0, 880 ] ] } ]

[ { "id": "NCT01774019_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T2", "type": "Value", "text": [ "18 or older" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T4", "type": "Condition", "text": [ "pancreatic cancer" ], "offsets": [ [ 156, 173 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T5", "type": "Mood", "text": [ "probable" ], "offsets": [ [ 147, 155 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T6", "type": "Condition", "text": [ "distal common bile duct (CBD) cholangiocarcinoma" ], "offsets": [ [ 175, 223 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T7", "type": "Condition", "text": [ "periampullary cancers" ], "offsets": [ [ 234, 255 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T8", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 228, 233 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T9", "type": "Scope", "text": [ "pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers" ], "offsets": [ [ 156, 255 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T10", "type": "Condition", "text": [ "Biliary obstructive symptoms" ], "offsets": [ [ 281, 309 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T11", "type": "Condition", "text": [ "iary obstructive sy", "ns\nBi" ], "offsets": [ [ 284, 303 ], [ 316, 321 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T12", "type": "Measurement", "text": [ "Bilirubin level" ], "offsets": [ [ 319, 334 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T13", "type": "Value", "text": [ "at/above 100 umol per liter" ], "offsets": [ [ 335, 362 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T14", "type": "Value", "text": [ "bove 100", "mg/dL)\nDi" ], "offsets": [ [ 339, 347 ], [ 368, 377 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T15", "type": "Condition", "text": [ "Distal biliary obstruction" ], "offsets": [ [ 375, 401 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T16", "type": "Condition", "text": [ "pancreatic cancer" ], "offsets": [ [ 418, 435 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T17", "type": "Condition", "text": [ "distal CBD cholangiocarcinoma" ], "offsets": [ [ 437, 466 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T18", "type": "Condition", "text": [ "periampullary malignancy" ], "offsets": [ [ 476, 500 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T19", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 470, 475 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T20", "type": "Condition", "text": [ "distal biliary obstruction" ], "offsets": [ [ 513, 539 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T21", "type": "Procedure", "text": [ "stent" ], "offsets": [ [ 590, 595 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T22", "type": "Mood", "text": [ "would allow" ], "offsets": [ [ 556, 567 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T23", "type": "Qualifier", "text": [ "at least 2cm from the hilum" ], "offsets": [ [ 613, 640 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T24", "type": "Condition", "text": [ "deemed as resectable" ], "offsets": [ [ 650, 670 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T25", "type": "Procedure", "text": [ "pancreatic protocol CT" ], "offsets": [ [ 674, 696 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T26", "type": "Procedure", "text": [ "tic protocol CT or", "gic" ], "offsets": [ [ 681, 699 ], [ 707, 710 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T27", "type": "Scope", "text": [ "pancreatic protocol CT or MRI" ], "offsets": [ [ 674, 703 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T28", "type": "Condition", "text": [ "Surgical candidate" ], "offsets": [ [ 704, 722 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T29", "type": "Qualifier", "text": [ "per pancreatobiliary surgeon" ], "offsets": [ [ 723, 751 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T30", "type": "Procedure", "text": [ "Surgery" ], "offsets": [ [ 788, 795 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T31", "type": "Mood", "text": [ "intent" ], "offsets": [ [ 796, 802 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T32", "type": "Temporal", "text": [ "within 4 weeks" ], "offsets": [ [ 803, 817 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T33", "type": "Procedure", "text": [ "surgical treatment" ], "offsets": [ [ 833, 851 ] ], "normalized": [] }, { "id": "NCT01774019_inc_T34", "type": "Procedure", "text": [ " and surg", "to be pro" ], "offsets": [ [ 828, 837 ], [ 852, 861 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01774019_inc_R1", "type": "Has_value", "arg1_id": "NCT01774019_inc_T1", "arg2_id": "NCT01774019_inc_T2", "normalized": [] }, { "id": "NCT01774019_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01774019_inc_T7", "arg2_id": "NCT01774019_inc_T8", "normalized": [] }, { "id": "NCT01774019_inc_R3", "type": "Has_mood", "arg1_id": "NCT01774019_inc_T9", "arg2_id": "NCT01774019_inc_T5", "normalized": [] }, { "id": "NCT01774019_inc_R4", "type": "Subsumes", "arg1_id": "NCT01774019_inc_T13", "arg2_id": "NCT01774019_inc_T14", "normalized": [] }, { "id": "NCT01774019_inc_R5", "type": "Has_value", "arg1_id": "NCT01774019_inc_T12", "arg2_id": "NCT01774019_inc_T13", "normalized": [] }, { "id": "NCT01774019_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01774019_inc_T18", "arg2_id": "NCT01774019_inc_T19", "normalized": [] }, { "id": "NCT01774019_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT01774019_inc_T21", "arg2_id": "NCT01774019_inc_T23", "normalized": [] }, { "id": "NCT01774019_inc_R8", "type": "Has_mood", "arg1_id": "NCT01774019_inc_T21", "arg2_id": "NCT01774019_inc_T22", "normalized": [] }, { "id": "NCT01774019_inc_R9", "type": "AND", "arg1_id": "NCT01774019_inc_T27", "arg2_id": "NCT01774019_inc_T24", "normalized": [] }, { "id": "NCT01774019_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT01774019_inc_T28", "arg2_id": "NCT01774019_inc_T29", "normalized": [] }, { "id": "NCT01774019_inc_R11", "type": "Has_mood", "arg1_id": "NCT01774019_inc_T30", "arg2_id": "NCT01774019_inc_T31", "normalized": [] }, { "id": "NCT01774019_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01774019_inc_T30", "arg2_id": "NCT01774019_inc_T32", "normalized": [] } ]

[ { "id": "NCT01793519_exc_text", "type": "exclusion", "text": [ "Had dose increase of anti-TNF agent or DMARD in the last 6 months\nHad change of anti-TNF agent or DMARD in the last 6 months\nTreated currently with golimumab or certolizumab\nTreated with greater than 10 mg of prednisone (or equivalent) daily in the last 6 months\nTreated with greater than 5 mg of prednisone (or equivalent) daily in the last 3 months\nTreated with intramuscular or intravenous corticosteroids in the last 6 months for RA activity\nTreated with anakinra, abatacept, or tocilizumab in the last 6 months\nTreated with rituximab in the last 12 months\nTreated with an investigational RA drug in the last 6 months\nPregnant (or anticipate pregnancy during the study period) or lactating women\nAbsence of documentation in the medical record of clinical remission for the last 6 months\nUnwilling to discontinue anti-TNF agent\nAbsence of documentation of negative tuberculin skin test, negative QuantiFERON-TB Gold test, or treatment for latent tuberculosis prior to starting treatment with the anti-TNF agent\nTreatment of solid malignancy or non-melanoma skin cancer within the past 5 years, or any history of melanoma or hematologic or lymphoproliferative malignancy\nAbsence of documentation of age-appropriate cancer screening at the time of randomization\nAbsence of documentation of negative hepatitis B serologies, absence of completion of treatment for chronic hepatitis B, or absence of suppressive antiviral treatment\nUnable to provide informed consent\nAnticipate not being available or able to comply with the schedule of study visits\n" ], "offsets": [ [ 0, 1548 ] ] } ]

[ { "id": "NCT01793519_exc_T1", "type": "Drug", "text": [ "anti-TNF agent" ], "offsets": [ [ 21, 35 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T2", "type": "Drug", "text": [ "DMARD" ], "offsets": [ [ 39, 44 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T3", "type": "Multiplier", "text": [ "dose increase" ], "offsets": [ [ 4, 17 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T4", "type": "Scope", "text": [ "anti-TNF agent or DMARD" ], "offsets": [ [ 21, 44 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T5", "type": "Drug", "text": [ "anti-TNF agent" ], "offsets": [ [ 80, 94 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T6", "type": "Drug", "text": [ "DMARD" ], "offsets": [ [ 98, 103 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T7", "type": "Procedure", "text": [ "change" ], "offsets": [ [ 70, 76 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T8", "type": "Scope", "text": [ "anti-TNF agent or DMARD" ], "offsets": [ [ 80, 103 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T9", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 45, 65 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T10", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 104, 124 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T11", "type": "Drug", "text": [ "golimumab" ], "offsets": [ [ 148, 157 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T12", "type": "Drug", "text": [ "certolizumab" ], "offsets": [ [ 161, 173 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T13", "type": "Multiplier", "text": [ "greater than 10 mg" ], "offsets": [ [ 187, 205 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T14", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 209, 219 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T15", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 236, 241 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T16", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 242, 262 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T17", "type": "Multiplier", "text": [ "greater than 5 mg" ], "offsets": [ [ 276, 293 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T18", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 297, 307 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T19", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 324, 329 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T20", "type": "Temporal", "text": [ "in the last 3 months" ], "offsets": [ [ 330, 350 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T21", "type": "Qualifier", "text": [ "intramuscular" ], "offsets": [ [ 364, 377 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T22", "type": "Qualifier", "text": [ "intravenous" ], "offsets": [ [ 381, 392 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T23", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 393, 408 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T24", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 409, 429 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T25", "type": "Condition", "text": [ "RA" ], "offsets": [ [ 434, 436 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T26", "type": "Scope", "text": [ "intramuscular or intravenous" ], "offsets": [ [ 364, 392 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T27", "type": "Drug", "text": [ "anakinra" ], "offsets": [ [ 459, 467 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T28", "type": "Drug", "text": [ "abatacept" ], "offsets": [ [ 469, 478 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T29", "type": "Drug", "text": [ "tocilizumab" ], "offsets": [ [ 483, 494 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T30", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 495, 515 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T31", "type": "Scope", "text": [ "anakinra, abatacept, or tocilizumab" ], "offsets": [ [ 459, 494 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T32", "type": "Drug", "text": [ "rituximab" ], "offsets": [ [ 529, 538 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T33", "type": "Temporal", "text": [ "in the last 12 months" ], "offsets": [ [ 539, 560 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T34", "type": "Qualifier", "text": [ "investigational" ], "offsets": [ [ 577, 592 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T35", "type": "Drug", "text": [ "RA drug" ], "offsets": [ [ 593, 600 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T36", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 601, 621 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T37", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 622, 630 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T38", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 684, 693 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T39", "type": "Person", "text": [ "women" ], "offsets": [ [ 694, 699 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T40", "type": "Mood", "text": [ "e pregnanc", "e study period) or lact" ], "offsets": [ [ 644, 654 ], [ 665, 688 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T41", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 646, 655 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T42", "type": "Negation", "text": [ "Absence of" ], "offsets": [ [ 700, 710 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T43", "type": "Condition", "text": [ "clinical remission" ], "offsets": [ [ 750, 768 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T44", "type": "Temporal", "text": [ "for the last 6 months" ], "offsets": [ [ 769, 790 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T45", "type": "Mood", "text": [ "Unwilling" ], "offsets": [ [ 791, 800 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T46", "type": "Procedure", "text": [ "discontinue" ], "offsets": [ [ 804, 815 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T47", "type": "Drug", "text": [ "anti-TNF agent" ], "offsets": [ [ 816, 830 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T48", "type": "Negation", "text": [ "Absence of" ], "offsets": [ [ 831, 841 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T49", "type": "Value", "text": [ "negative" ], "offsets": [ [ 859, 867 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T50", "type": "Procedure", "text": [ "tuberculin skin test" ], "offsets": [ [ 868, 888 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T51", "type": "Value", "text": [ "negative" ], "offsets": [ [ 890, 898 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T52", "type": "Measurement", "text": [ "QuantiFERON-TB Gold test" ], "offsets": [ [ 899, 923 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T53", "type": "Qualifier", "text": [ "latent" ], "offsets": [ [ 942, 948 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T54", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 949, 961 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T55", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 928, 937 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T56", "type": "Temporal", "text": [ "prior to starting treatment with the anti-TNF agent" ], "offsets": [ [ 962, 1013 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T57", "type": "Reference_point", "text": [ "starting treatment with the anti-TNF agent" ], "offsets": [ [ 971, 1013 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T58", "type": "Procedure", "text": [ "treatment with the anti-TNF agent" ], "offsets": [ [ 980, 1013 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T59", "type": "Drug", "text": [ "anti-TNF agent" ], "offsets": [ [ 999, 1013 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T60", "type": "Condition", "text": [ "solid malignancy" ], "offsets": [ [ 1027, 1043 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T61", "type": "Condition", "text": [ "non-melanoma skin cancer" ], "offsets": [ [ 1047, 1071 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T62", "type": "Temporal", "text": [ "within the past 5 years" ], "offsets": [ [ 1072, 1095 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T63", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 1115, 1123 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T64", "type": "Condition", "text": [ "hematologic" ], "offsets": [ [ 1127, 1138 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T65", "type": "Condition", "text": [ "lymphoproliferative malignancy" ], "offsets": [ [ 1142, 1172 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T67", "type": "Scope", "text": [ "solid malignancy or non-melanoma skin cancer" ], "offsets": [ [ 1027, 1071 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T66", "type": "Procedure", "text": [ "cancer screening" ], "offsets": [ [ 1217, 1233 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T68", "type": "Qualifier", "text": [ "age-appropriate" ], "offsets": [ [ 1201, 1216 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T69", "type": "Temporal", "text": [ "at the time of randomization" ], "offsets": [ [ 1234, 1262 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T70", "type": "Reference_point", "text": [ "the time of randomization" ], "offsets": [ [ 1237, 1262 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T71", "type": "Measurement", "text": [ "hepatitis B serologies" ], "offsets": [ [ 1300, 1322 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T72", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1291, 1299 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T73", "type": "Negation", "text": [ "Absence of" ], "offsets": [ [ 1263, 1273 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T74", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1349, 1358 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T75", "type": "Condition", "text": [ "chronic hepatitis B" ], "offsets": [ [ 1363, 1382 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T76", "type": "Negation", "text": [ "absence of" ], "offsets": [ [ 1324, 1334 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T78", "type": "Procedure", "text": [ "suppressive antiviral treatment" ], "offsets": [ [ 1398, 1429 ] ], "normalized": [] }, { "id": "NCT01793519_exc_T79", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 1387, 1394 ] ], "normalized": [] } ]

[]

[]

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"NCT01793519_exc_R8", "type": "Has_multiplier", "arg1_id": "NCT01793519_exc_T18", "arg2_id": "NCT01793519_exc_T17", "normalized": [] }, { "id": "NCT01793519_exc_R9", "type": "Has_multiplier", "arg1_id": "NCT01793519_exc_T18", "arg2_id": "NCT01793519_exc_T19", "normalized": [] }, { "id": "NCT01793519_exc_R10", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T18", "arg2_id": "NCT01793519_exc_T20", "normalized": [] }, { "id": "NCT01793519_exc_R11", "type": "Has_scope", "arg1_id": "NCT01793519_exc_T23", "arg2_id": "NCT01793519_exc_T26", "normalized": [] }, { "id": "NCT01793519_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T23", "arg2_id": "NCT01793519_exc_T24", "normalized": [] }, { "id": "NCT01793519_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T31", "arg2_id": "NCT01793519_exc_T30", "normalized": [] }, { "id": "NCT01793519_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T32", "arg2_id": "NCT01793519_exc_T33", "normalized": [] }, { "id": "NCT01793519_exc_R15", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T35", "arg2_id": "NCT01793519_exc_T36", "normalized": [] }, { "id": "NCT01793519_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT01793519_exc_T35", "arg2_id": "NCT01793519_exc_T34", "normalized": [] }, { "id": "NCT01793519_exc_R17", "type": "Has_mood", "arg1_id": "NCT01793519_exc_T41", "arg2_id": "NCT01793519_exc_T40", "normalized": [] }, { "id": "NCT01793519_exc_R18", "type": "Subsumes", "arg1_id": "NCT01793519_exc_T37", "arg2_id": "NCT01793519_exc_T41", "normalized": [] }, { "id": "NCT01793519_exc_R19", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T43", "arg2_id": "NCT01793519_exc_T44", "normalized": [] }, { "id": "NCT01793519_exc_R20", "type": "Has_negation", "arg1_id": "NCT01793519_exc_T43", "arg2_id": "NCT01793519_exc_T42", "normalized": [] }, { "id": "NCT01793519_exc_R21", "type": "AND", "arg1_id": "NCT01793519_exc_T46", "arg2_id": "NCT01793519_exc_T47", "normalized": [] }, { "id": "NCT01793519_exc_R22", "type": "Has_mood", "arg1_id": "NCT01793519_exc_T46", "arg2_id": "NCT01793519_exc_T45", "normalized": [] }, { "id": "NCT01793519_exc_R23", "type": "Has_value", "arg1_id": "NCT01793519_exc_T50", "arg2_id": "NCT01793519_exc_T49", "normalized": [] }, { "id": "NCT01793519_exc_R24", "type": "Has_negation", "arg1_id": "NCT01793519_exc_T50", "arg2_id": "NCT01793519_exc_T48", "normalized": [] }, { "id": "NCT01793519_exc_R25", "type": "Has_value", "arg1_id": "NCT01793519_exc_T52", "arg2_id": "NCT01793519_exc_T51", "normalized": [] }, { "id": "NCT01793519_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT01793519_exc_T54", "arg2_id": "NCT01793519_exc_T53", "normalized": [] }, { "id": "NCT01793519_exc_R27", "type": "AND", "arg1_id": "NCT01793519_exc_T55", "arg2_id": "NCT01793519_exc_T54", "normalized": [] }, { "id": "NCT01793519_exc_R30", "type": "Has_index", "arg1_id": "NCT01793519_exc_T56", "arg2_id": "NCT01793519_exc_T57", "normalized": [] }, { "id": "NCT01793519_exc_R31", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T55", "arg2_id": "NCT01793519_exc_T56", "normalized": [] }, { "id": "NCT01793519_exc_R32", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T67", "arg2_id": "NCT01793519_exc_T62", "normalized": [] }, { "id": "NCT01793519_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT01793519_exc_T66", "arg2_id": "NCT01793519_exc_T68", "normalized": [] }, { "id": "NCT01793519_exc_R34", "type": "Has_index", "arg1_id": "NCT01793519_exc_T69", "arg2_id": "NCT01793519_exc_T70", "normalized": [] }, { "id": "NCT01793519_exc_R35", "type": "Has_temporal", "arg1_id": "NCT01793519_exc_T66", "arg2_id": "NCT01793519_exc_T69", "normalized": [] }, { "id": "NCT01793519_exc_R36", "type": "Has_value", "arg1_id": "NCT01793519_exc_T71", "arg2_id": "NCT01793519_exc_T72", "normalized": [] }, { "id": "NCT01793519_exc_R37", "type": "Has_negation", "arg1_id": "NCT01793519_exc_T71", "arg2_id": "NCT01793519_exc_T73", "normalized": [] }, { "id": "NCT01793519_exc_R38", "type": "AND", "arg1_id": "NCT01793519_exc_T74", "arg2_id": "NCT01793519_exc_T75", "normalized": [] }, { "id": "NCT01793519_exc_R39", "type": "Has_negation", "arg1_id": "NCT01793519_exc_T78", "arg2_id": "NCT01793519_exc_T79", "normalized": [] }, { "id": "NCT01793519_exc_R40", "type": "Has_negation", "arg1_id": "NCT01793519_exc_T75", "arg2_id": "NCT01793519_exc_T76", "normalized": [] } ]

[ { "id": "NCT01793519_inc_text", "type": "inclusion", "text": [ "Age greater than or equal to 18 years\nHave RA, as defined by the 1987 revised American College of Rheumatology criteria\nIn sustained clinical remission for the last 6 months while receiving treatment with either etanercept, infliximab, or adalimumab, and greater than or equal to 1 DMARD (methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, minocycline, cyclosporine, azathioprine, gold, penicillamine). DAS28 should be less than 2.6 on each visit over the preceding 6 months, with at least one visit 2-4 months before enrollment. If there is no visit 6 months before enrollment, the nearest visit in the 6-12 month period before enrollment should be considered and have a DAS28 less than 2.6.\n" ], "offsets": [ [ 0, 704 ] ] } ]

[ { "id": "NCT01793519_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T2", "type": "Value", "text": [ "greater than or equal to 18 years" ], "offsets": [ [ 4, 37 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T3", "type": "Condition", "text": [ "RA" ], "offsets": [ [ 43, 45 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T4", "type": "Qualifier", "text": [ "1987 revised American College of Rheumatology criteria" ], "offsets": [ [ 65, 119 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T5", "type": "Condition", "text": [ "sustained clinical remission" ], "offsets": [ [ 123, 151 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T6", "type": "Multiplier", "text": [ "for the last 6 months" ], "offsets": [ [ 152, 173 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T7", "type": "Drug", "text": [ "etanercept" ], "offsets": [ [ 212, 222 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T8", "type": "Drug", "text": [ "infliximab" ], "offsets": [ [ 224, 234 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T9", "type": "Drug", "text": [ "adalimumab" ], "offsets": [ [ 239, 249 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T10", "type": "Multiplier", "text": [ "greater than or equal to 1" ], "offsets": [ [ 255, 281 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T11", "type": "Drug", "text": [ "DMARD" ], "offsets": [ [ 282, 287 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T12", "type": "Drug", "text": [ "methotrexate" ], "offsets": [ [ 289, 301 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T13", "type": "Drug", "text": [ "hydroxychloroquine" ], "offsets": [ [ 303, 321 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T14", "type": "Drug", "text": [ "sulfasalazine" ], "offsets": [ [ 323, 336 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T15", "type": "Drug", "text": [ "leflunomide" ], "offsets": [ [ 338, 349 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T16", "type": "Drug", "text": [ "minocycline" ], "offsets": [ [ 351, 362 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T17", "type": "Drug", "text": [ "cyclosporine" ], "offsets": [ [ 364, 376 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T18", "type": "Drug", "text": [ "azathioprine" ], "offsets": [ [ 378, 390 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T19", "type": "Drug", "text": [ "gold" ], "offsets": [ [ 392, 396 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T20", "type": "Drug", "text": [ "penicillamine" ], "offsets": [ [ 398, 411 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T21", "type": "Scope", "text": [ "methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, minocycline, cyclosporine, azathioprine, gold, penicillamine" ], "offsets": [ [ 289, 411 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T22", "type": "Measurement", "text": [ "DAS28" ], "offsets": [ [ 414, 419 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T23", "type": "Value", "text": [ "less than 2.6" ], "offsets": [ [ 430, 443 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T24", "type": "Multiplier", "text": [ "over the preceding 6 months" ], "offsets": [ [ 458, 485 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T25", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 492, 504 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T26", "type": "Procedure", "text": [ "visit" ], "offsets": [ [ 505, 510 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T27", "type": "Procedure", "text": [ "visit" ], "offsets": [ [ 452, 457 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T28", "type": "Multiplier", "text": [ "on each visit" ], "offsets": [ [ 444, 457 ] ], "normalized": [] }, { "id": "NCT01793519_inc_T29", "type": "Temporal", "text": [ "2-4 months before enrollment" ], "offsets": [ [ 511, 539 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01793519_inc_R1", "type": "Has_value", "arg1_id": "NCT01793519_inc_T1", "arg2_id": "NCT01793519_inc_T2", "normalized": [] }, { "id": "NCT01793519_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01793519_inc_T3", "arg2_id": "NCT01793519_inc_T4", "normalized": [] }, { "id": "NCT01793519_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT01793519_inc_T5", "arg2_id": "NCT01793519_inc_T6", "normalized": [] }, { "id": "NCT01793519_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT01793519_inc_T11", "arg2_id": "NCT01793519_inc_T10", "normalized": [] }, { "id": "NCT01793519_inc_R5", "type": "Subsumes", "arg1_id": "NCT01793519_inc_T11", "arg2_id": "NCT01793519_inc_T21", "normalized": [] }, { "id": "NCT01793519_inc_R6", "type": "Has_value", "arg1_id": "NCT01793519_inc_T22", "arg2_id": "NCT01793519_inc_T23", "normalized": [] }, { "id": "NCT01793519_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT01793519_inc_T26", "arg2_id": "NCT01793519_inc_T25", "normalized": [] }, { "id": "NCT01793519_inc_R11", "type": "Has_temporal", "arg1_id": "NCT01793519_inc_T26", "arg2_id": "NCT01793519_inc_T29", "normalized": [] }, { "id": "NCT01793519_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01793519_inc_T22", "arg2_id": "NCT01793519_inc_T28", "normalized": [] }, { "id": "NCT01793519_inc_R9", "type": "Has_multiplier", "arg1_id": "NCT01793519_inc_T22", "arg2_id": "NCT01793519_inc_T24", "normalized": [] } ]

[ { "id": "NCT01793831_exc_text", "type": "exclusion", "text": [ "Diagnosis as CD first time or first year.\nNo history of using 5-ASA, biological or immunomodulatory therapy\n" ], "offsets": [ [ 0, 108 ] ] } ]

[ { "id": "NCT01793831_exc_T1", "type": "Condition", "text": [ "CD" ], "offsets": [ [ 13, 15 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T2", "type": "Qualifier", "text": [ "first time" ], "offsets": [ [ 16, 26 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T3", "type": "Qualifier", "text": [ "first year" ], "offsets": [ [ 30, 40 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T4", "type": "Scope", "text": [ "first time or first year" ], "offsets": [ [ 16, 40 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T5", "type": "Negation", "text": [ "No" ], "offsets": [ [ 42, 44 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 45, 52 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T7", "type": "Drug", "text": [ "5-ASA" ], "offsets": [ [ 62, 67 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T8", "type": "Procedure", "text": [ "herapy", "iological" ], "offsets": [ [ 101, 107 ], [ 70, 79 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T9", "type": "Procedure", "text": [ "immunomodulatory therapy" ], "offsets": [ [ 83, 107 ] ], "normalized": [] }, { "id": "NCT01793831_exc_T10", "type": "Scope", "text": [ "5-ASA, biological or immunomodulatory therapy" ], "offsets": [ [ 62, 107 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01793831_exc_R1", "type": "Has_scope", "arg1_id": "NCT01793831_exc_T1", "arg2_id": "NCT01793831_exc_T4", "normalized": [] }, { "id": "NCT01793831_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01793831_exc_T10", "arg2_id": "NCT01793831_exc_T6", "normalized": [] }, { "id": "NCT01793831_exc_R3", "type": "Has_negation", "arg1_id": "NCT01793831_exc_T10", "arg2_id": "NCT01793831_exc_T5", "normalized": [] } ]

[ { "id": "NCT01793831_inc_text", "type": "inclusion", "text": [ "Moderate to severe CD define as HBI score > 4.\nMontreal classification: no limitation, except age> 6.\n" ], "offsets": [ [ 0, 102 ] ] } ]

[ { "id": "NCT01793831_inc_T1", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T2", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T3", "type": "Condition", "text": [ "CD" ], "offsets": [ [ 19, 21 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T4", "type": "Measurement", "text": [ "HBI score" ], "offsets": [ [ 32, 41 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T5", "type": "Value", "text": [ "> 4" ], "offsets": [ [ 42, 45 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T6", "type": "Scope", "text": [ "Moderate to severe" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01793831_inc_T7", "type": "Scope", "text": [ "HBI score > 4" ], "offsets": [ [ 32, 45 ] ], "normalized": [] } ]

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[ { "id": "NCT01793831_inc_R1", "type": "Has_value", "arg1_id": "NCT01793831_inc_T4", "arg2_id": "NCT01793831_inc_T5", "normalized": [] }, { "id": "NCT01793831_inc_R2", "type": "Has_scope", "arg1_id": "NCT01793831_inc_T3", "arg2_id": "NCT01793831_inc_T6", "normalized": [] }, { "id": "NCT01793831_inc_R3", "type": "Subsumes", "arg1_id": "NCT01793831_inc_T6", "arg2_id": "NCT01793831_inc_T7", "normalized": [] } ]

[ { "id": "NCT01794793_exc_text", "type": "exclusion", "text": [ "Patient has been permanently discontinued from pasireotide study 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 pasireotide was dispensed in combination with another study medication and is still receiving combination therapy. (only patients receiving pasireotide monotherapy can be included)\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\nTotal abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\nFemale sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\nMale sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.\nUse of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception\nPlacement of an intrauterine device (IUD) or intrauterine system (IUS)\nBarrier methods of contraception: Condom or Occlusive cap diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment\nSexually active males unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid If a study patient or partner becomes pregnant or suspects being pregnant during the study or within 1 month after the final dose of pasireotide s.c. or 3 months after the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately and ongoing study treatment with pasireotide has to be stopped immediately For patients taking pasireotide LAR, the future dose injections will be cancelled.\n" ], "offsets": [ [ 0, 2694 ] ] } ]

[ { "id": "NCT01794793_exc_T5", "type": "Procedure", "text": [ "Female sterilization" ], "offsets": [ [ 889, 909 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T6", "type": "Procedure", "text": [ "bilateral oophorectomy" ], "offsets": [ [ 929, 951 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T7", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 968, 980 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T8", "type": "Procedure", "text": [ "tubal ligation" ], "offsets": [ [ 985, 999 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T9", "type": "Temporal", "text": [ "at least six weeks before taking study treatment" ], "offsets": [ [ 1000, 1048 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T10", "type": "Reference_point", "text": [ "taking study treatment" ], "offsets": [ [ 1026, 1048 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T11", "type": "Scope", "text": [ "Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation" ], "offsets": [ [ 889, 999 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T13", "type": "Procedure", "text": [ "Male sterilization" ], "offsets": [ [ 1185, 1203 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T14", "type": "Temporal", "text": [ "at least 6 months prior to screening" ], "offsets": [ [ 1205, 1241 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T15", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1232, 1241 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T18", "type": "Procedure", "text": [ "hormone vaginal ring" ], "offsets": [ [ 1524, 1544 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T19", "type": "Procedure", "text": [ "transdermal hormone contraception" ], "offsets": [ [ 1548, 1581 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T20", "type": "Device", "text": [ "intrauterine device" ], "offsets": [ [ 1598, 1617 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T21", "type": "Device", "text": [ "IUD" ], "offsets": [ [ 1619, 1622 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T22", "type": "Device", "text": [ "intrauterine system" ], "offsets": [ [ 1627, 1646 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T23", "type": "Device", "text": [ "IUS" ], "offsets": [ [ 1648, 1651 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T24", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 1672, 1685 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T25", "type": "Device", "text": [ "Condom" ], "offsets": [ [ 1687, 1693 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T26", "type": "Device", "text": [ "Occlusive cap diaphragm" ], "offsets": [ [ 1697, 1720 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T27", "type": "Device", "text": [ "vault caps" ], "offsets": [ [ 1733, 1743 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T28", "type": "Device", "text": [ "/vault c", "th s" ], "offsets": [ [ 1732, 1740 ], [ 1747, 1751 ] ], "normalized": [] }, { "id": "NCT01794793_exc_T29", "type": "Procedure", "text": [ "spermicidal foam" ], "offsets": [ [ 1750, 1766 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01794793_exc_R1", "type": "Has_index", "arg1_id": "NCT01794793_exc_T9", "arg2_id": "NCT01794793_exc_T10", "normalized": [] }, { "id": "NCT01794793_exc_R2", "type": "Subsumes", "arg1_id": "NCT01794793_exc_T5", "arg2_id": "NCT01794793_exc_T6", "normalized": [] }, { "id": "NCT01794793_exc_R3", "type": "Subsumes", "arg1_id": "NCT01794793_exc_T5", "arg2_id": "NCT01794793_exc_T7", "normalized": [] }, { "id": "NCT01794793_exc_R4", "type": "Subsumes", "arg1_id": "NCT01794793_exc_T11", "arg2_id": "NCT01794793_exc_T9", "normalized": [] }, { "id": "NCT01794793_exc_R5", "type": "Has_index", "arg1_id": "NCT01794793_exc_T14", "arg2_id": "NCT01794793_exc_T15", "normalized": [] }, { "id": "NCT01794793_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01794793_exc_T13", "arg2_id": "NCT01794793_exc_T14", "normalized": [] }, { "id": "NCT01794793_exc_R7", "type": "Subsumes", "arg1_id": "NCT01794793_exc_T20", "arg2_id": "NCT01794793_exc_T21", "normalized": [] }, { "id": "NCT01794793_exc_R8", "type": "Subsumes", "arg1_id": "NCT01794793_exc_T22", "arg2_id": "NCT01794793_exc_T23", "normalized": [] } ]

[ { "id": "NCT01794793_inc_text", "type": "inclusion", "text": [ "Patient is currently participating in a Novartis Oncology sponsored study receiving pasireotide (LAR and/or s.c.) and has fulfilled all required assessments in the parent study (unless the study is being terminated) and patients that are benefiting from the study drug have no other alternatives\nPatient is currently benefiting from the treatment with pasireotide, as determined by the investigator\nPatient has demonstrated compliance, as assessed by the investigator, with the parent study 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 and receiving study medication • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness\n" ], "offsets": [ [ 0, 845 ] ] } ]

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[]

[ { "id": "NCT01799681_exc_text", "type": "exclusion", "text": [ "any neurological conditions other than PD; \nsignificant musculoskeletal or cardiopulmonary diseases; \nother disorders that may affect balance or locomotion; \ntaken any structured behavioral or exercise programs in the past 3 months \nor they are receiving regular physical rehabilitation at present; \nunstable condition on anti-parkinsonian medications; \nsurgical interventions for PD; \ncommunication or cognitive deficits with mini-mental state examination, (MMSE) <24/30 (Folstein et al., 1975); \na history of more than two falls in the previous 12 months. \n \n" ], "offsets": [ [ 0, 570 ] ] } ]

[ { "id": "NCT01799681_exc_T1", "type": "Condition", "text": [ "neurological conditions" ], "offsets": [ [ 4, 27 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T2", "type": "Condition", "text": [ "PD" ], "offsets": [ [ 39, 41 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T3", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 28, 38 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T4", "type": "Condition", "text": [ "cardiopulmonary diseases" ], "offsets": [ [ 75, 99 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T5", "type": "Condition", "text": [ "musculoskeletal", "diseases" ], "offsets": [ [ 56, 71 ], [ 91, 99 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T6", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 44, 55 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T9", "type": "Scope", "text": [ "musculoskeletal or cardiopulmonary diseases" ], "offsets": [ [ 56, 99 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T10", "type": "Condition", "text": [ "disorders that may affect balance or locomotion" ], "offsets": [ [ 108, 155 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T12", "type": "Procedure", "text": [ "structured", "exercise programs" ], "offsets": [ [ 168, 178 ], [ 193, 210 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T13", "type": "Procedure", "text": [ "structured behavioral", "programs" ], "offsets": [ [ 168, 189 ], [ 202, 210 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T14", "type": "Temporal", "text": [ "in the past 3 months" ], "offsets": [ [ 211, 231 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T15", "type": "Scope", "text": [ "structured behavioral or exercise programs" ], "offsets": [ [ 168, 210 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T16", "type": "Procedure", "text": [ "regular physical rehabilitation" ], "offsets": [ [ 255, 286 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T17", "type": "Temporal", "text": [ "at present" ], "offsets": [ [ 287, 297 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T18", "type": "Condition", "text": [ "unstable condition" ], "offsets": [ [ 300, 318 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T19", "type": "Drug", "text": [ "anti-parkinsonian medications" ], "offsets": [ [ 322, 351 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T21", "type": "Procedure", "text": [ "surgical interventions for PD" ], "offsets": [ [ 354, 383 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T22", "type": "Condition", "text": [ "PD" ], "offsets": [ [ 381, 383 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T23", "type": "Condition", "text": [ "cognitive deficits" ], "offsets": [ [ 403, 421 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T24", "type": "Measurement", "text": [ "mini-mental state examination, (MMSE)" ], "offsets": [ [ 427, 464 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T25", "type": "Value", "text": [ "<24/30" ], "offsets": [ [ 465, 471 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T26", "type": "Condition", "text": [ "communication", "deficits" ], "offsets": [ [ 386, 399 ], [ 413, 421 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T27", "type": "Scope", "text": [ "communication or cognitive deficits" ], "offsets": [ [ 386, 421 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T28", "type": "Multiplier", "text": [ "more than two" ], "offsets": [ [ 511, 524 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T29", "type": "Condition", "text": [ "falls" ], "offsets": [ [ 525, 530 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T30", "type": "Temporal", "text": [ "in the previous 12 months" ], "offsets": [ [ 531, 556 ] ], "normalized": [] }, { "id": "NCT01799681_exc_T31", "type": "Observation", "text": [ "history" ], "offsets": [ [ 500, 507 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01799681_exc_R1", "type": "Has_negation", "arg1_id": "NCT01799681_exc_T2", "arg2_id": "NCT01799681_exc_T3", "normalized": [] }, { "id": "NCT01799681_exc_R2", "type": "AND", "arg1_id": "NCT01799681_exc_T1", "arg2_id": "NCT01799681_exc_T2", "normalized": [] }, { "id": "NCT01799681_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01799681_exc_T9", "arg2_id": "NCT01799681_exc_T6", "normalized": [] }, { "id": "NCT01799681_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01799681_exc_T15", "arg2_id": "NCT01799681_exc_T14", "normalized": [] }, { "id": "NCT01799681_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01799681_exc_T16", "arg2_id": "NCT01799681_exc_T17", "normalized": [] }, { "id": "NCT01799681_exc_R6", "type": "AND", "arg1_id": "NCT01799681_exc_T18", "arg2_id": "NCT01799681_exc_T19", "normalized": [] }, { "id": "NCT01799681_exc_R7", "type": "AND", "arg1_id": "NCT01799681_exc_T21", "arg2_id": "NCT01799681_exc_T22", "normalized": [] }, { "id": "NCT01799681_exc_R8", "type": "Has_value", "arg1_id": "NCT01799681_exc_T24", "arg2_id": "NCT01799681_exc_T25", "normalized": [] }, { "id": "NCT01799681_exc_R9", "type": "AND", "arg1_id": "NCT01799681_exc_T27", "arg2_id": "NCT01799681_exc_T24", "normalized": [] }, { "id": "NCT01799681_exc_R10", "type": "Has_multiplier", "arg1_id": "NCT01799681_exc_T29", "arg2_id": "NCT01799681_exc_T28", "normalized": [] }, { "id": "NCT01799681_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01799681_exc_T29", "arg2_id": "NCT01799681_exc_T30", "normalized": [] }, { "id": "NCT01799681_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01799681_exc_T29", "arg2_id": "NCT01799681_exc_T31", "normalized": [] } ]

[ { "id": "NCT01799681_inc_text", "type": "inclusion", "text": [ "diagnosed with PD by a neurologist (Fahn and Elton, 1987); \naged 30 to 85 years; \nat modified Hoehn and Yahr (H&Y) stage 1.5 to 3 (Hoehn and Yahr ,1967; Goetz et al., 2004); \nable and willing to give written consent for participation in the study; \nliving at home in the community; \nable to walk independently for 30 metres with or without an assistive device. \n" ], "offsets": [ [ 0, 362 ] ] } ]

[ { "id": "NCT01799681_inc_T1", "type": "Condition", "text": [ "PD" ], "offsets": [ [ 15, 17 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T2", "type": "Qualifier", "text": [ "by a neurologist" ], "offsets": [ [ 18, 34 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 60, 64 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T5", "type": "Value", "text": [ "30 to 85 years" ], "offsets": [ [ 65, 79 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T6", "type": "Measurement", "text": [ "modified Hoehn and Yahr (H&Y)" ], "offsets": [ [ 85, 114 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T7", "type": "Value", "text": [ "stage 1.5 to 3" ], "offsets": [ [ 115, 129 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T10", "type": "Observation", "text": [ "living at home in the community" ], "offsets": [ [ 249, 280 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T11", "type": "Condition", "text": [ "able to walk independently", "with or without an assistive device" ], "offsets": [ [ 283, 309 ], [ 324, 359 ] ], "normalized": [] }, { "id": "NCT01799681_inc_T12", "type": "Multiplier", "text": [ "for 30 metres" ], "offsets": [ [ 310, 323 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01799681_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01799681_inc_T1", "arg2_id": "NCT01799681_inc_T2", "normalized": [] }, { "id": "NCT01799681_inc_R2", "type": "Has_value", "arg1_id": "NCT01799681_inc_T4", "arg2_id": "NCT01799681_inc_T5", "normalized": [] }, { "id": "NCT01799681_inc_R3", "type": "Has_value", "arg1_id": "NCT01799681_inc_T6", "arg2_id": "NCT01799681_inc_T7", "normalized": [] }, { "id": "NCT01799681_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT01799681_inc_T11", "arg2_id": "NCT01799681_inc_T12", "normalized": [] } ]

[ { "id": "NCT01801072_exc_text", "type": "exclusion", "text": [ "History of seizures within last 10 years\nHistory of epilepsy\nHistory of prior stroke\nCurrently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.)\nBrain tumor\nPregnant or nursing woman\nKnown levetiracetam allergy\n" ], "offsets": [ [ 0, 266 ] ] } ]

[ { "id": "NCT01801072_exc_T1", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 11, 19 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T2", "type": "Temporal", "text": [ "within last 10 years" ], "offsets": [ [ 20, 40 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T3", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 52, 60 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T4", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 78, 84 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T5", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 72, 77 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T6", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 106, 116 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T7", "type": "Qualifier", "text": [ "anti-epileptic activity" ], "offsets": [ [ 122, 145 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T8", "type": "Drug", "text": [ "keppra" ], "offsets": [ [ 147, 153 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T9", "type": "Drug", "text": [ "dilantin" ], "offsets": [ [ 155, 163 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T10", "type": "Drug", "text": [ "tegretol" ], "offsets": [ [ 165, 173 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T11", "type": "Drug", "text": [ "lamictal" ], "offsets": [ [ 175, 183 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T12", "type": "Drug", "text": [ "topamax" ], "offsets": [ [ 185, 192 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T13", "type": "Scope", "text": [ "keppra, dilantin, tegretol, lamictal, topamax" ], "offsets": [ [ 147, 192 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T14", "type": "Scope", "text": [ "medication with anti-epileptic activity" ], "offsets": [ [ 106, 145 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T15", "type": "Condition", "text": [ "Brain tumor" ], "offsets": [ [ 200, 211 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T16", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 212, 220 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T17", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 224, 231 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T18", "type": "Person", "text": [ "woman" ], "offsets": [ [ 232, 237 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T19", "type": "Drug", "text": [ "levetiracetam" ], "offsets": [ [ 244, 257 ] ], "normalized": [] }, { "id": "NCT01801072_exc_T20", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 258, 265 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01801072_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01801072_exc_T1", "arg2_id": "NCT01801072_exc_T2", "normalized": [] }, { "id": "NCT01801072_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01801072_exc_T4", "arg2_id": "NCT01801072_exc_T5", "normalized": [] }, { "id": "NCT01801072_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01801072_exc_T6", "arg2_id": "NCT01801072_exc_T7", "normalized": [] }, { "id": "NCT01801072_exc_R4", "type": "Subsumes", "arg1_id": "NCT01801072_exc_T14", "arg2_id": "NCT01801072_exc_T13", "normalized": [] }, { "id": "NCT01801072_exc_R5", "type": "AND", "arg1_id": "NCT01801072_exc_T20", "arg2_id": "NCT01801072_exc_T19", "normalized": [] } ]

[ { "id": "NCT01801072_inc_text", "type": "inclusion", "text": [ "Adult (=18 years)\nPresence of intracranial aneurysm (with or without rupture)\nTreating surgeon has recommended surgical repair of the aneurysm\n" ], "offsets": [ [ 0, 143 ] ] } ]

[ { "id": "NCT01801072_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T2", "type": "Value", "text": [ "=18 years" ], "offsets": [ [ 7, 16 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 11, 16 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T4", "type": "Scope", "text": [ "=18 years" ], "offsets": [ [ 7, 16 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T5", "type": "Condition", "text": [ "intracranial aneurysm" ], "offsets": [ [ 30, 51 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T6", "type": "Qualifier", "text": [ "without rupture" ], "offsets": [ [ 61, 76 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T7", "type": "Qualifier", "text": [ "ith", "upture)" ], "offsets": [ [ 54, 57 ], [ 70, 77 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T8", "type": "Scope", "text": [ "with or without rupture" ], "offsets": [ [ 53, 76 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T9", "type": "Procedure", "text": [ "surgical repair" ], "offsets": [ [ 111, 126 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T10", "type": "Condition", "text": [ "aneurysm" ], "offsets": [ [ 134, 142 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T11", "type": "Mood", "text": [ "recommended" ], "offsets": [ [ 99, 110 ] ], "normalized": [] }, { "id": "NCT01801072_inc_T12", "type": "Qualifier", "text": [ "Treating surgeon" ], "offsets": [ [ 78, 94 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01801072_inc_R1", "type": "Has_value", "arg1_id": "NCT01801072_inc_T3", "arg2_id": "NCT01801072_inc_T2", "normalized": [] }, { "id": "NCT01801072_inc_R2", "type": "Subsumes", "arg1_id": "NCT01801072_inc_T1", "arg2_id": "NCT01801072_inc_T4", "normalized": [] }, { "id": "NCT01801072_inc_R3", "type": "Has_scope", "arg1_id": "NCT01801072_inc_T5", "arg2_id": "NCT01801072_inc_T8", "normalized": [] }, { "id": "NCT01801072_inc_R4", "type": "AND", "arg1_id": "NCT01801072_inc_T9", "arg2_id": "NCT01801072_inc_T10", "normalized": [] }, { "id": "NCT01801072_inc_R5", "type": "Has_mood", "arg1_id": "NCT01801072_inc_T9", "arg2_id": "NCT01801072_inc_T11", "normalized": [] }, { "id": "NCT01801072_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01801072_inc_T11", "arg2_id": "NCT01801072_inc_T12", "normalized": [] } ]

[ { "id": "NCT01803438_exc_text", "type": "exclusion", "text": [ "Subject has documented typical atrial flutter.\nSubject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.\nSubject had any previous left atrial ablation.\nSubject had any previous cardiac surgery, e.g. prosthetic valves.\nSubject has permanent pacemaker or defibrillator implant.\nSubject has 2° type II, 3° degree AV-block or left/right bundle branch block pattern.\nSubject has unstable angina pectoris.\nSubject has history of previous myocardial infarction or percutaneous intervention during the last three months.\nSubject has symptomatic carotid stenosis.\nSubject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.\nSubject has any contraindication for oral anticoagulation.\nSubject has any history of previous transient ischemic attack or stroke.\nSubject has known intra-cardiac thrombus formation.\nSubject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).\nSubject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.\nSubject has hypertrophic cardiomyopathy.\nSubject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.\nSubject has sarcoidosis.\nSubject has pulmonary vein stent.\nSubject has myxoma. Exclusion criteria based on laboratory abnormalities\nSubject has thrombocytosis (platelet count > 600,000 / µl) or thrombocytopenia (platelet count <100,000 / µl).\nSubject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.\nSubject has renal dysfunction with glomerular filtration rate < 60 ml / min.\nSubject has known cryoglobulinaemia. General exclusion criteria\nSubject has a reversible causes for AF like hyperthyroidism and alcoholism.\nSubject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] (who must have a negative pregnancy test within 1 week of the start of the therapy) or sterile woman can be enrolled.\nSubject is a breastfeeding woman.\nSubject has an active systemic infection.\nSubject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.\nSubject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer, severe bleeding in history or a suspected pro-coagulant state.\nLegal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.\nSubject has a life expectancy of = 1 year.\nSubject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.\n" ], "offsets": [ [ 0, 3335 ] ] } ]

[ { "id": "NCT01803438_exc_T1", "type": "Condition", "text": [ "atrial flutter" ], "offsets": [ [ 31, 45 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T3", "type": "Condition", "text": [ "AF" ], "offsets": [ [ 114, 116 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T4", "type": "Drug", "text": [ "antiarrhythmic" ], "offsets": [ [ 137, 151 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T5", "type": "Drug", "text": [ "sotalol" ], "offsets": [ [ 155, 162 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T6", "type": "Qualifier", "text": [ "class I" ], "offsets": [ [ 122, 129 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T7", "type": "Qualifier", "text": [ "lass", "II" ], "offsets": [ [ 123, 127 ], [ 134, 136 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T8", "type": "Scope", "text": [ "class I or III" ], "offsets": [ [ 122, 136 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T10", "type": "Scope", "text": [ "antiarrhythmic or sotalol" ], "offsets": [ [ 137, 162 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T2", "type": "Procedure", "text": [ "atrial ablation" ], "offsets": [ [ 353, 368 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T11", "type": "Qualifier", "text": [ "left" ], "offsets": [ [ 348, 352 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T12", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 395, 410 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T13", "type": "Device", "text": [ "prosthetic valves" ], "offsets": [ [ 417, 434 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T14", "type": "Device", "text": [ "permanent pacemaker" ], "offsets": [ [ 448, 467 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T15", "type": "Device", "text": [ "defibrillator implant" ], "offsets": [ [ 471, 492 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T16", "type": "Condition", "text": [ "3° degree AV-block" ], "offsets": [ [ 518, 536 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T17", "type": "Condition", "text": [ "pe II, 3°", "ock or l" ], "offsets": [ [ 511, 520 ], [ 533, 541 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T18", "type": "Condition", "text": [ "right bundle branch block" ], "offsets": [ [ 545, 570 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T19", "type": "Condition", "text": [ "righ", "e branch block patt" ], "offsets": [ [ 545, 549 ], [ 556, 575 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T20", "type": "Condition", "text": [ "unstable angina pectoris" ], "offsets": [ [ 592, 616 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T21", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 650, 671 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T22", "type": "Procedure", "text": [ "percutaneous intervention" ], "offsets": [ [ 675, 700 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T23", "type": "Temporal", "text": [ "last three months" ], "offsets": [ [ 712, 729 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T24", "type": "Scope", "text": [ "myocardial infarction or percutaneous intervention" ], "offsets": [ [ 650, 700 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T25", "type": "Condition", "text": [ "carotid stenosis" ], "offsets": [ [ 755, 771 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T26", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 743, 754 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T27", "type": "Condition", "text": [ "chronic obstructive pulmonary disease" ], "offsets": [ [ 785, 822 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T28", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 837, 859 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T29", "type": "Condition", "text": [ "lung disease" ], "offsets": [ [ 897, 909 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T30", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 885, 896 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T31", "type": "Scope", "text": [ "pulmonary hypertension or any other evidence of significant lung disease" ], "offsets": [ [ 837, 909 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T32", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 927, 943 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T33", "type": "Drug", "text": [ "oral anticoagulation" ], "offsets": [ [ 948, 968 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T34", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 1006, 1031 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T35", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 1035, 1041 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T36", "type": "Condition", "text": [ "intra-cardiac thrombus" ], "offsets": [ [ 1061, 1083 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T37", "type": "Condition", "text": [ "congenital heart defect" ], "offsets": [ [ 1123, 1146 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T38", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1111, 1122 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T39", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1165, 1171 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T40", "type": "Condition", "text": [ "patent foramen ovale" ], "offsets": [ [ 1176, 1196 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T41", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 1239, 1263 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T42", "type": "Measurement", "text": [ "NYHA class" ], "offsets": [ [ 1265, 1275 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T43", "type": "Value", "text": [ "II" ], "offsets": [ [ 1281, 1283 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T44", "type": "Value", "text": [ "III" ], "offsets": [ [ 1280, 1283 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T45", "type": "Value", "text": [ "IV" ], "offsets": [ [ 1287, 1289 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T46", "type": "Condition", "text": [ "sinus rhythm" ], "offsets": [ [ 1294, 1306 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T47", "type": "Scope", "text": [ "II, III or IV" ], "offsets": [ [ 1276, 1289 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T48", "type": "Condition", "text": [ "hypertrophic cardiomyopathy" ], "offsets": [ [ 1320, 1347 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T49", "type": "Measurement", "text": [ "QT interval" ], "offsets": [ [ 1384, 1395 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T50", "type": "Qualifier", "text": [ "abnormal" ], "offsets": [ [ 1361, 1369 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T51", "type": "Value", "text": [ "long" ], "offsets": [ [ 1370, 1374 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T52", "type": "Value", "text": [ "short" ], "offsets": [ [ 1378, 1383 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T53", "type": "Condition", "text": [ "Brugada syndrome" ], "offsets": [ [ 1406, 1422 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T54", "type": "Condition", "text": [ "inheriting ion channel disease" ], "offsets": [ [ 1430, 1460 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T55", "type": "Observation", "text": [ "inheriting ion channel disease on the family" ], "offsets": [ [ 1430, 1474 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T56", "type": "Condition", "text": [ "right ventricular dysplasia" ], "offsets": [ [ 1491, 1518 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T57", "type": "Qualifier", "text": [ "arrhythmogenic" ], "offsets": [ [ 1476, 1490 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T58", "type": "Scope", "text": [ "long or short" ], "offsets": [ [ 1370, 1383 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T59", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 1532, 1543 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T60", "type": "Device", "text": [ "pulmonary vein stent" ], "offsets": [ [ 1557, 1577 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T61", "type": "Condition", "text": [ "myxoma" ], "offsets": [ [ 1591, 1597 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T63", "type": "Condition", "text": [ "thrombocytosis" ], "offsets": [ [ 1664, 1678 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T64", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 1680, 1694 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T65", "type": "Value", "text": [ "> 600,000 / µl" ], "offsets": [ [ 1695, 1709 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T66", "type": "Condition", "text": [ "thrombocytopenia" ], "offsets": [ [ 1714, 1730 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T67", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 1732, 1746 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T68", "type": "Value", "text": [ "<100,000 / µl" ], "offsets": [ [ 1747, 1760 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T69", "type": "Condition", "text": [ "hyperthyroidism" ], "offsets": [ [ 1805, 1820 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T70", "type": "Condition", "text": [ "hypothyroidism" ], "offsets": [ [ 1824, 1838 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T71", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 1779, 1788 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T72", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1792, 1804 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T73", "type": "Scope", "text": [ "hyperthyroidism or hypothyroidism" ], "offsets": [ [ 1805, 1838 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T74", "type": "Scope", "text": [ "untreated or uncontrolled" ], "offsets": [ [ 1779, 1804 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T75", "type": "Condition", "text": [ "renal dysfunction" ], "offsets": [ [ 1852, 1869 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T76", "type": "Measurement", "text": [ "glomerular filtration rate" ], "offsets": [ [ 1875, 1901 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T77", "type": "Value", "text": [ "< 60 ml / min" ], "offsets": [ [ 1902, 1915 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T78", "type": "Condition", "text": [ "cryoglobulinaemia" ], "offsets": [ [ 1935, 1952 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T79", "type": "Condition", "text": [ "hyperthyroidism" ], "offsets": [ [ 2025, 2040 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T80", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 2045, 2055 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T83", "type": "Condition", "text": [ "systemic infection" ], "offsets": [ [ 2429, 2447 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T84", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 2422, 2428 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T88", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 3040, 3055 ] ], "normalized": [] }, { "id": "NCT01803438_exc_T89", "type": "Value", "text": [ "= 1 year" ], "offsets": [ [ 3059, 3067 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT01803438_inc_text", "type": "inclusion", "text": [ "Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above and at least two symptomatic episodes in the last six months prior to inclusion.\nAt least one episode of AF must be documented during the prior year by any kind of ECG recording.\nSubject has structural normal heart with an LVEF = 50%, thickness of the inter-ventricular septum =12 mm and left atrium diameters (short axis) < 46 mm obtained by transthoracic echocardiography.\nSubject has normal ECG parameters (QRS width in the 12 channel surface ECG =120 ms, QTc - interval < 440 ms, PQ - interval = 210 ms; all parameters should be measured at sinus rhythm).\nSubject is at least 18 and not older than 75years old.\nSubject is able and willing to give informed consent.\n" ], "offsets": [ [ 0, 761 ] ] } ]

[ { "id": "NCT01803438_inc_T1", "type": "Condition", "text": [ "paroxysmal atrial fibrillation" ], "offsets": [ [ 44, 74 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T2", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 32, 43 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T3", "type": "Multiplier", "text": [ "at least two" ], "offsets": [ [ 96, 108 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T4", "type": "Condition", "text": [ "episodes" ], "offsets": [ [ 121, 129 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T5", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 109, 120 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T6", "type": "Temporal", "text": [ "last six months prior to inclusion" ], "offsets": [ [ 137, 171 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T7", "type": "Reference_point", "text": [ "inclusion" ], "offsets": [ [ 162, 171 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T8", "type": "Multiplier", "text": [ "At least one" ], "offsets": [ [ 173, 185 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T9", "type": "Condition", "text": [ "episode" ], "offsets": [ [ 186, 193 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T10", "type": "Condition", "text": [ "AF" ], "offsets": [ [ 197, 199 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T11", "type": "Temporal", "text": [ "prior year" ], "offsets": [ [ 230, 240 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T12", "type": "Measurement", "text": [ "ECG" ], "offsets": [ [ 256, 259 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T13", "type": "Condition", "text": [ "heart" ], "offsets": [ [ 301, 306 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T14", "type": "Qualifier", "text": [ "normal" ], "offsets": [ [ 294, 300 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T15", "type": "Qualifier", "text": [ "structural" ], "offsets": [ [ 283, 293 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T16", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 315, 319 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T17", "type": "Value", "text": [ "= 50%," ], "offsets": [ [ 320, 326 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T18", "type": "Measurement", "text": [ "thickness of the inter-ventricular septum" ], "offsets": [ [ 327, 368 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T19", "type": "Value", "text": [ "=12 mm" ], "offsets": [ [ 369, 375 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T20", "type": "Measurement", "text": [ "left atrium diameters" ], "offsets": [ [ 380, 401 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T21", "type": "Value", "text": [ "< 46 mm" ], "offsets": [ [ 415, 422 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T22", "type": "Measurement", "text": [ "short axis" ], "offsets": [ [ 403, 413 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T23", "type": "Procedure", "text": [ "transthoracic echocardiography" ], "offsets": [ [ 435, 465 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T24", "type": "Scope", "text": [ "LVEF = 50%, thickness of the inter-ventricular septum =12 mm and left atrium diameters (short axis) < 46 mm" ], "offsets": [ [ 315, 422 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T25", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 486, 489 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T26", "type": "Value", "text": [ "normal" ], "offsets": [ [ 479, 485 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T27", "type": "Measurement", "text": [ "QRS width" ], "offsets": [ [ 502, 511 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T28", "type": "Qualifier", "text": [ "12 channel surface ECG" ], "offsets": [ [ 519, 541 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T29", "type": "Value", "text": [ "=120 ms" ], "offsets": [ [ 542, 549 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T30", "type": "Measurement", "text": [ "QTc - interval" ], "offsets": [ [ 551, 565 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T31", "type": "Value", "text": [ "< 440 ms" ], "offsets": [ [ 566, 574 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T32", "type": "Measurement", "text": [ "PQ - interval" ], "offsets": [ [ 576, 589 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T33", "type": "Value", "text": [ "= 210 ms" ], "offsets": [ [ 590, 598 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T34", "type": "Condition", "text": [ "sinus rhythm" ], "offsets": [ [ 637, 649 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T35", "type": "Scope", "text": [ "QRS width in the 12 channel surface ECG =120 ms, QTc - interval < 440 ms, PQ - interval = 210 ms; all parameters should be measured at sinus rhythm" ], "offsets": [ [ 502, 649 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T36", "type": "Person", "text": [ "old" ], "offsets": [ [ 702, 705 ] ], "normalized": [] }, { "id": "NCT01803438_inc_T37", "type": "Value", "text": [ "at least 18 and not older than 75years" ], "offsets": [ [ 663, 701 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01803438_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01803438_inc_T1", "arg2_id": "NCT01803438_inc_T2", "normalized": [] }, { "id": "NCT01803438_inc_R2", "type": "Has_index", "arg1_id": "NCT01803438_inc_T6", "arg2_id": "NCT01803438_inc_T7", "normalized": [] }, { "id": "NCT01803438_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01803438_inc_T4", "arg2_id": "NCT01803438_inc_T5", "normalized": [] }, { "id": "NCT01803438_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT01803438_inc_T4", "arg2_id": "NCT01803438_inc_T3", "normalized": [] }, { "id": "NCT01803438_inc_R5", "type": "AND", "arg1_id": "NCT01803438_inc_T1", "arg2_id": "NCT01803438_inc_T4", "normalized": [] }, { "id": "NCT01803438_inc_R6", "type": "Has_multiplier", "arg1_id": "NCT01803438_inc_T9", "arg2_id": "NCT01803438_inc_T8", "normalized": [] }, { "id": "NCT01803438_inc_R7", "type": "AND", "arg1_id": "NCT01803438_inc_T10", "arg2_id": "NCT01803438_inc_T9", "normalized": [] }, { "id": "NCT01803438_inc_R8", "type": "AND", "arg1_id": "NCT01803438_inc_T12", "arg2_id": "NCT01803438_inc_T9", "normalized": [] }, { "id": "NCT01803438_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01803438_inc_T9", "arg2_id": "NCT01803438_inc_T11", "normalized": [] }, { "id": "NCT01803438_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT01803438_inc_T13", "arg2_id": "NCT01803438_inc_T14", "normalized": [] }, { "id": "NCT01803438_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT01803438_inc_T13", "arg2_id": "NCT01803438_inc_T15", "normalized": [] }, { "id": "NCT01803438_inc_R12", "type": "Has_value", "arg1_id": "NCT01803438_inc_T16", "arg2_id": "NCT01803438_inc_T17", "normalized": [] }, { "id": "NCT01803438_inc_R13", "type": "Has_value", "arg1_id": "NCT01803438_inc_T18", "arg2_id": "NCT01803438_inc_T19", "normalized": [] }, { "id": "NCT01803438_inc_R14", "type": "Subsumes", "arg1_id": "NCT01803438_inc_T20", "arg2_id": "NCT01803438_inc_T22", "normalized": [] }, { "id": "NCT01803438_inc_R15", "type": "Has_value", "arg1_id": "NCT01803438_inc_T20", "arg2_id": "NCT01803438_inc_T21", "normalized": [] }, { "id": "NCT01803438_inc_R16", "type": "Has_scope", "arg1_id": "NCT01803438_inc_T23", "arg2_id": "NCT01803438_inc_T24", "normalized": [] }, { "id": "NCT01803438_inc_R17", "type": "AND", "arg1_id": "NCT01803438_inc_T13", "arg2_id": "NCT01803438_inc_T23", "normalized": [] }, { "id": "NCT01803438_inc_R18", "type": "Has_value", "arg1_id": "NCT01803438_inc_T25", "arg2_id": "NCT01803438_inc_T26", "normalized": [] }, { "id": "NCT01803438_inc_R19", "type": "Has_qualifier", "arg1_id": "NCT01803438_inc_T27", "arg2_id": "NCT01803438_inc_T28", "normalized": [] }, { "id": "NCT01803438_inc_R20", "type": "Has_value", "arg1_id": "NCT01803438_inc_T27", "arg2_id": "NCT01803438_inc_T29", "normalized": [] }, { "id": "NCT01803438_inc_R21", "type": "Has_value", "arg1_id": "NCT01803438_inc_T30", "arg2_id": "NCT01803438_inc_T31", "normalized": [] }, { "id": "NCT01803438_inc_R22", "type": "Has_value", "arg1_id": "NCT01803438_inc_T32", "arg2_id": "NCT01803438_inc_T33", "normalized": [] }, { "id": "NCT01803438_inc_R23", "type": "Subsumes", "arg1_id": "NCT01803438_inc_T25", "arg2_id": "NCT01803438_inc_T35", "normalized": [] }, { "id": "NCT01803438_inc_R24", "type": "Has_value", "arg1_id": "NCT01803438_inc_T36", "arg2_id": "NCT01803438_inc_T37", "normalized": [] } ]

[ { "id": "NCT01803828_exc_text", "type": "exclusion", "text": [ "congenital or valvular cardiomyopathy;\nischemic heart disease;\nendocrine diseases: male hypogonadism, hyperthyroidism, adrenal diseases, pituitary diseases\nproliferative retinopathy or autonomic neuropathy;\ncontraindications to sildenafil use or CMR imaging;\n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT01803828_exc_T1", "type": "Qualifier", "text": [ "valvular" ], "offsets": [ [ 14, 22 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T2", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T3", "type": "Scope", "text": [ "congenital or valvular" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T4", "type": "Condition", "text": [ "cardiomyopathy" ], "offsets": [ [ 23, 37 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T5", "type": "Condition", "text": [ "ischemic heart disease" ], "offsets": [ [ 39, 61 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T6", "type": "Condition", "text": [ "endocrine diseases" ], "offsets": [ [ 63, 81 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T7", "type": "Condition", "text": [ "male hypogonadism" ], "offsets": [ [ 83, 100 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T8", "type": "Condition", "text": [ "hyperthyroidism" ], "offsets": [ [ 102, 117 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T9", "type": "Condition", "text": [ "adrenal diseases" ], "offsets": [ [ 119, 135 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T10", "type": "Condition", "text": [ "pituitary diseases" ], "offsets": [ [ 137, 155 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T11", "type": "Scope", "text": [ "male hypogonadism, hyperthyroidism, adrenal diseases, pituitary diseases" ], "offsets": [ [ 83, 155 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T12", "type": "Condition", "text": [ "proliferative retinopathy" ], "offsets": [ [ 156, 181 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T13", "type": "Condition", "text": [ "autonomic neuropathy" ], "offsets": [ [ 185, 205 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T14", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 207, 224 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T15", "type": "Drug", "text": [ "sildenafil" ], "offsets": [ [ 228, 238 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T16", "type": "Procedure", "text": [ "CMR imaging" ], "offsets": [ [ 246, 257 ] ], "normalized": [] }, { "id": "NCT01803828_exc_T17", "type": "Scope", "text": [ "sildenafil use or CMR imaging" ], "offsets": [ [ 228, 257 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01803828_exc_R1", "type": "Has_scope", "arg1_id": "NCT01803828_exc_T4", "arg2_id": "NCT01803828_exc_T3", "normalized": [] }, { "id": "NCT01803828_exc_R2", "type": "Subsumes", "arg1_id": "NCT01803828_exc_T6", "arg2_id": "NCT01803828_exc_T11", "normalized": [] }, { "id": "NCT01803828_exc_R3", "type": "Has_scope", "arg1_id": "NCT01803828_exc_T14", "arg2_id": "NCT01803828_exc_T17", "normalized": [] } ]

[ { "id": "NCT01803828_inc_text", "type": "inclusion", "text": [ "age 35-75 years;\nDiagnosis of Type 2 Diabetes from at least 3 years;\nHbA1c < 10%;\nnormal blood pressure or controlled hypertension;\nBMI < 40;\n" ], "offsets": [ [ 0, 142 ] ] } ]

[ { "id": "NCT01803828_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T2", "type": "Value", "text": [ "35-75 years" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T3", "type": "Condition", "text": [ "Type 2 Diabetes" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T4", "type": "Temporal", "text": [ "at least 3 years" ], "offsets": [ [ 51, 67 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T5", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 69, 74 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T6", "type": "Value", "text": [ "< 10%" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T7", "type": "Condition", "text": [ "normal blood pressure" ], "offsets": [ [ 82, 103 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T8", "type": "Condition", "text": [ "controlled hypertension" ], "offsets": [ [ 107, 130 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T9", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 132, 135 ] ], "normalized": [] }, { "id": "NCT01803828_inc_T10", "type": "Value", "text": [ "< 40" ], "offsets": [ [ 136, 140 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01803828_inc_R1", "type": "Has_value", "arg1_id": "NCT01803828_inc_T1", "arg2_id": "NCT01803828_inc_T2", "normalized": [] }, { "id": "NCT01803828_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01803828_inc_T3", "arg2_id": "NCT01803828_inc_T4", "normalized": [] }, { "id": "NCT01803828_inc_R3", "type": "Has_value", "arg1_id": "NCT01803828_inc_T5", "arg2_id": "NCT01803828_inc_T6", "normalized": [] }, { "id": "NCT01803828_inc_R4", "type": "Has_value", "arg1_id": "NCT01803828_inc_T9", "arg2_id": "NCT01803828_inc_T10", "normalized": [] } ]

[ { "id": "NCT01806558_exc_text", "type": "exclusion", "text": [ "1. Are unable to understand and sign the consent form \n2. Are pregnant or lactating \n3. Are physically unable to sit upright and still for 40 minutes \n4. Have undergone bilateral mastectomy \n5. Are not scheduled to undergo conventional ultrasound \n \n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT01806558_exc_T3", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 62, 70 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T4", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 74, 83 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T5", "type": "Condition", "text": [ "physically unable to sit upright and still" ], "offsets": [ [ 92, 134 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T6", "type": "Multiplier", "text": [ "for 40 minutes" ], "offsets": [ [ 135, 149 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T7", "type": "Procedure", "text": [ "bilateral mastectomy" ], "offsets": [ [ 169, 189 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T8", "type": "Negation", "text": [ "not" ], "offsets": [ [ 198, 201 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T9", "type": "Observation", "text": [ "scheduled" ], "offsets": [ [ 202, 211 ] ], "normalized": [] }, { "id": "NCT01806558_exc_T10", "type": "Procedure", "text": [ "conventional ultrasound" ], "offsets": [ [ 223, 246 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01806558_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT01806558_exc_T5", "arg2_id": "NCT01806558_exc_T6", "normalized": [] }, { "id": "NCT01806558_exc_R2", "type": "Has_negation", "arg1_id": "NCT01806558_exc_T10", "arg2_id": "NCT01806558_exc_T8", "normalized": [] }, { "id": "NCT01806558_exc_R3", "type": "Has_mood", "arg1_id": "NCT01806558_exc_T10", "arg2_id": "NCT01806558_exc_T9", "normalized": [] } ]

[ { "id": "NCT01806558_inc_text", "type": "inclusion", "text": [ "1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound. \n2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size. \n3. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound. \n" ], "offsets": [ [ 0, 418 ] ] } ]

[ { "id": "NCT01806558_inc_T1", "type": "Condition", "text": [ "mass lesion" ], "offsets": [ [ 23, 34 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T2", "type": "Procedure", "text": [ "mammography" ], "offsets": [ [ 38, 49 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T3", "type": "Procedure", "text": [ "breast MRI" ], "offsets": [ [ 53, 63 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T4", "type": "Measurement", "text": [ "BIRADS" ], "offsets": [ [ 65, 71 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T5", "type": "Value", "text": [ "0, 4 or 5" ], "offsets": [ [ 72, 81 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T6", "type": "Condition", "text": [ "mass lesion" ], "offsets": [ [ 210, 221 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T7", "type": "Value", "text": [ ">0.5 cm and < 2 cm" ], "offsets": [ [ 91, 109 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T8", "type": "Measurement", "text": [ "size" ], "offsets": [ [ 113, 117 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T9", "type": "Scope", "text": [ "mammography or breast MRI (BIRADS 0, 4 or 5)" ], "offsets": [ [ 38, 82 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T11", "type": "Procedure", "text": [ "ultrasound" ], "offsets": [ [ 225, 235 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T12", "type": "Measurement", "text": [ "BIRADS" ], "offsets": [ [ 237, 243 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T13", "type": "Value", "text": [ "0, 4 or 5" ], "offsets": [ [ 244, 253 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T14", "type": "Value", "text": [ "> 0.5 cm and < 2 cm" ], "offsets": [ [ 263, 282 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T15", "type": "Measurement", "text": [ "size" ], "offsets": [ [ 286, 290 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T17", "type": "Procedure", "text": [ "MBI" ], "offsets": [ [ 323, 326 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T18", "type": "Condition", "text": [ "positive finding" ], "offsets": [ [ 303, 319 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T20", "type": "Value", "text": [ "< 2 cm" ], "offsets": [ [ 335, 341 ] ], "normalized": [] }, { "id": "NCT01806558_inc_T21", "type": "Measurement", "text": [ "size" ], "offsets": [ [ 345, 349 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01806558_inc_R1", "type": "Has_value", "arg1_id": "NCT01806558_inc_T4", "arg2_id": "NCT01806558_inc_T5", "normalized": [] }, { "id": "NCT01806558_inc_R2", "type": "Has_value", "arg1_id": "NCT01806558_inc_T8", "arg2_id": "NCT01806558_inc_T7", "normalized": [] }, { "id": "NCT01806558_inc_R3", "type": "AND", "arg1_id": "NCT01806558_inc_T1", "arg2_id": "NCT01806558_inc_T8", "normalized": [] }, { "id": "NCT01806558_inc_R4", "type": "AND", "arg1_id": "NCT01806558_inc_T3", "arg2_id": "NCT01806558_inc_T4", "normalized": [] }, { "id": "NCT01806558_inc_R5", "type": "Has_scope", "arg1_id": "NCT01806558_inc_T1", "arg2_id": "NCT01806558_inc_T9", "normalized": [] }, { "id": "NCT01806558_inc_R6", "type": "Has_value", "arg1_id": "NCT01806558_inc_T12", "arg2_id": "NCT01806558_inc_T13", "normalized": [] }, { "id": "NCT01806558_inc_R7", "type": "Has_value", "arg1_id": "NCT01806558_inc_T15", "arg2_id": "NCT01806558_inc_T14", "normalized": [] }, { "id": "NCT01806558_inc_R8", "type": "AND", "arg1_id": "NCT01806558_inc_T6", "arg2_id": "NCT01806558_inc_T15", "normalized": [] }, { "id": "NCT01806558_inc_R9", "type": "AND", "arg1_id": "NCT01806558_inc_T6", "arg2_id": "NCT01806558_inc_T11", "normalized": [] }, { "id": "NCT01806558_inc_R10", "type": "AND", "arg1_id": "NCT01806558_inc_T11", "arg2_id": "NCT01806558_inc_T12", "normalized": [] }, { "id": "NCT01806558_inc_R11", "type": "Has_value", "arg1_id": "NCT01806558_inc_T21", "arg2_id": "NCT01806558_inc_T20", "normalized": [] }, { "id": "NCT01806558_inc_R12", "type": "AND", "arg1_id": "NCT01806558_inc_T18", "arg2_id": "NCT01806558_inc_T17", "normalized": [] }, { "id": "NCT01806558_inc_R13", "type": "AND", "arg1_id": "NCT01806558_inc_T17", "arg2_id": "NCT01806558_inc_T21", "normalized": [] } ]

[ { "id": "NCT01807897_exc_text", "type": "exclusion", "text": [ "Hospitalization for acute decompensated HF within previous 30 days\nHospitalization for myocardial infarction or cardiac surgery within previous 90 days\nPresence of a left ventricular assist device\nHistory of heart transplantation\nPoorly controlled hypertension (>170/>110)\nPoorly controlled diabetes (HbA1c > 9.0)\nSevere renal failure with estimated glomerular filtration rate <30 ml/min\nPrior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records\nSevere chronic insomnia, with reported usual sleep duration <4 hours\nSevere daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year, and deemed a safety risk by study physician\nAwake resting oxyhemoglobin saturation <89%\nPregnancy\nSmoking by subject or other person in the subject's bedroom, or other open flame in bedroom\nCurrent use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy\n" ], "offsets": [ [ 0, 1164 ] ] } ]

[ { "id": "NCT01807897_exc_T1", "type": "Observation", "text": [ "Hospitalization" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T2", "type": "Condition", "text": [ "acute decompensated HF" ], "offsets": [ [ 20, 42 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T3", "type": "Temporal", "text": [ "within previous 30 days" ], "offsets": [ [ 43, 66 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T4", "type": "Observation", "text": [ "Hospitalization" ], "offsets": [ [ 67, 82 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T5", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 87, 108 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T6", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 112, 127 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T7", "type": "Temporal", "text": [ "within previous 90 days" ], "offsets": [ [ 128, 151 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T8", "type": "Scope", "text": [ "myocardial infarction or cardiac surgery" ], "offsets": [ [ 87, 127 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T9", "type": "Device", "text": [ "left ventricular assist device" ], "offsets": [ [ 166, 196 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T10", "type": "Procedure", "text": [ "heart transplantation" ], "offsets": [ [ 208, 229 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T11", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 248, 260 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T12", "type": "Qualifier", "text": [ "Poorly controlled" ], "offsets": [ [ 230, 247 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T13", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 291, 299 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T14", "type": "Qualifier", "text": [ "Poorly controlled" ], "offsets": [ [ 273, 290 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T15", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 301, 306 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T16", "type": "Value", "text": [ "> 9.0" ], "offsets": [ [ 307, 312 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T17", "type": "Condition", "text": [ "renal failure" ], "offsets": [ [ 321, 334 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T18", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 314, 320 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T19", "type": "Measurement", "text": [ "estimated glomerular filtration rate" ], "offsets": [ [ 340, 376 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T20", "type": "Value", "text": [ "<30 ml/min" ], "offsets": [ [ 377, 387 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T21", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 394, 400 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T22", "type": "Condition", "text": [ "functional impairment" ], "offsets": [ [ 406, 427 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T24", "type": "Condition", "text": [ "chronic insomnia" ], "offsets": [ [ 596, 612 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T25", "type": "Observation", "text": [ "sleep duration" ], "offsets": [ [ 634, 648 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T26", "type": "Value", "text": [ "<4 hours" ], "offsets": [ [ 649, 657 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T27", "type": "Condition", "text": [ "daytime sleepiness" ], "offsets": [ [ 665, 683 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T28", "type": "Measurement", "text": [ "Epworth Sleepiness Scale" ], "offsets": [ [ 696, 720 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T29", "type": "Value", "text": [ "score 18 or higher" ], "offsets": [ [ 721, 739 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T31", "type": "Measurement", "text": [ "oxyhemoglobin saturation" ], "offsets": [ [ 862, 886 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T32", "type": "Qualifier", "text": [ "resting" ], "offsets": [ [ 854, 861 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T33", "type": "Qualifier", "text": [ "Awake" ], "offsets": [ [ 848, 853 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T34", "type": "Value", "text": [ "<89%" ], "offsets": [ [ 887, 891 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T35", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 892, 901 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T37", "type": "Device", "text": [ "positive airway pressure device" ], "offsets": [ [ 1011, 1042 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T38", "type": "Device", "text": [ "bi-level positive airway pressure" ], "offsets": [ [ 1068, 1101 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T39", "type": "Device", "text": [ " bi-leve", "re or adaptive" ], "offsets": [ [ 1067, 1075 ], [ 1099, 1113 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T40", "type": "Device", "text": [ "adaptive servo-ventilation" ], "offsets": [ [ 1105, 1131 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T41", "type": "Procedure", "text": [ "supplemental oxygen therapy" ], "offsets": [ [ 1136, 1163 ] ], "normalized": [] }, { "id": "NCT01807897_exc_T42", "type": "Scope", "text": [ "continuous or bi-level positive airway pressure or adaptive servo-ventilation" ], "offsets": [ [ 1054, 1131 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01807897_exc_R1", "type": "AND", "arg1_id": "NCT01807897_exc_T1", "arg2_id": "NCT01807897_exc_T2", "normalized": [] }, { "id": "NCT01807897_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01807897_exc_T1", "arg2_id": "NCT01807897_exc_T3", "normalized": [] }, { "id": "NCT01807897_exc_R3", "type": "Has_scope", "arg1_id": "NCT01807897_exc_T4", "arg2_id": "NCT01807897_exc_T8", "normalized": [] }, { "id": "NCT01807897_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01807897_exc_T8", "arg2_id": "NCT01807897_exc_T7", "normalized": [] }, { "id": "NCT01807897_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01807897_exc_T11", "arg2_id": "NCT01807897_exc_T12", "normalized": [] }, { "id": "NCT01807897_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01807897_exc_T13", "arg2_id": "NCT01807897_exc_T14", "normalized": [] }, { "id": "NCT01807897_exc_R7", "type": "Has_value", "arg1_id": "NCT01807897_exc_T15", "arg2_id": "NCT01807897_exc_T16", "normalized": [] }, { "id": "NCT01807897_exc_R8", "type": "AND", "arg1_id": "NCT01807897_exc_T13", "arg2_id": "NCT01807897_exc_T15", "normalized": [] }, { "id": "NCT01807897_exc_R9", "type": "Has_value", "arg1_id": "NCT01807897_exc_T19", "arg2_id": "NCT01807897_exc_T20", "normalized": [] }, { "id": "NCT01807897_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01807897_exc_T17", "arg2_id": "NCT01807897_exc_T18", "normalized": [] }, { "id": "NCT01807897_exc_R11", "type": "AND", "arg1_id": "NCT01807897_exc_T17", "arg2_id": "NCT01807897_exc_T19", "normalized": [] }, { "id": "NCT01807897_exc_R12", "type": "AND", "arg1_id": "NCT01807897_exc_T21", "arg2_id": "NCT01807897_exc_T22", "normalized": [] }, { "id": "NCT01807897_exc_R13", "type": "Has_value", "arg1_id": "NCT01807897_exc_T25", "arg2_id": "NCT01807897_exc_T26", "normalized": [] }, { "id": "NCT01807897_exc_R15", "type": "Has_value", "arg1_id": "NCT01807897_exc_T28", "arg2_id": "NCT01807897_exc_T29", "normalized": [] }, { "id": "NCT01807897_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT01807897_exc_T31", "arg2_id": "NCT01807897_exc_T32", "normalized": [] }, { "id": "NCT01807897_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01807897_exc_T31", "arg2_id": "NCT01807897_exc_T33", "normalized": [] }, { "id": "NCT01807897_exc_R18", "type": "Has_value", "arg1_id": "NCT01807897_exc_T31", "arg2_id": "NCT01807897_exc_T34", "normalized": [] }, { "id": "NCT01807897_exc_R19", "type": "Subsumes", "arg1_id": "NCT01807897_exc_T37", "arg2_id": "NCT01807897_exc_T42", "normalized": [] } ]

[ { "id": "NCT01807897_inc_text", "type": "inclusion", "text": [ "Veteran receiving care within the Veterans Health Administration healthcare system\nAge 18 years\nPhysician diagnosis of chronic heart failure, American Heart Association Stage C-D\nLVEF <45%\nNo change in active cardiac medications for 4 weeks prior to randomization\nAbility to provide informed consent\nModerate to severe central or mixed central and obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) 15 events per hour, with a central AHI >5 events/hour\n" ], "offsets": [ [ 0, 468 ] ] } ]

[ { "id": "NCT01807897_inc_T1", "type": "Person", "text": [ "Veteran" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T2", "type": "Visit", "text": [ "Veterans Health Administration healthcare system" ], "offsets": [ [ 34, 82 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T3", "type": "Person", "text": [ "Age" ], "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T4", "type": "Value", "text": [ "18 years" ], "offsets": [ [ 87, 95 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T5", "type": "Condition", "text": [ "chronic heart failure" ], "offsets": [ [ 119, 140 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T6", "type": "Measurement", "text": [ "American Heart Association Stage" ], "offsets": [ [ 142, 174 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T7", "type": "Value", "text": [ "C-D" ], "offsets": [ [ 175, 178 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T8", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 179, 183 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T9", "type": "Value", "text": [ "<45%" ], "offsets": [ [ 184, 188 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T10", "type": "Negation", "text": [ "No" ], "offsets": [ [ 189, 191 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T11", "type": "Qualifier", "text": [ "change" ], "offsets": [ [ 192, 198 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T12", "type": "Drug", "text": [ "cardiac medications" ], "offsets": [ [ 209, 228 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T13", "type": "Temporal", "text": [ "for 4 weeks prior to randomization" ], "offsets": [ [ 229, 263 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T14", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 250, 263 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T16", "type": "Condition", "text": [ "obstructive sleep apnea" ], "offsets": [ [ 348, 371 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T17", "type": "Condition", "text": [ "l or mi", "apnea, defi" ], "offsets": [ [ 325, 332 ], [ 366, 377 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T18", "type": "Condition", "text": [ "central and o", "apnea, defi" ], "offsets": [ [ 336, 349 ], [ 366, 377 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T19", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 312, 318 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T20", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 300, 308 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T21", "type": "Measurement", "text": [ "apnea-hypopnea index" ], "offsets": [ [ 387, 407 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T22", "type": "Measurement", "text": [ "AHI" ], "offsets": [ [ 409, 412 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T23", "type": "Value", "text": [ "15 events per hour," ], "offsets": [ [ 414, 433 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T24", "type": "Measurement", "text": [ "central AHI" ], "offsets": [ [ 441, 452 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T25", "type": "Value", "text": [ ">5 events/hour" ], "offsets": [ [ 453, 467 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T26", "type": "Scope", "text": [ "apnea-hypopnea index (AHI) 15 events per hour, with a central AHI >5 events/hour" ], "offsets": [ [ 387, 467 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T27", "type": "Scope", "text": [ "central or mixed central and obstructive sleep apnea" ], "offsets": [ [ 319, 371 ] ], "normalized": [] }, { "id": "NCT01807897_inc_T28", "type": "Scope", "text": [ "Moderate to severe" ], "offsets": [ [ 300, 318 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01807897_inc_R1", "type": "AND", "arg1_id": "NCT01807897_inc_T1", "arg2_id": "NCT01807897_inc_T2", "normalized": [] }, { "id": "NCT01807897_inc_R2", "type": "Has_value", "arg1_id": "NCT01807897_inc_T3", "arg2_id": "NCT01807897_inc_T4", "normalized": [] }, { "id": "NCT01807897_inc_R3", "type": "AND", "arg1_id": "NCT01807897_inc_T5", "arg2_id": "NCT01807897_inc_T6", "normalized": [] }, { "id": "NCT01807897_inc_R4", "type": "Has_value", "arg1_id": "NCT01807897_inc_T6", "arg2_id": "NCT01807897_inc_T7", "normalized": [] }, { "id": "NCT01807897_inc_R5", "type": "Has_value", "arg1_id": "NCT01807897_inc_T8", "arg2_id": "NCT01807897_inc_T9", "normalized": [] }, { "id": "NCT01807897_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01807897_inc_T12", "arg2_id": "NCT01807897_inc_T11", "normalized": [] }, { "id": "NCT01807897_inc_R7", "type": "Has_negation", "arg1_id": "NCT01807897_inc_T11", "arg2_id": "NCT01807897_inc_T10", "normalized": [] }, { "id": "NCT01807897_inc_R8", "type": "Has_index", "arg1_id": "NCT01807897_inc_T13", "arg2_id": "NCT01807897_inc_T14", "normalized": [] }, { "id": "NCT01807897_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01807897_inc_T12", "arg2_id": "NCT01807897_inc_T13", "normalized": [] }, { "id": "NCT01807897_inc_R10", "type": "Subsumes", "arg1_id": "NCT01807897_inc_T21", "arg2_id": "NCT01807897_inc_T22", "normalized": [] }, { "id": "NCT01807897_inc_R11", "type": "Has_value", "arg1_id": "NCT01807897_inc_T21", "arg2_id": "NCT01807897_inc_T23", "normalized": [] }, { "id": "NCT01807897_inc_R12", "type": "Has_value", "arg1_id": "NCT01807897_inc_T24", "arg2_id": "NCT01807897_inc_T25", "normalized": [] }, { "id": "NCT01807897_inc_R13", "type": "Has_scope", "arg1_id": "NCT01807897_inc_T27", "arg2_id": "NCT01807897_inc_T28", "normalized": [] }, { "id": "NCT01807897_inc_R14", "type": "Has_scope", "arg1_id": "NCT01807897_inc_T27", "arg2_id": "NCT01807897_inc_T26", "normalized": [] } ]

[ { "id": "NCT01809041_exc_text", "type": "exclusion", "text": [ "Patients are not expected to be alive for longer than 3 months.\nMini-mental State Examination (MMSE) [18] score = 23.\nhistory of dementia, psychiatric illness or any diseases of central nervous system.\ncurrent use of sedatives or antidepressant.\nalcoholism and drug dependence.\npatients previously included in this study (for patients who have second intra-abdominal surgery during the study period).\ndifficult to follow up or patients with poor compliance.\nuncontrolled hypertension (> 180/100 mmHg)\n" ], "offsets": [ [ 0, 501 ] ] } ]

[ { "id": "NCT01809041_exc_T1", "type": "Observation", "text": [ "expected to be alive" ], "offsets": [ [ 17, 37 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T2", "type": "Negation", "text": [ "not" ], "offsets": [ [ 13, 16 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T3", "type": "Value", "text": [ "longer than 3 months" ], "offsets": [ [ 42, 62 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T4", "type": "Measurement", "text": [ "Mini-mental State Examination (MMSE)" ], "offsets": [ [ 64, 100 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T5", "type": "Value", "text": [ "= 23" ], "offsets": [ [ 112, 116 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T6", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 129, 137 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T7", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 139, 158 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T8", "type": "Condition", "text": [ "diseases of central nervous system" ], "offsets": [ [ 166, 200 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T9", "type": "Drug", "text": [ "sedatives" ], "offsets": [ [ 217, 226 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T10", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 202, 209 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T11", "type": "Drug", "text": [ "antidepressant" ], "offsets": [ [ 230, 244 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T12", "type": "Scope", "text": [ "sedatives or antidepressant" ], "offsets": [ [ 217, 244 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T13", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 246, 256 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T14", "type": "Condition", "text": [ "drug dependence" ], "offsets": [ [ 261, 276 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T17", "type": "Condition", "text": [ "uncontrolled hypertension" ], "offsets": [ [ 458, 483 ] ], "normalized": [] }, { "id": "NCT01809041_exc_T18", "type": "Value", "text": [ "> 180/100 mmHg" ], "offsets": [ [ 485, 499 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01809041_exc_R1", "type": "Has_value", "arg1_id": "NCT01809041_exc_T1", "arg2_id": "NCT01809041_exc_T3", "normalized": [] }, { "id": "NCT01809041_exc_R2", "type": "Has_negation", "arg1_id": "NCT01809041_exc_T1", "arg2_id": "NCT01809041_exc_T2", "normalized": [] }, { "id": "NCT01809041_exc_R3", "type": "Has_value", "arg1_id": "NCT01809041_exc_T4", "arg2_id": "NCT01809041_exc_T5", "normalized": [] }, { "id": "NCT01809041_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01809041_exc_T12", "arg2_id": "NCT01809041_exc_T10", "normalized": [] }, { "id": "NCT01809041_exc_R5", "type": "Has_value", "arg1_id": "NCT01809041_exc_T17", "arg2_id": "NCT01809041_exc_T18", "normalized": [] } ]

[ { "id": "NCT01809041_inc_text", "type": "inclusion", "text": [ "major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are = 60 years old.\nthe surgery is laparoscopic surgery and is expected to last for = 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.\nlack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.\n" ], "offsets": [ [ 0, 395 ] ] } ]

[ { "id": "NCT01809041_inc_T1", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 6, 14 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T2", "type": "Procedure", "text": [ "gastrointestinal", "surgery" ], "offsets": [ [ 15, 31 ], [ 68, 75 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T3", "type": "Procedure", "text": [ "bladder surgery" ], "offsets": [ [ 60, 75 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T4", "type": "Procedure", "text": [ "prostate", "surgery" ], "offsets": [ [ 48, 56 ], [ 68, 75 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T5", "type": "Procedure", "text": [ "gynecological", "surgery" ], "offsets": [ [ 33, 46 ], [ 68, 75 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T6", "type": "Scope", "text": [ "gastrointestinal, gynecological, prostate or bladder surgery" ], "offsets": [ [ 15, 75 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T7", "type": "Value", "text": [ "= 60 years old" ], "offsets": [ [ 93, 107 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T8", "type": "Person", "text": [ "old" ], "offsets": [ [ 104, 107 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T9", "type": "Procedure", "text": [ "laparoscopic surgery" ], "offsets": [ [ 124, 144 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T10", "type": "Measurement", "text": [ "last" ], "offsets": [ [ 164, 168 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T11", "type": "Value", "text": [ "= 2 hour" ], "offsets": [ [ 173, 181 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T12", "type": "Mood", "text": [ "expected" ], "offsets": [ [ 152, 160 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T13", "type": "Qualifier", "text": [ "under general anesthesia" ], "offsets": [ [ 183, 207 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T14", "type": "Mood", "text": [ "will" ], "offsets": [ [ 224, 228 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T15", "type": "Procedure", "text": [ "stay in hospital" ], "offsets": [ [ 229, 245 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T16", "type": "Value", "text": [ "at least 7 days after surgery" ], "offsets": [ [ 250, 279 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T17", "type": "Negation", "text": [ "lack of" ], "offsets": [ [ 281, 288 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T18", "type": "Condition", "text": [ "vision impairment" ], "offsets": [ [ 309, 326 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T19", "type": "Condition", "text": [ "aring a", "pairment a" ], "offsets": [ [ 299, 306 ], [ 318, 328 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T20", "type": "Scope", "text": [ "hearing and vision impairment" ], "offsets": [ [ 297, 326 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T21", "type": "Condition", "text": [ "able to read" ], "offsets": [ [ 334, 346 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T22", "type": "Procedure", "text": [ "neurobehavioral tests" ], "offsets": [ [ 355, 376 ] ], "normalized": [] }, { "id": "NCT01809041_inc_T23", "type": "Mood", "text": [ "can be performed" ], "offsets": [ [ 377, 393 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01809041_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01809041_inc_T6", "arg2_id": "NCT01809041_inc_T1", "normalized": [] }, { "id": "NCT01809041_inc_R2", "type": "Has_value", "arg1_id": "NCT01809041_inc_T8", "arg2_id": "NCT01809041_inc_T7", "normalized": [] }, { "id": "NCT01809041_inc_R3", "type": "Has_value", "arg1_id": "NCT01809041_inc_T10", "arg2_id": "NCT01809041_inc_T11", "normalized": [] }, { "id": "NCT01809041_inc_R4", "type": "Has_mood", "arg1_id": "NCT01809041_inc_T10", "arg2_id": "NCT01809041_inc_T12", "normalized": [] }, { "id": "NCT01809041_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01809041_inc_T10", "arg2_id": "NCT01809041_inc_T13", "normalized": [] }, { "id": "NCT01809041_inc_R6", "type": "Has_mood", "arg1_id": "NCT01809041_inc_T15", "arg2_id": "NCT01809041_inc_T14", "normalized": [] }, { "id": "NCT01809041_inc_R7", "type": "Has_value", "arg1_id": "NCT01809041_inc_T15", "arg2_id": "NCT01809041_inc_T16", "normalized": [] }, { "id": "NCT01809041_inc_R8", "type": "Has_negation", "arg1_id": "NCT01809041_inc_T20", "arg2_id": "NCT01809041_inc_T17", "normalized": [] }, { "id": "NCT01809041_inc_R9", "type": "Has_mood", "arg1_id": "NCT01809041_inc_T22", "arg2_id": "NCT01809041_inc_T23", "normalized": [] } ]

[ { "id": "NCT01815580_exc_text", "type": "exclusion", "text": [ "Prior receipt of investigational anti-HIV vaccine\nOngoing therapy with any of the following: Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed; Systemic chemotherapeutic agents; Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine; Immunomodulatory treatments including Interleukin-2; Investigational agents\nKnown allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations\nActive drug or alcohol use or dependence that would interfere with adherence to study requirements\nSerious medical or psychiatric illness that would interfere with the ability to adhere to study requirements\nChronic or acute hepatitis B infection\nUse of female hormonal products based on estrogen or derivatives\n" ], "offsets": [ [ 0, 840 ] ] } ]

[ { "id": "NCT01815580_exc_T1", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T2", "type": "Qualifier", "text": [ "investigational" ], "offsets": [ [ 17, 32 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T3", "type": "Drug", "text": [ "anti-HIV vaccine" ], "offsets": [ [ 33, 49 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T4", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 50, 57 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T5", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 58, 65 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T6", "type": "Drug", "text": [ "Systemic corticosteroids" ], "offsets": [ [ 93, 117 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T7", "type": "Multiplier", "text": [ "Short course" ], "offsets": [ [ 119, 131 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T8", "type": "Multiplier", "text": [ "less than or equal to 21 days" ], "offsets": [ [ 132, 161 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T9", "type": "Condition", "text": [ "corticosteroids" ], "offsets": [ [ 165, 180 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T10", "type": "Negation", "text": [ "is allowed" ], "offsets": [ [ 181, 191 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T11", "type": "Scope", "text": [ "Short course less than or equal to 21 days of corticosteroids is allowed" ], "offsets": [ [ 119, 191 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T12", "type": "Drug", "text": [ "Systemic chemotherapeutic agents" ], "offsets": [ [ 193, 225 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T13", "type": "Drug", "text": [ "Nephrotoxic systemic agents" ], "offsets": [ [ 227, 254 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T14", "type": "Drug", "text": [ "aminoglycosides" ], "offsets": [ [ 266, 281 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T15", "type": "Drug", "text": [ "amphotericin B" ], "offsets": [ [ 283, 297 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T16", "type": "Drug", "text": [ "cidofovir" ], "offsets": [ [ 299, 308 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T17", "type": "Drug", "text": [ "cisplatin" ], "offsets": [ [ 310, 319 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T18", "type": "Drug", "text": [ "foscarnet" ], "offsets": [ [ 321, 330 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T19", "type": "Drug", "text": [ "pentamidine" ], "offsets": [ [ 332, 343 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T20", "type": "Procedure", "text": [ "Immunomodulatory treatments" ], "offsets": [ [ 345, 372 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T21", "type": "Drug", "text": [ "Interleukin-2" ], "offsets": [ [ 383, 396 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T22", "type": "Drug", "text": [ "Investigational agents" ], "offsets": [ [ 398, 420 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T23", "type": "Scope", "text": [ "Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed; Systemic chemotherapeutic agents; Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine; Immunomodulatory treatments including Interleukin-2; Investigational agents" ], "offsets": [ [ 93, 420 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T24", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 427, 434 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T25", "type": "Condition", "text": [ "sensitivity" ], "offsets": [ [ 435, 446 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T26", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 454, 470 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T27", "type": "Drug", "text": [ "components of study drugs" ], "offsets": [ [ 474, 499 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T28", "type": "Drug", "text": [ "ART" ], "offsets": [ [ 501, 504 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T29", "type": "Drug", "text": [ "or their formulations" ], "offsets": [ [ 506, 527 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T30", "type": "Scope", "text": [ "components of study drugs (ART) or their formulations" ], "offsets": [ [ 474, 527 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T31", "type": "Condition", "text": [ "alcohol use" ], "offsets": [ [ 543, 554 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T32", "type": "Condition", "text": [ "use" ], "offsets": [ [ 551, 554 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T33", "type": "Condition", "text": [ "g or", "endence th" ], "offsets": [ [ 538, 542 ], [ 561, 571 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T34", "type": "Condition", "text": [ "ohol us", "endence th" ], "offsets": [ [ 546, 553 ], [ 561, 571 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T35", "type": "Qualifier", "text": [ "would interfere with adherence to study requirements" ], "offsets": [ [ 574, 626 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T36", "type": "Scope", "text": [ "drug or alcohol use or dependence" ], "offsets": [ [ 535, 568 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T37", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 528, 534 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T38", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 646, 665 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T39", "type": "Condition", "text": [ "cal or", "ess tha" ], "offsets": [ [ 639, 645 ], [ 662, 669 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T40", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 627, 634 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T41", "type": "Scope", "text": [ "medical or psychiatric illness" ], "offsets": [ [ 635, 665 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T42", "type": "Qualifier", "text": [ "would interfere with the ability to adhere to study requirements" ], "offsets": [ [ 671, 735 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T43", "type": "Condition", "text": [ "ic or a", "itis B infection\nUse" ], "offsets": [ [ 741, 748 ], [ 758, 778 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T44", "type": "Condition", "text": [ "acute hepatitis B infection" ], "offsets": [ [ 747, 774 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T45", "type": "Drug", "text": [ "female hormonal products" ], "offsets": [ [ 782, 806 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T46", "type": "Qualifier", "text": [ "en or de", "tives" ], "offsets": [ [ 822, 830 ], [ 834, 839 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T47", "type": "Qualifier", "text": [ "estrogen" ], "offsets": [ [ 816, 824 ] ], "normalized": [] }, { "id": "NCT01815580_exc_T48", "type": "Scope", "text": [ "estrogen or derivatives" ], "offsets": [ [ 816, 839 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01815580_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01815580_exc_T3", "arg2_id": "NCT01815580_exc_T2", "normalized": [] }, { "id": "NCT01815580_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01815580_exc_T3", "arg2_id": "NCT01815580_exc_T1", "normalized": [] }, { "id": "NCT01815580_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01815580_exc_T5", "arg2_id": "NCT01815580_exc_T4", "normalized": [] }, { "id": "NCT01815580_exc_R4", "type": "Subsumes", "arg1_id": "NCT01815580_exc_T7", "arg2_id": "NCT01815580_exc_T8", "normalized": [] }, { "id": "NCT01815580_exc_R5", "type": "Has_multiplier", "arg1_id": "NCT01815580_exc_T9", "arg2_id": "NCT01815580_exc_T7", "normalized": [] }, { "id": "NCT01815580_exc_R6", "type": "Has_negation", "arg1_id": "NCT01815580_exc_T9", "arg2_id": "NCT01815580_exc_T10", "normalized": [] }, { "id": "NCT01815580_exc_R7", "type": "Subsumes", "arg1_id": "NCT01815580_exc_T20", "arg2_id": "NCT01815580_exc_T21", "normalized": [] }, { "id": "NCT01815580_exc_R8", "type": "Has_scope", "arg1_id": "NCT01815580_exc_T6", "arg2_id": "NCT01815580_exc_T11", "normalized": [] }, { "id": "NCT01815580_exc_R9", "type": "Has_scope", "arg1_id": "NCT01815580_exc_T5", "arg2_id": "NCT01815580_exc_T23", "normalized": [] }, { "id": "NCT01815580_exc_R10", "type": "Subsumes", "arg1_id": "NCT01815580_exc_T27", "arg2_id": "NCT01815580_exc_T28", "normalized": [] }, { "id": "NCT01815580_exc_R11", "type": "Has_scope", "arg1_id": "NCT01815580_exc_T26", "arg2_id": "NCT01815580_exc_T30", "normalized": [] }, { "id": "NCT01815580_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01815580_exc_T36", "arg2_id": "NCT01815580_exc_T37", "normalized": [] }, { "id": "NCT01815580_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01815580_exc_T36", "arg2_id": "NCT01815580_exc_T35", "normalized": [] }, { "id": "NCT01815580_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT01815580_exc_T41", "arg2_id": "NCT01815580_exc_T40", "normalized": [] }, { "id": "NCT01815580_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT01815580_exc_T41", "arg2_id": "NCT01815580_exc_T42", "normalized": [] }, { "id": "NCT01815580_exc_R16", "type": "Has_scope", "arg1_id": "NCT01815580_exc_T45", "arg2_id": "NCT01815580_exc_T48", "normalized": [] } ]

[ { "id": "NCT01815580_inc_text", "type": "inclusion", "text": [ "Adult men who have sex with men, and transgender women\nUnaware of HIV status at enrollment in follow-up cohort\nHigh risk for HIV infection\nWilling to test for HIV\nNo prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days\nWilling to provide informed consent\n" ], "offsets": [ [ 0, 302 ] ] } ]

[ { "id": "NCT01815580_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T2", "type": "Person", "text": [ "men who have sex with men" ], "offsets": [ [ 6, 31 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T3", "type": "Person", "text": [ "transgender women" ], "offsets": [ [ 37, 54 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T4", "type": "Measurement", "text": [ "HIV status" ], "offsets": [ [ 66, 76 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T5", "type": "Value", "text": [ "Unaware" ], "offsets": [ [ 55, 62 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T6", "type": "Observation", "text": [ "Unaware of HIV status" ], "offsets": [ [ 55, 76 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T7", "type": "Temporal", "text": [ "at enrollment in follow-up cohort" ], "offsets": [ [ 77, 110 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T8", "type": "Reference_point", "text": [ "enrollment in follow-up cohort" ], "offsets": [ [ 80, 110 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T9", "type": "Condition", "text": [ "HIV infection" ], "offsets": [ [ 125, 138 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T10", "type": "Mood", "text": [ "High risk for" ], "offsets": [ [ 111, 124 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T11", "type": "Mood", "text": [ "Willing to" ], "offsets": [ [ 139, 149 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T12", "type": "Condition", "text": [ "test for HIV" ], "offsets": [ [ 150, 162 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T13", "type": "Negation", "text": [ "No" ], "offsets": [ [ 163, 165 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T14", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 166, 171 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T15", "type": "Procedure", "text": [ "ART" ], "offsets": [ [ 172, 175 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T16", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 187, 192 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T17", "type": "Procedure", "text": [ "administration" ], "offsets": [ [ 193, 207 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T18", "type": "Drug", "text": [ "post-exposure prophylaxis" ], "offsets": [ [ 220, 245 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T19", "type": "Drug", "text": [ " an", "sure prophylaxis in" ], "offsets": [ [ 215, 218 ], [ 229, 248 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T20", "type": "Temporal", "text": [ "in the last 30 days" ], "offsets": [ [ 246, 265 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T21", "type": "Scope", "text": [ "pre- and post-exposure prophylaxis" ], "offsets": [ [ 211, 245 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T22", "type": "Scope", "text": [ "prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days" ], "offsets": [ [ 166, 265 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T23", "type": "Observation", "text": [ "informed consent" ], "offsets": [ [ 285, 301 ] ], "normalized": [] }, { "id": "NCT01815580_inc_T24", "type": "Mood", "text": [ "Willing to provide" ], "offsets": [ [ 266, 284 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01815580_inc_R1", "type": "Has_value", "arg1_id": "NCT01815580_inc_T4", "arg2_id": "NCT01815580_inc_T5", "normalized": [] }, { "id": "NCT01815580_inc_R3", "type": "Has_index", "arg1_id": "NCT01815580_inc_T7", "arg2_id": "NCT01815580_inc_T8", "normalized": [] }, { "id": "NCT01815580_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01815580_inc_T4", "arg2_id": "NCT01815580_inc_T7", "normalized": [] }, { "id": "NCT01815580_inc_R5", "type": "Has_mood", "arg1_id": "NCT01815580_inc_T9", "arg2_id": "NCT01815580_inc_T10", "normalized": [] }, { "id": "NCT01815580_inc_R6", "type": "Has_mood", "arg1_id": "NCT01815580_inc_T12", "arg2_id": "NCT01815580_inc_T11", "normalized": [] }, { "id": "NCT01815580_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01815580_inc_T15", "arg2_id": "NCT01815580_inc_T14", "normalized": [] }, { "id": "NCT01815580_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01815580_inc_T17", "arg2_id": "NCT01815580_inc_T16", "normalized": [] }, { "id": "NCT01815580_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01815580_inc_T17", "arg2_id": "NCT01815580_inc_T20", "normalized": [] }, { "id": "NCT01815580_inc_R8", "type": "Has_negation", "arg1_id": "NCT01815580_inc_T22", "arg2_id": "NCT01815580_inc_T13", "normalized": [] }, { "id": "NCT01815580_inc_R11", "type": "Has_mood", "arg1_id": "NCT01815580_inc_T23", "arg2_id": "NCT01815580_inc_T24", "normalized": [] } ]

[ { "id": "NCT01816997_exc_text", "type": "exclusion", "text": [ "A1C >7.0%\n2hr glucose during OGTT >200 mg/dL\nTotal cholesterol >280 mg/dL\nPrevious diabetic history, coronary artery disease\nAllergy to rosuvastatin or parvastatin\nBaseline ALT more than 3 times UNL\nSerum Cr > 2.0 mg/dL\nPregnancy, breast feeding or plan to be pregnant woman.\n" ], "offsets": [ [ 0, 276 ] ] } ]

[ { "id": "NCT01816997_exc_T1", "type": "Measurement", "text": [ "A1C" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T2", "type": "Value", "text": [ ">7.0%" ], "offsets": [ [ 4, 9 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T3", "type": "Measurement", "text": [ "2hr glucose during OGTT" ], "offsets": [ [ 10, 33 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T4", "type": "Value", "text": [ ">200 mg/dL" ], "offsets": [ [ 34, 44 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T5", "type": "Measurement", "text": [ "Total cholesterol" ], "offsets": [ [ 45, 62 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T6", "type": "Value", "text": [ ">280 mg/dL" ], "offsets": [ [ 63, 73 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T7", "type": "Condition", "text": [ "diabetic" ], "offsets": [ [ 83, 91 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T8", "type": "Observation", "text": [ "history" ], "offsets": [ [ 92, 99 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T9", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 74, 82 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T10", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 101, 124 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T11", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T12", "type": "Drug", "text": [ "rosuvastatin" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T13", "type": "Drug", "text": [ "parvastatin" ], "offsets": [ [ 152, 163 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T14", "type": "Scope", "text": [ "rosuvastatin or parvastatin" ], "offsets": [ [ 136, 163 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T15", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 164, 172 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T16", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 173, 176 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T17", "type": "Value", "text": [ "more than 3 times UNL" ], "offsets": [ [ 177, 198 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T18", "type": "Measurement", "text": [ "Serum Cr" ], "offsets": [ [ 199, 207 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T19", "type": "Value", "text": [ "> 2.0 mg/dL" ], "offsets": [ [ 208, 219 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T20", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 220, 229 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T21", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 231, 245 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T22", "type": "Mood", "text": [ "plan to be" ], "offsets": [ [ 249, 259 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T23", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 260, 268 ] ], "normalized": [] }, { "id": "NCT01816997_exc_T24", "type": "Person", "text": [ "woman" ], "offsets": [ [ 269, 274 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01816997_exc_R1", "type": "Has_value", "arg1_id": "NCT01816997_exc_T1", "arg2_id": "NCT01816997_exc_T2", "normalized": [] }, { "id": "NCT01816997_exc_R2", "type": "Has_value", "arg1_id": "NCT01816997_exc_T3", "arg2_id": "NCT01816997_exc_T4", "normalized": [] }, { "id": "NCT01816997_exc_R3", "type": "Has_value", "arg1_id": "NCT01816997_exc_T5", "arg2_id": "NCT01816997_exc_T6", "normalized": [] }, { "id": "NCT01816997_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01816997_exc_T7", "arg2_id": "NCT01816997_exc_T8", "normalized": [] }, { "id": "NCT01816997_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01816997_exc_T7", "arg2_id": "NCT01816997_exc_T9", "normalized": [] }, { "id": "NCT01816997_exc_R6", "type": "Has_scope", "arg1_id": "NCT01816997_exc_T11", "arg2_id": "NCT01816997_exc_T14", "normalized": [] }, { "id": "NCT01816997_exc_R7", "type": "Has_value", "arg1_id": "NCT01816997_exc_T16", "arg2_id": "NCT01816997_exc_T17", "normalized": [] }, { "id": "NCT01816997_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01816997_exc_T16", "arg2_id": "NCT01816997_exc_T15", "normalized": [] }, { "id": "NCT01816997_exc_R9", "type": "Has_value", "arg1_id": "NCT01816997_exc_T18", "arg2_id": "NCT01816997_exc_T19", "normalized": [] }, { "id": "NCT01816997_exc_R10", "type": "Has_mood", "arg1_id": "NCT01816997_exc_T23", "arg2_id": "NCT01816997_exc_T22", "normalized": [] } ]

[ { "id": "NCT01816997_inc_text", "type": "inclusion", "text": [ "Age 35-70 years old\nFasting blood glucose 100-125 mg/dL\n" ], "offsets": [ [ 0, 56 ] ] } ]

[ { "id": "NCT01816997_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01816997_inc_T2", "type": "Value", "text": [ "35-70 years old" ], "offsets": [ [ 4, 19 ] ], "normalized": [] }, { "id": "NCT01816997_inc_T3", "type": "Measurement", "text": [ "Fasting blood glucose" ], "offsets": [ [ 20, 41 ] ], "normalized": [] }, { "id": "NCT01816997_inc_T4", "type": "Value", "text": [ "100-125 mg/dL" ], "offsets": [ [ 42, 55 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01816997_inc_R1", "type": "Has_value", "arg1_id": "NCT01816997_inc_T1", "arg2_id": "NCT01816997_inc_T2", "normalized": [] }, { "id": "NCT01816997_inc_R2", "type": "Has_value", "arg1_id": "NCT01816997_inc_T3", "arg2_id": "NCT01816997_inc_T4", "normalized": [] } ]

[ { "id": "NCT01822262_exc_text", "type": "exclusion", "text": [ "Gallbladder's wall >3mm, atrophied gallbladder,gallstone obstruct the Hartmann's pouch.\nAbdominal ultrasound display the contractibility of gallbladder is poor.\nThe aged patients with bad heart and lung function.\nPatients who has acute cholecystitis,pancreatitis,pancreaticobiliary diseases, especially choledocholithiasis.\nPregnant or lactational women.\n" ], "offsets": [ [ 0, 355 ] ] } ]

[ { "id": "NCT01822262_exc_T1", "type": "Measurement", "text": [ "Gallbladder's wall" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T2", "type": "Value", "text": [ ">3mm" ], "offsets": [ [ 19, 23 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T3", "type": "Condition", "text": [ "atrophied gallbladder" ], "offsets": [ [ 25, 46 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T4", "type": "Condition", "text": [ "gallstone obstruct" ], "offsets": [ [ 47, 65 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T5", "type": "Qualifier", "text": [ "Hartmann's pouch" ], "offsets": [ [ 70, 86 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T6", "type": "Procedure", "text": [ "Abdominal ultrasound" ], "offsets": [ [ 88, 108 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T7", "type": "Measurement", "text": [ "contractibility of gallbladder" ], "offsets": [ [ 121, 151 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T8", "type": "Value", "text": [ "poor" ], "offsets": [ [ 155, 159 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T9", "type": "Person", "text": [ "aged" ], "offsets": [ [ 165, 169 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T10", "type": "Condition", "text": [ "d heart a", "nction." ], "offsets": [ [ 186, 195 ], [ 205, 212 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T11", "type": "Condition", "text": [ "d h", "ng function." ], "offsets": [ [ 186, 189 ], [ 200, 212 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T12", "type": "Scope", "text": [ "bad heart and lung function" ], "offsets": [ [ 184, 211 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T13", "type": "Condition", "text": [ "acute cholecystitis" ], "offsets": [ [ 230, 249 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T14", "type": "Condition", "text": [ "pancreatitis" ], "offsets": [ [ 250, 262 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T15", "type": "Condition", "text": [ "pancreaticobiliary diseases" ], "offsets": [ [ 263, 290 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T16", "type": "Condition", "text": [ "choledocholithiasis" ], "offsets": [ [ 303, 322 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T17", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 324, 332 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T18", "type": "Condition", "text": [ "lactational" ], "offsets": [ [ 336, 347 ] ], "normalized": [] }, { "id": "NCT01822262_exc_T19", "type": "Person", "text": [ "women" ], "offsets": [ [ 348, 353 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01822262_exc_R1", "type": "Has_value", "arg1_id": "NCT01822262_exc_T1", "arg2_id": "NCT01822262_exc_T2", "normalized": [] }, { "id": "NCT01822262_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01822262_exc_T4", "arg2_id": "NCT01822262_exc_T5", "normalized": [] }, { "id": "NCT01822262_exc_R3", "type": "Has_value", "arg1_id": "NCT01822262_exc_T7", "arg2_id": "NCT01822262_exc_T8", "normalized": [] }, { "id": "NCT01822262_exc_R4", "type": "AND", "arg1_id": "NCT01822262_exc_T6", "arg2_id": "NCT01822262_exc_T7", "normalized": [] }, { "id": "NCT01822262_exc_R5", "type": "Has_scope", "arg1_id": "NCT01822262_exc_T9", "arg2_id": "NCT01822262_exc_T12", "normalized": [] } ]

[ { "id": "NCT01822262_inc_text", "type": "inclusion", "text": [ "Clinical diagnosis of calculous cholecystitis.\n" ], "offsets": [ [ 0, 47 ] ] } ]

[ { "id": "NCT01822262_inc_T1", "type": "Condition", "text": [ "calculous cholecystitis" ], "offsets": [ [ 22, 45 ] ], "normalized": [] }, { "id": "NCT01822262_inc_T2", "type": "Qualifier", "text": [ "Clinical diagnosis" ], "offsets": [ [ 0, 18 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01822262_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01822262_inc_T1", "arg2_id": "NCT01822262_inc_T2", "normalized": [] } ]

[ { "id": "NCT01824537_exc_text", "type": "exclusion", "text": [ "Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners)\nAny history of cervical, penile, oral or anal cancers\nBeing pregnant or plan on immediately becoming pregnant\n" ], "offsets": [ [ 0, 190 ] ] } ]

[ { "id": "NCT01824537_exc_T1", "type": "Negation", "text": [ "not" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T2", "type": "Temporal", "text": [ "have been" ], "offsets": [ [ 20, 29 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T3", "type": "Procedure", "text": [ "vaccinated" ], "offsets": [ [ 30, 40 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T4", "type": "Condition", "text": [ "HPV-Gardasil-9" ], "offsets": [ [ 49, 63 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T5", "type": "Observation", "text": [ "Any history" ], "offsets": [ [ 80, 91 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T6", "type": "Condition", "text": [ "ancers", "ervical," ], "offsets": [ [ 127, 133 ], [ 96, 104 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T7", "type": "Condition", "text": [ "enile,", "ancers" ], "offsets": [ [ 106, 112 ], [ 127, 133 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T8", "type": "Condition", "text": [ "ral", "ancers" ], "offsets": [ [ 114, 117 ], [ 127, 133 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T9", "type": "Condition", "text": [ "anal cancers" ], "offsets": [ [ 121, 133 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T10", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 140, 148 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T11", "type": "Mood", "text": [ "plan on immediately becoming" ], "offsets": [ [ 152, 180 ] ], "normalized": [] }, { "id": "NCT01824537_exc_T12", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 181, 189 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01824537_exc_R1", "type": "AND", "arg1_id": "NCT01824537_exc_T3", "arg2_id": "NCT01824537_exc_T4", "normalized": [] }, { "id": "NCT01824537_exc_R2", "type": "Has_negation", "arg1_id": "NCT01824537_exc_T3", "arg2_id": "NCT01824537_exc_T1", "normalized": [] }, { "id": "NCT01824537_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01824537_exc_T3", "arg2_id": "NCT01824537_exc_T2", "normalized": [] }, { "id": "NCT01824537_exc_R4", "type": "Has_mood", "arg1_id": "NCT01824537_exc_T12", "arg2_id": "NCT01824537_exc_T11", "normalized": [] } ]

[ { "id": "NCT01824537_inc_text", "type": "inclusion", "text": [ "Couple must have been in a new relationship that started no more than six months prior to study entry\nBoth partners plan on remaining in Montreal for at least 1 year\nPlan on having continued sexual contact with partner\nBe willing to comply with study procedures\n" ], "offsets": [ [ 0, 262 ] ] } ]

[ { "id": "NCT01824537_inc_T1", "type": "Observation", "text": [ "new relationship" ], "offsets": [ [ 27, 43 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T2", "type": "Temporal", "text": [ "no more than six months prior to study entry" ], "offsets": [ [ 57, 101 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T3", "type": "Observation", "text": [ "remaining in Montreal" ], "offsets": [ [ 124, 145 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T4", "type": "Multiplier", "text": [ "for at least 1 year" ], "offsets": [ [ 146, 165 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T5", "type": "Mood", "text": [ "Plan on" ], "offsets": [ [ 166, 173 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T6", "type": "Mood", "text": [ "plan on" ], "offsets": [ [ 116, 123 ] ], "normalized": [] }, { "id": "NCT01824537_inc_T7", "type": "Observation", "text": [ "having continued sexual contact with partner" ], "offsets": [ [ 174, 218 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01824537_inc_R1", "type": "Has_temporal", "arg1_id": "NCT01824537_inc_T1", "arg2_id": "NCT01824537_inc_T2", "normalized": [] }, { "id": "NCT01824537_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT01824537_inc_T3", "arg2_id": "NCT01824537_inc_T4", "normalized": [] }, { "id": "NCT01824537_inc_R3", "type": "Has_mood", "arg1_id": "NCT01824537_inc_T3", "arg2_id": "NCT01824537_inc_T6", "normalized": [] }, { "id": "NCT01824537_inc_R4", "type": "Has_mood", "arg1_id": "NCT01824537_inc_T7", "arg2_id": "NCT01824537_inc_T5", "normalized": [] } ]

[ { "id": "NCT01846507_exc_text", "type": "exclusion", "text": [ "1. Active thromboembolic disease, history of thromboembolic disease (including retinal vein or artery occlusion), known inherited thrombophilia, or family history of thrombosis in a first degree relative \n2. Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance \n3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders such as type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects, and patients with bleeding due to Ehlers Danlos syndrome WILL be eligible to participate in the study. \n4. Pregnancy within the past 6 months and/or breast-feeding \n5. Use of hormonal contraception (estrogen and progestin) within 3 months of study entry, or anticipated need to initiate estrogen-containing hormonal contraception during the study period \n6. Use of systemic steroids within 1 month of study entry \n7. History of subarachnoid hemorrhage \n8. History of Hepatitis B, C, or HIV \n9. Baseline creatinine >20% above the upper limit of normal for age \n10. Severe anemia (hemoglobin <8 g/dL) \n11. Systolic blood pressure <85 or diastolic blood pressure <55 \n12. Heart rate <50 at time of screening \n13. Use of intranasal DDAVP during menses will be permitted, but only if the patient has a history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment, so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical procedures during the study period. \n \n" ], "offsets": [ [ 0, 1739 ] ] } ]

[ { "id": "NCT01846507_exc_T1", "type": "Condition", "text": [ "thromboembolic disease" ], "offsets": [ [ 10, 32 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T2", "type": "Condition", "text": [ "thromboembolic disease" ], "offsets": [ [ 45, 67 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 34, 41 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T4", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 3, 9 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T5", "type": "Condition", "text": [ "retinal vein" ], "offsets": [ [ 79, 91 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T6", "type": "Condition", "text": [ "artery occlusion" ], "offsets": [ [ 95, 111 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T7", "type": "Scope", "text": [ "retinal vein or artery occlusion" ], "offsets": [ [ 79, 111 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T8", "type": "Condition", "text": [ "inherited thrombophilia" ], "offsets": [ [ 120, 143 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T9", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 148, 162 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T10", "type": "Condition", "text": [ "thrombosis" ], "offsets": [ [ 166, 176 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T11", "type": "Observation", "text": [ "in a first degree relative" ], "offsets": [ [ 177, 203 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T12", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 240, 259 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T13", "type": "Condition", "text": [ "medical", "illness" ], "offsets": [ [ 229, 236 ], [ 252, 259 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T14", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 222, 228 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T15", "type": "Scope", "text": [ "medical or psychiatric illness" ], "offsets": [ [ 229, 259 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T17", "type": "Qualifier", "text": [ "in the opinion of the Investigator, would affect subject safety or compliance" ], "offsets": [ [ 266, 343 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T19", "type": "Condition", "text": [ "bleeding disorder" ], "offsets": [ [ 376, 393 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T20", "type": "Condition", "text": [ "bleeding disorders" ], "offsets": [ [ 414, 432 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T21", "type": "Condition", "text": [ "type 1 von Willebrand disease" ], "offsets": [ [ 441, 470 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T22", "type": "Condition", "text": [ "mild platelet function defects" ], "offsets": [ [ 472, 502 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T23", "type": "Condition", "text": [ "platelet storage pool", "defects" ], "offsets": [ [ 511, 532 ], [ 544, 551 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T24", "type": "Condition", "text": [ "platelet", "release defects" ], "offsets": [ [ 511, 519 ], [ 536, 551 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T25", "type": "Scope", "text": [ "platelet storage pool or release defects" ], "offsets": [ [ 511, 551 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T26", "type": "Condition", "text": [ "Ehlers Danlos syndrome" ], "offsets": [ [ 587, 609 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T28", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 571, 579 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T29", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 369, 375 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T31", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 409, 413 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T33", "type": "Scope", "text": [ "type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects" ], "offsets": [ [ 441, 551 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T34", "type": "Scope", "text": [ "mild bleeding disorders" ], "offsets": [ [ 409, 432 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T35", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 660, 669 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T36", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 670, 694 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T37", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 702, 716 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T38", "type": "Procedure", "text": [ "hormonal contraception" ], "offsets": [ [ 728, 750 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T39", "type": "Drug", "text": [ "estrogen" ], "offsets": [ [ 752, 760 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T40", "type": "Drug", "text": [ "progestin" ], "offsets": [ [ 765, 774 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T41", "type": "Scope", "text": [ "estrogen and progestin" ], "offsets": [ [ 752, 774 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T42", "type": "Temporal", "text": [ "within 3 months of study entry" ], "offsets": [ [ 776, 806 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T43", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 795, 806 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T44", "type": "Observation", "text": [ "anticipated need" ], "offsets": [ [ 811, 827 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T45", "type": "Procedure", "text": [ "estrogen-containing hormonal contraception" ], "offsets": [ [ 840, 882 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T46", "type": "Drug", "text": [ "estrogen" ], "offsets": [ [ 840, 848 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T47", "type": "Qualifier", "text": [ "estrogen-containing" ], "offsets": [ [ 840, 859 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T48", "type": "Temporal", "text": [ "during the study period" ], "offsets": [ [ 883, 906 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T49", "type": "Reference_point", "text": [ "the study period" ], "offsets": [ [ 890, 906 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T50", "type": "Drug", "text": [ "systemic steroids" ], "offsets": [ [ 918, 935 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T51", "type": "Temporal", "text": [ "within 1 month of study entry" ], "offsets": [ [ 936, 965 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T52", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 954, 965 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T53", "type": "Condition", "text": [ "subarachnoid hemorrhage" ], "offsets": [ [ 981, 1004 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T54", "type": "Observation", "text": [ "History" ], "offsets": [ [ 970, 977 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T55", "type": "Condition", "text": [ "Hepatitis B" ], "offsets": [ [ 1020, 1031 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T56", "type": "Condition", "text": [ "Hepatitis", "C" ], "offsets": [ [ 1020, 1029 ], [ 1033, 1034 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T57", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 1039, 1042 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T58", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1009, 1016 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T59", "type": "Scope", "text": [ "Hepatitis B, C, or HIV" ], "offsets": [ [ 1020, 1042 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T60", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 1056, 1066 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T61", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 1047, 1055 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T62", "type": "Value", "text": [ ">20% above the upper limit of normal for age" ], "offsets": [ [ 1067, 1111 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T63", "type": "Person", "text": [ "age" ], "offsets": [ [ 1108, 1111 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T64", "type": "Condition", "text": [ "anemia" ], "offsets": [ [ 1124, 1130 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T65", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 1117, 1123 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T66", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 1132, 1142 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T67", "type": "Value", "text": [ "<8 g/dL" ], "offsets": [ [ 1143, 1150 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T68", "type": "Measurement", "text": [ "Systolic blood pressure" ], "offsets": [ [ 1157, 1180 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T69", "type": "Value", "text": [ "<85" ], "offsets": [ [ 1181, 1184 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T70", "type": "Measurement", "text": [ "diastolic blood pressure" ], "offsets": [ [ 1188, 1212 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T71", "type": "Value", "text": [ "<55" ], "offsets": [ [ 1213, 1216 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T72", "type": "Measurement", "text": [ "Heart rate" ], "offsets": [ [ 1222, 1232 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T73", "type": "Value", "text": [ "<50" ], "offsets": [ [ 1233, 1236 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T74", "type": "Temporal", "text": [ "at time of screening" ], "offsets": [ [ 1237, 1257 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T75", "type": "Reference_point", "text": [ "time of screening" ], "offsets": [ [ 1240, 1257 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T76", "type": "Device", "text": [ "intranasal DDAVP" ], "offsets": [ [ 1270, 1286 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T77", "type": "Temporal", "text": [ "during menses" ], "offsets": [ [ 1287, 1300 ] ], "normalized": [] }, { "id": "NCT01846507_exc_T78", "type": "Reference_point", "text": [ "menses" ], "offsets": [ [ 1294, 1300 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01846507_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T2", "arg2_id": "NCT01846507_exc_T3", "normalized": [] }, { "id": "NCT01846507_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T1", "arg2_id": "NCT01846507_exc_T4", "normalized": [] }, { "id": "NCT01846507_exc_R3", "type": "Subsumes", "arg1_id": "NCT01846507_exc_T2", "arg2_id": "NCT01846507_exc_T7", "normalized": [] }, { "id": "NCT01846507_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T15", "arg2_id": "NCT01846507_exc_T14", "normalized": [] }, { "id": "NCT01846507_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T15", "arg2_id": "NCT01846507_exc_T17", "normalized": [] }, { "id": "NCT01846507_exc_R8", "type": "Subsumes", "arg1_id": "NCT01846507_exc_T22", "arg2_id": "NCT01846507_exc_T25", "normalized": [] }, { "id": "NCT01846507_exc_R9", "type": "AND", "arg1_id": "NCT01846507_exc_T28", "arg2_id": "NCT01846507_exc_T26", "normalized": [] }, { "id": "NCT01846507_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T19", "arg2_id": "NCT01846507_exc_T29", "normalized": [] }, { "id": "NCT01846507_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T20", "arg2_id": "NCT01846507_exc_T31", "normalized": [] }, { "id": "NCT01846507_exc_R12", "type": "Subsumes", "arg1_id": "NCT01846507_exc_T34", "arg2_id": "NCT01846507_exc_T33", "normalized": [] }, { "id": "NCT01846507_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T35", "arg2_id": "NCT01846507_exc_T36", "normalized": [] }, { "id": "NCT01846507_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T37", "arg2_id": "NCT01846507_exc_T36", "normalized": [] }, { "id": "NCT01846507_exc_R15", "type": "Subsumes", "arg1_id": "NCT01846507_exc_T38", "arg2_id": "NCT01846507_exc_T41", "normalized": [] }, { "id": "NCT01846507_exc_R16", "type": "Has_index", "arg1_id": "NCT01846507_exc_T42", "arg2_id": "NCT01846507_exc_T43", "normalized": [] }, { "id": "NCT01846507_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T45", "arg2_id": "NCT01846507_exc_T47", "normalized": [] }, { "id": "NCT01846507_exc_R18", "type": "AND", "arg1_id": "NCT01846507_exc_T47", "arg2_id": "NCT01846507_exc_T46", "normalized": [] }, { "id": "NCT01846507_exc_R19", "type": "Has_index", "arg1_id": "NCT01846507_exc_T48", "arg2_id": "NCT01846507_exc_T49", "normalized": [] }, { "id": "NCT01846507_exc_R21", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T45", "arg2_id": "NCT01846507_exc_T48", "normalized": [] }, { "id": "NCT01846507_exc_R22", "type": "Has_index", "arg1_id": "NCT01846507_exc_T51", "arg2_id": "NCT01846507_exc_T52", "normalized": [] }, { "id": "NCT01846507_exc_R23", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T50", "arg2_id": "NCT01846507_exc_T51", "normalized": [] }, { "id": "NCT01846507_exc_R24", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T53", "arg2_id": "NCT01846507_exc_T54", "normalized": [] }, { "id": "NCT01846507_exc_R25", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T59", "arg2_id": "NCT01846507_exc_T58", "normalized": [] }, { "id": "NCT01846507_exc_R26", "type": "Has_value", "arg1_id": "NCT01846507_exc_T60", "arg2_id": "NCT01846507_exc_T62", "normalized": [] }, { "id": "NCT01846507_exc_R27", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T60", "arg2_id": "NCT01846507_exc_T61", "normalized": [] }, { "id": "NCT01846507_exc_R28", "type": "Has_value", "arg1_id": "NCT01846507_exc_T66", "arg2_id": "NCT01846507_exc_T67", "normalized": [] }, { "id": "NCT01846507_exc_R29", "type": "Subsumes", "arg1_id": "NCT01846507_exc_T65", "arg2_id": "NCT01846507_exc_T66", "normalized": [] }, { "id": "NCT01846507_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT01846507_exc_T64", "arg2_id": "NCT01846507_exc_T65", "normalized": [] }, { "id": "NCT01846507_exc_R31", "type": "Has_value", "arg1_id": "NCT01846507_exc_T70", "arg2_id": "NCT01846507_exc_T71", "normalized": [] }, { "id": "NCT01846507_exc_R32", "type": "Has_value", "arg1_id": "NCT01846507_exc_T68", "arg2_id": "NCT01846507_exc_T69", "normalized": [] }, { "id": "NCT01846507_exc_R33", "type": "Has_value", "arg1_id": "NCT01846507_exc_T72", "arg2_id": "NCT01846507_exc_T73", "normalized": [] }, { "id": "NCT01846507_exc_R34", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T72", "arg2_id": "NCT01846507_exc_T74", "normalized": [] }, { "id": "NCT01846507_exc_R35", "type": "Has_index", "arg1_id": "NCT01846507_exc_T74", "arg2_id": "NCT01846507_exc_T75", "normalized": [] }, { "id": "NCT01846507_exc_R36", "type": "Has_index", "arg1_id": "NCT01846507_exc_T77", "arg2_id": "NCT01846507_exc_T78", "normalized": [] }, { "id": "NCT01846507_exc_R37", "type": "Has_temporal", "arg1_id": "NCT01846507_exc_T76", "arg2_id": "NCT01846507_exc_T77", "normalized": [] } ]

[ { "id": "NCT01846507_inc_text", "type": "inclusion", "text": [ "1. Menstruating females 10-19 years of age \n2. Non-smoker \n3. Physician and patient have agreed to initiate Lysteda \n4. Diagnosis of HMB based on the medical judgment of the principal or site investigator \n5. Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period \n6. Negative pregnancy test \n7. Informed consent obtained and signed \n8. Informed assent obtained and signed \n9. Understanding of study procedures \n10. Ability to comply with study procedures for the entire length of the study \n11. Subjects should be either sexually inactive (abstinent) or agree to use a barrier method with spermicide in the event of sexual activity throughout the study period \n" ], "offsets": [ [ 0, 745 ] ] } ]

[ { "id": "NCT01846507_inc_T1", "type": "Condition", "text": [ "Menstruating" ], "offsets": [ [ 3, 15 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T2", "type": "Person", "text": [ "females" ], "offsets": [ [ 16, 23 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T3", "type": "Value", "text": [ "10-19 years" ], "offsets": [ [ 24, 35 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 39, 42 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T5", "type": "Condition", "text": [ "Non-smoker" ], "offsets": [ [ 47, 57 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T6", "type": "Drug", "text": [ "Lysteda" ], "offsets": [ [ 108, 115 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T8", "type": "Condition", "text": [ "HMB" ], "offsets": [ [ 133, 136 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T11", "type": "Condition", "text": [ "menstrual periods" ], "offsets": [ [ 230, 247 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T12", "type": "Temporal", "text": [ "within 21-60 days from the start of one period" ], "offsets": [ [ 258, 304 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T13", "type": "Reference_point", "text": [ "the start of one period" ], "offsets": [ [ 281, 304 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T14", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 360, 374 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T15", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 351, 359 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T24", "type": "Condition", "text": [ "sexually inactive" ], "offsets": [ [ 605, 622 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T25", "type": "Condition", "text": [ "sexually", "abstinent" ], "offsets": [ [ 605, 613 ], [ 624, 633 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T26", "type": "Device", "text": [ "barrier method with spermicide" ], "offsets": [ [ 653, 683 ] ], "normalized": [] }, { "id": "NCT01846507_inc_T27", "type": "Observation", "text": [ "agree to use" ], "offsets": [ [ 638, 650 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01846507_inc_R1", "type": "Has_value", "arg1_id": "NCT01846507_inc_T4", "arg2_id": "NCT01846507_inc_T3", "normalized": [] }, { "id": "NCT01846507_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01846507_inc_T11", "arg2_id": "NCT01846507_inc_T12", "normalized": [] }, { "id": "NCT01846507_inc_R3", "type": "Has_value", "arg1_id": "NCT01846507_inc_T14", "arg2_id": "NCT01846507_inc_T15", "normalized": [] }, { "id": "NCT01846507_inc_R4", "type": "Subsumes", "arg1_id": "NCT01846507_inc_T24", "arg2_id": "NCT01846507_inc_T25", "normalized": [] } ]

[ { "id": "NCT01850147_exc_text", "type": "exclusion", "text": [ "Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry \nUncontrolled hypertension \nCHF, angina or arrhythmias \nLVEF < 1 UNL \nExisting a second malignancy within 5 years \nInfected with HIV \n \n" ], "offsets": [ [ 0, 251 ] ] } ]

[ { "id": "NCT01850147_exc_T1", "type": "Condition", "text": [ "hemoptysis" ], "offsets": [ [ 13, 23 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T2", "type": "Qualifier", "text": [ "severity" ], "offsets": [ [ 29, 37 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T3", "type": "Value", "text": [ "> grade 3" ], "offsets": [ [ 38, 47 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T4", "type": "Measurement", "text": [ "NCI CTCAE criteria" ], "offsets": [ [ 51, 69 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T5", "type": "Temporal", "text": [ "within 4 weeks prior to study entry" ], "offsets": [ [ 70, 105 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T6", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 94, 105 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T7", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 120, 132 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T8", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 107, 119 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T9", "type": "Condition", "text": [ "CHF" ], "offsets": [ [ 134, 137 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T10", "type": "Condition", "text": [ "angina" ], "offsets": [ [ 139, 145 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T11", "type": "Condition", "text": [ "arrhythmias" ], "offsets": [ [ 149, 160 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T12", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 162, 166 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T13", "type": "Value", "text": [ "< 1 UNL" ], "offsets": [ [ 167, 174 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T14", "type": "Condition", "text": [ "second malignancy" ], "offsets": [ [ 187, 204 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T15", "type": "Temporal", "text": [ "within 5 years" ], "offsets": [ [ 205, 219 ] ], "normalized": [] }, { "id": "NCT01850147_exc_T17", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 235, 238 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01850147_exc_R1", "type": "Has_value", "arg1_id": "NCT01850147_exc_T2", "arg2_id": "NCT01850147_exc_T3", "normalized": [] }, { "id": "NCT01850147_exc_R2", "type": "AND", "arg1_id": "NCT01850147_exc_T2", "arg2_id": "NCT01850147_exc_T4", "normalized": [] }, { "id": "NCT01850147_exc_R3", "type": "Has_index", "arg1_id": "NCT01850147_exc_T5", "arg2_id": "NCT01850147_exc_T6", "normalized": [] }, { "id": "NCT01850147_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01850147_exc_T7", "arg2_id": "NCT01850147_exc_T8", "normalized": [] }, { "id": "NCT01850147_exc_R5", "type": "Has_value", "arg1_id": "NCT01850147_exc_T12", "arg2_id": "NCT01850147_exc_T13", "normalized": [] }, { "id": "NCT01850147_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01850147_exc_T14", "arg2_id": "NCT01850147_exc_T15", "normalized": [] } ]

[ { "id": "NCT01850147_inc_text", "type": "inclusion", "text": [ "Histologic or cytologic diagnosis of stage IIIB/IV NSCLC \nECOG PS: 0,1 \nUnidimensional or bi-dimensional measurable disease \nReceive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor \nEvidence of disease progression \nLife expectancy >12 weeks \nNeutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL \n" ], "offsets": [ [ 0, 502 ] ] } ]

[ { "id": "NCT01850147_inc_T1", "type": "Procedure", "text": [ "Histologic" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T2", "type": "Procedure", "text": [ "cytologic" ], "offsets": [ [ 14, 23 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T3", "type": "Condition", "text": [ "NSCLC" ], "offsets": [ [ 51, 56 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T4", "type": "Qualifier", "text": [ "stage IIIB/IV" ], "offsets": [ [ 37, 50 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T5", "type": "Measurement", "text": [ "ECOG PS" ], "offsets": [ [ 58, 65 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T6", "type": "Value", "text": [ "0,1" ], "offsets": [ [ 67, 70 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T8", "type": "Qualifier", "text": [ "measurable" ], "offsets": [ [ 105, 115 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T11", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 139, 148 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T12", "type": "Procedure", "text": [ "platinum-based chemotherapy" ], "offsets": [ [ 170, 197 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T13", "type": "Procedure", "text": [ "second-line chemotherapy" ], "offsets": [ [ 208, 232 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T14", "type": "Drug", "text": [ "1 EGF/EGFR inhibitor" ], "offsets": [ [ 237, 257 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T15", "type": "Qualifier", "text": [ "standard" ], "offsets": [ [ 199, 207 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T16", "type": "Scope", "text": [ "platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor" ], "offsets": [ [ 170, 257 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T17", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 271, 290 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T18", "type": "Observation", "text": [ "Evidence" ], "offsets": [ [ 259, 267 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T21", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 292, 307 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T22", "type": "Value", "text": [ ">12 weeks" ], "offsets": [ [ 308, 317 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T23", "type": "Measurement", "text": [ "Neutrophils" ], "offsets": [ [ 319, 330 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T24", "type": "Value", "text": [ "> 1.5 109/l" ], "offsets": [ [ 331, 342 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T25", "type": "Measurement", "text": [ "Platelets" ], "offsets": [ [ 344, 353 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T26", "type": "Value", "text": [ "> 100 109/l" ], "offsets": [ [ 354, 365 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T27", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 367, 377 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T28", "type": "Value", "text": [ "> 9g/dl" ], "offsets": [ [ 378, 385 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T29", "type": "Measurement", "text": [ "Total bilirubin" ], "offsets": [ [ 387, 402 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T30", "type": "Value", "text": [ "< 1.5 UNL" ], "offsets": [ [ 403, 412 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T31", "type": "Measurement", "text": [ "ALT (SGPT)" ], "offsets": [ [ 429, 439 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T32", "type": "Value", "text": [ "< 2.5 UNL" ], "offsets": [ [ 440, 449 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T33", "type": "Measurement", "text": [ "AST (SGOT)" ], "offsets": [ [ 414, 424 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T34", "type": "Measurement", "text": [ "Alkaline phosphatases" ], "offsets": [ [ 451, 472 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T35", "type": "Value", "text": [ "< 5 UNL" ], "offsets": [ [ 473, 480 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T36", "type": "Measurement", "text": [ "Creatinine" ], "offsets": [ [ 482, 492 ] ], "normalized": [] }, { "id": "NCT01850147_inc_T37", "type": "Value", "text": [ "< 1 UNL" ], "offsets": [ [ 493, 500 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01850147_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01850147_inc_T3", "arg2_id": "NCT01850147_inc_T4", "normalized": [] }, { "id": "NCT01850147_inc_R2", "type": "AND", "arg1_id": "NCT01850147_inc_T3", "arg2_id": "NCT01850147_inc_T2", "normalized": [] }, { "id": "NCT01850147_inc_R3", "type": "AND", "arg1_id": "NCT01850147_inc_T3", "arg2_id": "NCT01850147_inc_T1", "normalized": [] }, { "id": "NCT01850147_inc_R4", "type": "Has_value", "arg1_id": "NCT01850147_inc_T5", "arg2_id": "NCT01850147_inc_T6", "normalized": [] }, { "id": "NCT01850147_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01850147_inc_T13", "arg2_id": "NCT01850147_inc_T15", "normalized": [] }, { "id": "NCT01850147_inc_R6", "type": "Subsumes", "arg1_id": "NCT01850147_inc_T11", "arg2_id": "NCT01850147_inc_T16", "normalized": [] }, { "id": "NCT01850147_inc_R7", "type": "Has_value", "arg1_id": "NCT01850147_inc_T21", "arg2_id": "NCT01850147_inc_T22", "normalized": [] }, { "id": "NCT01850147_inc_R8", "type": "Has_value", "arg1_id": "NCT01850147_inc_T31", "arg2_id": "NCT01850147_inc_T32", "normalized": [] }, { "id": "NCT01850147_inc_R9", "type": "Has_value", "arg1_id": "NCT01850147_inc_T33", "arg2_id": "NCT01850147_inc_T32", "normalized": [] }, { "id": "NCT01850147_inc_R10", "type": "Has_value", "arg1_id": "NCT01850147_inc_T36", "arg2_id": "NCT01850147_inc_T37", "normalized": [] }, { "id": "NCT01850147_inc_R11", "type": "Has_value", "arg1_id": "NCT01850147_inc_T34", "arg2_id": "NCT01850147_inc_T35", "normalized": [] }, { "id": "NCT01850147_inc_R12", "type": "Has_value", "arg1_id": "NCT01850147_inc_T29", "arg2_id": "NCT01850147_inc_T30", "normalized": [] }, { "id": "NCT01850147_inc_R13", "type": "Has_value", "arg1_id": "NCT01850147_inc_T27", "arg2_id": "NCT01850147_inc_T28", "normalized": [] }, { "id": "NCT01850147_inc_R14", "type": "Has_value", "arg1_id": "NCT01850147_inc_T25", "arg2_id": "NCT01850147_inc_T26", "normalized": [] }, { "id": "NCT01850147_inc_R15", "type": "Has_value", "arg1_id": "NCT01850147_inc_T23", "arg2_id": "NCT01850147_inc_T24", "normalized": [] } ]

[ { "id": "NCT01856491_exc_text", "type": "exclusion", "text": [ "Known or suspected sensitivity to Dexamethasone Acetate (DXA) \nMechanical tricuspid heart valve \nSubject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following: \nSchedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits); \nRELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject); \nConduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations \nCurrently on the active heart transplant list \nDocumented life expectancy of less than 12 months \nWomen of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion) \nCurrently requiring chronic dialysis \n \n" ], "offsets": [ [ 0, 1040 ] ] } ]

[ { "id": "NCT01856491_exc_T1", "type": "Condition", "text": [ "sensitivity to Dexamethasone Acetate (DXA)" ], "offsets": [ [ 19, 61 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T2", "type": "Drug", "text": [ "Dexamethasone Acetate (DXA)" ], "offsets": [ [ 34, 61 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T3", "type": "Observation", "text": [ "suspected" ], "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T4", "type": "Observation", "text": [ "Known" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T5", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T6", "type": "Device", "text": [ "Mechanical tricuspid heart valve" ], "offsets": [ [ 63, 95 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T15", "type": "Observation", "text": [ "active heart transplant list" ], "offsets": [ [ 767, 795 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T16", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 808, 823 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T17", "type": "Value", "text": [ "less than 12 months" ], "offsets": [ [ 827, 846 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T18", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 857, 879 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T19", "type": "Person", "text": [ "Women" ], "offsets": [ [ 848, 853 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T20", "type": "Observation", "text": [ "are or might be" ], "offsets": [ [ 884, 899 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T22", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 900, 908 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T23", "type": "Temporal", "text": [ "at the time of study enrollment" ], "offsets": [ [ 909, 940 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T21", "type": "Scope", "text": [ "Women of childbearing potential" ], "offsets": [ [ 848, 879 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T24", "type": "Procedure", "text": [ "chronic dialysis" ], "offsets": [ [ 1011, 1027 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T25", "type": "Condition", "text": [ "requiring chronic dialysis" ], "offsets": [ [ 1001, 1027 ] ], "normalized": [] }, { "id": "NCT01856491_exc_T26", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 991, 1000 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01856491_exc_R1", "type": "Has_scope", "arg1_id": "NCT01856491_exc_T1", "arg2_id": "NCT01856491_exc_T5", "normalized": [] }, { "id": "NCT01856491_exc_R2", "type": "Has_value", "arg1_id": "NCT01856491_exc_T16", "arg2_id": "NCT01856491_exc_T17", "normalized": [] }, { "id": "NCT01856491_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01856491_exc_T22", "arg2_id": "NCT01856491_exc_T23", "normalized": [] }, { "id": "NCT01856491_exc_R5", "type": "AND", "arg1_id": "NCT01856491_exc_T21", "arg2_id": "NCT01856491_exc_T22", "normalized": [] }, { "id": "NCT01856491_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01856491_exc_T25", "arg2_id": "NCT01856491_exc_T26", "normalized": [] } ]

[ { "id": "NCT01856491_inc_text", "type": "inclusion", "text": [ "Willing and capable of providing informed consent \nHas an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography \nSubjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead \nWilling and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol \nAge 18 or above, or of legal age to give informed consent specific to state and national law \n" ], "offsets": [ [ 0, 521 ] ] } ]

[ { "id": "NCT01856491_inc_T2", "type": "Observation", "text": [ "indication" ], "offsets": [ [ 58, 68 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T3", "type": "Procedure", "text": [ "chamber ICD", "implantation of a single" ], "offsets": [ [ 106, 117 ], [ 73, 97 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T4", "type": "Procedure", "text": [ "dual chamber ICD", "implantation of a" ], "offsets": [ [ 101, 117 ], [ 73, 90 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T5", "type": "Procedure", "text": [ "CRT-D system", "implantation of a" ], "offsets": [ [ 121, 133 ], [ 73, 90 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T6", "type": "Scope", "text": [ "implantation of a single or dual chamber ICD or CRT-D system" ], "offsets": [ [ 73, 133 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T7", "type": "Observation", "text": [ "planned" ], "offsets": [ [ 174, 181 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T8", "type": "Procedure", "text": [ "implanted with the RELIANCE 4-FRONT Passive Fixation Lead" ], "offsets": [ [ 188, 245 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T9", "type": "Device", "text": [ "RELIANCE 4-FRONT Passive Fixation Lead" ], "offsets": [ [ 207, 245 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T11", "type": "Person", "text": [ "Age" ], "offsets": [ [ 427, 430 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T12", "type": "Value", "text": [ "18 or above" ], "offsets": [ [ 431, 442 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T13", "type": "Value", "text": [ "of legal age" ], "offsets": [ [ 447, 459 ] ], "normalized": [] }, { "id": "NCT01856491_inc_T14", "type": "Scope", "text": [ "18 or above, or of legal age" ], "offsets": [ [ 431, 459 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01856491_inc_R2", "type": "Has_scope", "arg1_id": "NCT01856491_inc_T11", "arg2_id": "NCT01856491_inc_T14", "normalized": [] } ]

[ { "id": "NCT01857167_exc_text", "type": "exclusion", "text": [ "1. Deny to sign the informed consent; \n2. type 1 diabetes; \n3. Family history of hypertriglyceridemia or fasting triglyceride>4.56 mmol/L; \n4. Have severe liver disease, kidney disease or cancer; \n5. Participating in the other clinical trial within 30 days; \n6. Other diseases or conditions, for which the doctor of the patients do not agree his or her participating. \n \n" ], "offsets": [ [ 0, 380 ] ] } ]

[ { "id": "NCT01857167_exc_T3", "type": "Condition", "text": [ "type 1 diabetes" ], "offsets": [ [ 42, 57 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T4", "type": "Condition", "text": [ "hypertriglyceridemia" ], "offsets": [ [ 81, 101 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T5", "type": "Measurement", "text": [ "fasting triglyceride" ], "offsets": [ [ 105, 125 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T6", "type": "Value", "text": [ ">4.56 mmol/L" ], "offsets": [ [ 125, 137 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T7", "type": "Observation", "text": [ "Family history" ], "offsets": [ [ 63, 77 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T8", "type": "Scope", "text": [ "hypertriglyceridemia or fasting triglyceride>4.56 mmol/L" ], "offsets": [ [ 81, 137 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 148, 154 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T10", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 155, 168 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T11", "type": "Condition", "text": [ "kidney disease" ], "offsets": [ [ 170, 184 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T12", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 188, 194 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T14", "type": "Condition", "text": [ "Other diseases" ], "offsets": [ [ 262, 276 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T15", "type": "Condition", "text": [ "Other", "conditions" ], "offsets": [ [ 262, 267 ], [ 280, 290 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T18", "type": "Qualifier", "text": [ "for which the doctor of the patients do not agree his or her participating" ], "offsets": [ [ 292, 366 ] ], "normalized": [] }, { "id": "NCT01857167_exc_T19", "type": "Scope", "text": [ "Other diseases or conditions" ], "offsets": [ [ 262, 290 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01857167_exc_R1", "type": "Has_value", "arg1_id": "NCT01857167_exc_T5", "arg2_id": "NCT01857167_exc_T6", "normalized": [] }, { "id": "NCT01857167_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01857167_exc_T10", "arg2_id": "NCT01857167_exc_T9", "normalized": [] }, { "id": "NCT01857167_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01857167_exc_T19", "arg2_id": "NCT01857167_exc_T18", "normalized": [] } ]

[ { "id": "NCT01857167_inc_text", "type": "inclusion", "text": [ "1. Fasting glucose > 7.0 or have diabetes medication; \n2. Male, 35-80 years; female, postmenopausal to 80 years; \n3. Agree to participant in the trial. \n" ], "offsets": [ [ 0, 153 ] ] } ]

[ { "id": "NCT01857167_inc_T1", "type": "Measurement", "text": [ "Fasting glucose" ], "offsets": [ [ 3, 18 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T2", "type": "Value", "text": [ "> 7.0" ], "offsets": [ [ 19, 24 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T3", "type": "Drug", "text": [ "diabetes medication" ], "offsets": [ [ 33, 52 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T4", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 33, 41 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T6", "type": "Person", "text": [ "Male" ], "offsets": [ [ 58, 62 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T7", "type": "Person", "text": [ "35-80 years" ], "offsets": [ [ 64, 75 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T8", "type": "Value", "text": [ "35-80 years" ], "offsets": [ [ 64, 75 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T9", "type": "Person", "text": [ "female" ], "offsets": [ [ 77, 83 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T10", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 85, 99 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T11", "type": "Person", "text": [ "to 80 years" ], "offsets": [ [ 100, 111 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T12", "type": "Value", "text": [ "to 80 years" ], "offsets": [ [ 100, 111 ] ], "normalized": [] }, { "id": "NCT01857167_inc_T13", "type": "Scope", "text": [ "female, postmenopausal" ], "offsets": [ [ 77, 99 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01857167_inc_R1", "type": "Has_value", "arg1_id": "NCT01857167_inc_T1", "arg2_id": "NCT01857167_inc_T2", "normalized": [] }, { "id": "NCT01857167_inc_R2", "type": "Has_value", "arg1_id": "NCT01857167_inc_T7", "arg2_id": "NCT01857167_inc_T8", "normalized": [] }, { "id": "NCT01857167_inc_R3", "type": "Has_value", "arg1_id": "NCT01857167_inc_T13", "arg2_id": "NCT01857167_inc_T12", "normalized": [] }, { "id": "NCT01857167_inc_R4", "type": "Has_value", "arg1_id": "NCT01857167_inc_T6", "arg2_id": "NCT01857167_inc_T8", "normalized": [] } ]

[ { "id": "NCT01866800_exc_text", "type": "exclusion", "text": [ "History of acute coronary syndrome in the past 30 days.\nHistory of congesting heart failure with left ventricular ejection fraction <30% or exacerbation in the past 30 days.\nCurrent dialysis treatment.\nKnown furosemide hypersensitivity.\nContraindications to placement of a Foley catheter in the bladder.\n" ], "offsets": [ [ 0, 304 ] ] } ]

[ { "id": "NCT01866800_exc_T1", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 11, 34 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T2", "type": "Temporal", "text": [ "in the past 30 days" ], "offsets": [ [ 35, 54 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T3", "type": "Condition", "text": [ "congesting heart failure" ], "offsets": [ [ 67, 91 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T4", "type": "Measurement", "text": [ "left ventricular ejection fraction" ], "offsets": [ [ 97, 131 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T5", "type": "Value", "text": [ "<30%" ], "offsets": [ [ 132, 136 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T6", "type": "Condition", "text": [ "exacerbation" ], "offsets": [ [ 140, 152 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T7", "type": "Temporal", "text": [ "in the past 30 days" ], "offsets": [ [ 153, 172 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T8", "type": "Scope", "text": [ "left ventricular ejection fraction <30% or exacerbation in the past 30 days" ], "offsets": [ [ 97, 172 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T9", "type": "Procedure", "text": [ "dialysis treatment" ], "offsets": [ [ 182, 200 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T10", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 174, 181 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T11", "type": "Drug", "text": [ "furosemide" ], "offsets": [ [ 208, 218 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T12", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 219, 235 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T13", "type": "Condition", "text": [ "Contraindications" ], "offsets": [ [ 237, 254 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T14", "type": "Procedure", "text": [ "placement of a Foley catheter" ], "offsets": [ [ 258, 287 ] ], "normalized": [] }, { "id": "NCT01866800_exc_T15", "type": "Qualifier", "text": [ "bladder" ], "offsets": [ [ 295, 302 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01866800_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01866800_exc_T1", "arg2_id": "NCT01866800_exc_T2", "normalized": [] }, { "id": "NCT01866800_exc_R2", "type": "Has_value", "arg1_id": "NCT01866800_exc_T4", "arg2_id": "NCT01866800_exc_T5", "normalized": [] }, { "id": "NCT01866800_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01866800_exc_T6", "arg2_id": "NCT01866800_exc_T7", "normalized": [] }, { "id": "NCT01866800_exc_R4", "type": "Has_scope", "arg1_id": "NCT01866800_exc_T3", "arg2_id": "NCT01866800_exc_T8", "normalized": [] }, { "id": "NCT01866800_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01866800_exc_T9", "arg2_id": "NCT01866800_exc_T10", "normalized": [] }, { "id": "NCT01866800_exc_R6", "type": "AND", "arg1_id": "NCT01866800_exc_T12", "arg2_id": "NCT01866800_exc_T11", "normalized": [] }, { "id": "NCT01866800_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01866800_exc_T14", "arg2_id": "NCT01866800_exc_T15", "normalized": [] }, { "id": "NCT01866800_exc_R8", "type": "AND", "arg1_id": "NCT01866800_exc_T13", "arg2_id": "NCT01866800_exc_T14", "normalized": [] } ]

[ { "id": "NCT01866800_inc_text", "type": "inclusion", "text": [ "Subject is 65 years old who is able and willing to give an informed consent.\nPatients undergoing planned trans-femoral TAVI.\nCalculated eGFR below 60ml/min/1.73m2 (MDRD)\n" ], "offsets": [ [ 0, 170 ] ] } ]

[ { "id": "NCT01866800_inc_T1", "type": "Value", "text": [ "65 years" ], "offsets": [ [ 11, 19 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T4", "type": "Procedure", "text": [ "trans-femoral TAVI" ], "offsets": [ [ 105, 123 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T5", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 86, 96 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T6", "type": "Qualifier", "text": [ "planned" ], "offsets": [ [ 97, 104 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T7", "type": "Measurement", "text": [ "Calculated eGFR" ], "offsets": [ [ 125, 140 ] ], "normalized": [] }, { "id": "NCT01866800_inc_T8", "type": "Value", "text": [ "below 60ml/min/1.73m2" ], "offsets": [ [ 141, 162 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01866800_inc_R1", "type": "Has_value", "arg1_id": "NCT01866800_inc_T2", "arg2_id": "NCT01866800_inc_T1", "normalized": [] }, { "id": "NCT01866800_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01866800_inc_T4", "arg2_id": "NCT01866800_inc_T6", "normalized": [] }, { "id": "NCT01866800_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01866800_inc_T4", "arg2_id": "NCT01866800_inc_T5", "normalized": [] }, { "id": "NCT01866800_inc_R4", "type": "Has_value", "arg1_id": "NCT01866800_inc_T7", "arg2_id": "NCT01866800_inc_T8", "normalized": [] } ]

[ { "id": "NCT01884337_exc_text", "type": "exclusion", "text": [ "Women who are pregnant or breastfeeding\nKnown or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative\nActive bleeding or at high risk for bleeding.\nBrain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery\nActive hepatobiliary disease\nHemoglobin <9 g/dL\nPlatelet count <100,000/mm3\nCreatinine clearance <30 mL/min\n" ], "offsets": [ [ 0, 424 ] ] } ]

[ { "id": "NCT01884337_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T2", "type": "Observation", "text": [ "pregnant" ], "offsets": [ [ 14, 22 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T3", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 26, 39 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T4", "type": "Mood", "text": [ "Known" ], "offsets": [ [ 40, 45 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T5", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 49, 58 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T6", "type": "Condition", "text": [ "coagulation disorder" ], "offsets": [ [ 84, 104 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T7", "type": "Condition", "text": [ "leeding", "isorder" ], "offsets": [ [ 73, 80 ], [ 97, 104 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T8", "type": "Condition", "text": [ "cquired", "isorder" ], "offsets": [ [ 61, 68 ], [ 97, 104 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T9", "type": "Person", "text": [ "in the subject" ], "offsets": [ [ 105, 119 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T10", "type": "Person", "text": [ "first degree relative" ], "offsets": [ [ 125, 146 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T11", "type": "Scope", "text": [ "in the subject or a first degree relative" ], "offsets": [ [ 105, 146 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T12", "type": "Scope", "text": [ "acquired or bleeding or coagulation disorder" ], "offsets": [ [ 60, 104 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T13", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 40, 58 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T14", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 147, 153 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T15", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 154, 162 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T16", "type": "Mood", "text": [ "at high risk for" ], "offsets": [ [ 166, 182 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T17", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 183, 191 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T18", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 233, 240 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T19", "type": "Condition", "text": [ "trauma" ], "offsets": [ [ 244, 250 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T20", "type": "Scope", "text": [ "surgery or trauma" ], "offsets": [ [ 233, 250 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T21", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 227, 232 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T22", "type": "Qualifier", "text": [ "ophthalmologic" ], "offsets": [ [ 208, 222 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T23", "type": "Qualifier", "text": [ "spinal" ], "offsets": [ [ 200, 206 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T24", "type": "Qualifier", "text": [ "Brain" ], "offsets": [ [ 193, 198 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T25", "type": "Scope", "text": [ "Brain, spinal, ophthalmologic, or major" ], "offsets": [ [ 193, 232 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T26", "type": "Temporal", "text": [ "within the past 90 days" ], "offsets": [ [ 251, 274 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T27", "type": "Procedure", "text": [ "ctive knee/hi", "gery\nAc" ], "offsets": [ [ 293, 306 ], [ 311, 318 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T28", "type": "Procedure", "text": [ "ctive kn", " surgery\nA" ], "offsets": [ [ 293, 301 ], [ 307, 317 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T29", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 275, 285 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T30", "type": "Scope", "text": [ "elective knee/hip surgery" ], "offsets": [ [ 290, 315 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T31", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 316, 322 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T32", "type": "Condition", "text": [ "hepatobiliary disease" ], "offsets": [ [ 323, 344 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T33", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 345, 355 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T34", "type": "Value", "text": [ "<9 g/dL" ], "offsets": [ [ 356, 363 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T35", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 364, 378 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T36", "type": "Value", "text": [ "<100,000/mm3" ], "offsets": [ [ 379, 391 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T37", "type": "Measurement", "text": [ "Creatinine clearance" ], "offsets": [ [ 392, 412 ] ], "normalized": [] }, { "id": "NCT01884337_exc_T38", "type": "Value", "text": [ "<30 mL/min" ], "offsets": [ [ 413, 423 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01884337_exc_R1", "type": "Has_scope", "arg1_id": "NCT01884337_exc_T12", "arg2_id": "NCT01884337_exc_T13", "normalized": [] }, { "id": "NCT01884337_exc_R2", "type": "Has_scope", "arg1_id": "NCT01884337_exc_T12", "arg2_id": "NCT01884337_exc_T11", "normalized": [] }, { "id": "NCT01884337_exc_R3", "type": "Has_mood", "arg1_id": "NCT01884337_exc_T17", "arg2_id": "NCT01884337_exc_T16", "normalized": [] }, { "id": "NCT01884337_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01884337_exc_T15", "arg2_id": "NCT01884337_exc_T14", "normalized": [] }, { "id": "NCT01884337_exc_R5", "type": "Has_negation", "arg1_id": "NCT01884337_exc_T30", "arg2_id": "NCT01884337_exc_T29", "normalized": [] }, { "id": "NCT01884337_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01884337_exc_T20", "arg2_id": "NCT01884337_exc_T26", "normalized": [] }, { "id": "NCT01884337_exc_R7", "type": "Has_scope", "arg1_id": "NCT01884337_exc_T20", "arg2_id": "NCT01884337_exc_T25", "normalized": [] }, { "id": "NCT01884337_exc_R8", "type": "Has_scope", "arg1_id": "NCT01884337_exc_T20", "arg2_id": "NCT01884337_exc_T30", "normalized": [] }, { "id": "NCT01884337_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01884337_exc_T32", "arg2_id": "NCT01884337_exc_T31", "normalized": [] }, { "id": "NCT01884337_exc_R10", "type": "Has_value", "arg1_id": "NCT01884337_exc_T33", "arg2_id": "NCT01884337_exc_T34", "normalized": [] }, { "id": "NCT01884337_exc_R11", "type": "Has_value", "arg1_id": "NCT01884337_exc_T35", "arg2_id": "NCT01884337_exc_T36", "normalized": [] }, { "id": "NCT01884337_exc_R12", "type": "Has_value", "arg1_id": "NCT01884337_exc_T37", "arg2_id": "NCT01884337_exc_T38", "normalized": [] } ]

[ { "id": "NCT01884337_inc_text", "type": "inclusion", "text": [ "Age =18 years\nSubjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement\n" ], "offsets": [ [ 0, 148 ] ] } ]

[ { "id": "NCT01884337_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T2", "type": "Value", "text": [ "=18 years" ], "offsets": [ [ 4, 13 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T3", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T4", "type": "Procedure", "text": [ "otal knee", "eplacement" ], "offsets": [ [ 44, 53 ], [ 62, 72 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T5", "type": "Procedure", "text": [ "otal", "ip replacement" ], "offsets": [ [ 44, 48 ], [ 58, 72 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T6", "type": "Procedure", "text": [ " total kne", "eplacement", "evision of" ], "offsets": [ [ 117, 127 ], [ 137, 147 ], [ 79, 89 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T7", "type": "Qualifier", "text": [ "at least one component" ], "offsets": [ [ 90, 112 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T8", "type": "Procedure", "text": [ "", "ip replacement", "evision of" ], "offsets": [ [ 117, 117 ], [ 133, 147 ], [ 79, 89 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T9", "type": "Scope", "text": [ "f a total knee or hip replacement", "evision of" ], "offsets": [ [ 114, 147 ], [ 79, 89 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T10", "type": "Scope", "text": [ "total knee or hip replacement" ], "offsets": [ [ 43, 72 ] ], "normalized": [] }, { "id": "NCT01884337_inc_T11", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 23, 33 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01884337_inc_R1", "type": "Has_value", "arg1_id": "NCT01884337_inc_T1", "arg2_id": "NCT01884337_inc_T2", "normalized": [] }, { "id": "NCT01884337_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01884337_inc_T9", "arg2_id": "NCT01884337_inc_T7", "normalized": [] }, { "id": "NCT01884337_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01884337_inc_T10", "arg2_id": "NCT01884337_inc_T3", "normalized": [] }, { "id": "NCT01884337_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01884337_inc_T10", "arg2_id": "NCT01884337_inc_T11", "normalized": [] }, { "id": "NCT01884337_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01884337_inc_T9", "arg2_id": "NCT01884337_inc_T11", "normalized": [] } ]

[ { "id": "NCT01888965_exc_text", "type": "exclusion", "text": [ "Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant. \nWomen who are breast-feeding \nFertile males unwilling to use contraception \nPatients with brain metastases or any history of brain metastases \nPatients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy \nPatients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months \nImpairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib \nThe subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. \nPatients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy \nCirrhosis, chronic active hepatitis or chronic persistent hepatitis \nPatients who are currently receiving prasugrel \nNo concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate \nNo concurrent use of other investigational drugs or antineoplastic therapies. \nPatients with impaired cardiac function or clinically significant cardiac diseases. \n \n" ], "offsets": [ [ 0, 1524 ] ] } ]

[ { "id": "NCT01888965_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T2", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 9, 32 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T3", "type": "Condition", "text": [ "biologically able to conceive" ], "offsets": [ [ 42, 71 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T4", "type": "Multiplier", "text": [ "two" ], "offsets": [ [ 87, 90 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T5", "type": "Device", "text": [ "highly effective contraception" ], "offsets": [ [ 100, 130 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T6", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 142, 150 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T7", "type": "Negation", "text": [ "not" ], "offsets": [ [ 73, 76 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T8", "type": "Scope", "text": [ "Women of child-bearing potential, who are biologically able to conceive" ], "offsets": [ [ 0, 71 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T9", "type": "Scope", "text": [ "not employing two forms of highly effective contraception or who are pregnant" ], "offsets": [ [ 73, 150 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T10", "type": "Person", "text": [ "Women" ], "offsets": [ [ 153, 158 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T11", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 167, 181 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T12", "type": "Person", "text": [ "males" ], "offsets": [ [ 191, 196 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T13", "type": "Condition", "text": [ "Fertile" ], "offsets": [ [ 183, 190 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T14", "type": "Observation", "text": [ "unwilling to use contraception" ], "offsets": [ [ 197, 227 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T17", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 243, 259 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T18", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 278, 294 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T19", "type": "Observation", "text": [ "history" ], "offsets": [ [ 267, 274 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T20", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 324, 337 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T21", "type": "Procedure", "text": [ "intra-thoracic" ], "offsets": [ [ 345, 359 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T22", "type": "Procedure", "text": [ "intra", "-abdominal" ], "offsets": [ [ 345, 350 ], [ 361, 371 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T23", "type": "Procedure", "text": [ "intra", "-pelvic" ], "offsets": [ [ 345, 350 ], [ 376, 383 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T24", "type": "Scope", "text": [ "intra-thoracic, -abdominal, or -pelvic" ], "offsets": [ [ 345, 383 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T26", "type": "Value", "text": [ "</= 4 weeks prior to starting study treatment" ], "offsets": [ [ 385, 430 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T27", "type": "Reference_point", "text": [ "starting study treatment" ], "offsets": [ [ 406, 430 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T30", "type": "Condition", "text": [ "pulmonary embolism" ], "offsets": [ [ 503, 521 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T31", "type": "Condition", "text": [ "deep vein thrombosis" ], "offsets": [ [ 536, 556 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T32", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 526, 535 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T33", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 557, 581 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T34", "type": "Observation", "text": [ "history" ], "offsets": [ [ 492, 499 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T35", "type": "Scope", "text": [ "pulmonary embolism, or untreated deep vein thrombosis" ], "offsets": [ [ 503, 556 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T36", "type": "Condition", "text": [ "Impairment of gastrointestinal (GI) function" ], "offsets": [ [ 583, 627 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T37", "type": "Condition", "text": [ "GI disease" ], "offsets": [ [ 631, 641 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T38", "type": "Qualifier", "text": [ "may significantly alter the absorption of dovitinib" ], "offsets": [ [ 647, 698 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T40", "type": "Scope", "text": [ "Impairment of gastrointestinal (GI) function or GI disease" ], "offsets": [ [ 583, 641 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T41", "type": "Condition", "text": [ "active malignancy" ], "offsets": [ [ 728, 745 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T42", "type": "Temporal", "text": [ "within the past 5 years" ], "offsets": [ [ 746, 769 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T43", "type": "Condition", "text": [ "cervical cancer in situ" ], "offsets": [ [ 781, 804 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T44", "type": "Negation", "text": [ "except" ], "offsets": [ [ 770, 776 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T45", "type": "Condition", "text": [ "in situ carcinoma of the bladder" ], "offsets": [ [ 806, 838 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T46", "type": "Condition", "text": [ "non-melanoma carcinoma of the skin" ], "offsets": [ [ 842, 876 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T47", "type": "Scope", "text": [ "cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin" ], "offsets": [ [ 781, 876 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T48", "type": "Procedure", "text": [ "anticancer therapy" ], "offsets": [ [ 936, 954 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T49", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 965, 977 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T50", "type": "Procedure", "text": [ "immunotherapy" ], "offsets": [ [ 979, 992 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T51", "type": "Procedure", "text": [ "hormonal therapy" ], "offsets": [ [ 994, 1010 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T52", "type": "Drug", "text": [ "monoclonal antibodies" ], "offsets": [ [ 1015, 1036 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T53", "type": "Temporal", "text": [ "</= 2 weeks prior to starting the study drug" ], "offsets": [ [ 1037, 1081 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T54", "type": "Reference_point", "text": [ "starting the study drug" ], "offsets": [ [ 1058, 1081 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T55", "type": "Condition", "text": [ "recovered from the side effects of such therapy" ], "offsets": [ [ 1099, 1146 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T56", "type": "Negation", "text": [ "not" ], "offsets": [ [ 443, 446 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T57", "type": "Condition", "text": [ "recovered from such therapy" ], "offsets": [ [ 447, 474 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T58", "type": "Scope", "text": [ "chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies" ], "offsets": [ [ 965, 1036 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T59", "type": "Condition", "text": [ "Cirrhosis" ], "offsets": [ [ 1148, 1157 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T60", "type": "Condition", "text": [ "chronic active hepatitis" ], "offsets": [ [ 1159, 1183 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T61", "type": "Condition", "text": [ "chronic persistent hepatitis" ], "offsets": [ [ 1187, 1215 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T62", "type": "Drug", "text": [ "prasugrel" ], "offsets": [ [ 1254, 1263 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T63", "type": "Drug", "text": [ "isoniazid" ], "offsets": [ [ 1286, 1295 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T64", "type": "Drug", "text": [ "labetolol" ], "offsets": [ [ 1297, 1306 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T65", "type": "Drug", "text": [ "trovafloxacin" ], "offsets": [ [ 1308, 1321 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T66", "type": "Drug", "text": [ "tolcapone" ], "offsets": [ [ 1323, 1332 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T67", "type": "Drug", "text": [ "felbamate" ], "offsets": [ [ 1338, 1347 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T68", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1265, 1267 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T69", "type": "Scope", "text": [ "isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate" ], "offsets": [ [ 1286, 1347 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T70", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1349, 1351 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T71", "type": "Drug", "text": [ "other investigational drugs" ], "offsets": [ [ 1370, 1397 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T72", "type": "Procedure", "text": [ "antineoplastic therapies" ], "offsets": [ [ 1401, 1425 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T74", "type": "Scope", "text": [ "other investigational drugs or antineoplastic therapies" ], "offsets": [ [ 1370, 1425 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T75", "type": "Condition", "text": [ "impaired cardiac function" ], "offsets": [ [ 1442, 1467 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T76", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1471, 1493 ] ], "normalized": [] }, { "id": "NCT01888965_exc_T77", "type": "Condition", "text": [ "cardiac diseases" ], "offsets": [ [ 1494, 1510 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT01888965_inc_text", "type": "inclusion", "text": [ "Patients with a confirmed diagnosis of: \n1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance \"standard of care\", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1. \n2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less. \nPrior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment. \nNo concomitant anti-cancer treatment is allowed \nAge >/= 18 years \nPerformance status of 0-1 \nAdequate hepatic, bone marrow, and renal function \nPartial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5. \nLife expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts \nWomen of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating. \nSubject is capable of understanding and complying with protocol demands and able to sign and date the informed consent \n" ], "offsets": [ [ 0, 1550 ] ] } ]

[ { "id": "NCT01888965_inc_T2", "type": "Condition", "text": [ "colon cancer" ], "offsets": [ [ 52, 64 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T3", "type": "Qualifier", "text": [ "Stage 4" ], "offsets": [ [ 44, 51 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T4", "type": "Condition", "text": [ "s/p metastasectomy" ], "offsets": [ [ 72, 90 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T5", "type": "Procedure", "text": [ "metastasectomy" ], "offsets": [ [ 76, 90 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T6", "type": "Condition", "text": [ "post-initial chemotherapy" ], "offsets": [ [ 94, 119 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T7", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 107, 119 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T8", "type": "Drug", "text": [ "5-fluorouracil/leucovorin (5-FU/LV)" ], "offsets": [ [ 172, 207 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T9", "type": "Drug", "text": [ "bevacizumab" ], "offsets": [ [ 227, 238 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T10", "type": "Scope", "text": [ "5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab" ], "offsets": [ [ 172, 238 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T11", "type": "Procedure", "text": [ "maintenance \"standard of care\"" ], "offsets": [ [ 123, 153 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T13", "type": "Multiplier", "text": [ "2" ], "offsets": [ [ 291, 292 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T14", "type": "Procedure", "text": [ "CT scans" ], "offsets": [ [ 305, 313 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T15", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 322, 328 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T16", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 329, 336 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T18", "type": "Condition", "text": [ "treatment-related toxicity" ], "offsets": [ [ 379, 405 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T19", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 373, 378 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T20", "type": "Negation", "text": [ "not" ], "offsets": [ [ 341, 344 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T21", "type": "Condition", "text": [ "Pancreas cancer" ], "offsets": [ [ 425, 440 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T22", "type": "Condition", "text": [ "s/p resection" ], "offsets": [ [ 449, 462 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T23", "type": "Procedure", "text": [ "resection" ], "offsets": [ [ 453, 462 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T24", "type": "Condition", "text": [ "s/p", "adjuvant chemotherapy" ], "offsets": [ [ 449, 452 ], [ 467, 488 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T25", "type": "Procedure", "text": [ "adjuvant chemotherapy" ], "offsets": [ [ 467, 488 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T26", "type": "Condition", "text": [ "pancreas cancer" ], "offsets": [ [ 509, 524 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T27", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 492, 508 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T28", "type": "Condition", "text": [ "s/p chemotherapy" ], "offsets": [ [ 525, 541 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T29", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 529, 541 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T30", "type": "Condition", "text": [ "s/p", "radiation" ], "offsets": [ [ 525, 528 ], [ 546, 555 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T31", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 546, 555 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T32", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 565, 577 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T33", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 581, 598 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T34", "type": "Temporal", "text": [ "between 2 weeks and 2 months prior to study start" ], "offsets": [ [ 621, 670 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T35", "type": "Reference_point", "text": [ "study start" ], "offsets": [ [ 659, 670 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T36", "type": "Condition", "text": [ "recovered from prior treatment" ], "offsets": [ [ 695, 725 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T37", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 716, 725 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T38", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 710, 715 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T39", "type": "Scope", "text": [ "s/p resection and adjuvant chemotherapy" ], "offsets": [ [ 449, 488 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T40", "type": "Scope", "text": [ "locally advanced pancreas cancer s/p chemotherapy and radiation" ], "offsets": [ [ 492, 555 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T41", "type": "Observation", "text": [ "may have been stopped" ], "offsets": [ [ 599, 620 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T42", "type": "Scope", "text": [ "chemotherapy or radiation therapy" ], "offsets": [ [ 565, 598 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T43", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 770, 777 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T44", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 764, 769 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T45", "type": "Procedure", "text": [ "metastasectomy" ], "offsets": [ [ 808, 822 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T46", "type": "Procedure", "text": [ "tumor resection" ], "offsets": [ [ 789, 804 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T47", "type": "Temporal", "text": [ "at least 4 weeks prior to study enrollment" ], "offsets": [ [ 848, 890 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T48", "type": "Reference_point", "text": [ "study enrollment" ], "offsets": [ [ 874, 890 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T49", "type": "Scope", "text": [ "tumor resection or metastasectomy" ], "offsets": [ [ 789, 822 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T52", "type": "Person", "text": [ "Age" ], "offsets": [ [ 942, 945 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T53", "type": "Value", "text": [ ">/= 18 years" ], "offsets": [ [ 946, 958 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T54", "type": "Measurement", "text": [ "Performance status" ], "offsets": [ [ 960, 978 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T55", "type": "Value", "text": [ "0-1" ], "offsets": [ [ 982, 985 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T56", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 1022, 1036 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T57", "type": "Measurement", "text": [ "bone marrow", "function" ], "offsets": [ [ 1005, 1016 ], [ 1028, 1036 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T58", "type": "Measurement", "text": [ "function", "hepatic" ], "offsets": [ [ 1028, 1036 ], [ 996, 1003 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T59", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 987, 995 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T60", "type": "Measurement", "text": [ "Partial thromboplastin time (PTT)" ], "offsets": [ [ 1038, 1071 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T61", "type": "Value", "text": [ "</= 1.5 x upper normal limit" ], "offsets": [ [ 1080, 1108 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T62", "type": "Measurement", "text": [ "INR (International Normalized Ratio)" ], "offsets": [ [ 1143, 1179 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T63", "type": "Value", "text": [ "< 1.5" ], "offsets": [ [ 1180, 1185 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T64", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 1188, 1203 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T65", "type": "Value", "text": [ ">/= 4 months" ], "offsets": [ [ 1204, 1216 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T67", "type": "Observation", "text": [ "maintenance cohorts" ], "offsets": [ [ 1221, 1240 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T68", "type": "Value", "text": [ ">/= 6 months" ], "offsets": [ [ 1245, 1257 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T69", "type": "Observation", "text": [ "adjuvant cohorts" ], "offsets": [ [ 1262, 1278 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T70", "type": "Scope", "text": [ ">/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts" ], "offsets": [ [ 1204, 1278 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T71", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1289, 1311 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T72", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1280, 1285 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T73", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 1333, 1353 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T74", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1324, 1332 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T75", "type": "Temporal", "text": [ "within 14 days prior to initiation of treatment" ], "offsets": [ [ 1354, 1401 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T76", "type": "Reference_point", "text": [ "initiation of treatment" ], "offsets": [ [ 1378, 1401 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T77", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1418, 1427 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T78", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1411, 1414 ] ], "normalized": [] }, { "id": "NCT01888965_inc_T79", "type": "Scope", "text": [ "Women of childbearing potential" ], "offsets": [ [ 1280, 1311 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT01890759_exc_text", "type": "exclusion", "text": [ "Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. \nReceipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for: \n(i) influenza vaccination, which may be received at least 2 weeks before study vaccines. \n(ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule \n(iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs) \nPrevious vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine \nReceipt of immune globulins, blood or blood-derived products in the past 3 months \nKnown or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) \nHistory of meningococcal diseases, confirmed either clinically, serologically, or microbiologically \nAt high risk, in the opinion of the Investigator, for meningococcal disease during the trial \nKnown or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances \nKnown thrombocytopenia, contraindicating intramuscular vaccination \nBleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination \nIn an emergency setting, or hospitalized involuntarily \nChronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion \nFor subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). \nFor subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C). \nA prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. \nReceipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw \nIdentified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study \nPersonal history of Guillain-Barré Syndrome. \n \n" ], "offsets": [ [ 0, 2869 ] ] } ]

[ { "id": "NCT01890759_exc_T1", "type": "Temporal", "text": [ "4 weeks preceding inclusion" ], "offsets": [ [ 21, 48 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T2", "type": "Reference_point", "text": [ "inclusion" ], "offsets": [ [ 39, 48 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T3", "type": "Observation", "text": [ "planned participation" ], "offsets": [ [ 52, 73 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T6", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 217, 224 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T7", "type": "Temporal", "text": [ "in the 4 weeks preceding each trial vaccination" ], "offsets": [ [ 225, 272 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T8", "type": "Reference_point", "text": [ "each trial vaccination" ], "offsets": [ [ 250, 272 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T9", "type": "Temporal", "text": [ "in the 4 weeks following each trial vaccination" ], "offsets": [ [ 307, 354 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T10", "type": "Reference_point", "text": [ "each trial vaccination" ], "offsets": [ [ 332, 354 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T11", "type": "Observation", "text": [ "planned receipt" ], "offsets": [ [ 276, 291 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T12", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 299, 306 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T14", "type": "Drug", "text": [ "influenza vaccination" ], "offsets": [ [ 373, 394 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T15", "type": "Temporal", "text": [ "at least 2 weeks before study vaccines" ], "offsets": [ [ 418, 456 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T16", "type": "Reference_point", "text": [ "study vaccines" ], "offsets": [ [ 442, 456 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T17", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 356, 366 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T18", "type": "Procedure", "text": [ "measles (M)", "vaccination" ], "offsets": [ [ 464, 475 ], [ 517, 528 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T19", "type": "Procedure", "text": [ "measles, mumps, rubella (MMR)", "vaccination" ], "offsets": [ [ 479, 508 ], [ 517, 528 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T20", "type": "Temporal", "text": [ "concomitantly with the first dose of study vaccine" ], "offsets": [ [ 556, 606 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T21", "type": "Reference_point", "text": [ "the first dose of study vaccine" ], "offsets": [ [ 575, 606 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T22", "type": "Scope", "text": [ "measles (M) or measles, mumps, rubella (MMR) routine vaccination" ], "offsets": [ [ 464, 528 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T23", "type": "Visit", "text": [ "Indian sites" ], "offsets": [ [ 676, 688 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T24", "type": "Drug", "text": [ "oral poliomyelitis vaccine (OPV)" ], "offsets": [ [ 690, 722 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T25", "type": "Temporal", "text": [ "during National Immunization Days (NIDs)" ], "offsets": [ [ 732, 772 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T26", "type": "Reference_point", "text": [ "National Immunization Days (NIDs)" ], "offsets": [ [ 739, 772 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T27", "type": "Temporal", "text": [ "during", "supplementary immunization activity days (SIADs)" ], "offsets": [ [ 732, 738 ], [ 777, 825 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T28", "type": "Reference_point", "text": [ "supplementary immunization activity days (SIADs)" ], "offsets": [ [ 777, 825 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T29", "type": "Scope", "text": [ "during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)" ], "offsets": [ [ 732, 825 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T30", "type": "Procedure", "text": [ "vaccination against meningococcal disease" ], "offsets": [ [ 836, 877 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T31", "type": "Drug", "text": [ "study vaccine" ], "offsets": [ [ 894, 907 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T32", "type": "Drug", "text": [ "another meningococcal vaccine" ], "offsets": [ [ 911, 940 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T33", "type": "Drug", "text": [ "immune globulins" ], "offsets": [ [ 953, 969 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T34", "type": "Drug", "text": [ "blood" ], "offsets": [ [ 971, 976 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T35", "type": "Drug", "text": [ "blood-derived products" ], "offsets": [ [ 980, 1002 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T36", "type": "Temporal", "text": [ "in the past 3 months" ], "offsets": [ [ 1003, 1023 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T37", "type": "Scope", "text": [ "immune globulins, blood or blood-derived products" ], "offsets": [ [ 953, 1002 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T38", "type": "Condition", "text": [ "acquired immunodeficiency" ], "offsets": [ [ 1058, 1083 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T39", "type": "Condition", "text": [ "congenital", "immunodeficiency" ], "offsets": [ [ 1044, 1054 ], [ 1067, 1083 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T40", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 1099, 1124 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T41", "type": "Procedure", "text": [ "anti-cancer chemotherapy" ], "offsets": [ [ 1134, 1158 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T42", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 1162, 1179 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T43", "type": "Temporal", "text": [ "within the preceding 6 months" ], "offsets": [ [ 1181, 1210 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T44", "type": "Procedure", "text": [ "systemic corticosteroid therapy" ], "offsets": [ [ 1225, 1256 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T45", "type": "Multiplier", "text": [ "long-term" ], "offsets": [ [ 1215, 1224 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T46", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 1258, 1268 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T47", "type": "Temporal", "text": [ "for more than 2 consecutive weeks" ], "offsets": [ [ 1283, 1316 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T48", "type": "Temporal", "text": [ "within the past 3 months" ], "offsets": [ [ 1317, 1341 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T49", "type": "Scope", "text": [ "anti-cancer chemotherapy or radiation therapy" ], "offsets": [ [ 1134, 1179 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T50", "type": "Observation", "text": [ "suspected" ], "offsets": [ [ 1034, 1043 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T51", "type": "Observation", "text": [ "Known" ], "offsets": [ [ 1025, 1030 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T52", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 1025, 1043 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T53", "type": "Scope", "text": [ "congenital or acquired immunodeficiency" ], "offsets": [ [ 1044, 1083 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T54", "type": "Condition", "text": [ "meningococcal diseases" ], "offsets": [ [ 1355, 1377 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T55", "type": "Procedure", "text": [ "serologically" ], "offsets": [ [ 1408, 1421 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T56", "type": "Procedure", "text": [ "microbiologically" ], "offsets": [ [ 1426, 1443 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T57", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 1379, 1388 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T60", "type": "Condition", "text": [ "systemic hypersensitivity" ], "offsets": [ [ 1558, 1583 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T61", "type": "Drug", "text": [ "vaccine components" ], "offsets": [ [ 1598, 1616 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T62", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1621, 1628 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T63", "type": "Condition", "text": [ "life-threatening reaction" ], "offsets": [ [ 1634, 1659 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T64", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 1667, 1674 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T65", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 1701, 1708 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T66", "type": "Qualifier", "text": [ "used in the trial" ], "offsets": [ [ 1675, 1692 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T69", "type": "Condition", "text": [ "thrombocytopenia" ], "offsets": [ [ 1754, 1770 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T70", "type": "Condition", "text": [ "contraindicating" ], "offsets": [ [ 1772, 1788 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T71", "type": "Procedure", "text": [ "intramuscular vaccination" ], "offsets": [ [ 1789, 1814 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T72", "type": "Condition", "text": [ "Bleeding disorder" ], "offsets": [ [ 1816, 1833 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T73", "type": "Drug", "text": [ "anticoagulants" ], "offsets": [ [ 1849, 1863 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T74", "type": "Temporal", "text": [ "in the 3 weeks preceding inclusion" ], "offsets": [ [ 1864, 1898 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T75", "type": "Reference_point", "text": [ "inclusion" ], "offsets": [ [ 1889, 1898 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T76", "type": "Condition", "text": [ "contraindicating" ], "offsets": [ [ 1900, 1916 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T77", "type": "Procedure", "text": [ "intramuscular vaccination" ], "offsets": [ [ 1917, 1942 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T78", "type": "Scope", "text": [ "Bleeding disorder, or receipt of anticoagulants" ], "offsets": [ [ 1816, 1863 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T79", "type": "Visit", "text": [ "emergency setting" ], "offsets": [ [ 1950, 1967 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T80", "type": "Procedure", "text": [ "hospitalized" ], "offsets": [ [ 1972, 1984 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T81", "type": "Qualifier", "text": [ "involuntarily" ], "offsets": [ [ 1985, 1998 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T82", "type": "Condition", "text": [ "hospitalized involuntarily" ], "offsets": [ [ 1972, 1998 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T84", "type": "Visit", "text": [ "Indian sites" ], "offsets": [ [ 2156, 2168 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T85", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 2170, 2178 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T86", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2182, 2188 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T87", "type": "Condition", "text": [ "acute illness" ], "offsets": [ [ 2189, 2202 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T88", "type": "Condition", "text": [ "acute", "infection" ], "offsets": [ [ 2189, 2194 ], [ 2203, 2212 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T90", "type": "Temporal", "text": [ "on the day of vaccination" ], "offsets": [ [ 2250, 2275 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T91", "type": "Reference_point", "text": [ "the day of vaccination" ], "offsets": [ [ 2253, 2275 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T92", "type": "Condition", "text": [ "febrile illness" ], "offsets": [ [ 2279, 2294 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T93", "type": "Measurement", "text": [ "temperature" ], "offsets": [ [ 2296, 2307 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T94", "type": "Value", "text": [ "≥ 38.0°C" ], "offsets": [ [ 2308, 2316 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T95", "type": "Scope", "text": [ "acute illness/infection" ], "offsets": [ [ 2189, 2212 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T96", "type": "Scope", "text": [ "Moderate or severe" ], "offsets": [ [ 2170, 2188 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T97", "type": "Scope", "text": [ "Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C)" ], "offsets": [ [ 2170, 2317 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T98", "type": "Visit", "text": [ "Russian sites" ], "offsets": [ [ 2345, 2358 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T99", "type": "Condition", "text": [ "Acute disease" ], "offsets": [ [ 2360, 2373 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T100", "type": "Temporal", "text": [ "on the day of vaccination" ], "offsets": [ [ 2390, 2415 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T101", "type": "Reference_point", "text": [ "the day of vaccination" ], "offsets": [ [ 2393, 2415 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T102", "type": "Condition", "text": [ "febrile illness" ], "offsets": [ [ 2419, 2434 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T103", "type": "Measurement", "text": [ "axillary temperature" ], "offsets": [ [ 2436, 2456 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T104", "type": "Value", "text": [ "≥ 37.0°C" ], "offsets": [ [ 2457, 2465 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T105", "type": "Scope", "text": [ "Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C)" ], "offsets": [ [ 2360, 2466 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T108", "type": "Drug", "text": [ "antibiotic therapy" ], "offsets": [ [ 2626, 2644 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T109", "type": "Qualifier", "text": [ "injectable" ], "offsets": [ [ 2615, 2625 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T110", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 2607, 2611 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T111", "type": "Scope", "text": [ "oral or injectable" ], "offsets": [ [ 2607, 2625 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T112", "type": "Temporal", "text": [ "within 72 hours prior to the first blood draw" ], "offsets": [ [ 2645, 2690 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T113", "type": "Reference_point", "text": [ "the first blood draw" ], "offsets": [ [ 2670, 2690 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T115", "type": "Condition", "text": [ "Guillain-Barré Syndrome" ], "offsets": [ [ 2832, 2855 ] ], "normalized": [] }, { "id": "NCT01890759_exc_T116", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2821, 2828 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01890759_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T6", "arg2_id": "NCT01890759_exc_T7", "normalized": [] }, { "id": "NCT01890759_exc_R2", "type": "Has_index", "arg1_id": "NCT01890759_exc_T7", "arg2_id": "NCT01890759_exc_T8", "normalized": [] }, { "id": "NCT01890759_exc_R3", "type": "Has_mood", "arg1_id": "NCT01890759_exc_T12", "arg2_id": "NCT01890759_exc_T11", "normalized": [] }, { "id": "NCT01890759_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T11", "arg2_id": "NCT01890759_exc_T9", "normalized": [] }, { "id": "NCT01890759_exc_R5", "type": "Has_index", "arg1_id": "NCT01890759_exc_T9", "arg2_id": "NCT01890759_exc_T10", "normalized": [] }, { "id": "NCT01890759_exc_R6", "type": "Has_index", "arg1_id": "NCT01890759_exc_T15", "arg2_id": "NCT01890759_exc_T16", "normalized": [] }, { "id": "NCT01890759_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T14", "arg2_id": "NCT01890759_exc_T15", "normalized": [] }, { "id": "NCT01890759_exc_R8", "type": "Has_index", "arg1_id": "NCT01890759_exc_T20", "arg2_id": "NCT01890759_exc_T21", "normalized": [] }, { "id": "NCT01890759_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T22", "arg2_id": "NCT01890759_exc_T20", "normalized": [] }, { "id": "NCT01890759_exc_R10", "type": "Has_index", "arg1_id": "NCT01890759_exc_T25", "arg2_id": "NCT01890759_exc_T26", "normalized": [] }, { "id": "NCT01890759_exc_R11", "type": "Has_index", "arg1_id": "NCT01890759_exc_T27", "arg2_id": "NCT01890759_exc_T28", "normalized": [] }, { "id": "NCT01890759_exc_R12", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T24", "arg2_id": "NCT01890759_exc_T29", "normalized": [] }, { "id": "NCT01890759_exc_R13", "type": "AND", "arg1_id": "NCT01890759_exc_T23", "arg2_id": "NCT01890759_exc_T24", "normalized": [] }, { "id": "NCT01890759_exc_R14", "type": "AND", "arg1_id": "NCT01890759_exc_T30", "arg2_id": "NCT01890759_exc_T31", "normalized": [] }, { "id": "NCT01890759_exc_R15", "type": "AND", "arg1_id": "NCT01890759_exc_T30", "arg2_id": "NCT01890759_exc_T32", "normalized": [] }, { "id": "NCT01890759_exc_R16", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T37", "arg2_id": "NCT01890759_exc_T36", "normalized": [] }, { "id": "NCT01890759_exc_R17", "type": "Has_multiplier", "arg1_id": "NCT01890759_exc_T44", "arg2_id": "NCT01890759_exc_T45", "normalized": [] }, { "id": "NCT01890759_exc_R18", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T46", "arg2_id": "NCT01890759_exc_T47", "normalized": [] }, { "id": "NCT01890759_exc_R19", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T46", "arg2_id": "NCT01890759_exc_T48", "normalized": [] }, { "id": "NCT01890759_exc_R20", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T44", "arg2_id": "NCT01890759_exc_T46", "normalized": [] }, { "id": "NCT01890759_exc_R21", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T40", "arg2_id": "NCT01890759_exc_T49", "normalized": [] }, { "id": "NCT01890759_exc_R22", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T40", "arg2_id": "NCT01890759_exc_T43", "normalized": [] }, { "id": "NCT01890759_exc_R23", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T53", "arg2_id": "NCT01890759_exc_T52", "normalized": [] }, { "id": "NCT01890759_exc_R24", "type": "AND", "arg1_id": "NCT01890759_exc_T54", "arg2_id": "NCT01890759_exc_T55", "normalized": [] }, { "id": "NCT01890759_exc_R25", "type": "AND", "arg1_id": "NCT01890759_exc_T54", "arg2_id": "NCT01890759_exc_T56", "normalized": [] }, { "id": "NCT01890759_exc_R26", "type": "Has_value", "arg1_id": "NCT01890759_exc_T55", "arg2_id": "NCT01890759_exc_T57", "normalized": [] }, { "id": "NCT01890759_exc_R27", "type": "Has_value", "arg1_id": "NCT01890759_exc_T56", "arg2_id": "NCT01890759_exc_T57", "normalized": [] }, { "id": "NCT01890759_exc_R28", "type": "AND", "arg1_id": "NCT01890759_exc_T60", "arg2_id": "NCT01890759_exc_T61", "normalized": [] }, { "id": "NCT01890759_exc_R29", "type": "AND", "arg1_id": "NCT01890759_exc_T63", "arg2_id": "NCT01890759_exc_T64", "normalized": [] }, { "id": "NCT01890759_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT01890759_exc_T64", "arg2_id": "NCT01890759_exc_T66", "normalized": [] }, { "id": "NCT01890759_exc_R31", "type": "AND", "arg1_id": "NCT01890759_exc_T70", "arg2_id": "NCT01890759_exc_T71", "normalized": [] }, { "id": "NCT01890759_exc_R32", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T69", "arg2_id": "NCT01890759_exc_T70", "normalized": [] }, { "id": "NCT01890759_exc_R33", "type": "Has_index", "arg1_id": "NCT01890759_exc_T74", "arg2_id": "NCT01890759_exc_T75", "normalized": [] }, { "id": "NCT01890759_exc_R35", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T76", "arg2_id": "NCT01890759_exc_T77", "normalized": [] }, { "id": "NCT01890759_exc_R34", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T78", "arg2_id": "NCT01890759_exc_T74", "normalized": [] }, { "id": "NCT01890759_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT01890759_exc_T80", "arg2_id": "NCT01890759_exc_T81", "normalized": [] }, { "id": "NCT01890759_exc_R37", "type": "Has_index", "arg1_id": "NCT01890759_exc_T90", "arg2_id": "NCT01890759_exc_T91", "normalized": [] }, { "id": "NCT01890759_exc_R38", "type": "Has_value", "arg1_id": "NCT01890759_exc_T93", "arg2_id": "NCT01890759_exc_T94", "normalized": [] }, { "id": "NCT01890759_exc_R39", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T92", "arg2_id": "NCT01890759_exc_T93", "normalized": [] }, { "id": "NCT01890759_exc_R40", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T95", "arg2_id": "NCT01890759_exc_T96", "normalized": [] }, { "id": "NCT01890759_exc_R41", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T95", "arg2_id": "NCT01890759_exc_T90", "normalized": [] }, { "id": "NCT01890759_exc_R42", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T92", "arg2_id": "NCT01890759_exc_T90", "normalized": [] }, { "id": "NCT01890759_exc_R43", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T84", "arg2_id": "NCT01890759_exc_T97", "normalized": [] }, { "id": "NCT01890759_exc_R44", "type": "Has_index", "arg1_id": "NCT01890759_exc_T100", "arg2_id": "NCT01890759_exc_T101", "normalized": [] }, { "id": "NCT01890759_exc_R45", "type": "Has_value", "arg1_id": "NCT01890759_exc_T103", "arg2_id": "NCT01890759_exc_T104", "normalized": [] }, { "id": "NCT01890759_exc_R46", "type": "Subsumes", "arg1_id": "NCT01890759_exc_T102", "arg2_id": "NCT01890759_exc_T103", "normalized": [] }, { "id": "NCT01890759_exc_R47", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T99", "arg2_id": "NCT01890759_exc_T100", "normalized": [] }, { "id": "NCT01890759_exc_R48", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T98", "arg2_id": "NCT01890759_exc_T105", "normalized": [] }, { "id": "NCT01890759_exc_R49", "type": "Has_index", "arg1_id": "NCT01890759_exc_T112", "arg2_id": "NCT01890759_exc_T113", "normalized": [] }, { "id": "NCT01890759_exc_R50", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T108", "arg2_id": "NCT01890759_exc_T112", "normalized": [] }, { "id": "NCT01890759_exc_R51", "type": "Has_scope", "arg1_id": "NCT01890759_exc_T108", "arg2_id": "NCT01890759_exc_T111", "normalized": [] }, { "id": "NCT01890759_exc_R52", "type": "Has_temporal", "arg1_id": "NCT01890759_exc_T115", "arg2_id": "NCT01890759_exc_T116", "normalized": [] } ]

[ { "id": "NCT01890759_inc_text", "type": "inclusion", "text": [ "Male and female subjects aged 9 to 17 months on the day of inclusion \nInformed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) \nSubject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures. \n" ], "offsets": [ [ 0, 345 ] ] } ]

[ { "id": "NCT01890759_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01890759_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 9, 15 ] ], "normalized": [] }, { "id": "NCT01890759_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 25, 29 ] ], "normalized": [] }, { "id": "NCT01890759_inc_T4", "type": "Value", "text": [ "9 to 17 months" ], "offsets": [ [ 30, 44 ] ], "normalized": [] }, { "id": "NCT01890759_inc_T5", "type": "Temporal", "text": [ "on the day of inclusion" ], "offsets": [ [ 45, 68 ] ], "normalized": [] }, { "id": "NCT01890759_inc_T6", "type": "Reference_point", "text": [ "the day of inclusion" ], "offsets": [ [ 48, 68 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01890759_inc_R1", "type": "Has_index", "arg1_id": "NCT01890759_inc_T5", "arg2_id": "NCT01890759_inc_T6", "normalized": [] }, { "id": "NCT01890759_inc_R2", "type": "Has_value", "arg1_id": "NCT01890759_inc_T3", "arg2_id": "NCT01890759_inc_T4", "normalized": [] }, { "id": "NCT01890759_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01890759_inc_T3", "arg2_id": "NCT01890759_inc_T5", "normalized": [] } ]

[ { "id": "NCT01891383_exc_text", "type": "exclusion", "text": [ "Cases (with a history of TBI): \n1. History of penetrating brain injury \n2. History of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia \nControls (without a history of TBI): \nHistory of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia \n \n" ], "offsets": [ [ 0, 515 ] ] } ]

[ { "id": "NCT01891383_exc_T2", "type": "Observation", "text": [ "History" ], "offsets": [ [ 35, 42 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T3", "type": "Condition", "text": [ "penetrating brain injury" ], "offsets": [ [ 46, 70 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T4", "type": "Observation", "text": [ "History" ], "offsets": [ [ 75, 82 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T5", "type": "Condition", "text": [ "condition", "disabling neurological" ], "offsets": [ [ 124, 133 ], [ 86, 108 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T6", "type": "Condition", "text": [ "psychiatric condition", "disabling" ], "offsets": [ [ 112, 133 ], [ 86, 95 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T7", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 142, 150 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T8", "type": "Condition", "text": [ "posttraumatic epilepsy" ], "offsets": [ [ 160, 182 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T9", "type": "Negation", "text": [ "besides" ], "offsets": [ [ 152, 159 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T10", "type": "Condition", "text": [ "multiple sclerosis" ], "offsets": [ [ 185, 203 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T11", "type": "Condition", "text": [ "cortical stroke" ], "offsets": [ [ 205, 220 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T12", "type": "Condition", "text": [ "hypoxic-ischemic encephalopathy" ], "offsets": [ [ 222, 253 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T13", "type": "Condition", "text": [ "encephalitis" ], "offsets": [ [ 255, 267 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T14", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 272, 285 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T15", "type": "Scope", "text": [ "disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia" ], "offsets": [ [ 86, 285 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T17", "type": "Observation", "text": [ "History" ], "offsets": [ [ 325, 332 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T18", "type": "Condition", "text": [ "disabling neurological", "condition" ], "offsets": [ [ 336, 358 ], [ 374, 383 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T21", "type": "Condition", "text": [ "disabling", "psychiatric condition" ], "offsets": [ [ 336, 345 ], [ 362, 383 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T22", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 392, 400 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T23", "type": "Condition", "text": [ "multiple sclerosis" ], "offsets": [ [ 402, 420 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T24", "type": "Condition", "text": [ "cortical stroke" ], "offsets": [ [ 422, 437 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T25", "type": "Condition", "text": [ "hypoxic-ischemic encephalopathy" ], "offsets": [ [ 439, 470 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T26", "type": "Condition", "text": [ "encephalitis" ], "offsets": [ [ 472, 484 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T27", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 489, 502 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T28", "type": "Scope", "text": [ "epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia" ], "offsets": [ [ 142, 285 ] ], "normalized": [] }, { "id": "NCT01891383_exc_T29", "type": "Scope", "text": [ "disabling neurological or psychiatric condition" ], "offsets": [ [ 86, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01891383_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01891383_exc_T3", "arg2_id": "NCT01891383_exc_T2", "normalized": [] }, { "id": "NCT01891383_exc_R2", "type": "Has_negation", "arg1_id": "NCT01891383_exc_T8", "arg2_id": "NCT01891383_exc_T9", "normalized": [] }, { "id": "NCT01891383_exc_R3", "type": "AND", "arg1_id": "NCT01891383_exc_T7", "arg2_id": "NCT01891383_exc_T8", "normalized": [] }, { "id": "NCT01891383_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01891383_exc_T15", "arg2_id": "NCT01891383_exc_T4", "normalized": [] }, { "id": "NCT01891383_exc_R5", "type": "Subsumes", "arg1_id": "NCT01891383_exc_T29", "arg2_id": "NCT01891383_exc_T28", "normalized": [] } ]

[ { "id": "NCT01891383_inc_text", "type": "inclusion", "text": [ "Cases (with a history of TBI): \n1. Ages 50-95 years \n2. History of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID, and based on DoD/VA criteria) \n3. Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville \n4. MMSE score ≥ 20 \n5. Capacity to provide consent to participate in research (assessment made by study physician) \n6. Ability to read and write English \nControls (without a history of TBI): \n1. Ages 50-95 years \n2. No history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID) \n3. Residence in AFRH-Washington or the Veterans Home of California-Yountville \n4. MMSE score ≥ 20 \n5. Capacity to provide consent or assent to participate in research \n6. Ability to read and write English - \n" ], "offsets": [ [ 0, 965 ] ] } ]

[ { "id": "NCT01891383_inc_T2", "type": "Person", "text": [ "Ages" ], "offsets": [ [ 35, 39 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T3", "type": "Value", "text": [ "50-95 years" ], "offsets": [ [ 40, 51 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T4", "type": "Condition", "text": [ "traumatic brain injury" ], "offsets": [ [ 67, 89 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T5", "type": "Observation", "text": [ "History" ], "offsets": [ [ 56, 63 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T6", "type": "Qualifier", "text": [ "sufficient severity" ], "offsets": [ [ 93, 112 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T8", "type": "Measurement", "text": [ "Ohio State University TBI Identification Questionnaire—OSU TBI-ID" ], "offsets": [ [ 172, 237 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T9", "type": "Value", "text": [ "sufficient severity" ], "offsets": [ [ 93, 112 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T10", "type": "Visit", "text": [ "AFRH-Washington D.C." ], "offsets": [ [ 286, 306 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T11", "type": "Visit", "text": [ "Veterans Home of California-Yountville" ], "offsets": [ [ 314, 352 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T12", "type": "Measurement", "text": [ "MMSE" ], "offsets": [ [ 357, 361 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T13", "type": "Value", "text": [ "score ≥ 20" ], "offsets": [ [ 362, 372 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T19", "type": "Person", "text": [ "Ages" ], "offsets": [ [ 549, 553 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T20", "type": "Value", "text": [ "50-95 years" ], "offsets": [ [ 554, 565 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T21", "type": "Condition", "text": [ "traumatic brain injury" ], "offsets": [ [ 584, 606 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T22", "type": "Qualifier", "text": [ "sufficient severity" ], "offsets": [ [ 610, 629 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T23", "type": "Measurement", "text": [ "Ohio State University TBI Identification Questionnaire—OSU TBI-ID" ], "offsets": [ [ 689, 754 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T24", "type": "Negation", "text": [ "No" ], "offsets": [ [ 570, 572 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T25", "type": "Observation", "text": [ "history" ], "offsets": [ [ 573, 580 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T27", "type": "Value", "text": [ "sufficient severity" ], "offsets": [ [ 610, 629 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T28", "type": "Visit", "text": [ "AFRH-Washington" ], "offsets": [ [ 773, 788 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T29", "type": "Visit", "text": [ "Veterans Home of California-Yountville" ], "offsets": [ [ 796, 834 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T30", "type": "Observation", "text": [ "Residence" ], "offsets": [ [ 760, 769 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T31", "type": "Observation", "text": [ "Residence" ], "offsets": [ [ 273, 282 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T32", "type": "Scope", "text": [ "AFRH-Washington D.C. or the Veterans Home of California-Yountville" ], "offsets": [ [ 286, 352 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T33", "type": "Scope", "text": [ "AFRH-Washington or the Veterans Home of California-Yountville" ], "offsets": [ [ 773, 834 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T34", "type": "Measurement", "text": [ "MMSE" ], "offsets": [ [ 839, 843 ] ], "normalized": [] }, { "id": "NCT01891383_inc_T35", "type": "Value", "text": [ "score ≥ 20" ], "offsets": [ [ 844, 854 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01891383_inc_R1", "type": "Has_value", "arg1_id": "NCT01891383_inc_T2", "arg2_id": "NCT01891383_inc_T3", "normalized": [] }, { "id": "NCT01891383_inc_R2", "type": "Has_value", "arg1_id": "NCT01891383_inc_T8", "arg2_id": "NCT01891383_inc_T9", "normalized": [] }, { "id": "NCT01891383_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01891383_inc_T4", "arg2_id": "NCT01891383_inc_T6", "normalized": [] }, { "id": "NCT01891383_inc_R4", "type": "AND", "arg1_id": "NCT01891383_inc_T4", "arg2_id": "NCT01891383_inc_T8", "normalized": [] }, { "id": "NCT01891383_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01891383_inc_T4", "arg2_id": "NCT01891383_inc_T5", "normalized": [] }, { "id": "NCT01891383_inc_R6", "type": "Has_value", "arg1_id": "NCT01891383_inc_T12", "arg2_id": "NCT01891383_inc_T13", "normalized": [] }, { "id": "NCT01891383_inc_R7", "type": "Has_value", "arg1_id": "NCT01891383_inc_T19", "arg2_id": "NCT01891383_inc_T20", "normalized": [] }, { "id": "NCT01891383_inc_R8", "type": "Has_negation", "arg1_id": "NCT01891383_inc_T21", "arg2_id": "NCT01891383_inc_T24", "normalized": [] }, { "id": "NCT01891383_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01891383_inc_T21", "arg2_id": "NCT01891383_inc_T25", "normalized": [] }, { "id": "NCT01891383_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT01891383_inc_T21", "arg2_id": "NCT01891383_inc_T22", "normalized": [] }, { "id": "NCT01891383_inc_R11", "type": "Has_value", "arg1_id": "NCT01891383_inc_T23", "arg2_id": "NCT01891383_inc_T27", "normalized": [] }, { "id": "NCT01891383_inc_R14", "type": "Has_value", "arg1_id": "NCT01891383_inc_T34", "arg2_id": "NCT01891383_inc_T35", "normalized": [] } ]

[ { "id": "NCT01891513_exc_text", "type": "exclusion", "text": [ "Failure to provide informed consent \nInability to complete 400 m walk within 15 minutes without sitting or interpersonal assistance, as an indicator of disablement and likely inability to fully engage in the exercise intervention \nPrimary indication for ACE inhibitor use, i.e. Congestive Heart Failure, CAD, diabetes \nKnown hypersensitivity to ACE inhibitors \nResistant hypertension, defined as BP > 140/90, despite the use of three or more anti-hypertensive drugs \nOffice or average home SBP > 180 mm Hg or DBP > 110 mm Hg (Average home BP in any seven day period during trial) \nPrimary renal disease \nSerum creatinine >2.5 mg/dL in men, or >2.0 mg/dL in women \nSerum potassium >5.0 molar equivalent/L \nUrinary protein > 1 on dipstick \nAbnormal liver enzymes (Aspartate transaminase (AST), Alanine transaminase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal) \nSevere cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina \nAcute myocardial infarction identified by ECG \nLives in a nursing home (persons living in assisted or independent housing will not be excluded) \nSignificant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24 \nUnable to communicate because of severe hearing loss or speech disorder \nSevere visual impairment, which would preclude completion of the assessments and/or intervention \nOther significant co-morbid disease that would prevent participation in exercise \nPlanning to move out of the area during the study time frame \nSimultaneous participation in another intervention trial \n \n" ], "offsets": [ [ 0, 1766 ] ] } ]

[ { "id": "NCT01891513_exc_T2", "type": "Condition", "text": [ "Inability to complete 400 m walk within 15 minutes without sitting" ], "offsets": [ [ 37, 103 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T3", "type": "Condition", "text": [ "interpersonal assistance", "Inability to complete 400 m walk within 15 minutes without" ], "offsets": [ [ 107, 131 ], [ 37, 95 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T4", "type": "Drug", "text": [ "ACE inhibitor" ], "offsets": [ [ 254, 267 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T5", "type": "Condition", "text": [ "Primary indication for ACE inhibitor use" ], "offsets": [ [ 231, 271 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T6", "type": "Condition", "text": [ "Congestive Heart Failure" ], "offsets": [ [ 278, 302 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T7", "type": "Condition", "text": [ "CAD" ], "offsets": [ [ 304, 307 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T8", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 309, 317 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T9", "type": "Scope", "text": [ "Congestive Heart Failure, CAD, diabetes" ], "offsets": [ [ 278, 317 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T10", "type": "Condition", "text": [ "hypersensitivity to ACE inhibitors" ], "offsets": [ [ 325, 359 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T11", "type": "Drug", "text": [ "ACE inhibitors" ], "offsets": [ [ 345, 359 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T12", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 371, 383 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T13", "type": "Qualifier", "text": [ "Resistant" ], "offsets": [ [ 361, 370 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T14", "type": "Measurement", "text": [ "BP" ], "offsets": [ [ 396, 398 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T15", "type": "Value", "text": [ "> 140/90" ], "offsets": [ [ 399, 407 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T16", "type": "Qualifier", "text": [ "despite the use of three or more anti-hypertensive drugs" ], "offsets": [ [ 409, 465 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T17", "type": "Drug", "text": [ "anti-hypertensive drugs" ], "offsets": [ [ 442, 465 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T18", "type": "Multiplier", "text": [ "three or more" ], "offsets": [ [ 428, 441 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T19", "type": "Measurement", "text": [ "SBP" ], "offsets": [ [ 490, 493 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T20", "type": "Value", "text": [ "> 180 mm Hg" ], "offsets": [ [ 494, 505 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T21", "type": "Measurement", "text": [ "DBP" ], "offsets": [ [ 509, 512 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T22", "type": "Value", "text": [ "> 110 mm Hg" ], "offsets": [ [ 513, 524 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T23", "type": "Condition", "text": [ "Primary renal disease" ], "offsets": [ [ 581, 602 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T24", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 604, 620 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T25", "type": "Value", "text": [ ">2.5 mg/dL" ], "offsets": [ [ 621, 631 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T26", "type": "Person", "text": [ "men" ], "offsets": [ [ 635, 638 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T27", "type": "Value", "text": [ ">2.0 mg/dL" ], "offsets": [ [ 643, 653 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T28", "type": "Person", "text": [ "women" ], "offsets": [ [ 657, 662 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T29", "type": "Scope", "text": [ ">2.5 mg/dL in men, or >2.0 mg/dL in women" ], "offsets": [ [ 621, 662 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T30", "type": "Measurement", "text": [ "Serum potassium" ], "offsets": [ [ 664, 679 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T31", "type": "Value", "text": [ ">5.0 molar equivalent/L" ], "offsets": [ [ 680, 703 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T32", "type": "Measurement", "text": [ "Urinary protein", "on dipstick" ], "offsets": [ [ 705, 720 ], [ 725, 736 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T33", "type": "Value", "text": [ "> 1" ], "offsets": [ [ 721, 724 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T34", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 747, 760 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T35", "type": "Measurement", "text": [ "Aspartate transaminase (AST)" ], "offsets": [ [ 762, 790 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T36", "type": "Measurement", "text": [ "Alanine transaminase (ALT)" ], "offsets": [ [ 792, 818 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T37", "type": "Measurement", "text": [ "alkaline phosphatase" ], "offsets": [ [ 823, 843 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T38", "type": "Value", "text": [ "> 2.5 times the upper limit of normal" ], "offsets": [ [ 844, 881 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T39", "type": "Scope", "text": [ "Aspartate transaminase (AST), Alanine transaminase (ALT), or alkaline phosphatase" ], "offsets": [ [ 762, 843 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T40", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 738, 746 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T41", "type": "Scope", "text": [ "Abnormal liver enzymes" ], "offsets": [ [ 738, 760 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T42", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 891, 906 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T43", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 884, 890 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T44", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 918, 944 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T45", "type": "Value", "text": [ "Class III or IV" ], "offsets": [ [ 945, 960 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T46", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 961, 985 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T47", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 987, 1009 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T48", "type": "Condition", "text": [ "aortic stenosis" ], "offsets": [ [ 1010, 1025 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T49", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1027, 1034 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T50", "type": "Condition", "text": [ "cardiac arrest" ], "offsets": [ [ 1038, 1052 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T51", "type": "Device", "text": [ "cardiac defibrillator" ], "offsets": [ [ 1063, 1084 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T52", "type": "Condition", "text": [ "uncontrolled angina" ], "offsets": [ [ 1089, 1108 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T53", "type": "Qualifier", "text": [ "New York Heart Association Class III or IV" ], "offsets": [ [ 918, 960 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T54", "type": "Condition", "text": [ "Acute myocardial infarction" ], "offsets": [ [ 1110, 1137 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T55", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 1152, 1155 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T56", "type": "Observation", "text": [ "Lives in a nursing home" ], "offsets": [ [ 1157, 1180 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T57", "type": "Condition", "text": [ "cognitive impairment" ], "offsets": [ [ 1267, 1287 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T58", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 1255, 1266 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T59", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 1321, 1329 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T60", "type": "Measurement", "text": [ "Mini-Mental State Examination" ], "offsets": [ [ 1335, 1364 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T61", "type": "Value", "text": [ "score < 24" ], "offsets": [ [ 1370, 1380 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T62", "type": "Condition", "text": [ "Unable to communicate" ], "offsets": [ [ 1382, 1403 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T63", "type": "Condition", "text": [ "severe hearing loss" ], "offsets": [ [ 1415, 1434 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T64", "type": "Condition", "text": [ "speech disorder" ], "offsets": [ [ 1438, 1453 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T65", "type": "Scope", "text": [ "severe hearing loss or speech disorder" ], "offsets": [ [ 1415, 1453 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T66", "type": "Condition", "text": [ "visual impairment" ], "offsets": [ [ 1462, 1479 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T67", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 1455, 1461 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T68", "type": "Condition", "text": [ "co-morbid disease" ], "offsets": [ [ 1571, 1588 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T69", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1559, 1570 ] ], "normalized": [] }, { "id": "NCT01891513_exc_T70", "type": "Qualifier", "text": [ "that would prevent participation in exercise" ], "offsets": [ [ 1589, 1633 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01891513_exc_R1", "type": "Subsumes", "arg1_id": "NCT01891513_exc_T5", "arg2_id": "NCT01891513_exc_T9", "normalized": [] }, { "id": "NCT01891513_exc_R2", "type": "Has_value", "arg1_id": "NCT01891513_exc_T14", "arg2_id": "NCT01891513_exc_T15", "normalized": [] }, { "id": "NCT01891513_exc_R3", "type": "Subsumes", "arg1_id": "NCT01891513_exc_T13", "arg2_id": "NCT01891513_exc_T14", "normalized": [] }, { "id": "NCT01891513_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T12", "arg2_id": "NCT01891513_exc_T13", "normalized": [] }, { "id": "NCT01891513_exc_R5", "type": "Has_multiplier", "arg1_id": "NCT01891513_exc_T17", "arg2_id": "NCT01891513_exc_T18", "normalized": [] }, { "id": "NCT01891513_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T13", "arg2_id": "NCT01891513_exc_T16", "normalized": [] }, { "id": "NCT01891513_exc_R7", "type": "Has_value", "arg1_id": "NCT01891513_exc_T21", "arg2_id": "NCT01891513_exc_T22", "normalized": [] }, { "id": "NCT01891513_exc_R8", "type": "Has_value", "arg1_id": "NCT01891513_exc_T19", "arg2_id": "NCT01891513_exc_T20", "normalized": [] }, { "id": "NCT01891513_exc_R9", "type": "Has_value", "arg1_id": "NCT01891513_exc_T28", "arg2_id": "NCT01891513_exc_T27", "normalized": [] }, { "id": "NCT01891513_exc_R10", "type": "Has_value", "arg1_id": "NCT01891513_exc_T26", "arg2_id": "NCT01891513_exc_T25", "normalized": [] }, { "id": "NCT01891513_exc_R11", "type": "Has_scope", "arg1_id": "NCT01891513_exc_T24", "arg2_id": "NCT01891513_exc_T29", "normalized": [] }, { "id": "NCT01891513_exc_R12", "type": "Has_value", "arg1_id": "NCT01891513_exc_T30", "arg2_id": "NCT01891513_exc_T31", "normalized": [] }, { "id": "NCT01891513_exc_R13", "type": "Has_value", "arg1_id": "NCT01891513_exc_T32", "arg2_id": "NCT01891513_exc_T33", "normalized": [] }, { "id": "NCT01891513_exc_R14", "type": "Has_value", "arg1_id": "NCT01891513_exc_T39", "arg2_id": "NCT01891513_exc_T38", "normalized": [] }, { "id": "NCT01891513_exc_R15", "type": "Has_value", "arg1_id": "NCT01891513_exc_T34", "arg2_id": "NCT01891513_exc_T40", "normalized": [] }, { "id": "NCT01891513_exc_R16", "type": "Subsumes", "arg1_id": "NCT01891513_exc_T41", "arg2_id": "NCT01891513_exc_T39", "normalized": [] }, { "id": "NCT01891513_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T42", "arg2_id": "NCT01891513_exc_T43", "normalized": [] }, { "id": "NCT01891513_exc_R18", "type": "Has_value", "arg1_id": "NCT01891513_exc_T44", "arg2_id": "NCT01891513_exc_T45", "normalized": [] }, { "id": "NCT01891513_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T48", "arg2_id": "NCT01891513_exc_T47", "normalized": [] }, { "id": "NCT01891513_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T46", "arg2_id": "NCT01891513_exc_T53", "normalized": [] }, { "id": "NCT01891513_exc_R21", "type": "Has_temporal", "arg1_id": "NCT01891513_exc_T50", "arg2_id": "NCT01891513_exc_T49", "normalized": [] }, { "id": "NCT01891513_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T57", "arg2_id": "NCT01891513_exc_T58", "normalized": [] }, { "id": "NCT01891513_exc_R23", "type": "Has_value", "arg1_id": "NCT01891513_exc_T60", "arg2_id": "NCT01891513_exc_T61", "normalized": [] }, { "id": "NCT01891513_exc_R24", "type": "Subsumes", "arg1_id": "NCT01891513_exc_T65", "arg2_id": "NCT01891513_exc_T62", "normalized": [] }, { "id": "NCT01891513_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T66", "arg2_id": "NCT01891513_exc_T67", "normalized": [] }, { "id": "NCT01891513_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T68", "arg2_id": "NCT01891513_exc_T69", "normalized": [] }, { "id": "NCT01891513_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT01891513_exc_T68", "arg2_id": "NCT01891513_exc_T70", "normalized": [] } ]

[ { "id": "NCT01891513_inc_text", "type": "inclusion", "text": [ "Age 65 years and older \nHypertension - untreated (Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg) or treated \nPhysical limitations evidenced by either: \nScore ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.2 m/sec during 400 m usual-paced test \nSedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire \nWillingness to participate in all study procedures \n" ], "offsets": [ [ 0, 469 ] ] } ]

[ { "id": "NCT01891513_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T2", "type": "Value", "text": [ "65 years and older" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T3", "type": "Condition", "text": [ "Hypertension" ], "offsets": [ [ 24, 36 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T4", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 39, 48 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T5", "type": "Measurement", "text": [ "Systolic Blood Pressure (SBP)" ], "offsets": [ [ 50, 79 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T6", "type": "Value", "text": [ "≥ 140 mm Hg" ], "offsets": [ [ 80, 91 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T7", "type": "Measurement", "text": [ "Diastolic Blood Pressure (DBP)" ], "offsets": [ [ 95, 125 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T8", "type": "Value", "text": [ "≥ 90 mm Hg" ], "offsets": [ [ 126, 136 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T9", "type": "Scope", "text": [ "Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg" ], "offsets": [ [ 50, 136 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T10", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 141, 148 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T12", "type": "Measurement", "text": [ "Short Physical Performance Battery" ], "offsets": [ [ 211, 245 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T13", "type": "Value", "text": [ "Score ≤ 10" ], "offsets": [ [ 193, 203 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T14", "type": "Measurement", "text": [ "Walking speed" ], "offsets": [ [ 249, 262 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T15", "type": "Value", "text": [ "< 1.2 m/sec" ], "offsets": [ [ 263, 274 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T16", "type": "Procedure", "text": [ "400 m usual-paced test" ], "offsets": [ [ 282, 304 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T17", "type": "Condition", "text": [ "Sedentary lifestyle" ], "offsets": [ [ 306, 325 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T18", "type": "Value", "text": [ "<150 min/wk" ], "offsets": [ [ 338, 349 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T19", "type": "Measurement", "text": [ "moderate physical activity" ], "offsets": [ [ 353, 379 ] ], "normalized": [] }, { "id": "NCT01891513_inc_T20", "type": "Procedure", "text": [ "CHAMPS questionnaire" ], "offsets": [ [ 395, 415 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01891513_inc_R1", "type": "Has_value", "arg1_id": "NCT01891513_inc_T5", "arg2_id": "NCT01891513_inc_T6", "normalized": [] }, { "id": "NCT01891513_inc_R2", "type": "Has_value", "arg1_id": "NCT01891513_inc_T7", "arg2_id": "NCT01891513_inc_T8", "normalized": [] }, { "id": "NCT01891513_inc_R3", "type": "Subsumes", "arg1_id": "NCT01891513_inc_T3", "arg2_id": "NCT01891513_inc_T9", "normalized": [] }, { "id": "NCT01891513_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01891513_inc_T3", "arg2_id": "NCT01891513_inc_T4", "normalized": [] }, { "id": "NCT01891513_inc_R5", "type": "Has_value", "arg1_id": "NCT01891513_inc_T12", "arg2_id": "NCT01891513_inc_T13", "normalized": [] }, { "id": "NCT01891513_inc_R6", "type": "Has_value", "arg1_id": "NCT01891513_inc_T14", "arg2_id": "NCT01891513_inc_T15", "normalized": [] }, { "id": "NCT01891513_inc_R7", "type": "AND", "arg1_id": "NCT01891513_inc_T14", "arg2_id": "NCT01891513_inc_T16", "normalized": [] }, { "id": "NCT01891513_inc_R8", "type": "Has_value", "arg1_id": "NCT01891513_inc_T19", "arg2_id": "NCT01891513_inc_T18", "normalized": [] }, { "id": "NCT01891513_inc_R9", "type": "AND", "arg1_id": "NCT01891513_inc_T19", "arg2_id": "NCT01891513_inc_T20", "normalized": [] } ]

[ { "id": "NCT01895946_exc_text", "type": "exclusion", "text": [ "Clinically significant abnormalities of glucose metabolism \nSpinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids) \nEvidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and Human Immunodeficiency Virus (HIV) \nEvidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures \nA bad reaction to AZD5363 or any drugs similar to it in structure or class \n \n" ], "offsets": [ [ 0, 661 ] ] } ]

[ { "id": "NCT01895946_exc_T1", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T2", "type": "Condition", "text": [ "abnormalities of glucose metabolism" ], "offsets": [ [ 23, 58 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T3", "type": "Condition", "text": [ "Spinal cord compression" ], "offsets": [ [ 60, 83 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T4", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 87, 103 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T5", "type": "Condition", "text": [ "asymptomatic" ], "offsets": [ [ 111, 123 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T6", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 104, 110 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T7", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T8", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 137, 143 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T9", "type": "Scope", "text": [ "asymptomatic, treated and stable (not requiring steroids)" ], "offsets": [ [ 111, 168 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T10", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 159, 167 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T11", "type": "Negation", "text": [ "not" ], "offsets": [ [ 145, 148 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T12", "type": "Scope", "text": [ "Spinal cord compression or brain metastases" ], "offsets": [ [ 60, 103 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T13", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 192, 204 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T14", "type": "Condition", "text": [ "systemic diseases" ], "offsets": [ [ 205, 222 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T15", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 182, 188 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T16", "type": "Scope", "text": [ "severe or uncontrolled" ], "offsets": [ [ 182, 204 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T17", "type": "Condition", "text": [ "active bleeding diatheses" ], "offsets": [ [ 234, 259 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T18", "type": "Condition", "text": [ "active infections" ], "offsets": [ [ 263, 280 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T19", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 291, 302 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T20", "type": "Condition", "text": [ "Human Immunodeficiency Virus (HIV)" ], "offsets": [ [ 310, 344 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T21", "type": "Condition", "text": [ "hepatitis", "C" ], "offsets": [ [ 291, 300 ], [ 304, 305 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T22", "type": "Scope", "text": [ "hepatitis B, C and Human Immunodeficiency Virus (HIV)" ], "offsets": [ [ 291, 344 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T23", "type": "Scope", "text": [ "active bleeding diatheses or active infections including hepatitis B, C and Human Immunodeficiency Virus (HIV)" ], "offsets": [ [ 234, 344 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T24", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 358, 380 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T26", "type": "Condition", "text": [ "cardiac abnormalities" ], "offsets": [ [ 381, 402 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T27", "type": "Condition", "text": [ "uncontrolled hypotension" ], "offsets": [ [ 404, 428 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T28", "type": "Measurement", "text": [ "left ventricular ejection fraction" ], "offsets": [ [ 430, 464 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T29", "type": "Value", "text": [ "below the lower limit of normal" ], "offsets": [ [ 465, 496 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T30", "type": "Procedure", "text": [ "cardiac interventional procedures" ], "offsets": [ [ 539, 572 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T31", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 527, 538 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T33", "type": "Condition", "text": [ "bad reaction to AZD5363" ], "offsets": [ [ 576, 599 ] ], "normalized": [] }, { "id": "NCT01895946_exc_T34", "type": "Drug", "text": [ "AZD5363" ], "offsets": [ [ 592, 599 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01895946_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01895946_exc_T2", "arg2_id": "NCT01895946_exc_T1", "normalized": [] }, { "id": "NCT01895946_exc_R2", "type": "Has_negation", "arg1_id": "NCT01895946_exc_T10", "arg2_id": "NCT01895946_exc_T11", "normalized": [] }, { "id": "NCT01895946_exc_R3", "type": "Has_negation", "arg1_id": "NCT01895946_exc_T9", "arg2_id": "NCT01895946_exc_T6", "normalized": [] }, { "id": "NCT01895946_exc_R4", "type": "Has_scope", "arg1_id": "NCT01895946_exc_T12", "arg2_id": "NCT01895946_exc_T9", "normalized": [] }, { "id": "NCT01895946_exc_R5", "type": "AND", "arg1_id": "NCT01895946_exc_T8", "arg2_id": "NCT01895946_exc_T10", "normalized": [] }, { "id": "NCT01895946_exc_R6", "type": "Has_scope", "arg1_id": "NCT01895946_exc_T14", "arg2_id": "NCT01895946_exc_T16", "normalized": [] }, { "id": "NCT01895946_exc_R7", "type": "Subsumes", "arg1_id": "NCT01895946_exc_T18", "arg2_id": "NCT01895946_exc_T22", "normalized": [] }, { "id": "NCT01895946_exc_R8", "type": "Subsumes", "arg1_id": "NCT01895946_exc_T14", "arg2_id": "NCT01895946_exc_T23", "normalized": [] }, { "id": "NCT01895946_exc_R10", "type": "Has_value", "arg1_id": "NCT01895946_exc_T28", "arg2_id": "NCT01895946_exc_T29", "normalized": [] }, { "id": "NCT01895946_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT01895946_exc_T30", "arg2_id": "NCT01895946_exc_T31", "normalized": [] }, { "id": "NCT01895946_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT01895946_exc_T26", "arg2_id": "NCT01895946_exc_T24", "normalized": [] } ]

[ { "id": "NCT01895946_inc_text", "type": "inclusion", "text": [ "Aged at least 18 years \nThe presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist \nThe presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is suitable for repeated assessment \nEstimated life expectancy of more than 12 weeks \n" ], "offsets": [ [ 0, 421 ] ] } ]

[ { "id": "NCT01895946_inc_T1", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T2", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T3", "type": "Condition", "text": [ "solid, malignant tumour" ], "offsets": [ [ 42, 65 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T4", "type": "Condition", "text": [ "lymphoma" ], "offsets": [ [ 77, 85 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T5", "type": "Negation", "text": [ "excluding" ], "offsets": [ [ 67, 76 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T6", "type": "Qualifier", "text": [ "resistance to standard therapies" ], "offsets": [ [ 95, 127 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T7", "type": "Qualifier", "text": [ "for which no standard therapies exist" ], "offsets": [ [ 131, 168 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T8", "type": "Scope", "text": [ "resistance to standard therapies or for which no standard therapies exist" ], "offsets": [ [ 95, 168 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T9", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 186, 198 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T10", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 199, 205 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T11", "type": "Qualifier", "text": [ "accurately assessed at baseline" ], "offsets": [ [ 218, 249 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T12", "type": "Procedure", "text": [ "Computerised Tomography (CT)" ], "offsets": [ [ 253, 281 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T13", "type": "Procedure", "text": [ "Magnetic Resonance Imaging (MRI)" ], "offsets": [ [ 283, 315 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T14", "type": "Procedure", "text": [ "plain X-ray" ], "offsets": [ [ 319, 330 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T15", "type": "Qualifier", "text": [ "suitable for repeated assessment" ], "offsets": [ [ 338, 370 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T16", "type": "Scope", "text": [ "Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray" ], "offsets": [ [ 253, 330 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T17", "type": "Value", "text": [ "more than 12 weeks" ], "offsets": [ [ 401, 419 ] ], "normalized": [] }, { "id": "NCT01895946_inc_T18", "type": "Observation", "text": [ "Estimated life expectancy" ], "offsets": [ [ 372, 397 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01895946_inc_R1", "type": "Has_value", "arg1_id": "NCT01895946_inc_T2", "arg2_id": "NCT01895946_inc_T1", "normalized": [] }, { "id": "NCT01895946_inc_R2", "type": "Has_negation", "arg1_id": "NCT01895946_inc_T4", "arg2_id": "NCT01895946_inc_T5", "normalized": [] }, { "id": "NCT01895946_inc_R3", "type": "Has_scope", "arg1_id": "NCT01895946_inc_T3", "arg2_id": "NCT01895946_inc_T8", "normalized": [] }, { "id": "NCT01895946_inc_R4", "type": "AND", "arg1_id": "NCT01895946_inc_T3", "arg2_id": "NCT01895946_inc_T4", "normalized": [] }, { "id": "NCT01895946_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01895946_inc_T10", "arg2_id": "NCT01895946_inc_T11", "normalized": [] }, { "id": "NCT01895946_inc_R6", "type": "Has_scope", "arg1_id": "NCT01895946_inc_T11", "arg2_id": "NCT01895946_inc_T16", "normalized": [] }, { "id": "NCT01895946_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT01895946_inc_T10", "arg2_id": "NCT01895946_inc_T15", "normalized": [] }, { "id": "NCT01895946_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01895946_inc_T10", "arg2_id": "NCT01895946_inc_T9", "normalized": [] }, { "id": "NCT01895946_inc_R9", "type": "Has_value", "arg1_id": "NCT01895946_inc_T18", "arg2_id": "NCT01895946_inc_T17", "normalized": [] } ]

[ { "id": "NCT01907230_exc_text", "type": "exclusion", "text": [ "HCV, HIV, or HDV coinfection.\nHCC or other malignancy within 3 years.\nDecompensated liver cirrhosis (CTP score = 7).\nUremia patients under hemodialysis or continuous ambulatory peritoneal dialysis or patients with Ccr < 50 mL/min\nPregnant or breastfeeding women.\nWomen of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug.\n" ], "offsets": [ [ 0, 474 ] ] } ]

[ { "id": "NCT01907230_exc_T1", "type": "Condition", "text": [ "HCV", "coinfection" ], "offsets": [ [ 0, 3 ], [ 17, 28 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T2", "type": "Condition", "text": [ "coinfection", "HIV" ], "offsets": [ [ 17, 28 ], [ 5, 8 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T3", "type": "Condition", "text": [ "HDV", "coinfection" ], "offsets": [ [ 13, 16 ], [ 17, 28 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T4", "type": "Condition", "text": [ "HCC" ], "offsets": [ [ 30, 33 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T5", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 43, 53 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T6", "type": "Temporal", "text": [ "within 3 years" ], "offsets": [ [ 54, 68 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T7", "type": "Scope", "text": [ "HCC or other malignancy" ], "offsets": [ [ 30, 53 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T8", "type": "Condition", "text": [ "Decompensated liver cirrhosis" ], "offsets": [ [ 70, 99 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T9", "type": "Measurement", "text": [ "CTP score" ], "offsets": [ [ 101, 110 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T10", "type": "Value", "text": [ "= 7" ], "offsets": [ [ 111, 114 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T11", "type": "Condition", "text": [ "Uremia" ], "offsets": [ [ 117, 123 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T12", "type": "Procedure", "text": [ "hemodialysis" ], "offsets": [ [ 139, 151 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T13", "type": "Condition", "text": [ "continuous ambulatory peritoneal dialysis" ], "offsets": [ [ 155, 196 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T14", "type": "Measurement", "text": [ "Ccr" ], "offsets": [ [ 214, 217 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T15", "type": "Value", "text": [ "< 50 mL/min" ], "offsets": [ [ 218, 229 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T16", "type": "Scope", "text": [ "hemodialysis or continuous ambulatory peritoneal dialysis" ], "offsets": [ [ 139, 196 ] ], "normalized": [] }, { "id": "NCT01907230_exc_T17", "type": "Scope", "text": [ "hemodialysis or continuous ambulatory peritoneal dialysis or patients with Ccr < 50 mL/min" ], "offsets": [ [ 139, 229 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01907230_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01907230_exc_T7", "arg2_id": "NCT01907230_exc_T6", "normalized": [] }, { "id": "NCT01907230_exc_R2", "type": "Has_value", "arg1_id": "NCT01907230_exc_T9", "arg2_id": "NCT01907230_exc_T10", "normalized": [] }, { "id": "NCT01907230_exc_R3", "type": "AND", "arg1_id": "NCT01907230_exc_T8", "arg2_id": "NCT01907230_exc_T9", "normalized": [] }, { "id": "NCT01907230_exc_R4", "type": "Has_value", "arg1_id": "NCT01907230_exc_T14", "arg2_id": "NCT01907230_exc_T15", "normalized": [] }, { "id": "NCT01907230_exc_R5", "type": "Has_scope", "arg1_id": "NCT01907230_exc_T11", "arg2_id": "NCT01907230_exc_T17", "normalized": [] } ]

[ { "id": "NCT01907230_inc_text", "type": "inclusion", "text": [ "Age : from 20 to 90 y/o.\nHBsAg-positive for more than 6 months and HBV DNA < 2000 IU/ml (Subgroup 1)or HBsAg-negative but anti-HBc positive with HBV DNA < 2000 IU/ml (Subgroup 2).\nInflammatory arthritis patients who plan to treat with biological agents, including Humira or Enbrel or Simponi or Orencia or Mabthera or Actemra; as first line biologic treatment is indicated.\n" ], "offsets": [ [ 0, 374 ] ] } ]

[ { "id": "NCT01907230_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T2", "type": "Value", "text": [ "20 to 90 y/o" ], "offsets": [ [ 11, 23 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T3", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 25, 30 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T4", "type": "Value", "text": [ "positive" ], "offsets": [ [ 31, 39 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T5", "type": "Temporal", "text": [ "more than 6 months" ], "offsets": [ [ 44, 62 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T6", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 67, 74 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T7", "type": "Value", "text": [ "< 2000 IU/ml" ], "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T8", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 103, 108 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T9", "type": "Value", "text": [ "negative" ], "offsets": [ [ 109, 117 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T10", "type": "Measurement", "text": [ "anti-HBc" ], "offsets": [ [ 122, 130 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T11", "type": "Value", "text": [ "positive" ], "offsets": [ [ 131, 139 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T12", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 145, 152 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T13", "type": "Value", "text": [ "< 2000 IU/ml" ], "offsets": [ [ 153, 165 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T14", "type": "Scope", "text": [ "HBsAg-positive for more than 6 months and HBV DNA < 2000 IU/ml" ], "offsets": [ [ 25, 87 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T15", "type": "Scope", "text": [ "Age : from 20 to 90 y/o.", "BsAg-positive for more than 6 months and HBV DNA < 2000 IU/ml (Subgroup 1)or HBsAg-negative but anti-HBc positive with HBV DNA < 2000 IU/ml" ], "offsets": [ [ 0, 24 ], [ 26, 165 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T16", "type": "Scope", "text": [ "HBsAg-negative but anti-HBc positive with HBV DNA < 2000 IU/ml" ], "offsets": [ [ 103, 165 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T17", "type": "Condition", "text": [ "Inflammatory arthritis" ], "offsets": [ [ 180, 202 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T18", "type": "Procedure", "text": [ "biological agents" ], "offsets": [ [ 235, 252 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T19", "type": "Drug", "text": [ "Humira" ], "offsets": [ [ 264, 270 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T20", "type": "Drug", "text": [ "Enbrel" ], "offsets": [ [ 274, 280 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T21", "type": "Drug", "text": [ "Simponi" ], "offsets": [ [ 284, 291 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T22", "type": "Drug", "text": [ "Orencia" ], "offsets": [ [ 295, 302 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T23", "type": "Drug", "text": [ "Mabthera" ], "offsets": [ [ 306, 314 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T24", "type": "Drug", "text": [ "Actemra" ], "offsets": [ [ 318, 325 ] ], "normalized": [] }, { "id": "NCT01907230_inc_T25", "type": "Scope", "text": [ "Humira or Enbrel or Simponi or Orencia or Mabthera or Actemra" ], "offsets": [ [ 264, 325 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01907230_inc_R1", "type": "Has_value", "arg1_id": "NCT01907230_inc_T1", "arg2_id": "NCT01907230_inc_T2", "normalized": [] }, { "id": "NCT01907230_inc_R2", "type": "Has_value", "arg1_id": "NCT01907230_inc_T3", "arg2_id": "NCT01907230_inc_T4", "normalized": [] }, { "id": "NCT01907230_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01907230_inc_T3", "arg2_id": "NCT01907230_inc_T5", "normalized": [] }, { "id": "NCT01907230_inc_R4", "type": "Has_value", "arg1_id": "NCT01907230_inc_T6", "arg2_id": "NCT01907230_inc_T7", "normalized": [] }, { "id": "NCT01907230_inc_R5", "type": "Has_value", "arg1_id": "NCT01907230_inc_T8", "arg2_id": "NCT01907230_inc_T9", "normalized": [] }, { "id": "NCT01907230_inc_R6", "type": "Has_value", "arg1_id": "NCT01907230_inc_T10", "arg2_id": "NCT01907230_inc_T11", "normalized": [] }, { "id": "NCT01907230_inc_R7", "type": "Has_value", "arg1_id": "NCT01907230_inc_T12", "arg2_id": "NCT01907230_inc_T13", "normalized": [] }, { "id": "NCT01907230_inc_R8", "type": "AND", "arg1_id": "NCT01907230_inc_T17", "arg2_id": "NCT01907230_inc_T18", "normalized": [] }, { "id": "NCT01907230_inc_R9", "type": "Has_scope", "arg1_id": "NCT01907230_inc_T18", "arg2_id": "NCT01907230_inc_T25", "normalized": [] } ]

[ { "id": "NCT01908465_exc_text", "type": "exclusion", "text": [ "IBS subtype with constipation\nmedication: antidepressants or H1-receptor antagonists\npregnancy, breast feeding\nco-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases\n" ], "offsets": [ [ 0, 196 ] ] } ]

[ { "id": "NCT01908465_exc_T1", "type": "Condition", "text": [ "IBS subtype" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T2", "type": "Condition", "text": [ "constipation" ], "offsets": [ [ 17, 29 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T3", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 42, 57 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T4", "type": "Drug", "text": [ "H1-receptor antagonists" ], "offsets": [ [ 61, 84 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T5", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 85, 94 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T6", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 96, 110 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T7", "type": "Condition", "text": [ "ney- a", "ease or" ], "offsets": [ [ 135, 141 ], [ 156, 163 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T8", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 147, 160 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 125, 131 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T10", "type": "Condition", "text": [ "gastrointestinal diseases" ], "offsets": [ [ 170, 195 ] ], "normalized": [] }, { "id": "NCT01908465_exc_T11", "type": "Scope", "text": [ "kidney- and/or liver disease or other gastrointestinal diseases" ], "offsets": [ [ 132, 195 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01908465_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01908465_exc_T11", "arg2_id": "NCT01908465_exc_T9", "normalized": [] } ]

[ { "id": "NCT01908465_inc_text", "type": "inclusion", "text": [ "Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form\nage 18-65 years\n" ], "offsets": [ [ 0, 104 ] ] } ]

[ { "id": "NCT01908465_inc_T1", "type": "Condition", "text": [ "Irritable Bowel Syndrome (IBS)" ], "offsets": [ [ 0, 30 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T2", "type": "Qualifier", "text": [ "ROME III criteria" ], "offsets": [ [ 32, 49 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T3", "type": "Condition", "text": [ "diarrhea" ], "offsets": [ [ 65, 73 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T4", "type": "Qualifier", "text": [ "mixed form" ], "offsets": [ [ 77, 87 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T5", "type": "Scope", "text": [ "diarrhea or mixed form" ], "offsets": [ [ 65, 87 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 88, 91 ] ], "normalized": [] }, { "id": "NCT01908465_inc_T7", "type": "Value", "text": [ "18-65 years" ], "offsets": [ [ 92, 103 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01908465_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01908465_inc_T1", "arg2_id": "NCT01908465_inc_T2", "normalized": [] }, { "id": "NCT01908465_inc_R2", "type": "Has_scope", "arg1_id": "NCT01908465_inc_T1", "arg2_id": "NCT01908465_inc_T5", "normalized": [] }, { "id": "NCT01908465_inc_R3", "type": "Has_value", "arg1_id": "NCT01908465_inc_T6", "arg2_id": "NCT01908465_inc_T7", "normalized": [] } ]

[ { "id": "NCT01909934_exc_text", "type": "exclusion", "text": [ "Previous treatment with brentuximab vedotin.\nPreviously received an allogeneic transplant.\nPatients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).\nKnown cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)\nFemale patients who are lactating and breastfeeding or pregnant\nKnown human immunodeficiency virus (HIV) positive\nKnown hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection\n" ], "offsets": [ [ 0, 532 ] ] } ]

[ { "id": "NCT01909934_exc_T1", "type": "Drug", "text": [ "brentuximab" ], "offsets": [ [ 24, 35 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T2", "type": "Procedure", "text": [ "allogeneic transplant" ], "offsets": [ [ 68, 89 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T3", "type": "Condition", "text": [ "primary cutaneous ALCL" ], "offsets": [ [ 126, 148 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T4", "type": "Condition", "text": [ "sALCL" ], "offsets": [ [ 189, 194 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T5", "type": "Condition", "text": [ "meningeal disease" ], "offsets": [ [ 225, 242 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T6", "type": "Condition", "text": [ "ebral/me", "ease in" ], "offsets": [ [ 219, 227 ], [ 238, 245 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T7", "type": "Condition", "text": [ "progressive multifocal leukoencephalopathy" ], "offsets": [ [ 274, 316 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T8", "type": "Condition", "text": [ "PML" ], "offsets": [ [ 318, 321 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T9", "type": "Scope", "text": [ "cerebral/meningeal disease" ], "offsets": [ [ 216, 242 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T11", "type": "Measurement", "text": [ "human immunodeficiency virus" ], "offsets": [ [ 393, 421 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T12", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 423, 426 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T13", "type": "Value", "text": [ "positive" ], "offsets": [ [ 428, 436 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T14", "type": "Measurement", "text": [ "hepatitis B surface antigen" ], "offsets": [ [ 443, 470 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T15", "type": "Value", "text": [ "positive" ], "offsets": [ [ 471, 479 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T16", "type": "Condition", "text": [ "hepatitis C infection" ], "offsets": [ [ 510, 531 ] ], "normalized": [] }, { "id": "NCT01909934_exc_T17", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 503, 509 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01909934_exc_R1", "type": "Subsumes", "arg1_id": "NCT01909934_exc_T7", "arg2_id": "NCT01909934_exc_T8", "normalized": [] }, { "id": "NCT01909934_exc_R2", "type": "Subsumes", "arg1_id": "NCT01909934_exc_T9", "arg2_id": "NCT01909934_exc_T7", "normalized": [] }, { "id": "NCT01909934_exc_R3", "type": "Subsumes", "arg1_id": "NCT01909934_exc_T11", "arg2_id": "NCT01909934_exc_T12", "normalized": [] }, { "id": "NCT01909934_exc_R4", "type": "Has_value", "arg1_id": "NCT01909934_exc_T11", "arg2_id": "NCT01909934_exc_T13", "normalized": [] }, { "id": "NCT01909934_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01909934_exc_T16", "arg2_id": "NCT01909934_exc_T17", "normalized": [] }, { "id": "NCT01909934_exc_R6", "type": "Has_value", "arg1_id": "NCT01909934_exc_T14", "arg2_id": "NCT01909934_exc_T15", "normalized": [] } ]

[ { "id": "NCT01909934_inc_text", "type": "inclusion", "text": [ "Male or female patients age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy\nBidimensional measurable disease\nAn Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFemale patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence\nMale patients who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence\nClinical laboratory values as specified in the study protocol\n" ], "offsets": [ [ 0, 834 ] ] } ]

[ { "id": "NCT01909934_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 24, 27 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T4", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 28, 45 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T5", "type": "Condition", "text": [ "sALCL" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T6", "type": "Qualifier", "text": [ "refractory" ], "offsets": [ [ 64, 74 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T7", "type": "Qualifier", "text": [ "relapsed" ], "offsets": [ [ 52, 60 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T8", "type": "Multiplier", "text": [ "at least 1" ], "offsets": [ [ 110, 120 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T9", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 132, 144 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T10", "type": "Scope", "text": [ "relapsed or refractory" ], "offsets": [ [ 52, 74 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T12", "type": "Measurement", "text": [ "stern Cooperative Oncology Group (", "rformance status o" ], "offsets": [ [ 183, 217 ], [ 225, 243 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T13", "type": "Measurement", "text": [ "ECOG" ], "offsets": [ [ 217, 221 ] ], "normalized": [] }, { "id": "NCT01909934_inc_T14", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 245, 251 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01909934_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT01909934_inc_T9", "arg2_id": "NCT01909934_inc_T8", "normalized": [] }, { "id": "NCT01909934_inc_R2", "type": "Has_scope", "arg1_id": "NCT01909934_inc_T5", "arg2_id": "NCT01909934_inc_T10", "normalized": [] }, { "id": "NCT01909934_inc_R3", "type": "Has_value", "arg1_id": "NCT01909934_inc_T3", "arg2_id": "NCT01909934_inc_T4", "normalized": [] }, { "id": "NCT01909934_inc_R4", "type": "AND", "arg1_id": "NCT01909934_inc_T5", "arg2_id": "NCT01909934_inc_T9", "normalized": [] }, { "id": "NCT01909934_inc_R5", "type": "Subsumes", "arg1_id": "NCT01909934_inc_T12", "arg2_id": "NCT01909934_inc_T13", "normalized": [] }, { "id": "NCT01909934_inc_R6", "type": "Has_value", "arg1_id": "NCT01909934_inc_T12", "arg2_id": "NCT01909934_inc_T14", "normalized": [] } ]

[ { "id": "NCT01911650_exc_text", "type": "exclusion", "text": [ "1. bilateral AT \n2. insertional AT \n3. local steroid injection within 6 weeks or physical therapy within 4 weeks \n4. inability to comply with follow-up criteria \n5. history of surgery on the Achilles tendon or systemic diseases (general inflammatory diseases such as rheumatologic disorders and diabetes) \n6. daily use of opioids for pain \n7. anticoagulation or immunosuppressive therapy \n8. intent to use NSAIDs or steroids \n9. self-reported pregnancy \n \n" ], "offsets": [ [ 0, 465 ] ] } ]

[ { "id": "NCT01911650_exc_T1", "type": "Condition", "text": [ "bilateral AT" ], "offsets": [ [ 3, 15 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T2", "type": "Condition", "text": [ "insertional AT" ], "offsets": [ [ 20, 34 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T3", "type": "Procedure", "text": [ "local steroid injection" ], "offsets": [ [ 39, 62 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T4", "type": "Temporal", "text": [ "within 6 weeks" ], "offsets": [ [ 63, 77 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T5", "type": "Procedure", "text": [ "physical therapy" ], "offsets": [ [ 81, 97 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T6", "type": "Temporal", "text": [ "within 4 weeks" ], "offsets": [ [ 98, 112 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T10", "type": "Observation", "text": [ "history" ], "offsets": [ [ 165, 172 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T11", "type": "Procedure", "text": [ "surgery on the Achilles tendon" ], "offsets": [ [ 176, 206 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T12", "type": "Condition", "text": [ "systemic diseases" ], "offsets": [ [ 210, 227 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T13", "type": "Condition", "text": [ "general inflammatory diseases" ], "offsets": [ [ 229, 258 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T14", "type": "Condition", "text": [ "rheumatologic disorders" ], "offsets": [ [ 267, 290 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T15", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 295, 303 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T16", "type": "Scope", "text": [ "rheumatologic disorders and diabetes" ], "offsets": [ [ 267, 303 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T17", "type": "Drug", "text": [ "opioids" ], "offsets": [ [ 322, 329 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T18", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 334, 338 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T19", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 309, 314 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T20", "type": "Procedure", "text": [ "anticoagulation", "therapy" ], "offsets": [ [ 343, 358 ], [ 380, 387 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T21", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 362, 387 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T22", "type": "Drug", "text": [ "NSAIDs" ], "offsets": [ [ 406, 412 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T23", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 416, 424 ] ], "normalized": [] }, { "id": "NCT01911650_exc_T24", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 443, 452 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01911650_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01911650_exc_T5", "arg2_id": "NCT01911650_exc_T6", "normalized": [] }, { "id": "NCT01911650_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01911650_exc_T3", "arg2_id": "NCT01911650_exc_T4", "normalized": [] }, { "id": "NCT01911650_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01911650_exc_T11", "arg2_id": "NCT01911650_exc_T10", "normalized": [] }, { "id": "NCT01911650_exc_R4", "type": "Subsumes", "arg1_id": "NCT01911650_exc_T13", "arg2_id": "NCT01911650_exc_T16", "normalized": [] }, { "id": "NCT01911650_exc_R5", "type": "Subsumes", "arg1_id": "NCT01911650_exc_T12", "arg2_id": "NCT01911650_exc_T13", "normalized": [] }, { "id": "NCT01911650_exc_R6", "type": "AND", "arg1_id": "NCT01911650_exc_T17", "arg2_id": "NCT01911650_exc_T18", "normalized": [] }, { "id": "NCT01911650_exc_R7", "type": "Has_multiplier", "arg1_id": "NCT01911650_exc_T17", "arg2_id": "NCT01911650_exc_T19", "normalized": [] } ]

[ { "id": "NCT01911650_inc_text", "type": "inclusion", "text": [ "1. age 18-65 years, inclusive \n2. diagnosis of moderate to severe AT, confirmed by Dr. Wilson using clinical symptoms and exam findings consistent with chronic AT (>6 month duration) - which includes pain while palpating the intratendinous swelling part of the Achilles tendon and relief of pain when tendon placed under tension - and pre-procedure US \n3. self-reported AT-related pain for at least 6 months and VAS (Visual Analog Scale) pain >5 (0-10 scale) \n4. self-reported failure of eccentric exercise protocol (at least 75% completion) \n5. self-reported failure of at least 2 of the 3 most common treatments for AT (NSAIDS, rest/ice or taping) \n6. patient considered surgery but decided to wait and/or refused surgery - \n" ], "offsets": [ [ 0, 727 ] ] } ]

[ { "id": "NCT01911650_inc_T1", "type": "Value", "text": [ "18-65 years, inclusive" ], "offsets": [ [ 7, 29 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 3, 6 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T3", "type": "Qualifier", "text": [ "moderate to severe" ], "offsets": [ [ 47, 65 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T4", "type": "Condition", "text": [ "AT" ], "offsets": [ [ 66, 68 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T6", "type": "Condition", "text": [ "chronic AT" ], "offsets": [ [ 152, 162 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T7", "type": "Temporal", "text": [ ">6 month duration" ], "offsets": [ [ 164, 181 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T8", "type": "Condition", "text": [ "pain while palpating the intratendinous swelling part of the Achilles tendon" ], "offsets": [ [ 200, 276 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T9", "type": "Condition", "text": [ "relief of pain when tendon placed under tension" ], "offsets": [ [ 281, 328 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T10", "type": "Condition", "text": [ "AT-related pain" ], "offsets": [ [ 370, 385 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T11", "type": "Observation", "text": [ "self-reported" ], "offsets": [ [ 356, 369 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T12", "type": "Temporal", "text": [ "for at least 6 months" ], "offsets": [ [ 386, 407 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T13", "type": "Measurement", "text": [ "VAS (Visual Analog Scale) pain" ], "offsets": [ [ 412, 442 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T14", "type": "Value", "text": [ ">5" ], "offsets": [ [ 443, 445 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T15", "type": "Qualifier", "text": [ "0-10 scale" ], "offsets": [ [ 447, 457 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T16", "type": "Scope", "text": [ "T-related pain for at least 6 months and VAS (Visual Analog Scale) pain >5 (0-10 scale)" ], "offsets": [ [ 371, 458 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T17", "type": "Condition", "text": [ "failure of eccentric exercise protocol" ], "offsets": [ [ 477, 515 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T18", "type": "Value", "text": [ "at least 75%" ], "offsets": [ [ 517, 529 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T19", "type": "Observation", "text": [ "self-reported" ], "offsets": [ [ 463, 476 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T20", "type": "Observation", "text": [ "self-reported" ], "offsets": [ [ 546, 559 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T21", "type": "Condition", "text": [ "failure of at least 2 of the 3 most common treatments for AT" ], "offsets": [ [ 560, 620 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T22", "type": "Drug", "text": [ "NSAIDS" ], "offsets": [ [ 622, 628 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T23", "type": "Procedure", "text": [ "rest" ], "offsets": [ [ 630, 634 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T24", "type": "Drug", "text": [ "ice" ], "offsets": [ [ 635, 638 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T25", "type": "Procedure", "text": [ "taping" ], "offsets": [ [ 642, 648 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T26", "type": "Scope", "text": [ "NSAIDS, rest/ice or taping" ], "offsets": [ [ 622, 648 ] ], "normalized": [] }, { "id": "NCT01911650_inc_T27", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 673, 680 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01911650_inc_R1", "type": "Has_value", "arg1_id": "NCT01911650_inc_T2", "arg2_id": "NCT01911650_inc_T1", "normalized": [] }, { "id": "NCT01911650_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01911650_inc_T4", "arg2_id": "NCT01911650_inc_T3", "normalized": [] }, { "id": "NCT01911650_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01911650_inc_T6", "arg2_id": "NCT01911650_inc_T7", "normalized": [] }, { "id": "NCT01911650_inc_R4", "type": "Has_value", "arg1_id": "NCT01911650_inc_T13", "arg2_id": "NCT01911650_inc_T14", "normalized": [] }, { "id": "NCT01911650_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01911650_inc_T13", "arg2_id": "NCT01911650_inc_T15", "normalized": [] }, { "id": "NCT01911650_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01911650_inc_T10", "arg2_id": "NCT01911650_inc_T12", "normalized": [] }, { "id": "NCT01911650_inc_R8", "type": "Has_value", "arg1_id": "NCT01911650_inc_T17", "arg2_id": "NCT01911650_inc_T18", "normalized": [] }, { "id": "NCT01911650_inc_R10", "type": "Subsumes", "arg1_id": "NCT01911650_inc_T21", "arg2_id": "NCT01911650_inc_T26", "normalized": [] } ]

[ { "id": "NCT01912651_exc_text", "type": "exclusion", "text": [ "current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin/soft-tissue defect.\n" ], "offsets": [ [ 0, 304 ] ] } ]

[ { "id": "NCT01912651_exc_T1", "type": "Drug", "text": [ "antibiotic" ], "offsets": [ [ 56, 66 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T2", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 72, 83 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T3", "type": "Drug", "text": [ "clindamycin" ], "offsets": [ [ 92, 103 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T4", "type": "Drug", "text": [ "cephalexin" ], "offsets": [ [ 108, 118 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T5", "type": "Condition", "text": [ "persistent cutaneous malignancy" ], "offsets": [ [ 135, 166 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T6", "type": "Qualifier", "text": [ "site of the defect" ], "offsets": [ [ 174, 192 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T7", "type": "Temporal", "text": [ "following the reconstructive procedure" ], "offsets": [ [ 193, 231 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T8", "type": "Reference_point", "text": [ "the reconstructive procedure" ], "offsets": [ [ 203, 231 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T9", "type": "Procedure", "text": [ "reconstructive procedure" ], "offsets": [ [ 207, 231 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T10", "type": "Temporal", "text": [ "within one week of surgery" ], "offsets": [ [ 19, 45 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T11", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 11, 17 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T12", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T13", "type": "Scope", "text": [ "current or recent (within one week of surgery)" ], "offsets": [ [ 0, 46 ] ], "normalized": [] }, { "id": "NCT01912651_exc_T14", "type": "Scope", "text": [ "antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure" ], "offsets": [ [ 56, 231 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01912651_exc_R1", "type": "AND", "arg1_id": "NCT01912651_exc_T2", "arg2_id": "NCT01912651_exc_T3", "normalized": [] }, { "id": "NCT01912651_exc_R2", "type": "AND", "arg1_id": "NCT01912651_exc_T2", "arg2_id": "NCT01912651_exc_T4", "normalized": [] }, { "id": "NCT01912651_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01912651_exc_T5", "arg2_id": "NCT01912651_exc_T6", "normalized": [] }, { "id": "NCT01912651_exc_R4", "type": "AND", "arg1_id": "NCT01912651_exc_T8", "arg2_id": "NCT01912651_exc_T9", "normalized": [] }, { "id": "NCT01912651_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01912651_exc_T5", "arg2_id": "NCT01912651_exc_T7", "normalized": [] }, { "id": "NCT01912651_exc_R7", "type": "Subsumes", "arg1_id": "NCT01912651_exc_T11", "arg2_id": "NCT01912651_exc_T10", "normalized": [] }, { "id": "NCT01912651_exc_R8", "type": "Has_scope", "arg1_id": "NCT01912651_exc_T14", "arg2_id": "NCT01912651_exc_T13", "normalized": [] } ]

[ { "id": "NCT01912651_inc_text", "type": "inclusion", "text": [ "all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft\n" ], "offsets": [ [ 0, 143 ] ] } ]

[ { "id": "NCT01912651_inc_T1", "type": "Condition", "text": [ "facial skin/soft tissue defect" ], "offsets": [ [ 35, 65 ] ], "normalized": [] }, { "id": "NCT01912651_inc_T2", "type": "Condition", "text": [ "nasal", "skin/soft tissue defect" ], "offsets": [ [ 26, 31 ], [ 42, 65 ] ], "normalized": [] }, { "id": "NCT01912651_inc_T3", "type": "Procedure", "text": [ "reconstruction" ], "offsets": [ [ 76, 90 ] ], "normalized": [] }, { "id": "NCT01912651_inc_T4", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 66, 75 ] ], "normalized": [] }, { "id": "NCT01912651_inc_T5", "type": "Scope", "text": [ "nasal or facial skin/soft tissue defect" ], "offsets": [ [ 26, 65 ] ], "normalized": [] }, { "id": "NCT01912651_inc_T6", "type": "Device", "text": [ "full-thickness skin graft" ], "offsets": [ [ 117, 142 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01912651_inc_R1", "type": "Has_mood", "arg1_id": "NCT01912651_inc_T3", "arg2_id": "NCT01912651_inc_T4", "normalized": [] }, { "id": "NCT01912651_inc_R2", "type": "AND", "arg1_id": "NCT01912651_inc_T5", "arg2_id": "NCT01912651_inc_T3", "normalized": [] } ]

[ { "id": "NCT01912677_exc_text", "type": "exclusion", "text": [ "Indication for emergent cesarean or known fetal anomaly\nAnti-hypertensive therapy received in the past 12 hours\nHistory of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy\nActively wheezing at time of enrollment or history of asthma complications\nKnown coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta\n" ], "offsets": [ [ 0, 421 ] ] } ]

[ { "id": "NCT01912677_exc_T1", "type": "Condition", "text": [ "Indication" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T2", "type": "Procedure", "text": [ "emergent cesarean" ], "offsets": [ [ 15, 32 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T3", "type": "Condition", "text": [ "fetal anomaly" ], "offsets": [ [ 42, 55 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T4", "type": "Procedure", "text": [ "Anti-hypertensive therapy" ], "offsets": [ [ 56, 81 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T5", "type": "Temporal", "text": [ "past 12 hours" ], "offsets": [ [ 98, 111 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T6", "type": "Condition", "text": [ "eclampsia" ], "offsets": [ [ 123, 132 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T7", "type": "Condition", "text": [ "CNS complication" ], "offsets": [ [ 150, 166 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T8", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 174, 180 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T9", "type": "Condition", "text": [ "PRES" ], "offsets": [ [ 184, 188 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T10", "type": "Scope", "text": [ "stroke or PRES" ], "offsets": [ [ 174, 188 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T11", "type": "Temporal", "text": [ "in this pregnancy" ], "offsets": [ [ 190, 207 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T12", "type": "Scope", "text": [ "eclampsia or other adverse CNS complication (e.g., stroke or PRES" ], "offsets": [ [ 123, 188 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T13", "type": "Temporal", "text": [ "at time of enrollment" ], "offsets": [ [ 226, 247 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T14", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 237, 247 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T15", "type": "Condition", "text": [ "asthma complications" ], "offsets": [ [ 262, 282 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T16", "type": "Condition", "text": [ "wheezing" ], "offsets": [ [ 217, 225 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T17", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 289, 312 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T18", "type": "Condition", "text": [ "type I DM" ], "offsets": [ [ 316, 325 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T19", "type": "Condition", "text": [ "microvascular complications" ], "offsets": [ [ 331, 358 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T20", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 371, 384 ] ], "normalized": [] }, { "id": "NCT01912677_exc_T21", "type": "Condition", "text": [ "dissection of the aorta" ], "offsets": [ [ 397, 420 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01912677_exc_R1", "type": "AND", "arg1_id": "NCT01912677_exc_T1", "arg2_id": "NCT01912677_exc_T2", "normalized": [] }, { "id": "NCT01912677_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01912677_exc_T4", "arg2_id": "NCT01912677_exc_T5", "normalized": [] }, { "id": "NCT01912677_exc_R3", "type": "Has_scope", "arg1_id": "NCT01912677_exc_T7", "arg2_id": "NCT01912677_exc_T10", "normalized": [] }, { "id": "NCT01912677_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01912677_exc_T12", "arg2_id": "NCT01912677_exc_T11", "normalized": [] }, { "id": "NCT01912677_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01912677_exc_T16", "arg2_id": "NCT01912677_exc_T13", "normalized": [] }, { "id": "NCT01912677_exc_R6", "type": "AND", "arg1_id": "NCT01912677_exc_T18", "arg2_id": "NCT01912677_exc_T19", "normalized": [] } ]

[ { "id": "NCT01912677_inc_text", "type": "inclusion", "text": [ "Pregnant gestational age >= 28 weeks\nSystolic blood pressure >=160 mm Hg OR a diastolic blood pressure of >=110 mm Hg measured twice more than 15 minutes apart\nAble to swallow pills\n>= 18 years\n" ], "offsets": [ [ 0, 194 ] ] } ]

[ { "id": "NCT01912677_inc_T1", "type": "Measurement", "text": [ "gestational age" ], "offsets": [ [ 9, 24 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T2", "type": "Value", "text": [ ">= 28 weeks" ], "offsets": [ [ 25, 36 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T3", "type": "Measurement", "text": [ "Systolic blood pressure" ], "offsets": [ [ 37, 60 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T4", "type": "Value", "text": [ ">=160 mm Hg" ], "offsets": [ [ 61, 72 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T5", "type": "Measurement", "text": [ "diastolic blood pressure" ], "offsets": [ [ 78, 102 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T6", "type": "Value", "text": [ ">=110 mm Hg" ], "offsets": [ [ 106, 117 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T9", "type": "Person", "text": [ "years" ], "offsets": [ [ 188, 193 ] ], "normalized": [] }, { "id": "NCT01912677_inc_T10", "type": "Value", "text": [ ">= 18" ], "offsets": [ [ 182, 187 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01912677_inc_R1", "type": "Has_value", "arg1_id": "NCT01912677_inc_T1", "arg2_id": "NCT01912677_inc_T2", "normalized": [] }, { "id": "NCT01912677_inc_R2", "type": "Has_value", "arg1_id": "NCT01912677_inc_T3", "arg2_id": "NCT01912677_inc_T4", "normalized": [] }, { "id": "NCT01912677_inc_R3", "type": "Has_value", "arg1_id": "NCT01912677_inc_T5", "arg2_id": "NCT01912677_inc_T6", "normalized": [] }, { "id": "NCT01912677_inc_R4", "type": "Has_value", "arg1_id": "NCT01912677_inc_T9", "arg2_id": "NCT01912677_inc_T10", "normalized": [] } ]

[ { "id": "NCT01929434_exc_text", "type": "exclusion", "text": [ "Intracranial infection. \nSevere respiratory and circulatory system diseases. \nHematologic malignancies. \nPositive serological tests such as AIDS, hepatitis B virus, hepatitis C virus and syphilis （antigen or antibody）. \nTumors. \nGenetic and metabolic diseases. \n \n" ], "offsets": [ [ 0, 273 ] ] } ]

[ { "id": "NCT01929434_exc_T1", "type": "Condition", "text": [ "Intracranial infection" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T2", "type": "Condition", "text": [ "circulatory system disease" ], "offsets": [ [ 48, 74 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T3", "type": "Condition", "text": [ "respiratory", "system disease" ], "offsets": [ [ 32, 43 ], [ 60, 74 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T4", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 25, 31 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T5", "type": "Scope", "text": [ "respiratory and circulatory system diseases" ], "offsets": [ [ 32, 75 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T6", "type": "Condition", "text": [ "Hematologic malignancies" ], "offsets": [ [ 78, 102 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T7", "type": "Condition", "text": [ "AIDS" ], "offsets": [ [ 140, 144 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T8", "type": "Condition", "text": [ "hepatitis B virus" ], "offsets": [ [ 146, 163 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T9", "type": "Condition", "text": [ "hepatitis C virus" ], "offsets": [ [ 165, 182 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T10", "type": "Condition", "text": [ "syphilis" ], "offsets": [ [ 187, 195 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T11", "type": "Condition", "text": [ "Tumors" ], "offsets": [ [ 220, 226 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T13", "type": "Condition", "text": [ "metabolic diseases" ], "offsets": [ [ 241, 259 ] ], "normalized": [] }, { "id": "NCT01929434_exc_T14", "type": "Condition", "text": [ "Genetic", "diseases" ], "offsets": [ [ 229, 236 ], [ 251, 259 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01929434_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01929434_exc_T5", "arg2_id": "NCT01929434_exc_T4", "normalized": [] } ]

[ { "id": "NCT01929434_inc_text", "type": "inclusion", "text": [ "Patients with diagnosis of cerebral palsy. \nPatients' curator must be able to give voluntary consent. \n" ], "offsets": [ [ 0, 103 ] ] } ]

[ { "id": "NCT01929434_inc_T1", "type": "Condition", "text": [ "cerebral palsy" ], "offsets": [ [ 27, 41 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT01932996_exc_text", "type": "exclusion", "text": [ "Use of smoking cessation medications or interventions in last 30 days\nUnstable medical illness that requires immediate medical care\nAUDIT score of < 5 or > 26\nPregnancy or other Nicotine Replacement Therapy (NRT) contraindications\nCurrent history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months\nCognitive impairment\n" ], "offsets": [ [ 0, 390 ] ] } ]

[ { "id": "NCT01932996_exc_T1", "type": "Procedure", "text": [ "smoking cessation" ], "offsets": [ [ 7, 24 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T2", "type": "Procedure", "text": [ "medications" ], "offsets": [ [ 25, 36 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T3", "type": "Procedure", "text": [ "interventions" ], "offsets": [ [ 40, 53 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T4", "type": "Temporal", "text": [ "in last 30 days" ], "offsets": [ [ 54, 69 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T5", "type": "Scope", "text": [ "medications or interventions" ], "offsets": [ [ 25, 53 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T7", "type": "Measurement", "text": [ "AUDIT" ], "offsets": [ [ 132, 137 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T8", "type": "Value", "text": [ "score of < 5 or > 26" ], "offsets": [ [ 138, 158 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T9", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 159, 168 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T10", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 213, 230 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T11", "type": "Procedure", "text": [ "Nicotine Replacement Therapy" ], "offsets": [ [ 178, 206 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T12", "type": "Procedure", "text": [ "NRT" ], "offsets": [ [ 208, 211 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T13", "type": "Condition", "text": [ "psychotic disorder" ], "offsets": [ [ 270, 288 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T14", "type": "Condition", "text": [ "major depressive disorders" ], "offsets": [ [ 292, 318 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T15", "type": "Qualifier", "text": [ "not stable" ], "offsets": [ [ 327, 337 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T16", "type": "Temporal", "text": [ "for past 3 months" ], "offsets": [ [ 351, 368 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T17", "type": "Temporal", "text": [ "past 6 months" ], "offsets": [ [ 253, 266 ] ], "normalized": [] }, { "id": "NCT01932996_exc_T18", "type": "Condition", "text": [ "Cognitive impairment" ], "offsets": [ [ 369, 389 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01932996_exc_R1", "type": "AND", "arg1_id": "NCT01932996_exc_T5", "arg2_id": "NCT01932996_exc_T1", "normalized": [] }, { "id": "NCT01932996_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01932996_exc_T5", "arg2_id": "NCT01932996_exc_T4", "normalized": [] }, { "id": "NCT01932996_exc_R3", "type": "Has_value", "arg1_id": "NCT01932996_exc_T7", "arg2_id": "NCT01932996_exc_T8", "normalized": [] }, { "id": "NCT01932996_exc_R4", "type": "Subsumes", "arg1_id": "NCT01932996_exc_T11", "arg2_id": "NCT01932996_exc_T12", "normalized": [] }, { "id": "NCT01932996_exc_R5", "type": "AND", "arg1_id": "NCT01932996_exc_T10", "arg2_id": "NCT01932996_exc_T11", "normalized": [] }, { "id": "NCT01932996_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01932996_exc_T14", "arg2_id": "NCT01932996_exc_T15", "normalized": [] }, { "id": "NCT01932996_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01932996_exc_T14", "arg2_id": "NCT01932996_exc_T16", "normalized": [] }, { "id": "NCT01932996_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01932996_exc_T13", "arg2_id": "NCT01932996_exc_T17", "normalized": [] } ]

[ { "id": "NCT01932996_inc_text", "type": "inclusion", "text": [ "Currently Homeless\nSmoked at least 100 cigarettes in lifetime\nAUDIT score of > or equal to 5, < or equal to 26\nAged 18 years or older\nWilling to attend study sessions and follow other study protocol\n" ], "offsets": [ [ 0, 199 ] ] } ]

[ { "id": "NCT01932996_inc_T1", "type": "Person", "text": [ "Homeless" ], "offsets": [ [ 10, 18 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T2", "type": "Observation", "text": [ "Smoked" ], "offsets": [ [ 19, 25 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T3", "type": "Multiplier", "text": [ "at least 100 cigarettes" ], "offsets": [ [ 26, 49 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T4", "type": "Measurement", "text": [ "AUDIT" ], "offsets": [ [ 62, 67 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T5", "type": "Value", "text": [ "score of > or equal to 5, < or equal to 26" ], "offsets": [ [ 68, 110 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T6", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 111, 115 ] ], "normalized": [] }, { "id": "NCT01932996_inc_T7", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 116, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01932996_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT01932996_inc_T2", "arg2_id": "NCT01932996_inc_T3", "normalized": [] }, { "id": "NCT01932996_inc_R2", "type": "Has_value", "arg1_id": "NCT01932996_inc_T4", "arg2_id": "NCT01932996_inc_T5", "normalized": [] }, { "id": "NCT01932996_inc_R3", "type": "Has_value", "arg1_id": "NCT01932996_inc_T6", "arg2_id": "NCT01932996_inc_T7", "normalized": [] } ]

[ { "id": "NCT01942109_exc_text", "type": "exclusion", "text": [ "uncontrolled hypertension\nuncontrolled diabetes\ncreatinine > 2,5 mg/dl\npotassium > 6 mg/dl\nacute coronary syndrome\nhypertrophic cardiomyopathy\n" ], "offsets": [ [ 0, 143 ] ] } ]

[ { "id": "NCT01942109_exc_T1", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T2", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 13, 25 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T3", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 26, 38 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T4", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 39, 47 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T5", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 48, 58 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T6", "type": "Value", "text": [ "> 2,5 mg/dl" ], "offsets": [ [ 59, 70 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T7", "type": "Measurement", "text": [ "potassium" ], "offsets": [ [ 71, 80 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T8", "type": "Value", "text": [ "> 6 mg/dl" ], "offsets": [ [ 81, 90 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T9", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 91, 114 ] ], "normalized": [] }, { "id": "NCT01942109_exc_T10", "type": "Condition", "text": [ "hypertrophic cardiomyopathy" ], "offsets": [ [ 115, 142 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01942109_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01942109_exc_T2", "arg2_id": "NCT01942109_exc_T1", "normalized": [] }, { "id": "NCT01942109_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01942109_exc_T4", "arg2_id": "NCT01942109_exc_T3", "normalized": [] }, { "id": "NCT01942109_exc_R3", "type": "Has_value", "arg1_id": "NCT01942109_exc_T5", "arg2_id": "NCT01942109_exc_T6", "normalized": [] }, { "id": "NCT01942109_exc_R4", "type": "Has_value", "arg1_id": "NCT01942109_exc_T7", "arg2_id": "NCT01942109_exc_T8", "normalized": [] } ]

[ { "id": "NCT01942109_inc_text", "type": "inclusion", "text": [ "heart failure NYHA II-IV\nprevious treatment with diuretics\nage>18 years\n" ], "offsets": [ [ 0, 72 ] ] } ]

[ { "id": "NCT01942109_inc_T1", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T2", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 14, 18 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T3", "type": "Value", "text": [ "II-IV" ], "offsets": [ [ 19, 24 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T4", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 34, 43 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T5", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 25, 33 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T6", "type": "Drug", "text": [ "diuretics" ], "offsets": [ [ 49, 58 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T7", "type": "Person", "text": [ "age" ], "offsets": [ [ 59, 62 ] ], "normalized": [] }, { "id": "NCT01942109_inc_T8", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 62, 71 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01942109_inc_R1", "type": "Has_value", "arg1_id": "NCT01942109_inc_T2", "arg2_id": "NCT01942109_inc_T3", "normalized": [] }, { "id": "NCT01942109_inc_R2", "type": "AND", "arg1_id": "NCT01942109_inc_T1", "arg2_id": "NCT01942109_inc_T2", "normalized": [] }, { "id": "NCT01942109_inc_R3", "type": "AND", "arg1_id": "NCT01942109_inc_T4", "arg2_id": "NCT01942109_inc_T6", "normalized": [] }, { "id": "NCT01942109_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01942109_inc_T4", "arg2_id": "NCT01942109_inc_T5", "normalized": [] }, { "id": "NCT01942109_inc_R5", "type": "Has_value", "arg1_id": "NCT01942109_inc_T7", "arg2_id": "NCT01942109_inc_T8", "normalized": [] } ]

[ { "id": "NCT01942915_exc_text", "type": "exclusion", "text": [ "1. Patients with C class by child-pugh score \n2. Patients in the acute phase of severe hepatitis \n3. Patients have been diagnosed with cancer of the liver \n4. Patients with severe cardiopulmonary cerebral disease, and in the failure state \n5. Patients in Highly allergic constitution \n6. Patients with moderately severe mental disease \n \n" ], "offsets": [ [ 0, 347 ] ] } ]

[ { "id": "NCT01942915_exc_T1", "type": "Measurement", "text": [ "child-pugh score" ], "offsets": [ [ 28, 44 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T2", "type": "Value", "text": [ "C class" ], "offsets": [ [ 17, 24 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T3", "type": "Condition", "text": [ "severe hepatitis" ], "offsets": [ [ 80, 96 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T4", "type": "Qualifier", "text": [ "acute phase" ], "offsets": [ [ 65, 76 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T5", "type": "Condition", "text": [ "cancer of the liver" ], "offsets": [ [ 135, 154 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T6", "type": "Condition", "text": [ "cardiopulmonary cerebral disease" ], "offsets": [ [ 180, 212 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T7", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 173, 179 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T8", "type": "Condition", "text": [ "Highly allergic constitution" ], "offsets": [ [ 255, 283 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T9", "type": "Condition", "text": [ "mental disease" ], "offsets": [ [ 320, 334 ] ], "normalized": [] }, { "id": "NCT01942915_exc_T10", "type": "Qualifier", "text": [ "moderately severe" ], "offsets": [ [ 302, 319 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01942915_exc_R1", "type": "Has_value", "arg1_id": "NCT01942915_exc_T1", "arg2_id": "NCT01942915_exc_T2", "normalized": [] }, { "id": "NCT01942915_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01942915_exc_T3", "arg2_id": "NCT01942915_exc_T4", "normalized": [] }, { "id": "NCT01942915_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01942915_exc_T6", "arg2_id": "NCT01942915_exc_T7", "normalized": [] }, { "id": "NCT01942915_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01942915_exc_T9", "arg2_id": "NCT01942915_exc_T10", "normalized": [] } ]

[ { "id": "NCT01942915_inc_text", "type": "inclusion", "text": [ "Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment \n" ], "offsets": [ [ 0, 191 ] ] } ]

[ { "id": "NCT01942915_inc_T1", "type": "Condition", "text": [ "hepatocirrhosis" ], "offsets": [ [ 14, 29 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT01943409_exc_text", "type": "exclusion", "text": [ "• Patients without PN during their hospitalization\n" ], "offsets": [ [ 0, 51 ] ] } ]

[ { "id": "NCT01943409_exc_T1", "type": "Negation", "text": [ "without" ], "offsets": [ [ 11, 18 ] ], "normalized": [] }, { "id": "NCT01943409_exc_T2", "type": "Procedure", "text": [ "PN" ], "offsets": [ [ 19, 21 ] ], "normalized": [] }, { "id": "NCT01943409_exc_T3", "type": "Temporal", "text": [ "during their hospitalization" ], "offsets": [ [ 22, 50 ] ], "normalized": [] }, { "id": "NCT01943409_exc_T4", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 35, 50 ] ], "normalized": [] }, { "id": "NCT01943409_exc_T5", "type": "Reference_point", "text": [ "their hospitalization" ], "offsets": [ [ 29, 50 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01943409_exc_R1", "type": "Has_negation", "arg1_id": "NCT01943409_exc_T2", "arg2_id": "NCT01943409_exc_T1", "normalized": [] }, { "id": "NCT01943409_exc_R2", "type": "Has_index", "arg1_id": "NCT01943409_exc_T3", "arg2_id": "NCT01943409_exc_T5", "normalized": [] }, { "id": "NCT01943409_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01943409_exc_T2", "arg2_id": "NCT01943409_exc_T3", "normalized": [] } ]

[ { "id": "NCT01943409_inc_text", "type": "inclusion", "text": [ "Patients with PN during their hospitalization\nPatients hospitalized in medical, surgical or ICU wards\nSigned informed consent either from the patient, their legally authorized representative or a direct family member\n" ], "offsets": [ [ 0, 217 ] ] } ]

[ { "id": "NCT01943409_inc_T1", "type": "Procedure", "text": [ "PN" ], "offsets": [ [ 14, 16 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T2", "type": "Temporal", "text": [ "during their hospitalization" ], "offsets": [ [ 17, 45 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T3", "type": "Reference_point", "text": [ "their hospitalization" ], "offsets": [ [ 24, 45 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T4", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T5", "type": "Procedure", "text": [ "hospitalized" ], "offsets": [ [ 55, 67 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T6", "type": "Visit", "text": [ "ICU wards" ], "offsets": [ [ 92, 101 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T7", "type": "Visit", "text": [ "urgical", "ards" ], "offsets": [ [ 81, 88 ], [ 97, 101 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T8", "type": "Visit", "text": [ "edical,", "ards" ], "offsets": [ [ 72, 79 ], [ 97, 101 ] ], "normalized": [] }, { "id": "NCT01943409_inc_T9", "type": "Scope", "text": [ "medical, surgical or ICU wards" ], "offsets": [ [ 71, 101 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01943409_inc_R2", "type": "Has_index", "arg1_id": "NCT01943409_inc_T2", "arg2_id": "NCT01943409_inc_T3", "normalized": [] }, { "id": "NCT01943409_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01943409_inc_T1", "arg2_id": "NCT01943409_inc_T2", "normalized": [] }, { "id": "NCT01943409_inc_R4", "type": "Has_scope", "arg1_id": "NCT01943409_inc_T5", "arg2_id": "NCT01943409_inc_T9", "normalized": [] } ]

[ { "id": "NCT01943812_exc_text", "type": "exclusion", "text": [ "endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles\nUterine abnormality\nChronic medical disease\noocyte donation cycles\n" ], "offsets": [ [ 0, 155 ] ] } ]

[ { "id": "NCT01943812_exc_T1", "type": "Measurement", "text": [ "endometrial thickness" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T2", "type": "Value", "text": [ "< 7 mm" ], "offsets": [ [ 22, 28 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T3", "type": "Negation", "text": [ "no" ], "offsets": [ [ 32, 34 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T4", "type": "Observation", "text": [ "triple layer endometrium" ], "offsets": [ [ 35, 59 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T5", "type": "Observation", "text": [ "functional follicles" ], "offsets": [ [ 67, 87 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T6", "type": "Scope", "text": [ "triple layer endometrium and/or functional follicles" ], "offsets": [ [ 35, 87 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T7", "type": "Condition", "text": [ "Uterine abnormality" ], "offsets": [ [ 88, 107 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T8", "type": "Condition", "text": [ "Chronic medical disease" ], "offsets": [ [ 108, 131 ] ], "normalized": [] }, { "id": "NCT01943812_exc_T9", "type": "Procedure", "text": [ "oocyte donation cycles" ], "offsets": [ [ 132, 154 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01943812_exc_R1", "type": "Has_value", "arg1_id": "NCT01943812_exc_T1", "arg2_id": "NCT01943812_exc_T2", "normalized": [] }, { "id": "NCT01943812_exc_R2", "type": "Has_negation", "arg1_id": "NCT01943812_exc_T6", "arg2_id": "NCT01943812_exc_T3", "normalized": [] } ]

[ { "id": "NCT01943812_inc_text", "type": "inclusion", "text": [ "Endometrial thickness = 7 mm after stimulation\n18-45 years\nIVF/ICSI fertilisation\nBMI > 18,5 <30 kg/m2\ncycle length 25-34 days\n" ], "offsets": [ [ 0, 127 ] ] } ]

[ { "id": "NCT01943812_inc_T1", "type": "Measurement", "text": [ "Endometrial thickness" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T2", "type": "Value", "text": [ "= 7 mm" ], "offsets": [ [ 22, 28 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T3", "type": "Temporal", "text": [ "after stimulation" ], "offsets": [ [ 29, 46 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T4", "type": "Procedure", "text": [ "stimulation" ], "offsets": [ [ 35, 46 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T5", "type": "Reference_point", "text": [ "stimulation" ], "offsets": [ [ 35, 46 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T6", "type": "Value", "text": [ "18-45" ], "offsets": [ [ 47, 52 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T7", "type": "Person", "text": [ "years" ], "offsets": [ [ 53, 58 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T8", "type": "Procedure", "text": [ "F/I", "rtilisation\nB" ], "offsets": [ [ 61, 64 ], [ 70, 83 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T9", "type": "Procedure", "text": [ "ICSI fertilisation" ], "offsets": [ [ 63, 81 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T10", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 82, 85 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T11", "type": "Value", "text": [ "> 18,5 <30 kg/m2" ], "offsets": [ [ 86, 102 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T12", "type": "Measurement", "text": [ "cycle length" ], "offsets": [ [ 103, 115 ] ], "normalized": [] }, { "id": "NCT01943812_inc_T13", "type": "Value", "text": [ "25-34 days" ], "offsets": [ [ 116, 126 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01943812_inc_R1", "type": "Has_value", "arg1_id": "NCT01943812_inc_T1", "arg2_id": "NCT01943812_inc_T2", "normalized": [] }, { "id": "NCT01943812_inc_R3", "type": "AND", "arg1_id": "NCT01943812_inc_T3", "arg2_id": "NCT01943812_inc_T4", "normalized": [] }, { "id": "NCT01943812_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01943812_inc_T1", "arg2_id": "NCT01943812_inc_T3", "normalized": [] }, { "id": "NCT01943812_inc_R5", "type": "Has_value", "arg1_id": "NCT01943812_inc_T7", "arg2_id": "NCT01943812_inc_T6", "normalized": [] }, { "id": "NCT01943812_inc_R6", "type": "Has_value", "arg1_id": "NCT01943812_inc_T10", "arg2_id": "NCT01943812_inc_T11", "normalized": [] }, { "id": "NCT01943812_inc_R7", "type": "Has_value", "arg1_id": "NCT01943812_inc_T12", "arg2_id": "NCT01943812_inc_T13", "normalized": [] } ]

[ { "id": "NCT01944800_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01944800_inc_text", "type": "inclusion", "text": [ "intolerance of or allergy to ticagrelor or prasugrel\nhistory of any stroke, transient ischemic attack or intracranial bleeding\nknown intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm\nactive bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding\nfibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization\nknown platelet count < 100.000/µL at the time of screening\nknown anemia (hemoglobin <10 g/dL) at the time of screening\noral anticoagulation that cannot be safely discontinued for the duration of the study\nINR known to be greater than 1.5 at the time of screening\nchronic renal insufficiency requiring dialysis\nmoderate or severe hepatic dysfunction (Child Pugh B or C)\nincreased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)\nindex event is an acute complication (< 30 days) of PCI\nconcomitant medical illness that in the opinion of the investigator is associated with a life expectancy < 1 year\nconcomitant oral or i.v. therapy with strong CYP3A Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice > 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued\n=1 doses of ticagrelor or prasugrel within 5 days before randomisation\nno written informed consent\nparticipation in another investigational drug study\nprevious enrolment in this study\nfor women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study\nPregnancy, giving birth within the last 90 days, or lactation\ninability to cooperate with protocol requirements\n" ], "offsets": [ [ 0, 2035 ] ] } ]

[ { "id": "NCT01944800_inc_T1", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 29, 39 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T2", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T3", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 18, 25 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T4", "type": "Drug", "text": [ "prasugrel" ], "offsets": [ [ 43, 52 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T5", "type": "Scope", "text": [ "ticagrelor or prasugrel" ], "offsets": [ [ 29, 52 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T6", "type": "Scope", "text": [ "intolerance of or allergy" ], "offsets": [ [ 0, 25 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T7", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 68, 74 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T8", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 76, 101 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T9", "type": "Condition", "text": [ "intracranial bleeding" ], "offsets": [ [ 105, 126 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T10", "type": "Condition", "text": [ "intracranial neoplasm" ], "offsets": [ [ 133, 154 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T11", "type": "Condition", "text": [ "intracranial arteriovenous malformation" ], "offsets": [ [ 156, 195 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T12", "type": "Condition", "text": [ "intracranial aneurysm" ], "offsets": [ [ 199, 220 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T13", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 228, 236 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T14", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 221, 227 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T15", "type": "Condition", "text": [ "clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding" ], "offsets": [ [ 238, 348 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T16", "type": "Scope", "text": [ "bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding" ], "offsets": [ [ 228, 348 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T17", "type": "Procedure", "text": [ "fibrinolytic therapy" ], "offsets": [ [ 365, 385 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T18", "type": "Qualifier", "text": [ "fibrin-specific" ], "offsets": [ [ 349, 364 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T19", "type": "Temporal", "text": [ "less than 24 h before randomization" ], "offsets": [ [ 386, 421 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T20", "type": "Procedure", "text": [ "fibrinolytic therapy" ], "offsets": [ [ 443, 463 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T21", "type": "Qualifier", "text": [ "non-fibrin-specific" ], "offsets": [ [ 423, 442 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T22", "type": "Temporal", "text": [ "less than 48 h before randomization" ], "offsets": [ [ 464, 499 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T23", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 506, 520 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T24", "type": "Value", "text": [ "< 100.000/µL" ], "offsets": [ [ 521, 533 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T25", "type": "Temporal", "text": [ "at the time of screening" ], "offsets": [ [ 534, 558 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T26", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 408, 421 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T27", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 486, 499 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T28", "type": "Reference_point", "text": [ "the time of screening" ], "offsets": [ [ 537, 558 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T29", "type": "Condition", "text": [ "anemia" ], "offsets": [ [ 565, 571 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T30", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 573, 583 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T31", "type": "Value", "text": [ "<10 g/dL" ], "offsets": [ [ 584, 592 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T32", "type": "Temporal", "text": [ "at the time of screening" ], "offsets": [ [ 594, 618 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T33", "type": "Reference_point", "text": [ "the time of screening" ], "offsets": [ [ 597, 618 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T34", "type": "Procedure", "text": [ "oral anticoagulation" ], "offsets": [ [ 619, 639 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T35", "type": "Qualifier", "text": [ "cannot be safely discontinued" ], "offsets": [ [ 645, 674 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T36", "type": "Temporal", "text": [ "for the duration of the study" ], "offsets": [ [ 675, 704 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T37", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 695, 704 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T38", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 705, 708 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T39", "type": "Value", "text": [ "greater than 1.5" ], "offsets": [ [ 721, 737 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T40", "type": "Temporal", "text": [ "at the time of screening" ], "offsets": [ [ 738, 762 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T41", "type": "Reference_point", "text": [ "the time of screening" ], "offsets": [ [ 741, 762 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T42", "type": "Condition", "text": [ "chronic renal insufficiency" ], "offsets": [ [ 763, 790 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T43", "type": "Procedure", "text": [ "dialysis" ], "offsets": [ [ 801, 809 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T44", "type": "Condition", "text": [ "hepatic dysfunction" ], "offsets": [ [ 829, 848 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T45", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 822, 828 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T46", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 810, 818 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T47", "type": "Scope", "text": [ "moderate or severe" ], "offsets": [ [ 810, 828 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T48", "type": "Measurement", "text": [ "Child Pugh" ], "offsets": [ [ 850, 860 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T49", "type": "Value", "text": [ "B or C" ], "offsets": [ [ 861, 867 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T50", "type": "Condition", "text": [ "bradycardia events" ], "offsets": [ [ 887, 905 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T51", "type": "Mood", "text": [ "increased risk" ], "offsets": [ [ 869, 883 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T52", "type": "Condition", "text": [ "Sick Sinus" ], "offsets": [ [ 907, 917 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T53", "type": "Condition", "text": [ "AV block" ], "offsets": [ [ 919, 927 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T54", "type": "Measurement", "text": [ "grade" ], "offsets": [ [ 928, 933 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T55", "type": "Value", "text": [ "II or III" ], "offsets": [ [ 934, 943 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T56", "type": "Condition", "text": [ "bradycardia-induced syncope" ], "offsets": [ [ 945, 972 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T57", "type": "Scope", "text": [ "Sick Sinus, AV block grade II or III, bradycardia-induced syncope" ], "offsets": [ [ 907, 972 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T58", "type": "Condition", "text": [ " (< 30 days", "mitant" ], "offsets": [ [ 1010, 1021 ], [ 1035, 1041 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T59", "type": "Value", "text": [ "< 30 days" ], "offsets": [ [ 1012, 1021 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T60", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 992, 997 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T61", "type": "Condition", "text": [ "concomitant medical illness" ], "offsets": [ [ 1030, 1057 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T62", "type": "Qualifier", "text": [ "is associated with a life expectancy < 1 year" ], "offsets": [ [ 1098, 1143 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T63", "type": "Procedure", "text": [ "hera", "trong C" ], "offsets": [ [ 1170, 1174 ], [ 1183, 1190 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T64", "type": "Procedure", "text": [ "i.v. therapy" ], "offsets": [ [ 1164, 1176 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T65", "type": "Drug", "text": [ "strong CYP3A Inhibitors" ], "offsets": [ [ 1182, 1205 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T66", "type": "Drug", "text": [ "ketoconazole" ], "offsets": [ [ 1212, 1224 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T67", "type": "Drug", "text": [ "itraconazole" ], "offsets": [ [ 1226, 1238 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T68", "type": "Drug", "text": [ "voriconazole" ], "offsets": [ [ 1240, 1252 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T69", "type": "Drug", "text": [ "telithromycin" ], "offsets": [ [ 1254, 1267 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T70", "type": "Drug", "text": [ "clarithromycin" ], "offsets": [ [ 1269, 1283 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T71", "type": "Drug", "text": [ "nefazodone" ], "offsets": [ [ 1285, 1295 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T72", "type": "Drug", "text": [ "ritonavir" ], "offsets": [ [ 1297, 1306 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T73", "type": "Drug", "text": [ "saquinavir" ], "offsets": [ [ 1308, 1318 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T74", "type": "Drug", "text": [ "nelfinavir" ], "offsets": [ [ 1320, 1330 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T75", "type": "Drug", "text": [ "indinavir" ], "offsets": [ [ 1332, 1341 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T76", "type": "Drug", "text": [ "atazanavir" ], "offsets": [ [ 1343, 1353 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T77", "type": "Drug", "text": [ "grapefruit juice" ], "offsets": [ [ 1355, 1371 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T78", "type": "Multiplier", "text": [ "> 1 L/d" ], "offsets": [ [ 1372, 1379 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T79", "type": "Scope", "text": [ "ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice > 1 L/d" ], "offsets": [ [ 1212, 1379 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T80", "type": "Scope", "text": [ "oral or i.v. therapy" ], "offsets": [ [ 1156, 1176 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T81", "type": "Multiplier", "text": [ "=1 doses" ], "offsets": [ [ 1606, 1614 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T82", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 1618, 1628 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T83", "type": "Drug", "text": [ "prasugrel" ], "offsets": [ [ 1632, 1641 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T84", "type": "Temporal", "text": [ "within 5 days before randomisation" ], "offsets": [ [ 1642, 1676 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T85", "type": "Reference_point", "text": [ "randomisation" ], "offsets": [ [ 1663, 1676 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T86", "type": "Scope", "text": [ "ticagrelor or prasugrel" ], "offsets": [ [ 1618, 1641 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T93", "type": "Drug", "text": [ "CYP3A substrates with narrow therapeutic indices" ], "offsets": [ [ 1382, 1430 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T94", "type": "Drug", "text": [ "cyclosporine" ], "offsets": [ [ 1437, 1449 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T95", "type": "Drug", "text": [ "quinidine" ], "offsets": [ [ 1451, 1460 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T96", "type": "Drug", "text": [ "strong CYP3A inducers" ], "offsets": [ [ 1466, 1487 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T97", "type": "Drug", "text": [ "rifampin" ], "offsets": [ [ 1494, 1502 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T98", "type": "Drug", "text": [ "rifampicin" ], "offsets": [ [ 1503, 1513 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T99", "type": "Drug", "text": [ "phenytoin" ], "offsets": [ [ 1515, 1524 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T100", "type": "Drug", "text": [ "carbamazepine" ], "offsets": [ [ 1526, 1539 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T101", "type": "Drug", "text": [ "dexamethason" ], "offsets": [ [ 1541, 1553 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T102", "type": "Drug", "text": [ "phenobarbital" ], "offsets": [ [ 1555, 1568 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T103", "type": "Scope", "text": [ "rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital" ], "offsets": [ [ 1494, 1568 ] ], "normalized": [] }, { "id": "NCT01944800_inc_T104", "type": "Scope", "text": [ "cyclosporine, quinidine" ], "offsets": [ [ 1437, 1460 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01944800_inc_R1", "type": "Has_scope", "arg1_id": "NCT01944800_inc_T6", "arg2_id": "NCT01944800_inc_T5", "normalized": [] }, { "id": "NCT01944800_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T16", "arg2_id": "NCT01944800_inc_T14", "normalized": [] }, { "id": "NCT01944800_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01944800_inc_T17", "arg2_id": "NCT01944800_inc_T18", "normalized": [] }, { "id": "NCT01944800_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01944800_inc_T20", "arg2_id": "NCT01944800_inc_T21", "normalized": [] }, { "id": "NCT01944800_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T20", "arg2_id": "NCT01944800_inc_T22", "normalized": [] }, { "id": "NCT01944800_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T17", "arg2_id": "NCT01944800_inc_T19", "normalized": [] }, { "id": "NCT01944800_inc_R7", "type": "Has_index", "arg1_id": "NCT01944800_inc_T19", "arg2_id": "NCT01944800_inc_T26", "normalized": [] }, { "id": "NCT01944800_inc_R8", "type": "Has_index", "arg1_id": "NCT01944800_inc_T22", "arg2_id": "NCT01944800_inc_T27", "normalized": [] }, { "id": "NCT01944800_inc_R9", "type": "Has_index", "arg1_id": "NCT01944800_inc_T25", "arg2_id": "NCT01944800_inc_T28", "normalized": [] }, { "id": "NCT01944800_inc_R10", "type": "Has_value", "arg1_id": "NCT01944800_inc_T23", "arg2_id": "NCT01944800_inc_T24", "normalized": [] }, { "id": "NCT01944800_inc_R11", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T23", "arg2_id": "NCT01944800_inc_T25", "normalized": [] }, { "id": "NCT01944800_inc_R12", "type": "Has_value", "arg1_id": "NCT01944800_inc_T30", "arg2_id": "NCT01944800_inc_T31", "normalized": [] }, { "id": "NCT01944800_inc_R13", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T29", "arg2_id": "NCT01944800_inc_T30", "normalized": [] }, { "id": "NCT01944800_inc_R14", "type": "Has_index", "arg1_id": "NCT01944800_inc_T32", "arg2_id": "NCT01944800_inc_T33", "normalized": [] }, { "id": "NCT01944800_inc_R15", "type": "Has_index", "arg1_id": "NCT01944800_inc_T36", "arg2_id": "NCT01944800_inc_T37", "normalized": [] }, { "id": "NCT01944800_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT01944800_inc_T34", "arg2_id": "NCT01944800_inc_T35", "normalized": [] }, { "id": "NCT01944800_inc_R17", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T29", "arg2_id": "NCT01944800_inc_T32", "normalized": [] }, { "id": "NCT01944800_inc_R18", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T34", "arg2_id": "NCT01944800_inc_T36", "normalized": [] }, { "id": "NCT01944800_inc_R19", "type": "Has_index", "arg1_id": "NCT01944800_inc_T40", "arg2_id": "NCT01944800_inc_T41", "normalized": [] }, { "id": "NCT01944800_inc_R20", "type": "Has_value", "arg1_id": "NCT01944800_inc_T38", "arg2_id": "NCT01944800_inc_T39", "normalized": [] }, { "id": "NCT01944800_inc_R21", "type": "Has_temporal", "arg1_id": "NCT01944800_inc_T38", "arg2_id": "NCT01944800_inc_T40", "normalized": [] }, { "id": "NCT01944800_inc_R22", "type": "AND", "arg1_id": "NCT01944800_inc_T42", "arg2_id": "NCT01944800_inc_T43", "normalized": [] }, { "id": "NCT01944800_inc_R23", "type": "Has_scope", "arg1_id": "NCT01944800_inc_T44", "arg2_id": "NCT01944800_inc_T47", "normalized": [] }, { "id": "NCT01944800_inc_R24", "type": "Has_value", "arg1_id": "NCT01944800_inc_T48", "arg2_id": "NCT01944800_inc_T49", "normalized": [] }, { "id": "NCT01944800_inc_R25", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T47", "arg2_id": "NCT01944800_inc_T48", "normalized": [] }, { "id": "NCT01944800_inc_R26", "type": "Has_value", "arg1_id": "NCT01944800_inc_T54", "arg2_id": "NCT01944800_inc_T55", "normalized": [] }, { "id": "NCT01944800_inc_R27", "type": "AND", "arg1_id": "NCT01944800_inc_T53", "arg2_id": "NCT01944800_inc_T54", "normalized": [] }, { "id": "NCT01944800_inc_R28", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T50", "arg2_id": "NCT01944800_inc_T57", "normalized": [] }, { "id": "NCT01944800_inc_R29", "type": "Has_mood", "arg1_id": "NCT01944800_inc_T50", "arg2_id": "NCT01944800_inc_T51", "normalized": [] }, { "id": "NCT01944800_inc_R30", "type": "Has_qualifier", "arg1_id": "NCT01944800_inc_T58", "arg2_id": "NCT01944800_inc_T60", "normalized": [] }, { "id": "NCT01944800_inc_R31", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T60", "arg2_id": "NCT01944800_inc_T59", "normalized": [] }, { "id": "NCT01944800_inc_R32", "type": "Has_qualifier", "arg1_id": "NCT01944800_inc_T61", "arg2_id": "NCT01944800_inc_T62", "normalized": [] }, { "id": "NCT01944800_inc_R33", "type": "Has_multiplier", "arg1_id": "NCT01944800_inc_T77", "arg2_id": "NCT01944800_inc_T78", "normalized": [] }, { "id": "NCT01944800_inc_R34", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T65", "arg2_id": "NCT01944800_inc_T79", "normalized": [] }, { "id": "NCT01944800_inc_R35", "type": "AND", "arg1_id": "NCT01944800_inc_T80", "arg2_id": "NCT01944800_inc_T65", "normalized": [] }, { "id": "NCT01944800_inc_R36", "type": "Has_index", "arg1_id": "NCT01944800_inc_T84", "arg2_id": "NCT01944800_inc_T85", "normalized": [] }, { "id": "NCT01944800_inc_R37", "type": "Has_multiplier", "arg1_id": "NCT01944800_inc_T86", "arg2_id": "NCT01944800_inc_T81", "normalized": [] }, { "id": "NCT01944800_inc_R38", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T96", "arg2_id": "NCT01944800_inc_T103", "normalized": [] }, { "id": "NCT01944800_inc_R39", "type": "Subsumes", "arg1_id": "NCT01944800_inc_T93", "arg2_id": "NCT01944800_inc_T104", "normalized": [] } ]

[ { "id": "NCT01959061_exc_text", "type": "exclusion", "text": [ "Pregnant or lactating women\nPatients with severe organ dysfunction or failure\nWith severe cardiovascular disease, or mental\nExtraliver metastases\n" ], "offsets": [ [ 0, 146 ] ] } ]

[ { "id": "NCT01959061_exc_T1", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T2", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 12, 21 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T3", "type": "Person", "text": [ "women" ], "offsets": [ [ 22, 27 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T4", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 42, 48 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T5", "type": "Condition", "text": [ "organ dysfunction" ], "offsets": [ [ 49, 66 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T6", "type": "Condition", "text": [ "rgan", "ailure" ], "offsets": [ [ 50, 54 ], [ 71, 77 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T7", "type": "Scope", "text": [ "organ dysfunction or failure" ], "offsets": [ [ 49, 77 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T8", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 90, 112 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T9", "type": "Condition", "text": [ "sease,", "ntal\nE" ], "offsets": [ [ 107, 113 ], [ 119, 125 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T10", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 83, 89 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T11", "type": "Scope", "text": [ "cardiovascular disease, or mental" ], "offsets": [ [ 90, 123 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T12", "type": "Condition", "text": [ "Extraliver metastases" ], "offsets": [ [ 124, 145 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T13", "type": "Qualifier", "text": [ "Extraliver" ], "offsets": [ [ 124, 134 ] ], "normalized": [] }, { "id": "NCT01959061_exc_T14", "type": "Condition", "text": [ "metastases" ], "offsets": [ [ 135, 145 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01959061_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01959061_exc_T7", "arg2_id": "NCT01959061_exc_T4", "normalized": [] }, { "id": "NCT01959061_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01959061_exc_T11", "arg2_id": "NCT01959061_exc_T10", "normalized": [] }, { "id": "NCT01959061_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01959061_exc_T14", "arg2_id": "NCT01959061_exc_T13", "normalized": [] } ]

[ { "id": "NCT01959061_inc_text", "type": "inclusion", "text": [ "Histologically confirmed colorectal adenocarcinoma\nDisease limited to the liver Unresectable disease by surgery or other local therapies\nAge >18 years\nECOG performance status 0-2,Child pugh A or B\nExpected survival = 3 months\nAdequate hematological, hepatic, and renal function\n" ], "offsets": [ [ 0, 278 ] ] } ]

[ { "id": "NCT01959061_inc_T1", "type": "Qualifier", "text": [ "Histologically confirmed" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T2", "type": "Procedure", "text": [ "Histologically" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T3", "type": "Condition", "text": [ "colorectal adenocarcinoma" ], "offsets": [ [ 25, 50 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T4", "type": "Observation", "text": [ "Disease limited to the liver" ], "offsets": [ [ 51, 79 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T5", "type": "Condition", "text": [ "Unresectable disease" ], "offsets": [ [ 80, 100 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T6", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 104, 111 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T7", "type": "Procedure", "text": [ "local therapies" ], "offsets": [ [ 121, 136 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T8", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T9", "type": "Scope", "text": [ "surgery or other local therapies" ], "offsets": [ [ 104, 136 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T10", "type": "Person", "text": [ "Age" ], "offsets": [ [ 137, 140 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T11", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 141, 150 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T12", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 151, 174 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T13", "type": "Value", "text": [ "0-2" ], "offsets": [ [ 175, 178 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T14", "type": "Measurement", "text": [ "Child pugh" ], "offsets": [ [ 179, 189 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T15", "type": "Value", "text": [ "A" ], "offsets": [ [ 190, 191 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T16", "type": "Value", "text": [ "B" ], "offsets": [ [ 195, 196 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T17", "type": "Scope", "text": [ "A or B" ], "offsets": [ [ 190, 196 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T18", "type": "Observation", "text": [ "Expected survival" ], "offsets": [ [ 197, 214 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T19", "type": "Value", "text": [ "= 3 months" ], "offsets": [ [ 215, 225 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T20", "type": "Qualifier", "text": [ "Adequate" ], "offsets": [ [ 226, 234 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T21", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 263, 277 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T22", "type": "Measurement", "text": [ "ic, and", "ion" ], "offsets": [ [ 255, 262 ], [ 274, 277 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T23", "type": "Measurement", "text": [ "ological, hep", "ion" ], "offsets": [ [ 240, 253 ], [ 274, 277 ] ], "normalized": [] }, { "id": "NCT01959061_inc_T24", "type": "Scope", "text": [ "hematological, hepatic, and renal function" ], "offsets": [ [ 235, 277 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01959061_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01959061_inc_T3", "arg2_id": "NCT01959061_inc_T1", "normalized": [] }, { "id": "NCT01959061_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01959061_inc_T7", "arg2_id": "NCT01959061_inc_T8", "normalized": [] }, { "id": "NCT01959061_inc_R4", "type": "Has_scope", "arg1_id": "NCT01959061_inc_T5", "arg2_id": "NCT01959061_inc_T9", "normalized": [] }, { "id": "NCT01959061_inc_R5", "type": "Has_value", "arg1_id": "NCT01959061_inc_T10", "arg2_id": "NCT01959061_inc_T11", "normalized": [] }, { "id": "NCT01959061_inc_R6", "type": "Has_scope", "arg1_id": "NCT01959061_inc_T14", "arg2_id": "NCT01959061_inc_T17", "normalized": [] }, { "id": "NCT01959061_inc_R7", "type": "Has_value", "arg1_id": "NCT01959061_inc_T12", "arg2_id": "NCT01959061_inc_T13", "normalized": [] }, { "id": "NCT01959061_inc_R8", "type": "Has_value", "arg1_id": "NCT01959061_inc_T18", "arg2_id": "NCT01959061_inc_T19", "normalized": [] }, { "id": "NCT01959061_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT01959061_inc_T24", "arg2_id": "NCT01959061_inc_T20", "normalized": [] } ]

[ { "id": "NCT01959425_exc_text", "type": "exclusion", "text": [ "OAT required for reasons not related to AF (i.e., prosthetic valve, PV stenosis, previous pulmonary embolism, presence of spontaneous echo contrast [SEC] at standard echo performed at 3-months follow-up).\nAny cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure at any time (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)\nPrevious myocardial infarction (MI) or a percutaneous coronary intervention PCI within the past 3 months\nAwaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)\nDocumented left atrial thrombus\nSignificant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or COPD) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\nSignificant medical problem that in the opinion of the investigator would preclude enrollment in this study\nWomen who are pregnant (as evidenced by pregnancy test if pre-menopausal)\nAcute illness or active systemic infection or sepsis\nUnstable angina\nContraindication to anticoagulation (i.e., heparin, warfarin or another commercially available anticoagulation medication)\nHistory of blood clotting or bleeding abnormalities\nLife expectancy less than 360 days (12 months)\nUncontrolled Heart Failure or NYHA Class III or IV heart failure\nEnrollment in a clinical study evaluating another device or drug, within the past 6 months\nUnable or unwilling to comply with protocol requirements\n" ], "offsets": [ [ 0, 1524 ] ] } ]

[ { "id": "NCT01959425_exc_T1", "type": "Drug", "text": [ "OAT" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T2", "type": "Negation", "text": [ "not" ], "offsets": [ [ 25, 28 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T3", "type": "Qualifier", "text": [ "AF" ], "offsets": [ [ 40, 42 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T4", "type": "Device", "text": [ "prosthetic valve" ], "offsets": [ [ 50, 66 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T5", "type": "Condition", "text": [ "PV stenosis" ], "offsets": [ [ 68, 79 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T6", "type": "Condition", "text": [ "pulmonary embolism" ], "offsets": [ [ 90, 108 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T7", "type": "Measurement", "text": [ "standard echo" ], "offsets": [ [ 157, 170 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T8", "type": "Temporal", "text": [ "3-months follow-up" ], "offsets": [ [ 184, 202 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T9", "type": "Reference_point", "text": [ "follow-up" ], "offsets": [ [ 193, 202 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T10", "type": "Value", "text": [ "spontaneous echo contrast" ], "offsets": [ [ 122, 147 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T11", "type": "Value", "text": [ "SEC" ], "offsets": [ [ 149, 152 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T12", "type": "Scope", "text": [ "prosthetic valve, PV stenosis, previous pulmonary embolism, presence of spontaneous echo contrast [SEC] at standard echo performed at 3-months follow-up" ], "offsets": [ [ 50, 202 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T13", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 209, 224 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T14", "type": "Temporal", "text": [ "within the past 60 days" ], "offsets": [ [ 225, 248 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T15", "type": "Temporal", "text": [ "2 months" ], "offsets": [ [ 250, 258 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T16", "type": "Procedure", "text": [ "valvular cardiac surgical" ], "offsets": [ [ 263, 288 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T17", "type": "Procedure", "text": [ "ventriculotomy" ], "offsets": [ [ 318, 332 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T18", "type": "Procedure", "text": [ "atriotomy" ], "offsets": [ [ 334, 343 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T19", "type": "Procedure", "text": [ "valve repair" ], "offsets": [ [ 349, 361 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T20", "type": "Procedure", "text": [ "alve", "eplacement" ], "offsets": [ [ 350, 354 ], [ 366, 376 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T21", "type": "Device", "text": [ "prosthetic valve)" ], "offsets": [ [ 395, 412 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T22", "type": "Scope", "text": [ "ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve" ], "offsets": [ [ 318, 411 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T23", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 422, 443 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T24", "type": "Condition", "text": [ "MI" ], "offsets": [ [ 445, 447 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T25", "type": "Procedure", "text": [ "percutaneous coronary intervention" ], "offsets": [ [ 454, 488 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T26", "type": "Procedure", "text": [ "PCI" ], "offsets": [ [ 489, 492 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T27", "type": "Temporal", "text": [ "within the past 3 months" ], "offsets": [ [ 493, 517 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T28", "type": "Scope", "text": [ "myocardial infarction (MI) or a percutaneous coronary intervention PCI" ], "offsets": [ [ 422, 492 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T29", "type": "Procedure", "text": [ "cardiac transplantation" ], "offsets": [ [ 527, 550 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T30", "type": "Mood", "text": [ "Awaiting" ], "offsets": [ [ 518, 526 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T31", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 560, 575 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T32", "type": "Temporal", "text": [ "within the next 365 days" ], "offsets": [ [ 576, 600 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T33", "type": "Temporal", "text": [ "hin th", "months)\nD" ], "offsets": [ [ 579, 585 ], [ 605, 614 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T34", "type": "Scope", "text": [ "cardiac transplantation or other cardiac surgery" ], "offsets": [ [ 527, 575 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T35", "type": "Condition", "text": [ "left atrial thrombus" ], "offsets": [ [ 624, 644 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T36", "type": "Condition", "text": [ "pulmonary disease" ], "offsets": [ [ 657, 674 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T37", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 645, 656 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T38", "type": "Condition", "text": [ "restrictive pulmonary disease" ], "offsets": [ [ 683, 712 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T39", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 730, 734 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T41", "type": "Scope", "text": [ "restrictive pulmonary disease, constrictive or COPD)" ], "offsets": [ [ 683, 735 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T44", "type": "Condition", "text": [ "systemic infection" ], "offsets": [ [ 1044, 1062 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T45", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 1066, 1072 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T47", "type": "Condition", "text": [ "Unstable angina" ], "offsets": [ [ 1073, 1088 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T48", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 1089, 1105 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T49", "type": "Drug", "text": [ "anticoagulation" ], "offsets": [ [ 1109, 1124 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T50", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 1132, 1139 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T51", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 1141, 1149 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T53", "type": "Scope", "text": [ "heparin, warfarin" ], "offsets": [ [ 1132, 1149 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T54", "type": "Condition", "text": [ "bleeding abnormalities" ], "offsets": [ [ 1241, 1263 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T55", "type": "Condition", "text": [ "ing or bleedin", "es\nLife expec" ], "offsets": [ [ 1234, 1248 ], [ 1261, 1274 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T56", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 1264, 1279 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T57", "type": "Value", "text": [ "less than 360 days" ], "offsets": [ [ 1280, 1298 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T58", "type": "Value", "text": [ "0 days (1", "ncontroll" ], "offsets": [ [ 1292, 1301 ], [ 1312, 1321 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T59", "type": "Condition", "text": [ "Heart Failure" ], "offsets": [ [ 1324, 1337 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T60", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1311, 1323 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T61", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 1362, 1375 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T62", "type": "Qualifier", "text": [ "NYHA Class III" ], "offsets": [ [ 1341, 1355 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T63", "type": "Qualifier", "text": [ "I or IV he", "ur" ], "offsets": [ [ 1354, 1364 ], [ 1372, 1374 ] ], "normalized": [] }, { "id": "NCT01959425_exc_T64", "type": "Scope", "text": [ "NYHA Class III or IV" ], "offsets": [ [ 1341, 1361 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01959425_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01959425_exc_T1", "arg2_id": "NCT01959425_exc_T3", "normalized": [] }, { "id": "NCT01959425_exc_R2", "type": "Has_negation", "arg1_id": "NCT01959425_exc_T3", "arg2_id": "NCT01959425_exc_T2", "normalized": [] }, { "id": "NCT01959425_exc_R3", "type": "Has_index", "arg1_id": "NCT01959425_exc_T8", "arg2_id": "NCT01959425_exc_T9", "normalized": [] }, { "id": "NCT01959425_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01959425_exc_T7", "arg2_id": "NCT01959425_exc_T8", "normalized": [] }, { "id": "NCT01959425_exc_R5", "type": "Has_value", "arg1_id": "NCT01959425_exc_T7", "arg2_id": "NCT01959425_exc_T10", "normalized": [] }, { "id": "NCT01959425_exc_R6", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T10", "arg2_id": "NCT01959425_exc_T11", "normalized": [] }, { "id": "NCT01959425_exc_R7", "type": "Has_scope", "arg1_id": "NCT01959425_exc_T1", "arg2_id": "NCT01959425_exc_T12", "normalized": [] }, { "id": "NCT01959425_exc_R8", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T16", "arg2_id": "NCT01959425_exc_T22", "normalized": [] }, { "id": "NCT01959425_exc_R9", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T14", "arg2_id": "NCT01959425_exc_T15", "normalized": [] }, { "id": "NCT01959425_exc_R10", "type": "Has_temporal", "arg1_id": "NCT01959425_exc_T13", "arg2_id": "NCT01959425_exc_T14", "normalized": [] }, { "id": "NCT01959425_exc_R11", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T23", "arg2_id": "NCT01959425_exc_T24", "normalized": [] }, { "id": "NCT01959425_exc_R12", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T25", "arg2_id": "NCT01959425_exc_T26", "normalized": [] }, { "id": "NCT01959425_exc_R13", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T28", "arg2_id": "NCT01959425_exc_T27", "normalized": [] }, { "id": "NCT01959425_exc_R14", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T32", "arg2_id": "NCT01959425_exc_T33", "normalized": [] }, { "id": "NCT01959425_exc_R15", "type": "Has_mood", "arg1_id": "NCT01959425_exc_T34", "arg2_id": "NCT01959425_exc_T30", "normalized": [] }, { "id": "NCT01959425_exc_R16", "type": "Has_temporal", "arg1_id": "NCT01959425_exc_T34", "arg2_id": "NCT01959425_exc_T32", "normalized": [] }, { "id": "NCT01959425_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01959425_exc_T36", "arg2_id": "NCT01959425_exc_T37", "normalized": [] }, { "id": "NCT01959425_exc_R18", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T36", "arg2_id": "NCT01959425_exc_T41", "normalized": [] }, { "id": "NCT01959425_exc_R19", "type": "AND", "arg1_id": "NCT01959425_exc_T48", "arg2_id": "NCT01959425_exc_T49", "normalized": [] }, { "id": "NCT01959425_exc_R20", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T49", "arg2_id": "NCT01959425_exc_T53", "normalized": [] }, { "id": "NCT01959425_exc_R21", "type": "Subsumes", "arg1_id": "NCT01959425_exc_T57", "arg2_id": "NCT01959425_exc_T58", "normalized": [] }, { "id": "NCT01959425_exc_R22", "type": "Has_value", "arg1_id": "NCT01959425_exc_T56", "arg2_id": "NCT01959425_exc_T57", "normalized": [] }, { "id": "NCT01959425_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT01959425_exc_T59", "arg2_id": "NCT01959425_exc_T60", "normalized": [] }, { "id": "NCT01959425_exc_R24", "type": "Has_scope", "arg1_id": "NCT01959425_exc_T61", "arg2_id": "NCT01959425_exc_T64", "normalized": [] } ]

[ { "id": "NCT01959425_inc_text", "type": "inclusion", "text": [ "Successful cardiac ablation for AF\nDocumented freedom from AF recurrence (symptomatic or asymptomatic arrhythmic recurrences lasting longer than 30 seconds) 3 months after successful cardiac ablation (AF recurrence during 3-month blanking period is excluded).\nPatient must have been on a commercially approved anticoagulation therapy for at least two (2) months prior to randomization in the OAT Study.\nCHADS2 score = 2 or CHA2DS2-VASc score (=3)\nLeft ventricular ejection fraction > 25%\nLA size < 65\nHigh risk for thromboembolic events (i.e., CHADS2 score = 2 or CHA2DS2-VASc score = 3) and require OAT before undergoing cardiac ablation\nAble and willing to comply with all pre- and follow-up testing and requirements\nSigned informed consent form\nAge 18 years or older\n" ], "offsets": [ [ 0, 770 ] ] } ]

[ { "id": "NCT01959425_inc_T1", "type": "Procedure", "text": [ "cardiac ablation" ], "offsets": [ [ 11, 27 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T2", "type": "Condition", "text": [ "AF" ], "offsets": [ [ 32, 34 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T3", "type": "Qualifier", "text": [ "Successful" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T4", "type": "Negation", "text": [ "freedom" ], "offsets": [ [ 46, 53 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T5", "type": "Condition", "text": [ "AF recurrence" ], "offsets": [ [ 59, 72 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T6", "type": "Condition", "text": [ "arrhythmic recurrences" ], "offsets": [ [ 102, 124 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T7", "type": "Value", "text": [ "longer than 30 seconds" ], "offsets": [ [ 133, 155 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T8", "type": "Temporal", "text": [ "3 months after successful cardiac ablation" ], "offsets": [ [ 157, 199 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T9", "type": "Reference_point", "text": [ "cardiac ablation" ], "offsets": [ [ 183, 199 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T11", "type": "Drug", "text": [ "anticoagulation therapy" ], "offsets": [ [ 310, 333 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T12", "type": "Temporal", "text": [ "at least two (2) months prior to randomization" ], "offsets": [ [ 338, 384 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T13", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 371, 384 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T14", "type": "Measurement", "text": [ "CHADS2 score" ], "offsets": [ [ 403, 415 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T15", "type": "Value", "text": [ "= 2" ], "offsets": [ [ 416, 419 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T16", "type": "Measurement", "text": [ "CHA2DS2-VASc score" ], "offsets": [ [ 423, 441 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T17", "type": "Value", "text": [ "=3" ], "offsets": [ [ 443, 445 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T18", "type": "Measurement", "text": [ "Left ventricular ejection fraction" ], "offsets": [ [ 447, 481 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T19", "type": "Value", "text": [ "> 25%" ], "offsets": [ [ 482, 487 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T20", "type": "Measurement", "text": [ "LA size" ], "offsets": [ [ 488, 495 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T21", "type": "Value", "text": [ "< 65" ], "offsets": [ [ 496, 500 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T22", "type": "Observation", "text": [ "risk for thromboembolic events" ], "offsets": [ [ 506, 536 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T23", "type": "Value", "text": [ "High" ], "offsets": [ [ 501, 505 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T24", "type": "Measurement", "text": [ "CHADS2 score" ], "offsets": [ [ 544, 556 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T25", "type": "Value", "text": [ "= 2" ], "offsets": [ [ 557, 560 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T26", "type": "Measurement", "text": [ "CHA2DS2-VASc score" ], "offsets": [ [ 564, 582 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T27", "type": "Value", "text": [ "= 3" ], "offsets": [ [ 583, 586 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T28", "type": "Drug", "text": [ "OAT" ], "offsets": [ [ 600, 603 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T29", "type": "Temporal", "text": [ "before undergoing cardiac ablation" ], "offsets": [ [ 604, 638 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T30", "type": "Reference_point", "text": [ "cardiac ablation" ], "offsets": [ [ 622, 638 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T31", "type": "Scope", "text": [ "CHADS2 score = 2 or CHA2DS2-VASc score = 3" ], "offsets": [ [ 544, 586 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T34", "type": "Person", "text": [ "Age" ], "offsets": [ [ 748, 751 ] ], "normalized": [] }, { "id": "NCT01959425_inc_T35", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 752, 769 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01959425_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01959425_inc_T1", "arg2_id": "NCT01959425_inc_T3", "normalized": [] }, { "id": "NCT01959425_inc_R2", "type": "AND", "arg1_id": "NCT01959425_inc_T1", "arg2_id": "NCT01959425_inc_T2", "normalized": [] }, { "id": "NCT01959425_inc_R3", "type": "Has_negation", "arg1_id": "NCT01959425_inc_T5", "arg2_id": "NCT01959425_inc_T4", "normalized": [] }, { "id": "NCT01959425_inc_R4", "type": "Has_value", "arg1_id": "NCT01959425_inc_T6", "arg2_id": "NCT01959425_inc_T7", "normalized": [] }, { "id": "NCT01959425_inc_R5", "type": "AND", "arg1_id": "NCT01959425_inc_T5", "arg2_id": "NCT01959425_inc_T6", "normalized": [] }, { "id": "NCT01959425_inc_R6", "type": "Has_index", "arg1_id": "NCT01959425_inc_T8", "arg2_id": "NCT01959425_inc_T9", "normalized": [] }, { "id": "NCT01959425_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01959425_inc_T5", "arg2_id": "NCT01959425_inc_T8", "normalized": [] }, { "id": "NCT01959425_inc_R8", "type": "Has_index", "arg1_id": "NCT01959425_inc_T12", "arg2_id": "NCT01959425_inc_T13", "normalized": [] }, { "id": "NCT01959425_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01959425_inc_T11", "arg2_id": "NCT01959425_inc_T12", "normalized": [] }, { "id": "NCT01959425_inc_R10", "type": "Has_value", "arg1_id": "NCT01959425_inc_T14", "arg2_id": "NCT01959425_inc_T15", "normalized": [] }, { "id": "NCT01959425_inc_R11", "type": "Has_value", "arg1_id": "NCT01959425_inc_T16", "arg2_id": "NCT01959425_inc_T17", "normalized": [] }, { "id": "NCT01959425_inc_R12", "type": "Has_value", "arg1_id": "NCT01959425_inc_T18", "arg2_id": "NCT01959425_inc_T19", "normalized": [] }, { "id": "NCT01959425_inc_R13", "type": "Has_value", "arg1_id": "NCT01959425_inc_T20", "arg2_id": "NCT01959425_inc_T21", "normalized": [] }, { "id": "NCT01959425_inc_R14", "type": "Has_value", "arg1_id": "NCT01959425_inc_T22", "arg2_id": "NCT01959425_inc_T23", "normalized": [] }, { "id": "NCT01959425_inc_R15", "type": "Has_index", "arg1_id": "NCT01959425_inc_T29", "arg2_id": "NCT01959425_inc_T30", "normalized": [] }, { "id": "NCT01959425_inc_R16", "type": "Has_temporal", "arg1_id": "NCT01959425_inc_T28", "arg2_id": "NCT01959425_inc_T29", "normalized": [] }, { "id": "NCT01959425_inc_R17", "type": "Has_value", "arg1_id": "NCT01959425_inc_T24", "arg2_id": "NCT01959425_inc_T25", "normalized": [] }, { "id": "NCT01959425_inc_R18", "type": "Has_value", "arg1_id": "NCT01959425_inc_T26", "arg2_id": "NCT01959425_inc_T27", "normalized": [] }, { "id": "NCT01959425_inc_R19", "type": "Subsumes", "arg1_id": "NCT01959425_inc_T22", "arg2_id": "NCT01959425_inc_T31", "normalized": [] }, { "id": "NCT01959425_inc_R20", "type": "Has_value", "arg1_id": "NCT01959425_inc_T34", "arg2_id": "NCT01959425_inc_T35", "normalized": [] } ]

[ { "id": "NCT01963754_exc_text", "type": "exclusion", "text": [ "If smoking and/or other drug addiction is present\nIf local anesthetic allergy is present\nPatient subjected to chemical or radiotherapy\nif Hepatic disease is present\nIf immunodepression is present\nIf Pregnancy is present\nIf Diabetes is present\nIf Heart disease is present\n" ], "offsets": [ [ 0, 271 ] ] } ]

[ { "id": "NCT01963754_exc_T1", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 3, 10 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T2", "type": "Condition", "text": [ "drug addiction" ], "offsets": [ [ 24, 38 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T3", "type": "Drug", "text": [ "local anesthetic" ], "offsets": [ [ 53, 69 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T4", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 70, 77 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T5", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 122, 134 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T6", "type": "Procedure", "text": [ "chemical" ], "offsets": [ [ 110, 118 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T7", "type": "Condition", "text": [ "Hepatic disease" ], "offsets": [ [ 138, 153 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T8", "type": "Condition", "text": [ "immunodepression" ], "offsets": [ [ 168, 184 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T9", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 199, 208 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T10", "type": "Condition", "text": [ "Diabetes" ], "offsets": [ [ 223, 231 ] ], "normalized": [] }, { "id": "NCT01963754_exc_T11", "type": "Condition", "text": [ "Heart disease" ], "offsets": [ [ 246, 259 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01963754_exc_R1", "type": "AND", "arg1_id": "NCT01963754_exc_T4", "arg2_id": "NCT01963754_exc_T3", "normalized": [] } ]

[ { "id": "NCT01963754_inc_text", "type": "inclusion", "text": [ "Single unit implant rehabilitation\nMaxilla and mandible\nMust accept treatment plan\nMust sign informed consent\ndental extraction performed at least 3 month prior\nMust have at least 6 mm of residual bone\nAbsence of oral lesions\nkeratinized tissue must be present\n" ], "offsets": [ [ 0, 261 ] ] } ]

[ { "id": "NCT01963754_inc_T1", "type": "Procedure", "text": [ "Single unit implant rehabilitation" ], "offsets": [ [ 0, 34 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T2", "type": "Qualifier", "text": [ "Maxilla" ], "offsets": [ [ 35, 42 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T3", "type": "Qualifier", "text": [ "mandible" ], "offsets": [ [ 47, 55 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T6", "type": "Procedure", "text": [ "dental extraction" ], "offsets": [ [ 110, 127 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T7", "type": "Temporal", "text": [ "at least 3 month prior" ], "offsets": [ [ 138, 160 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T8", "type": "Value", "text": [ "at least 6 mm" ], "offsets": [ [ 171, 184 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T9", "type": "Measurement", "text": [ "residual bone" ], "offsets": [ [ 188, 201 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T10", "type": "Negation", "text": [ "Absence" ], "offsets": [ [ 202, 209 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T11", "type": "Condition", "text": [ "oral lesions" ], "offsets": [ [ 213, 225 ] ], "normalized": [] }, { "id": "NCT01963754_inc_T12", "type": "Condition", "text": [ "keratinized tissue must be present" ], "offsets": [ [ 226, 260 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01963754_inc_R1", "type": "Has_temporal", "arg1_id": "NCT01963754_inc_T6", "arg2_id": "NCT01963754_inc_T7", "normalized": [] }, { "id": "NCT01963754_inc_R2", "type": "Has_value", "arg1_id": "NCT01963754_inc_T9", "arg2_id": "NCT01963754_inc_T8", "normalized": [] }, { "id": "NCT01963754_inc_R3", "type": "Has_negation", "arg1_id": "NCT01963754_inc_T11", "arg2_id": "NCT01963754_inc_T10", "normalized": [] } ]

[ { "id": "NCT01967420_exc_text", "type": "exclusion", "text": [ "Active substance dependency \nHistory of severe head injury \n \n" ], "offsets": [ [ 0, 71 ] ] } ]

[ { "id": "NCT01967420_exc_T1", "type": "Condition", "text": [ "substance dependency" ], "offsets": [ [ 7, 27 ] ], "normalized": [] }, { "id": "NCT01967420_exc_T2", "type": "Condition", "text": [ "severe head injury" ], "offsets": [ [ 40, 58 ] ], "normalized": [] }, { "id": "NCT01967420_exc_T3", "type": "Observation", "text": [ "History" ], "offsets": [ [ 29, 36 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01967420_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01967420_exc_T2", "arg2_id": "NCT01967420_exc_T3", "normalized": [] } ]

[ { "id": "NCT01967420_inc_text", "type": "inclusion", "text": [ "Non-affective psychosis \nPremorbid IQ of over 70 \nA service user of the early intervention service \nAged 18 or over (up to the age of 35 which is the limit for the early intervention service) \nPsychiatrically stable enough to attend to completion (no hospitalisations or medication changes in last 4 weeks) \n" ], "offsets": [ [ 0, 308 ] ] } ]

[ { "id": "NCT01967420_inc_T1", "type": "Condition", "text": [ "Non-affective psychosis" ], "offsets": [ [ 0, 23 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T2", "type": "Measurement", "text": [ "Premorbid IQ" ], "offsets": [ [ 25, 37 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T3", "type": "Value", "text": [ "over 70" ], "offsets": [ [ 41, 48 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T5", "type": "Value", "text": [ "18 or over" ], "offsets": [ [ 105, 115 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T6", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 100, 104 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T7", "type": "Value", "text": [ "up to the age of 35" ], "offsets": [ [ 117, 136 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T8", "type": "Condition", "text": [ "Psychiatrically stable" ], "offsets": [ [ 193, 215 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T9", "type": "Procedure", "text": [ "hospitalisations" ], "offsets": [ [ 251, 267 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T10", "type": "Negation", "text": [ "no" ], "offsets": [ [ 248, 250 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T11", "type": "Observation", "text": [ "medication changes" ], "offsets": [ [ 271, 289 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T12", "type": "Temporal", "text": [ "in last 4 weeks" ], "offsets": [ [ 290, 305 ] ], "normalized": [] }, { "id": "NCT01967420_inc_T13", "type": "Scope", "text": [ "hospitalisations or medication changes" ], "offsets": [ [ 251, 289 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01967420_inc_R1", "type": "Has_value", "arg1_id": "NCT01967420_inc_T2", "arg2_id": "NCT01967420_inc_T3", "normalized": [] }, { "id": "NCT01967420_inc_R2", "type": "Has_value", "arg1_id": "NCT01967420_inc_T6", "arg2_id": "NCT01967420_inc_T5", "normalized": [] }, { "id": "NCT01967420_inc_R3", "type": "Has_value", "arg1_id": "NCT01967420_inc_T6", "arg2_id": "NCT01967420_inc_T7", "normalized": [] }, { "id": "NCT01967420_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01967420_inc_T13", "arg2_id": "NCT01967420_inc_T12", "normalized": [] }, { "id": "NCT01967420_inc_R5", "type": "Has_negation", "arg1_id": "NCT01967420_inc_T13", "arg2_id": "NCT01967420_inc_T10", "normalized": [] }, { "id": "NCT01967420_inc_R6", "type": "Subsumes", "arg1_id": "NCT01967420_inc_T8", "arg2_id": "NCT01967420_inc_T13", "normalized": [] } ]

[ { "id": "NCT01978028_exc_text", "type": "exclusion", "text": [ "Hemochromatosis, iron overload, defined as TSAT > 45%\nKnown hypersensitivity to Ferinject®.\nKnown active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.\nChronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.\nImmunosuppressive therapy or renal dialysis (current or planned within the next 6 months).\nHistory of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.\nUnstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.\nAcute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.\nCoronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.\nParticipation in a CHF training program.\nKnown HIV/AIDS.\nInability to fully comprehend and/or perform study procedures in the investigator's opinion.\nVitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).\nPregnancy or lactation.\nParticipation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.\nAnticoagulation\n" ], "offsets": [ [ 0, 1648 ] ] } ]

[ { "id": "NCT01978028_exc_T1", "type": "Condition", "text": [ "Hemochromatosis" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T2", "type": "Condition", "text": [ "iron overload" ], "offsets": [ [ 17, 30 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T3", "type": "Measurement", "text": [ "TSAT" ], "offsets": [ [ 43, 47 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T4", "type": "Value", "text": [ "> 45%" ], "offsets": [ [ 48, 53 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T5", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 60, 76 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T6", "type": "Drug", "text": [ "Ferinject®" ], "offsets": [ [ 80, 90 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T7", "type": "Measurement", "text": [ "CRP" ], "offsets": [ [ 116, 119 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T8", "type": "Value", "text": [ ">20 mg/L" ], "offsets": [ [ 119, 127 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T9", "type": "Condition", "text": [ "active infection" ], "offsets": [ [ 98, 114 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T10", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 129, 151 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T11", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 152, 160 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T12", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 162, 168 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T13", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 169, 179 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T14", "type": "Condition", "text": [ "Chronic liver disease" ], "offsets": [ [ 181, 202 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T15", "type": "Measurement", "text": [ "alanine transaminase (ALT)" ], "offsets": [ [ 220, 246 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T16", "type": "Measurement", "text": [ "aspartate transaminase (AST)" ], "offsets": [ [ 250, 278 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T17", "type": "Value", "text": [ "above three times the upper limit of the normal range" ], "offsets": [ [ 279, 332 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T18", "type": "Scope", "text": [ "alanine transaminase (ALT) or aspartate transaminase (AST)" ], "offsets": [ [ 220, 278 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T19", "type": "Procedure", "text": [ "Immunosuppressive therapy" ], "offsets": [ [ 334, 359 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T20", "type": "Condition", "text": [ "renal dialysis" ], "offsets": [ [ 363, 377 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T21", "type": "Mood", "text": [ "current" ], "offsets": [ [ 379, 386 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T22", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 390, 397 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T23", "type": "Temporal", "text": [ "within the next 6 months" ], "offsets": [ [ 398, 422 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T24", "type": "Reference_point", "text": [ "the next 6 months" ], "offsets": [ [ 405, 422 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T25", "type": "Scope", "text": [ "current or planned" ], "offsets": [ [ 379, 397 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T26", "type": "Scope", "text": [ "Immunosuppressive therapy or renal dialysis" ], "offsets": [ [ 334, 377 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T27", "type": "Drug", "text": [ "erythropoietin" ], "offsets": [ [ 436, 450 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T28", "type": "Procedure", "text": [ "oral iron therapy" ], "offsets": [ [ 461, 478 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T29", "type": "Procedure", "text": [ "blood transfusion" ], "offsets": [ [ 484, 501 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T30", "type": "Temporal", "text": [ "in previous 12 weeks" ], "offsets": [ [ 502, 522 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T31", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 543, 550 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T32", "type": "Temporal", "text": [ "within the next 6 months" ], "offsets": [ [ 551, 575 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T33", "type": "Reference_point", "text": [ "the next 6 months" ], "offsets": [ [ 558, 575 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T34", "type": "Procedure", "text": [ " or ", "therapy, and" ], "offsets": [ [ 457, 461 ], [ 471, 483 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T35", "type": "Scope", "text": [ "erythropoietin, i. v. or oral iron therapy, and blood transfusion" ], "offsets": [ [ 436, 501 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T36", "type": "Scope", "text": [ "in previous 12 weeks and/or such therapy planned within the next 6 months" ], "offsets": [ [ 502, 575 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T37", "type": "Condition", "text": [ "Unstable angina pectoris" ], "offsets": [ [ 577, 601 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T38", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 633, 655 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T39", "type": "Condition", "text": [ "valvular disease" ], "offsets": [ [ 668, 684 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T40", "type": "Condition", "text": [ "left ventricular outflow obstruction" ], "offsets": [ [ 688, 724 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T41", "type": "Condition", "text": [ "obstructive cardiomyopathy" ], "offsets": [ [ 726, 752 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T42", "type": "Qualifier", "text": [ "poorly controlled" ], "offsets": [ [ 754, 771 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T43", "type": "Condition", "text": [ "fast atrial fibrillation" ], "offsets": [ [ 772, 796 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T44", "type": "Condition", "text": [ "trial fibri", "r, poor" ], "offsets": [ [ 778, 789 ], [ 806, 813 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T45", "type": "Qualifier", "text": [ "poorly controlled" ], "offsets": [ [ 809, 826 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T46", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 827, 838 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T47", "type": "Condition", "text": [ "tachyarrhythmias" ], "offsets": [ [ 849, 865 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T48", "type": "Condition", "text": [ "brady-" ], "offsets": [ [ 839, 845 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T49", "type": "Scope", "text": [ "brady- or tachyarrhythmias" ], "offsets": [ [ 839, 865 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T50", "type": "Scope", "text": [ "fast atrial fibrillation or flutter" ], "offsets": [ [ 772, 807 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T51", "type": "Condition", "text": [ "Acute myocardial infarction" ], "offsets": [ [ 867, 894 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T52", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 898, 921 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T53", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 923, 948 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T54", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 952, 958 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T55", "type": "Temporal", "text": [ "within the last 3 months" ], "offsets": [ [ 959, 983 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T56", "type": "Reference_point", "text": [ "the last 3 months" ], "offsets": [ [ 966, 983 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T57", "type": "Scope", "text": [ "Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke" ], "offsets": [ [ 867, 958 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T58", "type": "Procedure", "text": [ "Coronary-artery bypass graft" ], "offsets": [ [ 985, 1013 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T59", "type": "Procedure", "text": [ "percutaneous intervention" ], "offsets": [ [ 1015, 1040 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T60", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 1118, 1131 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T61", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 1156, 1171 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T62", "type": "Procedure", "text": [ " and ca", " withi" ], "offsets": [ [ 1151, 1158 ], [ 1172, 1178 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T63", "type": "Temporal", "text": [ "within the last 3 months" ], "offsets": [ [ 1173, 1197 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T64", "type": "Reference_point", "text": [ "the last 3 months" ], "offsets": [ [ 1180, 1197 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T65", "type": "Scope", "text": [ "thoracic and cardiac surgery" ], "offsets": [ [ 1143, 1171 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T67", "type": "Condition", "text": [ "Known HIV" ], "offsets": [ [ 1240, 1249 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T68", "type": "Condition", "text": [ "AIDS" ], "offsets": [ [ 1250, 1254 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T70", "type": "Condition", "text": [ "and/or seru", "ccording t" ], "offsets": [ [ 1361, 1372 ], [ 1393, 1403 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T71", "type": "Condition", "text": [ "serum folate deficiency" ], "offsets": [ [ 1368, 1391 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T72", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 1488, 1497 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T73", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 1475, 1484 ] ], "normalized": [] }, { "id": "NCT01978028_exc_T74", "type": "Procedure", "text": [ "Anticoagulation" ], "offsets": [ [ 1632, 1647 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01978028_exc_R1", "type": "Has_value", "arg1_id": "NCT01978028_exc_T3", "arg2_id": "NCT01978028_exc_T4", "normalized": [] }, { "id": "NCT01978028_exc_R2", "type": "Subsumes", "arg1_id": "NCT01978028_exc_T1", "arg2_id": "NCT01978028_exc_T2", "normalized": [] }, { "id": "NCT01978028_exc_R3", "type": "Subsumes", "arg1_id": "NCT01978028_exc_T2", "arg2_id": "NCT01978028_exc_T3", "normalized": [] }, { "id": "NCT01978028_exc_R4", "type": "AND", "arg1_id": "NCT01978028_exc_T5", "arg2_id": "NCT01978028_exc_T6", "normalized": [] }, { "id": "NCT01978028_exc_R5", "type": "Has_value", "arg1_id": "NCT01978028_exc_T7", "arg2_id": "NCT01978028_exc_T8", "normalized": [] }, { "id": "NCT01978028_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01978028_exc_T13", "arg2_id": "NCT01978028_exc_T12", "normalized": [] }, { "id": "NCT01978028_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01978028_exc_T11", "arg2_id": "NCT01978028_exc_T10", "normalized": [] }, { "id": "NCT01978028_exc_R8", "type": "AND", "arg1_id": "NCT01978028_exc_T9", "arg2_id": "NCT01978028_exc_T7", "normalized": [] }, { "id": "NCT01978028_exc_R9", "type": "Has_value", "arg1_id": "NCT01978028_exc_T18", "arg2_id": "NCT01978028_exc_T17", "normalized": [] }, { "id": "NCT01978028_exc_R10", "type": "Has_index", "arg1_id": "NCT01978028_exc_T23", "arg2_id": "NCT01978028_exc_T24", "normalized": [] }, { "id": "NCT01978028_exc_R11", "type": "Has_scope", "arg1_id": "NCT01978028_exc_T26", "arg2_id": "NCT01978028_exc_T25", "normalized": [] }, { "id": "NCT01978028_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01978028_exc_T26", "arg2_id": "NCT01978028_exc_T23", "normalized": [] }, { "id": "NCT01978028_exc_R13", "type": "Has_mood", "arg1_id": "NCT01978028_exc_T32", "arg2_id": "NCT01978028_exc_T31", "normalized": [] }, { "id": "NCT01978028_exc_R14", "type": "Has_scope", "arg1_id": "NCT01978028_exc_T35", "arg2_id": "NCT01978028_exc_T36", "normalized": [] }, { "id": "NCT01978028_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT01978028_exc_T49", "arg2_id": "NCT01978028_exc_T46", "normalized": [] }, { "id": "NCT01978028_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT01978028_exc_T49", "arg2_id": "NCT01978028_exc_T45", "normalized": [] }, { "id": "NCT01978028_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01978028_exc_T50", "arg2_id": "NCT01978028_exc_T42", "normalized": [] }, { "id": "NCT01978028_exc_R18", "type": "Has_index", "arg1_id": "NCT01978028_exc_T55", "arg2_id": "NCT01978028_exc_T56", "normalized": [] }, { "id": "NCT01978028_exc_R19", "type": "Has_temporal", "arg1_id": "NCT01978028_exc_T57", "arg2_id": "NCT01978028_exc_T55", "normalized": [] }, { "id": "NCT01978028_exc_R20", "type": "Has_index", "arg1_id": "NCT01978028_exc_T63", "arg2_id": "NCT01978028_exc_T64", "normalized": [] }, { "id": "NCT01978028_exc_R21", "type": "Has_temporal", "arg1_id": "NCT01978028_exc_T65", "arg2_id": "NCT01978028_exc_T63", "normalized": [] }, { "id": "NCT01978028_exc_R22", "type": "Subsumes", "arg1_id": "NCT01978028_exc_T60", "arg2_id": "NCT01978028_exc_T65", "normalized": [] } ]

[ { "id": "NCT01978028_inc_text", "type": "inclusion", "text": [ "Patients with chronic heart failure of New York Heart Association Class II or III, a left ventricular ejection fraction of = 40% for patients in NYHA class II or = 45% for patients in NYHA class III, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%.\nAge =18 years\nObtained informed consent\nStable pharmacological therapy during the last 4 weeks (with the exception of diuretics)\n" ], "offsets": [ [ 0, 534 ] ] } ]

[ { "id": "NCT01978028_inc_T1", "type": "Condition", "text": [ "chronic heart failure" ], "offsets": [ [ 14, 35 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T2", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 39, 65 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T3", "type": "Value", "text": [ "Class II or III" ], "offsets": [ [ 66, 81 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T4", "type": "Measurement", "text": [ "left ventricular ejection fraction" ], "offsets": [ [ 85, 119 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T5", "type": "Value", "text": [ "= 40%" ], "offsets": [ [ 123, 128 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T6", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 145, 149 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T7", "type": "Value", "text": [ "class II" ], "offsets": [ [ 150, 158 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T8", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 184, 188 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T9", "type": "Value", "text": [ "class III" ], "offsets": [ [ 189, 198 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T10", "type": "Value", "text": [ "= 45%" ], "offsets": [ [ 162, 167 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T11", "type": "Scope", "text": [ "NYHA class III" ], "offsets": [ [ 184, 198 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T12", "type": "Scope", "text": [ "NYHA class II" ], "offsets": [ [ 145, 158 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T13", "type": "Scope", "text": [ "= 40% for patients in NYHA class II or = 45% for patients in NYHA class III" ], "offsets": [ [ 123, 198 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T14", "type": "Measurement", "text": [ "hemoglobin level" ], "offsets": [ [ 202, 218 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T15", "type": "Temporal", "text": [ "at the screening visit" ], "offsets": [ [ 219, 241 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T16", "type": "Reference_point", "text": [ "the screening visit" ], "offsets": [ [ 222, 241 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T17", "type": "Value", "text": [ "between 9.5-13.5 g/dl" ], "offsets": [ [ 242, 263 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T18", "type": "Condition", "text": [ "iron deficiency" ], "offsets": [ [ 269, 284 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T19", "type": "Measurement", "text": [ "serum ferritin level" ], "offsets": [ [ 306, 326 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T20", "type": "Value", "text": [ "< 100µg/l" ], "offsets": [ [ 327, 336 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T21", "type": "Value", "text": [ "between 100 and 299 µg/l" ], "offsets": [ [ 340, 364 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T22", "type": "Scope", "text": [ "< 100µg/l or between 100 and 299 µg/l" ], "offsets": [ [ 327, 364 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T23", "type": "Measurement", "text": [ "transferring saturation" ], "offsets": [ [ 371, 394 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T24", "type": "Value", "text": [ "< 20%" ], "offsets": [ [ 398, 403 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T25", "type": "Scope", "text": [ "serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%" ], "offsets": [ [ 306, 403 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T26", "type": "Person", "text": [ "Age" ], "offsets": [ [ 405, 408 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T27", "type": "Value", "text": [ "=18 years" ], "offsets": [ [ 409, 418 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T29", "type": "Procedure", "text": [ "pharmacological therapy" ], "offsets": [ [ 452, 475 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T30", "type": "Qualifier", "text": [ "Stable" ], "offsets": [ [ 445, 451 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T31", "type": "Temporal", "text": [ "during the last 4 weeks" ], "offsets": [ [ 476, 499 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T32", "type": "Reference_point", "text": [ "last 4 weeks" ], "offsets": [ [ 487, 499 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T33", "type": "Drug", "text": [ "diuretics" ], "offsets": [ [ 523, 532 ] ], "normalized": [] }, { "id": "NCT01978028_inc_T34", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 501, 522 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01978028_inc_R1", "type": "Has_value", "arg1_id": "NCT01978028_inc_T2", "arg2_id": "NCT01978028_inc_T3", "normalized": [] }, { "id": "NCT01978028_inc_R2", "type": "AND", "arg1_id": "NCT01978028_inc_T1", "arg2_id": "NCT01978028_inc_T2", "normalized": [] }, { "id": "NCT01978028_inc_R4", "type": "Has_value", "arg1_id": "NCT01978028_inc_T6", "arg2_id": "NCT01978028_inc_T7", "normalized": [] }, { "id": "NCT01978028_inc_R5", "type": "Has_value", "arg1_id": "NCT01978028_inc_T8", "arg2_id": "NCT01978028_inc_T9", "normalized": [] }, { "id": "NCT01978028_inc_R3", "type": "Has_value", "arg1_id": "NCT01978028_inc_T11", "arg2_id": "NCT01978028_inc_T10", "normalized": [] }, { "id": "NCT01978028_inc_R6", "type": "Has_value", "arg1_id": "NCT01978028_inc_T12", "arg2_id": "NCT01978028_inc_T5", "normalized": [] }, { "id": "NCT01978028_inc_R7", "type": "Has_scope", "arg1_id": "NCT01978028_inc_T4", "arg2_id": "NCT01978028_inc_T13", "normalized": [] }, { "id": "NCT01978028_inc_R8", "type": "Has_index", "arg1_id": "NCT01978028_inc_T15", "arg2_id": "NCT01978028_inc_T16", "normalized": [] }, { "id": "NCT01978028_inc_R9", "type": "Has_value", "arg1_id": "NCT01978028_inc_T14", "arg2_id": "NCT01978028_inc_T17", "normalized": [] }, { "id": "NCT01978028_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01978028_inc_T14", "arg2_id": "NCT01978028_inc_T15", "normalized": [] }, { "id": "NCT01978028_inc_R11", "type": "Has_scope", "arg1_id": "NCT01978028_inc_T19", "arg2_id": "NCT01978028_inc_T22", "normalized": [] }, { "id": "NCT01978028_inc_R12", "type": "Has_value", "arg1_id": "NCT01978028_inc_T23", "arg2_id": "NCT01978028_inc_T24", "normalized": [] }, { "id": "NCT01978028_inc_R13", "type": "Subsumes", "arg1_id": "NCT01978028_inc_T18", "arg2_id": "NCT01978028_inc_T25", "normalized": [] }, { "id": "NCT01978028_inc_R14", "type": "Has_value", "arg1_id": "NCT01978028_inc_T26", "arg2_id": "NCT01978028_inc_T27", "normalized": [] }, { "id": "NCT01978028_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT01978028_inc_T29", "arg2_id": "NCT01978028_inc_T30", "normalized": [] }, { "id": "NCT01978028_inc_R16", "type": "Has_index", "arg1_id": "NCT01978028_inc_T31", "arg2_id": "NCT01978028_inc_T32", "normalized": [] }, { "id": "NCT01978028_inc_R17", "type": "Has_negation", "arg1_id": "NCT01978028_inc_T33", "arg2_id": "NCT01978028_inc_T34", "normalized": [] }, { "id": "NCT01978028_inc_R18", "type": "AND", "arg1_id": "NCT01978028_inc_T29", "arg2_id": "NCT01978028_inc_T33", "normalized": [] }, { "id": "NCT01978028_inc_R19", "type": "Has_temporal", "arg1_id": "NCT01978028_inc_T29", "arg2_id": "NCT01978028_inc_T31", "normalized": [] } ]

[ { "id": "NCT01980680_exc_text", "type": "exclusion", "text": [ "Patients with >14 follicles on day of trigger\nPrevious hyperresponse with OHSS development\nPrevious low response (less than 3 oocytes on a high dose of FSH stimulation)\nEndocrine disorders\n" ], "offsets": [ [ 0, 189 ] ] } ]

[ { "id": "NCT01980680_exc_T1", "type": "Value", "text": [ ">14" ], "offsets": [ [ 14, 17 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T2", "type": "Measurement", "text": [ "follicles" ], "offsets": [ [ 18, 27 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T3", "type": "Temporal", "text": [ "on day of trigger" ], "offsets": [ [ 28, 45 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T4", "type": "Reference_point", "text": [ "day of trigger" ], "offsets": [ [ 31, 45 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T5", "type": "Condition", "text": [ "hyperresponse" ], "offsets": [ [ 55, 68 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T6", "type": "Observation", "text": [ "OHSS development" ], "offsets": [ [ 74, 90 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T7", "type": "Condition", "text": [ "low response" ], "offsets": [ [ 100, 112 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T8", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 46, 54 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T9", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 91, 99 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T10", "type": "Measurement", "text": [ "oocytes" ], "offsets": [ [ 126, 133 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T11", "type": "Value", "text": [ "less than 3" ], "offsets": [ [ 114, 125 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T12", "type": "Procedure", "text": [ "high dose of FSH stimulation" ], "offsets": [ [ 139, 167 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T13", "type": "Scope", "text": [ "less than 3 oocytes on a high dose of FSH stimulation" ], "offsets": [ [ 114, 167 ] ], "normalized": [] }, { "id": "NCT01980680_exc_T14", "type": "Condition", "text": [ "Endocrine disorders" ], "offsets": [ [ 169, 188 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01980680_exc_R1", "type": "Has_value", "arg1_id": "NCT01980680_exc_T2", "arg2_id": "NCT01980680_exc_T1", "normalized": [] }, { "id": "NCT01980680_exc_R2", "type": "Has_index", "arg1_id": "NCT01980680_exc_T3", "arg2_id": "NCT01980680_exc_T4", "normalized": [] }, { "id": "NCT01980680_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01980680_exc_T2", "arg2_id": "NCT01980680_exc_T3", "normalized": [] }, { "id": "NCT01980680_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01980680_exc_T5", "arg2_id": "NCT01980680_exc_T8", "normalized": [] }, { "id": "NCT01980680_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01980680_exc_T7", "arg2_id": "NCT01980680_exc_T9", "normalized": [] }, { "id": "NCT01980680_exc_R7", "type": "Has_value", "arg1_id": "NCT01980680_exc_T10", "arg2_id": "NCT01980680_exc_T11", "normalized": [] }, { "id": "NCT01980680_exc_R8", "type": "Subsumes", "arg1_id": "NCT01980680_exc_T7", "arg2_id": "NCT01980680_exc_T13", "normalized": [] } ]

[ { "id": "NCT01980680_inc_text", "type": "inclusion", "text": [ "Age between 20 and 40\nNormal menstrual cycles: 25-34 days\nOligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)\nBMI >18 and <35 kg/m2\n" ], "offsets": [ [ 0, 180 ] ] } ]

[ { "id": "NCT01980680_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T2", "type": "Value", "text": [ "between 20 and 40" ], "offsets": [ [ 4, 21 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T3", "type": "Condition", "text": [ "Normal menstrual cycles" ], "offsets": [ [ 22, 45 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T4", "type": "Value", "text": [ "25-34 days" ], "offsets": [ [ 47, 57 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T5", "type": "Condition", "text": [ "amenorrhea" ], "offsets": [ [ 73, 83 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T6", "type": "Condition", "text": [ "Oligomenorrhea" ], "offsets": [ [ 58, 72 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T7", "type": "Condition", "text": [ "polycystic syndrome" ], "offsets": [ [ 87, 106 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T8", "type": "Qualifier", "text": [ "Rotterdam criteria 2004" ], "offsets": [ [ 133, 156 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T9", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 158, 161 ] ], "normalized": [] }, { "id": "NCT01980680_inc_T10", "type": "Value", "text": [ ">18 and <35 kg/m2" ], "offsets": [ [ 162, 179 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01980680_inc_R1", "type": "Has_value", "arg1_id": "NCT01980680_inc_T1", "arg2_id": "NCT01980680_inc_T2", "normalized": [] }, { "id": "NCT01980680_inc_R2", "type": "Subsumes", "arg1_id": "NCT01980680_inc_T3", "arg2_id": "NCT01980680_inc_T4", "normalized": [] }, { "id": "NCT01980680_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01980680_inc_T7", "arg2_id": "NCT01980680_inc_T8", "normalized": [] }, { "id": "NCT01980680_inc_R4", "type": "Has_value", "arg1_id": "NCT01980680_inc_T9", "arg2_id": "NCT01980680_inc_T10", "normalized": [] } ]