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[ { "id": "NCT02414399_exc_text", "type": "exclusion", "text": [ "Contraindication to azithromycin use and other prophylactic antibiotic use\n" ], "offsets": [ [ 0, 75 ] ] } ]

[ { "id": "NCT02414399_exc_T1", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02414399_exc_T2", "type": "Drug", "text": [ "azithromycin" ], "offsets": [ [ 20, 32 ] ], "normalized": [] }, { "id": "NCT02414399_exc_T3", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 41, 46 ] ], "normalized": [] }, { "id": "NCT02414399_exc_T4", "type": "Drug", "text": [ "prophylactic antibiotic use" ], "offsets": [ [ 47, 74 ] ], "normalized": [] } ]

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[ { "id": "NCT02414399_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02414399_exc_T4", "arg2_id": "NCT02414399_exc_T3", "normalized": [] }, { "id": "NCT02414399_exc_R2", "type": "AND", "arg1_id": "NCT02414399_exc_T1", "arg2_id": "NCT02414399_exc_T2", "normalized": [] }, { "id": "NCT02414399_exc_R3", "type": "AND", "arg1_id": "NCT02414399_exc_T1", "arg2_id": "NCT02414399_exc_T4", "normalized": [] } ]

[ { "id": "NCT02414399_inc_text", "type": "inclusion", "text": [ "Age 1-59 months,\nPlan to remain in study area greater than 6 months\nDischarged from hospital following non-trauma related admission\n" ], "offsets": [ [ 0, 132 ] ] } ]

[ { "id": "NCT02414399_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T2", "type": "Value", "text": [ "1-59 months" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T3", "type": "Temporal", "text": [ "greater than 6 months" ], "offsets": [ [ 46, 67 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T4", "type": "Observation", "text": [ "remain in study area" ], "offsets": [ [ 25, 45 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T5", "type": "Mood", "text": [ "Plan" ], "offsets": [ [ 17, 21 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T6", "type": "Procedure", "text": [ "Discharged from hospital" ], "offsets": [ [ 68, 92 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T7", "type": "Procedure", "text": [ "non-trauma related admission" ], "offsets": [ [ 103, 131 ] ], "normalized": [] }, { "id": "NCT02414399_inc_T8", "type": "Visit", "text": [ "hospital" ], "offsets": [ [ 84, 92 ] ], "normalized": [] } ]

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[ { "id": "NCT02414399_inc_R1", "type": "Has_value", "arg1_id": "NCT02414399_inc_T1", "arg2_id": "NCT02414399_inc_T2", "normalized": [] }, { "id": "NCT02414399_inc_R2", "type": "Has_mood", "arg1_id": "NCT02414399_inc_T4", "arg2_id": "NCT02414399_inc_T5", "normalized": [] }, { "id": "NCT02414399_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02414399_inc_T4", "arg2_id": "NCT02414399_inc_T3", "normalized": [] }, { "id": "NCT02414399_inc_R4", "type": "AND", "arg1_id": "NCT02414399_inc_T6", "arg2_id": "NCT02414399_inc_T7", "normalized": [] } ]

[ { "id": "NCT02415257_exc_text", "type": "exclusion", "text": [ "impaired decision making\nneurofibromatosis\nsigns for central dysfunction\nremaining vestibular function\nPatients are advised not to participate in the gentamicin arm if\nhearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%\nthe neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss\n" ], "offsets": [ [ 0, 411 ] ] } ]

[ { "id": "NCT02415257_exc_T1", "type": "Condition", "text": [ "impaired decision making" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T2", "type": "Condition", "text": [ "neurofibromatosis" ], "offsets": [ [ 25, 42 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T3", "type": "Mood", "text": [ "signs" ], "offsets": [ [ 43, 48 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T4", "type": "Condition", "text": [ "central dysfunction" ], "offsets": [ [ 53, 72 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T5", "type": "Condition", "text": [ "remaining vestibular function" ], "offsets": [ [ 73, 102 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T7", "type": "Measurement", "text": [ "hearing" ], "offsets": [ [ 168, 175 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T8", "type": "Value", "text": [ "better than 30 deciBel (dB)" ], "offsets": [ [ 179, 206 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T9", "type": "Qualifier", "text": [ "pure tone average" ], "offsets": [ [ 210, 227 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T10", "type": "Qualifier", "text": [ "500, 1000, 2000, 3-4000 Hz" ], "offsets": [ [ 229, 255 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T11", "type": "Measurement", "text": [ "speech discrimination" ], "offsets": [ [ 261, 282 ] ], "normalized": [] }, { "id": "NCT02415257_exc_T12", "type": "Value", "text": [ "better than 70%" ], "offsets": [ [ 283, 298 ] ], "normalized": [] } ]

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[ { "id": "NCT02415257_exc_R1", "type": "Has_mood", "arg1_id": "NCT02415257_exc_T4", "arg2_id": "NCT02415257_exc_T3", "normalized": [] }, { "id": "NCT02415257_exc_R2", "type": "Subsumes", "arg1_id": "NCT02415257_exc_T9", "arg2_id": "NCT02415257_exc_T10", "normalized": [] }, { "id": "NCT02415257_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02415257_exc_T7", "arg2_id": "NCT02415257_exc_T9", "normalized": [] }, { "id": "NCT02415257_exc_R4", "type": "Has_value", "arg1_id": "NCT02415257_exc_T7", "arg2_id": "NCT02415257_exc_T8", "normalized": [] }, { "id": "NCT02415257_exc_R5", "type": "Has_value", "arg1_id": "NCT02415257_exc_T11", "arg2_id": "NCT02415257_exc_T12", "normalized": [] } ]

[ { "id": "NCT02415257_inc_text", "type": "inclusion", "text": [ "Vestibular schwannoma advised to surgical treatment\nNo measurable remaining vestibular function\n" ], "offsets": [ [ 0, 96 ] ] } ]

[ { "id": "NCT02415257_inc_T1", "type": "Condition", "text": [ "Vestibular schwannoma" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02415257_inc_T2", "type": "Mood", "text": [ "advised" ], "offsets": [ [ 22, 29 ] ], "normalized": [] }, { "id": "NCT02415257_inc_T5", "type": "Procedure", "text": [ "surgical treatment" ], "offsets": [ [ 33, 51 ] ], "normalized": [] }, { "id": "NCT02415257_inc_T4", "type": "Negation", "text": [ "No" ], "offsets": [ [ 52, 54 ] ], "normalized": [] }, { "id": "NCT02415257_inc_T6", "type": "Measurement", "text": [ "remaining vestibular function" ], "offsets": [ [ 66, 95 ] ], "normalized": [] } ]

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[ { "id": "NCT02415257_inc_R1", "type": "Has_mood", "arg1_id": "NCT02415257_inc_T5", "arg2_id": "NCT02415257_inc_T2", "normalized": [] }, { "id": "NCT02415257_inc_R2", "type": "AND", "arg1_id": "NCT02415257_inc_T1", "arg2_id": "NCT02415257_inc_T5", "normalized": [] }, { "id": "NCT02415257_inc_R3", "type": "Has_negation", "arg1_id": "NCT02415257_inc_T6", "arg2_id": "NCT02415257_inc_T4", "normalized": [] } ]

[ { "id": "NCT02416765_exc_text", "type": "exclusion", "text": [ "1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. \n2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. \n3. Ongoing pregnancy. \n4. Severe hypoglycemic episode within 1 month of screening. \n5. Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol. \n6. Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable. \n7. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition). \n8. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc). \n9. Living or planned travel outside Montreal (> 1h of driving) area during closed-loop procedures. \n \n" ], "offsets": [ [ 0, 1417 ] ] } ]

[ { "id": "NCT02416765_exc_T10", "type": "Condition", "text": [ "microvascular complications" ], "offsets": [ [ 26, 53 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T11", "type": "Measurement", "text": [ "estimated glomerular filtration rate" ], "offsets": [ [ 68, 104 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T12", "type": "Value", "text": [ "below 40 ml/min" ], "offsets": [ [ 105, 120 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T13", "type": "Condition", "text": [ "nephropathy" ], "offsets": [ [ 55, 66 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T14", "type": "Condition", "text": [ "neuropathy" ], "offsets": [ [ 123, 133 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T15", "type": "Condition", "text": [ "gastroparesis" ], "offsets": [ [ 156, 169 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T16", "type": "Condition", "text": [ "severe proliferative retinopathy" ], "offsets": [ [ 174, 206 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T18", "type": "Qualifier", "text": [ "as judged by the investigator" ], "offsets": [ [ 207, 236 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T19", "type": "Scope", "text": [ "nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy" ], "offsets": [ [ 55, 206 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T20", "type": "Temporal", "text": [ "< 3 months" ], "offsets": [ [ 250, 260 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T21", "type": "Temporal", "text": [ "Recent" ], "offsets": [ [ 242, 248 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T22", "type": "Condition", "text": [ "acute macrovascular event" ], "offsets": [ [ 262, 287 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T23", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 293, 316 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T24", "type": "Condition", "text": [ "cardiac surgery" ], "offsets": [ [ 320, 335 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T25", "type": "Scope", "text": [ "acute coronary syndrome or cardiac surgery" ], "offsets": [ [ 293, 335 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T26", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 349, 358 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T27", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 341, 348 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T28", "type": "Condition", "text": [ "hypoglycemic episode" ], "offsets": [ [ 371, 391 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T29", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 364, 370 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T30", "type": "Temporal", "text": [ "within 1 month of screening" ], "offsets": [ [ 392, 419 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T31", "type": "Drug", "text": [ "Agents affecting gastric emptying" ], "offsets": [ [ 425, 458 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T33", "type": "Drug", "text": [ "Motilium" ], "offsets": [ [ 460, 468 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T34", "type": "Drug", "text": [ "Prandase" ], "offsets": [ [ 471, 479 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T35", "type": "Drug", "text": [ "Victoza" ], "offsets": [ [ 482, 489 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T36", "type": "Drug", "text": [ "Byetta" ], "offsets": [ [ 492, 498 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T37", "type": "Drug", "text": [ "Symlin" ], "offsets": [ [ 504, 510 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T39", "type": "Scope", "text": [ "Motilium®, Prandase®, Victoza®, Byetta® and Symlin®" ], "offsets": [ [ 460, 511 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T40", "type": "Drug", "text": [ "oral anti-diabetic agents" ], "offsets": [ [ 524, 549 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T41", "type": "Drug", "text": [ "Metformin" ], "offsets": [ [ 551, 560 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T42", "type": "Drug", "text": [ "SGLT-2 inhibitors" ], "offsets": [ [ 562, 579 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T43", "type": "Drug", "text": [ "DPP-4 inhibitors" ], "offsets": [ [ 584, 600 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T45", "type": "Scope", "text": [ "Metformin, SGLT-2 inhibitors and DPP-4 inhibitors" ], "offsets": [ [ 551, 600 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T46", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 614, 625 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T47", "type": "Temporal", "text": [ "for 3 months" ], "offsets": [ [ 626, 638 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T48", "type": "Scope", "text": [ "stable dose for 3 months" ], "offsets": [ [ 614, 638 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T49", "type": "Negation", "text": [ "not" ], "offsets": [ [ 605, 608 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T51", "type": "Drug", "text": [ "Oral steroids" ], "offsets": [ [ 740, 753 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T52", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 754, 760 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T53", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 784, 795 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T54", "type": "Qualifier", "text": [ "low", "dose" ], "offsets": [ [ 780, 783 ], [ 791, 795 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T55", "type": "Multiplier", "text": [ "10 mg or less", "per day" ], "offsets": [ [ 802, 815 ], [ 830, 837 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T56", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 819, 829 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T57", "type": "Multiplier", "text": [ "physiological doses" ], "offsets": [ [ 841, 860 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T58", "type": "Multiplier", "text": [ "less than 35 mg/day" ], "offsets": [ [ 862, 881 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T59", "type": "Drug", "text": [ "hydrocortisone" ], "offsets": [ [ 886, 900 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T60", "type": "Drug", "text": [ "Cortef" ], "offsets": [ [ 901, 907 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T61", "type": "Scope", "text": [ "10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef" ], "offsets": [ [ 802, 907 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T63", "type": "Drug", "text": [ "Inhale steroids" ], "offsets": [ [ 911, 926 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T64", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 930, 941 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T65", "type": "Temporal", "text": [ "in the last month" ], "offsets": [ [ 942, 959 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T66", "type": "Condition", "text": [ "Other", "medical illness" ], "offsets": [ [ 980, 985 ], [ 994, 1009 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T67", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 986, 993 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T72", "type": "Condition", "text": [ "psychiatric condition" ], "offsets": [ [ 1148, 1169 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T73", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 1139, 1147 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T74", "type": "Scope", "text": [ "Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator" ], "offsets": [ [ 980, 1132 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T77", "type": "Procedure", "text": [ "closed-loop procedures" ], "offsets": [ [ 1381, 1403 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T78", "type": "Temporal", "text": [ "during closed-loop procedures" ], "offsets": [ [ 1374, 1403 ] ], "normalized": [] }, { "id": "NCT02416765_exc_T79", "type": "Reference_point", "text": [ "closed-loop procedures" ], "offsets": [ [ 1381, 1403 ] ], "normalized": [] } ]

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[ { "id": "NCT02416765_exc_R1", "type": "Has_value", "arg1_id": "NCT02416765_exc_T11", "arg2_id": "NCT02416765_exc_T12", "normalized": [] }, { "id": "NCT02416765_exc_R2", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T13", "arg2_id": "NCT02416765_exc_T11", "normalized": [] }, { "id": "NCT02416765_exc_R3", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T14", "arg2_id": "NCT02416765_exc_T15", "normalized": [] }, { "id": "NCT02416765_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T10", "arg2_id": "NCT02416765_exc_T18", "normalized": [] }, { "id": "NCT02416765_exc_R5", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T10", "arg2_id": "NCT02416765_exc_T19", "normalized": [] }, { "id": "NCT02416765_exc_R6", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T21", "arg2_id": "NCT02416765_exc_T20", "normalized": [] }, { "id": "NCT02416765_exc_R7", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T22", "arg2_id": "NCT02416765_exc_T25", "normalized": [] }, { "id": "NCT02416765_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02416765_exc_T22", "arg2_id": "NCT02416765_exc_T21", "normalized": [] }, { "id": "NCT02416765_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02416765_exc_T26", "arg2_id": "NCT02416765_exc_T27", "normalized": [] }, { "id": "NCT02416765_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T28", "arg2_id": "NCT02416765_exc_T29", "normalized": [] }, { "id": "NCT02416765_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02416765_exc_T28", "arg2_id": "NCT02416765_exc_T30", "normalized": [] }, { "id": "NCT02416765_exc_R12", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T31", "arg2_id": "NCT02416765_exc_T39", "normalized": [] }, { "id": "NCT02416765_exc_R13", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T40", "arg2_id": "NCT02416765_exc_T45", "normalized": [] }, { "id": "NCT02416765_exc_R14", "type": "Has_temporal", "arg1_id": "NCT02416765_exc_T46", "arg2_id": "NCT02416765_exc_T47", "normalized": [] }, { "id": "NCT02416765_exc_R15", "type": "Has_negation", "arg1_id": "NCT02416765_exc_T48", "arg2_id": "NCT02416765_exc_T49", "normalized": [] }, { "id": "NCT02416765_exc_R16", "type": "Has_scope", "arg1_id": "NCT02416765_exc_T40", "arg2_id": "NCT02416765_exc_T48", "normalized": [] }, { "id": "NCT02416765_exc_R17", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T59", "arg2_id": "NCT02416765_exc_T60", "normalized": [] }, { "id": "NCT02416765_exc_R18", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T57", "arg2_id": "NCT02416765_exc_T58", "normalized": [] }, { "id": "NCT02416765_exc_R19", "type": "Has_multiplier", "arg1_id": "NCT02416765_exc_T59", "arg2_id": "NCT02416765_exc_T57", "normalized": [] }, { "id": "NCT02416765_exc_R20", "type": "Has_multiplier", "arg1_id": "NCT02416765_exc_T56", "arg2_id": "NCT02416765_exc_T55", "normalized": [] }, { "id": "NCT02416765_exc_R21", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T54", "arg2_id": "NCT02416765_exc_T61", "normalized": [] }, { "id": "NCT02416765_exc_R22", "type": "Has_negation", "arg1_id": "NCT02416765_exc_T54", "arg2_id": "NCT02416765_exc_T52", "normalized": [] }, { "id": "NCT02416765_exc_R23", "type": "Has_negation", "arg1_id": "NCT02416765_exc_T53", "arg2_id": "NCT02416765_exc_T52", "normalized": [] }, { "id": "NCT02416765_exc_R24", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T51", "arg2_id": "NCT02416765_exc_T53", "normalized": [] }, { "id": "NCT02416765_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T51", "arg2_id": "NCT02416765_exc_T54", "normalized": [] }, { "id": "NCT02416765_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T63", "arg2_id": "NCT02416765_exc_T64", "normalized": [] }, { "id": "NCT02416765_exc_R27", "type": "Has_temporal", "arg1_id": "NCT02416765_exc_T63", "arg2_id": "NCT02416765_exc_T65", "normalized": [] }, { "id": "NCT02416765_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT02416765_exc_T72", "arg2_id": "NCT02416765_exc_T73", "normalized": [] }, { "id": "NCT02416765_exc_R29", "type": "Subsumes", "arg1_id": "NCT02416765_exc_T74", "arg2_id": "NCT02416765_exc_T72", "normalized": [] }, { "id": "NCT02416765_exc_R30", "type": "Has_index", "arg1_id": "NCT02416765_exc_T78", "arg2_id": "NCT02416765_exc_T79", "normalized": [] } ]

[ { "id": "NCT02416765_inc_text", "type": "inclusion", "text": [ "1. Males and females ≥ 18 years old. \n2. Clinical diagnosis of type 1 diabetes for at least one year. \n3. The subject will have been on insulin pump therapy for at least 3 months and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine). \n4. Last (less than 3 months) HbA1c ≤ 10%. \n5. Currently using carbohydrate counting as the meal insulin dose strategy. \n" ], "offsets": [ [ 0, 379 ] ] } ]

[ { "id": "NCT02416765_inc_T6", "type": "Person", "text": [ "Males" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T8", "type": "Person", "text": [ "females" ], "offsets": [ [ 13, 20 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T9", "type": "Person", "text": [ "old" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T10", "type": "Value", "text": [ "≥ 18 years old" ], "offsets": [ [ 21, 35 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T11", "type": "Condition", "text": [ "type 1 diabetes" ], "offsets": [ [ 63, 78 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T12", "type": "Temporal", "text": [ "for at least one year" ], "offsets": [ [ 79, 100 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T13", "type": "Procedure", "text": [ "insulin pump therapy" ], "offsets": [ [ 136, 156 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T14", "type": "Temporal", "text": [ "for at least 3 months" ], "offsets": [ [ 157, 178 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T15", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 183, 192 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T16", "type": "Drug", "text": [ "fast actin insulin analog" ], "offsets": [ [ 201, 226 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T17", "type": "Drug", "text": [ "Lispro" ], "offsets": [ [ 228, 234 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T18", "type": "Drug", "text": [ "Aspart" ], "offsets": [ [ 236, 242 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T19", "type": "Drug", "text": [ "Guilisine" ], "offsets": [ [ 246, 255 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T20", "type": "Scope", "text": [ "Lispro, Aspart or Guilisine" ], "offsets": [ [ 228, 255 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T21", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 288, 293 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T22", "type": "Value", "text": [ "≤ 10%" ], "offsets": [ [ 294, 299 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T23", "type": "Temporal", "text": [ "Last (less than 3 months)" ], "offsets": [ [ 262, 287 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T24", "type": "Procedure", "text": [ "carbohydrate counting" ], "offsets": [ [ 321, 342 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T25", "type": "Procedure", "text": [ "meal insulin dose strategy" ], "offsets": [ [ 350, 376 ] ], "normalized": [] }, { "id": "NCT02416765_inc_T26", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 305, 314 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02416765_inc_R1", "type": "Has_value", "arg1_id": "NCT02416765_inc_T9", "arg2_id": "NCT02416765_inc_T10", "normalized": [] }, { "id": "NCT02416765_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02416765_inc_T11", "arg2_id": "NCT02416765_inc_T12", "normalized": [] }, { "id": "NCT02416765_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02416765_inc_T13", "arg2_id": "NCT02416765_inc_T14", "normalized": [] }, { "id": "NCT02416765_inc_R4", "type": "Subsumes", "arg1_id": "NCT02416765_inc_T16", "arg2_id": "NCT02416765_inc_T20", "normalized": [] }, { "id": "NCT02416765_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02416765_inc_T16", "arg2_id": "NCT02416765_inc_T15", "normalized": [] }, { "id": "NCT02416765_inc_R6", "type": "Has_value", "arg1_id": "NCT02416765_inc_T21", "arg2_id": "NCT02416765_inc_T22", "normalized": [] }, { "id": "NCT02416765_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02416765_inc_T21", "arg2_id": "NCT02416765_inc_T23", "normalized": [] }, { "id": "NCT02416765_inc_R8", "type": "AND", "arg1_id": "NCT02416765_inc_T25", "arg2_id": "NCT02416765_inc_T24", "normalized": [] }, { "id": "NCT02416765_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02416765_inc_T24", "arg2_id": "NCT02416765_inc_T26", "normalized": [] } ]

[ { "id": "NCT02416869_exc_text", "type": "exclusion", "text": [ "Heavy tobacco smokers\nDrug and / or alcohol abusers\n" ], "offsets": [ [ 0, 52 ] ] } ]

[ { "id": "NCT02416869_exc_T1", "type": "Condition", "text": [ "Heavy tobacco smokers" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02416869_exc_T2", "type": "Condition", "text": [ "alcohol abusers" ], "offsets": [ [ 36, 51 ] ], "normalized": [] }, { "id": "NCT02416869_exc_T3", "type": "Condition", "text": [ "rug", "busers" ], "offsets": [ [ 23, 26 ], [ 45, 51 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT02416869_inc_text", "type": "inclusion", "text": [ "Healthy patients (ASA I)\nBilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification\n" ], "offsets": [ [ 0, 132 ] ] } ]

[ { "id": "NCT02416869_inc_T1", "type": "Condition", "text": [ "Healthy patients" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02416869_inc_T2", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 18, 21 ] ], "normalized": [] }, { "id": "NCT02416869_inc_T3", "type": "Value", "text": [ "I" ], "offsets": [ [ 22, 23 ] ], "normalized": [] }, { "id": "NCT02416869_inc_T4", "type": "Measurement", "text": [ "Pel-Gregory's and Winter's classification" ], "offsets": [ [ 90, 131 ] ], "normalized": [] }, { "id": "NCT02416869_inc_T5", "type": "Value", "text": [ "Bilateral symmetrically impacted lower third molars" ], "offsets": [ [ 25, 76 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02416869_inc_R1", "type": "Has_value", "arg1_id": "NCT02416869_inc_T2", "arg2_id": "NCT02416869_inc_T3", "normalized": [] }, { "id": "NCT02416869_inc_R2", "type": "Subsumes", "arg1_id": "NCT02416869_inc_T1", "arg2_id": "NCT02416869_inc_T2", "normalized": [] }, { "id": "NCT02416869_inc_R3", "type": "Has_value", "arg1_id": "NCT02416869_inc_T4", "arg2_id": "NCT02416869_inc_T5", "normalized": [] } ]

[ { "id": "NCT02419378_exc_text", "type": "exclusion", "text": [ "Participation in another clinical trial at present or within 4 weeks of study entry. There may be exceptions at the discretion of the Investigator.\nHas any progressive form of MS\nHypersensitivity to the active substance, or to any of the excipients of Lemtrada®\nMedical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study\nAny disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS\nMajor systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage\nKnown bleeding disorder (e.g,. dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or clotting factor deficiency)\nSignificant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis\nHistory of malignancy, except basal skin cell carcinoma\nMajor psychiatric disorder that is not adequately controlled by treatment\nEpileptic seizures that are not adequately controlled by Treatment\nActive infection, e.g., deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation\nIn the Investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)\nSeropositivity for human immunodeficiency virus (HIV)\nInfection with hepatitis C Virus\nPast or present hepatitis B infection (positive hepatitis B serology)\nActive infection with human cytomegaly virus (HCMV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV)\nLatent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.\nInvasive fungal infections in history and at present\nCervical cytology other than PAP I or PAP II (Papanicolaou) or cervical high risk human papillomavirus (HPV) positivity\nAny other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by study medication\nDifferential blood count < lower limit of normal (LLN) at Screening\nConfirmed platelet count < the LLN of the evaluating laboratory at Screening or documented at <100,000/µL within the past year on a sample without platelet clumping\nPresence (i.e., above the ULN) of anti-thyroid stimulating hormone receptor antibodies (anti-TSHR) and anti-thyroid peroxidase antibody (anti-TPO)\nVaccination less than 6 weeks prior to treatment with Lemtrada.\nTreatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion\nIntolerance of pulsed corticosteroids, especially a history of steroid psychosis\nInability to undergo MRI with gadolinium administration\nOf childbearing potential with a positive serum pregnancy test, pregnant or lactating\nFemale patients of childbearing potential: Unwilling to agree to use a reliable and acceptable contraceptive method (Pearl index <1) throughout the study period. These methods include: hormone releasing intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).\n" ], "offsets": [ [ 0, 3701 ] ] } ]

[ { "id": "NCT02419378_exc_T2", "type": "Condition", "text": [ "MS" ], "offsets": [ [ 176, 178 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T3", "type": "Qualifier", "text": [ "progressive" ], "offsets": [ [ 156, 167 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T4", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 179, 195 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T5", "type": "Drug", "text": [ "Lemtrada" ], "offsets": [ [ 252, 260 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T9", "type": "Condition", "text": [ "bleeding disorder" ], "offsets": [ [ 890, 907 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T10", "type": "Condition", "text": [ "dysfibrinogenemia" ], "offsets": [ [ 915, 932 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T11", "type": "Condition", "text": [ "factor IX deficiency" ], "offsets": [ [ 934, 954 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T12", "type": "Condition", "text": [ "hemophilia" ], "offsets": [ [ 956, 966 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T13", "type": "Condition", "text": [ "Von Willebrand's disease" ], "offsets": [ [ 968, 992 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T14", "type": "Condition", "text": [ "disseminated intravascular coagulation" ], "offsets": [ [ 994, 1032 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T15", "type": "Condition", "text": [ "DIC" ], "offsets": [ [ 1034, 1037 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T16", "type": "Condition", "text": [ "fibrinogen deficiency" ], "offsets": [ [ 1040, 1061 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T17", "type": "Condition", "text": [ "clotting factor deficiency" ], "offsets": [ [ 1066, 1092 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T18", "type": "Scope", "text": [ "dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or clotting factor deficiency" ], "offsets": [ [ 915, 1092 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T19", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1106, 1124 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T20", "type": "Condition", "text": [ "immune cytopenias," ], "offsets": [ [ 1154, 1172 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T21", "type": "Condition", "text": [ "rheumatoid arthritis," ], "offsets": [ [ 1173, 1194 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T22", "type": "Condition", "text": [ "systemic lupus erythematosus" ], "offsets": [ [ 1195, 1223 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T23", "type": "Condition", "text": [ "connective tissue disorders" ], "offsets": [ [ 1231, 1258 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T24", "type": "Condition", "text": [ "vasculitis" ], "offsets": [ [ 1260, 1270 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T25", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 1272, 1298 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T26", "type": "Condition", "text": [ "psoriasis" ], "offsets": [ [ 1307, 1316 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T27", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1300, 1306 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T28", "type": "Scope", "text": [ "immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis" ], "offsets": [ [ 1154, 1316 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T29", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1328, 1338 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T30", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1340, 1346 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T31", "type": "Condition", "text": [ "basal skin cell carcinoma" ], "offsets": [ [ 1347, 1372 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T32", "type": "Condition", "text": [ "psychiatric disorder" ], "offsets": [ [ 1379, 1399 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T33", "type": "Qualifier", "text": [ "Major" ], "offsets": [ [ 1373, 1378 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T34", "type": "Qualifier", "text": [ "adequately controlled" ], "offsets": [ [ 1412, 1433 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T35", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1408, 1411 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T36", "type": "Condition", "text": [ "Epileptic seizures" ], "offsets": [ [ 1447, 1465 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T37", "type": "Qualifier", "text": [ "adequately controlled" ], "offsets": [ [ 1479, 1500 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T38", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1475, 1478 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T39", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 1521, 1530 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T40", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 1514, 1520 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T41", "type": "Condition", "text": [ "deep-tissue infection" ], "offsets": [ [ 1538, 1559 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T42", "type": "Observation", "text": [ "risk for infection" ], "offsets": [ [ 1688, 1706 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T43", "type": "Qualifier", "text": [ "high" ], "offsets": [ [ 1683, 1687 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T44", "type": "Device", "text": [ "indwelling catheter" ], "offsets": [ [ 1714, 1733 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T45", "type": "Condition", "text": [ "dysphagia" ], "offsets": [ [ 1735, 1744 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T46", "type": "Condition", "text": [ "aspiration" ], "offsets": [ [ 1750, 1760 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T47", "type": "Condition", "text": [ "decubitus ulcer" ], "offsets": [ [ 1762, 1777 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T48", "type": "Condition", "text": [ "aspiration pneumonia" ], "offsets": [ [ 1796, 1816 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T49", "type": "Condition", "text": [ "urinary tract infection" ], "offsets": [ [ 1830, 1853 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T50", "type": "Qualifier", "text": [ "recurrent" ], "offsets": [ [ 1820, 1829 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T51", "type": "Scope", "text": [ "indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection" ], "offsets": [ [ 1714, 1853 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T52", "type": "Measurement", "text": [ "human immunodeficiency virus" ], "offsets": [ [ 1874, 1902 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T53", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 1904, 1907 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T54", "type": "Value", "text": [ "Seropositivity" ], "offsets": [ [ 1855, 1869 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T55", "type": "Qualifier", "text": [ "hepatitis C Virus" ], "offsets": [ [ 1924, 1941 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T56", "type": "Condition", "text": [ "Infection" ], "offsets": [ [ 1909, 1918 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T57", "type": "Condition", "text": [ "hepatitis B infection" ], "offsets": [ [ 1958, 1979 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T58", "type": "Measurement", "text": [ "hepatitis B serology" ], "offsets": [ [ 1990, 2010 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T59", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1981, 1989 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T60", "type": "Qualifier", "text": [ "human cytomegaly virus" ], "offsets": [ [ 2034, 2056 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T61", "type": "Qualifier", "text": [ "HCMV" ], "offsets": [ [ 2058, 2062 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T62", "type": "Qualifier", "text": [ "Epstein-Barr virus" ], "offsets": [ [ 2065, 2083 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T63", "type": "Qualifier", "text": [ "EBV" ], "offsets": [ [ 2085, 2088 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T64", "type": "Qualifier", "text": [ "varicella-zoster virus" ], "offsets": [ [ 2091, 2113 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T65", "type": "Qualifier", "text": [ "VZV" ], "offsets": [ [ 2115, 2118 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T66", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 2019, 2028 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T67", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 2012, 2018 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T68", "type": "Scope", "text": [ "human cytomegaly virus (HCMV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV)" ], "offsets": [ [ 2034, 2119 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T69", "type": "Condition", "text": [ "Latent tuberculosis" ], "offsets": [ [ 2120, 2139 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T70", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 2140, 2146 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T71", "type": "Procedure", "text": [ "anti-tuberculosis therapy" ], "offsets": [ [ 2157, 2182 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T72", "type": "Qualifier", "text": [ "completed" ], "offsets": [ [ 2192, 2201 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T73", "type": "Condition", "text": [ "active tuberculosis" ], "offsets": [ [ 2206, 2225 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T74", "type": "Condition", "text": [ "fungal infections" ], "offsets": [ [ 2236, 2253 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T75", "type": "Qualifier", "text": [ "Invasive" ], "offsets": [ [ 2227, 2235 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T76", "type": "Measurement", "text": [ "Cervical cytology" ], "offsets": [ [ 2280, 2297 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T77", "type": "Negation", "text": [ "other" ], "offsets": [ [ 2298, 2303 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T78", "type": "Qualifier", "text": [ "PAP I" ], "offsets": [ [ 2318, 2323 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T79", "type": "Qualifier", "text": [ "PAP II" ], "offsets": [ [ 2318, 2324 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T80", "type": "Qualifier", "text": [ "Papanicolaou" ], "offsets": [ [ 2326, 2338 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T82", "type": "Qualifier", "text": [ "human papillomavirus" ], "offsets": [ [ 2362, 2382 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T83", "type": "Qualifier", "text": [ "cervical high risk" ], "offsets": [ [ 2343, 2361 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T84", "type": "Qualifier", "text": [ "HPV" ], "offsets": [ [ 2384, 2387 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T85", "type": "Value", "text": [ "positivity" ], "offsets": [ [ 2389, 2399 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T86", "type": "Value", "text": [ "Participation" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T87", "type": "Scope", "text": [ "other than PAP I or PAP II (Papanicolaou) or cervical high risk human papillomavirus (HPV)" ], "offsets": [ [ 2298, 2388 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T88", "type": "Scope", "text": [ "PAP I or PAP II (Papanicolaou)" ], "offsets": [ [ 2309, 2339 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T89", "type": "Scope", "text": [ "cervical high risk human papillomavirus (HPV)" ], "offsets": [ [ 2343, 2388 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T81", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 2410, 2417 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T90", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 2421, 2430 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T91", "type": "Qualifier", "text": [ "latent" ], "offsets": [ [ 2432, 2438 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T92", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 2442, 2448 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T93", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 2442, 2448 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T95", "type": "Qualifier", "text": [ "exacerbated by study medication" ], "offsets": [ [ 2496, 2527 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T96", "type": "Drug", "text": [ "study medication" ], "offsets": [ [ 2511, 2527 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T97", "type": "Scope", "text": [ "latent or active" ], "offsets": [ [ 2432, 2448 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T98", "type": "Scope", "text": [ "illness or infection" ], "offsets": [ [ 2410, 2430 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T99", "type": "Measurement", "text": [ "Differential blood count" ], "offsets": [ [ 2528, 2552 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T100", "type": "Value", "text": [ "< lower limit of normal (LLN)" ], "offsets": [ [ 2553, 2582 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T101", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 2583, 2595 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T102", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 2606, 2620 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T103", "type": "Qualifier", "text": [ "Confirmed" ], "offsets": [ [ 2596, 2605 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T104", "type": "Value", "text": [ "< the LLN of the evaluating laboratory" ], "offsets": [ [ 2621, 2659 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T105", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 2660, 2672 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T106", "type": "Value", "text": [ "<100,000/µL" ], "offsets": [ [ 2690, 2701 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T107", "type": "Temporal", "text": [ "within the past year" ], "offsets": [ [ 2702, 2722 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T108", "type": "Qualifier", "text": [ "sample without platelet clumping" ], "offsets": [ [ 2728, 2760 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T109", "type": "Scope", "text": [ "< the LLN of the evaluating laboratory at Screening or documented at <100,000/µL within the past year" ], "offsets": [ [ 2621, 2722 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T110", "type": "Value", "text": [ "above the ULN" ], "offsets": [ [ 2777, 2790 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T111", "type": "Value", "text": [ "Presence" ], "offsets": [ [ 2761, 2769 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T112", "type": "Measurement", "text": [ "anti-thyroid stimulating hormone receptor antibodies (anti-TSHR)" ], "offsets": [ [ 2795, 2859 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T113", "type": "Measurement", "text": [ "anti-thyroid peroxidase antibody (anti-TPO)" ], "offsets": [ [ 2864, 2907 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T114", "type": "Scope", "text": [ "anti-thyroid stimulating hormone receptor antibodies (anti-TSHR) and anti-thyroid peroxidase antibody (anti-TPO)" ], "offsets": [ [ 2795, 2907 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T115", "type": "Drug", "text": [ "Vaccination" ], "offsets": [ [ 2908, 2919 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T116", "type": "Temporal", "text": [ "less than 6 weeks prior to treatment with Lemtrada" ], "offsets": [ [ 2920, 2970 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T117", "type": "Reference_point", "text": [ "treatment with Lemtrada" ], "offsets": [ [ 2947, 2970 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T118", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2947, 2956 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T119", "type": "Drug", "text": [ "Lemtrada" ], "offsets": [ [ 2962, 2970 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T120", "type": "Procedure", "text": [ "Treatment" ], "offsets": [ [ 2972, 2981 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T121", "type": "Drug", "text": [ "uppressive dru", "r to" ], "offsets": [ [ 3012, 3026 ], [ 3048, 3052 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T122", "type": "Drug", "text": [ "immunosuppressive drugs" ], "offsets": [ [ 3005, 3028 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T123", "type": "Temporal", "text": [ "within 8 weeks prior to study inclusion" ], "offsets": [ [ 3029, 3068 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T124", "type": "Reference_point", "text": [ "study inclusion" ], "offsets": [ [ 3053, 3068 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T125", "type": "Scope", "text": [ "antineoplastic or immunosuppressive drugs" ], "offsets": [ [ 2987, 3028 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T126", "type": "Drug", "text": [ "pulsed corticosteroids" ], "offsets": [ [ 3084, 3106 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T127", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 3121, 3131 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T128", "type": "Condition", "text": [ "steroid psychosis" ], "offsets": [ [ 3132, 3149 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T129", "type": "Condition", "text": [ "Intolerance" ], "offsets": [ [ 3069, 3080 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T130", "type": "Condition", "text": [ "Inability to undergo MRI" ], "offsets": [ [ 3150, 3174 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T131", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 3171, 3174 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T132", "type": "Drug", "text": [ "gadolinium" ], "offsets": [ [ 3180, 3190 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T133", "type": "Mood", "text": [ "Inability to" ], "offsets": [ [ 3150, 3162 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T134", "type": "Person", "text": [ "childbearing potential" ], "offsets": [ [ 3209, 3231 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T135", "type": "Value", "text": [ "positive" ], "offsets": [ [ 3239, 3247 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T136", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 3248, 3268 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T137", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 3270, 3278 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T138", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 3282, 3291 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T139", "type": "Person", "text": [ "Female" ], "offsets": [ [ 3292, 3298 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T140", "type": "Person", "text": [ "childbearing potential" ], "offsets": [ [ 3311, 3333 ] ], "normalized": [] }, { "id": "NCT02419378_exc_T141", "type": "Scope", "text": [ "Female patients of childbearing potential" ], "offsets": [ [ 3292, 3333 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02419378_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T2", "arg2_id": "NCT02419378_exc_T3", "normalized": [] }, { "id": "NCT02419378_exc_R2", "type": "AND", "arg1_id": "NCT02419378_exc_T4", "arg2_id": "NCT02419378_exc_T5", "normalized": [] }, { "id": "NCT02419378_exc_R3", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T14", "arg2_id": "NCT02419378_exc_T15", "normalized": [] }, { "id": "NCT02419378_exc_R4", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T9", "arg2_id": "NCT02419378_exc_T18", "normalized": [] }, { "id": "NCT02419378_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T26", "arg2_id": "NCT02419378_exc_T27", "normalized": [] }, { "id": "NCT02419378_exc_R6", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T19", "arg2_id": "NCT02419378_exc_T28", "normalized": [] }, { "id": "NCT02419378_exc_R7", "type": "Has_negation", "arg1_id": "NCT02419378_exc_T31", "arg2_id": "NCT02419378_exc_T30", "normalized": [] }, { "id": "NCT02419378_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T32", "arg2_id": "NCT02419378_exc_T33", "normalized": [] }, { "id": "NCT02419378_exc_R9", "type": "Has_negation", "arg1_id": "NCT02419378_exc_T34", "arg2_id": "NCT02419378_exc_T35", "normalized": [] }, { "id": "NCT02419378_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T32", "arg2_id": "NCT02419378_exc_T34", "normalized": [] }, { "id": "NCT02419378_exc_R11", "type": "Has_negation", "arg1_id": "NCT02419378_exc_T37", "arg2_id": "NCT02419378_exc_T38", "normalized": [] }, { "id": "NCT02419378_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T36", "arg2_id": "NCT02419378_exc_T37", "normalized": [] }, { "id": "NCT02419378_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T39", "arg2_id": "NCT02419378_exc_T40", "normalized": [] }, { "id": "NCT02419378_exc_R14", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T39", "arg2_id": "NCT02419378_exc_T41", "normalized": [] }, { "id": "NCT02419378_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T42", "arg2_id": "NCT02419378_exc_T43", "normalized": [] }, { "id": "NCT02419378_exc_R16", "type": "AND", "arg1_id": "NCT02419378_exc_T45", "arg2_id": "NCT02419378_exc_T46", "normalized": [] }, { "id": "NCT02419378_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T49", "arg2_id": "NCT02419378_exc_T50", "normalized": [] }, { "id": "NCT02419378_exc_R18", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T42", "arg2_id": "NCT02419378_exc_T51", "normalized": [] }, { "id": "NCT02419378_exc_R19", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T52", "arg2_id": "NCT02419378_exc_T53", "normalized": [] }, { "id": "NCT02419378_exc_R20", "type": "Has_value", "arg1_id": "NCT02419378_exc_T52", "arg2_id": "NCT02419378_exc_T54", "normalized": [] }, { "id": "NCT02419378_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T56", "arg2_id": "NCT02419378_exc_T55", "normalized": [] }, { "id": "NCT02419378_exc_R22", "type": "Has_value", "arg1_id": "NCT02419378_exc_T58", "arg2_id": "NCT02419378_exc_T59", "normalized": [] }, { "id": "NCT02419378_exc_R23", "type": "AND", "arg1_id": "NCT02419378_exc_T57", "arg2_id": "NCT02419378_exc_T58", "normalized": [] }, { "id": "NCT02419378_exc_R24", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T66", "arg2_id": "NCT02419378_exc_T67", "normalized": [] }, { "id": "NCT02419378_exc_R25", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T60", "arg2_id": "NCT02419378_exc_T61", "normalized": [] }, { "id": "NCT02419378_exc_R26", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T62", "arg2_id": "NCT02419378_exc_T63", "normalized": [] }, { "id": "NCT02419378_exc_R27", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T64", "arg2_id": "NCT02419378_exc_T65", "normalized": [] }, { "id": "NCT02419378_exc_R28", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T66", "arg2_id": "NCT02419378_exc_T68", "normalized": [] }, { "id": "NCT02419378_exc_R29", "type": "Has_negation", "arg1_id": "NCT02419378_exc_T72", "arg2_id": "NCT02419378_exc_T70", "normalized": [] }, { "id": "NCT02419378_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T71", "arg2_id": "NCT02419378_exc_T72", "normalized": [] }, { "id": "NCT02419378_exc_R31", "type": "AND", "arg1_id": "NCT02419378_exc_T69", "arg2_id": "NCT02419378_exc_T71", "normalized": [] }, { "id": "NCT02419378_exc_R32", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T74", "arg2_id": "NCT02419378_exc_T75", "normalized": [] }, { "id": "NCT02419378_exc_R35", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T82", "arg2_id": "NCT02419378_exc_T84", "normalized": [] }, { "id": "NCT02419378_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T82", "arg2_id": "NCT02419378_exc_T83", "normalized": [] }, { "id": "NCT02419378_exc_R37", "type": "Has_value", "arg1_id": "NCT02419378_exc_T76", "arg2_id": "NCT02419378_exc_T85", "normalized": [] }, { "id": "NCT02419378_exc_R38", "type": "Has_negation", "arg1_id": "NCT02419378_exc_T88", "arg2_id": "NCT02419378_exc_T77", "normalized": [] }, { "id": "NCT02419378_exc_R39", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T76", "arg2_id": "NCT02419378_exc_T87", "normalized": [] }, { "id": "NCT02419378_exc_R41", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T98", "arg2_id": "NCT02419378_exc_T97", "normalized": [] }, { "id": "NCT02419378_exc_R42", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T98", "arg2_id": "NCT02419378_exc_T95", "normalized": [] }, { "id": "NCT02419378_exc_R43", "type": "Has_value", "arg1_id": "NCT02419378_exc_T99", "arg2_id": "NCT02419378_exc_T100", "normalized": [] }, { "id": "NCT02419378_exc_R44", "type": "Has_temporal", "arg1_id": "NCT02419378_exc_T99", "arg2_id": "NCT02419378_exc_T101", "normalized": [] }, { "id": "NCT02419378_exc_R45", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T102", "arg2_id": "NCT02419378_exc_T103", "normalized": [] }, { "id": "NCT02419378_exc_R48", "type": "Has_temporal", "arg1_id": "NCT02419378_exc_T106", "arg2_id": "NCT02419378_exc_T107", "normalized": [] }, { "id": "NCT02419378_exc_R46", "type": "Has_temporal", "arg1_id": "NCT02419378_exc_T104", "arg2_id": "NCT02419378_exc_T105", "normalized": [] }, { "id": "NCT02419378_exc_R47", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T102", "arg2_id": "NCT02419378_exc_T109", "normalized": [] }, { "id": "NCT02419378_exc_R49", "type": "Has_qualifier", "arg1_id": "NCT02419378_exc_T102", "arg2_id": "NCT02419378_exc_T108", "normalized": [] }, { "id": "NCT02419378_exc_R50", "type": "Subsumes", "arg1_id": "NCT02419378_exc_T111", "arg2_id": "NCT02419378_exc_T110", "normalized": [] }, { "id": "NCT02419378_exc_R51", "type": "Has_value", "arg1_id": "NCT02419378_exc_T114", "arg2_id": "NCT02419378_exc_T111", "normalized": [] }, { "id": "NCT02419378_exc_R52", "type": "AND", "arg1_id": "NCT02419378_exc_T118", "arg2_id": "NCT02419378_exc_T119", "normalized": [] }, { "id": "NCT02419378_exc_R54", "type": "Has_index", "arg1_id": "NCT02419378_exc_T116", "arg2_id": "NCT02419378_exc_T117", "normalized": [] }, { "id": "NCT02419378_exc_R55", "type": "AND", "arg1_id": "NCT02419378_exc_T116", "arg2_id": "NCT02419378_exc_T115", "normalized": [] }, { "id": "NCT02419378_exc_R56", "type": "Has_index", "arg1_id": "NCT02419378_exc_T123", "arg2_id": "NCT02419378_exc_T124", "normalized": [] }, { "id": "NCT02419378_exc_R57", "type": "Has_scope", "arg1_id": "NCT02419378_exc_T120", "arg2_id": "NCT02419378_exc_T125", "normalized": [] }, { "id": "NCT02419378_exc_R59", "type": "Has_temporal", "arg1_id": "NCT02419378_exc_T128", "arg2_id": "NCT02419378_exc_T127", "normalized": [] }, { "id": "NCT02419378_exc_R58", "type": "AND", "arg1_id": "NCT02419378_exc_T129", "arg2_id": "NCT02419378_exc_T126", "normalized": [] }, { "id": "NCT02419378_exc_R60", "type": "AND", "arg1_id": "NCT02419378_exc_T131", "arg2_id": "NCT02419378_exc_T132", "normalized": [] }, { "id": "NCT02419378_exc_R61", "type": "Has_mood", "arg1_id": "NCT02419378_exc_T131", "arg2_id": "NCT02419378_exc_T133", "normalized": [] }, { "id": "NCT02419378_exc_R63", "type": "Has_value", "arg1_id": "NCT02419378_exc_T136", "arg2_id": "NCT02419378_exc_T135", "normalized": [] }, { "id": "NCT02419378_exc_R64", "type": "AND", "arg1_id": "NCT02419378_exc_T134", "arg2_id": "NCT02419378_exc_T136", "normalized": [] } ]

[ { "id": "NCT02419378_inc_text", "type": "inclusion", "text": [ "Signed informed consent form (ICF)\nAge 18 to 55 years old (inclusive) as of the date the ICF is signed\nDiagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years before Screening\nOnset of MS symptoms (as determined by a neurologist, either at present or retrospectively) within 10 years of the date the ICF is signed\nEDSS score 0.0 to 5.0 (inclusive) at Screening\nPatients with (highly) active RRMS disease course indicated to receive alemtuzumab according to the following conditions (at least 1 out of 3 conditions has to be fulfilled): 1. =2 MS relapses within 24 months, 2. clinical (=1 relapse) or MRI (new gadolinium enhancing lesions) disease activity under therapy with other diseasemodifying therapies, 3. severe relapse with high disease activity (=9 T2 hyperintense Lesions and =1 gadolinium enhancing lesion) on MRI.\nCompletion of all vaccinations required by the applicable immunization guidelines published by \"ständige Impfkommission\" (STIKO)\nHistory of chickenpox or positive test for antibodies against varicella zoster virus (VZV)\n" ], "offsets": [ [ 0, 1137 ] ] } ]

[ { "id": "NCT02419378_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 35, 38 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T3", "type": "Value", "text": [ "18 to 55 years old (" ], "offsets": [ [ 39, 59 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T4", "type": "Condition", "text": [ "MS" ], "offsets": [ [ 116, 118 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T5", "type": "Measurement", "text": [ "McDonald criteria 2010" ], "offsets": [ [ 136, 158 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T6", "type": "Procedure", "text": [ "cranial MRI scan" ], "offsets": [ [ 163, 179 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T7", "type": "Temporal", "text": [ "within 10 years before Screening" ], "offsets": [ [ 234, 266 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T8", "type": "Scope", "text": [ "McDonald criteria 2010 and cranial MRI scan" ], "offsets": [ [ 136, 179 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T9", "type": "Condition", "text": [ "MS symptoms" ], "offsets": [ [ 276, 287 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T10", "type": "Temporal", "text": [ "within 10 years" ], "offsets": [ [ 359, 374 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T11", "type": "Measurement", "text": [ "EDSS score" ], "offsets": [ [ 405, 415 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T12", "type": "Value", "text": [ "0.0 to 5.0" ], "offsets": [ [ 416, 426 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T13", "type": "Condition", "text": [ "RRMS" ], "offsets": [ [ 482, 486 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T14", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 475, 481 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T15", "type": "Drug", "text": [ "alemtuzumab" ], "offsets": [ [ 523, 534 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T16", "type": "Condition", "text": [ "MS relapses" ], "offsets": [ [ 633, 644 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T17", "type": "Multiplier", "text": [ "=2" ], "offsets": [ [ 630, 632 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T18", "type": "Temporal", "text": [ "within 24 months," ], "offsets": [ [ 645, 662 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T19", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 679, 686 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T20", "type": "Multiplier", "text": [ "=1" ], "offsets": [ [ 676, 678 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T21", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 691, 694 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T22", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 810, 817 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T23", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 803, 809 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T24", "type": "Condition", "text": [ "Lesions" ], "offsets": [ [ 865, 872 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T25", "type": "Qualifier", "text": [ "T2 hyperintense" ], "offsets": [ [ 849, 864 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T26", "type": "Multiplier", "text": [ "=9" ], "offsets": [ [ 846, 848 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T27", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 901, 907 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T28", "type": "Qualifier", "text": [ "gadolinium enhancing" ], "offsets": [ [ 880, 900 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T29", "type": "Multiplier", "text": [ "=1" ], "offsets": [ [ 877, 879 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T30", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 912, 915 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T31", "type": "Condition", "text": [ "lesions" ], "offsets": [ [ 721, 728 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T32", "type": "Qualifier", "text": [ "gadolinium enhancing" ], "offsets": [ [ 700, 720 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T33", "type": "Qualifier", "text": [ "new" ], "offsets": [ [ 696, 699 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T34", "type": "Scope", "text": [ "clinical (=1 relapse) or MRI (new gadolinium enhancing lesions)" ], "offsets": [ [ 666, 729 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T35", "type": "Scope", "text": [ "=9 T2 hyperintense Lesions and =1 gadolinium enhancing lesion" ], "offsets": [ [ 846, 907 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T37", "type": "Condition", "text": [ "chickenpox" ], "offsets": [ [ 1057, 1067 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T38", "type": "Measurement", "text": [ "test for antibodies" ], "offsets": [ [ 1080, 1099 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T39", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1071, 1079 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T40", "type": "Qualifier", "text": [ "varicella zoster virus" ], "offsets": [ [ 1108, 1130 ] ], "normalized": [] }, { "id": "NCT02419378_inc_T41", "type": "Qualifier", "text": [ "VZV" ], "offsets": [ [ 1132, 1135 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02419378_inc_R1", "type": "Has_value", "arg1_id": "NCT02419378_inc_T2", "arg2_id": "NCT02419378_inc_T3", "normalized": [] }, { "id": "NCT02419378_inc_R2", "type": "AND", "arg1_id": "NCT02419378_inc_T8", "arg2_id": "NCT02419378_inc_T4", "normalized": [] }, { "id": "NCT02419378_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02419378_inc_T4", "arg2_id": "NCT02419378_inc_T7", "normalized": [] }, { "id": "NCT02419378_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02419378_inc_T9", "arg2_id": "NCT02419378_inc_T10", "normalized": [] }, { "id": "NCT02419378_inc_R5", "type": "Has_value", "arg1_id": "NCT02419378_inc_T11", "arg2_id": "NCT02419378_inc_T12", "normalized": [] }, { "id": "NCT02419378_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T13", "arg2_id": "NCT02419378_inc_T14", "normalized": [] }, { "id": "NCT02419378_inc_R7", "type": "AND", "arg1_id": "NCT02419378_inc_T13", "arg2_id": "NCT02419378_inc_T15", "normalized": [] }, { "id": "NCT02419378_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT02419378_inc_T16", "arg2_id": "NCT02419378_inc_T17", "normalized": [] }, { "id": "NCT02419378_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02419378_inc_T16", "arg2_id": "NCT02419378_inc_T18", "normalized": [] }, { "id": "NCT02419378_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT02419378_inc_T19", "arg2_id": "NCT02419378_inc_T20", "normalized": [] }, { "id": "NCT02419378_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T31", "arg2_id": "NCT02419378_inc_T32", "normalized": [] }, { "id": "NCT02419378_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T31", "arg2_id": "NCT02419378_inc_T33", "normalized": [] }, { "id": "NCT02419378_inc_R13", "type": "AND", "arg1_id": "NCT02419378_inc_T21", "arg2_id": "NCT02419378_inc_T31", "normalized": [] }, { "id": "NCT02419378_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T22", "arg2_id": "NCT02419378_inc_T23", "normalized": [] }, { "id": "NCT02419378_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T24", "arg2_id": "NCT02419378_inc_T25", "normalized": [] }, { "id": "NCT02419378_inc_R16", "type": "Has_multiplier", "arg1_id": "NCT02419378_inc_T24", "arg2_id": "NCT02419378_inc_T26", "normalized": [] }, { "id": "NCT02419378_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T27", "arg2_id": "NCT02419378_inc_T28", "normalized": [] }, { "id": "NCT02419378_inc_R18", "type": "Has_multiplier", "arg1_id": "NCT02419378_inc_T27", "arg2_id": "NCT02419378_inc_T29", "normalized": [] }, { "id": "NCT02419378_inc_R19", "type": "Has_scope", "arg1_id": "NCT02419378_inc_T30", "arg2_id": "NCT02419378_inc_T35", "normalized": [] }, { "id": "NCT02419378_inc_R20", "type": "AND", "arg1_id": "NCT02419378_inc_T22", "arg2_id": "NCT02419378_inc_T30", "normalized": [] }, { "id": "NCT02419378_inc_R21", "type": "Subsumes", "arg1_id": "NCT02419378_inc_T40", "arg2_id": "NCT02419378_inc_T41", "normalized": [] }, { "id": "NCT02419378_inc_R22", "type": "Has_qualifier", "arg1_id": "NCT02419378_inc_T38", "arg2_id": "NCT02419378_inc_T40", "normalized": [] }, { "id": "NCT02419378_inc_R23", "type": "Has_value", "arg1_id": "NCT02419378_inc_T38", "arg2_id": "NCT02419378_inc_T39", "normalized": [] } ]

[ { "id": "NCT02420015_exc_text", "type": "exclusion", "text": [ "Have a history of myocardial infarction in the past 6 months\nHave a contraindication to NRT with no medical clearance from the primary care provider or study physician\nUse and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco\nAre pregnant\nMeet criteria for a current manic episode based on structured clinical interview\nAre currently enrolled in another smoking cessation trial\nAre currently imprisoned or in psychiatric hospitalization\n" ], "offsets": [ [ 0, 482 ] ] } ]

[ { "id": "NCT02420015_exc_T1", "type": "Condition", "text": [ "myocardial infarction i" ], "offsets": [ [ 18, 41 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T2", "type": "Temporal", "text": [ "past 6 months" ], "offsets": [ [ 47, 60 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T3", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 68, 84 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T4", "type": "Procedure", "text": [ "NRT" ], "offsets": [ [ 88, 91 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T6", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 275, 283 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T7", "type": "Condition", "text": [ "manic episode" ], "offsets": [ [ 312, 325 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T9", "type": "Person", "text": [ "imprisoned" ], "offsets": [ [ 437, 447 ] ], "normalized": [] }, { "id": "NCT02420015_exc_T10", "type": "Observation", "text": [ "psychiatric hospitalization" ], "offsets": [ [ 454, 481 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02420015_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02420015_exc_T1", "arg2_id": "NCT02420015_exc_T2", "normalized": [] }, { "id": "NCT02420015_exc_R2", "type": "AND", "arg1_id": "NCT02420015_exc_T3", "arg2_id": "NCT02420015_exc_T4", "normalized": [] } ]

[ { "id": "NCT02420015_inc_text", "type": "inclusion", "text": [ "Currently smoke at least ten cigarettes a day\nHave been smoking for at least one year\nMeet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview\nCan speak and write fluent conversational English\nAre between 18 and 70 years of age\nAre willing to make a smoking cessation attempt\nScore 26 or higher on the Montreal Cognitive Assessment\n" ], "offsets": [ [ 0, 403 ] ] } ]

[ { "id": "NCT02420015_inc_T1", "type": "Observation", "text": [ "smoke" ], "offsets": [ [ 10, 15 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T2", "type": "Multiplier", "text": [ "at least ten cigarettes a day" ], "offsets": [ [ 16, 45 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T3", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 56, 63 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T4", "type": "Temporal", "text": [ "at least one year" ], "offsets": [ [ 68, 85 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T5", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 104, 117 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T6", "type": "Condition", "text": [ "schizoaffective disorder" ], "offsets": [ [ 119, 143 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T7", "type": "Condition", "text": [ "psychotic disorder" ], "offsets": [ [ 156, 174 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T9", "type": "Person", "text": [ "age" ], "offsets": [ [ 295, 298 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T10", "type": "Value", "text": [ "between 18 and 70 years" ], "offsets": [ [ 268, 291 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T12", "type": "Measurement", "text": [ "Montreal Cognitive Assessment" ], "offsets": [ [ 373, 402 ] ], "normalized": [] }, { "id": "NCT02420015_inc_T13", "type": "Value", "text": [ "26 or higher" ], "offsets": [ [ 353, 365 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02420015_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT02420015_inc_T1", "arg2_id": "NCT02420015_inc_T2", "normalized": [] }, { "id": "NCT02420015_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02420015_inc_T3", "arg2_id": "NCT02420015_inc_T4", "normalized": [] }, { "id": "NCT02420015_inc_R3", "type": "Has_value", "arg1_id": "NCT02420015_inc_T9", "arg2_id": "NCT02420015_inc_T10", "normalized": [] }, { "id": "NCT02420015_inc_R4", "type": "Has_value", "arg1_id": "NCT02420015_inc_T12", "arg2_id": "NCT02420015_inc_T13", "normalized": [] } ]

[ { "id": "NCT02425774_exc_text", "type": "exclusion", "text": [ "adjuvant radiotherapy\nevident intra-abdominal inflammation (diagnosed by imaging and/or laboratory results, including an abscess or cholecystitis)\nchronic pancreatitis\npancreatic polypeptide producing endocrine tumor\nAmerican Society of Anesthesiologists physical-health status classification (ASA-PS)>3\nPoorly regulated diabetes (>200 mg/dl (=11 mmol/l))\n" ], "offsets": [ [ 0, 356 ] ] } ]

[ { "id": "NCT02425774_exc_T1", "type": "Procedure", "text": [ "adjuvant radiotherapy" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T2", "type": "Condition", "text": [ "intra-abdominal inflammation" ], "offsets": [ [ 30, 58 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T3", "type": "Procedure", "text": [ "imaging" ], "offsets": [ [ 73, 80 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T4", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 88, 98 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T5", "type": "Condition", "text": [ "abscess" ], "offsets": [ [ 121, 128 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T6", "type": "Condition", "text": [ "cholecystitis" ], "offsets": [ [ 132, 145 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T7", "type": "Scope", "text": [ "imaging and/or laboratory" ], "offsets": [ [ 73, 98 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T8", "type": "Scope", "text": [ "ntra-abdominal inflammation", "iagnosed by imaging and/or laboratory" ], "offsets": [ [ 31, 58 ], [ 61, 98 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T9", "type": "Scope", "text": [ "abscess or cholecystitis" ], "offsets": [ [ 121, 145 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T10", "type": "Condition", "text": [ "chronic pancreatitis" ], "offsets": [ [ 147, 167 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T11", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 147, 154 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T12", "type": "Condition", "text": [ "pancreatitis" ], "offsets": [ [ 155, 167 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T13", "type": "Condition", "text": [ "pancreatic polypeptide producing endocrine tumor" ], "offsets": [ [ 168, 216 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T14", "type": "Measurement", "text": [ "American Society of Anesthesiologists physical-health status classification (ASA-PS)" ], "offsets": [ [ 217, 301 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T15", "type": "Value", "text": [ ">3" ], "offsets": [ [ 301, 303 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T16", "type": "Qualifier", "text": [ "Poorly regulated" ], "offsets": [ [ 304, 320 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T17", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 321, 329 ] ], "normalized": [] }, { "id": "NCT02425774_exc_T18", "type": "Qualifier", "text": [ ">200 mg/dl (=11 mmol/l)" ], "offsets": [ [ 331, 354 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02425774_exc_R1", "type": "Has_scope", "arg1_id": "NCT02425774_exc_T2", "arg2_id": "NCT02425774_exc_T7", "normalized": [] }, { "id": "NCT02425774_exc_R2", "type": "Subsumes", "arg1_id": "NCT02425774_exc_T8", "arg2_id": "NCT02425774_exc_T9", "normalized": [] }, { "id": "NCT02425774_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT02425774_exc_T12", "arg2_id": "NCT02425774_exc_T11", "normalized": [] }, { "id": "NCT02425774_exc_R4", "type": "Has_value", "arg1_id": "NCT02425774_exc_T14", "arg2_id": "NCT02425774_exc_T15", "normalized": [] }, { "id": "NCT02425774_exc_R5", "type": "Subsumes", "arg1_id": "NCT02425774_exc_T16", "arg2_id": "NCT02425774_exc_T18", "normalized": [] }, { "id": "NCT02425774_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02425774_exc_T17", "arg2_id": "NCT02425774_exc_T16", "normalized": [] } ]

[ { "id": "NCT02425774_inc_text", "type": "inclusion", "text": [ "patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor\n" ], "offsets": [ [ 0, 97 ] ] } ]

[ { "id": "NCT02425774_inc_T1", "type": "Procedure", "text": [ "full resection of the pancreas" ], "offsets": [ [ 31, 61 ] ], "normalized": [] }, { "id": "NCT02425774_inc_T2", "type": "Procedure", "text": [ "partial", "resection of the pancreas" ], "offsets": [ [ 20, 27 ], [ 36, 61 ] ], "normalized": [] }, { "id": "NCT02425774_inc_T3", "type": "Condition", "text": [ "malignant tumor" ], "offsets": [ [ 81, 96 ] ], "normalized": [] }, { "id": "NCT02425774_inc_T4", "type": "Condition", "text": [ "benign", "tumor" ], "offsets": [ [ 71, 77 ], [ 91, 96 ] ], "normalized": [] }, { "id": "NCT02425774_inc_T5", "type": "Scope", "text": [ "benign or malignant tumor" ], "offsets": [ [ 71, 96 ] ], "normalized": [] }, { "id": "NCT02425774_inc_T6", "type": "Scope", "text": [ "partial or full resection of the pancreas" ], "offsets": [ [ 20, 61 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02425774_inc_R1", "type": "Has_scope", "arg1_id": "NCT02425774_inc_T6", "arg2_id": "NCT02425774_inc_T5", "normalized": [] } ]

[ { "id": "NCT02426034_exc_text", "type": "exclusion", "text": [ "Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; II-level arrhythmia (including QT interval prolongation, for man = 450 ms, for woman = 470 ms) together with Class II cardiac dysfunction;\nFactors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);\nSubjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;\nAbnormal Coagulation (INR>1.5<U+3001>APTT>1.5 UNL), with tendency of bleed;\nAssociated with CNS (central nervous system) metastases;\nPregnant or lactating women;\nOther conditions regimented at investigators' discretion.\n" ], "offsets": [ [ 0, 1121 ] ] } ]

[ { "id": "NCT02426034_exc_T1", "type": "Condition", "text": [ "arterial hypertension" ], "offsets": [ [ 30, 51 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T2", "type": "Qualifier", "text": [ "poor-controlled" ], "offsets": [ [ 14, 29 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T3", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 53, 76 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T4", "type": "Value", "text": [ "> 140 mmHg" ], "offsets": [ [ 76, 86 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T5", "type": "Measurement", "text": [ "diastolic blood pressure" ], "offsets": [ [ 91, 115 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T6", "type": "Value", "text": [ "> 90 mm Hg" ], "offsets": [ [ 116, 126 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T7", "type": "Scope", "text": [ "systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg" ], "offsets": [ [ 53, 126 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T8", "type": "Condition", "text": [ "Coronary heart disease" ], "offsets": [ [ 165, 187 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T9", "type": "Qualifier", "text": [ "greater than ClassII" ], "offsets": [ [ 188, 208 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T10", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 219, 229 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T11", "type": "Qualifier", "text": [ "II-level" ], "offsets": [ [ 210, 218 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T12", "type": "Qualifier", "text": [ "Subjects" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T13", "type": "Condition", "text": [ "QT interval prolongation" ], "offsets": [ [ 241, 265 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T14", "type": "Condition", "text": [ "cardiac dysfunction" ], "offsets": [ [ 328, 347 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T15", "type": "Qualifier", "text": [ "Class II" ], "offsets": [ [ 319, 327 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T16", "type": "Scope", "text": [ "II-level arrhythmia (including QT interval prolongation, for man = 450 ms, for woman = 470 ms) together with Class II cardiac dysfunction" ], "offsets": [ [ 210, 347 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T17", "type": "Condition", "text": [ "inability to swallow" ], "offsets": [ [ 411, 431 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T18", "type": "Condition", "text": [ "chronic diarrhea" ], "offsets": [ [ 433, 449 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T19", "type": "Condition", "text": [ "intestinal obstruction" ], "offsets": [ [ 454, 476 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T20", "type": "Observation", "text": [ "gastrointestinal bleeding risk" ], "offsets": [ [ 498, 528 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T21", "type": "Qualifier", "text": [ "high" ], "offsets": [ [ 493, 497 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T22", "type": "Condition", "text": [ "ulcer lesions" ], "offsets": [ [ 579, 592 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T23", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 572, 578 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T24", "type": "Measurement", "text": [ "fecal occult blood test" ], "offsets": [ [ 607, 630 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T25", "type": "Value", "text": [ "positive" ], "offsets": [ [ 598, 606 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T26", "type": "Value", "text": [ "++" ], "offsets": [ [ 632, 634 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T27", "type": "Condition", "text": [ "black stool" ], "offsets": [ [ 648, 659 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T28", "type": "Condition", "text": [ "vomiting blood" ], "offsets": [ [ 664, 678 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T29", "type": "Temporal", "text": [ "past 3 months" ], "offsets": [ [ 686, 699 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T30", "type": "Scope", "text": [ "black stool, or vomiting blood" ], "offsets": [ [ 648, 678 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T31", "type": "Condition", "text": [ "primary lesion" ], "offsets": [ [ 711, 725 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T32", "type": "Qualifier", "text": [ "stomach" ], "offsets": [ [ 729, 736 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T33", "type": "Measurement", "text": [ "fecal occult blood test" ], "offsets": [ [ 751, 774 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T34", "type": "Value", "text": [ "positive" ], "offsets": [ [ 742, 750 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T35", "type": "Value", "text": [ "+" ], "offsets": [ [ 776, 777 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T36", "type": "Condition", "text": [ "ulcerated gastric carcinoma" ], "offsets": [ [ 780, 807 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T37", "type": "Qualifier", "text": [ "alimentary tract" ], "offsets": [ [ 821, 837 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T38", "type": "Qualifier", "text": [ "massive" ], "offsets": [ [ 813, 820 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T39", "type": "Observation", "text": [ "bleeding risk" ], "offsets": [ [ 838, 851 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T40", "type": "Scope", "text": [ "local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result" ], "offsets": [ [ 566, 899 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T41", "type": "Condition", "text": [ "Abnormal Coagulation" ], "offsets": [ [ 901, 921 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T42", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 923, 926 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T43", "type": "Value", "text": [ ">1.5" ], "offsets": [ [ 926, 930 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T44", "type": "Measurement", "text": [ "APTT" ], "offsets": [ [ 938, 942 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T45", "type": "Value", "text": [ ">1.5 UNL" ], "offsets": [ [ 942, 950 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T46", "type": "Condition", "text": [ "tendency of bleed" ], "offsets": [ [ 958, 975 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T47", "type": "Scope", "text": [ "INR>1.5<U+3001>APTT>1.5 UNL" ], "offsets": [ [ 923, 950 ] ], "normalized": [] }, { "id": "NCT02426034_exc_T48", "type": "Condition", "text": [ "stases;\nPr", "(ce" ], "offsets": [ [ 1026, 1036 ], [ 997, 1000 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02426034_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T1", "arg2_id": "NCT02426034_exc_T2", "normalized": [] }, { "id": "NCT02426034_exc_R2", "type": "Has_value", "arg1_id": "NCT02426034_exc_T3", "arg2_id": "NCT02426034_exc_T4", "normalized": [] }, { "id": "NCT02426034_exc_R3", "type": "Has_value", "arg1_id": "NCT02426034_exc_T5", "arg2_id": "NCT02426034_exc_T6", "normalized": [] }, { "id": "NCT02426034_exc_R4", "type": "Has_scope", "arg1_id": "NCT02426034_exc_T1", "arg2_id": "NCT02426034_exc_T7", "normalized": [] }, { "id": "NCT02426034_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T8", "arg2_id": "NCT02426034_exc_T9", "normalized": [] }, { "id": "NCT02426034_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T10", "arg2_id": "NCT02426034_exc_T11", "normalized": [] }, { "id": "NCT02426034_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T14", "arg2_id": "NCT02426034_exc_T15", "normalized": [] }, { "id": "NCT02426034_exc_R8", "type": "Subsumes", "arg1_id": "NCT02426034_exc_T10", "arg2_id": "NCT02426034_exc_T13", "normalized": [] }, { "id": "NCT02426034_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T20", "arg2_id": "NCT02426034_exc_T21", "normalized": [] }, { "id": "NCT02426034_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T22", "arg2_id": "NCT02426034_exc_T23", "normalized": [] }, { "id": "NCT02426034_exc_R11", "type": "Has_value", "arg1_id": "NCT02426034_exc_T24", "arg2_id": "NCT02426034_exc_T25", "normalized": [] }, { "id": "NCT02426034_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02426034_exc_T30", "arg2_id": "NCT02426034_exc_T29", "normalized": [] }, { "id": "NCT02426034_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T31", "arg2_id": "NCT02426034_exc_T32", "normalized": [] }, { "id": "NCT02426034_exc_R12", "type": "Subsumes", "arg1_id": "NCT02426034_exc_T25", "arg2_id": "NCT02426034_exc_T26", "normalized": [] }, { "id": "NCT02426034_exc_R15", "type": "Subsumes", "arg1_id": "NCT02426034_exc_T34", "arg2_id": "NCT02426034_exc_T35", "normalized": [] }, { "id": "NCT02426034_exc_R16", "type": "Has_value", "arg1_id": "NCT02426034_exc_T33", "arg2_id": "NCT02426034_exc_T34", "normalized": [] }, { "id": "NCT02426034_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T39", "arg2_id": "NCT02426034_exc_T37", "normalized": [] }, { "id": "NCT02426034_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02426034_exc_T39", "arg2_id": "NCT02426034_exc_T38", "normalized": [] }, { "id": "NCT02426034_exc_R20", "type": "AND", "arg1_id": "NCT02426034_exc_T31", "arg2_id": "NCT02426034_exc_T33", "normalized": [] }, { "id": "NCT02426034_exc_R21", "type": "AND", "arg1_id": "NCT02426034_exc_T22", "arg2_id": "NCT02426034_exc_T24", "normalized": [] }, { "id": "NCT02426034_exc_R22", "type": "Subsumes", "arg1_id": "NCT02426034_exc_T20", "arg2_id": "NCT02426034_exc_T40", "normalized": [] }, { "id": "NCT02426034_exc_R23", "type": "Has_value", "arg1_id": "NCT02426034_exc_T42", "arg2_id": "NCT02426034_exc_T43", "normalized": [] }, { "id": "NCT02426034_exc_R24", "type": "Has_value", "arg1_id": "NCT02426034_exc_T44", "arg2_id": "NCT02426034_exc_T45", "normalized": [] }, { "id": "NCT02426034_exc_R25", "type": "Has_scope", "arg1_id": "NCT02426034_exc_T41", "arg2_id": "NCT02426034_exc_T47", "normalized": [] }, { "id": "NCT02426034_exc_R26", "type": "AND", "arg1_id": "NCT02426034_exc_T41", "arg2_id": "NCT02426034_exc_T46", "normalized": [] } ]

[ { "id": "NCT02426034_inc_text", "type": "inclusion", "text": [ "Age: 18 to75 years old;\nPathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring = 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);\nFailure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;\nECOG PS of 0-2;\nHB = 90g / L\nANC = 1.5 × 109 / L\nPLT = 80 × 109 / L\nBilirubin <1.25 times the upper limit of normal (ULN)\nALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN\nSerum Cr = 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)\nAn expected survival of = 3 months;\nPatient received apatinib treatment regimen at investigators' discretion;\nPatient has to voluntarily join the study and sign the Informed Consent Form for the study;\nPregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.\n" ], "offsets": [ [ 0, 1346 ] ] } ]

[ { "id": "NCT02426034_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T2", "type": "Value", "text": [ "18 to75 years old" ], "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T3", "type": "Condition", "text": [ "advanced gastric cancer" ], "offsets": [ [ 54, 77 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T4", "type": "Condition", "text": [ "adenocarcinoma" ], "offsets": [ [ 89, 103 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T5", "type": "Qualifier", "text": [ "gastroesophageal junction" ], "offsets": [ [ 111, 136 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T6", "type": "Condition", "text": [ "metastases" ], "offsets": [ [ 154, 164 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T7", "type": "Negation", "text": [ "outside" ], "offsets": [ [ 165, 172 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T8", "type": "Qualifier", "text": [ "stomach" ], "offsets": [ [ 177, 184 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T9", "type": "Multiplier", "text": [ "at least two" ], "offsets": [ [ 345, 357 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T10", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 364, 376 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T11", "type": "Qualifier", "text": [ "Failure" ], "offsets": [ [ 262, 269 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T12", "type": "Measurement", "text": [ "ECOG PS" ], "offsets": [ [ 387, 394 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T13", "type": "Value", "text": [ "0-2" ], "offsets": [ [ 398, 401 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T14", "type": "Measurement", "text": [ "HB" ], "offsets": [ [ 403, 405 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T15", "type": "Value", "text": [ "= 90g / L" ], "offsets": [ [ 406, 415 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T16", "type": "Measurement", "text": [ "ANC" ], "offsets": [ [ 416, 419 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T17", "type": "Value", "text": [ "= 1.5 × 109 / L" ], "offsets": [ [ 420, 435 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T18", "type": "Measurement", "text": [ "PLT" ], "offsets": [ [ 436, 439 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T19", "type": "Value", "text": [ "= 80 × 109 / L" ], "offsets": [ [ 440, 454 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T20", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 455, 464 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T21", "type": "Value", "text": [ "<1.25 times the upper limit of normal" ], "offsets": [ [ 465, 502 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T22", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 509, 512 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T23", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 517, 520 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T24", "type": "Value", "text": [ "<2.5 × ULN" ], "offsets": [ [ 521, 531 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T25", "type": "Condition", "text": [ "liver metastases" ], "offsets": [ [ 533, 549 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T26", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 563, 566 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T27", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 571, 574 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T28", "type": "Value", "text": [ "<5 × ULN" ], "offsets": [ [ 574, 582 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T29", "type": "Scope", "text": [ "ALT and AST" ], "offsets": [ [ 563, 574 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T30", "type": "Measurement", "text": [ "Serum Cr" ], "offsets": [ [ 583, 591 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T31", "type": "Value", "text": [ "= 1 × ULN" ], "offsets": [ [ 592, 601 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T32", "type": "Measurement", "text": [ "endogenous creatinine clearance" ], "offsets": [ [ 602, 633 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T33", "type": "Value", "text": [ ">50ml/min" ], "offsets": [ [ 633, 642 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T34", "type": "Observation", "text": [ "expected survival" ], "offsets": [ [ 672, 689 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T35", "type": "Value", "text": [ "= 3 months" ], "offsets": [ [ 693, 703 ] ], "normalized": [] }, { "id": "NCT02426034_inc_T36", "type": "Drug", "text": [ "apatinib" ], "offsets": [ [ 722, 730 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02426034_inc_R1", "type": "Has_value", "arg1_id": "NCT02426034_inc_T1", "arg2_id": "NCT02426034_inc_T2", "normalized": [] }, { "id": "NCT02426034_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02426034_inc_T4", "arg2_id": "NCT02426034_inc_T5", "normalized": [] }, { "id": "NCT02426034_inc_R3", "type": "Subsumes", "arg1_id": "NCT02426034_inc_T3", "arg2_id": "NCT02426034_inc_T4", "normalized": [] }, { "id": "NCT02426034_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02426034_inc_T6", "arg2_id": "NCT02426034_inc_T8", "normalized": [] }, { "id": "NCT02426034_inc_R5", "type": "Has_negation", "arg1_id": "NCT02426034_inc_T8", "arg2_id": "NCT02426034_inc_T7", "normalized": [] }, { "id": "NCT02426034_inc_R6", "type": "Has_multiplier", "arg1_id": "NCT02426034_inc_T10", "arg2_id": "NCT02426034_inc_T9", "normalized": [] }, { "id": "NCT02426034_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02426034_inc_T10", "arg2_id": "NCT02426034_inc_T11", "normalized": [] }, { "id": "NCT02426034_inc_R8", "type": "Has_value", "arg1_id": "NCT02426034_inc_T12", "arg2_id": "NCT02426034_inc_T13", "normalized": [] }, { "id": "NCT02426034_inc_R9", "type": "Has_value", "arg1_id": "NCT02426034_inc_T14", "arg2_id": "NCT02426034_inc_T15", "normalized": [] }, { "id": "NCT02426034_inc_R10", "type": "Has_value", "arg1_id": "NCT02426034_inc_T16", "arg2_id": "NCT02426034_inc_T17", "normalized": [] }, { "id": "NCT02426034_inc_R11", "type": "Has_value", "arg1_id": "NCT02426034_inc_T18", "arg2_id": "NCT02426034_inc_T19", "normalized": [] }, { "id": "NCT02426034_inc_R12", "type": "Has_value", "arg1_id": "NCT02426034_inc_T20", "arg2_id": "NCT02426034_inc_T21", "normalized": [] }, { "id": "NCT02426034_inc_R13", "type": "Has_value", "arg1_id": "NCT02426034_inc_T23", "arg2_id": "NCT02426034_inc_T24", "normalized": [] }, { "id": "NCT02426034_inc_R14", "type": "Has_value", "arg1_id": "NCT02426034_inc_T22", "arg2_id": "NCT02426034_inc_T24", "normalized": [] }, { "id": "NCT02426034_inc_R15", "type": "Has_value", "arg1_id": "NCT02426034_inc_T29", "arg2_id": "NCT02426034_inc_T28", "normalized": [] }, { "id": "NCT02426034_inc_R16", "type": "Has_scope", "arg1_id": "NCT02426034_inc_T25", "arg2_id": "NCT02426034_inc_T29", "normalized": [] }, { "id": "NCT02426034_inc_R17", "type": "Has_value", "arg1_id": "NCT02426034_inc_T30", "arg2_id": "NCT02426034_inc_T31", "normalized": [] }, { "id": "NCT02426034_inc_R18", "type": "Has_value", "arg1_id": "NCT02426034_inc_T32", "arg2_id": "NCT02426034_inc_T33", "normalized": [] }, { "id": "NCT02426034_inc_R19", "type": "Has_value", "arg1_id": "NCT02426034_inc_T34", "arg2_id": "NCT02426034_inc_T35", "normalized": [] } ]

[ { "id": "NCT02426944_exc_text", "type": "exclusion", "text": [ "thrombus in the LA or LAA;\nmechanical valve prosthesis;\nmitral stenosis;\nprevious LAA ligation during cardiac surgery;\nlife expectancy less than 2 years;\ncomorbidities other than AF, which present an indication for anticoagulation;\npatent foramen ovale with atrial septal aneurysm\nmobile plaque in the aorta;\nsymptomatic atherosclerosis of the carotid artery;\npericardial effusion greater than 10 mm;\nclinically significant bleeding within the 30 days prior to the scheduled procedure;\nstroke or other cardioembolic event within the 30 days prior to the scheduled procedure;\nacute coronary syndrome within the 90 days prior to the scheduled procedure,\ngravidity,\nsignificant valvular disease,\ncreatinine clearance less than 30 ml/min\n" ], "offsets": [ [ 0, 734 ] ] } ]

[ { "id": "NCT02426944_exc_T1", "type": "Condition", "text": [ "thrombus" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T2", "type": "Qualifier", "text": [ "LA" ], "offsets": [ [ 16, 18 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T3", "type": "Qualifier", "text": [ "LAA" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T4", "type": "Scope", "text": [ "LA or LAA" ], "offsets": [ [ 16, 25 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T5", "type": "Device", "text": [ "mechanical valve prosthesis" ], "offsets": [ [ 27, 54 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T6", "type": "Condition", "text": [ "mitral stenosis" ], "offsets": [ [ 56, 71 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T7", "type": "Procedure", "text": [ "LAA ligation" ], "offsets": [ [ 82, 94 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T8", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 102, 117 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T9", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 119, 134 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T10", "type": "Value", "text": [ "less than 2 years" ], "offsets": [ [ 135, 152 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T11", "type": "Condition", "text": [ "AF" ], "offsets": [ [ 179, 181 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T12", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 168, 178 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T13", "type": "Condition", "text": [ "comorbidities" ], "offsets": [ [ 154, 167 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T14", "type": "Condition", "text": [ "indication" ], "offsets": [ [ 200, 210 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T15", "type": "Procedure", "text": [ "anticoagulation" ], "offsets": [ [ 215, 230 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T16", "type": "Scope", "text": [ "comorbidities other than AF" ], "offsets": [ [ 154, 181 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T17", "type": "Condition", "text": [ "patent foramen ovale" ], "offsets": [ [ 232, 252 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T18", "type": "Condition", "text": [ "atrial septal aneurysm" ], "offsets": [ [ 258, 280 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T19", "type": "Condition", "text": [ "mobile plaque in the aorta" ], "offsets": [ [ 281, 307 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T20", "type": "Condition", "text": [ "atherosclerosis" ], "offsets": [ [ 321, 336 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T21", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 309, 320 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T22", "type": "Qualifier", "text": [ "of the carotid artery" ], "offsets": [ [ 337, 358 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T23", "type": "Condition", "text": [ "pericardial effusion" ], "offsets": [ [ 360, 380 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T24", "type": "Qualifier", "text": [ "greater than 10 mm" ], "offsets": [ [ 381, 399 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T25", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 401, 423 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T26", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 424, 432 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T27", "type": "Temporal", "text": [ "within the 30 days prior to the scheduled procedure" ], "offsets": [ [ 433, 484 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T28", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 486, 492 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T29", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 496, 501 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T30", "type": "Condition", "text": [ "cardioembolic event" ], "offsets": [ [ 502, 521 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T31", "type": "Temporal", "text": [ "within the 30 days prior to the scheduled procedure" ], "offsets": [ [ 522, 573 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T32", "type": "Reference_point", "text": [ "the scheduled procedure" ], "offsets": [ [ 461, 484 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T33", "type": "Reference_point", "text": [ "the scheduled procedure" ], "offsets": [ [ 550, 573 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T34", "type": "Scope", "text": [ "stroke or other cardioembolic event" ], "offsets": [ [ 486, 521 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T35", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 575, 598 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T36", "type": "Temporal", "text": [ "within the 90 days prior to the scheduled procedure" ], "offsets": [ [ 599, 650 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T37", "type": "Reference_point", "text": [ "the scheduled procedure" ], "offsets": [ [ 627, 650 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T38", "type": "Condition", "text": [ "gravidity" ], "offsets": [ [ 652, 661 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T39", "type": "Condition", "text": [ "valvular disease" ], "offsets": [ [ 675, 691 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T40", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 663, 674 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T41", "type": "Measurement", "text": [ "creatinine clearance" ], "offsets": [ [ 693, 713 ] ], "normalized": [] }, { "id": "NCT02426944_exc_T42", "type": "Value", "text": [ "less than 30 ml/min" ], "offsets": [ [ 714, 733 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02426944_exc_R1", "type": "Has_scope", "arg1_id": "NCT02426944_exc_T1", "arg2_id": "NCT02426944_exc_T4", "normalized": [] }, { "id": "NCT02426944_exc_R2", "type": "Has_value", "arg1_id": "NCT02426944_exc_T9", "arg2_id": "NCT02426944_exc_T10", "normalized": [] }, { "id": "NCT02426944_exc_R3", "type": "AND", "arg1_id": "NCT02426944_exc_T13", "arg2_id": "NCT02426944_exc_T11", "normalized": [] }, { "id": "NCT02426944_exc_R4", "type": "AND", "arg1_id": "NCT02426944_exc_T14", "arg2_id": "NCT02426944_exc_T15", "normalized": [] }, { "id": "NCT02426944_exc_R5", "type": "Has_negation", "arg1_id": "NCT02426944_exc_T11", "arg2_id": "NCT02426944_exc_T12", "normalized": [] }, { "id": "NCT02426944_exc_R6", "type": "AND", "arg1_id": "NCT02426944_exc_T16", "arg2_id": "NCT02426944_exc_T14", "normalized": [] }, { "id": "NCT02426944_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T20", "arg2_id": "NCT02426944_exc_T22", "normalized": [] }, { "id": "NCT02426944_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T20", "arg2_id": "NCT02426944_exc_T21", "normalized": [] }, { "id": "NCT02426944_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T23", "arg2_id": "NCT02426944_exc_T24", "normalized": [] }, { "id": "NCT02426944_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02426944_exc_T26", "arg2_id": "NCT02426944_exc_T27", "normalized": [] }, { "id": "NCT02426944_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T26", "arg2_id": "NCT02426944_exc_T25", "normalized": [] }, { "id": "NCT02426944_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T30", "arg2_id": "NCT02426944_exc_T29", "normalized": [] }, { "id": "NCT02426944_exc_R13", "type": "Has_index", "arg1_id": "NCT02426944_exc_T27", "arg2_id": "NCT02426944_exc_T32", "normalized": [] }, { "id": "NCT02426944_exc_R14", "type": "Has_index", "arg1_id": "NCT02426944_exc_T31", "arg2_id": "NCT02426944_exc_T33", "normalized": [] }, { "id": "NCT02426944_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02426944_exc_T34", "arg2_id": "NCT02426944_exc_T31", "normalized": [] }, { "id": "NCT02426944_exc_R16", "type": "Has_index", "arg1_id": "NCT02426944_exc_T36", "arg2_id": "NCT02426944_exc_T37", "normalized": [] }, { "id": "NCT02426944_exc_R17", "type": "Has_temporal", "arg1_id": "NCT02426944_exc_T35", "arg2_id": "NCT02426944_exc_T36", "normalized": [] }, { "id": "NCT02426944_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02426944_exc_T39", "arg2_id": "NCT02426944_exc_T40", "normalized": [] }, { "id": "NCT02426944_exc_R19", "type": "Has_value", "arg1_id": "NCT02426944_exc_T41", "arg2_id": "NCT02426944_exc_T42", "normalized": [] } ]

[ { "id": "NCT02426944_inc_text", "type": "inclusion", "text": [ "history of significant bleeding (i.e. bleeding which required intervention or hospitalization), even in the absence of anticoagulation treatment at the time of the bleeding event, or\na cardioembolic event, which occurred on anticoagulation, or\na high risk profile of the patient, defined as a CHA2DS2-VASc score = 3 and a HAS-BLED score = 2\n" ], "offsets": [ [ 0, 341 ] ] } ]

[ { "id": "NCT02426944_inc_T1", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 23, 31 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T2", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 11, 22 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T3", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 38, 46 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T4", "type": "Procedure", "text": [ "intervention" ], "offsets": [ [ 62, 74 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T5", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 78, 93 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T6", "type": "Scope", "text": [ "intervention or hospitalization" ], "offsets": [ [ 62, 93 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T7", "type": "Scope", "text": [ "bleeding which required intervention or hospitalization" ], "offsets": [ [ 38, 93 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T8", "type": "Scope", "text": [ "significant bleeding" ], "offsets": [ [ 11, 31 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T9", "type": "Condition", "text": [ "cardioembolic event" ], "offsets": [ [ 185, 204 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T10", "type": "Drug", "text": [ "anticoagulation" ], "offsets": [ [ 224, 239 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T11", "type": "Temporal", "text": [ "occurred on anticoagulation" ], "offsets": [ [ 212, 239 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T12", "type": "Measurement", "text": [ "CHA2DS2-VASc score" ], "offsets": [ [ 293, 311 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T13", "type": "Value", "text": [ "= 3" ], "offsets": [ [ 312, 315 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T14", "type": "Measurement", "text": [ "HAS-BLED score" ], "offsets": [ [ 322, 336 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T15", "type": "Value", "text": [ "= 2" ], "offsets": [ [ 337, 340 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T16", "type": "Condition", "text": [ "high risk profile" ], "offsets": [ [ 246, 263 ] ], "normalized": [] }, { "id": "NCT02426944_inc_T17", "type": "Scope", "text": [ "CHA2DS2-VASc score = 3 and a HAS-BLED score = 2" ], "offsets": [ [ 293, 340 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02426944_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02426944_inc_T1", "arg2_id": "NCT02426944_inc_T2", "normalized": [] }, { "id": "NCT02426944_inc_R2", "type": "Has_scope", "arg1_id": "NCT02426944_inc_T3", "arg2_id": "NCT02426944_inc_T6", "normalized": [] }, { "id": "NCT02426944_inc_R3", "type": "Subsumes", "arg1_id": "NCT02426944_inc_T8", "arg2_id": "NCT02426944_inc_T7", "normalized": [] }, { "id": "NCT02426944_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02426944_inc_T9", "arg2_id": "NCT02426944_inc_T11", "normalized": [] }, { "id": "NCT02426944_inc_R5", "type": "Has_value", "arg1_id": "NCT02426944_inc_T12", "arg2_id": "NCT02426944_inc_T13", "normalized": [] }, { "id": "NCT02426944_inc_R6", "type": "Has_value", "arg1_id": "NCT02426944_inc_T14", "arg2_id": "NCT02426944_inc_T15", "normalized": [] }, { "id": "NCT02426944_inc_R7", "type": "Subsumes", "arg1_id": "NCT02426944_inc_T16", "arg2_id": "NCT02426944_inc_T17", "normalized": [] } ]

[ { "id": "NCT02427295_exc_text", "type": "exclusion", "text": [ "Severe co-morbid illness such as untreatable other malignancy and/or active infections.\nPregnant or lactating women\nHypersensitivity to Sandostatin or any component of the formulation.\n" ], "offsets": [ [ 0, 185 ] ] } ]

[ { "id": "NCT02427295_exc_T1", "type": "Condition", "text": [ "co-morbid illness" ], "offsets": [ [ 7, 24 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T2", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T3", "type": "Qualifier", "text": [ "untreatable" ], "offsets": [ [ 33, 44 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T4", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 45, 50 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T5", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 51, 61 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T6", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 69, 75 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T7", "type": "Condition", "text": [ "infections" ], "offsets": [ [ 76, 86 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T8", "type": "Scope", "text": [ "untreatable other malignancy and/or active infections" ], "offsets": [ [ 33, 86 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T9", "type": "Scope", "text": [ "Severe co-morbid illness" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T10", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 88, 96 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T11", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 100, 109 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T12", "type": "Person", "text": [ "women" ], "offsets": [ [ 110, 115 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T13", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 116, 132 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T14", "type": "Drug", "text": [ "Sandostatin" ], "offsets": [ [ 136, 147 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T15", "type": "Drug", "text": [ "component of the formulation" ], "offsets": [ [ 155, 183 ] ], "normalized": [] }, { "id": "NCT02427295_exc_T16", "type": "Scope", "text": [ "Sandostatin or any component of the formulation" ], "offsets": [ [ 136, 183 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02427295_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02427295_exc_T1", "arg2_id": "NCT02427295_exc_T2", "normalized": [] }, { "id": "NCT02427295_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02427295_exc_T7", "arg2_id": "NCT02427295_exc_T6", "normalized": [] }, { "id": "NCT02427295_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02427295_exc_T5", "arg2_id": "NCT02427295_exc_T4", "normalized": [] }, { "id": "NCT02427295_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02427295_exc_T5", "arg2_id": "NCT02427295_exc_T3", "normalized": [] }, { "id": "NCT02427295_exc_R5", "type": "Subsumes", "arg1_id": "NCT02427295_exc_T9", "arg2_id": "NCT02427295_exc_T8", "normalized": [] }, { "id": "NCT02427295_exc_R6", "type": "Has_scope", "arg1_id": "NCT02427295_exc_T13", "arg2_id": "NCT02427295_exc_T16", "normalized": [] } ]

[ { "id": "NCT02427295_inc_text", "type": "inclusion", "text": [ "Age 18 or older.\nPatients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features.\nNo prior use of somatostatin analogues.\nAdequate hepatic and renal function\nProvision of a signed written informed consent\n" ], "offsets": [ [ 0, 351 ] ] } ]

[ { "id": "NCT02427295_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T2", "type": "Value", "text": [ "18 or older" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T3", "type": "Condition", "text": [ "acromegaly" ], "offsets": [ [ 41, 51 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T4", "type": "Condition", "text": [ "GH-secreting pituitary adenoma" ], "offsets": [ [ 57, 87 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T5", "type": "Procedure", "text": [ "sellar MRI" ], "offsets": [ [ 91, 101 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T6", "type": "Qualifier", "text": [ "biochemical criteria outlined above" ], "offsets": [ [ 115, 150 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T7", "type": "Condition", "text": [ "acromegalic features" ], "offsets": [ [ 206, 226 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T8", "type": "Qualifier", "text": [ "typical" ], "offsets": [ [ 198, 205 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T9", "type": "Drug", "text": [ "somatostatin analogues" ], "offsets": [ [ 244, 266 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T10", "type": "Negation", "text": [ "No" ], "offsets": [ [ 228, 230 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T11", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 231, 236 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T12", "type": "Condition", "text": [ "quate he", "al function\nPr" ], "offsets": [ [ 271, 279 ], [ 292, 306 ] ], "normalized": [] }, { "id": "NCT02427295_inc_T13", "type": "Condition", "text": [ "quate hepatic an", "ction\nPr" ], "offsets": [ [ 271, 287 ], [ 298, 306 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02427295_inc_R1", "type": "Has_value", "arg1_id": "NCT02427295_inc_T1", "arg2_id": "NCT02427295_inc_T2", "normalized": [] }, { "id": "NCT02427295_inc_R2", "type": "AND", "arg1_id": "NCT02427295_inc_T5", "arg2_id": "NCT02427295_inc_T4", "normalized": [] }, { "id": "NCT02427295_inc_R3", "type": "AND", "arg1_id": "NCT02427295_inc_T3", "arg2_id": "NCT02427295_inc_T5", "normalized": [] }, { "id": "NCT02427295_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02427295_inc_T3", "arg2_id": "NCT02427295_inc_T6", "normalized": [] }, { "id": "NCT02427295_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02427295_inc_T7", "arg2_id": "NCT02427295_inc_T8", "normalized": [] }, { "id": "NCT02427295_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02427295_inc_T9", "arg2_id": "NCT02427295_inc_T11", "normalized": [] }, { "id": "NCT02427295_inc_R7", "type": "Has_negation", "arg1_id": "NCT02427295_inc_T9", "arg2_id": "NCT02427295_inc_T10", "normalized": [] } ]

[ { "id": "NCT02429583_exc_text", "type": "exclusion", "text": [ "Received any vaccine within a month prior to study vaccine\nPositive serum antibody against Hep B surface antigen and/or core Hep B core antigen\nHIV positive\nFor HCV-negative, healthy volunteers: History of HCV infection or positive HCV antibody test\nParticipation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study\nIn the opinion of the investigator, the volunteer is unlikely to comply with the study protocol\nAny clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease (in addition to HCV infection, for HCV group)\nCurrently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications\nAny clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation\nUnable to continue participation for 156 weeks\nHistory of previous Hepatitis B vaccination(s)\nMale or female < 18 and > 62 years of age\nIs pregnant or lactating\nHistory of Hepatitis B infection\nClinical, laboratory, or biopsy evidence of cirrhosis\n" ], "offsets": [ [ 0, 1335 ] ] } ]

[ { "id": "NCT02429583_exc_T1", "type": "Procedure", "text": [ "vaccine" ], "offsets": [ [ 13, 20 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T2", "type": "Temporal", "text": [ "within a month prior to study vaccine" ], "offsets": [ [ 21, 58 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T3", "type": "Reference_point", "text": [ "study vaccine" ], "offsets": [ [ 45, 58 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T4", "type": "Measurement", "text": [ "serum antibody" ], "offsets": [ [ 68, 82 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T5", "type": "Qualifier", "text": [ "Hep B surface antige" ], "offsets": [ [ 91, 111 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T6", "type": "Qualifier", "text": [ "core Hep B core antigen" ], "offsets": [ [ 120, 143 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T7", "type": "Scope", "text": [ "Hep B surface antigen and/or core Hep B core antigen" ], "offsets": [ [ 91, 143 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T8", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 59, 67 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T9", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 144, 147 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T10", "type": "Value", "text": [ "positive" ], "offsets": [ [ 148, 156 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T11", "type": "Measurement", "text": [ "HCV" ], "offsets": [ [ 161, 164 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T12", "type": "Value", "text": [ "negative" ], "offsets": [ [ 165, 173 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T13", "type": "Observation", "text": [ "History of HCV infection" ], "offsets": [ [ 195, 219 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T16", "type": "Condition", "text": [ "immunodeficiency" ], "offsets": [ [ 601, 617 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T17", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 621, 639 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T18", "type": "Negation", "text": [ "in addition to" ], "offsets": [ [ 641, 655 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T19", "type": "Condition", "text": [ "HCV infection" ], "offsets": [ [ 656, 669 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T20", "type": "Drug", "text": [ "systemic steroids" ], "offsets": [ [ 703, 720 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T21", "type": "Procedure", "text": [ "immunomodulatory medications" ], "offsets": [ [ 730, 758 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T22", "type": "Procedure", "text": [ "anticancer medications" ], "offsets": [ [ 769, 791 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T23", "type": "Procedure", "text": [ "antiviral medications" ], "offsets": [ [ 796, 817 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T24", "type": "Scope", "text": [ "anticancer medications and antiviral medications" ], "offsets": [ [ 769, 817 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T25", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 929, 937 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T26", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 939, 962 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T27", "type": "Condition", "text": [ "rheumatologic illness" ], "offsets": [ [ 964, 985 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T28", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 987, 997 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T29", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 999, 1014 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T31", "type": "Procedure", "text": [ "Hepatitis B vaccination" ], "offsets": [ [ 1154, 1177 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T32", "type": "Person", "text": [ "Male" ], "offsets": [ [ 1181, 1185 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T33", "type": "Person", "text": [ "female" ], "offsets": [ [ 1189, 1195 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T34", "type": "Value", "text": [ "< 18 and > 62 years" ], "offsets": [ [ 1196, 1215 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T35", "type": "Person", "text": [ "age" ], "offsets": [ [ 1219, 1222 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T37", "type": "Condition", "text": [ "Hepatitis B infection" ], "offsets": [ [ 1259, 1280 ] ], "normalized": [] }, { "id": "NCT02429583_exc_T38", "type": "Condition", "text": [ "cirrhosis" ], "offsets": [ [ 1325, 1334 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02429583_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02429583_exc_T1", "arg2_id": "NCT02429583_exc_T2", "normalized": [] }, { "id": "NCT02429583_exc_R2", "type": "Has_index", "arg1_id": "NCT02429583_exc_T2", "arg2_id": "NCT02429583_exc_T3", "normalized": [] }, { "id": "NCT02429583_exc_R3", "type": "Has_value", "arg1_id": "NCT02429583_exc_T4", "arg2_id": "NCT02429583_exc_T8", "normalized": [] }, { "id": "NCT02429583_exc_R4", "type": "Has_scope", "arg1_id": "NCT02429583_exc_T4", "arg2_id": "NCT02429583_exc_T7", "normalized": [] }, { "id": "NCT02429583_exc_R5", "type": "Has_value", "arg1_id": "NCT02429583_exc_T9", "arg2_id": "NCT02429583_exc_T10", "normalized": [] }, { "id": "NCT02429583_exc_R6", "type": "Has_value", "arg1_id": "NCT02429583_exc_T11", "arg2_id": "NCT02429583_exc_T12", "normalized": [] }, { "id": "NCT02429583_exc_R7", "type": "Has_negation", "arg1_id": "NCT02429583_exc_T19", "arg2_id": "NCT02429583_exc_T18", "normalized": [] }, { "id": "NCT02429583_exc_R8", "type": "Subsumes", "arg1_id": "NCT02429583_exc_T21", "arg2_id": "NCT02429583_exc_T24", "normalized": [] }, { "id": "NCT02429583_exc_R9", "type": "Has_value", "arg1_id": "NCT02429583_exc_T35", "arg2_id": "NCT02429583_exc_T34", "normalized": [] } ]

[ { "id": "NCT02429583_inc_text", "type": "inclusion", "text": [ "Willing to receive three doses of an FDA-approved Hepatitis B vaccine\nVolunteer chronically infected with HCV (as demonstrated by serology and/or viral load laboratory studies)\nHealthy volunteer without significant medical problems\n" ], "offsets": [ [ 0, 232 ] ] } ]

[ { "id": "NCT02429583_inc_T2", "type": "Condition", "text": [ "CV", "nfected" ], "offsets": [ [ 107, 109 ], [ 93, 100 ] ], "normalized": [] }, { "id": "NCT02429583_inc_T3", "type": "Qualifier", "text": [ "chronically" ], "offsets": [ [ 80, 91 ] ], "normalized": [] }, { "id": "NCT02429583_inc_T4", "type": "Person", "text": [ "volunteer" ], "offsets": [ [ 185, 194 ] ], "normalized": [] }, { "id": "NCT02429583_inc_T5", "type": "Qualifier", "text": [ "Healthy" ], "offsets": [ [ 177, 184 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02429583_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02429583_inc_T2", "arg2_id": "NCT02429583_inc_T3", "normalized": [] }, { "id": "NCT02429583_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02429583_inc_T4", "arg2_id": "NCT02429583_inc_T5", "normalized": [] } ]

[ { "id": "NCT02429765_exc_text", "type": "exclusion", "text": [ "A diagnosis of sleep disordered breathing;\nNocturnal oxygen therapy.\n" ], "offsets": [ [ 0, 69 ] ] } ]

[ { "id": "NCT02429765_exc_T1", "type": "Condition", "text": [ "sleep disordered breathing" ], "offsets": [ [ 15, 41 ] ], "normalized": [] }, { "id": "NCT02429765_exc_T2", "type": "Procedure", "text": [ "Nocturnal oxygen therapy" ], "offsets": [ [ 43, 67 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT02429765_inc_text", "type": "inclusion", "text": [ "Moderate to severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) 30-79%predicted);\nResting functional residual capacity (FRC) >120% predicted;\nClinically stable and on stable triple therapy with an ICS/LABA and tiotropium;\nSymptomatic: Baseline Dyspnea Index =8 and answer \"in the morning\" when asked about what time of day their COPD symptoms are worst.\n" ], "offsets": [ [ 0, 374 ] ] } ]

[ { "id": "NCT02429765_inc_T1", "type": "Qualifier", "text": [ "Moderate to severe" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T2", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 19, 23 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T3", "type": "Qualifier", "text": [ "post-bronchodilator" ], "offsets": [ [ 25, 44 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T4", "type": "Measurement", "text": [ "forced expiratory volume in 1 s (FEV1)" ], "offsets": [ [ 45, 83 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T5", "type": "Value", "text": [ "30-79%predicted" ], "offsets": [ [ 84, 99 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T6", "type": "Measurement", "text": [ "Resting functional residual capacity (FRC)" ], "offsets": [ [ 102, 144 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T7", "type": "Value", "text": [ ">120% predicted" ], "offsets": [ [ 145, 160 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T8", "type": "Procedure", "text": [ "stable triple therapy" ], "offsets": [ [ 187, 208 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T9", "type": "Condition", "text": [ "Clinically stable" ], "offsets": [ [ 162, 179 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T10", "type": "Drug", "text": [ "ICS/LABA" ], "offsets": [ [ 217, 225 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T11", "type": "Drug", "text": [ "tiotropium" ], "offsets": [ [ 230, 240 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T12", "type": "Scope", "text": [ "ICS/LABA and tiotropium" ], "offsets": [ [ 217, 240 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T13", "type": "Measurement", "text": [ "Baseline Dyspnea Index" ], "offsets": [ [ 255, 277 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T14", "type": "Value", "text": [ "=8" ], "offsets": [ [ 278, 280 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T15", "type": "Observation", "text": [ "what time of day their COPD symptoms are worst" ], "offsets": [ [ 326, 372 ] ], "normalized": [] }, { "id": "NCT02429765_inc_T16", "type": "Value", "text": [ "in the morning" ], "offsets": [ [ 293, 307 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02429765_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02429765_inc_T2", "arg2_id": "NCT02429765_inc_T1", "normalized": [] }, { "id": "NCT02429765_inc_R2", "type": "Has_value", "arg1_id": "NCT02429765_inc_T4", "arg2_id": "NCT02429765_inc_T5", "normalized": [] }, { "id": "NCT02429765_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02429765_inc_T4", "arg2_id": "NCT02429765_inc_T3", "normalized": [] }, { "id": "NCT02429765_inc_R4", "type": "Has_value", "arg1_id": "NCT02429765_inc_T6", "arg2_id": "NCT02429765_inc_T7", "normalized": [] }, { "id": "NCT02429765_inc_R5", "type": "Has_scope", "arg1_id": "NCT02429765_inc_T8", "arg2_id": "NCT02429765_inc_T12", "normalized": [] }, { "id": "NCT02429765_inc_R6", "type": "Has_value", "arg1_id": "NCT02429765_inc_T13", "arg2_id": "NCT02429765_inc_T14", "normalized": [] }, { "id": "NCT02429765_inc_R7", "type": "Has_value", "arg1_id": "NCT02429765_inc_T15", "arg2_id": "NCT02429765_inc_T16", "normalized": [] } ]

[ { "id": "NCT02430740_exc_text", "type": "exclusion", "text": [ "polycystic ovaries\nuntreated thyroid pathology\nhypogonadotropic hypogonadism\nuntreaed hyperprolactinemia\nstudy drug hypersensitivity\nprevious OHSS\nunilateral ovariectomy\ngenital malformation\nBMI>40\n" ], "offsets": [ [ 0, 198 ] ] } ]

[ { "id": "NCT02430740_exc_T1", "type": "Condition", "text": [ "polycystic ovaries" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T2", "type": "Condition", "text": [ "thyroid pathology" ], "offsets": [ [ 29, 46 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T3", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 19, 28 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T4", "type": "Condition", "text": [ "hypogonadotropic hypogonadism" ], "offsets": [ [ 47, 76 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T5", "type": "Qualifier", "text": [ "untreaed" ], "offsets": [ [ 77, 85 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T6", "type": "Condition", "text": [ "hyperprolactinemia" ], "offsets": [ [ 86, 104 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T7", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 116, 132 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T8", "type": "Drug", "text": [ "study drug" ], "offsets": [ [ 105, 115 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T9", "type": "Condition", "text": [ "OHSS" ], "offsets": [ [ 142, 146 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T10", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 133, 141 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T11", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 147, 157 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T12", "type": "Procedure", "text": [ "ovariectomy" ], "offsets": [ [ 158, 169 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T13", "type": "Condition", "text": [ "genital malformation" ], "offsets": [ [ 170, 190 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T14", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 191, 194 ] ], "normalized": [] }, { "id": "NCT02430740_exc_T15", "type": "Value", "text": [ ">40" ], "offsets": [ [ 194, 197 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02430740_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02430740_exc_T2", "arg2_id": "NCT02430740_exc_T3", "normalized": [] }, { "id": "NCT02430740_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02430740_exc_T6", "arg2_id": "NCT02430740_exc_T5", "normalized": [] }, { "id": "NCT02430740_exc_R3", "type": "AND", "arg1_id": "NCT02430740_exc_T7", "arg2_id": "NCT02430740_exc_T8", "normalized": [] }, { "id": "NCT02430740_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02430740_exc_T9", "arg2_id": "NCT02430740_exc_T10", "normalized": [] }, { "id": "NCT02430740_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02430740_exc_T12", "arg2_id": "NCT02430740_exc_T11", "normalized": [] }, { "id": "NCT02430740_exc_R6", "type": "Has_value", "arg1_id": "NCT02430740_exc_T14", "arg2_id": "NCT02430740_exc_T15", "normalized": [] } ]

[ { "id": "NCT02430740_inc_text", "type": "inclusion", "text": [ "female infertile patients eligible for IVF treatment\n" ], "offsets": [ [ 0, 53 ] ] } ]

[ { "id": "NCT02430740_inc_T1", "type": "Person", "text": [ "female" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02430740_inc_T2", "type": "Condition", "text": [ "infertile" ], "offsets": [ [ 7, 16 ] ], "normalized": [] }, { "id": "NCT02430740_inc_T3", "type": "Mood", "text": [ "eligible" ], "offsets": [ [ 26, 34 ] ], "normalized": [] }, { "id": "NCT02430740_inc_T4", "type": "Procedure", "text": [ "IVF treatment" ], "offsets": [ [ 39, 52 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02430740_inc_R1", "type": "Has_mood", "arg1_id": "NCT02430740_inc_T4", "arg2_id": "NCT02430740_inc_T3", "normalized": [] } ]

[ { "id": "NCT02431442_exc_text", "type": "exclusion", "text": [ "Fasting blood glucose >126 mg/dL at screening. Heterozygous subjects will be excluded for a fasting blood glucose >140 mg/dL. \nResting heart rate <45 bpm or >90 bpm at screening. \nAbnormal thyroid stimulating hormone (TSH) or thyroxine (T4) levels on screening. \nElevated ALT or serum creatinine on screening or any clinically significant abnormalities on screening laboratory tests as determined by the Investigator. \nHistory of medically treated diabetes or of treated or medically diagnosed hypertension. Heterozygous subjects who have diagnosed hypertension and are well controlled on treatment (Refer to Exclusion Criteria 20 below), are eligible. . \nPresence of a skin lesion suspicious for malignancy, unless excised prior to Day 1. \nHistory of malignancy except for treated cervical carcinoma in situ in the past 5 years. \nActive or history of any clinically significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic, psychiatric or hematological disease, based on Investigator judgment. \nAcute illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data. \nPositive hepatitis B surface antigen, positive hepatitis C antibody or positive HIV test at screening or a history of positive testing (e.g. liver biopsy, serology) suggesting acute or chronic hepatitis. \nAbnormal 12-lead electrocardiogram (ECG) at screening or pre-dose (Day -1 or Day 1), except minor deviations deemed to be of no clinical significance by the Investigator. \nReceived any experimental drugs or devices within 30 days or 5 half lives, whichever is longer, prior to dosing. \nOngoing participation in a prior clinical study at the time of screening. \nBlood donation within 60 days prior to screening or intent to donate within 60 days after Final Study Visit. \nHospitalization for major surgery including but not limited to abdominal, thoracic, or cardiovascular surgery within the past 3 months prior to screening, or for a clinically significant non-surgical illness, based on Investigator judgment, within the past 3 months. \nPlanned elective surgery within 30 days of the Final Study Visit. \nPoor venous access or inability to tolerate venipuncture. \nHistory of significant drug hypersensitivity or anaphylaxis. \nHistory of hypersensitivity to proteins (e.g., allergy shots). \nUse of prescription medications on a regular basis. The last use of any prescription medication must have been greater than 5 half-lives for the specific medication or at least 14 days prior to admission (Day -1), whichever is longer. Hormonal contraception is allowed for female subjects. \nHeterozygous cohorts: Use of prescription medications on a regular basis is not allowed with the following exceptions: \nAntihypertensives (<3 medications on a stable dose for ≥ 30 days); \nStatins (dose must be ≤ half the maximum dose; must be on a stable dose ≥3 months); \nFibrates (must be on stable dose for ≥3 months); \nNiacin (must be on stable dose for ≥3 months); \nThyroxin (stable dose for ≥ 30 days); The last use of any other prescription medication will need follow the criteria for all other cohorts, as outlined above. \nUse of prescription medications not listed above may be allowed at the discretion of the Investigator upon consultation with Rhythm. \nUse of a non-prescription drug and herbal substances during the study (through the Final Study Visit). The last dose of any non-prescription drug must have been taken greater than 5 half-lives for that drug before receiving study drug. \nInability to attend all study visits or to comply with protocol requirements including fasting and restrictions on alcohol, caffeine, nicotine and concomitant medication intake. \nA significant history of drug/solvent abuse within 5 years of screening or a positive test for drugs of abuse test at screening or on Day -1. \nPositive alcohol (breath test) or nicotine screen at Screening Visit or Day 1 (positive nicotine screen does not apply to heterozygous cohort). \nHistory of alcohol abuse (defined as average intake of three or more units of alcohol per day) within 5 years of the Screening Visit. \nHistory of tobacco or tobacco product use unless abstinent for at least one year prior to the Screening Visit. This criterion does not apply to heterozygous subjects. \nPreviously randomized and dosed in this study. This criterion does not apply to heterozygous subjects. \nAny other reason, which in the opinion of the Investigator would confound proper evaluation of the study. \n \n" ], "offsets": [ [ 0, 4692 ] ] } ]

[ { "id": "NCT02431442_exc_T1", "type": "Measurement", "text": [ "Fasting blood glucose" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T2", "type": "Value", "text": [ ">126 mg/dL" ], "offsets": [ [ 22, 32 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T3", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 33, 45 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T4", "type": "Condition", "text": [ "Heterozygous" ], "offsets": [ [ 47, 59 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T5", "type": "Measurement", "text": [ "fasting blood glucose" ], "offsets": [ [ 92, 113 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T6", "type": "Value", "text": [ ">140 mg/dL" ], "offsets": [ [ 114, 124 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T7", "type": "Measurement", "text": [ "Resting heart rate" ], "offsets": [ [ 127, 145 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T8", "type": "Value", "text": [ "<45 bpm" ], "offsets": [ [ 146, 153 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T9", "type": "Value", "text": [ ">90 bpm" ], "offsets": [ [ 157, 164 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T10", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 165, 177 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T11", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 168, 177 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T12", "type": "Scope", "text": [ "<45 bpm or >90 bpm" ], "offsets": [ [ 146, 164 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T13", "type": "Measurement", "text": [ "thyroid stimulating hormone (TSH)" ], "offsets": [ [ 189, 222 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T14", "type": "Measurement", "text": [ "thyroxine (T4)" ], "offsets": [ [ 226, 240 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T15", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 180, 188 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T16", "type": "Temporal", "text": [ "on screening" ], "offsets": [ [ 248, 260 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T17", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 251, 260 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T18", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 272, 275 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T19", "type": "Value", "text": [ "Elevated" ], "offsets": [ [ 263, 271 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T20", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 279, 295 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T21", "type": "Temporal", "text": [ "on screening" ], "offsets": [ [ 296, 308 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T22", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 299, 308 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T23", "type": "Measurement", "text": [ "laboratory tests" ], "offsets": [ [ 366, 382 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T27", "type": "Value", "text": [ "abnormalities" ], "offsets": [ [ 339, 352 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T28", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 448, 456 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T29", "type": "Qualifier", "text": [ "medically treated" ], "offsets": [ [ 430, 447 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T30", "type": "Drug", "text": [ "medically" ], "offsets": [ [ 430, 439 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T31", "type": "Procedure", "text": [ "medically treated" ], "offsets": [ [ 430, 447 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T32", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 494, 506 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T33", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 463, 470 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T34", "type": "Drug", "text": [ "medically" ], "offsets": [ [ 474, 483 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T35", "type": "Scope", "text": [ "treated or medically" ], "offsets": [ [ 463, 483 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T36", "type": "Observation", "text": [ "History" ], "offsets": [ [ 419, 426 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T37", "type": "Condition", "text": [ "Heterozygous" ], "offsets": [ [ 508, 520 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T39", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 549, 561 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T40", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 589, 598 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T41", "type": "Qualifier", "text": [ "well controlled" ], "offsets": [ [ 570, 585 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T44", "type": "Condition", "text": [ "skin lesion" ], "offsets": [ [ 670, 681 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T45", "type": "Qualifier", "text": [ "suspicious for malignancy" ], "offsets": [ [ 682, 707 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T46", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 697, 707 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T47", "type": "Procedure", "text": [ "excised" ], "offsets": [ [ 716, 723 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T48", "type": "Temporal", "text": [ "prior to Day 1" ], "offsets": [ [ 724, 738 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T49", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 733, 738 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T50", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 752, 762 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T51", "type": "Observation", "text": [ "History" ], "offsets": [ [ 741, 748 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T52", "type": "Condition", "text": [ "cervical carcinoma in situ" ], "offsets": [ [ 782, 808 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T53", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 774, 781 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T54", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 774, 781 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T55", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 763, 773 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T56", "type": "Temporal", "text": [ "in the past 5 years" ], "offsets": [ [ 809, 828 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T57", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 879, 896 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T58", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 856, 878 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T61", "type": "Observation", "text": [ "history" ], "offsets": [ [ 841, 848 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T62", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 831, 837 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T63", "type": "Scope", "text": [ "Active or history" ], "offsets": [ [ 831, 848 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T64", "type": "Condition", "text": [ "disease", "renal" ], "offsets": [ [ 1059, 1066 ], [ 907, 912 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T65", "type": "Condition", "text": [ "hematological disease" ], "offsets": [ [ 1045, 1066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T66", "type": "Condition", "text": [ "psychiatric", "disease" ], "offsets": [ [ 1030, 1041 ], [ 1059, 1066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T67", "type": "Condition", "text": [ "neurologic", "disease" ], "offsets": [ [ 1018, 1028 ], [ 1059, 1066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T68", "type": "Condition", "text": [ "metabolic", "disease" ], "offsets": [ [ 1007, 1016 ], [ 1059, 1066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T69", "type": "Condition", "text": [ "disease", "immunologic" ], "offsets": [ [ 1059, 1066 ], [ 994, 1005 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T70", "type": "Condition", "text": [ "disease", "endocrine" ], "offsets": [ [ 1059, 1066 ], [ 983, 992 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T71", "type": "Condition", "text": [ "disease", "genitourinary" ], "offsets": [ [ 1059, 1066 ], [ 968, 981 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T72", "type": "Condition", "text": [ "disease", "cardiovascular" ], "offsets": [ [ 1059, 1066 ], [ 952, 966 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T73", "type": "Condition", "text": [ "disease", "gastrointestinal" ], "offsets": [ [ 1059, 1066 ], [ 934, 950 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T74", "type": "Condition", "text": [ "disease", "pulmonary" ], "offsets": [ [ 1059, 1066 ], [ 923, 932 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T75", "type": "Condition", "text": [ "disease", "hepatic" ], "offsets": [ [ 1059, 1066 ], [ 914, 921 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T76", "type": "Qualifier", "text": [ "based on Investigator judgment" ], "offsets": [ [ 1068, 1098 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T79", "type": "Scope", "text": [ "renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic, psychiatric or hematological disease" ], "offsets": [ [ 907, 1066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T83", "type": "Measurement", "text": [ "hepatitis B surface antigen" ], "offsets": [ [ 1319, 1346 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T84", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 1310, 1318 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T85", "type": "Measurement", "text": [ "hepatitis C antibody" ], "offsets": [ [ 1357, 1377 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T86", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1348, 1356 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T87", "type": "Measurement", "text": [ "HIV test" ], "offsets": [ [ 1390, 1398 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T88", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1381, 1389 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T89", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1399, 1411 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T90", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1402, 1411 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T91", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1417, 1424 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T92", "type": "Scope", "text": [ "Positive hepatitis B surface antigen, positive hepatitis C antibody or positive HIV test" ], "offsets": [ [ 1310, 1398 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T93", "type": "Procedure", "text": [ "liver biopsy" ], "offsets": [ [ 1451, 1463 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T94", "type": "Procedure", "text": [ "serology" ], "offsets": [ [ 1465, 1473 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T95", "type": "Procedure", "text": [ "testing" ], "offsets": [ [ 1437, 1444 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T96", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1428, 1436 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T97", "type": "Scope", "text": [ "liver biopsy, serology" ], "offsets": [ [ 1451, 1473 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T100", "type": "Condition", "text": [ "chronic hepatitis" ], "offsets": [ [ 1495, 1512 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T101", "type": "Condition", "text": [ "acute", "hepatitis" ], "offsets": [ [ 1486, 1491 ], [ 1503, 1512 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T102", "type": "Scope", "text": [ "acute or chronic hepatitis" ], "offsets": [ [ 1486, 1512 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T103", "type": "Procedure", "text": [ "12-lead electrocardiogram (ECG)" ], "offsets": [ [ 1524, 1555 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T104", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 1515, 1523 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T105", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1556, 1568 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T106", "type": "Temporal", "text": [ "at", "pre-dose" ], "offsets": [ [ 1556, 1558 ], [ 1572, 1580 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T107", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1559, 1568 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T108", "type": "Reference_point", "text": [ "pre-dose" ], "offsets": [ [ 1572, 1580 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T109", "type": "Temporal", "text": [ "Day -1" ], "offsets": [ [ 1582, 1588 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T110", "type": "Temporal", "text": [ "Day 1" ], "offsets": [ [ 1592, 1597 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T111", "type": "Drug", "text": [ "experimental drugs" ], "offsets": [ [ 1700, 1718 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T112", "type": "Device", "text": [ "experimental", "devices" ], "offsets": [ [ 1700, 1712 ], [ 1722, 1729 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T113", "type": "Temporal", "text": [ "within 30 days" ], "offsets": [ [ 1730, 1744 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T114", "type": "Temporal", "text": [ "within", "5 half lives" ], "offsets": [ [ 1730, 1736 ], [ 1748, 1760 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T115", "type": "Scope", "text": [ "experimental drugs or devices" ], "offsets": [ [ 1700, 1729 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T116", "type": "Scope", "text": [ "within 30 days or 5 half lives" ], "offsets": [ [ 1730, 1760 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T121", "type": "Procedure", "text": [ "Blood donation" ], "offsets": [ [ 1876, 1890 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T122", "type": "Temporal", "text": [ "within 60 days prior to screening" ], "offsets": [ [ 1891, 1924 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T123", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1915, 1924 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T124", "type": "Observation", "text": [ "intent to donate" ], "offsets": [ [ 1928, 1944 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T126", "type": "Temporal", "text": [ "within 60 days after Final Study Visit" ], "offsets": [ [ 1945, 1983 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T127", "type": "Reference_point", "text": [ "Final Study Visit" ], "offsets": [ [ 1966, 1983 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T128", "type": "Procedure", "text": [ "Hospitalization" ], "offsets": [ [ 1986, 2001 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T129", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 2012, 2019 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T130", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 2006, 2011 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T133", "type": "Procedure", "text": [ "cardiovascular surgery" ], "offsets": [ [ 2073, 2095 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T134", "type": "Procedure", "text": [ "thoracic", "surgery" ], "offsets": [ [ 2060, 2068 ], [ 2088, 2095 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T135", "type": "Procedure", "text": [ "abdominal", "surgery" ], "offsets": [ [ 2049, 2058 ], [ 2088, 2095 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T136", "type": "Temporal", "text": [ "within the past 3 months prior to screening" ], "offsets": [ [ 2096, 2139 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T137", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 2130, 2139 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T138", "type": "Condition", "text": [ "non-surgical illness" ], "offsets": [ [ 2173, 2193 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T139", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 2150, 2172 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T143", "type": "Temporal", "text": [ "within the past 3 months" ], "offsets": [ [ 2227, 2251 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T144", "type": "Scope", "text": [ "abdominal, thoracic, or cardiovascular surgery" ], "offsets": [ [ 2049, 2095 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T145", "type": "Procedure", "text": [ "elective surgery" ], "offsets": [ [ 2262, 2278 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T146", "type": "Observation", "text": [ "Planned" ], "offsets": [ [ 2254, 2261 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T148", "type": "Temporal", "text": [ "within 30 days of the Final Study Visit" ], "offsets": [ [ 2279, 2318 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T149", "type": "Reference_point", "text": [ "Final Study Visit" ], "offsets": [ [ 2301, 2318 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T150", "type": "Condition", "text": [ "Poor venous access" ], "offsets": [ [ 2321, 2339 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T151", "type": "Procedure", "text": [ "venipuncture" ], "offsets": [ [ 2365, 2377 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T152", "type": "Condition", "text": [ "inability to tolerate venipuncture" ], "offsets": [ [ 2343, 2377 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T153", "type": "Condition", "text": [ "drug hypersensitivity" ], "offsets": [ [ 2403, 2424 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T154", "type": "Condition", "text": [ "drug", "anaphylaxis" ], "offsets": [ [ 2403, 2407 ], [ 2428, 2439 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T155", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2391, 2402 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T157", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2380, 2387 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T158", "type": "Condition", "text": [ "hypersensitivity to proteins" ], "offsets": [ [ 2453, 2481 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T159", "type": "Condition", "text": [ "hypersensitivity to", "allergy shots" ], "offsets": [ [ 2453, 2472 ], [ 2489, 2502 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T160", "type": "Drug", "text": [ "prescription medications" ], "offsets": [ [ 2513, 2537 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T161", "type": "Drug", "text": [ "any prescription medication" ], "offsets": [ [ 2574, 2601 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T162", "type": "Temporal", "text": [ "last use", "greater than 5 half-lives" ], "offsets": [ [ 2562, 2570 ], [ 2617, 2642 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T163", "type": "Temporal", "text": [ "at least 14 days prior to admission" ], "offsets": [ [ 2674, 2709 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T164", "type": "Reference_point", "text": [ "admission" ], "offsets": [ [ 2700, 2709 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T166", "type": "Temporal", "text": [ "regular basis" ], "offsets": [ [ 2543, 2556 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T167", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2442, 2449 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T171", "type": "Drug", "text": [ "Antihypertensives" ], "offsets": [ [ 2917, 2934 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T172", "type": "Multiplier", "text": [ "<3 medications" ], "offsets": [ [ 2936, 2950 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T173", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 2956, 2967 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T174", "type": "Temporal", "text": [ "for ≥ 30 days" ], "offsets": [ [ 2968, 2981 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T175", "type": "Drug", "text": [ "Statins" ], "offsets": [ [ 2985, 2992 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T176", "type": "Multiplier", "text": [ "≤ half the maximum dose" ], "offsets": [ [ 3007, 3030 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T177", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 3045, 3056 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T178", "type": "Temporal", "text": [ "≥3 months" ], "offsets": [ [ 3057, 3066 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T179", "type": "Drug", "text": [ "Fibrates" ], "offsets": [ [ 3070, 3078 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T180", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 3091, 3102 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T181", "type": "Temporal", "text": [ "≥3 months" ], "offsets": [ [ 3107, 3116 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T182", "type": "Drug", "text": [ "Niacin" ], "offsets": [ [ 3120, 3126 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T183", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 3139, 3150 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T184", "type": "Temporal", "text": [ "≥3 months" ], "offsets": [ [ 3155, 3164 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T185", "type": "Drug", "text": [ "Thyroxin" ], "offsets": [ [ 3168, 3176 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T186", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 3178, 3189 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T187", "type": "Temporal", "text": [ "≥ 30 days" ], "offsets": [ [ 3194, 3203 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T190", "type": "Drug", "text": [ "prescription medications" ], "offsets": [ [ 3336, 3360 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T191", "type": "Drug", "text": [ "non-prescription drug" ], "offsets": [ [ 3472, 3493 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T193", "type": "Drug", "text": [ "herbal substances" ], "offsets": [ [ 3498, 3515 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T194", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 3516, 3532 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T196", "type": "Drug", "text": [ "any non-prescription drug" ], "offsets": [ [ 3583, 3608 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T165", "type": "Temporal", "text": [ "greater than 5 half-lives", "before receiving study drug" ], "offsets": [ [ 3630, 3655 ], [ 3670, 3697 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T199", "type": "Condition", "text": [ "drug/solvent abuse" ], "offsets": [ [ 3904, 3922 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T200", "type": "Observation", "text": [ "history" ], "offsets": [ [ 3893, 3900 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T201", "type": "Temporal", "text": [ "within 5 years of screening" ], "offsets": [ [ 3923, 3950 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T202", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 3941, 3950 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T203", "type": "Measurement", "text": [ "drugs of abuse test" ], "offsets": [ [ 3974, 3993 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T204", "type": "Value", "text": [ "positive" ], "offsets": [ [ 3956, 3964 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T205", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 3994, 4006 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T206", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 3997, 4006 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T207", "type": "Measurement", "text": [ "breath test" ], "offsets": [ [ 4040, 4051 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T208", "type": "Measurement", "text": [ "alcohol", "test" ], "offsets": [ [ 4031, 4038 ], [ 4047, 4051 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T209", "type": "Scope", "text": [ "alcohol (breath test)" ], "offsets": [ [ 4031, 4052 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T210", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 4022, 4030 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T211", "type": "Measurement", "text": [ "nicotine screen" ], "offsets": [ [ 4056, 4071 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T212", "type": "Temporal", "text": [ "at Screening Visit" ], "offsets": [ [ 4072, 4090 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T213", "type": "Reference_point", "text": [ "Screening Visit" ], "offsets": [ [ 4075, 4090 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T214", "type": "Scope", "text": [ "Positive alcohol (breath test) or nicotine screen" ], "offsets": [ [ 4022, 4071 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T215", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 4178, 4191 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T216", "type": "Observation", "text": [ "History" ], "offsets": [ [ 4167, 4174 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T217", "type": "Multiplier", "text": [ "three or more units", "per day" ], "offsets": [ [ 4222, 4241 ], [ 4253, 4260 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T218", "type": "Drug", "text": [ "alcohol" ], "offsets": [ [ 4245, 4252 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T219", "type": "Temporal", "text": [ "within 5 years of the Screening Visit" ], "offsets": [ [ 4262, 4299 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T220", "type": "Reference_point", "text": [ "the Screening Visit" ], "offsets": [ [ 4280, 4299 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T221", "type": "Observation", "text": [ "History" ], "offsets": [ [ 4302, 4309 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T222", "type": "Condition", "text": [ "tobacco", "use" ], "offsets": [ [ 4313, 4320 ], [ 4340, 4343 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T223", "type": "Condition", "text": [ "tobacco product use" ], "offsets": [ [ 4324, 4343 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T224", "type": "Condition", "text": [ "abstinent" ], "offsets": [ [ 4351, 4360 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T225", "type": "Temporal", "text": [ "for at least one year prior to the Screening Visit" ], "offsets": [ [ 4361, 4411 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T226", "type": "Reference_point", "text": [ "the Screening Visit" ], "offsets": [ [ 4392, 4411 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T227", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 4344, 4350 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T228", "type": "Scope", "text": [ "tobacco or tobacco product use" ], "offsets": [ [ 4313, 4343 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T234", "type": "Procedure", "text": [ "Hormonal contraception" ], "offsets": [ [ 2741, 2763 ] ], "normalized": [] }, { "id": "NCT02431442_exc_T235", "type": "Person", "text": [ "female" ], "offsets": [ [ 2779, 2785 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02431442_exc_R1", "type": "Has_value", "arg1_id": "NCT02431442_exc_T1", "arg2_id": "NCT02431442_exc_T2", "normalized": [] }, { "id": "NCT02431442_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T1", "arg2_id": "NCT02431442_exc_T3", "normalized": [] }, { "id": "NCT02431442_exc_R3", "type": "Has_value", "arg1_id": "NCT02431442_exc_T5", "arg2_id": "NCT02431442_exc_T6", "normalized": [] }, { "id": "NCT02431442_exc_R4", "type": "AND", "arg1_id": "NCT02431442_exc_T4", "arg2_id": "NCT02431442_exc_T5", "normalized": [] }, { "id": "NCT02431442_exc_R5", "type": "Has_index", "arg1_id": "NCT02431442_exc_T10", "arg2_id": "NCT02431442_exc_T11", "normalized": [] }, { "id": "NCT02431442_exc_R6", "type": "Has_scope", "arg1_id": "NCT02431442_exc_T7", "arg2_id": "NCT02431442_exc_T12", "normalized": [] }, { "id": "NCT02431442_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T7", "arg2_id": "NCT02431442_exc_T10", "normalized": [] }, { "id": "NCT02431442_exc_R8", "type": "Has_value", "arg1_id": "NCT02431442_exc_T13", "arg2_id": "NCT02431442_exc_T15", "normalized": [] }, { "id": "NCT02431442_exc_R9", "type": "Has_value", "arg1_id": "NCT02431442_exc_T14", "arg2_id": "NCT02431442_exc_T15", "normalized": [] }, { "id": "NCT02431442_exc_R10", "type": "Has_index", "arg1_id": "NCT02431442_exc_T16", "arg2_id": "NCT02431442_exc_T17", "normalized": [] }, { "id": "NCT02431442_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T13", "arg2_id": "NCT02431442_exc_T16", "normalized": [] }, { "id": "NCT02431442_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T14", "arg2_id": "NCT02431442_exc_T16", "normalized": [] }, { "id": "NCT02431442_exc_R13", "type": "Has_value", "arg1_id": "NCT02431442_exc_T18", "arg2_id": "NCT02431442_exc_T19", "normalized": [] }, { "id": "NCT02431442_exc_R14", "type": "Has_index", "arg1_id": "NCT02431442_exc_T21", "arg2_id": "NCT02431442_exc_T22", "normalized": [] }, { "id": "NCT02431442_exc_R15", "type": "Has_value", "arg1_id": "NCT02431442_exc_T23", "arg2_id": "NCT02431442_exc_T27", "normalized": [] }, { "id": "NCT02431442_exc_R17", "type": "Has_value", "arg1_id": "NCT02431442_exc_T20", "arg2_id": "NCT02431442_exc_T19", "normalized": [] }, { "id": "NCT02431442_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T18", "arg2_id": "NCT02431442_exc_T21", "normalized": [] }, { "id": "NCT02431442_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T20", "arg2_id": "NCT02431442_exc_T21", "normalized": [] }, { "id": "NCT02431442_exc_R20", "type": "AND", "arg1_id": "NCT02431442_exc_T29", "arg2_id": "NCT02431442_exc_T31", "normalized": [] }, { "id": "NCT02431442_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T28", "arg2_id": "NCT02431442_exc_T29", "normalized": [] }, { "id": "NCT02431442_exc_R22", "type": "Has_scope", "arg1_id": "NCT02431442_exc_T32", "arg2_id": "NCT02431442_exc_T35", "normalized": [] }, { "id": "NCT02431442_exc_R23", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T28", "arg2_id": "NCT02431442_exc_T36", "normalized": [] }, { "id": "NCT02431442_exc_R24", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T32", "arg2_id": "NCT02431442_exc_T36", "normalized": [] }, { "id": "NCT02431442_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T39", "arg2_id": "NCT02431442_exc_T41", "normalized": [] }, { "id": "NCT02431442_exc_R26", "type": "AND", "arg1_id": "NCT02431442_exc_T37", "arg2_id": "NCT02431442_exc_T39", "normalized": [] }, { "id": "NCT02431442_exc_R27", "type": "AND", "arg1_id": "NCT02431442_exc_T41", "arg2_id": "NCT02431442_exc_T40", "normalized": [] }, { "id": "NCT02431442_exc_R28", "type": "AND", "arg1_id": "NCT02431442_exc_T45", "arg2_id": "NCT02431442_exc_T46", "normalized": [] }, { "id": "NCT02431442_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T44", "arg2_id": "NCT02431442_exc_T45", "normalized": [] }, { "id": "NCT02431442_exc_R30", "type": "Has_index", "arg1_id": "NCT02431442_exc_T48", "arg2_id": "NCT02431442_exc_T49", "normalized": [] }, { "id": "NCT02431442_exc_R31", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T47", "arg2_id": "NCT02431442_exc_T48", "normalized": [] }, { "id": "NCT02431442_exc_R32", "type": "AND", "arg1_id": "NCT02431442_exc_T44", "arg2_id": "NCT02431442_exc_T47", "normalized": [] }, { "id": "NCT02431442_exc_R33", "type": "AND", "arg1_id": "NCT02431442_exc_T53", "arg2_id": "NCT02431442_exc_T54", "normalized": [] }, { "id": "NCT02431442_exc_R34", "type": "AND", "arg1_id": "NCT02431442_exc_T50", "arg2_id": "NCT02431442_exc_T52", "normalized": [] }, { "id": "NCT02431442_exc_R35", "type": "Has_negation", "arg1_id": "NCT02431442_exc_T52", "arg2_id": "NCT02431442_exc_T55", "normalized": [] }, { "id": "NCT02431442_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T52", "arg2_id": "NCT02431442_exc_T53", "normalized": [] }, { "id": "NCT02431442_exc_R37", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T50", "arg2_id": "NCT02431442_exc_T51", "normalized": [] }, { "id": "NCT02431442_exc_R38", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T50", "arg2_id": "NCT02431442_exc_T56", "normalized": [] }, { "id": "NCT02431442_exc_R39", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T57", "arg2_id": "NCT02431442_exc_T58", "normalized": [] }, { "id": "NCT02431442_exc_R40", "type": "Subsumes", "arg1_id": "NCT02431442_exc_T57", "arg2_id": "NCT02431442_exc_T79", "normalized": [] }, { "id": "NCT02431442_exc_R41", "type": "Has_scope", "arg1_id": "NCT02431442_exc_T57", "arg2_id": "NCT02431442_exc_T63", "normalized": [] }, { "id": "NCT02431442_exc_R42", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T58", "arg2_id": "NCT02431442_exc_T76", "normalized": [] }, { "id": "NCT02431442_exc_R43", "type": "Has_value", "arg1_id": "NCT02431442_exc_T83", "arg2_id": "NCT02431442_exc_T84", "normalized": [] }, { "id": "NCT02431442_exc_R44", "type": "Has_value", "arg1_id": "NCT02431442_exc_T87", "arg2_id": "NCT02431442_exc_T88", "normalized": [] }, { "id": "NCT02431442_exc_R45", "type": "Has_value", "arg1_id": "NCT02431442_exc_T85", "arg2_id": "NCT02431442_exc_T86", "normalized": [] }, { "id": "NCT02431442_exc_R46", "type": "Has_index", "arg1_id": "NCT02431442_exc_T89", "arg2_id": "NCT02431442_exc_T90", "normalized": [] }, { "id": "NCT02431442_exc_R47", "type": "Has_value", "arg1_id": "NCT02431442_exc_T95", "arg2_id": "NCT02431442_exc_T96", "normalized": [] }, { "id": "NCT02431442_exc_R48", "type": "Subsumes", "arg1_id": "NCT02431442_exc_T95", "arg2_id": "NCT02431442_exc_T97", "normalized": [] }, { "id": "NCT02431442_exc_R49", "type": "Has_scope", "arg1_id": "NCT02431442_exc_T95", "arg2_id": "NCT02431442_exc_T102", "normalized": [] }, { "id": "NCT02431442_exc_R50", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T95", "arg2_id": "NCT02431442_exc_T91", "normalized": [] }, { "id": "NCT02431442_exc_R51", "type": "Has_value", "arg1_id": "NCT02431442_exc_T103", "arg2_id": "NCT02431442_exc_T104", "normalized": [] }, { "id": "NCT02431442_exc_R52", "type": "Has_index", "arg1_id": "NCT02431442_exc_T105", "arg2_id": "NCT02431442_exc_T107", "normalized": [] }, { "id": "NCT02431442_exc_R53", "type": "Has_index", "arg1_id": "NCT02431442_exc_T106", "arg2_id": "NCT02431442_exc_T108", "normalized": [] }, { "id": "NCT02431442_exc_R54", "type": "Has_scope", "arg1_id": "NCT02431442_exc_T115", "arg2_id": "NCT02431442_exc_T116", "normalized": [] }, { "id": "NCT02431442_exc_R55", "type": "Has_index", "arg1_id": "NCT02431442_exc_T122", "arg2_id": "NCT02431442_exc_T123", "normalized": [] }, { "id": "NCT02431442_exc_R56", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T121", "arg2_id": "NCT02431442_exc_T122", "normalized": [] }, { "id": "NCT02431442_exc_R57", "type": "Has_index", "arg1_id": "NCT02431442_exc_T126", "arg2_id": "NCT02431442_exc_T127", "normalized": [] }, { "id": "NCT02431442_exc_R58", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T124", "arg2_id": "NCT02431442_exc_T126", "normalized": [] }, { "id": "NCT02431442_exc_R59", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T129", "arg2_id": "NCT02431442_exc_T130", "normalized": [] }, { "id": "NCT02431442_exc_R60", "type": "Has_index", "arg1_id": "NCT02431442_exc_T136", "arg2_id": "NCT02431442_exc_T137", "normalized": [] }, { "id": "NCT02431442_exc_R61", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T138", "arg2_id": "NCT02431442_exc_T139", "normalized": [] }, { "id": "NCT02431442_exc_R62", "type": "AND", "arg1_id": "NCT02431442_exc_T128", "arg2_id": "NCT02431442_exc_T129", "normalized": [] }, { "id": "NCT02431442_exc_R63", "type": "Subsumes", "arg1_id": "NCT02431442_exc_T129", "arg2_id": "NCT02431442_exc_T144", "normalized": [] }, { "id": "NCT02431442_exc_R64", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T129", "arg2_id": "NCT02431442_exc_T136", "normalized": [] }, { "id": "NCT02431442_exc_R65", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T138", "arg2_id": "NCT02431442_exc_T143", "normalized": [] }, { "id": "NCT02431442_exc_R66", "type": "Has_mood", "arg1_id": "NCT02431442_exc_T145", "arg2_id": "NCT02431442_exc_T146", "normalized": [] }, { "id": "NCT02431442_exc_R67", "type": "Has_index", "arg1_id": "NCT02431442_exc_T148", "arg2_id": "NCT02431442_exc_T149", "normalized": [] }, { "id": "NCT02431442_exc_R68", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T145", "arg2_id": "NCT02431442_exc_T148", "normalized": [] }, { "id": "NCT02431442_exc_R69", "type": "AND", "arg1_id": "NCT02431442_exc_T152", "arg2_id": "NCT02431442_exc_T151", "normalized": [] }, { "id": "NCT02431442_exc_R70", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T154", "arg2_id": "NCT02431442_exc_T155", "normalized": [] }, { "id": "NCT02431442_exc_R71", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T153", "arg2_id": "NCT02431442_exc_T155", "normalized": [] }, { "id": "NCT02431442_exc_R72", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T154", "arg2_id": "NCT02431442_exc_T157", "normalized": [] }, { "id": "NCT02431442_exc_R73", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T153", "arg2_id": "NCT02431442_exc_T157", "normalized": [] }, { "id": "NCT02431442_exc_R74", "type": "Subsumes", "arg1_id": "NCT02431442_exc_T158", "arg2_id": "NCT02431442_exc_T159", "normalized": [] }, { "id": "NCT02431442_exc_R75", "type": "Has_index", "arg1_id": "NCT02431442_exc_T163", "arg2_id": "NCT02431442_exc_T164", "normalized": [] }, { "id": "NCT02431442_exc_R77", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T160", "arg2_id": "NCT02431442_exc_T166", "normalized": [] }, { "id": "NCT02431442_exc_R78", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T159", "arg2_id": "NCT02431442_exc_T167", "normalized": [] }, { "id": "NCT02431442_exc_R79", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T158", "arg2_id": "NCT02431442_exc_T167", "normalized": [] }, { "id": "NCT02431442_exc_R80", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T161", "arg2_id": "NCT02431442_exc_T162", "normalized": [] }, { "id": "NCT02431442_exc_R81", "type": "Has_multiplier", "arg1_id": "NCT02431442_exc_T173", "arg2_id": "NCT02431442_exc_T172", "normalized": [] }, { "id": "NCT02431442_exc_R82", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T173", "arg2_id": "NCT02431442_exc_T174", "normalized": [] }, { "id": "NCT02431442_exc_R83", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T171", "arg2_id": "NCT02431442_exc_T173", "normalized": [] }, { "id": "NCT02431442_exc_R84", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T177", "arg2_id": "NCT02431442_exc_T178", "normalized": [] }, { "id": "NCT02431442_exc_R85", "type": "Has_multiplier", "arg1_id": "NCT02431442_exc_T175", "arg2_id": "NCT02431442_exc_T176", "normalized": [] }, { "id": "NCT02431442_exc_R86", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T175", "arg2_id": "NCT02431442_exc_T177", "normalized": [] }, { "id": "NCT02431442_exc_R87", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T180", "arg2_id": "NCT02431442_exc_T181", "normalized": [] }, { "id": "NCT02431442_exc_R88", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T179", "arg2_id": "NCT02431442_exc_T180", "normalized": [] }, { "id": "NCT02431442_exc_R89", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T183", "arg2_id": "NCT02431442_exc_T184", "normalized": [] }, { "id": "NCT02431442_exc_R90", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T182", "arg2_id": "NCT02431442_exc_T183", "normalized": [] }, { "id": "NCT02431442_exc_R91", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T186", "arg2_id": "NCT02431442_exc_T187", "normalized": [] }, { "id": "NCT02431442_exc_R92", "type": "Has_qualifier", "arg1_id": "NCT02431442_exc_T185", "arg2_id": "NCT02431442_exc_T186", "normalized": [] }, { "id": "NCT02431442_exc_R93", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T191", "arg2_id": "NCT02431442_exc_T194", "normalized": [] }, { "id": "NCT02431442_exc_R94", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T193", "arg2_id": "NCT02431442_exc_T194", "normalized": [] }, { "id": "NCT02431442_exc_R76", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T196", "arg2_id": "NCT02431442_exc_T165", "normalized": [] }, { "id": "NCT02431442_exc_R95", "type": "Has_index", "arg1_id": "NCT02431442_exc_T201", "arg2_id": "NCT02431442_exc_T202", "normalized": [] }, { "id": "NCT02431442_exc_R96", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T199", "arg2_id": "NCT02431442_exc_T201", "normalized": [] }, { "id": "NCT02431442_exc_R97", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T199", "arg2_id": "NCT02431442_exc_T200", "normalized": [] }, { "id": "NCT02431442_exc_R98", "type": "Has_value", "arg1_id": "NCT02431442_exc_T203", "arg2_id": "NCT02431442_exc_T204", "normalized": [] }, { "id": "NCT02431442_exc_R99", "type": "Has_index", "arg1_id": "NCT02431442_exc_T205", "arg2_id": "NCT02431442_exc_T206", "normalized": [] }, { "id": "NCT02431442_exc_R100", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T203", "arg2_id": "NCT02431442_exc_T205", "normalized": [] }, { "id": "NCT02431442_exc_R101", "type": "Has_value", "arg1_id": "NCT02431442_exc_T209", "arg2_id": "NCT02431442_exc_T210", "normalized": [] }, { "id": "NCT02431442_exc_R102", "type": "Has_value", "arg1_id": "NCT02431442_exc_T211", "arg2_id": "NCT02431442_exc_T210", "normalized": [] }, { "id": "NCT02431442_exc_R103", "type": "Has_index", "arg1_id": "NCT02431442_exc_T212", "arg2_id": "NCT02431442_exc_T213", "normalized": [] }, { "id": "NCT02431442_exc_R104", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T214", "arg2_id": "NCT02431442_exc_T212", "normalized": [] }, { "id": "NCT02431442_exc_R105", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T215", "arg2_id": "NCT02431442_exc_T216", "normalized": [] }, { "id": "NCT02431442_exc_R106", "type": "Has_multiplier", "arg1_id": "NCT02431442_exc_T218", "arg2_id": "NCT02431442_exc_T217", "normalized": [] }, { "id": "NCT02431442_exc_R107", "type": "Subsumes", "arg1_id": "NCT02431442_exc_T215", "arg2_id": "NCT02431442_exc_T218", "normalized": [] }, { "id": "NCT02431442_exc_R108", "type": "Has_index", "arg1_id": "NCT02431442_exc_T219", "arg2_id": "NCT02431442_exc_T220", "normalized": [] }, { "id": "NCT02431442_exc_R111", "type": "Has_index", "arg1_id": "NCT02431442_exc_T225", "arg2_id": "NCT02431442_exc_T226", "normalized": [] }, { "id": "NCT02431442_exc_R112", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T224", "arg2_id": "NCT02431442_exc_T225", "normalized": [] }, { "id": "NCT02431442_exc_R113", "type": "Has_negation", "arg1_id": "NCT02431442_exc_T224", "arg2_id": "NCT02431442_exc_T227", "normalized": [] }, { "id": "NCT02431442_exc_R109", "type": "Has_temporal", "arg1_id": "NCT02431442_exc_T228", "arg2_id": "NCT02431442_exc_T221", "normalized": [] }, { "id": "NCT02431442_exc_R110", "type": "AND", "arg1_id": "NCT02431442_exc_T228", "arg2_id": "NCT02431442_exc_T224", "normalized": [] }, { "id": "NCT02431442_exc_R114", "type": "AND", "arg1_id": "NCT02431442_exc_T235", "arg2_id": "NCT02431442_exc_T234", "normalized": [] } ]

[ { "id": "NCT02431442_inc_text", "type": "inclusion", "text": [ "Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures. \nHealthy obese male and female volunteers aged 18 to 55 years, inclusive. Heterozygous subjects may be 18 to 65 years inclusive. \nIn good general health, without significant medical history, physical examination findings, or clinical laboratory abnormalities. \nBody Mass Index of 30-40 kg/m2, inclusive. Heterozygous subjects may have a broader BMI range; to be eligible heterozygous subjects may have a BMI 27 -55 kg/ m2, inclusive. \nStable body weight during the previous 6 months, based on Investigator judgment. \nBlood pressure <140/90 mmHg at Screening and D-1. Measurement may be repeated within 24 hours, based on Investigator judgment. \nFemales must not be pregnant and must have a negative serum pregnancy test result at the Screening Visit and Day -1. \nFemales of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the Screening Period through the Final Study Visit: hormonal, condom with spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or IUD. Hormonal contraception must have started at least 3 months prior to screening. A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. Subjects must agree to practice the above birth control methods for 30 days from the final visit as a safety precaution. \nFemales of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening FSH level in the post-menopausal range), do not require contraception during the study. \nMales with female partners of childbearing potential must agree to use two medically acceptable forms of contraception as described above, with one of the two forms being condom with spermicide, from the Screening Period through the Final Study Visit. Males with female partners of childbearing potential who themselves are surgically sterile (status post vasectomy) must agree to use condoms with spermicide over the same period of time. Male subjects must agree to practice the above birth control methods for 30 days from the final visit as a safety precaution. \n" ], "offsets": [ [ 0, 2399 ] ] } ]

[ { "id": "NCT02431442_inc_T3", "type": "Condition", "text": [ "obese" ], "offsets": [ [ 143, 148 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T4", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 135, 142 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T5", "type": "Person", "text": [ "male" ], "offsets": [ [ 149, 153 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T6", "type": "Person", "text": [ "female" ], "offsets": [ [ 158, 164 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T8", "type": "Person", "text": [ "aged" ], "offsets": [ [ 176, 180 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T9", "type": "Value", "text": [ "18 to 55 years, inclusive" ], "offsets": [ [ 181, 206 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T10", "type": "Condition", "text": [ "Heterozygous" ], "offsets": [ [ 208, 220 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T12", "type": "Value", "text": [ "18 to 65 years inclusive" ], "offsets": [ [ 237, 261 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T14", "type": "Condition", "text": [ "good general health" ], "offsets": [ [ 267, 286 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T18", "type": "Measurement", "text": [ "Body Mass Index" ], "offsets": [ [ 395, 410 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T19", "type": "Value", "text": [ "30-40 kg/m2, inclusive" ], "offsets": [ [ 414, 436 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T20", "type": "Condition", "text": [ "Heterozygous" ], "offsets": [ [ 438, 450 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T22", "type": "Condition", "text": [ "heterozygous" ], "offsets": [ [ 505, 517 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T23", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 538, 541 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T24", "type": "Value", "text": [ "27 -55 kg/ m2, inclusive" ], "offsets": [ [ 542, 566 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T26", "type": "Measurement", "text": [ "body weight" ], "offsets": [ [ 576, 587 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T27", "type": "Qualifier", "text": [ "Stable" ], "offsets": [ [ 569, 575 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T28", "type": "Temporal", "text": [ "during the previous 6 months" ], "offsets": [ [ 588, 616 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T30", "type": "Measurement", "text": [ "Blood pressure" ], "offsets": [ [ 651, 665 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T31", "type": "Value", "text": [ "<140/90 mmHg" ], "offsets": [ [ 666, 678 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T32", "type": "Temporal", "text": [ "at Screening and D-1" ], "offsets": [ [ 679, 699 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T33", "type": "Reference_point", "text": [ "Screening and D-1" ], "offsets": [ [ 682, 699 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T37", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 799, 807 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T38", "type": "Negation", "text": [ "not" ], "offsets": [ [ 792, 795 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T39", "type": "Person", "text": [ "Females" ], "offsets": [ [ 779, 786 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T40", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 833, 853 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T41", "type": "Value", "text": [ "negative" ], "offsets": [ [ 824, 832 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T42", "type": "Temporal", "text": [ "at the Screening Visit and Day -1" ], "offsets": [ [ 861, 894 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T43", "type": "Reference_point", "text": [ "the Screening Visit and Day -1" ], "offsets": [ [ 864, 894 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T45", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 908, 930 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T48", "type": "Procedure", "text": [ "Hormonal contraception" ], "offsets": [ [ 1195, 1217 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T49", "type": "Temporal", "text": [ "at least 3 months prior to screening" ], "offsets": [ [ 1236, 1272 ] ], "normalized": [] }, { "id": "NCT02431442_inc_T50", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1263, 1272 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02431442_inc_R1", "type": "Has_value", "arg1_id": "NCT02431442_inc_T8", "arg2_id": "NCT02431442_inc_T9", "normalized": [] }, { "id": "NCT02431442_inc_R2", "type": "Has_value", "arg1_id": "NCT02431442_inc_T18", "arg2_id": "NCT02431442_inc_T19", "normalized": [] }, { "id": "NCT02431442_inc_R3", "type": "Has_value", "arg1_id": "NCT02431442_inc_T23", "arg2_id": "NCT02431442_inc_T24", "normalized": [] }, { "id": "NCT02431442_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02431442_inc_T26", "arg2_id": "NCT02431442_inc_T27", "normalized": [] }, { "id": "NCT02431442_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02431442_inc_T26", "arg2_id": "NCT02431442_inc_T28", "normalized": [] }, { "id": "NCT02431442_inc_R6", "type": "Has_index", "arg1_id": "NCT02431442_inc_T32", "arg2_id": "NCT02431442_inc_T33", "normalized": [] }, { "id": "NCT02431442_inc_R7", "type": "Has_value", "arg1_id": "NCT02431442_inc_T30", "arg2_id": "NCT02431442_inc_T31", "normalized": [] }, { "id": "NCT02431442_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02431442_inc_T30", "arg2_id": "NCT02431442_inc_T32", "normalized": [] }, { "id": "NCT02431442_inc_R9", "type": "Has_negation", "arg1_id": "NCT02431442_inc_T37", "arg2_id": "NCT02431442_inc_T38", "normalized": [] }, { "id": "NCT02431442_inc_R10", "type": "Has_index", "arg1_id": "NCT02431442_inc_T42", "arg2_id": "NCT02431442_inc_T43", "normalized": [] }, { "id": "NCT02431442_inc_R11", "type": "Has_value", "arg1_id": "NCT02431442_inc_T40", "arg2_id": "NCT02431442_inc_T41", "normalized": [] }, { "id": "NCT02431442_inc_R12", "type": "Has_temporal", "arg1_id": "NCT02431442_inc_T40", "arg2_id": "NCT02431442_inc_T42", "normalized": [] }, { "id": "NCT02431442_inc_R13", "type": "Has_index", "arg1_id": "NCT02431442_inc_T49", "arg2_id": "NCT02431442_inc_T50", "normalized": [] }, { "id": "NCT02431442_inc_R14", "type": "Has_temporal", "arg1_id": "NCT02431442_inc_T48", "arg2_id": "NCT02431442_inc_T49", "normalized": [] } ]

[ { "id": "NCT02431559_exc_text", "type": "exclusion", "text": [ "1. Prior exposure to doxorubicin, PLD or any other anthracycline, motolimod and other TLR agonists, MEDI4736 or checkpoint inhibitors, such as anti-CTLA4 and anti-PD1/anti-PD-L1 antibodies. \n2. Subjects with platinum-refractory disease, defined as disease progression while receiving first line platinum-based therapy. \n3. Clinically significant persistent immune-related adverse events following prior therapy. \n4. Subjects with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or, within six months prior to Day 1 of this study, history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage. \n5. Subjects with clinically significant cardiovascular disease. This includes: \n1. Resisted hypertension \n2. Myocardial infarction or unstable angina within 6 months prior to Day 1 of the study. \n3. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled with anti-arrhythmic medication. \n4. Baseline ejection fraction ≤ 50% as assessed by echocardiogram or MUGA. \n5. New York Heart Association (NYHA) Class II or higher congestive heart failure. \n6. Grade 2 or higher peripheral ischemia, except for brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit. \n6. History of pneumonitis or interstitial lung disease. \n7. Active, suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegner's granulomatosis, active Hashimoto's thyroiditis, rheumatoid arthritis, lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis). Vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted. \n8. Other malignancy within 2 years prior to Day 1 of the study, except for those treated with surgical intervention only. \n9. Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who require drainage gastrostomy tube and/or parenteral hydration or nutrition. \n10. Known immunodeficiency or HIV, Hepatitis B or Hepatitis C positivity. \n11. History of severe allergic reactions to any unknown allergens or components of the study drugs. \n12. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders). \n13. Prior treatment in any other interventional clinical trial within 4 weeks prior to Day 1 of the study. \n14. Mental impairment that may compromise compliance with the requirements of the study. \n15. Lack of availability for immunological and clinical follow-up assessment. \n16. Women who are breastfeeding or pregnant as evidenced by positive serum pregnancy test \n17. Subjects unwilling to use acceptable methods of contraception. \n-Female subjects should refrain from breastfeeding throughout this period. \n18. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk. \n19. Subjects must not donate blood while on study and for at least 90 days following the last MEDI4736 treatment. \n20. History of allogeneic organ transplant \n \n" ], "offsets": [ [ 0, 3558 ] ] } ]

[ { "id": "NCT02431559_exc_T27", "type": "Drug", "text": [ "doxorubicin" ], "offsets": [ [ 21, 32 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T28", "type": "Drug", "text": [ "PLD" ], "offsets": [ [ 34, 37 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T29", "type": "Drug", "text": [ "anthracycline" ], "offsets": [ [ 51, 64 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T30", "type": "Drug", "text": [ "motolimod" ], "offsets": [ [ 66, 75 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T31", "type": "Drug", "text": [ "TLR agonists" ], "offsets": [ [ 86, 98 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T32", "type": "Drug", "text": [ "MEDI4736" ], "offsets": [ [ 100, 108 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T33", "type": "Drug", "text": [ "checkpoint inhibitors" ], "offsets": [ [ 112, 133 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T34", "type": "Drug", "text": [ "anti-CTLA4" ], "offsets": [ [ 143, 153 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T35", "type": "Drug", "text": [ "anti-PD1", "antibodies" ], "offsets": [ [ 158, 166 ], [ 178, 188 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T36", "type": "Drug", "text": [ "anti-PD-L1 antibodies" ], "offsets": [ [ 167, 188 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T37", "type": "Scope", "text": [ "anti-CTLA4 and anti-PD1/anti-PD-L1 antibodies" ], "offsets": [ [ 143, 188 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T39", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T40", "type": "Scope", "text": [ "doxorubicin, PLD or any other anthracycline, motolimod and other TLR agonists, MEDI4736 or checkpoint inhibitors, such as anti-CTLA4 and anti-PD1/anti-PD-L1 antibodies" ], "offsets": [ [ 21, 188 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T41", "type": "Condition", "text": [ "platinum-refractory disease" ], "offsets": [ [ 208, 235 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T43", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 248, 267 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T44", "type": "Temporal", "text": [ "while receiving first line platinum-based therapy" ], "offsets": [ [ 268, 317 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T45", "type": "Reference_point", "text": [ "first line platinum-based therapy" ], "offsets": [ [ 284, 317 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T46", "type": "Condition", "text": [ "immune-related adverse events" ], "offsets": [ [ 357, 386 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T47", "type": "Temporal", "text": [ "following prior therapy" ], "offsets": [ [ 387, 410 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T48", "type": "Reference_point", "text": [ "prior therapy" ], "offsets": [ [ 397, 410 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T49", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 323, 345 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T50", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 346, 356 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T53", "type": "Condition", "text": [ "CNS disease" ], "offsets": [ [ 479, 490 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T54", "type": "Condition", "text": [ "primary brain tumor" ], "offsets": [ [ 502, 521 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T55", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 523, 531 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T56", "type": "Qualifier", "text": [ "controlled" ], "offsets": [ [ 536, 546 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T57", "type": "Negation", "text": [ "not" ], "offsets": [ [ 532, 535 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T58", "type": "Drug", "text": [ "standard medical therapy" ], "offsets": [ [ 552, 576 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T59", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 582, 598 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T60", "type": "Temporal", "text": [ "within six months prior to Day 1 of this study" ], "offsets": [ [ 604, 650 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T61", "type": "Reference_point", "text": [ "Day 1 of this study" ], "offsets": [ [ 631, 650 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T62", "type": "Condition", "text": [ "cerebrovascular accident" ], "offsets": [ [ 663, 687 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T63", "type": "Condition", "text": [ "CVA" ], "offsets": [ [ 689, 692 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T64", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 694, 700 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T65", "type": "Scope", "text": [ "CVA, stroke" ], "offsets": [ [ 689, 700 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T66", "type": "Condition", "text": [ "transient ischemic attack (TIA)" ], "offsets": [ [ 703, 734 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T67", "type": "Condition", "text": [ "subarachnoid hemorrhage" ], "offsets": [ [ 738, 761 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T68", "type": "Scope", "text": [ "cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage" ], "offsets": [ [ 663, 761 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T69", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 804, 826 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T70", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 781, 803 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T74", "type": "Condition", "text": [ "Resisted hypertension" ], "offsets": [ [ 847, 868 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T75", "type": "Condition", "text": [ "Myocardial infarction" ], "offsets": [ [ 873, 894 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T76", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 898, 913 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T77", "type": "Temporal", "text": [ "within 6 months prior to Day 1 of the study" ], "offsets": [ [ 914, 957 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T78", "type": "Reference_point", "text": [ "Day 1 of the study" ], "offsets": [ [ 939, 957 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T79", "type": "Condition", "text": [ "ventricular arrhythmia" ], "offsets": [ [ 982, 1004 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T80", "type": "Scope", "text": [ "Myocardial infarction or unstable angina" ], "offsets": [ [ 873, 913 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T81", "type": "Condition", "text": [ "ventricular tachycardia" ], "offsets": [ [ 1012, 1035 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T82", "type": "Condition", "text": [ "ventricular fibrillation" ], "offsets": [ [ 1039, 1063 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T83", "type": "Scope", "text": [ "ventricular tachycardia or ventricular fibrillation" ], "offsets": [ [ 1012, 1063 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T84", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 974, 981 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T85", "type": "Observation", "text": [ "History" ], "offsets": [ [ 963, 970 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T86", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 1068, 1087 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T87", "type": "Drug", "text": [ "anti-arrhythmic medications" ], "offsets": [ [ 1098, 1125 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T88", "type": "Qualifier", "text": [ "requiring anti-arrhythmic medications" ], "offsets": [ [ 1088, 1125 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T89", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 1138, 1157 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T90", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1127, 1133 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T91", "type": "Qualifier", "text": [ "well controlled with anti-arrhythmic medication" ], "offsets": [ [ 1166, 1213 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T92", "type": "Drug", "text": [ "anti-arrhythmic medication" ], "offsets": [ [ 1187, 1213 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T93", "type": "Measurement", "text": [ "ejection fraction" ], "offsets": [ [ 1228, 1245 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T94", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 1219, 1227 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T95", "type": "Value", "text": [ "≤ 50%" ], "offsets": [ [ 1246, 1251 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T96", "type": "Procedure", "text": [ "echocardiogram" ], "offsets": [ [ 1267, 1281 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T97", "type": "Procedure", "text": [ "MUGA" ], "offsets": [ [ 1285, 1289 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T98", "type": "Scope", "text": [ "echocardiogram or MUGA" ], "offsets": [ [ 1267, 1289 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T99", "type": "Measurement", "text": [ "New York Heart Association (NYHA)" ], "offsets": [ [ 1295, 1328 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T100", "type": "Value", "text": [ "Class II or higher" ], "offsets": [ [ 1329, 1347 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T101", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 1348, 1372 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T102", "type": "Condition", "text": [ "peripheral ischemia" ], "offsets": [ [ 1396, 1415 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T103", "type": "Qualifier", "text": [ "Grade 2 or higher" ], "offsets": [ [ 1378, 1395 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T104", "type": "Value", "text": [ "2 or higher" ], "offsets": [ [ 1384, 1395 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T105", "type": "Temporal", "text": [ "brief" ], "offsets": [ [ 1428, 1433 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T106", "type": "Value", "text": [ "< 24 hrs" ], "offsets": [ [ 1435, 1443 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T107", "type": "Condition", "text": [ "ischemia" ], "offsets": [ [ 1457, 1465 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T108", "type": "Procedure", "text": [ "surgically" ], "offsets": [ [ 1478, 1488 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T109", "type": "Negation", "text": [ "non" ], "offsets": [ [ 1474, 1477 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T110", "type": "Condition", "text": [ "permanent deficit" ], "offsets": [ [ 1501, 1518 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T111", "type": "Negation", "text": [ "without" ], "offsets": [ [ 1493, 1500 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T112", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1417, 1423 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T113", "type": "Scope", "text": [ "brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit" ], "offsets": [ [ 1428, 1518 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T114", "type": "Condition", "text": [ "pneumonitis" ], "offsets": [ [ 1535, 1546 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T115", "type": "Condition", "text": [ "interstitial lung disease" ], "offsets": [ [ 1550, 1575 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T116", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1524, 1531 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T117", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1619, 1637 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T118", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 1649, 1675 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T119", "type": "Condition", "text": [ "celiac disease" ], "offsets": [ [ 1677, 1691 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T120", "type": "Condition", "text": [ "Wegner's granulomatosis" ], "offsets": [ [ 1693, 1716 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T121", "type": "Condition", "text": [ "Hashimoto's thyroiditis" ], "offsets": [ [ 1725, 1748 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T122", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 1750, 1770 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T123", "type": "Condition", "text": [ "lupus" ], "offsets": [ [ 1772, 1777 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T124", "type": "Condition", "text": [ "scleroderma" ], "offsets": [ [ 1779, 1790 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T125", "type": "Condition", "text": [ "scleroderma", "variants" ], "offsets": [ [ 1779, 1790 ], [ 1799, 1807 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T126", "type": "Condition", "text": [ "multiple sclerosis" ], "offsets": [ [ 1809, 1827 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T127", "type": "Condition", "text": [ "myasthenia gravis" ], "offsets": [ [ 1829, 1846 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T128", "type": "Scope", "text": [ "inflammatory bowel disease, celiac disease, Wegner's granulomatosis, active Hashimoto's thyroiditis, rheumatoid arthritis, lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis" ], "offsets": [ [ 1649, 1846 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T129", "type": "Condition", "text": [ "Vitiligo" ], "offsets": [ [ 1849, 1857 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T130", "type": "Condition", "text": [ "type I diabetes mellitus" ], "offsets": [ [ 1859, 1883 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T131", "type": "Condition", "text": [ "residual hypothyroidism" ], "offsets": [ [ 1885, 1908 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T132", "type": "Condition", "text": [ "autoimmune condition" ], "offsets": [ [ 1916, 1936 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T133", "type": "Qualifier", "text": [ "due to autoimmune condition" ], "offsets": [ [ 1909, 1936 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T134", "type": "Drug", "text": [ "hormone replacement" ], "offsets": [ [ 1952, 1971 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T135", "type": "Qualifier", "text": [ "requiring hormone replacement" ], "offsets": [ [ 1942, 1971 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T136", "type": "Qualifier", "text": [ "requiring systemic treatment" ], "offsets": [ [ 1987, 2015 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T137", "type": "Procedure", "text": [ "systemic treatment" ], "offsets": [ [ 1997, 2015 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T138", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1983, 1986 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T139", "type": "Condition", "text": [ "psoriasis" ], "offsets": [ [ 1973, 1982 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T140", "type": "Qualifier", "text": [ "not expected to recur" ], "offsets": [ [ 2031, 2052 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T142", "type": "Condition", "text": [ "conditions" ], "offsets": [ [ 2020, 2030 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T144", "type": "Temporal", "text": [ "within 2 years prior to Day 1 of the study" ], "offsets": [ [ 2127, 2169 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T145", "type": "Reference_point", "text": [ "Day 1 of the study" ], "offsets": [ [ 2151, 2169 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T146", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 2116, 2126 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T147", "type": "Procedure", "text": [ "surgical intervention" ], "offsets": [ [ 2201, 2222 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T148", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 2171, 2181 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T149", "type": "Condition", "text": [ "those" ], "offsets": [ [ 2182, 2187 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T151", "type": "Condition", "text": [ "clinical symptoms", "of gastrointestinal obstruction" ], "offsets": [ [ 2247, 2264 ], [ 2274, 2305 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T152", "type": "Condition", "text": [ "signs of gastrointestinal obstruction" ], "offsets": [ [ 2268, 2305 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T153", "type": "Device", "text": [ "drainage gastrostomy tube" ], "offsets": [ [ 2325, 2350 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T154", "type": "Procedure", "text": [ "parenteral hydration" ], "offsets": [ [ 2358, 2378 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T155", "type": "Procedure", "text": [ "parenteral", "nutrition" ], "offsets": [ [ 2358, 2368 ], [ 2382, 2391 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T156", "type": "Condition", "text": [ "immunodeficiency" ], "offsets": [ [ 2404, 2420 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T157", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 2424, 2427 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T158", "type": "Condition", "text": [ "Hepatitis B" ], "offsets": [ [ 2429, 2440 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T159", "type": "Condition", "text": [ "Hepatitis C" ], "offsets": [ [ 2444, 2455 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T160", "type": "Condition", "text": [ "allergic reactions" ], "offsets": [ [ 2491, 2509 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T161", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2484, 2490 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T162", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2473, 2480 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T164", "type": "Drug", "text": [ "to any unknown allergens or components of the study drugs" ], "offsets": [ [ 2510, 2567 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T163", "type": "Condition", "text": [ "illnesses" ], "offsets": [ [ 2588, 2597 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T166", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2580, 2587 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T169", "type": "Condition", "text": [ "infections requiring antibiotics" ], "offsets": [ [ 2613, 2645 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T171", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2605, 2612 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T172", "type": "Condition", "text": [ "bleeding disorders" ], "offsets": [ [ 2647, 2665 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T173", "type": "Scope", "text": [ "serious infections requiring antibiotics, bleeding disorders" ], "offsets": [ [ 2605, 2665 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T174", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2679, 2688 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T177", "type": "Condition", "text": [ "Mental impairment" ], "offsets": [ [ 2781, 2798 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T178", "type": "Observation", "text": [ "compromise compliance" ], "offsets": [ [ 2808, 2829 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T182", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 2964, 2977 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T183", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 2981, 2989 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T184", "type": "Person", "text": [ "Women" ], "offsets": [ [ 2950, 2955 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T185", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 3015, 3035 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T186", "type": "Value", "text": [ "positive" ], "offsets": [ [ 3006, 3014 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T187", "type": "Scope", "text": [ "breastfeeding or pregnant" ], "offsets": [ [ 2964, 2989 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T190", "type": "Person", "text": [ "Female" ], "offsets": [ [ 3106, 3112 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T191", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 3142, 3155 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T193", "type": "Temporal", "text": [ "throughout this period." ], "offsets": [ [ 3156, 3179 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T194", "type": "Reference_point", "text": [ "this period" ], "offsets": [ [ 3167, 3178 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T199", "type": "Procedure", "text": [ "donate blood" ], "offsets": [ [ 3410, 3422 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T200", "type": "Negation", "text": [ "not" ], "offsets": [ [ 3406, 3409 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T201", "type": "Temporal", "text": [ "while on study" ], "offsets": [ [ 3423, 3437 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T202", "type": "Reference_point", "text": [ "on study" ], "offsets": [ [ 3429, 3437 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T203", "type": "Temporal", "text": [ "for at least 90 days following the last MEDI4736 treatment" ], "offsets": [ [ 3442, 3500 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T204", "type": "Reference_point", "text": [ "the last MEDI4736 treatment" ], "offsets": [ [ 3473, 3500 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T205", "type": "Scope", "text": [ "while on study and for at least 90 days following the last MEDI4736 treatment" ], "offsets": [ [ 3423, 3500 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T206", "type": "Procedure", "text": [ "allogeneic organ transplant" ], "offsets": [ [ 3518, 3545 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T207", "type": "Observation", "text": [ "History" ], "offsets": [ [ 3507, 3514 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T176", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 2673, 2678 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T188", "type": "Negation", "text": [ "refrain from" ], "offsets": [ [ 3129, 3141 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T180", "type": "Negation", "text": [ "Lack of" ], "offsets": [ [ 2871, 2878 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T181", "type": "Procedure", "text": [ "immunological", "follow-up assessment" ], "offsets": [ [ 2896, 2909 ], [ 2923, 2943 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T189", "type": "Procedure", "text": [ "clinical follow-up assessment" ], "offsets": [ [ 2914, 2943 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T192", "type": "Scope", "text": [ "immunological and clinical follow-up assessment" ], "offsets": [ [ 2896, 2943 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T195", "type": "Mood", "text": [ "availability for" ], "offsets": [ [ 2879, 2895 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T196", "type": "Condition", "text": [ "unwilling" ], "offsets": [ [ 3050, 3059 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T208", "type": "Qualifier", "text": [ "acceptable" ], "offsets": [ [ 3067, 3077 ] ], "normalized": [] }, { "id": "NCT02431559_exc_T209", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 3089, 3102 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02431559_exc_R1", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T33", "arg2_id": "NCT02431559_exc_T37", "normalized": [] }, { "id": "NCT02431559_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T40", "arg2_id": "NCT02431559_exc_T39", "normalized": [] }, { "id": "NCT02431559_exc_R3", "type": "Has_index", "arg1_id": "NCT02431559_exc_T44", "arg2_id": "NCT02431559_exc_T45", "normalized": [] }, { "id": "NCT02431559_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T43", "arg2_id": "NCT02431559_exc_T44", "normalized": [] }, { "id": "NCT02431559_exc_R5", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T41", "arg2_id": "NCT02431559_exc_T43", "normalized": [] }, { "id": "NCT02431559_exc_R6", "type": "Has_index", "arg1_id": "NCT02431559_exc_T47", "arg2_id": "NCT02431559_exc_T48", "normalized": [] }, { "id": "NCT02431559_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T46", "arg2_id": "NCT02431559_exc_T47", "normalized": [] }, { "id": "NCT02431559_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T46", "arg2_id": "NCT02431559_exc_T50", "normalized": [] }, { "id": "NCT02431559_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T46", "arg2_id": "NCT02431559_exc_T49", "normalized": [] }, { "id": "NCT02431559_exc_R10", "type": "AND", "arg1_id": "NCT02431559_exc_T56", "arg2_id": "NCT02431559_exc_T58", "normalized": [] }, { "id": "NCT02431559_exc_R11", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T56", "arg2_id": "NCT02431559_exc_T57", "normalized": [] }, { "id": "NCT02431559_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T55", "arg2_id": "NCT02431559_exc_T56", "normalized": [] }, { "id": "NCT02431559_exc_R13", "type": "Has_index", "arg1_id": "NCT02431559_exc_T60", "arg2_id": "NCT02431559_exc_T61", "normalized": [] }, { "id": "NCT02431559_exc_R14", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T62", "arg2_id": "NCT02431559_exc_T65", "normalized": [] }, { "id": "NCT02431559_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T68", "arg2_id": "NCT02431559_exc_T60", "normalized": [] }, { "id": "NCT02431559_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T69", "arg2_id": "NCT02431559_exc_T70", "normalized": [] }, { "id": "NCT02431559_exc_R17", "type": "Has_index", "arg1_id": "NCT02431559_exc_T77", "arg2_id": "NCT02431559_exc_T78", "normalized": [] }, { "id": "NCT02431559_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T80", "arg2_id": "NCT02431559_exc_T77", "normalized": [] }, { "id": "NCT02431559_exc_R19", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T79", "arg2_id": "NCT02431559_exc_T83", "normalized": [] }, { "id": "NCT02431559_exc_R20", "type": "AND", "arg1_id": "NCT02431559_exc_T88", "arg2_id": "NCT02431559_exc_T87", "normalized": [] }, { "id": "NCT02431559_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T86", "arg2_id": "NCT02431559_exc_T88", "normalized": [] }, { "id": "NCT02431559_exc_R22", "type": "AND", "arg1_id": "NCT02431559_exc_T91", "arg2_id": "NCT02431559_exc_T92", "normalized": [] }, { "id": "NCT02431559_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T89", "arg2_id": "NCT02431559_exc_T91", "normalized": [] }, { "id": "NCT02431559_exc_R24", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T89", "arg2_id": "NCT02431559_exc_T90", "normalized": [] }, { "id": "NCT02431559_exc_R25", "type": "AND", "arg1_id": "NCT02431559_exc_T86", "arg2_id": "NCT02431559_exc_T89", "normalized": [] }, { "id": "NCT02431559_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T79", "arg2_id": "NCT02431559_exc_T84", "normalized": [] }, { "id": "NCT02431559_exc_R27", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T79", "arg2_id": "NCT02431559_exc_T85", "normalized": [] }, { "id": "NCT02431559_exc_R28", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T86", "arg2_id": "NCT02431559_exc_T85", "normalized": [] }, { "id": "NCT02431559_exc_R29", "type": "Has_value", "arg1_id": "NCT02431559_exc_T93", "arg2_id": "NCT02431559_exc_T95", "normalized": [] }, { "id": "NCT02431559_exc_R30", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T93", "arg2_id": "NCT02431559_exc_T94", "normalized": [] }, { "id": "NCT02431559_exc_R31", "type": "Has_scope", "arg1_id": "NCT02431559_exc_T93", "arg2_id": "NCT02431559_exc_T98", "normalized": [] }, { "id": "NCT02431559_exc_R32", "type": "Has_value", "arg1_id": "NCT02431559_exc_T99", "arg2_id": "NCT02431559_exc_T100", "normalized": [] }, { "id": "NCT02431559_exc_R33", "type": "AND", "arg1_id": "NCT02431559_exc_T101", "arg2_id": "NCT02431559_exc_T99", "normalized": [] }, { "id": "NCT02431559_exc_R34", "type": "Has_value", "arg1_id": "NCT02431559_exc_T103", "arg2_id": "NCT02431559_exc_T104", "normalized": [] }, { "id": "NCT02431559_exc_R35", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T102", "arg2_id": "NCT02431559_exc_T103", "normalized": [] }, { "id": "NCT02431559_exc_R36", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T105", "arg2_id": "NCT02431559_exc_T106", "normalized": [] }, { "id": "NCT02431559_exc_R37", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T108", "arg2_id": "NCT02431559_exc_T109", "normalized": [] }, { "id": "NCT02431559_exc_R38", "type": "AND", "arg1_id": "NCT02431559_exc_T107", "arg2_id": "NCT02431559_exc_T108", "normalized": [] }, { "id": "NCT02431559_exc_R39", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T110", "arg2_id": "NCT02431559_exc_T111", "normalized": [] }, { "id": "NCT02431559_exc_R40", "type": "AND", "arg1_id": "NCT02431559_exc_T107", "arg2_id": "NCT02431559_exc_T110", "normalized": [] }, { "id": "NCT02431559_exc_R41", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T107", "arg2_id": "NCT02431559_exc_T105", "normalized": [] }, { "id": "NCT02431559_exc_R42", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T113", "arg2_id": "NCT02431559_exc_T112", "normalized": [] }, { "id": "NCT02431559_exc_R43", "type": "Has_scope", "arg1_id": "NCT02431559_exc_T102", "arg2_id": "NCT02431559_exc_T113", "normalized": [] }, { "id": "NCT02431559_exc_R44", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T114", "arg2_id": "NCT02431559_exc_T116", "normalized": [] }, { "id": "NCT02431559_exc_R45", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T115", "arg2_id": "NCT02431559_exc_T116", "normalized": [] }, { "id": "NCT02431559_exc_R46", "type": "Subsumes", "arg1_id": "NCT02431559_exc_T117", "arg2_id": "NCT02431559_exc_T128", "normalized": [] }, { "id": "NCT02431559_exc_R47", "type": "AND", "arg1_id": "NCT02431559_exc_T133", "arg2_id": "NCT02431559_exc_T132", "normalized": [] }, { "id": "NCT02431559_exc_R48", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T131", "arg2_id": "NCT02431559_exc_T133", "normalized": [] }, { "id": "NCT02431559_exc_R49", "type": "AND", "arg1_id": "NCT02431559_exc_T135", "arg2_id": "NCT02431559_exc_T134", "normalized": [] }, { "id": "NCT02431559_exc_R50", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T132", "arg2_id": "NCT02431559_exc_T135", "normalized": [] }, { "id": "NCT02431559_exc_R51", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T136", "arg2_id": "NCT02431559_exc_T138", "normalized": [] }, { "id": "NCT02431559_exc_R52", "type": "AND", "arg1_id": "NCT02431559_exc_T136", "arg2_id": "NCT02431559_exc_T137", "normalized": [] }, { "id": "NCT02431559_exc_R53", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T139", "arg2_id": "NCT02431559_exc_T136", "normalized": [] }, { "id": "NCT02431559_exc_R54", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T142", "arg2_id": "NCT02431559_exc_T140", "normalized": [] }, { "id": "NCT02431559_exc_R55", "type": "Has_index", "arg1_id": "NCT02431559_exc_T144", "arg2_id": "NCT02431559_exc_T145", "normalized": [] }, { "id": "NCT02431559_exc_R56", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T146", "arg2_id": "NCT02431559_exc_T144", "normalized": [] }, { "id": "NCT02431559_exc_R57", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T147", "arg2_id": "NCT02431559_exc_T148", "normalized": [] }, { "id": "NCT02431559_exc_R58", "type": "AND", "arg1_id": "NCT02431559_exc_T149", "arg2_id": "NCT02431559_exc_T147", "normalized": [] }, { "id": "NCT02431559_exc_R59", "type": "AND", "arg1_id": "NCT02431559_exc_T146", "arg2_id": "NCT02431559_exc_T149", "normalized": [] }, { "id": "NCT02431559_exc_R60", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T160", "arg2_id": "NCT02431559_exc_T161", "normalized": [] }, { "id": "NCT02431559_exc_R61", "type": "AND", "arg1_id": "NCT02431559_exc_T160", "arg2_id": "NCT02431559_exc_T164", "normalized": [] }, { "id": "NCT02431559_exc_R62", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T160", "arg2_id": "NCT02431559_exc_T162", "normalized": [] }, { "id": "NCT02431559_exc_R63", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T169", "arg2_id": "NCT02431559_exc_T171", "normalized": [] }, { "id": "NCT02431559_exc_R64", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T163", "arg2_id": "NCT02431559_exc_T166", "normalized": [] }, { "id": "NCT02431559_exc_R65", "type": "Has_scope", "arg1_id": "NCT02431559_exc_T163", "arg2_id": "NCT02431559_exc_T173", "normalized": [] }, { "id": "NCT02431559_exc_R67", "type": "Has_value", "arg1_id": "NCT02431559_exc_T185", "arg2_id": "NCT02431559_exc_T186", "normalized": [] }, { "id": "NCT02431559_exc_R68", "type": "AND", "arg1_id": "NCT02431559_exc_T187", "arg2_id": "NCT02431559_exc_T185", "normalized": [] }, { "id": "NCT02431559_exc_R69", "type": "Has_index", "arg1_id": "NCT02431559_exc_T193", "arg2_id": "NCT02431559_exc_T194", "normalized": [] }, { "id": "NCT02431559_exc_R70", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T199", "arg2_id": "NCT02431559_exc_T200", "normalized": [] }, { "id": "NCT02431559_exc_R71", "type": "Has_index", "arg1_id": "NCT02431559_exc_T201", "arg2_id": "NCT02431559_exc_T202", "normalized": [] }, { "id": "NCT02431559_exc_R72", "type": "Has_index", "arg1_id": "NCT02431559_exc_T203", "arg2_id": "NCT02431559_exc_T204", "normalized": [] }, { "id": "NCT02431559_exc_R73", "type": "Has_scope", "arg1_id": "NCT02431559_exc_T199", "arg2_id": "NCT02431559_exc_T205", "normalized": [] }, { "id": "NCT02431559_exc_R74", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T206", "arg2_id": "NCT02431559_exc_T207", "normalized": [] }, { "id": "NCT02431559_exc_R75", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T174", "arg2_id": "NCT02431559_exc_T176", "normalized": [] }, { "id": "NCT02431559_exc_R76", "type": "Has_temporal", "arg1_id": "NCT02431559_exc_T191", "arg2_id": "NCT02431559_exc_T193", "normalized": [] }, { "id": "NCT02431559_exc_R77", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T191", "arg2_id": "NCT02431559_exc_T188", "normalized": [] }, { "id": "NCT02431559_exc_R79", "type": "Has_negation", "arg1_id": "NCT02431559_exc_T192", "arg2_id": "NCT02431559_exc_T180", "normalized": [] }, { "id": "NCT02431559_exc_R80", "type": "Has_mood", "arg1_id": "NCT02431559_exc_T192", "arg2_id": "NCT02431559_exc_T195", "normalized": [] }, { "id": "NCT02431559_exc_R81", "type": "Has_qualifier", "arg1_id": "NCT02431559_exc_T209", "arg2_id": "NCT02431559_exc_T208", "normalized": [] }, { "id": "NCT02431559_exc_R82", "type": "AND", "arg1_id": "NCT02431559_exc_T196", "arg2_id": "NCT02431559_exc_T209", "normalized": [] } ]

[ { "id": "NCT02431559_inc_text", "type": "inclusion", "text": [ "1. Subjects must have recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with measureable disease (as defined by RECIST 1.1.) after first or second line platinum-based chemotherapy, for which treatment with PLD is indicated. Platinum-based therapy is defined as treatment with carboplatin, cisplatin or another organoplatinum compound. Platinum-resistant is defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy. \nSubjects are allowed to have received, but are not required to have received: \none additional cytotoxic regimen and/or PARP inhibitor for management of recurrent or persistent disease. \nbiologic therapy (e.g., bevacizumab) as part of their primary treatment regimen or part of their treatment for management of recurrent or persistent disease. \n2. Histologic documentation of the original primary tumor. \n3. Documented radiographic disease progression < 12 months after the last dose of first- or second-line platinum-based chemotherapy. \n4. Subjects in Phase 2 must have disease amenable to biopsy and must be willing to undergo pre- and post-treatment tumor biopsies. Optional for Phase 1. \nNote: archival tissue will be requested for all subjects preferably from primary tumor site prior to cancer treatment; however, archival tissue is not a requirement for study entry. \n5. ECOG performance status of 0 or 1. \n6. Laboratory parameters for vital functions should be in the normal range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified, regardless of clinical significance: \nHemoglobin: ≥ 9 g/dL \nNeutrophil count: ≥ 1.5 x 109/L \nPlatelet count: ≥ 100,000/mm3 \nSerum creatinine, ≤ 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine Clearance ≥ 50 mL/min (by Cockcroft-Gault formula) \nSerum bilirubin: ≤ 1.2 mg/dL \nAST/ALT: ≤ 2.5 x ULN \nAlkaline phosphatase: ≤ 2.5 x ULN \n7. Age ≥18 years. \n8. Able and willing to give valid written informed consent. \n9. Body weight > 30 kg \n" ], "offsets": [ [ 0, 2244 ] ] } ]

[ { "id": "NCT02431559_inc_T7", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 1833, 1843 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T8", "type": "Value", "text": [ "≥ 9 g/dL" ], "offsets": [ [ 1845, 1853 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T9", "type": "Value", "text": [ "≥ 1.5 x 109/L" ], "offsets": [ [ 1873, 1886 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T10", "type": "Measurement", "text": [ "Neutrophil count" ], "offsets": [ [ 1855, 1871 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T11", "type": "Value", "text": [ "≥ 100,000/mm3" ], "offsets": [ [ 1904, 1917 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T12", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 1888, 1902 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T13", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 1919, 1935 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T14", "type": "Value", "text": [ "≤ 1.5x Institutional Upper Limit of Normal (ULN)" ], "offsets": [ [ 1937, 1985 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T15", "type": "Measurement", "text": [ "Creatinine Clearance" ], "offsets": [ [ 1990, 2010 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T16", "type": "Value", "text": [ "≥ 50 mL/min" ], "offsets": [ [ 2011, 2022 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T17", "type": "Qualifier", "text": [ "Cockcroft-Gault formula" ], "offsets": [ [ 2027, 2050 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T18", "type": "Measurement", "text": [ "Serum bilirubin" ], "offsets": [ [ 2053, 2068 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T19", "type": "Value", "text": [ "≤ 1.2 mg/dL" ], "offsets": [ [ 2070, 2081 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T20", "type": "Condition", "text": [ "primary peritoneal carcinoma" ], "offsets": [ [ 104, 132 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T21", "type": "Condition", "text": [ "carcinoma", "fallopian tube" ], "offsets": [ [ 123, 132 ], [ 85, 99 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T22", "type": "Condition", "text": [ "carcinoma", "epithelial ovarian" ], "offsets": [ [ 123, 132 ], [ 65, 83 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T23", "type": "Qualifier", "text": [ "recurrent" ], "offsets": [ [ 22, 31 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T24", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 35, 45 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T25", "type": "Qualifier", "text": [ "platinum-resistant" ], "offsets": [ [ 46, 64 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T27", "type": "Scope", "text": [ "epithelial ovarian, fallopian tube, or primary peritoneal carcinoma" ], "offsets": [ [ 65, 132 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T26", "type": "Scope", "text": [ "recurrent or persistent" ], "offsets": [ [ 22, 45 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T28", "type": "Condition", "text": [ "measureable disease" ], "offsets": [ [ 138, 157 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T29", "type": "Temporal", "text": [ "after first", "line platinum-based chemotherapy" ], "offsets": [ [ 186, 197 ], [ 208, 240 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T30", "type": "Reference_point", "text": [ "first", "line platinum-based chemotherapy" ], "offsets": [ [ 192, 197 ], [ 208, 240 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T31", "type": "Temporal", "text": [ "after", "second line platinum-based chemotherapy" ], "offsets": [ [ 186, 191 ], [ 201, 240 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T32", "type": "Reference_point", "text": [ "second line platinum-based chemotherapy" ], "offsets": [ [ 201, 240 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T33", "type": "Scope", "text": [ "after first or second line platinum-based chemotherapy" ], "offsets": [ [ 186, 240 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T34", "type": "Procedure", "text": [ "treatment with PLD" ], "offsets": [ [ 252, 270 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T35", "type": "Drug", "text": [ "PLD" ], "offsets": [ [ 267, 270 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T36", "type": "Qualifier", "text": [ "indicated" ], "offsets": [ [ 274, 283 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T39", "type": "Procedure", "text": [ "Platinum-based therapy" ], "offsets": [ [ 285, 307 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T40", "type": "Drug", "text": [ "carboplatin" ], "offsets": [ [ 337, 348 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T41", "type": "Drug", "text": [ "cisplatin" ], "offsets": [ [ 350, 359 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T42", "type": "Drug", "text": [ "another organoplatinum compound" ], "offsets": [ [ 363, 394 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T44", "type": "Scope", "text": [ "carboplatin, cisplatin or another organoplatinum compound" ], "offsets": [ [ 337, 394 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T45", "type": "Measurement", "text": [ "platinum-free interval (PFI)" ], "offsets": [ [ 438, 466 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T46", "type": "Temporal", "text": [ "< 12 months after first- or second-line platinum-based chemotherapy" ], "offsets": [ [ 470, 537 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T47", "type": "Reference_point", "text": [ "first- or second-line platinum-based chemotherapy" ], "offsets": [ [ 488, 537 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T48", "type": "Condition", "text": [ "Platinum-resistant" ], "offsets": [ [ 396, 414 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T49", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 549, 568 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T50", "type": "Procedure", "text": [ "second-line platinum-based chemotherapy" ], "offsets": [ [ 585, 624 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T51", "type": "Scope", "text": [ "disease progression while receiving second-line platinum-based chemotherapy" ], "offsets": [ [ 549, 624 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T52", "type": "Scope", "text": [ "platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy" ], "offsets": [ [ 438, 624 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T54", "type": "Drug", "text": [ "cytotoxic regimen" ], "offsets": [ [ 721, 738 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T55", "type": "Drug", "text": [ "PARP inhibitor" ], "offsets": [ [ 746, 760 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T56", "type": "Multiplier", "text": [ "one additional" ], "offsets": [ [ 706, 720 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T57", "type": "Scope", "text": [ "cytotoxic regimen and/or PARP inhibitor" ], "offsets": [ [ 721, 760 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T58", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 803, 810 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T59", "type": "Temporal", "text": [ "persistent" ], "offsets": [ [ 792, 802 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T60", "type": "Temporal", "text": [ "recurrent" ], "offsets": [ [ 779, 788 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T61", "type": "Scope", "text": [ "recurrent or persistent" ], "offsets": [ [ 779, 802 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T62", "type": "Drug", "text": [ "bevacizumab" ], "offsets": [ [ 837, 848 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T64", "type": "Procedure", "text": [ "biologic therapy" ], "offsets": [ [ 813, 829 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T65", "type": "Procedure", "text": [ "primary treatment regimen" ], "offsets": [ [ 867, 892 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T66", "type": "Temporal", "text": [ "persistent" ], "offsets": [ [ 951, 961 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T67", "type": "Temporal", "text": [ "recurrent" ], "offsets": [ [ 938, 947 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T68", "type": "Scope", "text": [ "recurrent or persistent" ], "offsets": [ [ 938, 961 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T69", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 962, 969 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T70", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 910, 919 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T73", "type": "Procedure", "text": [ "Histologic" ], "offsets": [ [ 975, 985 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T74", "type": "Condition", "text": [ "original primary tumor" ], "offsets": [ [ 1007, 1029 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T75", "type": "Value", "text": [ "documentation" ], "offsets": [ [ 986, 999 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T76", "type": "Procedure", "text": [ "radiographic" ], "offsets": [ [ 1046, 1058 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T77", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 1059, 1078 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T78", "type": "Temporal", "text": [ "< 12 months after the last dose of first- or second-line platinum-based chemotherapy" ], "offsets": [ [ 1079, 1163 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T79", "type": "Reference_point", "text": [ "the last dose of first- or second-line platinum-based chemotherapy" ], "offsets": [ [ 1097, 1163 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T80", "type": "Condition", "text": [ "disease amenable to biopsy" ], "offsets": [ [ 1199, 1225 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T87", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 1506, 1529 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T88", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 1533, 1539 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T89", "type": "Measurement", "text": [ "Laboratory parameters for vital functions" ], "offsets": [ [ 1545, 1586 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T91", "type": "Value", "text": [ "normal range" ], "offsets": [ [ 1604, 1616 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T92", "type": "Measurement", "text": [ "AST/ALT" ], "offsets": [ [ 2083, 2090 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T93", "type": "Value", "text": [ "≤ 2.5 x ULN" ], "offsets": [ [ 2092, 2103 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T94", "type": "Measurement", "text": [ "Alkaline phosphatase" ], "offsets": [ [ 2105, 2125 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T95", "type": "Value", "text": [ "≤ 2.5 x ULN" ], "offsets": [ [ 2127, 2138 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T97", "type": "Person", "text": [ "Age" ], "offsets": [ [ 2143, 2146 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T98", "type": "Value", "text": [ "≥18 years" ], "offsets": [ [ 2147, 2156 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T103", "type": "Measurement", "text": [ "Body weight" ], "offsets": [ [ 2223, 2234 ] ], "normalized": [] }, { "id": "NCT02431559_inc_T104", "type": "Value", "text": [ "> 30 kg" ], "offsets": [ [ 2235, 2242 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02431559_inc_R1", "type": "Has_value", "arg1_id": "NCT02431559_inc_T7", "arg2_id": "NCT02431559_inc_T8", "normalized": [] }, { "id": "NCT02431559_inc_R2", "type": "Has_value", "arg1_id": "NCT02431559_inc_T10", "arg2_id": "NCT02431559_inc_T9", "normalized": [] }, { "id": "NCT02431559_inc_R3", "type": "Has_value", "arg1_id": "NCT02431559_inc_T12", "arg2_id": "NCT02431559_inc_T11", "normalized": [] }, { "id": "NCT02431559_inc_R4", "type": "Has_value", "arg1_id": "NCT02431559_inc_T13", "arg2_id": "NCT02431559_inc_T14", "normalized": [] }, { "id": "NCT02431559_inc_R5", "type": "Has_value", "arg1_id": "NCT02431559_inc_T15", "arg2_id": "NCT02431559_inc_T16", "normalized": [] }, { "id": "NCT02431559_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02431559_inc_T15", "arg2_id": "NCT02431559_inc_T17", "normalized": [] }, { "id": "NCT02431559_inc_R7", "type": "Has_value", "arg1_id": "NCT02431559_inc_T18", "arg2_id": "NCT02431559_inc_T19", "normalized": [] }, { "id": "NCT02431559_inc_R8", "type": "Has_scope", "arg1_id": "NCT02431559_inc_T27", "arg2_id": "NCT02431559_inc_T26", "normalized": [] }, { "id": "NCT02431559_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT02431559_inc_T27", "arg2_id": "NCT02431559_inc_T25", "normalized": [] }, { "id": "NCT02431559_inc_R10", "type": "Has_index", "arg1_id": "NCT02431559_inc_T29", "arg2_id": "NCT02431559_inc_T30", "normalized": [] }, { "id": "NCT02431559_inc_R11", "type": "Has_index", "arg1_id": "NCT02431559_inc_T31", "arg2_id": "NCT02431559_inc_T32", "normalized": [] }, { "id": "NCT02431559_inc_R12", "type": "Has_scope", "arg1_id": "NCT02431559_inc_T28", "arg2_id": "NCT02431559_inc_T33", "normalized": [] }, { "id": "NCT02431559_inc_R13", "type": "AND", "arg1_id": "NCT02431559_inc_T27", "arg2_id": "NCT02431559_inc_T28", "normalized": [] }, { "id": "NCT02431559_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT02431559_inc_T34", "arg2_id": "NCT02431559_inc_T36", "normalized": [] }, { "id": "NCT02431559_inc_R15", "type": "AND", "arg1_id": "NCT02431559_inc_T27", "arg2_id": "NCT02431559_inc_T34", "normalized": [] }, { "id": "NCT02431559_inc_R16", "type": "Subsumes", "arg1_id": "NCT02431559_inc_T39", "arg2_id": "NCT02431559_inc_T44", "normalized": [] }, { "id": "NCT02431559_inc_R17", "type": "Has_index", "arg1_id": "NCT02431559_inc_T46", "arg2_id": "NCT02431559_inc_T47", "normalized": [] }, { "id": "NCT02431559_inc_R18", "type": "Has_temporal", "arg1_id": "NCT02431559_inc_T45", "arg2_id": "NCT02431559_inc_T46", "normalized": [] }, { "id": "NCT02431559_inc_R19", "type": "Subsumes", "arg1_id": "NCT02431559_inc_T48", "arg2_id": "NCT02431559_inc_T52", "normalized": [] }, { "id": "NCT02431559_inc_R20", "type": "Has_multiplier", "arg1_id": "NCT02431559_inc_T57", "arg2_id": "NCT02431559_inc_T56", "normalized": [] }, { "id": "NCT02431559_inc_R21", "type": "Has_scope", "arg1_id": "NCT02431559_inc_T58", "arg2_id": "NCT02431559_inc_T61", "normalized": [] }, { "id": "NCT02431559_inc_R22", "type": "AND", "arg1_id": "NCT02431559_inc_T57", "arg2_id": "NCT02431559_inc_T58", "normalized": [] }, { "id": "NCT02431559_inc_R23", "type": "Subsumes", "arg1_id": "NCT02431559_inc_T64", "arg2_id": "NCT02431559_inc_T62", "normalized": [] }, { "id": "NCT02431559_inc_R24", "type": "Has_scope", "arg1_id": "NCT02431559_inc_T69", "arg2_id": "NCT02431559_inc_T68", "normalized": [] }, { "id": "NCT02431559_inc_R25", "type": "AND", "arg1_id": "NCT02431559_inc_T70", "arg2_id": "NCT02431559_inc_T69", "normalized": [] }, { "id": "NCT02431559_inc_R26", "type": "Subsumes", "arg1_id": "NCT02431559_inc_T65", "arg2_id": "NCT02431559_inc_T64", "normalized": [] }, { "id": "NCT02431559_inc_R27", "type": "Subsumes", "arg1_id": "NCT02431559_inc_T65", "arg2_id": "NCT02431559_inc_T70", "normalized": [] }, { "id": "NCT02431559_inc_R28", "type": "Has_value", "arg1_id": "NCT02431559_inc_T73", "arg2_id": "NCT02431559_inc_T75", "normalized": [] }, { "id": "NCT02431559_inc_R29", "type": "AND", "arg1_id": "NCT02431559_inc_T74", "arg2_id": "NCT02431559_inc_T73", "normalized": [] }, { "id": "NCT02431559_inc_R30", "type": "AND", "arg1_id": "NCT02431559_inc_T76", "arg2_id": "NCT02431559_inc_T77", "normalized": [] }, { "id": "NCT02431559_inc_R31", "type": "Has_index", "arg1_id": "NCT02431559_inc_T78", "arg2_id": "NCT02431559_inc_T79", "normalized": [] }, { "id": "NCT02431559_inc_R32", "type": "Has_temporal", "arg1_id": "NCT02431559_inc_T77", "arg2_id": "NCT02431559_inc_T78", "normalized": [] }, { "id": "NCT02431559_inc_R33", "type": "Has_value", "arg1_id": "NCT02431559_inc_T87", "arg2_id": "NCT02431559_inc_T88", "normalized": [] }, { "id": "NCT02431559_inc_R34", "type": "Has_value", "arg1_id": "NCT02431559_inc_T89", "arg2_id": "NCT02431559_inc_T91", "normalized": [] }, { "id": "NCT02431559_inc_R35", "type": "Has_value", "arg1_id": "NCT02431559_inc_T92", "arg2_id": "NCT02431559_inc_T93", "normalized": [] }, { "id": "NCT02431559_inc_R36", "type": "Has_value", "arg1_id": "NCT02431559_inc_T94", "arg2_id": "NCT02431559_inc_T95", "normalized": [] }, { "id": "NCT02431559_inc_R37", "type": "Has_value", "arg1_id": "NCT02431559_inc_T97", "arg2_id": "NCT02431559_inc_T98", "normalized": [] }, { "id": "NCT02431559_inc_R38", "type": "Has_value", "arg1_id": "NCT02431559_inc_T103", "arg2_id": "NCT02431559_inc_T104", "normalized": [] } ]

[ { "id": "NCT02432404_exc_text", "type": "exclusion", "text": [ "Current pregnancy\nDesire/intent to become pregnant over the course of the study\nWomen who are less than 6 weeks postpartum\nContraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years\nCurrent IUD\nUnable to comprehend consent material because of language barrier or psychological difficulty\n" ], "offsets": [ [ 0, 377 ] ] } ]

[ { "id": "NCT02432404_exc_T1", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 8, 17 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T2", "type": "Observation", "text": [ "Desire/intent to become pregnant" ], "offsets": [ [ 18, 50 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T3", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 42, 50 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T4", "type": "Temporal", "text": [ "over the course of the study" ], "offsets": [ [ 51, 79 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T5", "type": "Person", "text": [ "Women" ], "offsets": [ [ 80, 85 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T6", "type": "Temporal", "text": [ "less than 6 weeks postpartum" ], "offsets": [ [ 94, 122 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T7", "type": "Reference_point", "text": [ "postpartum" ], "offsets": [ [ 112, 122 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T8", "type": "Procedure", "text": [ "hormonal contraceptive" ], "offsets": [ [ 144, 166 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T9", "type": "Observation", "text": [ "Contraindications to hormonal contraceptive" ], "offsets": [ [ 123, 166 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T10", "type": "Condition", "text": [ "deep vein thrombosis" ], "offsets": [ [ 212, 232 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T11", "type": "Person", "text": [ "women" ], "offsets": [ [ 245, 250 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T12", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 234, 241 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T13", "type": "Value", "text": [ "older than 35 years" ], "offsets": [ [ 251, 270 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T14", "type": "Scope", "text": [ "deep vein thrombosis, smoking in women older than 35 years" ], "offsets": [ [ 212, 270 ] ], "normalized": [] }, { "id": "NCT02432404_exc_T15", "type": "Procedure", "text": [ "IUD" ], "offsets": [ [ 279, 282 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02432404_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02432404_exc_T2", "arg2_id": "NCT02432404_exc_T4", "normalized": [] }, { "id": "NCT02432404_exc_R3", "type": "Has_index", "arg1_id": "NCT02432404_exc_T6", "arg2_id": "NCT02432404_exc_T7", "normalized": [] }, { "id": "NCT02432404_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02432404_exc_T5", "arg2_id": "NCT02432404_exc_T6", "normalized": [] }, { "id": "NCT02432404_exc_R7", "type": "Has_value", "arg1_id": "NCT02432404_exc_T11", "arg2_id": "NCT02432404_exc_T13", "normalized": [] }, { "id": "NCT02432404_exc_R8", "type": "Subsumes", "arg1_id": "NCT02432404_exc_T9", "arg2_id": "NCT02432404_exc_T14", "normalized": [] } ]

[ { "id": "NCT02432404_inc_text", "type": "inclusion", "text": [ "=18-40 year old women\nBV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months\nWilling to use the NuvaRing as directed\nNot intending or wishing to become pregnant over the course of the study\nCapable of providing written informed consent\n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT02432404_inc_T1", "type": "Person", "text": [ "women" ], "offsets": [ [ 16, 21 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 12, 15 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T3", "type": "Value", "text": [ "18-40 year" ], "offsets": [ [ 1, 11 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T4", "type": "Measurement", "text": [ "Amsel criteria" ], "offsets": [ [ 29, 43 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T5", "type": "Measurement", "text": [ "Nugent score" ], "offsets": [ [ 48, 60 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T6", "type": "Value", "text": [ "BV+" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T7", "type": "Condition", "text": [ "BV" ], "offsets": [ [ 75, 77 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T8", "type": "Condition", "text": [ "BV" ], "offsets": [ [ 22, 24 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T9", "type": "Temporal", "text": [ "in the prior 6 months" ], "offsets": [ [ 78, 99 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T10", "type": "Scope", "text": [ "BV+ by Amsel criteria and Nugent score" ], "offsets": [ [ 22, 60 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T14", "type": "Scope", "text": [ "Amsel criteria and Nugent score" ], "offsets": [ [ 29, 60 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T11", "type": "Observation", "text": [ "Willing to use" ], "offsets": [ [ 100, 114 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T15", "type": "Drug", "text": [ "NuvaRing" ], "offsets": [ [ 119, 127 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T13", "type": "Observation", "text": [ "written informed consent" ], "offsets": [ [ 234, 258 ] ], "normalized": [] }, { "id": "NCT02432404_inc_T16", "type": "Observation", "text": [ "Capable of providing written informed consent" ], "offsets": [ [ 213, 258 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02432404_inc_R1", "type": "Has_value", "arg1_id": "NCT02432404_inc_T2", "arg2_id": "NCT02432404_inc_T3", "normalized": [] }, { "id": "NCT02432404_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02432404_inc_T7", "arg2_id": "NCT02432404_inc_T9", "normalized": [] }, { "id": "NCT02432404_inc_R2", "type": "Has_value", "arg1_id": "NCT02432404_inc_T14", "arg2_id": "NCT02432404_inc_T6", "normalized": [] }, { "id": "NCT02432404_inc_R5", "type": "AND", "arg1_id": "NCT02432404_inc_T11", "arg2_id": "NCT02432404_inc_T15", "normalized": [] } ]

[ { "id": "NCT02437045_exc_text", "type": "exclusion", "text": [ "Patient not expected to survive more than 4 days\nPatient allergic to a penicillin or a carbapenem\nPatient with significant polymicrobial bacteraemia (that is, a Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).\nTreatment is not with the intent to cure the infection (that is, palliative care is an exclusion).\nPregnancy or breast-feeding.\nUse of concomitant antimicrobials in the first 4 days after enrolment with known activity against Gram-negative bacilli (except trimethoprim/sulphamethoxazole may be continued as Pneumocystis prophylaxis).\nSevere acute illness as defined by Pitt bacteraemia score of >4\nLikely source to be from (proven or suspected at the time of randomisation) the central nervous system, e.g. brain abscess, post-surgical meningitis, shunt infection (due to concerns over CNS penetration of piperacillin/tazobactam)\n" ], "offsets": [ [ 0, 910 ] ] } ]

[ { "id": "NCT02437045_exc_T1", "type": "Observation", "text": [ "survive" ], "offsets": [ [ 24, 31 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T2", "type": "Negation", "text": [ "not" ], "offsets": [ [ 8, 11 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T3", "type": "Value", "text": [ "more than 4 days" ], "offsets": [ [ 32, 48 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T4", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 57, 65 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T5", "type": "Drug", "text": [ "penicillin" ], "offsets": [ [ 71, 81 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T6", "type": "Drug", "text": [ "carbapenem" ], "offsets": [ [ 87, 97 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T7", "type": "Scope", "text": [ "penicillin or a carbapenem" ], "offsets": [ [ 71, 97 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T8", "type": "Condition", "text": [ "bacteraemia" ], "offsets": [ [ 137, 148 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T9", "type": "Qualifier", "text": [ "polymicrobial" ], "offsets": [ [ 123, 136 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T12", "type": "Drug", "text": [ "antimicrobials" ], "offsets": [ [ 427, 441 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T13", "type": "Qualifier", "text": [ "concomitant" ], "offsets": [ [ 415, 426 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T14", "type": "Temporal", "text": [ "first 4 days after enrolment" ], "offsets": [ [ 449, 477 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T15", "type": "Reference_point", "text": [ "enrolment" ], "offsets": [ [ 468, 477 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T16", "type": "Observation", "text": [ "Gram-negative bacilli" ], "offsets": [ [ 506, 527 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T17", "type": "Negation", "text": [ "except" ], "offsets": [ [ 529, 535 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T18", "type": "Drug", "text": [ "rimethoprim/sulphamethoxazole" ], "offsets": [ [ 537, 566 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T19", "type": "Measurement", "text": [ "Pitt bacteraemia score" ], "offsets": [ [ 649, 671 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T20", "type": "Value", "text": [ ">4" ], "offsets": [ [ 675, 677 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T21", "type": "Condition", "text": [ "brain abscess" ], "offsets": [ [ 787, 800 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T22", "type": "Condition", "text": [ "meningitis" ], "offsets": [ [ 816, 826 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T23", "type": "Qualifier", "text": [ "post-surgical" ], "offsets": [ [ 802, 815 ] ], "normalized": [] }, { "id": "NCT02437045_exc_T24", "type": "Condition", "text": [ "shunt infection" ], "offsets": [ [ 828, 843 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02437045_exc_R1", "type": "Has_value", "arg1_id": "NCT02437045_exc_T1", "arg2_id": "NCT02437045_exc_T3", "normalized": [] }, { "id": "NCT02437045_exc_R2", "type": "Has_negation", "arg1_id": "NCT02437045_exc_T3", "arg2_id": "NCT02437045_exc_T2", "normalized": [] }, { "id": "NCT02437045_exc_R3", "type": "Has_scope", "arg1_id": "NCT02437045_exc_T4", "arg2_id": "NCT02437045_exc_T7", "normalized": [] }, { "id": "NCT02437045_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02437045_exc_T8", "arg2_id": "NCT02437045_exc_T9", "normalized": [] }, { "id": "NCT02437045_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02437045_exc_T12", "arg2_id": "NCT02437045_exc_T13", "normalized": [] }, { "id": "NCT02437045_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02437045_exc_T12", "arg2_id": "NCT02437045_exc_T14", "normalized": [] }, { "id": "NCT02437045_exc_R7", "type": "Has_index", "arg1_id": "NCT02437045_exc_T14", "arg2_id": "NCT02437045_exc_T15", "normalized": [] }, { "id": "NCT02437045_exc_R9", "type": "Has_negation", "arg1_id": "NCT02437045_exc_T18", "arg2_id": "NCT02437045_exc_T17", "normalized": [] }, { "id": "NCT02437045_exc_R10", "type": "Has_value", "arg1_id": "NCT02437045_exc_T19", "arg2_id": "NCT02437045_exc_T20", "normalized": [] }, { "id": "NCT02437045_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02437045_exc_T22", "arg2_id": "NCT02437045_exc_T23", "normalized": [] } ]

[ { "id": "NCT02437045_inc_text", "type": "inclusion", "text": [ "Bloodstream infection with Enterobacter spp., Serratia marcescens, Providencia spp., Morganella morganii or Citrobacter freundii (i.e. likely AmpC-producer), and susceptibility to 3rd generation cephalosporins (i.e. ceftriaxone, cefotaxime or ceftazidime), meropenem and piperacillin-tazobactam from at least one blood culture draw. This will be determined in accordance with laboratory methods and susceptibility breakpoints defined by protocols used in the recruiting site laboratories..\nNo more than 72 hours has elapsed since the first positive blood culture collection.\nPatient is aged 18 years and over (>=21y in Singapore).\n" ], "offsets": [ [ 0, 631 ] ] } ]

[ { "id": "NCT02437045_inc_T1", "type": "Condition", "text": [ "Bloodstream infection" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T2", "type": "Qualifier", "text": [ "Enterobacter spp." ], "offsets": [ [ 27, 44 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T3", "type": "Qualifier", "text": [ "Serratia marcescens" ], "offsets": [ [ 46, 65 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T4", "type": "Qualifier", "text": [ "Providencia spp." ], "offsets": [ [ 67, 83 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T5", "type": "Qualifier", "text": [ "Morganella morganii" ], "offsets": [ [ 85, 104 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T6", "type": "Qualifier", "text": [ "Citrobacter freundii" ], "offsets": [ [ 108, 128 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T7", "type": "Scope", "text": [ "nterobacter spp., Serratia marcescens, Providencia spp., Morganella morganii or Citrobacter freundii" ], "offsets": [ [ 28, 128 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T8", "type": "Drug", "text": [ "3rd generation cephalosporins (" ], "offsets": [ [ 180, 211 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T9", "type": "Drug", "text": [ "ceftriaxone" ], "offsets": [ [ 216, 227 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T10", "type": "Drug", "text": [ "cefotaxime" ], "offsets": [ [ 229, 239 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T11", "type": "Drug", "text": [ "ceftazidime" ], "offsets": [ [ 243, 254 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T12", "type": "Scope", "text": [ "ceftriaxone, cefotaxime or ceftazidime" ], "offsets": [ [ 216, 254 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T13", "type": "Drug", "text": [ "meropenem" ], "offsets": [ [ 257, 266 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T14", "type": "Drug", "text": [ "piperacillin-tazobactam" ], "offsets": [ [ 271, 294 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T15", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 300, 312 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T16", "type": "Measurement", "text": [ "blood culture" ], "offsets": [ [ 313, 326 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T17", "type": "Person", "text": [ "aged" ], "offsets": [ [ 586, 590 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T18", "type": "Value", "text": [ "18 years and over" ], "offsets": [ [ 591, 608 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T19", "type": "Temporal", "text": [ "o more than 72 hours", "ince the first positive blood culture collection." ], "offsets": [ [ 491, 511 ], [ 525, 574 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T20", "type": "Reference_point", "text": [ "the first positive blood culture collection" ], "offsets": [ [ 530, 573 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T21", "type": "Value", "text": [ "positive" ], "offsets": [ [ 540, 548 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T22", "type": "Measurement", "text": [ "blood culture collection" ], "offsets": [ [ 549, 573 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T23", "type": "Value", "text": [ ">=21y" ], "offsets": [ [ 610, 615 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T24", "type": "Person", "text": [ "Singapore" ], "offsets": [ [ 619, 628 ] ], "normalized": [] }, { "id": "NCT02437045_inc_T25", "type": "Scope", "text": [ "18 years and over (>=21y in Singapore)" ], "offsets": [ [ 591, 629 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02437045_inc_R1", "type": "Has_scope", "arg1_id": "NCT02437045_inc_T1", "arg2_id": "NCT02437045_inc_T7", "normalized": [] }, { "id": "NCT02437045_inc_R2", "type": "Subsumes", "arg1_id": "NCT02437045_inc_T8", "arg2_id": "NCT02437045_inc_T12", "normalized": [] }, { "id": "NCT02437045_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02437045_inc_T16", "arg2_id": "NCT02437045_inc_T15", "normalized": [] }, { "id": "NCT02437045_inc_R4", "type": "AND", "arg1_id": "NCT02437045_inc_T16", "arg2_id": "NCT02437045_inc_T1", "normalized": [] }, { "id": "NCT02437045_inc_R5", "type": "AND", "arg1_id": "NCT02437045_inc_T1", "arg2_id": "NCT02437045_inc_T8", "normalized": [] }, { "id": "NCT02437045_inc_R7", "type": "Has_value", "arg1_id": "NCT02437045_inc_T22", "arg2_id": "NCT02437045_inc_T21", "normalized": [] }, { "id": "NCT02437045_inc_R9", "type": "Has_value", "arg1_id": "NCT02437045_inc_T24", "arg2_id": "NCT02437045_inc_T23", "normalized": [] }, { "id": "NCT02437045_inc_R6", "type": "Has_scope", "arg1_id": "NCT02437045_inc_T17", "arg2_id": "NCT02437045_inc_T25", "normalized": [] } ]

[ { "id": "NCT02437084_exc_text", "type": "exclusion", "text": [ "Less than 30 yrs of age or > 65 yrs of age\nAny significant co-morbidities, such as active heart, kidney, or liver diseases, accelerated or malignant hypertension, heart failure, severe anemia.\n" ], "offsets": [ [ 0, 193 ] ] } ]

[ { "id": "NCT02437084_exc_T1", "type": "Value", "text": [ "Less than 30 yrs" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T3", "type": "Value", "text": [ "> 65 yrs" ], "offsets": [ [ 27, 35 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 39, 42 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T5", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 47, 58 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T6", "type": "Condition", "text": [ "co-morbidities" ], "offsets": [ [ 59, 73 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T7", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 83, 89 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T8", "type": "Condition", "text": [ "iseases,", "eart," ], "offsets": [ [ 115, 123 ], [ 91, 96 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T9", "type": "Condition", "text": [ "iseases,", "idney," ], "offsets": [ [ 115, 123 ], [ 98, 104 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T10", "type": "Condition", "text": [ "liver diseases" ], "offsets": [ [ 108, 122 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T11", "type": "Scope", "text": [ "heart, kidney, or liver diseases" ], "offsets": [ [ 90, 122 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T12", "type": "Qualifier", "text": [ "malignant" ], "offsets": [ [ 139, 148 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T13", "type": "Qualifier", "text": [ "accelerated" ], "offsets": [ [ 124, 135 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T14", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 149, 161 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T15", "type": "Scope", "text": [ "accelerated or malignant" ], "offsets": [ [ 124, 148 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T16", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 163, 176 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T17", "type": "Condition", "text": [ "severe anemia" ], "offsets": [ [ 178, 191 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T18", "type": "Scope", "text": [ "active heart, kidney, or liver diseases, accelerated or malignant hypertension, heart failure, severe anemia" ], "offsets": [ [ 83, 191 ] ], "normalized": [] }, { "id": "NCT02437084_exc_T19", "type": "Scope", "text": [ "significant co-morbidities" ], "offsets": [ [ 47, 73 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02437084_exc_R1", "type": "Has_value", "arg1_id": "NCT02437084_exc_T4", "arg2_id": "NCT02437084_exc_T3", "normalized": [] }, { "id": "NCT02437084_exc_R2", "type": "Has_value", "arg1_id": "NCT02437084_exc_T2", "arg2_id": "NCT02437084_exc_T1", "normalized": [] }, { "id": "NCT02437084_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02437084_exc_T6", "arg2_id": "NCT02437084_exc_T5", "normalized": [] }, { "id": "NCT02437084_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02437084_exc_T11", "arg2_id": "NCT02437084_exc_T7", "normalized": [] }, { "id": "NCT02437084_exc_R5", "type": "Has_scope", "arg1_id": "NCT02437084_exc_T14", "arg2_id": "NCT02437084_exc_T15", "normalized": [] }, { "id": "NCT02437084_exc_R6", "type": "Subsumes", "arg1_id": "NCT02437084_exc_T19", "arg2_id": "NCT02437084_exc_T18", "normalized": [] } ]

[ { "id": "NCT02437084_inc_text", "type": "inclusion", "text": [ "Healthy adults 30- 65 years old,\nBMI 25-35 kg/m2,\nnondiabetic as defined by fasting plasma glucose <126 mg/dL\nLipids: one group with an LDL =/>130 and Triglycerides < 150 mg/dL The 2nd group will have and LDL=/>130 mg/dL and Triglycerides =/>150 mg/dL but less than 400 mg/dL.\n" ], "offsets": [ [ 0, 277 ] ] } ]

[ { "id": "NCT02437084_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T2", "type": "Person", "text": [ "adults" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T3", "type": "Value", "text": [ "30- 65 years old" ], "offsets": [ [ 15, 31 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T4", "type": "Person", "text": [ "old" ], "offsets": [ [ 28, 31 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T5", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T6", "type": "Value", "text": [ "25-35 kg/m2" ], "offsets": [ [ 37, 48 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T7", "type": "Condition", "text": [ "nondiabetic" ], "offsets": [ [ 50, 61 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T8", "type": "Measurement", "text": [ "fasting plasma glucose" ], "offsets": [ [ 76, 98 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T9", "type": "Value", "text": [ "<126 mg/dL" ], "offsets": [ [ 99, 109 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T11", "type": "Measurement", "text": [ "LDL" ], "offsets": [ [ 136, 139 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T10", "type": "Value", "text": [ "=/>130" ], "offsets": [ [ 140, 146 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T12", "type": "Measurement", "text": [ "Triglycerides" ], "offsets": [ [ 151, 164 ] ], "normalized": [] }, { "id": "NCT02437084_inc_T13", "type": "Value", "text": [ "< 150 mg/dL" ], "offsets": [ [ 165, 176 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02437084_inc_R1", "type": "Has_value", "arg1_id": "NCT02437084_inc_T4", "arg2_id": "NCT02437084_inc_T3", "normalized": [] }, { "id": "NCT02437084_inc_R2", "type": "Has_value", "arg1_id": "NCT02437084_inc_T5", "arg2_id": "NCT02437084_inc_T6", "normalized": [] }, { "id": "NCT02437084_inc_R3", "type": "Has_value", "arg1_id": "NCT02437084_inc_T8", "arg2_id": "NCT02437084_inc_T9", "normalized": [] }, { "id": "NCT02437084_inc_R4", "type": "Has_value", "arg1_id": "NCT02437084_inc_T11", "arg2_id": "NCT02437084_inc_T10", "normalized": [] }, { "id": "NCT02437084_inc_R5", "type": "Has_value", "arg1_id": "NCT02437084_inc_T12", "arg2_id": "NCT02437084_inc_T13", "normalized": [] } ]

[ { "id": "NCT02441179_exc_text", "type": "exclusion", "text": [ "1. Orthopedic injuries that are unstable \n2. Osteoporosis with high risk of pathological fracture \n3. Cutaneous lesions and/or pressure ulcers \n4. Joint contractures \n5. Cardiopulmonary diseases \n6. Body weight exceeding 150 Kg \n \n" ], "offsets": [ [ 0, 240 ] ] } ]

[ { "id": "NCT02441179_exc_T7", "type": "Condition", "text": [ "Orthopedic injuries" ], "offsets": [ [ 3, 22 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T8", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 32, 40 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T9", "type": "Condition", "text": [ "Osteoporosis" ], "offsets": [ [ 45, 57 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T10", "type": "Qualifier", "text": [ "high risk of pathological fracture" ], "offsets": [ [ 63, 97 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T14", "type": "Condition", "text": [ "Cutaneous lesions" ], "offsets": [ [ 102, 119 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T15", "type": "Condition", "text": [ "pressure ulcers" ], "offsets": [ [ 127, 142 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T16", "type": "Condition", "text": [ "Joint contractures" ], "offsets": [ [ 147, 165 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T17", "type": "Condition", "text": [ "Cardiopulmonary diseases" ], "offsets": [ [ 170, 194 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T18", "type": "Measurement", "text": [ "Body weight" ], "offsets": [ [ 199, 210 ] ], "normalized": [] }, { "id": "NCT02441179_exc_T19", "type": "Value", "text": [ "exceeding 150 Kg" ], "offsets": [ [ 211, 227 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02441179_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02441179_exc_T7", "arg2_id": "NCT02441179_exc_T8", "normalized": [] }, { "id": "NCT02441179_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02441179_exc_T9", "arg2_id": "NCT02441179_exc_T10", "normalized": [] }, { "id": "NCT02441179_exc_R3", "type": "Has_value", "arg1_id": "NCT02441179_exc_T18", "arg2_id": "NCT02441179_exc_T19", "normalized": [] } ]

[ { "id": "NCT02441179_inc_text", "type": "inclusion", "text": [ "1. Patients ≥ 18 years-old from \"Instituto Teletón Santiago\" and \"Hospital Clínico Mutual de seguridad\". \n2. C5 to T12 spinal cord injury, classified as ISNCSCI grades C and D \n3. Traumatic and non-traumatic, non-progressive lesions \n4. Onset > 6 months \n5. Ability to ambulate with or without assistive devices \n6. Ability to follow verbal or visual commands \n7. Signed informed consent \n" ], "offsets": [ [ 0, 389 ] ] } ]

[ { "id": "NCT02441179_inc_T8", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 12, 22 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T9", "type": "Person", "text": [ "years-old" ], "offsets": [ [ 17, 26 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T10", "type": "Visit", "text": [ "Instituto Teletón Santiago" ], "offsets": [ [ 33, 59 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T11", "type": "Visit", "text": [ "Hospital Clínico Mutual de seguridad" ], "offsets": [ [ 66, 102 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T13", "type": "Condition", "text": [ "spinal cord injury" ], "offsets": [ [ 119, 137 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T14", "type": "Qualifier", "text": [ "C5 to T12" ], "offsets": [ [ 109, 118 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T15", "type": "Measurement", "text": [ "ISNCSCI" ], "offsets": [ [ 153, 160 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T16", "type": "Value", "text": [ "grades C and D" ], "offsets": [ [ 161, 175 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T17", "type": "Qualifier", "text": [ "non-traumatic" ], "offsets": [ [ 194, 207 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T18", "type": "Condition", "text": [ "lesions" ], "offsets": [ [ 225, 232 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T19", "type": "Qualifier", "text": [ "Traumatic" ], "offsets": [ [ 180, 189 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T20", "type": "Qualifier", "text": [ "non-progressive" ], "offsets": [ [ 209, 224 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T21", "type": "Temporal", "text": [ "Onset > 6 months" ], "offsets": [ [ 237, 253 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T22", "type": "Condition", "text": [ "Ability to ambulate with", "assistive devices" ], "offsets": [ [ 258, 282 ], [ 294, 311 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T23", "type": "Condition", "text": [ "Ability to ambulate", "without assistive devices" ], "offsets": [ [ 258, 277 ], [ 286, 311 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T24", "type": "Condition", "text": [ "Ability to follow verbal", "commands" ], "offsets": [ [ 316, 340 ], [ 351, 359 ] ], "normalized": [] }, { "id": "NCT02441179_inc_T25", "type": "Condition", "text": [ "Ability to follow", "visual commands" ], "offsets": [ [ 316, 333 ], [ 344, 359 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02441179_inc_R1", "type": "Has_value", "arg1_id": "NCT02441179_inc_T9", "arg2_id": "NCT02441179_inc_T8", "normalized": [] }, { "id": "NCT02441179_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02441179_inc_T13", "arg2_id": "NCT02441179_inc_T14", "normalized": [] }, { "id": "NCT02441179_inc_R3", "type": "Has_value", "arg1_id": "NCT02441179_inc_T15", "arg2_id": "NCT02441179_inc_T16", "normalized": [] }, { "id": "NCT02441179_inc_R4", "type": "AND", "arg1_id": "NCT02441179_inc_T13", "arg2_id": "NCT02441179_inc_T15", "normalized": [] }, { "id": "NCT02441179_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02441179_inc_T18", "arg2_id": "NCT02441179_inc_T20", "normalized": [] }, { "id": "NCT02441179_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02441179_inc_T18", "arg2_id": "NCT02441179_inc_T17", "normalized": [] }, { "id": "NCT02441179_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02441179_inc_T18", "arg2_id": "NCT02441179_inc_T19", "normalized": [] } ]

[ { "id": "NCT02443623_exc_text", "type": "exclusion", "text": [ "History of severe related adverse event(s) from previous participation in VA-001 or VA-006 trials or to any smallpox vaccination.\nEczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the investigator's discretion.\nA history of immunodeficiency.\nCurrently or has recently received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs.\nEye disease treated with topical steroids.\nKnown or suspected disorders of immunoglobulin synthesis.\nLeukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.\nHas been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time.\nIs a transplant recipient (except for corneal transplant).\nIs pregnant, planning pregnancy or breast feeding (female subjects of childbearing potential must have negative pregnancy test prior to vaccination).\nHousehold or other close/intimate contact(s) under the age of 12 months.\nHistory of allergies to phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluents.\nSubjects with kidney disease (except kidney stones).\nSubjects with abnormal EKG at screening (if applicable). To mitigate the risk of enrolling at risk subjects and potentially jeopardizing subject safety an EKG will be performed prior to vaccination with ACAM2000 smallpox vaccine in all potential subjects =50 years old and for all potential subjects <50 with two cardiac risk factors as listed immediately below including; severely or morbidly obese or higher obesity classification (BMI =36); high blood pressure; high blood cholesterol; diabetes or high blood sugar; a first degree relative who had a heart condition before the age of 50; and current tobacco smokers.\nSeverely or morbidly obese or higher obesity classification (BMI =36)\nHigh blood pressure diagnosed by a doctor\nHigh blood cholesterol diagnosed by a doctor\nDiabetes or high blood sugar diagnosed by a doctor\nA first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50\nCurrently smokes tobacco (cigarettes)\nArrhythmia\nSyncope related to cardiac disease\nPrevious myocardial infarction\nAngina\nCoronary artery disease\nCongestive heart failure\nCardiomyopathy\nStroke or transient ischemic attack\nMyocarditis\nPericarditis\nChest pain or shortness of breath with activity (such as climbing stairs), peripheral edema, heart palpitations, dry cough, irregular heartbeat, excessive fatigue, unexplained syncope\nOther heart conditions being treated by a physician\n" ], "offsets": [ [ 0, 2689 ] ] } ]

[ { "id": "NCT02443623_exc_T1", "type": "Condition", "text": [ "adverse event" ], "offsets": [ [ 26, 39 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T2", "type": "Procedure", "text": [ "smallpox vaccination" ], "offsets": [ [ 108, 128 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T4", "type": "Condition", "text": [ "Eczema" ], "offsets": [ [ 130, 136 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T5", "type": "Observation", "text": [ "history of eczema" ], "offsets": [ [ 138, 155 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T6", "type": "Condition", "text": [ "exfoliative skin conditions" ], "offsets": [ [ 157, 184 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T7", "type": "Condition", "text": [ "wounds" ], "offsets": [ [ 186, 192 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T8", "type": "Condition", "text": [ "burns" ], "offsets": [ [ 194, 199 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T9", "type": "Condition", "text": [ "other skin conditions" ], "offsets": [ [ 204, 225 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T11", "type": "Condition", "text": [ "history of immunodeficiency" ], "offsets": [ [ 262, 289 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T12", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 326, 338 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T13", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 342, 354 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T14", "type": "Temporal", "text": [ "recently" ], "offsets": [ [ 308, 316 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T15", "type": "Drug", "text": [ "adrenocorticotropic hormone" ], "offsets": [ [ 356, 383 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T16", "type": "Drug", "text": [ "ACTH" ], "offsets": [ [ 385, 389 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T17", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 392, 407 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T18", "type": "Procedure", "text": [ "immunosuppressive drugs" ], "offsets": [ [ 412, 435 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T19", "type": "Scope", "text": [ "radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs" ], "offsets": [ [ 326, 435 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T20", "type": "Condition", "text": [ "Eye disease" ], "offsets": [ [ 437, 448 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T21", "type": "Procedure", "text": [ "topical steroids" ], "offsets": [ [ 462, 478 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T22", "type": "Condition", "text": [ "disorders of immunoglobulin synthesis" ], "offsets": [ [ 499, 536 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T23", "type": "Qualifier", "text": [ "Known" ], "offsets": [ [ 480, 485 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T24", "type": "Qualifier", "text": [ "suspected" ], "offsets": [ [ 489, 498 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T25", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 480, 498 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T26", "type": "Condition", "text": [ "Leukemia" ], "offsets": [ [ 538, 546 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T27", "type": "Condition", "text": [ "lymphomas" ], "offsets": [ [ 548, 557 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T28", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 571, 579 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T29", "type": "Condition", "text": [ "malignant neoplasms" ], "offsets": [ [ 590, 609 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T30", "type": "Qualifier", "text": [ "affecting the bone marrow" ], "offsets": [ [ 610, 635 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T31", "type": "Condition", "text": [ "bone marrow" ], "offsets": [ [ 624, 635 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T32", "type": "Condition", "text": [ "lymphatic systems" ], "offsets": [ [ 639, 656 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T33", "type": "Qualifier", "text": [ "ing the b", "tic systems.\nHas" ], "offsets": [ [ 616, 625 ], [ 645, 661 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T34", "type": "Scope", "text": [ "affecting the bone marrow or lymphatic systems" ], "offsets": [ [ 610, 656 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T35", "type": "Condition", "text": [ "diagnosed with cancer" ], "offsets": [ [ 667, 688 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T36", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 716, 728 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T37", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 732, 749 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T38", "type": "Temporal", "text": [ "during the vaccination healing time" ], "offsets": [ [ 750, 785 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T39", "type": "Reference_point", "text": [ "vaccination healing time" ], "offsets": [ [ 761, 785 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T40", "type": "Scope", "text": [ "chemotherapy or radiation therapy" ], "offsets": [ [ 716, 749 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T41", "type": "Person", "text": [ "transplant recipient" ], "offsets": [ [ 792, 812 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T42", "type": "Negation", "text": [ "except" ], "offsets": [ [ 814, 820 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T43", "type": "Condition", "text": [ "corneal transplant" ], "offsets": [ [ 825, 843 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T44", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 849, 857 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T45", "type": "Observation", "text": [ "planning pregnancy" ], "offsets": [ [ 859, 877 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T46", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 881, 895 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T48", "type": "Person", "text": [ "close/intimate contact(s)" ], "offsets": [ [ 1015, 1040 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T49", "type": "Person", "text": [ "age" ], "offsets": [ [ 1051, 1054 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T50", "type": "Value", "text": [ "age o", "\nHistor" ], "offsets": [ [ 1051, 1056 ], [ 1068, 1075 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T51", "type": "Person", "text": [ "Household" ], "offsets": [ [ 996, 1005 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T52", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 1080, 1089 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T53", "type": "Drug", "text": [ "phenol" ], "offsets": [ [ 1093, 1099 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T54", "type": "Procedure", "text": [ "antibiotics" ], "offsets": [ [ 1112, 1123 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T55", "type": "Qualifier", "text": [ "listed in the vaccine content" ], "offsets": [ [ 1124, 1153 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T56", "type": "Procedure", "text": [ "vaccine" ], "offsets": [ [ 1138, 1145 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T57", "type": "Drug", "text": [ "ACAM2000" ], "offsets": [ [ 1181, 1189 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T58", "type": "Drug", "text": [ " its di", "ubjects" ], "offsets": [ [ 1192, 1199 ], [ 1208, 1215 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T59", "type": "Scope", "text": [ "phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluents." ], "offsets": [ [ 1093, 1206 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T60", "type": "Condition", "text": [ "kidney disease" ], "offsets": [ [ 1221, 1235 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T61", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1237, 1243 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T62", "type": "Condition", "text": [ "kidney stones" ], "offsets": [ [ 1244, 1257 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T63", "type": "Procedure", "text": [ "EKG" ], "offsets": [ [ 1283, 1286 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T64", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 1274, 1282 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T65", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1287, 1299 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T66", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1290, 1299 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T68", "type": "Condition", "text": [ "obese" ], "offsets": [ [ 1901, 1906 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T69", "type": "Qualifier", "text": [ "morbidly" ], "offsets": [ [ 1892, 1900 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T70", "type": "Qualifier", "text": [ "Severely" ], "offsets": [ [ 1880, 1888 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T71", "type": "Observation", "text": [ "higher obesity classification" ], "offsets": [ [ 1910, 1939 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T72", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 1941, 1944 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T73", "type": "Value", "text": [ "=36" ], "offsets": [ [ 1945, 1948 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T74", "type": "Condition", "text": [ "High blood pressure" ], "offsets": [ [ 1950, 1969 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T75", "type": "Condition", "text": [ "High blood cholesterol" ], "offsets": [ [ 1992, 2014 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T76", "type": "Condition", "text": [ "Diabetes" ], "offsets": [ [ 2037, 2045 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T77", "type": "Condition", "text": [ "high blood sugar" ], "offsets": [ [ 2049, 2065 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T78", "type": "Person", "text": [ "A first degree relative" ], "offsets": [ [ 2088, 2111 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T79", "type": "Condition", "text": [ "heart condition" ], "offsets": [ [ 2169, 2184 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T80", "type": "Temporal", "text": [ "before the age of 50" ], "offsets": [ [ 2185, 2205 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T81", "type": "Reference_point", "text": [ "age of 50" ], "offsets": [ [ 2196, 2205 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T82", "type": "Person", "text": [ "age" ], "offsets": [ [ 2196, 2199 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T83", "type": "Value", "text": [ "50" ], "offsets": [ [ 2203, 2205 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T84", "type": "Person", "text": [ "mother" ], "offsets": [ [ 2126, 2132 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T85", "type": "Person", "text": [ "father" ], "offsets": [ [ 2134, 2140 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T86", "type": "Person", "text": [ "brother" ], "offsets": [ [ 2142, 2149 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T87", "type": "Person", "text": [ "sister" ], "offsets": [ [ 2151, 2157 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T88", "type": "Scope", "text": [ "mother, father, brother, sister" ], "offsets": [ [ 2126, 2157 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T89", "type": "Observation", "text": [ "smokes tobacco" ], "offsets": [ [ 2216, 2230 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T90", "type": "Observation", "text": [ "arette", "mia\nSyncop" ], "offsets": [ [ 2235, 2241 ], [ 2251, 2261 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T91", "type": "Condition", "text": [ "Arrhythmia" ], "offsets": [ [ 2244, 2254 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T92", "type": "Condition", "text": [ "Syncope" ], "offsets": [ [ 2255, 2262 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T93", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 2274, 2289 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T94", "type": "Condition", "text": [ "Previous myocardial infarction" ], "offsets": [ [ 2290, 2320 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T95", "type": "Condition", "text": [ "Angina" ], "offsets": [ [ 2321, 2327 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T96", "type": "Condition", "text": [ "Coronary artery disease" ], "offsets": [ [ 2328, 2351 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T97", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 2352, 2376 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T98", "type": "Condition", "text": [ "Cardiomyopathy" ], "offsets": [ [ 2377, 2391 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T99", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 2402, 2427 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T100", "type": "Condition", "text": [ "Stroke" ], "offsets": [ [ 2392, 2398 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T101", "type": "Condition", "text": [ "Myocarditis" ], "offsets": [ [ 2428, 2439 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T102", "type": "Condition", "text": [ "Pericarditis" ], "offsets": [ [ 2440, 2452 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T103", "type": "Condition", "text": [ "Chest pain" ], "offsets": [ [ 2453, 2463 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T104", "type": "Condition", "text": [ "shortness of breath with activity" ], "offsets": [ [ 2467, 2500 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T105", "type": "Condition", "text": [ "peripheral edema" ], "offsets": [ [ 2528, 2544 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T106", "type": "Condition", "text": [ "heart palpitations" ], "offsets": [ [ 2546, 2564 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T107", "type": "Condition", "text": [ "dry cough" ], "offsets": [ [ 2566, 2575 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T108", "type": "Condition", "text": [ "irregular heartbeat" ], "offsets": [ [ 2577, 2596 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T109", "type": "Condition", "text": [ "excessive fatigue" ], "offsets": [ [ 2598, 2615 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T110", "type": "Condition", "text": [ "syncope" ], "offsets": [ [ 2629, 2636 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T111", "type": "Condition", "text": [ "Other heart conditions" ], "offsets": [ [ 2637, 2659 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T47", "type": "Person", "text": [ "female" ], "offsets": [ [ 897, 903 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T112", "type": "Observation", "text": [ "childbearing potential" ], "offsets": [ [ 916, 938 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T113", "type": "Value", "text": [ "negative" ], "offsets": [ [ 949, 957 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T114", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 958, 972 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T115", "type": "Temporal", "text": [ "prior to vaccination" ], "offsets": [ [ 973, 993 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T116", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 982, 993 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T117", "type": "Reference_point", "text": [ "vaccination" ], "offsets": [ [ 982, 993 ] ], "normalized": [] }, { "id": "NCT02443623_exc_T118", "type": "Scope", "text": [ "female subjects of childbearing potential" ], "offsets": [ [ 897, 938 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02443623_exc_R1", "type": "AND", "arg1_id": "NCT02443623_exc_T1", "arg2_id": "NCT02443623_exc_T2", "normalized": [] }, { "id": "NCT02443623_exc_R2", "type": "Subsumes", "arg1_id": "NCT02443623_exc_T15", "arg2_id": "NCT02443623_exc_T16", "normalized": [] }, { "id": "NCT02443623_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02443623_exc_T19", "arg2_id": "NCT02443623_exc_T14", "normalized": [] }, { "id": "NCT02443623_exc_R4", "type": "AND", "arg1_id": "NCT02443623_exc_T20", "arg2_id": "NCT02443623_exc_T21", "normalized": [] }, { "id": "NCT02443623_exc_R5", "type": "Has_scope", "arg1_id": "NCT02443623_exc_T22", "arg2_id": "NCT02443623_exc_T25", "normalized": [] }, { "id": "NCT02443623_exc_R8", "type": "Has_scope", "arg1_id": "NCT02443623_exc_T29", "arg2_id": "NCT02443623_exc_T34", "normalized": [] }, { "id": "NCT02443623_exc_R9", "type": "Has_index", "arg1_id": "NCT02443623_exc_T38", "arg2_id": "NCT02443623_exc_T39", "normalized": [] }, { "id": "NCT02443623_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02443623_exc_T40", "arg2_id": "NCT02443623_exc_T38", "normalized": [] }, { "id": "NCT02443623_exc_R11", "type": "Has_negation", "arg1_id": "NCT02443623_exc_T43", "arg2_id": "NCT02443623_exc_T42", "normalized": [] }, { "id": "NCT02443623_exc_R12", "type": "Has_value", "arg1_id": "NCT02443623_exc_T49", "arg2_id": "NCT02443623_exc_T50", "normalized": [] }, { "id": "NCT02443623_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT02443623_exc_T54", "arg2_id": "NCT02443623_exc_T55", "normalized": [] }, { "id": "NCT02443623_exc_R13", "type": "Has_scope", "arg1_id": "NCT02443623_exc_T52", "arg2_id": "NCT02443623_exc_T59", "normalized": [] }, { "id": "NCT02443623_exc_R16", "type": "Has_negation", "arg1_id": "NCT02443623_exc_T62", "arg2_id": "NCT02443623_exc_T61", "normalized": [] }, { "id": "NCT02443623_exc_R17", "type": "Has_index", "arg1_id": "NCT02443623_exc_T65", "arg2_id": "NCT02443623_exc_T66", "normalized": [] }, { "id": "NCT02443623_exc_R18", "type": "Has_value", "arg1_id": "NCT02443623_exc_T63", "arg2_id": "NCT02443623_exc_T64", "normalized": [] }, { "id": "NCT02443623_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02443623_exc_T63", "arg2_id": "NCT02443623_exc_T65", "normalized": [] }, { "id": "NCT02443623_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT02443623_exc_T68", "arg2_id": "NCT02443623_exc_T69", "normalized": [] }, { "id": "NCT02443623_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02443623_exc_T68", "arg2_id": "NCT02443623_exc_T70", "normalized": [] }, { "id": "NCT02443623_exc_R22", "type": "Has_value", "arg1_id": "NCT02443623_exc_T72", "arg2_id": "NCT02443623_exc_T73", "normalized": [] }, { "id": "NCT02443623_exc_R23", "type": "Has_value", "arg1_id": "NCT02443623_exc_T82", "arg2_id": "NCT02443623_exc_T83", "normalized": [] }, { "id": "NCT02443623_exc_R25", "type": "Has_index", "arg1_id": "NCT02443623_exc_T80", "arg2_id": "NCT02443623_exc_T81", "normalized": [] }, { "id": "NCT02443623_exc_R26", "type": "Has_temporal", "arg1_id": "NCT02443623_exc_T79", "arg2_id": "NCT02443623_exc_T80", "normalized": [] }, { "id": "NCT02443623_exc_R27", "type": "AND", "arg1_id": "NCT02443623_exc_T78", "arg2_id": "NCT02443623_exc_T79", "normalized": [] }, { "id": "NCT02443623_exc_R28", "type": "Subsumes", "arg1_id": "NCT02443623_exc_T78", "arg2_id": "NCT02443623_exc_T88", "normalized": [] }, { "id": "NCT02443623_exc_R29", "type": "Subsumes", "arg1_id": "NCT02443623_exc_T89", "arg2_id": "NCT02443623_exc_T90", "normalized": [] }, { "id": "NCT02443623_exc_R30", "type": "AND", "arg1_id": "NCT02443623_exc_T92", "arg2_id": "NCT02443623_exc_T93", "normalized": [] }, { "id": "NCT02443623_exc_R32", "type": "AND", "arg1_id": "NCT02443623_exc_T115", "arg2_id": "NCT02443623_exc_T116", "normalized": [] }, { "id": "NCT02443623_exc_R33", "type": "Has_temporal", "arg1_id": "NCT02443623_exc_T114", "arg2_id": "NCT02443623_exc_T115", "normalized": [] }, { "id": "NCT02443623_exc_R34", "type": "Has_value", "arg1_id": "NCT02443623_exc_T114", "arg2_id": "NCT02443623_exc_T113", "normalized": [] }, { "id": "NCT02443623_exc_R35", "type": "AND", "arg1_id": "NCT02443623_exc_T118", "arg2_id": "NCT02443623_exc_T114", "normalized": [] } ]

[ { "id": "NCT02443623_inc_text", "type": "inclusion", "text": [ "Signed written informed consent.\nAge 18 to 65.\nNormal and healthy (immune competent) as determined by medical history, physical exam, vital signs and clinical laboratory tests during the screening period.\nIf all lab results for quantitative IgA immunoglobulin level are lower than 15% below normal range, the subject may not proceed further in the screening process.\nSubject must meet all required subject suitability criteria that pertain to normal source plasma donors.\nNegative HIV serology during screening period.\nSubject must have been previously immunized for smallpox, at =3 years prior to commencement of screening assessments, and vaccination history must be confirmed by oral or written history and the presence of a visible pathognomonic smallpox vaccination scar.\nFemale subjects of childbearing potential must agree to use highly effective birth control methods.\n" ], "offsets": [ [ 0, 877 ] ] } ]

[ { "id": "NCT02443623_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T3", "type": "Value", "text": [ "18 to 65" ], "offsets": [ [ 37, 45 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T4", "type": "Qualifier", "text": [ "Normal" ], "offsets": [ [ 47, 53 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T5", "type": "Qualifier", "text": [ "healthy" ], "offsets": [ [ 58, 65 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T6", "type": "Temporal", "text": [ "during the screening period" ], "offsets": [ [ 176, 203 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T7", "type": "Reference_point", "text": [ "screening period" ], "offsets": [ [ 187, 203 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T8", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 102, 117 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T9", "type": "Procedure", "text": [ "physical exam" ], "offsets": [ [ 119, 132 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T10", "type": "Measurement", "text": [ "vital signs" ], "offsets": [ [ 134, 145 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T11", "type": "Measurement", "text": [ "clinical laboratory tests" ], "offsets": [ [ 150, 175 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T12", "type": "Scope", "text": [ "medical history, physical exam, vital signs and clinical laboratory tests" ], "offsets": [ [ 102, 175 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T13", "type": "Measurement", "text": [ "quantitative IgA immunoglobulin level" ], "offsets": [ [ 228, 265 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T14", "type": "Value", "text": [ "lower than 15% below normal range" ], "offsets": [ [ 270, 303 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T17", "type": "Measurement", "text": [ "HIV serology" ], "offsets": [ [ 481, 493 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T18", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 472, 480 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T19", "type": "Temporal", "text": [ "during screening period" ], "offsets": [ [ 494, 517 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T20", "type": "Reference_point", "text": [ "screening period" ], "offsets": [ [ 501, 517 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T21", "type": "Condition", "text": [ "smallpox" ], "offsets": [ [ 567, 575 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T22", "type": "Procedure", "text": [ "immunized" ], "offsets": [ [ 553, 562 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T23", "type": "Temporal", "text": [ "3 years prior to commencement of screening assessments" ], "offsets": [ [ 581, 635 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T24", "type": "Reference_point", "text": [ "commencement of screening assessments" ], "offsets": [ [ 598, 635 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T26", "type": "Person", "text": [ "Female" ], "offsets": [ [ 777, 783 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T27", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 796, 818 ] ], "normalized": [] }, { "id": "NCT02443623_inc_T28", "type": "Procedure", "text": [ "birth control methods" ], "offsets": [ [ 854, 875 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02443623_inc_R1", "type": "Has_value", "arg1_id": "NCT02443623_inc_T2", "arg2_id": "NCT02443623_inc_T3", "normalized": [] }, { "id": "NCT02443623_inc_R2", "type": "Has_index", "arg1_id": "NCT02443623_inc_T6", "arg2_id": "NCT02443623_inc_T7", "normalized": [] }, { "id": "NCT02443623_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02443623_inc_T12", "arg2_id": "NCT02443623_inc_T5", "normalized": [] }, { "id": "NCT02443623_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02443623_inc_T12", "arg2_id": "NCT02443623_inc_T4", "normalized": [] }, { "id": "NCT02443623_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02443623_inc_T12", "arg2_id": "NCT02443623_inc_T6", "normalized": [] }, { "id": "NCT02443623_inc_R6", "type": "Has_value", "arg1_id": "NCT02443623_inc_T13", "arg2_id": "NCT02443623_inc_T14", "normalized": [] }, { "id": "NCT02443623_inc_R7", "type": "Has_index", "arg1_id": "NCT02443623_inc_T19", "arg2_id": "NCT02443623_inc_T20", "normalized": [] }, { "id": "NCT02443623_inc_R8", "type": "Has_value", "arg1_id": "NCT02443623_inc_T17", "arg2_id": "NCT02443623_inc_T18", "normalized": [] }, { "id": "NCT02443623_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02443623_inc_T17", "arg2_id": "NCT02443623_inc_T19", "normalized": [] }, { "id": "NCT02443623_inc_R10", "type": "AND", "arg1_id": "NCT02443623_inc_T22", "arg2_id": "NCT02443623_inc_T21", "normalized": [] }, { "id": "NCT02443623_inc_R11", "type": "Has_temporal", "arg1_id": "NCT02443623_inc_T22", "arg2_id": "NCT02443623_inc_T23", "normalized": [] }, { "id": "NCT02443623_inc_R12", "type": "Has_index", "arg1_id": "NCT02443623_inc_T23", "arg2_id": "NCT02443623_inc_T24", "normalized": [] }, { "id": "NCT02443623_inc_R13", "type": "AND", "arg1_id": "NCT02443623_inc_T26", "arg2_id": "NCT02443623_inc_T27", "normalized": [] }, { "id": "NCT02443623_inc_R14", "type": "AND", "arg1_id": "NCT02443623_inc_T26", "arg2_id": "NCT02443623_inc_T28", "normalized": [] } ]

[ { "id": "NCT02443844_exc_text", "type": "exclusion", "text": [ "Patients who have previous prostate surgery Patients who have muscle invasive bladder cancer\n" ], "offsets": [ [ 0, 93 ] ] } ]

[ { "id": "NCT02443844_exc_T1", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 18, 26 ] ], "normalized": [] }, { "id": "NCT02443844_exc_T2", "type": "Condition", "text": [ "prostate surgery" ], "offsets": [ [ 27, 43 ] ], "normalized": [] }, { "id": "NCT02443844_exc_T5", "type": "Condition", "text": [ "bladder cancer" ], "offsets": [ [ 78, 92 ] ], "normalized": [] }, { "id": "NCT02443844_exc_T6", "type": "Qualifier", "text": [ "muscle invasive" ], "offsets": [ [ 62, 77 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02443844_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02443844_exc_T5", "arg2_id": "NCT02443844_exc_T6", "normalized": [] }, { "id": "NCT02443844_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02443844_exc_T2", "arg2_id": "NCT02443844_exc_T1", "normalized": [] } ]

[ { "id": "NCT02443844_inc_text", "type": "inclusion", "text": [ "Patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old\n" ], "offsets": [ [ 0, 100 ] ] } ]

[ { "id": "NCT02443844_inc_T1", "type": "Condition", "text": [ "non muscle invasive bladder cancer" ], "offsets": [ [ 18, 52 ] ], "normalized": [] }, { "id": "NCT02443844_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 96, 99 ] ], "normalized": [] }, { "id": "NCT02443844_inc_T3", "type": "Value", "text": [ "between 40-80 years" ], "offsets": [ [ 76, 95 ] ], "normalized": [] }, { "id": "NCT02443844_inc_T4", "type": "Person", "text": [ "male" ], "offsets": [ [ 53, 57 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02443844_inc_R1", "type": "Has_value", "arg1_id": "NCT02443844_inc_T2", "arg2_id": "NCT02443844_inc_T3", "normalized": [] } ]

[ { "id": "NCT02445339_exc_text", "type": "exclusion", "text": [ "Active opioid dependence\nAcute or chronic pain requiring opioid treatment\nAcute liver injury (liver aminotransferase concentrations >5 times the upper limit of normal)\nHealth condition considered unsafe for inclusion (at discretion of PI and/or attending physician)\nLack of capacity or willingness to consent\nCurrently prescribed pharmacotherapy for alcohol dependence (not including treatment of acute alcohol withdrawal syndrome)\nPrevious significant adverse reaction to naltrexone or diluent\nPregnant, nursing, or not using effective methods of birth control\nPrisoners (as defined by Office of Human Research Protection) at the time of enrollment ARE NOT ELIGIBLE for study entry. However, subjects who become prisoners after being enrolled will be included and not be withdrawn from the study. Patients on parole or probation are eligible for enrollment.\n" ], "offsets": [ [ 0, 859 ] ] } ]

[ { "id": "NCT02445339_exc_T1", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T2", "type": "Condition", "text": [ "opioid dependence" ], "offsets": [ [ 7, 24 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T3", "type": "Qualifier", "text": [ "Acute" ], "offsets": [ [ 25, 30 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T4", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 34, 41 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T5", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 42, 46 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T6", "type": "Scope", "text": [ "Acute or chronic" ], "offsets": [ [ 25, 41 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T7", "type": "Procedure", "text": [ "opioid treatment" ], "offsets": [ [ 57, 73 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T8", "type": "Condition", "text": [ "Acute liver injury" ], "offsets": [ [ 74, 92 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T9", "type": "Measurement", "text": [ "liver aminotransferase concentrations" ], "offsets": [ [ 94, 131 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T10", "type": "Value", "text": [ ">5 times the upper limit of normal" ], "offsets": [ [ 132, 166 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T11", "type": "Scope", "text": [ "liver aminotransferase concentrations >5 times the upper limit of normal" ], "offsets": [ [ 94, 166 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T12", "type": "Condition", "text": [ "Health condition" ], "offsets": [ [ 168, 184 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T13", "type": "Qualifier", "text": [ "considered unsafe for inclusion" ], "offsets": [ [ 185, 216 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T15", "type": "Observation", "text": [ "willingness to consent" ], "offsets": [ [ 286, 308 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T16", "type": "Negation", "text": [ "Lack of" ], "offsets": [ [ 266, 273 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T17", "type": "Observation", "text": [ "city or", "onsent\nCur" ], "offsets": [ [ 278, 285 ], [ 302, 312 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T18", "type": "Scope", "text": [ "capacity or willingness to consent" ], "offsets": [ [ 274, 308 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T19", "type": "Condition", "text": [ "alcohol dependence" ], "offsets": [ [ 350, 368 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T20", "type": "Procedure", "text": [ "pharmacotherapy" ], "offsets": [ [ 330, 345 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T21", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 309, 318 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T22", "type": "Negation", "text": [ "not including" ], "offsets": [ [ 370, 383 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T23", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 384, 393 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T24", "type": "Condition", "text": [ "acute alcohol withdrawal syndrome" ], "offsets": [ [ 397, 430 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T25", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 432, 440 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T26", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 441, 452 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T27", "type": "Condition", "text": [ "adverse reaction" ], "offsets": [ [ 453, 469 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T28", "type": "Drug", "text": [ "naltrexone" ], "offsets": [ [ 473, 483 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T29", "type": "Drug", "text": [ "diluent" ], "offsets": [ [ 487, 494 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T30", "type": "Scope", "text": [ "naltrexone or diluent" ], "offsets": [ [ 473, 494 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T31", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 495, 503 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T32", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 505, 512 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T33", "type": "Negation", "text": [ "not" ], "offsets": [ [ 517, 520 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T34", "type": "Procedure", "text": [ "birth control" ], "offsets": [ [ 548, 561 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T35", "type": "Qualifier", "text": [ "effective methods" ], "offsets": [ [ 527, 544 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T36", "type": "Person", "text": [ "Prisoners" ], "offsets": [ [ 562, 571 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T37", "type": "Qualifier", "text": [ "Office of Human Research Protection" ], "offsets": [ [ 587, 622 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T38", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 624, 649 ] ], "normalized": [] }, { "id": "NCT02445339_exc_T39", "type": "Reference_point", "text": [ "the time of enrollment" ], "offsets": [ [ 627, 649 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02445339_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02445339_exc_T2", "arg2_id": "NCT02445339_exc_T1", "normalized": [] }, { "id": "NCT02445339_exc_R2", "type": "Has_scope", "arg1_id": "NCT02445339_exc_T5", "arg2_id": "NCT02445339_exc_T6", "normalized": [] }, { "id": "NCT02445339_exc_R3", "type": "AND", "arg1_id": "NCT02445339_exc_T5", "arg2_id": "NCT02445339_exc_T7", "normalized": [] }, { "id": "NCT02445339_exc_R4", "type": "Has_value", "arg1_id": "NCT02445339_exc_T9", "arg2_id": "NCT02445339_exc_T10", "normalized": [] }, { "id": "NCT02445339_exc_R5", "type": "Subsumes", "arg1_id": "NCT02445339_exc_T8", "arg2_id": "NCT02445339_exc_T11", "normalized": [] }, { "id": "NCT02445339_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02445339_exc_T12", "arg2_id": "NCT02445339_exc_T13", "normalized": [] }, { "id": "NCT02445339_exc_R7", "type": "Has_negation", "arg1_id": "NCT02445339_exc_T18", "arg2_id": "NCT02445339_exc_T16", "normalized": [] }, { "id": "NCT02445339_exc_R8", "type": "AND", "arg1_id": "NCT02445339_exc_T20", "arg2_id": "NCT02445339_exc_T19", "normalized": [] }, { "id": "NCT02445339_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02445339_exc_T20", "arg2_id": "NCT02445339_exc_T21", "normalized": [] }, { "id": "NCT02445339_exc_R10", "type": "AND", "arg1_id": "NCT02445339_exc_T23", "arg2_id": "NCT02445339_exc_T24", "normalized": [] }, { "id": "NCT02445339_exc_R11", "type": "Has_negation", "arg1_id": "NCT02445339_exc_T23", "arg2_id": "NCT02445339_exc_T22", "normalized": [] }, { "id": "NCT02445339_exc_R12", "type": "AND", "arg1_id": "NCT02445339_exc_T20", "arg2_id": "NCT02445339_exc_T23", "normalized": [] }, { "id": "NCT02445339_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT02445339_exc_T27", "arg2_id": "NCT02445339_exc_T26", "normalized": [] }, { "id": "NCT02445339_exc_R14", "type": "Has_temporal", "arg1_id": "NCT02445339_exc_T27", "arg2_id": "NCT02445339_exc_T25", "normalized": [] }, { "id": "NCT02445339_exc_R15", "type": "Has_scope", "arg1_id": "NCT02445339_exc_T27", "arg2_id": "NCT02445339_exc_T30", "normalized": [] }, { "id": "NCT02445339_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT02445339_exc_T34", "arg2_id": "NCT02445339_exc_T35", "normalized": [] }, { "id": "NCT02445339_exc_R17", "type": "Has_negation", "arg1_id": "NCT02445339_exc_T34", "arg2_id": "NCT02445339_exc_T33", "normalized": [] }, { "id": "NCT02445339_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02445339_exc_T36", "arg2_id": "NCT02445339_exc_T37", "normalized": [] }, { "id": "NCT02445339_exc_R19", "type": "Has_index", "arg1_id": "NCT02445339_exc_T38", "arg2_id": "NCT02445339_exc_T39", "normalized": [] }, { "id": "NCT02445339_exc_R20", "type": "Has_temporal", "arg1_id": "NCT02445339_exc_T36", "arg2_id": "NCT02445339_exc_T38", "normalized": [] } ]

[ { "id": "NCT02445339_inc_text", "type": "inclusion", "text": [ "English or Spanish speaking*\nEmergency Department patient\nAged 18-80\nHave had >4 emergency department visits within 12 months for 2 consecutive 12-month periods. Period of time can be extended by up to 6 months if incarcerated or institutionalized for ≥ 6 months.\nMeet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcohol dependence or & DSM-V criteria for alcohol use disorder, severe.\nHave ≥2 days/week of heavy drinking (>4 drinks/day)\nCapable of giving informed consent.\n" ], "offsets": [ [ 0, 497 ] ] } ]

[ { "id": "NCT02445339_inc_T1", "type": "Observation", "text": [ "English", "speaking" ], "offsets": [ [ 0, 7 ], [ 19, 27 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T2", "type": "Observation", "text": [ "Spanish speaking" ], "offsets": [ [ 11, 27 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T3", "type": "Visit", "text": [ "Emergency Department" ], "offsets": [ [ 29, 49 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T4", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 58, 62 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T5", "type": "Value", "text": [ "18-80" ], "offsets": [ [ 63, 68 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T6", "type": "Multiplier", "text": [ ">4" ], "offsets": [ [ 78, 80 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T7", "type": "Visit", "text": [ "emergency department visits" ], "offsets": [ [ 81, 108 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T8", "type": "Temporal", "text": [ "within 12 months" ], "offsets": [ [ 109, 125 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T9", "type": "Temporal", "text": [ "12-month periods" ], "offsets": [ [ 144, 160 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T10", "type": "Multiplier", "text": [ "2 consecutive" ], "offsets": [ [ 130, 143 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T11", "type": "Person", "text": [ "incarcerated" ], "offsets": [ [ 214, 226 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T12", "type": "Person", "text": [ "institutionalized" ], "offsets": [ [ 230, 247 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T14", "type": "Scope", "text": [ "incarcerated or institutionalized" ], "offsets": [ [ 214, 247 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T13", "type": "Temporal", "text": [ "extended by up to 6 months" ], "offsets": [ [ 184, 210 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T15", "type": "Qualifier", "text": [ "Diagnostic and Statistical Manual version IV (DSM-IV) criteria" ], "offsets": [ [ 269, 331 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T16", "type": "Condition", "text": [ "alcohol dependence" ], "offsets": [ [ 336, 354 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T17", "type": "Qualifier", "text": [ "DSM-V criteria" ], "offsets": [ [ 360, 374 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T18", "type": "Condition", "text": [ "alcohol use disorder" ], "offsets": [ [ 379, 399 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T19", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 401, 407 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T20", "type": "Multiplier", "text": [ "≥2 days/week" ], "offsets": [ [ 414, 426 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T21", "type": "Condition", "text": [ "heavy drinking" ], "offsets": [ [ 430, 444 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T22", "type": "Value", "text": [ ">4" ], "offsets": [ [ 446, 448 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T23", "type": "Measurement", "text": [ "drinks/day" ], "offsets": [ [ 449, 459 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T24", "type": "Observation", "text": [ "informed consent" ], "offsets": [ [ 479, 495 ] ], "normalized": [] }, { "id": "NCT02445339_inc_T25", "type": "Mood", "text": [ "Capable of giving" ], "offsets": [ [ 461, 478 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02445339_inc_R1", "type": "Has_value", "arg1_id": "NCT02445339_inc_T4", "arg2_id": "NCT02445339_inc_T5", "normalized": [] }, { "id": "NCT02445339_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02445339_inc_T9", "arg2_id": "NCT02445339_inc_T10", "normalized": [] }, { "id": "NCT02445339_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02445339_inc_T7", "arg2_id": "NCT02445339_inc_T8", "normalized": [] }, { "id": "NCT02445339_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02445339_inc_T7", "arg2_id": "NCT02445339_inc_T9", "normalized": [] }, { "id": "NCT02445339_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT02445339_inc_T7", "arg2_id": "NCT02445339_inc_T6", "normalized": [] }, { "id": "NCT02445339_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02445339_inc_T14", "arg2_id": "NCT02445339_inc_T13", "normalized": [] }, { "id": "NCT02445339_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02445339_inc_T18", "arg2_id": "NCT02445339_inc_T19", "normalized": [] }, { "id": "NCT02445339_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT02445339_inc_T18", "arg2_id": "NCT02445339_inc_T17", "normalized": [] }, { "id": "NCT02445339_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT02445339_inc_T16", "arg2_id": "NCT02445339_inc_T15", "normalized": [] }, { "id": "NCT02445339_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT02445339_inc_T21", "arg2_id": "NCT02445339_inc_T20", "normalized": [] }, { "id": "NCT02445339_inc_R11", "type": "Has_value", "arg1_id": "NCT02445339_inc_T23", "arg2_id": "NCT02445339_inc_T22", "normalized": [] }, { "id": "NCT02445339_inc_R12", "type": "Has_mood", "arg1_id": "NCT02445339_inc_T24", "arg2_id": "NCT02445339_inc_T25", "normalized": [] } ]

[ { "id": "NCT02455921_exc_text", "type": "exclusion", "text": [ "Parents refusal\nCognitive impairment\nDifficulty in communication due to language issues\nPsychiatric disorder\nSevere systematic disorder\nKnown allergy to any drug used\n" ], "offsets": [ [ 0, 167 ] ] } ]

[ { "id": "NCT02455921_exc_T1", "type": "Observation", "text": [ "Parents refusal" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T2", "type": "Condition", "text": [ "Cognitive impairment" ], "offsets": [ [ 16, 36 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T3", "type": "Condition", "text": [ "Difficulty in communication" ], "offsets": [ [ 37, 64 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T4", "type": "Condition", "text": [ "language issues" ], "offsets": [ [ 72, 87 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T5", "type": "Condition", "text": [ "Psychiatric disorder" ], "offsets": [ [ 88, 108 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T6", "type": "Condition", "text": [ "Severe systematic disorder" ], "offsets": [ [ 109, 135 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T7", "type": "Condition", "text": [ "Known allergy" ], "offsets": [ [ 136, 149 ] ], "normalized": [] }, { "id": "NCT02455921_exc_T8", "type": "Drug", "text": [ "any drug used" ], "offsets": [ [ 153, 166 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02455921_exc_R1", "type": "AND", "arg1_id": "NCT02455921_exc_T3", "arg2_id": "NCT02455921_exc_T4", "normalized": [] }, { "id": "NCT02455921_exc_R2", "type": "AND", "arg1_id": "NCT02455921_exc_T7", "arg2_id": "NCT02455921_exc_T8", "normalized": [] } ]

[ { "id": "NCT02455921_inc_text", "type": "inclusion", "text": [ "Children undergoing ENT surgery under general anaesthesia.\n" ], "offsets": [ [ 0, 59 ] ] } ]

[ { "id": "NCT02455921_inc_T1", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02455921_inc_T2", "type": "Procedure", "text": [ "ENT surgery" ], "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT02455921_inc_T3", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 9, 19 ] ], "normalized": [] }, { "id": "NCT02455921_inc_T4", "type": "Procedure", "text": [ "general anaesthesia" ], "offsets": [ [ 38, 57 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02455921_inc_R1", "type": "Has_temporal", "arg1_id": "NCT02455921_inc_T2", "arg2_id": "NCT02455921_inc_T3", "normalized": [] }, { "id": "NCT02455921_inc_R2", "type": "AND", "arg1_id": "NCT02455921_inc_T2", "arg2_id": "NCT02455921_inc_T4", "normalized": [] } ]

[ { "id": "NCT02456129_exc_text", "type": "exclusion", "text": [ "Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal \nKnown or suspected liver diseases \nClinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination) \n \n" ], "offsets": [ [ 0, 363 ] ] } ]

[ { "id": "NCT02456129_exc_T1", "type": "Condition", "text": [ "pre-existing diseases" ], "offsets": [ [ 19, 40 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T2", "type": "Qualifier", "text": [ "Incompletely cured" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T5", "type": "Condition", "text": [ "liver diseases" ], "offsets": [ [ 197, 211 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T6", "type": "Qualifier", "text": [ "suspected" ], "offsets": [ [ 187, 196 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T7", "type": "Qualifier", "text": [ "Known" ], "offsets": [ [ 178, 183 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T8", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 178, 196 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T11", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 247, 261 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T12", "type": "Procedure", "text": [ "electrocardiogram(ECG)" ], "offsets": [ [ 263, 285 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T13", "type": "Procedure", "text": [ "gynecological examination" ], "offsets": [ [ 300, 325 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T14", "type": "Procedure", "text": [ "physical", "examination" ], "offsets": [ [ 287, 295 ], [ 314, 325 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T15", "type": "Procedure", "text": [ "laboratory examination" ], "offsets": [ [ 327, 349 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T16", "type": "Scope", "text": [ "blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination" ], "offsets": [ [ 247, 349 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T17", "type": "Qualifier", "text": [ "Clinically relevant" ], "offsets": [ [ 213, 232 ] ], "normalized": [] }, { "id": "NCT02456129_exc_T18", "type": "Condition", "text": [ "findings" ], "offsets": [ [ 233, 241 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02456129_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02456129_exc_T1", "arg2_id": "NCT02456129_exc_T2", "normalized": [] }, { "id": "NCT02456129_exc_R2", "type": "Has_scope", "arg1_id": "NCT02456129_exc_T5", "arg2_id": "NCT02456129_exc_T8", "normalized": [] }, { "id": "NCT02456129_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02456129_exc_T18", "arg2_id": "NCT02456129_exc_T17", "normalized": [] }, { "id": "NCT02456129_exc_R4", "type": "Subsumes", "arg1_id": "NCT02456129_exc_T18", "arg2_id": "NCT02456129_exc_T16", "normalized": [] } ]

[ { "id": "NCT02456129_inc_text", "type": "inclusion", "text": [ "Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m² \nPostmenopausal state revealed by: \nMedical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women < 65 years old, follicle stimulating hormone (FSH) > 40 IU/L \n" ], "offsets": [ [ 0, 382 ] ] } ]

[ { "id": "NCT02456129_inc_T1", "type": "Measurement", "text": [ "Body mass index (BMI)" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T2", "type": "Value", "text": [ "18 ≤ BMI ≤ 32 kg/m²" ], "offsets": [ [ 23, 42 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T3", "type": "Condition", "text": [ "Postmenopausal state" ], "offsets": [ [ 44, 64 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T5", "type": "Condition", "text": [ "natural menopause" ], "offsets": [ [ 111, 128 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T6", "type": "Temporal", "text": [ "at least 12 months prior to first study drug administration" ], "offsets": [ [ 129, 188 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T7", "type": "Reference_point", "text": [ "first study drug administration" ], "offsets": [ [ 157, 188 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T8", "type": "Condition", "text": [ "surgical menopause" ], "offsets": [ [ 193, 211 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T9", "type": "Procedure", "text": [ "bilateral ovariectomy" ], "offsets": [ [ 215, 236 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T10", "type": "Temporal", "text": [ "at least 3 months prior to first study drug administration" ], "offsets": [ [ 237, 295 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T11", "type": "Reference_point", "text": [ "first study drug administration" ], "offsets": [ [ 264, 295 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T12", "type": "Value", "text": [ "< 65 years" ], "offsets": [ [ 320, 330 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T13", "type": "Person", "text": [ "years old" ], "offsets": [ [ 325, 334 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T14", "type": "Measurement", "text": [ "follicle stimulating hormone (FSH)" ], "offsets": [ [ 336, 370 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T15", "type": "Value", "text": [ "> 40 IU/L" ], "offsets": [ [ 371, 380 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T16", "type": "Person", "text": [ "women" ], "offsets": [ [ 314, 319 ] ], "normalized": [] }, { "id": "NCT02456129_inc_T17", "type": "Scope", "text": [ "women < 65 years old" ], "offsets": [ [ 314, 334 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02456129_inc_R1", "type": "Has_value", "arg1_id": "NCT02456129_inc_T1", "arg2_id": "NCT02456129_inc_T2", "normalized": [] }, { "id": "NCT02456129_inc_R2", "type": "Has_index", "arg1_id": "NCT02456129_inc_T6", "arg2_id": "NCT02456129_inc_T7", "normalized": [] }, { "id": "NCT02456129_inc_R3", "type": "AND", "arg1_id": "NCT02456129_inc_T8", "arg2_id": "NCT02456129_inc_T9", "normalized": [] }, { "id": "NCT02456129_inc_R4", "type": "Has_index", "arg1_id": "NCT02456129_inc_T10", "arg2_id": "NCT02456129_inc_T11", "normalized": [] }, { "id": "NCT02456129_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02456129_inc_T8", "arg2_id": "NCT02456129_inc_T10", "normalized": [] }, { "id": "NCT02456129_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02456129_inc_T5", "arg2_id": "NCT02456129_inc_T6", "normalized": [] }, { "id": "NCT02456129_inc_R7", "type": "Has_value", "arg1_id": "NCT02456129_inc_T13", "arg2_id": "NCT02456129_inc_T12", "normalized": [] }, { "id": "NCT02456129_inc_R8", "type": "Has_value", "arg1_id": "NCT02456129_inc_T14", "arg2_id": "NCT02456129_inc_T15", "normalized": [] }, { "id": "NCT02456129_inc_R9", "type": "AND", "arg1_id": "NCT02456129_inc_T17", "arg2_id": "NCT02456129_inc_T14", "normalized": [] } ]

[ { "id": "NCT02456532_exc_text", "type": "exclusion", "text": [ "acute or unstable medical disease,\ncurrent or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders\n" ], "offsets": [ [ 0, 143 ] ] } ]

[ { "id": "NCT02456532_exc_T1", "type": "Condition", "text": [ "medical disease" ], "offsets": [ [ 18, 33 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T2", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T3", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 9, 17 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T4", "type": "Scope", "text": [ "acute or unstable" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T5", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 62, 81 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T6", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 83, 93 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T7", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 97, 107 ] ], "normalized": [] }, { "id": "NCT02456532_exc_T8", "type": "Condition", "text": [ "primary sleep disorders" ], "offsets": [ [ 119, 142 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02456532_exc_R1", "type": "Has_scope", "arg1_id": "NCT02456532_exc_T1", "arg2_id": "NCT02456532_exc_T4", "normalized": [] } ]

[ { "id": "NCT02456532_inc_text", "type": "inclusion", "text": [ "DSM-5 diagnosis of insomnia\n" ], "offsets": [ [ 0, 28 ] ] } ]

[ { "id": "NCT02456532_inc_T1", "type": "Condition", "text": [ "insomnia" ], "offsets": [ [ 19, 27 ] ], "normalized": [] }, { "id": "NCT02456532_inc_T2", "type": "Qualifier", "text": [ "DSM-5" ], "offsets": [ [ 0, 5 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02456532_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02456532_inc_T1", "arg2_id": "NCT02456532_inc_T2", "normalized": [] } ]

[ { "id": "NCT02457442_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02457442_inc_text", "type": "inclusion", "text": [ "ASA physical status 1 or 2\nWritten informed consent\nCardiovascular disease\nPulmonary disease\nLiver disease\nCNS disease\nAlcohol or drug abuse\nChronic intake of CNS active drugs\nBody mass index > 35\nDiabetes mellitus\nHypersensitivity or allergy to one of the study drugs\n" ], "offsets": [ [ 0, 269 ] ] } ]

[ { "id": "NCT02457442_inc_T1", "type": "Measurement", "text": [ "ASA physical status" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T2", "type": "Value", "text": [ "1" ], "offsets": [ [ 20, 21 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T3", "type": "Value", "text": [ "2" ], "offsets": [ [ 25, 26 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T4", "type": "Scope", "text": [ "1 or 2" ], "offsets": [ [ 20, 26 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T6", "type": "Condition", "text": [ "Cardiovascular disease" ], "offsets": [ [ 52, 74 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T7", "type": "Condition", "text": [ "Pulmonary disease" ], "offsets": [ [ 75, 92 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T8", "type": "Condition", "text": [ "Liver disease" ], "offsets": [ [ 93, 106 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T9", "type": "Condition", "text": [ "CNS disease" ], "offsets": [ [ 107, 118 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T10", "type": "Condition", "text": [ "l or dr", "Chron" ], "offsets": [ [ 125, 132 ], [ 141, 146 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T11", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 130, 140 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T12", "type": "Multiplier", "text": [ "Chronic intake" ], "offsets": [ [ 141, 155 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T13", "type": "Drug", "text": [ "CNS active drugs" ], "offsets": [ [ 159, 175 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T14", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 176, 191 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T15", "type": "Value", "text": [ "> 35" ], "offsets": [ [ 192, 196 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T16", "type": "Condition", "text": [ "Diabetes mellitus" ], "offsets": [ [ 197, 214 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T17", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 215, 231 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T18", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 235, 242 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T19", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 257, 268 ] ], "normalized": [] }, { "id": "NCT02457442_inc_T20", "type": "Scope", "text": [ "Hypersensitivity or allergy" ], "offsets": [ [ 215, 242 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02457442_inc_R1", "type": "Has_scope", "arg1_id": "NCT02457442_inc_T1", "arg2_id": "NCT02457442_inc_T4", "normalized": [] }, { "id": "NCT02457442_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02457442_inc_T13", "arg2_id": "NCT02457442_inc_T12", "normalized": [] }, { "id": "NCT02457442_inc_R3", "type": "Has_value", "arg1_id": "NCT02457442_inc_T14", "arg2_id": "NCT02457442_inc_T15", "normalized": [] }, { "id": "NCT02457442_inc_R4", "type": "AND", "arg1_id": "NCT02457442_inc_T20", "arg2_id": "NCT02457442_inc_T19", "normalized": [] } ]

[ { "id": "NCT02462317_exc_text", "type": "exclusion", "text": [ "Previous antispastic drugs\nContraindication for baclofen or toxin\nAntecedent of epileptic seizure\nPsychiatric antecedent\n" ], "offsets": [ [ 0, 121 ] ] } ]

[ { "id": "NCT02462317_exc_T1", "type": "Drug", "text": [ "antispastic drugs" ], "offsets": [ [ 9, 26 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T2", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 27, 43 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T3", "type": "Drug", "text": [ "baclofen" ], "offsets": [ [ 48, 56 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T4", "type": "Drug", "text": [ "toxin" ], "offsets": [ [ 60, 65 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T5", "type": "Scope", "text": [ "baclofen or toxin" ], "offsets": [ [ 48, 65 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T6", "type": "Condition", "text": [ "epileptic seizure" ], "offsets": [ [ 80, 97 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T7", "type": "Temporal", "text": [ "Antecedent" ], "offsets": [ [ 66, 76 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T8", "type": "Condition", "text": [ "Psychiatric" ], "offsets": [ [ 98, 109 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T9", "type": "Temporal", "text": [ "antecedent" ], "offsets": [ [ 110, 120 ] ], "normalized": [] }, { "id": "NCT02462317_exc_T10", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02462317_exc_R1", "type": "Has_scope", "arg1_id": "NCT02462317_exc_T2", "arg2_id": "NCT02462317_exc_T5", "normalized": [] }, { "id": "NCT02462317_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02462317_exc_T6", "arg2_id": "NCT02462317_exc_T7", "normalized": [] }, { "id": "NCT02462317_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02462317_exc_T8", "arg2_id": "NCT02462317_exc_T9", "normalized": [] }, { "id": "NCT02462317_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02462317_exc_T1", "arg2_id": "NCT02462317_exc_T10", "normalized": [] } ]

[ { "id": "NCT02462317_inc_text", "type": "inclusion", "text": [ "First single stroke ischaemic or haemorrhagic responsible of an hemiplegia\nStoke since less than 2 month\nA sufficient understood\nA spasticity : a Tardieu score upper or equal to 2 on at least one of the following muscle-triceps surae, flexors of fingers, of wrist and of elbow\nA free consent\n" ], "offsets": [ [ 0, 292 ] ] } ]

[ { "id": "NCT02462317_inc_T1", "type": "Multiplier", "text": [ "First" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T2", "type": "Multiplier", "text": [ "single" ], "offsets": [ [ 6, 12 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T3", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 13, 19 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T4", "type": "Qualifier", "text": [ "ischaemic" ], "offsets": [ [ 20, 29 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T5", "type": "Qualifier", "text": [ "haemorrhagic" ], "offsets": [ [ 33, 45 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T6", "type": "Condition", "text": [ "hemiplegia" ], "offsets": [ [ 64, 74 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T7", "type": "Scope", "text": [ "ischaemic or haemorrhagic" ], "offsets": [ [ 20, 45 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T8", "type": "Condition", "text": [ "Stoke" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T9", "type": "Temporal", "text": [ "since less than 2 month" ], "offsets": [ [ 81, 104 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T11", "type": "Condition", "text": [ "spasticity" ], "offsets": [ [ 131, 141 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T12", "type": "Measurement", "text": [ "Tardieu score" ], "offsets": [ [ 146, 159 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T13", "type": "Value", "text": [ "upper or equal to 2" ], "offsets": [ [ 160, 179 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T14", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 183, 195 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T15", "type": "Qualifier", "text": [ "muscle-triceps surae" ], "offsets": [ [ 213, 233 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T16", "type": "Qualifier", "text": [ "flexors of fingers" ], "offsets": [ [ 235, 253 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T17", "type": "Qualifier", "text": [ "wrist" ], "offsets": [ [ 258, 263 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T18", "type": "Qualifier", "text": [ "elbow" ], "offsets": [ [ 271, 276 ] ], "normalized": [] }, { "id": "NCT02462317_inc_T19", "type": "Scope", "text": [ "muscle-triceps surae, flexors of fingers, of wrist and of elbow" ], "offsets": [ [ 213, 276 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02462317_inc_R1", "type": "Has_scope", "arg1_id": "NCT02462317_inc_T3", "arg2_id": "NCT02462317_inc_T7", "normalized": [] }, { "id": "NCT02462317_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02462317_inc_T3", "arg2_id": "NCT02462317_inc_T2", "normalized": [] }, { "id": "NCT02462317_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02462317_inc_T3", "arg2_id": "NCT02462317_inc_T1", "normalized": [] }, { "id": "NCT02462317_inc_R4", "type": "AND", "arg1_id": "NCT02462317_inc_T3", "arg2_id": "NCT02462317_inc_T6", "normalized": [] }, { "id": "NCT02462317_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02462317_inc_T8", "arg2_id": "NCT02462317_inc_T9", "normalized": [] }, { "id": "NCT02462317_inc_R6", "type": "Has_value", "arg1_id": "NCT02462317_inc_T12", "arg2_id": "NCT02462317_inc_T13", "normalized": [] }, { "id": "NCT02462317_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT02462317_inc_T19", "arg2_id": "NCT02462317_inc_T14", "normalized": [] }, { "id": "NCT02462317_inc_R8", "type": "AND", "arg1_id": "NCT02462317_inc_T11", "arg2_id": "NCT02462317_inc_T12", "normalized": [] }, { "id": "NCT02462317_inc_R9", "type": "Has_scope", "arg1_id": "NCT02462317_inc_T12", "arg2_id": "NCT02462317_inc_T19", "normalized": [] } ]

[ { "id": "NCT02462590_exc_text", "type": "exclusion", "text": [ "Invasively mechanically ventilated >72 hours at the time of screening;\nPatients at potential increased risk of iatrogenic probiotic infection (see Section 2.6 for detailed explanation) including specific immunocompromised populations (HIV <200 CD4 cells/µL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500]). However, patients receiving corticosteroids previously or presently or projected to receive corticosteroids are not excluded;\nPatients at risk for endovascular infection (previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bio-prosthetic cardiac valves], previous or current endocarditis, permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts), tunnelled (not short-term) hemodialysis catheters, pacemakers or defibrillators. Patients with temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria;\nPatients with a primary diagnosis of severe acute pancreatitis, without reference to a Ranson score [Ranson 1974]). However, patients with mild or moderate pancreatitis are not excluded;\nPatients with percutaneous gastric or jejunal feeding tubes already in situ as per Health Canada guidance;\nStrict contraindication or inability to receive enteral medications;\nIntent to withdraw advanced life support as per the ICU physician;\nPrevious enrolment in this or current enrolment in a potentially confounding tria\n" ], "offsets": [ [ 0, 2253 ] ] } ]

[ { "id": "NCT02462590_exc_T1", "type": "Procedure", "text": [ "mechanically ventilated" ], "offsets": [ [ 11, 34 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T2", "type": "Temporal", "text": [ ">72 hours" ], "offsets": [ [ 35, 44 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T3", "type": "Observation", "text": [ "risk of iatrogenic probiotic infection" ], "offsets": [ [ 103, 141 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T4", "type": "Condition", "text": [ "immunocompromised" ], "offsets": [ [ 204, 221 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T5", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 235, 238 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T6", "type": "Measurement", "text": [ "CD4" ], "offsets": [ [ 244, 247 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T7", "type": "Value", "text": [ "200", "ells/µL," ], "offsets": [ [ 240, 243 ], [ 249, 257 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T8", "type": "Procedure", "text": [ "immunosuppressive medications" ], "offsets": [ [ 282, 311 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T9", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 274, 281 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T10", "type": "Drug", "text": [ "azathioprine" ], "offsets": [ [ 319, 331 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T11", "type": "Drug", "text": [ "cyclosporine" ], "offsets": [ [ 333, 345 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T12", "type": "Drug", "text": [ "cyclophosphamide" ], "offsets": [ [ 347, 363 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T13", "type": "Drug", "text": [ "tacrolimus" ], "offsets": [ [ 365, 375 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T14", "type": "Drug", "text": [ "methotrexate" ], "offsets": [ [ 377, 389 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T15", "type": "Drug", "text": [ "mycofenolate" ], "offsets": [ [ 391, 403 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T16", "type": "Drug", "text": [ "Anti-IL2" ], "offsets": [ [ 405, 413 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T17", "type": "Scope", "text": [ "azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2" ], "offsets": [ [ 319, 413 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T18", "type": "Procedure", "text": [ "transplantation" ], "offsets": [ [ 425, 440 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T19", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 497, 509 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T20", "type": "Temporal", "text": [ "last 3 months" ], "offsets": [ [ 517, 530 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T21", "type": "Condition", "text": [ "neutropenia" ], "offsets": [ [ 532, 543 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T22", "type": "Measurement", "text": [ "absolute neutrophil count" ], "offsets": [ [ 545, 570 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T23", "type": "Value", "text": [ "< 500]" ], "offsets": [ [ 571, 577 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T24", "type": "Scope", "text": [ "immunocompromised populations (HIV <200 CD4 cells/µL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500])" ], "offsets": [ [ 204, 578 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T25", "type": "Observation", "text": [ "risk for endovascular infection" ], "offsets": [ [ 718, 749 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T26", "type": "Condition", "text": [ "rheumatic heart disease" ], "offsets": [ [ 773, 796 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T27", "type": "Condition", "text": [ "congenital valve disease" ], "offsets": [ [ 798, 822 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T28", "type": "Condition", "text": [ "congenital heart disease" ], "offsets": [ [ 844, 868 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T29", "type": "Qualifier", "text": [ "surgically repaired" ], "offsets": [ [ 824, 843 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T30", "type": "Condition", "text": [ "cyanotic congenital heart disease" ], "offsets": [ [ 881, 914 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T31", "type": "Qualifier", "text": [ "unrepaired" ], "offsets": [ [ 870, 880 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T32", "type": "Procedure", "text": [ "intracardiac repair" ], "offsets": [ [ 920, 939 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T33", "type": "Device", "text": [ "prosthetic material" ], "offsets": [ [ 945, 964 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T34", "type": "Device", "text": [ "bio-prosthetic cardiac valves]" ], "offsets": [ [ 980, 1010 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T35", "type": "Device", "text": [ "chanical o", "rdiac valves]," ], "offsets": [ [ 968, 978 ], [ 997, 1011 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T36", "type": "Scope", "text": [ "mechanical or bio-prosthetic cardiac valves" ], "offsets": [ [ 966, 1009 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T37", "type": "Condition", "text": [ "endocarditis" ], "offsets": [ [ 1032, 1044 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T38", "type": "Device", "text": [ "endovascular devices" ], "offsets": [ [ 1056, 1076 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T39", "type": "Qualifier", "text": [ "permanent" ], "offsets": [ [ 1046, 1055 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T40", "type": "Device", "text": [ "endovascular grafts" ], "offsets": [ [ 1084, 1103 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T41", "type": "Procedure", "text": [ "aortic aneurysm repair" ], "offsets": [ [ 1111, 1133 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T42", "type": "Device", "text": [ "stents" ], "offsets": [ [ 1135, 1141 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T43", "type": "Qualifier", "text": [ "large arteries" ], "offsets": [ [ 1152, 1166 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T44", "type": "Device", "text": [ "inferior vena cava filters" ], "offsets": [ [ 1206, 1232 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T45", "type": "Device", "text": [ "dialysis vascular grafts" ], "offsets": [ [ 1234, 1258 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T46", "type": "Device", "text": [ "hemodialysis catheters" ], "offsets": [ [ 1288, 1310 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T47", "type": "Device", "text": [ "pacemakers" ], "offsets": [ [ 1312, 1322 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T48", "type": "Device", "text": [ "central venous catheters" ], "offsets": [ [ 1366, 1390 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T49", "type": "Device", "text": [ "central venous dialysis catheters" ], "offsets": [ [ 1392, 1425 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T50", "type": "Device", "text": [ "peripherally inserted central catheters" ], "offsets": [ [ 1429, 1468 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T51", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1481, 1484 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T52", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1600, 1603 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T53", "type": "Device", "text": [ "coronary artery stents" ], "offsets": [ [ 1512, 1534 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T54", "type": "Device", "text": [ "coronary artery bypass grafts" ], "offsets": [ [ 1536, 1565 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T55", "type": "Device", "text": [ "neurovascular coils" ], "offsets": [ [ 1576, 1595 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T56", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1679, 1682 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T57", "type": "Condition", "text": [ "mitral valve prolapse" ], "offsets": [ [ 1628, 1649 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T58", "type": "Condition", "text": [ "bicuspid aortic valve" ], "offsets": [ [ 1653, 1674 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T59", "type": "Scope", "text": [ "mitral valve prolapse or bicuspid aortic valve" ], "offsets": [ [ 1628, 1674 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T60", "type": "Scope", "text": [ "coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils" ], "offsets": [ [ 1512, 1595 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T61", "type": "Device", "text": [ "PICCs" ], "offsets": [ [ 1470, 1475 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T62", "type": "Scope", "text": [ "central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs)" ], "offsets": [ [ 1366, 1476 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T63", "type": "Scope", "text": [ "endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts" ], "offsets": [ [ 1084, 1258 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T64", "type": "Scope", "text": [ "previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bio-prosthetic cardiac valves], previous or current endocarditis, permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts), tunnelled (not short-term) hemodialysis catheters, pacemakers or defibrillators. Patients with temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria" ], "offsets": [ [ 751, 1739 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T65", "type": "Condition", "text": [ "acute pancreatitis" ], "offsets": [ [ 1785, 1803 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T66", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1778, 1784 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T67", "type": "Negation", "text": [ "without" ], "offsets": [ [ 1805, 1812 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T68", "type": "Measurement", "text": [ "Ranson score" ], "offsets": [ [ 1828, 1840 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T69", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1914, 1917 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T70", "type": "Condition", "text": [ "pancreatitis" ], "offsets": [ [ 1897, 1909 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T71", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 1880, 1884 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T72", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 1888, 1896 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T73", "type": "Scope", "text": [ "mild or moderate" ], "offsets": [ [ 1880, 1896 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T74", "type": "Device", "text": [ "jejunal feeding tubes" ], "offsets": [ [ 1966, 1987 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T75", "type": "Device", "text": [ "ric or", "ing tubes alr" ], "offsets": [ [ 1959, 1965 ], [ 1978, 1991 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T76", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 2042, 2058 ] ], "normalized": [] }, { "id": "NCT02462590_exc_T77", "type": "Procedure", "text": [ "enteral medications" ], "offsets": [ [ 2083, 2102 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02462590_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02462590_exc_T1", "arg2_id": "NCT02462590_exc_T2", "normalized": [] }, { "id": "NCT02462590_exc_R2", "type": "Has_value", "arg1_id": "NCT02462590_exc_T6", "arg2_id": "NCT02462590_exc_T7", "normalized": [] }, { "id": "NCT02462590_exc_R3", "type": "AND", "arg1_id": "NCT02462590_exc_T5", "arg2_id": "NCT02462590_exc_T6", "normalized": [] }, { "id": "NCT02462590_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T8", "arg2_id": "NCT02462590_exc_T9", "normalized": [] }, { "id": "NCT02462590_exc_R5", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T8", "arg2_id": "NCT02462590_exc_T17", "normalized": [] }, { "id": "NCT02462590_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02462590_exc_T19", "arg2_id": "NCT02462590_exc_T20", "normalized": [] }, { "id": "NCT02462590_exc_R7", "type": "Has_value", "arg1_id": "NCT02462590_exc_T22", "arg2_id": "NCT02462590_exc_T23", "normalized": [] }, { "id": "NCT02462590_exc_R8", "type": "AND", "arg1_id": "NCT02462590_exc_T21", "arg2_id": "NCT02462590_exc_T22", "normalized": [] }, { "id": "NCT02462590_exc_R9", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T3", "arg2_id": "NCT02462590_exc_T24", "normalized": [] }, { "id": "NCT02462590_exc_R10", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T4", "arg2_id": "NCT02462590_exc_T5", "normalized": [] }, { "id": "NCT02462590_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T28", "arg2_id": "NCT02462590_exc_T29", "normalized": [] }, { "id": "NCT02462590_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T30", "arg2_id": "NCT02462590_exc_T31", "normalized": [] }, { "id": "NCT02462590_exc_R13", "type": "AND", "arg1_id": "NCT02462590_exc_T32", "arg2_id": "NCT02462590_exc_T33", "normalized": [] }, { "id": "NCT02462590_exc_R14", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T33", "arg2_id": "NCT02462590_exc_T36", "normalized": [] }, { "id": "NCT02462590_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T38", "arg2_id": "NCT02462590_exc_T39", "normalized": [] }, { "id": "NCT02462590_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T42", "arg2_id": "NCT02462590_exc_T43", "normalized": [] }, { "id": "NCT02462590_exc_R17", "type": "Has_negation", "arg1_id": "NCT02462590_exc_T59", "arg2_id": "NCT02462590_exc_T56", "normalized": [] }, { "id": "NCT02462590_exc_R18", "type": "Has_negation", "arg1_id": "NCT02462590_exc_T60", "arg2_id": "NCT02462590_exc_T52", "normalized": [] }, { "id": "NCT02462590_exc_R19", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T50", "arg2_id": "NCT02462590_exc_T61", "normalized": [] }, { "id": "NCT02462590_exc_R20", "type": "Has_negation", "arg1_id": "NCT02462590_exc_T62", "arg2_id": "NCT02462590_exc_T51", "normalized": [] }, { "id": "NCT02462590_exc_R21", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T38", "arg2_id": "NCT02462590_exc_T63", "normalized": [] }, { "id": "NCT02462590_exc_R22", "type": "Subsumes", "arg1_id": "NCT02462590_exc_T25", "arg2_id": "NCT02462590_exc_T64", "normalized": [] }, { "id": "NCT02462590_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT02462590_exc_T65", "arg2_id": "NCT02462590_exc_T66", "normalized": [] }, { "id": "NCT02462590_exc_R24", "type": "Has_negation", "arg1_id": "NCT02462590_exc_T68", "arg2_id": "NCT02462590_exc_T67", "normalized": [] }, { "id": "NCT02462590_exc_R25", "type": "AND", "arg1_id": "NCT02462590_exc_T65", "arg2_id": "NCT02462590_exc_T68", "normalized": [] }, { "id": "NCT02462590_exc_R26", "type": "Has_scope", "arg1_id": "NCT02462590_exc_T70", "arg2_id": "NCT02462590_exc_T73", "normalized": [] }, { "id": "NCT02462590_exc_R27", "type": "Has_negation", "arg1_id": "NCT02462590_exc_T70", "arg2_id": "NCT02462590_exc_T69", "normalized": [] }, { "id": "NCT02462590_exc_R28", "type": "AND", "arg1_id": "NCT02462590_exc_T76", "arg2_id": "NCT02462590_exc_T77", "normalized": [] } ]

[ { "id": "NCT02462590_inc_text", "type": "inclusion", "text": [ "Adults = 18 years of age\nAdmitted to any ICU and receiving invasive mechanical ventilation\nAnticipated ventilation of =72 hours at the time of screening, as per the ICU physician.\n" ], "offsets": [ [ 0, 180 ] ] } ]

[ { "id": "NCT02462590_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T1", "type": "Value", "text": [ "= 18 years" ], "offsets": [ [ 7, 17 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T3", "type": "Person", "text": [ "Adults" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T4", "type": "Visit", "text": [ "ICU" ], "offsets": [ [ 41, 44 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T5", "type": "Procedure", "text": [ "mechanical ventilation" ], "offsets": [ [ 68, 90 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T6", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 59, 67 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T7", "type": "Temporal", "text": [ "=72 hours" ], "offsets": [ [ 118, 127 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T8", "type": "Procedure", "text": [ "ventilation" ], "offsets": [ [ 103, 114 ] ], "normalized": [] }, { "id": "NCT02462590_inc_T9", "type": "Mood", "text": [ "Anticipated" ], "offsets": [ [ 91, 102 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02462590_inc_R1", "type": "Has_value", "arg1_id": "NCT02462590_inc_T2", "arg2_id": "NCT02462590_inc_T1", "normalized": [] }, { "id": "NCT02462590_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02462590_inc_T5", "arg2_id": "NCT02462590_inc_T6", "normalized": [] }, { "id": "NCT02462590_inc_R3", "type": "Has_mood", "arg1_id": "NCT02462590_inc_T8", "arg2_id": "NCT02462590_inc_T9", "normalized": [] }, { "id": "NCT02462590_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02462590_inc_T8", "arg2_id": "NCT02462590_inc_T7", "normalized": [] } ]

[ { "id": "NCT02464813_exc_text", "type": "exclusion", "text": [ "Other spinal pathology or other associated medical condition\nMajor neurologic developmental delay\nNeed for anterior surgery or for vertebral column resection.\nPreoperative opioid use\nInability to use PCA\n" ], "offsets": [ [ 0, 204 ] ] } ]

[ { "id": "NCT02464813_exc_T1", "type": "Condition", "text": [ "spinal pathology" ], "offsets": [ [ 6, 22 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T2", "type": "Condition", "text": [ "associated medical condition" ], "offsets": [ [ 32, 60 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T3", "type": "Condition", "text": [ "Major neurologic developmental delay" ], "offsets": [ [ 61, 97 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T4", "type": "Procedure", "text": [ "anterior surgery" ], "offsets": [ [ 107, 123 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T5", "type": "Mood", "text": [ "Need for" ], "offsets": [ [ 98, 106 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T6", "type": "Procedure", "text": [ "vertebral column resection" ], "offsets": [ [ 131, 157 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T7", "type": "Temporal", "text": [ "Preoperative" ], "offsets": [ [ 159, 171 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T8", "type": "Drug", "text": [ "opioid" ], "offsets": [ [ 172, 178 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T9", "type": "Condition", "text": [ "Inability to use" ], "offsets": [ [ 183, 199 ] ], "normalized": [] }, { "id": "NCT02464813_exc_T10", "type": "Procedure", "text": [ "PCA" ], "offsets": [ [ 200, 203 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02464813_exc_R1", "type": "Has_mood", "arg1_id": "NCT02464813_exc_T4", "arg2_id": "NCT02464813_exc_T5", "normalized": [] }, { "id": "NCT02464813_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02464813_exc_T8", "arg2_id": "NCT02464813_exc_T7", "normalized": [] }, { "id": "NCT02464813_exc_R3", "type": "AND", "arg1_id": "NCT02464813_exc_T9", "arg2_id": "NCT02464813_exc_T10", "normalized": [] } ]

[ { "id": "NCT02464813_inc_text", "type": "inclusion", "text": [ "Adolescent (10-21 years) undergoing spinal fusion for idiopathic scoliosis, spondylolisthesis or Scheuermann kyphosis.\nPosterior spinal fusion\nNo contraindication for Pregabalin use\nASA I-III\nWritten informed consent\n" ], "offsets": [ [ 0, 217 ] ] } ]

[ { "id": "NCT02464813_inc_T1", "type": "Person", "text": [ "Adolescent" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T2", "type": "Value", "text": [ "10-21 years" ], "offsets": [ [ 12, 23 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 18, 23 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T4", "type": "Scope", "text": [ "10-21 years" ], "offsets": [ [ 12, 23 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T5", "type": "Procedure", "text": [ "spinal fusion" ], "offsets": [ [ 36, 49 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T6", "type": "Condition", "text": [ "idiopathic scoliosis" ], "offsets": [ [ 54, 74 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T7", "type": "Condition", "text": [ "spondylolisthesis" ], "offsets": [ [ 76, 93 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T8", "type": "Condition", "text": [ "Scheuermann kyphosis" ], "offsets": [ [ 97, 117 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T9", "type": "Scope", "text": [ "idiopathic scoliosis, spondylolisthesis or Scheuermann kyphosis" ], "offsets": [ [ 54, 117 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T10", "type": "Procedure", "text": [ "Posterior spinal fusion" ], "offsets": [ [ 119, 142 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T11", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 146, 162 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T12", "type": "Negation", "text": [ "No" ], "offsets": [ [ 143, 145 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T13", "type": "Drug", "text": [ "Pregabalin" ], "offsets": [ [ 167, 177 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T14", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 182, 185 ] ], "normalized": [] }, { "id": "NCT02464813_inc_T15", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 186, 191 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02464813_inc_R1", "type": "Has_value", "arg1_id": "NCT02464813_inc_T3", "arg2_id": "NCT02464813_inc_T2", "normalized": [] }, { "id": "NCT02464813_inc_R2", "type": "Subsumes", "arg1_id": "NCT02464813_inc_T1", "arg2_id": "NCT02464813_inc_T4", "normalized": [] }, { "id": "NCT02464813_inc_R3", "type": "Has_scope", "arg1_id": "NCT02464813_inc_T5", "arg2_id": "NCT02464813_inc_T9", "normalized": [] }, { "id": "NCT02464813_inc_R4", "type": "AND", "arg1_id": "NCT02464813_inc_T11", "arg2_id": "NCT02464813_inc_T13", "normalized": [] }, { "id": "NCT02464813_inc_R5", "type": "Has_negation", "arg1_id": "NCT02464813_inc_T11", "arg2_id": "NCT02464813_inc_T12", "normalized": [] }, { "id": "NCT02464813_inc_R6", "type": "Has_value", "arg1_id": "NCT02464813_inc_T14", "arg2_id": "NCT02464813_inc_T15", "normalized": [] } ]

[ { "id": "NCT02464865_exc_text", "type": "exclusion", "text": [ "pathological obesity\nchronic diseases e.g. cerebral palsy, metabolic disease, etc.\ndiseases of red blood cells\non medication e.g. steroid, multivitamins, thiamine-containing vitamins, diuretic drugs\nhemodialysis or peritoneal dialysis\nbariatric surgery\n" ], "offsets": [ [ 0, 253 ] ] } ]

[ { "id": "NCT02464865_exc_T1", "type": "Condition", "text": [ "pathological obesity" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T2", "type": "Condition", "text": [ "chronic diseases" ], "offsets": [ [ 21, 37 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T3", "type": "Condition", "text": [ "cerebral palsy" ], "offsets": [ [ 43, 57 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T4", "type": "Condition", "text": [ "metabolic disease" ], "offsets": [ [ 59, 76 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T5", "type": "Scope", "text": [ "cerebral palsy, metabolic disease" ], "offsets": [ [ 43, 76 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T6", "type": "Condition", "text": [ "diseases of red blood cells" ], "offsets": [ [ 83, 110 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T7", "type": "Drug", "text": [ "steroid" ], "offsets": [ [ 130, 137 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T8", "type": "Drug", "text": [ "multivitamins" ], "offsets": [ [ 139, 152 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T9", "type": "Drug", "text": [ "thiamine-containing vitamins" ], "offsets": [ [ 154, 182 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T10", "type": "Drug", "text": [ "diuretic drugs" ], "offsets": [ [ 184, 198 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T11", "type": "Procedure", "text": [ "hemodialysis" ], "offsets": [ [ 199, 211 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T12", "type": "Procedure", "text": [ "peritoneal dialysis" ], "offsets": [ [ 215, 234 ] ], "normalized": [] }, { "id": "NCT02464865_exc_T13", "type": "Procedure", "text": [ "bariatric surgery" ], "offsets": [ [ 235, 252 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02464865_exc_R1", "type": "Subsumes", "arg1_id": "NCT02464865_exc_T2", "arg2_id": "NCT02464865_exc_T5", "normalized": [] } ]

[ { "id": "NCT02464865_inc_text", "type": "inclusion", "text": [ "obese : weight for height > median + 3 standard deviations\nsimple obesity\n" ], "offsets": [ [ 0, 74 ] ] } ]

[ { "id": "NCT02464865_inc_T1", "type": "Condition", "text": [ "obese" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02464865_inc_T2", "type": "Measurement", "text": [ "weight for height" ], "offsets": [ [ 8, 25 ] ], "normalized": [] }, { "id": "NCT02464865_inc_T3", "type": "Value", "text": [ "> median + 3 standard deviations" ], "offsets": [ [ 26, 58 ] ], "normalized": [] }, { "id": "NCT02464865_inc_T4", "type": "Scope", "text": [ "weight for height > median + 3 standard deviations" ], "offsets": [ [ 8, 58 ] ], "normalized": [] }, { "id": "NCT02464865_inc_T5", "type": "Condition", "text": [ "simple obesity" ], "offsets": [ [ 59, 73 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02464865_inc_R1", "type": "Has_value", "arg1_id": "NCT02464865_inc_T2", "arg2_id": "NCT02464865_inc_T3", "normalized": [] }, { "id": "NCT02464865_inc_R2", "type": "Subsumes", "arg1_id": "NCT02464865_inc_T1", "arg2_id": "NCT02464865_inc_T4", "normalized": [] } ]

[ { "id": "NCT02466113_exc_text", "type": "exclusion", "text": [ "With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. \nWith bad compliance or contraindication to enrollment. \nPregnant woman or lactating woman. \nWith contraindication to receive adjuvant chemotherapy. \n \n" ], "offsets": [ [ 0, 309 ] ] } ]

[ { "id": "NCT02466113_exc_T1", "type": "Condition", "text": [ "comorbidities" ], "offsets": [ [ 12, 25 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T2", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 5, 11 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T3", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 35, 57 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T5", "type": "Condition", "text": [ "chronic obstructive pulmonary disease" ], "offsets": [ [ 59, 96 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T6", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 98, 115 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T7", "type": "Condition", "text": [ "chronic renal dysfunction" ], "offsets": [ [ 121, 146 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T9", "type": "Scope", "text": [ "cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction" ], "offsets": [ [ 35, 146 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T10", "type": "Scope", "text": [ "severe comorbidities" ], "offsets": [ [ 5, 25 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T11", "type": "Condition", "text": [ "bad compliance" ], "offsets": [ [ 154, 168 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T13", "type": "Condition", "text": [ "contraindication to enrollment" ], "offsets": [ [ 172, 202 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T16", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 205, 213 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T17", "type": "Person", "text": [ "woman" ], "offsets": [ [ 214, 219 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T18", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 223, 232 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T19", "type": "Person", "text": [ "woman" ], "offsets": [ [ 233, 238 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T20", "type": "Scope", "text": [ "lactating woman" ], "offsets": [ [ 223, 238 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T21", "type": "Scope", "text": [ "Pregnant woman" ], "offsets": [ [ 205, 219 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T22", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 246, 262 ] ], "normalized": [] }, { "id": "NCT02466113_exc_T23", "type": "Procedure", "text": [ "adjuvant chemotherapy" ], "offsets": [ [ 274, 295 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02466113_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02466113_exc_T1", "arg2_id": "NCT02466113_exc_T2", "normalized": [] }, { "id": "NCT02466113_exc_R2", "type": "Subsumes", "arg1_id": "NCT02466113_exc_T10", "arg2_id": "NCT02466113_exc_T9", "normalized": [] }, { "id": "NCT02466113_exc_R3", "type": "AND", "arg1_id": "NCT02466113_exc_T22", "arg2_id": "NCT02466113_exc_T23", "normalized": [] } ]

[ { "id": "NCT02466113_inc_text", "type": "inclusion", "text": [ "The informed consent has been obtained from the patient. \nWith confirmed diagnosis of stage II colon cancer. \nWith moderate/good ECOG health rating (PS): 0-1 score. \nThe patient receive no anti-cancer treatment before primary surgery. \nThe patient receive radical operation for colon cancer with negative margin. \n" ], "offsets": [ [ 0, 314 ] ] } ]

[ { "id": "NCT02466113_inc_T3", "type": "Condition", "text": [ "colon cancer" ], "offsets": [ [ 95, 107 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T4", "type": "Qualifier", "text": [ "stage II" ], "offsets": [ [ 86, 94 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T5", "type": "Measurement", "text": [ "ECOG health rating (PS)" ], "offsets": [ [ 129, 152 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T6", "type": "Value", "text": [ "0-1 score" ], "offsets": [ [ 154, 163 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T7", "type": "Value", "text": [ "moderate/good" ], "offsets": [ [ 115, 128 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T8", "type": "Drug", "text": [ "anti-cancer treatment" ], "offsets": [ [ 189, 210 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T9", "type": "Negation", "text": [ "no" ], "offsets": [ [ 186, 188 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T10", "type": "Temporal", "text": [ "before primary surgery" ], "offsets": [ [ 211, 233 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T11", "type": "Procedure", "text": [ "primary surgery" ], "offsets": [ [ 218, 233 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T12", "type": "Reference_point", "text": [ "primary surgery" ], "offsets": [ [ 218, 233 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T13", "type": "Procedure", "text": [ "radical operation", "negative margin" ], "offsets": [ [ 256, 273 ], [ 296, 311 ] ], "normalized": [] }, { "id": "NCT02466113_inc_T14", "type": "Condition", "text": [ "colon cancer" ], "offsets": [ [ 278, 290 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02466113_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02466113_inc_T3", "arg2_id": "NCT02466113_inc_T4", "normalized": [] }, { "id": "NCT02466113_inc_R2", "type": "Subsumes", "arg1_id": "NCT02466113_inc_T7", "arg2_id": "NCT02466113_inc_T6", "normalized": [] }, { "id": "NCT02466113_inc_R3", "type": "Has_value", "arg1_id": "NCT02466113_inc_T5", "arg2_id": "NCT02466113_inc_T7", "normalized": [] }, { "id": "NCT02466113_inc_R4", "type": "Has_index", "arg1_id": "NCT02466113_inc_T10", "arg2_id": "NCT02466113_inc_T12", "normalized": [] }, { "id": "NCT02466113_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02466113_inc_T8", "arg2_id": "NCT02466113_inc_T10", "normalized": [] }, { "id": "NCT02466113_inc_R6", "type": "Has_negation", "arg1_id": "NCT02466113_inc_T8", "arg2_id": "NCT02466113_inc_T9", "normalized": [] }, { "id": "NCT02466113_inc_R7", "type": "AND", "arg1_id": "NCT02466113_inc_T13", "arg2_id": "NCT02466113_inc_T14", "normalized": [] } ]

[ { "id": "NCT02467686_exc_text", "type": "exclusion", "text": [ "Women did not have breast cancer\ndo not use tamoxifen or aromatase inhibitor\nnot in menopause and not have hot flashes\n" ], "offsets": [ [ 0, 119 ] ] } ]

[ { "id": "NCT02467686_exc_T1", "type": "Negation", "text": [ "not" ], "offsets": [ [ 10, 13 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T2", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 19, 32 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T3", "type": "Drug", "text": [ "tamoxifen" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T4", "type": "Drug", "text": [ "aromatase inhibitor" ], "offsets": [ [ 57, 76 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T5", "type": "Negation", "text": [ "not" ], "offsets": [ [ 36, 39 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T6", "type": "Scope", "text": [ "tamoxifen or aromatase inhibitor" ], "offsets": [ [ 44, 76 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T7", "type": "Negation", "text": [ "not" ], "offsets": [ [ 77, 80 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T8", "type": "Condition", "text": [ "menopause" ], "offsets": [ [ 84, 93 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T9", "type": "Negation", "text": [ "not" ], "offsets": [ [ 98, 101 ] ], "normalized": [] }, { "id": "NCT02467686_exc_T10", "type": "Condition", "text": [ "hot flashes" ], "offsets": [ [ 107, 118 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02467686_exc_R1", "type": "Has_negation", "arg1_id": "NCT02467686_exc_T2", "arg2_id": "NCT02467686_exc_T1", "normalized": [] }, { "id": "NCT02467686_exc_R2", "type": "Has_negation", "arg1_id": "NCT02467686_exc_T6", "arg2_id": "NCT02467686_exc_T5", "normalized": [] }, { "id": "NCT02467686_exc_R3", "type": "Has_negation", "arg1_id": "NCT02467686_exc_T10", "arg2_id": "NCT02467686_exc_T9", "normalized": [] }, { "id": "NCT02467686_exc_R4", "type": "Has_negation", "arg1_id": "NCT02467686_exc_T8", "arg2_id": "NCT02467686_exc_T7", "normalized": [] } ]

[ { "id": "NCT02467686_inc_text", "type": "inclusion", "text": [ "Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.\nWith hot flashes and with or without active sexual life.\n" ], "offsets": [ [ 0, 145 ] ] } ]

[ { "id": "NCT02467686_inc_T1", "type": "Condition", "text": [ "Menopausal" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 11, 16 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T3", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 22, 35 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T4", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 36, 43 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T5", "type": "Drug", "text": [ "tamoxifen" ], "offsets": [ [ 54, 63 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T6", "type": "Drug", "text": [ "aromatase inhibitor" ], "offsets": [ [ 67, 86 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T7", "type": "Scope", "text": [ "tamoxifen or aromatase inhibitor" ], "offsets": [ [ 54, 86 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T8", "type": "Condition", "text": [ "hot flashes" ], "offsets": [ [ 93, 104 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T9", "type": "Observation", "text": [ "without active sexual life" ], "offsets": [ [ 117, 143 ] ], "normalized": [] }, { "id": "NCT02467686_inc_T10", "type": "Observation", "text": [ "ith", "ctive sexual life." ], "offsets": [ [ 110, 113 ], [ 126, 144 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02467686_inc_R1", "type": "Has_scope", "arg1_id": "NCT02467686_inc_T4", "arg2_id": "NCT02467686_inc_T7", "normalized": [] } ]

[ { "id": "NCT02469610_exc_text", "type": "exclusion", "text": [ "Previous thoracic operation in the same side.\n" ], "offsets": [ [ 0, 46 ] ] } ]

[ { "id": "NCT02469610_exc_T1", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02469610_exc_T2", "type": "Procedure", "text": [ "thoracic operation" ], "offsets": [ [ 9, 27 ] ], "normalized": [] }, { "id": "NCT02469610_exc_T3", "type": "Qualifier", "text": [ "same side" ], "offsets": [ [ 35, 44 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02469610_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02469610_exc_T2", "arg2_id": "NCT02469610_exc_T3", "normalized": [] }, { "id": "NCT02469610_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02469610_exc_T2", "arg2_id": "NCT02469610_exc_T1", "normalized": [] } ]

[ { "id": "NCT02469610_inc_text", "type": "inclusion", "text": [ "Thoracoscopic surgery candidate.\nOver 18 years old.\nNo known allergy to Bupivacaine.\nPatient is able to read understand and singe an inform consent.\n" ], "offsets": [ [ 0, 149 ] ] } ]

[ { "id": "NCT02469610_inc_T1", "type": "Procedure", "text": [ "Thoracoscopic surgery" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T2", "type": "Mood", "text": [ "candidate" ], "offsets": [ [ 22, 31 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T3", "type": "Value", "text": [ "Over 18 years old" ], "offsets": [ [ 33, 50 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T4", "type": "Person", "text": [ "old" ], "offsets": [ [ 47, 50 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T5", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 61, 68 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T6", "type": "Drug", "text": [ "Bupivacaine" ], "offsets": [ [ 72, 83 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T7", "type": "Negation", "text": [ "No" ], "offsets": [ [ 52, 54 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T8", "type": "Observation", "text": [ "able to read" ], "offsets": [ [ 96, 108 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T9", "type": "Observation", "text": [ "understand" ], "offsets": [ [ 109, 119 ] ], "normalized": [] }, { "id": "NCT02469610_inc_T10", "type": "Observation", "text": [ "singe" ], "offsets": [ [ 124, 129 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02469610_inc_R1", "type": "Has_mood", "arg1_id": "NCT02469610_inc_T1", "arg2_id": "NCT02469610_inc_T2", "normalized": [] }, { "id": "NCT02469610_inc_R2", "type": "Has_value", "arg1_id": "NCT02469610_inc_T4", "arg2_id": "NCT02469610_inc_T3", "normalized": [] }, { "id": "NCT02469610_inc_R3", "type": "AND", "arg1_id": "NCT02469610_inc_T5", "arg2_id": "NCT02469610_inc_T6", "normalized": [] }, { "id": "NCT02469610_inc_R4", "type": "Has_negation", "arg1_id": "NCT02469610_inc_T5", "arg2_id": "NCT02469610_inc_T7", "normalized": [] } ]

[ { "id": "NCT02473809_exc_text", "type": "exclusion", "text": [ "Type 1 diabetes\nTreatment with insulin\nBody weight > 140 kg\nHbA1c > 75 mmol/mol\nTreatment with GLP-1 analogues, Dipeptidyl peptidase-4 inhibitors, or glitazones\nChronic kidney disease\nHepatic disease\nPancreatitis\nInflammatory bowel disease\nOsteoporosis\nFamily or personal history of medullary thyroid carcinoma\nTreatment with glucocorticoids\nHormone replacement therapy\nDiabetic gastroparesis\nPregnancy or lactation\n" ], "offsets": [ [ 0, 416 ] ] } ]

[ { "id": "NCT02473809_exc_T1", "type": "Condition", "text": [ "Type 1 diabetes" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T2", "type": "Drug", "text": [ "insulin" ], "offsets": [ [ 31, 38 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T3", "type": "Procedure", "text": [ "Treatment" ], "offsets": [ [ 16, 25 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T4", "type": "Measurement", "text": [ "Body weight" ], "offsets": [ [ 39, 50 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T5", "type": "Value", "text": [ "> 140 kg" ], "offsets": [ [ 51, 59 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T6", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 60, 65 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T7", "type": "Value", "text": [ "> 75 mmol/mol" ], "offsets": [ [ 66, 79 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T8", "type": "Drug", "text": [ "GLP-1 analogues" ], "offsets": [ [ 95, 110 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T9", "type": "Drug", "text": [ "Dipeptidyl peptidase-4 inhibitors" ], "offsets": [ [ 112, 145 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T10", "type": "Drug", "text": [ "glitazones" ], "offsets": [ [ 150, 160 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T11", "type": "Condition", "text": [ "Pancreatitis" ], "offsets": [ [ 200, 212 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T12", "type": "Condition", "text": [ "Chronic kidney disease" ], "offsets": [ [ 161, 183 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T13", "type": "Condition", "text": [ "Hepatic disease" ], "offsets": [ [ 184, 199 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T14", "type": "Condition", "text": [ "Inflammatory bowel disease" ], "offsets": [ [ 213, 239 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T15", "type": "Condition", "text": [ "Osteoporosis" ], "offsets": [ [ 240, 252 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T16", "type": "Condition", "text": [ "medullary thyroid carcinoma" ], "offsets": [ [ 283, 310 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T17", "type": "Observation", "text": [ "personal history" ], "offsets": [ [ 263, 279 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T18", "type": "Observation", "text": [ "Family" ], "offsets": [ [ 253, 259 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T19", "type": "Scope", "text": [ "Family or personal history" ], "offsets": [ [ 253, 279 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T20", "type": "Drug", "text": [ "glucocorticoids" ], "offsets": [ [ 326, 341 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T21", "type": "Procedure", "text": [ "Treatment" ], "offsets": [ [ 311, 320 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T22", "type": "Procedure", "text": [ "Hormone replacement therapy" ], "offsets": [ [ 342, 369 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T23", "type": "Condition", "text": [ "Diabetic gastroparesis" ], "offsets": [ [ 370, 392 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T24", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 393, 402 ] ], "normalized": [] }, { "id": "NCT02473809_exc_T25", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 406, 415 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02473809_exc_R1", "type": "AND", "arg1_id": "NCT02473809_exc_T3", "arg2_id": "NCT02473809_exc_T2", "normalized": [] }, { "id": "NCT02473809_exc_R2", "type": "Has_value", "arg1_id": "NCT02473809_exc_T4", "arg2_id": "NCT02473809_exc_T5", "normalized": [] }, { "id": "NCT02473809_exc_R3", "type": "Has_value", "arg1_id": "NCT02473809_exc_T6", "arg2_id": "NCT02473809_exc_T7", "normalized": [] }, { "id": "NCT02473809_exc_R4", "type": "AND", "arg1_id": "NCT02473809_exc_T21", "arg2_id": "NCT02473809_exc_T20", "normalized": [] }, { "id": "NCT02473809_exc_R5", "type": "Has_scope", "arg1_id": "NCT02473809_exc_T16", "arg2_id": "NCT02473809_exc_T19", "normalized": [] } ]

[ { "id": "NCT02473809_inc_text", "type": "inclusion", "text": [ "Informed consent\nDiagnosis of type 2 diabetes (HbA1c > 48 mmol/mol)\nAge older than 30 years\n" ], "offsets": [ [ 0, 92 ] ] } ]

[ { "id": "NCT02473809_inc_T2", "type": "Condition", "text": [ "type 2 diabetes" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT02473809_inc_T3", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 47, 52 ] ], "normalized": [] }, { "id": "NCT02473809_inc_T4", "type": "Value", "text": [ "> 48 mmol/mol" ], "offsets": [ [ 53, 66 ] ], "normalized": [] }, { "id": "NCT02473809_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 68, 71 ] ], "normalized": [] }, { "id": "NCT02473809_inc_T6", "type": "Value", "text": [ "older than 30 years" ], "offsets": [ [ 72, 91 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02473809_inc_R1", "type": "Has_value", "arg1_id": "NCT02473809_inc_T3", "arg2_id": "NCT02473809_inc_T4", "normalized": [] }, { "id": "NCT02473809_inc_R2", "type": "Has_value", "arg1_id": "NCT02473809_inc_T5", "arg2_id": "NCT02473809_inc_T6", "normalized": [] } ]

[ { "id": "NCT02476461_exc_text", "type": "exclusion", "text": [ "previous treated dupuytrens contracture same hand\nmore than tree fingers involvement\nwe will not include thumbs\nother things affecting hand function\nASA>3\nexpected to live under five years\nTetracycline treatment within two weeks\npregnancy\nnursing\nallergy to clostridium histolyticum\nparticipant in other trial\n" ], "offsets": [ [ 0, 310 ] ] } ]

[ { "id": "NCT02476461_exc_T1", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T2", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T3", "type": "Condition", "text": [ "dupuytrens contracture" ], "offsets": [ [ 17, 39 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T4", "type": "Qualifier", "text": [ "same hand" ], "offsets": [ [ 40, 49 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T5", "type": "Multiplier", "text": [ "more than tree" ], "offsets": [ [ 50, 64 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T6", "type": "Condition", "text": [ "fingers involvement" ], "offsets": [ [ 65, 84 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T8", "type": "Condition", "text": [ "other things" ], "offsets": [ [ 112, 124 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T9", "type": "Qualifier", "text": [ "affecting hand function" ], "offsets": [ [ 125, 148 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T10", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 149, 152 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T11", "type": "Value", "text": [ ">3" ], "offsets": [ [ 152, 154 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T12", "type": "Observation", "text": [ "expected to live" ], "offsets": [ [ 155, 171 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T13", "type": "Value", "text": [ "under five years" ], "offsets": [ [ 172, 188 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T14", "type": "Drug", "text": [ "Tetracycline" ], "offsets": [ [ 189, 201 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T15", "type": "Temporal", "text": [ "within two weeks" ], "offsets": [ [ 212, 228 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T16", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 229, 238 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T17", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 239, 246 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T18", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 247, 254 ] ], "normalized": [] }, { "id": "NCT02476461_exc_T19", "type": "Observation", "text": [ "clostridium histolyticum" ], "offsets": [ [ 258, 282 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02476461_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02476461_exc_T3", "arg2_id": "NCT02476461_exc_T4", "normalized": [] }, { "id": "NCT02476461_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02476461_exc_T3", "arg2_id": "NCT02476461_exc_T2", "normalized": [] }, { "id": "NCT02476461_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02476461_exc_T3", "arg2_id": "NCT02476461_exc_T1", "normalized": [] }, { "id": "NCT02476461_exc_R4", "type": "Has_multiplier", "arg1_id": "NCT02476461_exc_T6", "arg2_id": "NCT02476461_exc_T5", "normalized": [] }, { "id": "NCT02476461_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02476461_exc_T8", "arg2_id": "NCT02476461_exc_T9", "normalized": [] }, { "id": "NCT02476461_exc_R6", "type": "Has_value", "arg1_id": "NCT02476461_exc_T10", "arg2_id": "NCT02476461_exc_T11", "normalized": [] }, { "id": "NCT02476461_exc_R7", "type": "Has_value", "arg1_id": "NCT02476461_exc_T12", "arg2_id": "NCT02476461_exc_T13", "normalized": [] }, { "id": "NCT02476461_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02476461_exc_T14", "arg2_id": "NCT02476461_exc_T15", "normalized": [] } ]

[ { "id": "NCT02476461_inc_text", "type": "inclusion", "text": [ "symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees\n" ], "offsets": [ [ 0, 109 ] ] } ]

[ { "id": "NCT02476461_inc_T1", "type": "Condition", "text": [ "Dupuytrens contracture" ], "offsets": [ [ 12, 34 ] ], "normalized": [] }, { "id": "NCT02476461_inc_T2", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT02476461_inc_T3", "type": "Condition", "text": [ "palpable cord" ], "offsets": [ [ 40, 53 ] ], "normalized": [] }, { "id": "NCT02476461_inc_T4", "type": "Qualifier", "text": [ "involving MCP" ], "offsets": [ [ 55, 68 ] ], "normalized": [] }, { "id": "NCT02476461_inc_T5", "type": "Measurement", "text": [ "total contracture size" ], "offsets": [ [ 70, 92 ] ], "normalized": [] }, { "id": "NCT02476461_inc_T6", "type": "Value", "text": [ "over 30 degrees" ], "offsets": [ [ 93, 108 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02476461_inc_R1", "type": "Has_value", "arg1_id": "NCT02476461_inc_T5", "arg2_id": "NCT02476461_inc_T6", "normalized": [] }, { "id": "NCT02476461_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02476461_inc_T1", "arg2_id": "NCT02476461_inc_T2", "normalized": [] }, { "id": "NCT02476461_inc_R3", "type": "AND", "arg1_id": "NCT02476461_inc_T1", "arg2_id": "NCT02476461_inc_T3", "normalized": [] }, { "id": "NCT02476461_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02476461_inc_T1", "arg2_id": "NCT02476461_inc_T4", "normalized": [] }, { "id": "NCT02476461_inc_R5", "type": "AND", "arg1_id": "NCT02476461_inc_T1", "arg2_id": "NCT02476461_inc_T5", "normalized": [] } ]

[ { "id": "NCT02477280_exc_text", "type": "exclusion", "text": [ "Affected by alcohol or drugs during the last month.\nUntreated severe comorbid psychiatric or somatic illness.\nBloodpressure 150/95 or higher.\nIrregular pulse, or pulse 100 or higher.\nNo counter indications according to the Medikinet pill.\nConcurrent clinical diagnosis that significantly could affect test performance.\nConcurrent prescription of medicines for ADHD or medicines that significantly could affect test performance.\n" ], "offsets": [ [ 0, 428 ] ] } ]

[ { "id": "NCT02477280_exc_T1", "type": "Observation", "text": [ "alcohol" ], "offsets": [ [ 12, 19 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T2", "type": "Observation", "text": [ "drugs" ], "offsets": [ [ 23, 28 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T3", "type": "Temporal", "text": [ "last month" ], "offsets": [ [ 40, 50 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T4", "type": "Scope", "text": [ "alcohol or drugs" ], "offsets": [ [ 12, 28 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T5", "type": "Condition", "text": [ "llness.", "sychiatric" ], "offsets": [ [ 102, 109 ], [ 79, 89 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T6", "type": "Condition", "text": [ "somatic illness" ], "offsets": [ [ 93, 108 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T7", "type": "Qualifier", "text": [ "Untreated" ], "offsets": [ [ 52, 61 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T8", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 62, 68 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T9", "type": "Qualifier", "text": [ "comorbid" ], "offsets": [ [ 69, 77 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T10", "type": "Scope", "text": [ "Untreated severe comorbid" ], "offsets": [ [ 52, 77 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T11", "type": "Scope", "text": [ "psychiatric or somatic illness" ], "offsets": [ [ 78, 108 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T12", "type": "Measurement", "text": [ "Bloodpressure" ], "offsets": [ [ 110, 123 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T13", "type": "Value", "text": [ "150/95 or higher" ], "offsets": [ [ 124, 140 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T14", "type": "Measurement", "text": [ "pulse" ], "offsets": [ [ 152, 157 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T15", "type": "Value", "text": [ "Irregular" ], "offsets": [ [ 142, 151 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T16", "type": "Measurement", "text": [ "pulse" ], "offsets": [ [ 162, 167 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T17", "type": "Value", "text": [ "100 or higher" ], "offsets": [ [ 168, 181 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T20", "type": "Drug", "text": [ "medicines" ], "offsets": [ [ 346, 355 ] ], "normalized": [] }, { "id": "NCT02477280_exc_T21", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 360, 364 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02477280_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02477280_exc_T4", "arg2_id": "NCT02477280_exc_T3", "normalized": [] }, { "id": "NCT02477280_exc_R2", "type": "Has_scope", "arg1_id": "NCT02477280_exc_T11", "arg2_id": "NCT02477280_exc_T10", "normalized": [] }, { "id": "NCT02477280_exc_R3", "type": "Has_value", "arg1_id": "NCT02477280_exc_T12", "arg2_id": "NCT02477280_exc_T13", "normalized": [] }, { "id": "NCT02477280_exc_R4", "type": "Has_value", "arg1_id": "NCT02477280_exc_T14", "arg2_id": "NCT02477280_exc_T15", "normalized": [] }, { "id": "NCT02477280_exc_R5", "type": "Has_value", "arg1_id": "NCT02477280_exc_T16", "arg2_id": "NCT02477280_exc_T17", "normalized": [] }, { "id": "NCT02477280_exc_R6", "type": "AND", "arg1_id": "NCT02477280_exc_T20", "arg2_id": "NCT02477280_exc_T21", "normalized": [] } ]

[ { "id": "NCT02477280_inc_text", "type": "inclusion", "text": [ "18 years old or older.\nADHD is diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5 criteria).\nSubstance Use Disorder is diagnosed according to DSM-5 criteria.\nQb-score 1.3 or higher on at least one of the weighted summary parameters QbActivity, QbInattention or QbImpulsivity on the QbTest.\nParticipants are given their written informed consent to participate in the study.\n" ], "offsets": [ [ 0, 421 ] ] } ]

[ { "id": "NCT02477280_inc_T1", "type": "Person", "text": [ "old" ], "offsets": [ [ 9, 12 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T2", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 0, 8 ], [ 13, 21 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T3", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 23, 27 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T4", "type": "Qualifier", "text": [ "DSM-5" ], "offsets": [ [ 124, 129 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T5", "type": "Condition", "text": [ "Substance Use Disorder" ], "offsets": [ [ 141, 163 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T6", "type": "Qualifier", "text": [ "DSM-5" ], "offsets": [ [ 190, 195 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T7", "type": "Measurement", "text": [ "Qb-score" ], "offsets": [ [ 206, 214 ] ], "normalized": [] }, { "id": "NCT02477280_inc_T8", "type": "Value", "text": [ "1.3 or higher" ], "offsets": [ [ 215, 228 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02477280_inc_R1", "type": "Has_value", "arg1_id": "NCT02477280_inc_T1", "arg2_id": "NCT02477280_inc_T2", "normalized": [] }, { "id": "NCT02477280_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02477280_inc_T3", "arg2_id": "NCT02477280_inc_T4", "normalized": [] }, { "id": "NCT02477280_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02477280_inc_T5", "arg2_id": "NCT02477280_inc_T6", "normalized": [] }, { "id": "NCT02477280_inc_R4", "type": "Has_value", "arg1_id": "NCT02477280_inc_T7", "arg2_id": "NCT02477280_inc_T8", "normalized": [] } ]

[ { "id": "NCT02478346_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02478346_inc_text", "type": "inclusion", "text": [ "Adult patients (age = 18)\nDiagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.\nThe patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein\nPatient or legally authorized representative provides written informed consent to enroll in this study\n" ], "offsets": [ [ 0, 475 ] ] } ]

[ { "id": "NCT02478346_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T3", "type": "Value", "text": [ "= 18" ], "offsets": [ [ 20, 24 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T4", "type": "Scope", "text": [ "age = 18" ], "offsets": [ [ 16, 24 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T5", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 39, 51 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T6", "type": "Procedure", "text": [ "imaging modalities" ], "offsets": [ [ 52, 70 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T7", "type": "Condition", "text": [ "brain tumor" ], "offsets": [ [ 81, 92 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T8", "type": "Condition", "text": [ "metastatic brain tumors" ], "offsets": [ [ 104, 127 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T9", "type": "Condition", "text": [ "vascular lesions" ], "offsets": [ [ 132, 148 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T10", "type": "Condition", "text": [ "aneurysm" ], "offsets": [ [ 150, 158 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T11", "type": "Condition", "text": [ "arteriovenous malformation" ], "offsets": [ [ 160, 186 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T12", "type": "Condition", "text": [ "arteriovenous fistula" ], "offsets": [ [ 190, 211 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T13", "type": "Procedure", "text": [ "surgical intervention" ], "offsets": [ [ 223, 244 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T14", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 316, 321 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T15", "type": "Condition", "text": [ "vascular lesion" ], "offsets": [ [ 325, 340 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T16", "type": "Qualifier", "text": [ "would take up fluorescein" ], "offsets": [ [ 346, 371 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T17", "type": "Drug", "text": [ "fluorescein" ], "offsets": [ [ 360, 371 ] ], "normalized": [] }, { "id": "NCT02478346_inc_T18", "type": "Scope", "text": [ "tumor or vascular lesion" ], "offsets": [ [ 316, 340 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02478346_inc_R1", "type": "Has_value", "arg1_id": "NCT02478346_inc_T2", "arg2_id": "NCT02478346_inc_T3", "normalized": [] }, { "id": "NCT02478346_inc_R2", "type": "Subsumes", "arg1_id": "NCT02478346_inc_T1", "arg2_id": "NCT02478346_inc_T4", "normalized": [] }, { "id": "NCT02478346_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02478346_inc_T6", "arg2_id": "NCT02478346_inc_T5", "normalized": [] }, { "id": "NCT02478346_inc_R4", "type": "AND", "arg1_id": "NCT02478346_inc_T7", "arg2_id": "NCT02478346_inc_T6", "normalized": [] }, { "id": "NCT02478346_inc_R5", "type": "Subsumes", "arg1_id": "NCT02478346_inc_T7", "arg2_id": "NCT02478346_inc_T8", "normalized": [] }, { "id": "NCT02478346_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02478346_inc_T18", "arg2_id": "NCT02478346_inc_T16", "normalized": [] } ]

[ { "id": "NCT02478515_exc_text", "type": "exclusion", "text": [ "Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)\nHistory of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO\nOcular disorders in the study eye that may confound interpretation of study results\nBCVA over 77 letters between screening and Day 0\nThe pregnant or lactating woman\n" ], "offsets": [ [ 0, 356 ] ] } ]

[ { "id": "NCT02478515_exc_T1", "type": "Drug", "text": [ "anti-VEGF drugs" ], "offsets": [ [ 24, 39 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T2", "type": "Drug", "text": [ "corticosteroid" ], "offsets": [ [ 43, 57 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T3", "type": "Procedure", "text": [ "grid laser photocoagulation (" ], "offsets": [ [ 61, 90 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T4", "type": "Procedure", "text": [ "vitrectomy surgery" ], "offsets": [ [ 112, 130 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T5", "type": "Procedure", "text": [ "submacular surgery" ], "offsets": [ [ 132, 150 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T6", "type": "Procedure", "text": [ "surgical intervention" ], "offsets": [ [ 161, 182 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T7", "type": "Condition", "text": [ "RVO" ], "offsets": [ [ 187, 190 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T9", "type": "Measurement", "text": [ "BCVA" ], "offsets": [ [ 275, 279 ] ], "normalized": [] }, { "id": "NCT02478515_exc_T10", "type": "Value", "text": [ "over 77 letters" ], "offsets": [ [ 280, 295 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02478515_exc_R1", "type": "AND", "arg1_id": "NCT02478515_exc_T6", "arg2_id": "NCT02478515_exc_T7", "normalized": [] }, { "id": "NCT02478515_exc_R2", "type": "Has_value", "arg1_id": "NCT02478515_exc_T9", "arg2_id": "NCT02478515_exc_T10", "normalized": [] } ]

[ { "id": "NCT02478515_inc_text", "type": "inclusion", "text": [ "Signed informed consent form\nMacula edema secondary to BRVO\nBCVA of 77 to 20 letters assessed with the use of ETDRS charts\nCRT <U+2267>250µm\n" ], "offsets": [ [ 0, 141 ] ] } ]

[ { "id": "NCT02478515_inc_T2", "type": "Condition", "text": [ "Macula edema" ], "offsets": [ [ 29, 41 ] ], "normalized": [] }, { "id": "NCT02478515_inc_T3", "type": "Condition", "text": [ "BRVO" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT02478515_inc_T4", "type": "Measurement", "text": [ "BCVA" ], "offsets": [ [ 60, 64 ] ], "normalized": [] }, { "id": "NCT02478515_inc_T5", "type": "Value", "text": [ "77 to 20 letters" ], "offsets": [ [ 68, 84 ] ], "normalized": [] }, { "id": "NCT02478515_inc_T6", "type": "Measurement", "text": [ "CRT" ], "offsets": [ [ 123, 126 ] ], "normalized": [] }, { "id": "NCT02478515_inc_T7", "type": "Value", "text": [ "250µm" ], "offsets": [ [ 135, 140 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02478515_inc_R1", "type": "AND", "arg1_id": "NCT02478515_inc_T2", "arg2_id": "NCT02478515_inc_T3", "normalized": [] }, { "id": "NCT02478515_inc_R2", "type": "Has_value", "arg1_id": "NCT02478515_inc_T4", "arg2_id": "NCT02478515_inc_T5", "normalized": [] }, { "id": "NCT02478515_inc_R3", "type": "Has_value", "arg1_id": "NCT02478515_inc_T6", "arg2_id": "NCT02478515_inc_T7", "normalized": [] } ]

[ { "id": "NCT02481518_exc_text", "type": "exclusion", "text": [ "Prior treatment with cisplatin before randomization\nUncontrolled concurrent disease\nPregnancy\n" ], "offsets": [ [ 0, 94 ] ] } ]

[ { "id": "NCT02481518_exc_T1", "type": "Drug", "text": [ "cisplatin" ], "offsets": [ [ 21, 30 ] ], "normalized": [] }, { "id": "NCT02481518_exc_T2", "type": "Temporal", "text": [ "before randomization" ], "offsets": [ [ 31, 51 ] ], "normalized": [] }, { "id": "NCT02481518_exc_T3", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 38, 51 ] ], "normalized": [] }, { "id": "NCT02481518_exc_T4", "type": "Condition", "text": [ "concurrent disease" ], "offsets": [ [ 65, 83 ] ], "normalized": [] }, { "id": "NCT02481518_exc_T5", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 52, 64 ] ], "normalized": [] }, { "id": "NCT02481518_exc_T6", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 84, 93 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02481518_exc_R1", "type": "Has_index", "arg1_id": "NCT02481518_exc_T2", "arg2_id": "NCT02481518_exc_T3", "normalized": [] }, { "id": "NCT02481518_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02481518_exc_T1", "arg2_id": "NCT02481518_exc_T2", "normalized": [] }, { "id": "NCT02481518_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02481518_exc_T4", "arg2_id": "NCT02481518_exc_T5", "normalized": [] } ]

[ { "id": "NCT02481518_inc_text", "type": "inclusion", "text": [ "Age > 18 years\nEastern Cooperative Oncology Group score 0-2\nFirst Diagnosed Head and neck cancer and plan for treatment with cisplatin\nSerum creatinine =1.5 mg/dl or eGFR=60(ml/min/1.73 m2)\n" ], "offsets": [ [ 0, 190 ] ] } ]

[ { "id": "NCT02481518_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T2", "type": "Value", "text": [ "> 18 years" ], "offsets": [ [ 4, 14 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T3", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group" ], "offsets": [ [ 15, 49 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T4", "type": "Value", "text": [ "score 0-2" ], "offsets": [ [ 50, 59 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T5", "type": "Condition", "text": [ "Head and neck cancer" ], "offsets": [ [ 76, 96 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T6", "type": "Mood", "text": [ "plan" ], "offsets": [ [ 101, 105 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T7", "type": "Drug", "text": [ "cisplatin" ], "offsets": [ [ 125, 134 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T8", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 135, 151 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T9", "type": "Value", "text": [ "=1.5 mg/dl" ], "offsets": [ [ 152, 162 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T10", "type": "Measurement", "text": [ "eGFR" ], "offsets": [ [ 166, 170 ] ], "normalized": [] }, { "id": "NCT02481518_inc_T11", "type": "Value", "text": [ "=60(ml/min/1.73 m2)" ], "offsets": [ [ 170, 189 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02481518_inc_R1", "type": "Has_value", "arg1_id": "NCT02481518_inc_T1", "arg2_id": "NCT02481518_inc_T2", "normalized": [] }, { "id": "NCT02481518_inc_R2", "type": "Has_value", "arg1_id": "NCT02481518_inc_T3", "arg2_id": "NCT02481518_inc_T4", "normalized": [] }, { "id": "NCT02481518_inc_R3", "type": "Has_mood", "arg1_id": "NCT02481518_inc_T7", "arg2_id": "NCT02481518_inc_T6", "normalized": [] }, { "id": "NCT02481518_inc_R4", "type": "AND", "arg1_id": "NCT02481518_inc_T5", "arg2_id": "NCT02481518_inc_T7", "normalized": [] }, { "id": "NCT02481518_inc_R5", "type": "Has_value", "arg1_id": "NCT02481518_inc_T10", "arg2_id": "NCT02481518_inc_T11", "normalized": [] }, { "id": "NCT02481518_inc_R6", "type": "Has_value", "arg1_id": "NCT02481518_inc_T8", "arg2_id": "NCT02481518_inc_T9", "normalized": [] } ]

[ { "id": "NCT02483715_exc_text", "type": "exclusion", "text": [ "pregnant or nursing woman\nserious concomitant illness and malignant tumor of any kind\nhistory of hypersensitivity to test drugs\nserious bleeding during the course of the ulcer\nprevious gastric surgery\nreceiving bismuth salts, PPIs, or antibiotics in the previous month.\n" ], "offsets": [ [ 0, 270 ] ] } ]

[ { "id": "NCT02483715_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T2", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 12, 19 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T3", "type": "Person", "text": [ "woman" ], "offsets": [ [ 20, 25 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T4", "type": "Scope", "text": [ "pregnant or nursing" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T5", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 46, 53 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T6", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 34, 45 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T7", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 26, 33 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T8", "type": "Condition", "text": [ "malignant tumor" ], "offsets": [ [ 58, 73 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T9", "type": "Qualifier", "text": [ "any kind" ], "offsets": [ [ 77, 85 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T10", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 86, 96 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T11", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 97, 113 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T12", "type": "Drug", "text": [ "test drugs" ], "offsets": [ [ 117, 127 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T13", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 128, 135 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T14", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 136, 144 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T15", "type": "Temporal", "text": [ "during the course of the ulcer" ], "offsets": [ [ 145, 175 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T16", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 176, 184 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T17", "type": "Procedure", "text": [ "gastric surgery" ], "offsets": [ [ 185, 200 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T18", "type": "Drug", "text": [ "bismuth salts" ], "offsets": [ [ 211, 224 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T19", "type": "Drug", "text": [ "PPIs" ], "offsets": [ [ 226, 230 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T20", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 235, 246 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T21", "type": "Temporal", "text": [ "in the previous month" ], "offsets": [ [ 247, 268 ] ], "normalized": [] }, { "id": "NCT02483715_exc_T22", "type": "Scope", "text": [ "bismuth salts, PPIs, or antibiotics" ], "offsets": [ [ 211, 246 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02483715_exc_R1", "type": "Has_scope", "arg1_id": "NCT02483715_exc_T3", "arg2_id": "NCT02483715_exc_T4", "normalized": [] }, { "id": "NCT02483715_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02483715_exc_T5", "arg2_id": "NCT02483715_exc_T7", "normalized": [] }, { "id": "NCT02483715_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02483715_exc_T5", "arg2_id": "NCT02483715_exc_T6", "normalized": [] }, { "id": "NCT02483715_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02483715_exc_T8", "arg2_id": "NCT02483715_exc_T9", "normalized": [] }, { "id": "NCT02483715_exc_R5", "type": "AND", "arg1_id": "NCT02483715_exc_T11", "arg2_id": "NCT02483715_exc_T12", "normalized": [] }, { "id": "NCT02483715_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02483715_exc_T11", "arg2_id": "NCT02483715_exc_T10", "normalized": [] }, { "id": "NCT02483715_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02483715_exc_T14", "arg2_id": "NCT02483715_exc_T13", "normalized": [] }, { "id": "NCT02483715_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02483715_exc_T14", "arg2_id": "NCT02483715_exc_T15", "normalized": [] }, { "id": "NCT02483715_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02483715_exc_T17", "arg2_id": "NCT02483715_exc_T16", "normalized": [] }, { "id": "NCT02483715_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02483715_exc_T22", "arg2_id": "NCT02483715_exc_T21", "normalized": [] } ]

[ { "id": "NCT02483715_inc_text", "type": "inclusion", "text": [ "Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.\n" ], "offsets": [ [ 0, 171 ] ] } ]

[ { "id": "NCT02483715_inc_T1", "type": "Qualifier", "text": [ "H. pylori related" ], "offsets": [ [ 20, 37 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T2", "type": "Condition", "text": [ "chronic gastritis" ], "offsets": [ [ 38, 55 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T3", "type": "Condition", "text": [ "peptic ulcers" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 91, 95 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T5", "type": "Value", "text": [ "greater than 20 years old" ], "offsets": [ [ 96, 121 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T6", "type": "Procedure", "text": [ "eradication therapy" ], "offsets": [ [ 150, 169 ] ], "normalized": [] }, { "id": "NCT02483715_inc_T7", "type": "Mood", "text": [ "willing to receive" ], "offsets": [ [ 130, 148 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02483715_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02483715_inc_T2", "arg2_id": "NCT02483715_inc_T1", "normalized": [] }, { "id": "NCT02483715_inc_R2", "type": "Has_value", "arg1_id": "NCT02483715_inc_T4", "arg2_id": "NCT02483715_inc_T5", "normalized": [] }, { "id": "NCT02483715_inc_R3", "type": "Has_mood", "arg1_id": "NCT02483715_inc_T6", "arg2_id": "NCT02483715_inc_T7", "normalized": [] } ]

[ { "id": "NCT02488057_exc_text", "type": "exclusion", "text": [ "pregnant\n30 min or more of moderate to vigorous activity more than 3 times per week\ncardiovascular disease\nphysical limitations that might be aggravated by moderate physical activity\nplanning to move in next 12-24 months\ndiabetic\n" ], "offsets": [ [ 0, 230 ] ] } ]

[ { "id": "NCT02488057_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T2", "type": "Observation", "text": [ "moderate to vigorous activity" ], "offsets": [ [ 27, 56 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T3", "type": "Multiplier", "text": [ "more than 3 times per week" ], "offsets": [ [ 57, 83 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T4", "type": "Multiplier", "text": [ "30 min or more" ], "offsets": [ [ 9, 23 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T5", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 84, 106 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T6", "type": "Condition", "text": [ "physical limitations" ], "offsets": [ [ 107, 127 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T7", "type": "Qualifier", "text": [ "ravated by mo", "sical activity\npl" ], "offsets": [ [ 145, 158 ], [ 168, 185 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T8", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 156, 164 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T9", "type": "Observation", "text": [ "planning to move" ], "offsets": [ [ 183, 199 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T10", "type": "Temporal", "text": [ "in next 12-24 months" ], "offsets": [ [ 200, 220 ] ], "normalized": [] }, { "id": "NCT02488057_exc_T11", "type": "Condition", "text": [ "diabetic" ], "offsets": [ [ 221, 229 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02488057_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT02488057_exc_T2", "arg2_id": "NCT02488057_exc_T4", "normalized": [] }, { "id": "NCT02488057_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT02488057_exc_T2", "arg2_id": "NCT02488057_exc_T3", "normalized": [] }, { "id": "NCT02488057_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02488057_exc_T7", "arg2_id": "NCT02488057_exc_T8", "normalized": [] }, { "id": "NCT02488057_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02488057_exc_T6", "arg2_id": "NCT02488057_exc_T7", "normalized": [] }, { "id": "NCT02488057_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02488057_exc_T9", "arg2_id": "NCT02488057_exc_T10", "normalized": [] } ]

[ { "id": "NCT02488057_inc_text", "type": "inclusion", "text": [ "Mexican-american\nFemale\nBMI 30-42\nwillingness to complete protocol\npre-diabetic\nEnglish or Spanish literate\n" ], "offsets": [ [ 0, 108 ] ] } ]

[ { "id": "NCT02488057_inc_T1", "type": "Person", "text": [ "Mexican-american" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02488057_inc_T2", "type": "Person", "text": [ "Female" ], "offsets": [ [ 17, 23 ] ], "normalized": [] }, { "id": "NCT02488057_inc_T3", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 24, 27 ] ], "normalized": [] }, { "id": "NCT02488057_inc_T4", "type": "Value", "text": [ "30-42" ], "offsets": [ [ 28, 33 ] ], "normalized": [] }, { "id": "NCT02488057_inc_T6", "type": "Condition", "text": [ "pre-diabetic" ], "offsets": [ [ 67, 79 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02488057_inc_R1", "type": "Has_value", "arg1_id": "NCT02488057_inc_T3", "arg2_id": "NCT02488057_inc_T4", "normalized": [] } ]

[ { "id": "NCT02489045_exc_text", "type": "exclusion", "text": [ "Females who are pregnant or nursing.\nPatients not scheduled for trans-jugular liver biopsy\nPatients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h afterwards,.\nPatients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts\nPatients with pulmonary hypertension or unstable cardiopulmonary conditions\nPatients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.\nPatients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:\nPatients on life support or in a critical care unit.\nPatients with unstable occlusive disease (e.g., crescendo angina)\nPatients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.\nPatients with uncontrolled congestive heart failure (NYHA Class IV)\nPatients with recent cerebral hemorrhage.\nPatients who have undergone surgery within 24 hours prior to the study sonographic examination.\nPatients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID).\nPatients with congenital heart defects.\nPatients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.\nPatients with respiratory distress syndrome\nPatients with thrombosis within the hepatic, portal, or mesenteric veins.\n" ], "offsets": [ [ 0, 1763 ] ] } ]

[ { "id": "NCT02489045_exc_T1", "type": "Person", "text": [ "Females" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T2", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 16, 24 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T3", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 28, 35 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T4", "type": "Negation", "text": [ "not" ], "offsets": [ [ 46, 49 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T5", "type": "Mood", "text": [ "scheduled" ], "offsets": [ [ 50, 59 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T6", "type": "Procedure", "text": [ "trans-jugular liver biopsy" ], "offsets": [ [ 64, 90 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T8", "type": "Condition", "text": [ "transient right-to-left cardiac shunts" ], "offsets": [ [ 303, 341 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T9", "type": "Condition", "text": [ "directional, o", "diac shunts\nPa" ], "offsets": [ [ 287, 301 ], [ 330, 344 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T10", "type": "Condition", "text": [ "ht-to-left, b", "diac shunts\nPa" ], "offsets": [ [ 272, 285 ], [ 330, 344 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T11", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 259, 268 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T12", "type": "Mood", "text": [ "known" ], "offsets": [ [ 250, 255 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T13", "type": "Scope", "text": [ "known or suspected" ], "offsets": [ [ 250, 268 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T14", "type": "Scope", "text": [ "right-to-left, bi-directional, or transient right-to-left cardiac shunts" ], "offsets": [ [ 269, 341 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T15", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 356, 378 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T16", "type": "Condition", "text": [ "unstable cardiopulmonary conditions" ], "offsets": [ [ 382, 417 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T17", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 440, 452 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T18", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 427, 436 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T19", "type": "Procedure", "text": [ "hepatic loco-regional treatment" ], "offsets": [ [ 505, 536 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T20", "type": "Procedure", "text": [ "mic or h", "regional treatment.\nPat" ], "offsets": [ [ 498, 506 ], [ 518, 541 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T21", "type": "Condition", "text": [ "primary cancers" ], "offsets": [ [ 467, 482 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T22", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 461, 466 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T23", "type": "Scope", "text": [ "systemic or hepatic loco-regional treatment" ], "offsets": [ [ 493, 536 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T24", "type": "Scope", "text": [ "chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment" ], "offsets": [ [ 440, 536 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T25", "type": "Condition", "text": [ "medically unstable" ], "offsets": [ [ 555, 573 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T26", "type": "Condition", "text": [ "sly or te", "nd" ], "offsets": [ [ 598, 607 ], [ 622, 624 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T27", "type": "Condition", "text": [ "terminally ill" ], "offsets": [ [ 605, 619 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T28", "type": "Condition", "text": [ "clinical course is unpredictable" ], "offsets": [ [ 640, 672 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T29", "type": "Procedure", "text": [ "life support" ], "offsets": [ [ 699, 711 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T30", "type": "Visit", "text": [ "critical care unit" ], "offsets": [ [ 720, 738 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T31", "type": "Condition", "text": [ "unstable occlusive disease" ], "offsets": [ [ 754, 780 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T32", "type": "Scope", "text": [ "crescendo angina" ], "offsets": [ [ 788, 804 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T33", "type": "Qualifier", "text": [ "clinically unstable" ], "offsets": [ [ 820, 839 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T34", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 840, 859 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T35", "type": "Condition", "text": [ "ventricular tachycardia" ], "offsets": [ [ 879, 902 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T36", "type": "Multiplier", "text": [ "recurrent" ], "offsets": [ [ 869, 878 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T37", "type": "Scope", "text": [ "clinically unstable cardiac arrhythmias" ], "offsets": [ [ 820, 859 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T38", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 918, 930 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T39", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 931, 955 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T40", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 957, 961 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T41", "type": "Value", "text": [ "Class IV" ], "offsets": [ [ 962, 970 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T42", "type": "Scope", "text": [ "uncontrolled congestive heart failure" ], "offsets": [ [ 918, 955 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T43", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 986, 992 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T44", "type": "Condition", "text": [ "cerebral hemorrhage" ], "offsets": [ [ 993, 1012 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T45", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1042, 1049 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T46", "type": "Temporal", "text": [ "within 24 hours prior to the study sonographic examination" ], "offsets": [ [ 1050, 1108 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T47", "type": "Reference_point", "text": [ "the study sonographic examination" ], "offsets": [ [ 1075, 1108 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T48", "type": "Procedure", "text": [ "sonographic examination" ], "offsets": [ [ 1085, 1108 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T49", "type": "Condition", "text": [ "anaphylactic allergy" ], "offsets": [ [ 1137, 1157 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T50", "type": "Drug", "text": [ "eggs" ], "offsets": [ [ 1161, 1165 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T51", "type": "Drug", "text": [ "egg products" ], "offsets": [ [ 1169, 1181 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T52", "type": "Scope", "text": [ "eggs or egg products" ], "offsets": [ [ 1161, 1181 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T53", "type": "Condition", "text": [ "generalized urticaria" ], "offsets": [ [ 1236, 1257 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T54", "type": "Condition", "text": [ "difficulty in breathing" ], "offsets": [ [ 1259, 1282 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T55", "type": "Condition", "text": [ "swelling of the mouth" ], "offsets": [ [ 1284, 1305 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T56", "type": "Condition", "text": [ "he mouth and th", "ension" ], "offsets": [ [ 1297, 1312 ], [ 1323, 1329 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T57", "type": "Condition", "text": [ "hypotension" ], "offsets": [ [ 1318, 1329 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T58", "type": "Condition", "text": [ "shock" ], "offsets": [ [ 1334, 1339 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T59", "type": "Scope", "text": [ "generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock" ], "offsets": [ [ 1236, 1339 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T60", "type": "Scope", "text": [ "anaphylactic allergy to eggs or egg products" ], "offsets": [ [ 1137, 1181 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T61", "type": "Condition", "text": [ "congenital heart defects" ], "offsets": [ [ 1531, 1555 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T62", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1571, 1577 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T63", "type": "Condition", "text": [ "emphysema" ], "offsets": [ [ 1578, 1587 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T64", "type": "Condition", "text": [ "pulmonary vasculitis" ], "offsets": [ [ 1589, 1609 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T65", "type": "Condition", "text": [ "pulmonary emboli" ], "offsets": [ [ 1627, 1643 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T66", "type": "Condition", "text": [ "respiratory distress syndrome" ], "offsets": [ [ 1659, 1688 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T67", "type": "Condition", "text": [ "thrombosis" ], "offsets": [ [ 1703, 1713 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T68", "type": "Qualifier", "text": [ "mesenteric veins" ], "offsets": [ [ 1745, 1761 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T69", "type": "Qualifier", "text": [ "eric v", "" ], "offsets": [ [ 1751, 1757 ], [ 1773, 1773 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T70", "type": "Qualifier", "text": [ "or mese", "" ], "offsets": [ [ 1742, 1749 ], [ 1773, 1773 ] ], "normalized": [] }, { "id": "NCT02489045_exc_T71", "type": "Scope", "text": [ "hepatic, portal, or mesenteric veins" ], "offsets": [ [ 1725, 1761 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02489045_exc_R1", "type": "Has_mood", "arg1_id": "NCT02489045_exc_T6", "arg2_id": "NCT02489045_exc_T5", "normalized": [] }, { "id": "NCT02489045_exc_R2", "type": "Has_negation", "arg1_id": "NCT02489045_exc_T5", "arg2_id": "NCT02489045_exc_T4", "normalized": [] }, { "id": "NCT02489045_exc_R3", "type": "Has_scope", "arg1_id": "NCT02489045_exc_T14", "arg2_id": "NCT02489045_exc_T13", "normalized": [] }, { "id": "NCT02489045_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02489045_exc_T21", "arg2_id": "NCT02489045_exc_T22", "normalized": [] }, { "id": "NCT02489045_exc_R5", "type": "Has_scope", "arg1_id": "NCT02489045_exc_T21", "arg2_id": "NCT02489045_exc_T23", "normalized": [] }, { "id": "NCT02489045_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02489045_exc_T24", "arg2_id": "NCT02489045_exc_T18", "normalized": [] }, { "id": "NCT02489045_exc_R7", "type": "AND", "arg1_id": "NCT02489045_exc_T29", "arg2_id": "NCT02489045_exc_T30", "normalized": [] }, { "id": "NCT02489045_exc_R8", "type": "Subsumes", "arg1_id": "NCT02489045_exc_T31", "arg2_id": "NCT02489045_exc_T32", "normalized": [] }, { "id": "NCT02489045_exc_R9", "type": "Has_multiplier", "arg1_id": "NCT02489045_exc_T35", "arg2_id": "NCT02489045_exc_T36", "normalized": [] }, { "id": "NCT02489045_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02489045_exc_T34", "arg2_id": "NCT02489045_exc_T33", "normalized": [] }, { "id": "NCT02489045_exc_R11", "type": "AND", "arg1_id": "NCT02489045_exc_T37", "arg2_id": "NCT02489045_exc_T35", "normalized": [] }, { "id": "NCT02489045_exc_R12", "type": "Has_value", "arg1_id": "NCT02489045_exc_T40", "arg2_id": "NCT02489045_exc_T41", "normalized": [] }, { "id": "NCT02489045_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT02489045_exc_T39", "arg2_id": "NCT02489045_exc_T38", "normalized": [] }, { "id": "NCT02489045_exc_R14", "type": "Subsumes", "arg1_id": "NCT02489045_exc_T42", "arg2_id": "NCT02489045_exc_T40", "normalized": [] }, { "id": "NCT02489045_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02489045_exc_T44", "arg2_id": "NCT02489045_exc_T43", "normalized": [] }, { "id": "NCT02489045_exc_R16", "type": "Has_index", "arg1_id": "NCT02489045_exc_T46", "arg2_id": "NCT02489045_exc_T47", "normalized": [] }, { "id": "NCT02489045_exc_R17", "type": "AND", "arg1_id": "NCT02489045_exc_T47", "arg2_id": "NCT02489045_exc_T48", "normalized": [] }, { "id": "NCT02489045_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02489045_exc_T45", "arg2_id": "NCT02489045_exc_T46", "normalized": [] }, { "id": "NCT02489045_exc_R19", "type": "Has_scope", "arg1_id": "NCT02489045_exc_T49", "arg2_id": "NCT02489045_exc_T52", "normalized": [] }, { "id": "NCT02489045_exc_R20", "type": "Subsumes", "arg1_id": "NCT02489045_exc_T60", "arg2_id": "NCT02489045_exc_T59", "normalized": [] }, { "id": "NCT02489045_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02489045_exc_T63", "arg2_id": "NCT02489045_exc_T62", "normalized": [] }, { "id": "NCT02489045_exc_R22", "type": "Has_scope", "arg1_id": "NCT02489045_exc_T67", "arg2_id": "NCT02489045_exc_T71", "normalized": [] } ]

[ { "id": "NCT02489045_inc_text", "type": "inclusion", "text": [ "Be scheduled for trans-jugular liver biopsy the day of the ultrasound procedure.\nBe at least 21 years of age.\nBe medically stable.\nIf a female of child-bearing potential, must have a negative pregnancy test.\nBe conscious and able to comply with study procedures.\nHave read and signed the IRB-approved Informed Consent form for participating in the study.\n" ], "offsets": [ [ 0, 355 ] ] } ]

[ { "id": "NCT02489045_inc_T1", "type": "Procedure", "text": [ "trans-jugular liver biopsy" ], "offsets": [ [ 17, 43 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T2", "type": "Temporal", "text": [ "the day of the ultrasound procedure" ], "offsets": [ [ 44, 79 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T3", "type": "Reference_point", "text": [ "ultrasound procedure" ], "offsets": [ [ 59, 79 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T4", "type": "Procedure", "text": [ "ultrasound procedure" ], "offsets": [ [ 59, 79 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T5", "type": "Value", "text": [ "at least 21 years" ], "offsets": [ [ 84, 101 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 105, 108 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T7", "type": "Condition", "text": [ "medically stable" ], "offsets": [ [ 113, 129 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T8", "type": "Person", "text": [ "female" ], "offsets": [ [ 136, 142 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T9", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 146, 169 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T10", "type": "Condition", "text": [ "negative" ], "offsets": [ [ 183, 191 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T11", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 192, 206 ] ], "normalized": [] }, { "id": "NCT02489045_inc_T12", "type": "Scope", "text": [ "female of child-bearing potential" ], "offsets": [ [ 136, 169 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02489045_inc_R1", "type": "AND", "arg1_id": "NCT02489045_inc_T3", "arg2_id": "NCT02489045_inc_T4", "normalized": [] }, { "id": "NCT02489045_inc_R2", "type": "Has_index", "arg1_id": "NCT02489045_inc_T2", "arg2_id": "NCT02489045_inc_T3", "normalized": [] }, { "id": "NCT02489045_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02489045_inc_T1", "arg2_id": "NCT02489045_inc_T2", "normalized": [] }, { "id": "NCT02489045_inc_R4", "type": "Has_value", "arg1_id": "NCT02489045_inc_T6", "arg2_id": "NCT02489045_inc_T5", "normalized": [] }, { "id": "NCT02489045_inc_R5", "type": "AND", "arg1_id": "NCT02489045_inc_T11", "arg2_id": "NCT02489045_inc_T10", "normalized": [] }, { "id": "NCT02489045_inc_R6", "type": "AND", "arg1_id": "NCT02489045_inc_T12", "arg2_id": "NCT02489045_inc_T11", "normalized": [] } ]

[ { "id": "NCT02490839_exc_text", "type": "exclusion", "text": [ "pregnant or nursing woman\nserious concomitant illness and malignant tumor of any kind\nhistory of hypersensitivity to test drugs\nserious bleeding during the course of the ulcer\nprevious gastric surgery\nreceiving bismuth salts, PPIs, or antibiotics in the previous month.\n" ], "offsets": [ [ 0, 270 ] ] } ]

[ { "id": "NCT02490839_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T2", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 12, 19 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T3", "type": "Person", "text": [ "woman" ], "offsets": [ [ 20, 25 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T4", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 26, 33 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T5", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 34, 45 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T6", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 46, 53 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T7", "type": "Condition", "text": [ "malignant tumor" ], "offsets": [ [ 58, 73 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T8", "type": "Qualifier", "text": [ "any kind" ], "offsets": [ [ 77, 85 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T9", "type": "Observation", "text": [ "history" ], "offsets": [ [ 86, 93 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T10", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 97, 113 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T11", "type": "Drug", "text": [ "test drugs" ], "offsets": [ [ 117, 127 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T12", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 128, 135 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T13", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 136, 144 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T14", "type": "Temporal", "text": [ "during the course of the ulcer" ], "offsets": [ [ 145, 175 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T15", "type": "Reference_point", "text": [ "the ulcer" ], "offsets": [ [ 166, 175 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T16", "type": "Condition", "text": [ "ulcer" ], "offsets": [ [ 170, 175 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T17", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 176, 184 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T18", "type": "Procedure", "text": [ "gastric surgery" ], "offsets": [ [ 185, 200 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T19", "type": "Drug", "text": [ "bismuth salts" ], "offsets": [ [ 211, 224 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T20", "type": "Drug", "text": [ "PPIs" ], "offsets": [ [ 226, 230 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T21", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 235, 246 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T22", "type": "Temporal", "text": [ "in the previous month" ], "offsets": [ [ 247, 268 ] ], "normalized": [] }, { "id": "NCT02490839_exc_T23", "type": "Scope", "text": [ "bismuth salts, PPIs, or antibiotics" ], "offsets": [ [ 211, 246 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02490839_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02490839_exc_T7", "arg2_id": "NCT02490839_exc_T8", "normalized": [] }, { "id": "NCT02490839_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02490839_exc_T6", "arg2_id": "NCT02490839_exc_T5", "normalized": [] }, { "id": "NCT02490839_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02490839_exc_T6", "arg2_id": "NCT02490839_exc_T4", "normalized": [] }, { "id": "NCT02490839_exc_R4", "type": "AND", "arg1_id": "NCT02490839_exc_T10", "arg2_id": "NCT02490839_exc_T11", "normalized": [] }, { "id": "NCT02490839_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02490839_exc_T10", "arg2_id": "NCT02490839_exc_T9", "normalized": [] }, { "id": "NCT02490839_exc_R7", "type": "Has_index", "arg1_id": "NCT02490839_exc_T14", "arg2_id": "NCT02490839_exc_T15", "normalized": [] }, { "id": "NCT02490839_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02490839_exc_T13", "arg2_id": "NCT02490839_exc_T12", "normalized": [] }, { "id": "NCT02490839_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02490839_exc_T13", "arg2_id": "NCT02490839_exc_T14", "normalized": [] }, { "id": "NCT02490839_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02490839_exc_T18", "arg2_id": "NCT02490839_exc_T17", "normalized": [] }, { "id": "NCT02490839_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02490839_exc_T23", "arg2_id": "NCT02490839_exc_T22", "normalized": [] } ]

[ { "id": "NCT02490839_inc_text", "type": "inclusion", "text": [ "Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.\n" ], "offsets": [ [ 0, 171 ] ] } ]

[ { "id": "NCT02490839_inc_T1", "type": "Qualifier", "text": [ "H. pylori related" ], "offsets": [ [ 20, 37 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T2", "type": "Condition", "text": [ "chronic gastritis" ], "offsets": [ [ 38, 55 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T3", "type": "Condition", "text": [ "peptic ulcers" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 91, 95 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T5", "type": "Value", "text": [ "greater than 20 years old" ], "offsets": [ [ 96, 121 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T6", "type": "Mood", "text": [ "willing to received" ], "offsets": [ [ 130, 149 ] ], "normalized": [] }, { "id": "NCT02490839_inc_T7", "type": "Procedure", "text": [ "eradication therapy" ], "offsets": [ [ 150, 169 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02490839_inc_R1", "type": "Has_mood", "arg1_id": "NCT02490839_inc_T7", "arg2_id": "NCT02490839_inc_T6", "normalized": [] }, { "id": "NCT02490839_inc_R2", "type": "Has_value", "arg1_id": "NCT02490839_inc_T4", "arg2_id": "NCT02490839_inc_T5", "normalized": [] }, { "id": "NCT02490839_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02490839_inc_T2", "arg2_id": "NCT02490839_inc_T1", "normalized": [] } ]

[ { "id": "NCT02498483_exc_text", "type": "exclusion", "text": [ "Newborns of substance abusing mothers.\nNewborns with any contraindications to routine circumcision, anatomical or hematologic.\n" ], "offsets": [ [ 0, 127 ] ] } ]

[ { "id": "NCT02498483_exc_T1", "type": "Person", "text": [ "Newborns" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02498483_exc_T2", "type": "Person", "text": [ "mothers" ], "offsets": [ [ 30, 37 ] ], "normalized": [] }, { "id": "NCT02498483_exc_T3", "type": "Condition", "text": [ "substance abusing" ], "offsets": [ [ 12, 29 ] ], "normalized": [] }, { "id": "NCT02498483_exc_T4", "type": "Person", "text": [ "Newborns" ], "offsets": [ [ 39, 47 ] ], "normalized": [] }, { "id": "NCT02498483_exc_T5", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 57, 74 ] ], "normalized": [] }, { "id": "NCT02498483_exc_T6", "type": "Procedure", "text": [ "circumcision" ], "offsets": [ [ 86, 98 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02498483_exc_R1", "type": "AND", "arg1_id": "NCT02498483_exc_T2", "arg2_id": "NCT02498483_exc_T3", "normalized": [] }, { "id": "NCT02498483_exc_R2", "type": "AND", "arg1_id": "NCT02498483_exc_T5", "arg2_id": "NCT02498483_exc_T6", "normalized": [] } ]

[ { "id": "NCT02498483_inc_text", "type": "inclusion", "text": [ "Apgar score at 5 minutes >7\nbirthweight greater than 2.4 kg\nAge of at least 10 hours\nAt least one void.\n" ], "offsets": [ [ 0, 104 ] ] } ]

[ { "id": "NCT02498483_inc_T1", "type": "Measurement", "text": [ "Apgar score" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T2", "type": "Value", "text": [ ">7" ], "offsets": [ [ 25, 27 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T3", "type": "Temporal", "text": [ "at 5 minutes" ], "offsets": [ [ 12, 24 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T4", "type": "Measurement", "text": [ "birthweight" ], "offsets": [ [ 28, 39 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T5", "type": "Value", "text": [ "greater than 2.4 kg" ], "offsets": [ [ 40, 59 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T6", "type": "Person", "text": [ "Age" ], "offsets": [ [ 60, 63 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T7", "type": "Value", "text": [ "at least 10 hours" ], "offsets": [ [ 67, 84 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T8", "type": "Multiplier", "text": [ "At least one" ], "offsets": [ [ 85, 97 ] ], "normalized": [] }, { "id": "NCT02498483_inc_T9", "type": "Observation", "text": [ "void" ], "offsets": [ [ 98, 102 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02498483_inc_R1", "type": "Has_value", "arg1_id": "NCT02498483_inc_T1", "arg2_id": "NCT02498483_inc_T2", "normalized": [] }, { "id": "NCT02498483_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02498483_inc_T1", "arg2_id": "NCT02498483_inc_T3", "normalized": [] }, { "id": "NCT02498483_inc_R3", "type": "Has_value", "arg1_id": "NCT02498483_inc_T4", "arg2_id": "NCT02498483_inc_T5", "normalized": [] }, { "id": "NCT02498483_inc_R4", "type": "Has_value", "arg1_id": "NCT02498483_inc_T6", "arg2_id": "NCT02498483_inc_T7", "normalized": [] }, { "id": "NCT02498483_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT02498483_inc_T9", "arg2_id": "NCT02498483_inc_T8", "normalized": [] } ]

[ { "id": "NCT02499185_exc_text", "type": "exclusion", "text": [ "Ongoing acute kidney injury Stage 2/3\nHistory of kidney transplant\n" ], "offsets": [ [ 0, 67 ] ] } ]

[ { "id": "NCT02499185_exc_T1", "type": "Condition", "text": [ "acute kidney injury" ], "offsets": [ [ 8, 27 ] ], "normalized": [] }, { "id": "NCT02499185_exc_T2", "type": "Measurement", "text": [ "Stage" ], "offsets": [ [ 28, 33 ] ], "normalized": [] }, { "id": "NCT02499185_exc_T3", "type": "Value", "text": [ "2/3" ], "offsets": [ [ 34, 37 ] ], "normalized": [] }, { "id": "NCT02499185_exc_T4", "type": "Procedure", "text": [ "kidney transplant" ], "offsets": [ [ 49, 66 ] ], "normalized": [] }, { "id": "NCT02499185_exc_T5", "type": "Observation", "text": [ "History" ], "offsets": [ [ 38, 45 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02499185_exc_R1", "type": "Has_value", "arg1_id": "NCT02499185_exc_T2", "arg2_id": "NCT02499185_exc_T3", "normalized": [] }, { "id": "NCT02499185_exc_R2", "type": "AND", "arg1_id": "NCT02499185_exc_T1", "arg2_id": "NCT02499185_exc_T2", "normalized": [] }, { "id": "NCT02499185_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02499185_exc_T4", "arg2_id": "NCT02499185_exc_T5", "normalized": [] } ]

[ { "id": "NCT02499185_inc_text", "type": "inclusion", "text": [ "= 18 years\nHigh risk patients: General Surgery AKI Risk Index Class III, IV or V\nMajor abdominal surgery\n" ], "offsets": [ [ 0, 105 ] ] } ]

[ { "id": "NCT02499185_inc_T1", "type": "Person", "text": [ "= 18 years" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT02499185_inc_T2", "type": "Value", "text": [ "= 18 years" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT02499185_inc_T3", "type": "Condition", "text": [ "High risk" ], "offsets": [ [ 11, 20 ] ], "normalized": [] }, { "id": "NCT02499185_inc_T4", "type": "Measurement", "text": [ "General Surgery AKI Risk Index" ], "offsets": [ [ 31, 61 ] ], "normalized": [] }, { "id": "NCT02499185_inc_T5", "type": "Value", "text": [ "Class III, IV or V" ], "offsets": [ [ 62, 80 ] ], "normalized": [] }, { "id": "NCT02499185_inc_T6", "type": "Procedure", "text": [ "Major abdominal surgery" ], "offsets": [ [ 81, 104 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02499185_inc_R1", "type": "Has_value", "arg1_id": "NCT02499185_inc_T1", "arg2_id": "NCT02499185_inc_T2", "normalized": [] }, { "id": "NCT02499185_inc_R2", "type": "Has_value", "arg1_id": "NCT02499185_inc_T4", "arg2_id": "NCT02499185_inc_T5", "normalized": [] }, { "id": "NCT02499185_inc_R3", "type": "Subsumes", "arg1_id": "NCT02499185_inc_T3", "arg2_id": "NCT02499185_inc_T4", "normalized": [] } ]

[ { "id": "NCT02502734_exc_text", "type": "exclusion", "text": [ "A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s). \nSubjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or emergency room attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening. \nSignificant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis). \nCulture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. \nAny fracture in the leg to be measured within 6 months prior to the screening visit. \nAny metabolic disorders or other diseases that may impact on normal growth patterns. \nNo major surgery requiring general anaesthesia for at least 3 months prior to the screening visit. \nNo febrile illnesses with temperature >39 degree celsius for more than five consecutive days within the week preceding the Screening Visit. \nAny significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the Investigator's opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study. \nClinical visual evidence of candidiasis at Visit 1 (Screening). \nUse of any of the prohibited medications listed in protocol. \nStrenuous physical exercise within 3 hours of Visit 1 (Screening) \nDrug allergies: Any adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e., lactose, FF). \nMilk Protein Allergy: History of severe milk protein allergy. \nThe subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). \nExposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day. \nUnable to use the ELLIPTA inhaler and peak flow meter correctly. \nAn affiliation with the Investigator site: the parents/guardians or child is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. \nThe Parent or Guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect: validity of consent to participate in the study; adequate supervision of the subject during the study; compliance of subject with study medication and study procedures (e.g. completion of daily diary, attending scheduled clinic visits); subject safety and well-being. \nChildren in care: Children who are wards of the government or state are not eligible for participation in this study. \n \n" ], "offsets": [ [ 0, 3502 ] ] } ]

[ { "id": "NCT02502734_exc_T1", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 30, 36 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T2", "type": "Qualifier", "text": [ "life-threatening" ], "offsets": [ [ 13, 29 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2, 9 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T4", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 98, 108 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T5", "type": "Condition", "text": [ "asthma episode" ], "offsets": [ [ 69, 83 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T6", "type": "Condition", "text": [ "hypercapnea" ], "offsets": [ [ 110, 121 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T7", "type": "Device", "text": [ "non-invasive ventilatory support" ], "offsets": [ [ 132, 164 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T8", "type": "Condition", "text": [ "respiratory arrest" ], "offsets": [ [ 166, 184 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T9", "type": "Condition", "text": [ "hypoxic seizures" ], "offsets": [ [ 186, 202 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T10", "type": "Condition", "text": [ "asthma-related syncopal episode" ], "offsets": [ [ 206, 237 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T11", "type": "Scope", "text": [ "asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode" ], "offsets": [ [ 69, 237 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T12", "type": "Observation", "text": [ "history" ], "offsets": [ [ 259, 266 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T13", "type": "Condition", "text": [ "asthma exacerbation" ], "offsets": [ [ 270, 289 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T14", "type": "Drug", "text": [ "systemic corticosteroids" ], "offsets": [ [ 311, 335 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T15", "type": "Temporal", "text": [ "for at least 3 days" ], "offsets": [ [ 372, 391 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T16", "type": "Drug", "text": [ "depot corticosteroid injection" ], "offsets": [ [ 397, 427 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T17", "type": "Temporal", "text": [ "within 3 months" ], "offsets": [ [ 458, 473 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T18", "type": "Procedure", "text": [ "emergency room attendance" ], "offsets": [ [ 431, 456 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T19", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 488, 503 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T20", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 508, 514 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T21", "type": "Temporal", "text": [ "within 6 months" ], "offsets": [ [ 516, 531 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T22", "type": "Condition", "text": [ "pulmonary disease" ], "offsets": [ [ 589, 606 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T24", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 554, 565 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T26", "type": "Qualifier", "text": [ "non-reversible" ], "offsets": [ [ 567, 581 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T27", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 582, 588 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T28", "type": "Condition", "text": [ "cystic fibrosis" ], "offsets": [ [ 613, 628 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T29", "type": "Condition", "text": [ "bronchiectasis" ], "offsets": [ [ 630, 644 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T30", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 646, 658 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T31", "type": "Scope", "text": [ "cystic fibrosis, bronchiectasis, tuberculosis" ], "offsets": [ [ 613, 658 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T32", "type": "Condition", "text": [ "viral infection of the upper", "respiratory tract" ], "offsets": [ [ 707, 735 ], [ 745, 762 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T33", "type": "Condition", "text": [ "bacterial", "infection of the upper", "respiratory tract" ], "offsets": [ [ 694, 703 ], [ 713, 735 ], [ 745, 762 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T34", "type": "Condition", "text": [ "viral infection of the", "lower respiratory tract" ], "offsets": [ [ 707, 729 ], [ 739, 762 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T35", "type": "Condition", "text": [ "bacterial", "infection of the", "lower respiratory tract" ], "offsets": [ [ 694, 703 ], [ 713, 729 ], [ 739, 762 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T36", "type": "Condition", "text": [ "viral infection of the", "sinus" ], "offsets": [ [ 707, 729 ], [ 764, 769 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T37", "type": "Condition", "text": [ "bacterial", "infection of the", "sinus" ], "offsets": [ [ 694, 703 ], [ 713, 729 ], [ 764, 769 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T38", "type": "Condition", "text": [ "viral infection of the", "middle ear" ], "offsets": [ [ 707, 729 ], [ 773, 783 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T39", "type": "Condition", "text": [ "bacterial", "infection of the", "middle ear" ], "offsets": [ [ 694, 703 ], [ 713, 729 ], [ 773, 783 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T40", "type": "Procedure", "text": [ "Culture" ], "offsets": [ [ 662, 669 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T41", "type": "Observation", "text": [ "suspected" ], "offsets": [ [ 684, 693 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T42", "type": "Scope", "text": [ "Culture-documented or suspected" ], "offsets": [ [ 662, 693 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T43", "type": "Scope", "text": [ "bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear" ], "offsets": [ [ 694, 783 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T44", "type": "Qualifier", "text": [ "resolved" ], "offsets": [ [ 796, 804 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T45", "type": "Negation", "text": [ "not" ], "offsets": [ [ 792, 795 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T46", "type": "Temporal", "text": [ "within 4 weeks of Visit 1" ], "offsets": [ [ 805, 830 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T47", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 823, 830 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T48", "type": "Observation", "text": [ "change in asthma management" ], "offsets": [ [ 844, 871 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T53", "type": "Procedure", "text": [ "asthma management" ], "offsets": [ [ 854, 871 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T54", "type": "Condition", "text": [ "fracture in the leg" ], "offsets": [ [ 1021, 1040 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T55", "type": "Temporal", "text": [ "within 6 months prior to the screening visit" ], "offsets": [ [ 1056, 1100 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T56", "type": "Reference_point", "text": [ "the screening visit" ], "offsets": [ [ 1081, 1100 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T57", "type": "Condition", "text": [ "metabolic disorders" ], "offsets": [ [ 1107, 1126 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T58", "type": "Qualifier", "text": [ "may impact on normal growth patterns" ], "offsets": [ [ 1150, 1186 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T61", "type": "Condition", "text": [ "other diseases" ], "offsets": [ [ 1130, 1144 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T62", "type": "Scope", "text": [ "metabolic disorders or other diseases" ], "offsets": [ [ 1107, 1144 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T63", "type": "Condition", "text": [ "major surgery" ], "offsets": [ [ 1192, 1205 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T65", "type": "Procedure", "text": [ "general anaesthesia" ], "offsets": [ [ 1216, 1235 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T66", "type": "Temporal", "text": [ "for at least 3 months prior to the screening visit" ], "offsets": [ [ 1236, 1286 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T67", "type": "Reference_point", "text": [ "the screening visit" ], "offsets": [ [ 1267, 1286 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T68", "type": "Condition", "text": [ "febrile illnesses" ], "offsets": [ [ 1292, 1309 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T69", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1189, 1191 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T71", "type": "Measurement", "text": [ "temperature" ], "offsets": [ [ 1315, 1326 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T72", "type": "Value", "text": [ ">39 degree celsius" ], "offsets": [ [ 1327, 1345 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T73", "type": "Temporal", "text": [ "for more than five consecutive days" ], "offsets": [ [ 1346, 1381 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T74", "type": "Temporal", "text": [ "within the week preceding the Screening Visit" ], "offsets": [ [ 1382, 1427 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T75", "type": "Reference_point", "text": [ "the Screening Visit" ], "offsets": [ [ 1408, 1427 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T76", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1289, 1291 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T77", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1434, 1445 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T80", "type": "Condition", "text": [ "abnormality" ], "offsets": [ [ 1446, 1457 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T81", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 1461, 1478 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T82", "type": "Scope", "text": [ "abnormality or medical condition" ], "offsets": [ [ 1446, 1478 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T86", "type": "Condition", "text": [ "visual evidence" ], "offsets": [ [ 1725, 1740 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T87", "type": "Condition", "text": [ "candidiasis" ], "offsets": [ [ 1744, 1755 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T88", "type": "Temporal", "text": [ "at Visit 1 (Screening)" ], "offsets": [ [ 1756, 1778 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T89", "type": "Reference_point", "text": [ "Visit 1 (Screening)" ], "offsets": [ [ 1759, 1778 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T91", "type": "Drug", "text": [ "prohibited medications listed in protocol" ], "offsets": [ [ 1799, 1840 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T92", "type": "Condition", "text": [ "Strenuous physical exercise" ], "offsets": [ [ 1843, 1870 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T93", "type": "Temporal", "text": [ "within 3 hours of Visit 1 (Screening)" ], "offsets": [ [ 1871, 1908 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T94", "type": "Reference_point", "text": [ "Visit 1 (Screening)" ], "offsets": [ [ 1889, 1908 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T95", "type": "Condition", "text": [ "Drug allergies" ], "offsets": [ [ 1910, 1924 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T96", "type": "Drug", "text": [ "intranasal", "corticosteroid" ], "offsets": [ [ 2002, 2012 ], [ 2035, 2049 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T97", "type": "Drug", "text": [ "systemic corticosteroid" ], "offsets": [ [ 2026, 2049 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T98", "type": "Drug", "text": [ "inhaled", "corticosteroid" ], "offsets": [ [ 2014, 2021 ], [ 2035, 2049 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T99", "type": "Scope", "text": [ "intranasal, inhaled, or systemic corticosteroid" ], "offsets": [ [ 2002, 2049 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T100", "type": "Condition", "text": [ "immediate", "hypersensitivity" ], "offsets": [ [ 1957, 1966 ], [ 1978, 1994 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T101", "type": "Condition", "text": [ "delayed hypersensitivity" ], "offsets": [ [ 1970, 1994 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T102", "type": "Condition", "text": [ "adverse reaction" ], "offsets": [ [ 1930, 1946 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T103", "type": "Scope", "text": [ "immediate or delayed hypersensitivity" ], "offsets": [ [ 1957, 1994 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T104", "type": "Scope", "text": [ "adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid" ], "offsets": [ [ 1930, 2049 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T105", "type": "Condition", "text": [ "sensitivity" ], "offsets": [ [ 2078, 2089 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T106", "type": "Drug", "text": [ "constituents of the ELLIPTA Inhaler" ], "offsets": [ [ 2097, 2132 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T107", "type": "Drug", "text": [ "lactose" ], "offsets": [ [ 2140, 2147 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T108", "type": "Drug", "text": [ "FF" ], "offsets": [ [ 2149, 2151 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T109", "type": "Scope", "text": [ "lactose, FF" ], "offsets": [ [ 2140, 2151 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T110", "type": "Condition", "text": [ "Milk Protein Allergy" ], "offsets": [ [ 2155, 2175 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T111", "type": "Condition", "text": [ "milk protein allergy" ], "offsets": [ [ 2195, 2215 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T112", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2188, 2194 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T115", "type": "Multiplier", "text": [ "more than 4" ], "offsets": [ [ 2532, 2543 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T116", "type": "Drug", "text": [ "investigational medicinal products" ], "offsets": [ [ 2544, 2578 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T117", "type": "Temporal", "text": [ "within 12 months prior to the first dosing day" ], "offsets": [ [ 2579, 2625 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T118", "type": "Reference_point", "text": [ "the first dosing day" ], "offsets": [ [ 2605, 2625 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T119", "type": "Drug", "text": [ "ELLIPTA inhaler" ], "offsets": [ [ 2646, 2661 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T120", "type": "Device", "text": [ "peak flow meter" ], "offsets": [ [ 2666, 2681 ] ], "normalized": [] }, { "id": "NCT02502734_exc_T121", "type": "Condition", "text": [ "Unable to use the ELLIPTA inhaler and peak flow meter correctly." ], "offsets": [ [ 2628, 2692 ] ], "normalized": [] } ]

[]

[]

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"type": "Has_temporal", "arg1_id": "NCT02502734_exc_T14", "arg2_id": "NCT02502734_exc_T15", "normalized": [] }, { "id": "NCT02502734_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T13", "arg2_id": "NCT02502734_exc_T12", "normalized": [] }, { "id": "NCT02502734_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T22", "arg2_id": "NCT02502734_exc_T26", "normalized": [] }, { "id": "NCT02502734_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T22", "arg2_id": "NCT02502734_exc_T24", "normalized": [] }, { "id": "NCT02502734_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T22", "arg2_id": "NCT02502734_exc_T27", "normalized": [] }, { "id": "NCT02502734_exc_R13", "type": "Subsumes", "arg1_id": "NCT02502734_exc_T22", "arg2_id": "NCT02502734_exc_T31", "normalized": [] }, { "id": "NCT02502734_exc_R14", "type": "Has_scope", "arg1_id": "NCT02502734_exc_T43", "arg2_id": "NCT02502734_exc_T42", "normalized": [] }, { "id": "NCT02502734_exc_R15", "type": "Has_negation", "arg1_id": "NCT02502734_exc_T44", "arg2_id": "NCT02502734_exc_T45", "normalized": [] }, { "id": "NCT02502734_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T43", "arg2_id": "NCT02502734_exc_T44", "normalized": [] }, { "id": "NCT02502734_exc_R17", "type": "Has_index", "arg1_id": "NCT02502734_exc_T46", "arg2_id": "NCT02502734_exc_T47", "normalized": [] }, { "id": "NCT02502734_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T43", "arg2_id": "NCT02502734_exc_T46", "normalized": [] }, { "id": "NCT02502734_exc_R20", "type": "AND", "arg1_id": "NCT02502734_exc_T48", "arg2_id": "NCT02502734_exc_T53", "normalized": [] }, { "id": "NCT02502734_exc_R21", "type": "Has_index", "arg1_id": "NCT02502734_exc_T55", "arg2_id": "NCT02502734_exc_T56", "normalized": [] }, { "id": "NCT02502734_exc_R22", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T54", "arg2_id": "NCT02502734_exc_T55", "normalized": [] }, { "id": "NCT02502734_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T62", "arg2_id": "NCT02502734_exc_T58", "normalized": [] }, { "id": "NCT02502734_exc_R24", "type": "AND", "arg1_id": "NCT02502734_exc_T63", "arg2_id": "NCT02502734_exc_T65", "normalized": [] }, { "id": "NCT02502734_exc_R25", "type": "Has_index", "arg1_id": "NCT02502734_exc_T66", "arg2_id": "NCT02502734_exc_T67", "normalized": [] }, { "id": "NCT02502734_exc_R26", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T65", "arg2_id": "NCT02502734_exc_T66", "normalized": [] }, { "id": "NCT02502734_exc_R27", "type": "Has_negation", "arg1_id": "NCT02502734_exc_T63", "arg2_id": "NCT02502734_exc_T69", "normalized": [] }, { "id": "NCT02502734_exc_R28", "type": "Has_value", "arg1_id": "NCT02502734_exc_T71", "arg2_id": "NCT02502734_exc_T72", "normalized": [] }, { "id": "NCT02502734_exc_R29", "type": "Has_index", "arg1_id": "NCT02502734_exc_T74", "arg2_id": "NCT02502734_exc_T75", "normalized": [] }, { "id": "NCT02502734_exc_R30", "type": "AND", "arg1_id": "NCT02502734_exc_T68", "arg2_id": "NCT02502734_exc_T71", "normalized": [] }, { "id": "NCT02502734_exc_R31", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T71", "arg2_id": "NCT02502734_exc_T73", "normalized": [] }, { "id": "NCT02502734_exc_R32", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T71", "arg2_id": "NCT02502734_exc_T74", "normalized": [] }, { "id": "NCT02502734_exc_R33", "type": "Has_negation", "arg1_id": "NCT02502734_exc_T68", "arg2_id": "NCT02502734_exc_T76", "normalized": [] }, { "id": "NCT02502734_exc_R34", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T82", "arg2_id": "NCT02502734_exc_T77", "normalized": [] }, { "id": "NCT02502734_exc_R35", "type": "Has_index", "arg1_id": "NCT02502734_exc_T88", "arg2_id": "NCT02502734_exc_T89", "normalized": [] }, { "id": "NCT02502734_exc_R36", "type": "AND", "arg1_id": "NCT02502734_exc_T86", "arg2_id": "NCT02502734_exc_T87", "normalized": [] }, { "id": "NCT02502734_exc_R37", "type": "Has_index", "arg1_id": "NCT02502734_exc_T93", "arg2_id": "NCT02502734_exc_T94", "normalized": [] }, { "id": "NCT02502734_exc_R38", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T92", "arg2_id": "NCT02502734_exc_T93", "normalized": [] }, { "id": "NCT02502734_exc_R39", "type": "Subsumes", "arg1_id": "NCT02502734_exc_T102", "arg2_id": "NCT02502734_exc_T103", "normalized": [] }, { "id": "NCT02502734_exc_R40", "type": "Has_scope", "arg1_id": "NCT02502734_exc_T103", "arg2_id": "NCT02502734_exc_T99", "normalized": [] }, { "id": "NCT02502734_exc_R41", "type": "Subsumes", "arg1_id": "NCT02502734_exc_T95", "arg2_id": "NCT02502734_exc_T104", "normalized": [] }, { "id": "NCT02502734_exc_R42", "type": "Subsumes", "arg1_id": "NCT02502734_exc_T106", "arg2_id": "NCT02502734_exc_T109", "normalized": [] }, { "id": "NCT02502734_exc_R43", "type": "AND", "arg1_id": "NCT02502734_exc_T105", "arg2_id": "NCT02502734_exc_T106", "normalized": [] }, { "id": "NCT02502734_exc_R44", "type": "Has_qualifier", "arg1_id": "NCT02502734_exc_T111", "arg2_id": "NCT02502734_exc_T112", "normalized": [] }, { "id": "NCT02502734_exc_R45", "type": "Subsumes", "arg1_id": "NCT02502734_exc_T110", "arg2_id": "NCT02502734_exc_T111", "normalized": [] }, { "id": "NCT02502734_exc_R46", "type": "Has_index", "arg1_id": "NCT02502734_exc_T117", "arg2_id": "NCT02502734_exc_T118", "normalized": [] }, { "id": "NCT02502734_exc_R47", "type": "Has_temporal", "arg1_id": "NCT02502734_exc_T116", "arg2_id": "NCT02502734_exc_T117", "normalized": [] }, { "id": "NCT02502734_exc_R48", "type": "Has_multiplier", "arg1_id": "NCT02502734_exc_T116", "arg2_id": "NCT02502734_exc_T115", "normalized": [] } ]

[ { "id": "NCT02502734_inc_text", "type": "inclusion", "text": [ "Aged 5 years to less than 12 years at Visit 1. At least 15 (25%) children of the total study population must be aged 5 to less than 8 years. \nMale or pre-menarchial female subjects. \nSubjects must be pre-adolescent without any signs of puberty (Tanner Stage 1). \nNormal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts. \nHave a documented diagnosis of persistent asthma, as defined by the National Institutes of Health for at least 3 months prior to the Screening Visit. \nA pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening) >=80% predicted. There should be no Short acting beta-agonist (SABA) use within 4 hours of this measurement. \nUsing one of the following asthma therapies prior to entry into the study: SABA inhaler alone (e.g. salbutamol) on an as required basis and/or Regular non-inhaled corticosteroid (ICS) controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or Previously treated with ICS (equipotent to inhaled budesonide <=400 micrograms (mcg) total daily dose). There must be no ICS use within 2 weeks of Visit 1 (Screening). \nAble to replace their current SABA treatment with study supplied rescue SABA provided at Visit 1 for use as needed for the duration of the study. \nWritten informed consent from at least one parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study: (1) If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible independent ethics committee (IEC). (2) Subject and their legal guardian(s) understand that the study requires them to be treated on an outpatient basis. (3) Subject and their legal guardian(s) understand that they must comply with study medication and study assessments including recording of peak expiratory flow and rescue SABA use, attending scheduled study visits, and being accessible by a telephone call. \n" ], "offsets": [ [ 0, 2317 ] ] } ]

[ { "id": "NCT02502734_inc_T1", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T2", "type": "Value", "text": [ "5 years to less than 12 years" ], "offsets": [ [ 5, 34 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T3", "type": "Temporal", "text": [ "at Visit 1" ], "offsets": [ [ 35, 45 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T4", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 38, 45 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T6", "type": "Person", "text": [ "Male" ], "offsets": [ [ 142, 146 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T7", "type": "Person", "text": [ "pre-menarchial" ], "offsets": [ [ 150, 164 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T8", "type": "Person", "text": [ "female" ], "offsets": [ [ 165, 171 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T9", "type": "Scope", "text": [ "pre-menarchial female" ], "offsets": [ [ 150, 171 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T10", "type": "Person", "text": [ "pre-adolescent" ], "offsets": [ [ 200, 214 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T11", "type": "Condition", "text": [ "signs of puberty" ], "offsets": [ [ 227, 243 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T12", "type": "Negation", "text": [ "without any" ], "offsets": [ [ 215, 226 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T13", "type": "Measurement", "text": [ "Tanner Stage" ], "offsets": [ [ 245, 257 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T14", "type": "Value", "text": [ "1" ], "offsets": [ [ 258, 259 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T15", "type": "Scope", "text": [ "without any signs of puberty" ], "offsets": [ [ 215, 243 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T16", "type": "Measurement", "text": [ "height" ], "offsets": [ [ 286, 292 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T17", "type": "Value", "text": [ "Normal range" ], "offsets": [ [ 263, 275 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T18", "type": "Measurement", "text": [ "weight" ], "offsets": [ [ 297, 303 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T19", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 305, 311 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T21", "type": "Measurement", "text": [ "height" ], "offsets": [ [ 316, 322 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T22", "type": "Value", "text": [ "within the percentile range 3-97%" ], "offsets": [ [ 348, 381 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T20", "type": "Condition", "text": [ "persistent asthma" ], "offsets": [ [ 474, 491 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T23", "type": "Qualifier", "text": [ "as defined by the National Institutes of Health" ], "offsets": [ [ 493, 540 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T24", "type": "Temporal", "text": [ "at least 3 months prior to the Screening Visit" ], "offsets": [ [ 545, 591 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T25", "type": "Reference_point", "text": [ "Screening Visit" ], "offsets": [ [ 576, 591 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T26", "type": "Qualifier", "text": [ "pre-bronchodilatory" ], "offsets": [ [ 596, 615 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T27", "type": "Measurement", "text": [ "forced expiratory flow in 1 second (FEV1)" ], "offsets": [ [ 616, 657 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T28", "type": "Temporal", "text": [ "at Visit 1 (Screening)" ], "offsets": [ [ 658, 680 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T29", "type": "Reference_point", "text": [ "Visit 1 (Screening)" ], "offsets": [ [ 661, 680 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T30", "type": "Value", "text": [ ">=80% predicted" ], "offsets": [ [ 681, 696 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T31", "type": "Drug", "text": [ "Short acting beta-agonist (SABA)" ], "offsets": [ [ 717, 749 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T32", "type": "Temporal", "text": [ "within 4 hours of this measurement" ], "offsets": [ [ 754, 788 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T33", "type": "Reference_point", "text": [ "this measurement" ], "offsets": [ [ 772, 788 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T34", "type": "Negation", "text": [ "no" ], "offsets": [ [ 714, 716 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T35", "type": "Procedure", "text": [ "asthma therapies" ], "offsets": [ [ 818, 834 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T36", "type": "Temporal", "text": [ "prior to entry into the study" ], "offsets": [ [ 835, 864 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T37", "type": "Reference_point", "text": [ "entry into the study" ], "offsets": [ [ 844, 864 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T38", "type": "Drug", "text": [ "SABA inhaler" ], "offsets": [ [ 866, 878 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T39", "type": "Drug", "text": [ "salbutamol" ], "offsets": [ [ 891, 901 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T40", "type": "Drug", "text": [ "leukotriene receptor antagonists" ], "offsets": [ [ 1027, 1059 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T41", "type": "Drug", "text": [ "cromones" ], "offsets": [ [ 1015, 1023 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T42", "type": "Drug", "text": [ "ICS" ], "offsets": [ [ 1092, 1095 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T43", "type": "Drug", "text": [ "budesonide" ], "offsets": [ [ 1119, 1129 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T44", "type": "Value", "text": [ "<=400 micrograms (mcg)" ], "offsets": [ [ 1130, 1152 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T45", "type": "Scope", "text": [ "SABA inhaler alone (e.g. salbutamol) on an as required basis and/or Regular non-inhaled corticosteroid (ICS) controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or Previously treated with ICS (equipotent to inhaled budesonide <=400 micrograms (mcg) total daily dose)" ], "offsets": [ [ 866, 1170 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T46", "type": "Procedure", "text": [ "ICS" ], "offsets": [ [ 1189, 1192 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T47", "type": "Negation", "text": [ "no" ], "offsets": [ [ 1186, 1188 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T48", "type": "Temporal", "text": [ "within 2 weeks of Visit 1 (Screening)" ], "offsets": [ [ 1197, 1234 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T49", "type": "Reference_point", "text": [ "Visit 1 (Screening)" ], "offsets": [ [ 1215, 1234 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T50", "type": "Drug", "text": [ "SABA" ], "offsets": [ [ 1267, 1271 ] ], "normalized": [] }, { "id": "NCT02502734_inc_T51", "type": "Drug", "text": [ "rescue SABA" ], "offsets": [ [ 1302, 1313 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02502734_inc_R1", "type": "Has_index", "arg1_id": "NCT02502734_inc_T3", "arg2_id": "NCT02502734_inc_T4", "normalized": [] }, { "id": "NCT02502734_inc_R2", "type": "Has_value", "arg1_id": "NCT02502734_inc_T1", "arg2_id": "NCT02502734_inc_T2", "normalized": [] }, { "id": "NCT02502734_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02502734_inc_T2", "arg2_id": "NCT02502734_inc_T3", "normalized": [] }, { "id": "NCT02502734_inc_R4", "type": "Has_negation", "arg1_id": "NCT02502734_inc_T11", "arg2_id": "NCT02502734_inc_T12", "normalized": [] }, { "id": "NCT02502734_inc_R5", "type": "Has_value", "arg1_id": "NCT02502734_inc_T13", "arg2_id": "NCT02502734_inc_T14", "normalized": [] }, { "id": "NCT02502734_inc_R6", "type": "Subsumes", "arg1_id": "NCT02502734_inc_T15", "arg2_id": "NCT02502734_inc_T13", "normalized": [] }, { "id": "NCT02502734_inc_R7", "type": "Has_value", "arg1_id": "NCT02502734_inc_T16", "arg2_id": "NCT02502734_inc_T17", "normalized": [] }, { "id": "NCT02502734_inc_R8", "type": "Has_value", "arg1_id": "NCT02502734_inc_T18", "arg2_id": "NCT02502734_inc_T17", "normalized": [] }, { "id": "NCT02502734_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT02502734_inc_T20", "arg2_id": "NCT02502734_inc_T23", "normalized": [] }, { "id": "NCT02502734_inc_R10", "type": "Has_index", "arg1_id": "NCT02502734_inc_T24", "arg2_id": "NCT02502734_inc_T25", "normalized": [] }, { "id": "NCT02502734_inc_R11", "type": "Has_value", "arg1_id": "NCT02502734_inc_T27", "arg2_id": "NCT02502734_inc_T30", "normalized": [] }, { "id": "NCT02502734_inc_R12", "type": "Has_temporal", "arg1_id": "NCT02502734_inc_T27", "arg2_id": "NCT02502734_inc_T28", "normalized": [] }, { "id": "NCT02502734_inc_R13", "type": "Has_qualifier", "arg1_id": "NCT02502734_inc_T27", "arg2_id": "NCT02502734_inc_T26", "normalized": [] }, { "id": "NCT02502734_inc_R14", "type": "Has_index", "arg1_id": "NCT02502734_inc_T32", "arg2_id": "NCT02502734_inc_T33", "normalized": [] }, { "id": "NCT02502734_inc_R15", "type": "Has_temporal", "arg1_id": "NCT02502734_inc_T31", "arg2_id": "NCT02502734_inc_T32", "normalized": [] }, { "id": "NCT02502734_inc_R16", "type": "Has_negation", "arg1_id": "NCT02502734_inc_T31", "arg2_id": "NCT02502734_inc_T34", "normalized": [] }, { "id": "NCT02502734_inc_R17", "type": "Has_index", "arg1_id": "NCT02502734_inc_T36", "arg2_id": "NCT02502734_inc_T37", "normalized": [] }, { "id": "NCT02502734_inc_R18", "type": "Has_temporal", "arg1_id": "NCT02502734_inc_T35", "arg2_id": "NCT02502734_inc_T36", "normalized": [] }, { "id": "NCT02502734_inc_R19", "type": "Subsumes", "arg1_id": "NCT02502734_inc_T38", "arg2_id": "NCT02502734_inc_T39", "normalized": [] }, { "id": "NCT02502734_inc_R20", "type": "Has_value", "arg1_id": "NCT02502734_inc_T43", "arg2_id": "NCT02502734_inc_T44", "normalized": [] }, { "id": "NCT02502734_inc_R21", "type": "Subsumes", "arg1_id": "NCT02502734_inc_T42", "arg2_id": "NCT02502734_inc_T43", "normalized": [] }, { "id": "NCT02502734_inc_R22", "type": "Subsumes", "arg1_id": "NCT02502734_inc_T35", "arg2_id": "NCT02502734_inc_T45", "normalized": [] }, { "id": "NCT02502734_inc_R23", "type": "Has_negation", "arg1_id": "NCT02502734_inc_T46", "arg2_id": "NCT02502734_inc_T47", "normalized": [] }, { "id": "NCT02502734_inc_R24", "type": "Has_index", "arg1_id": "NCT02502734_inc_T48", "arg2_id": "NCT02502734_inc_T49", "normalized": [] }, { "id": "NCT02502734_inc_R25", "type": "Has_temporal", "arg1_id": "NCT02502734_inc_T46", "arg2_id": "NCT02502734_inc_T48", "normalized": [] } ]

[ { "id": "NCT02504203_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02504203_inc_text", "type": "inclusion", "text": [ "Children born outside the cluster, and returning more than 72 hours after the delivery\nChildren that the nurse evaluates to die within the next 24 hours.\n" ], "offsets": [ [ 0, 154 ] ] } ]

[]

[]

[]

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[ { "id": "NCT02509091_exc_text", "type": "exclusion", "text": [ "Active bleeding without control;\nReceiving nasal or facial surgery recently;\nWith severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.\nWith other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.\nBe allergic to amikacin\n" ], "offsets": [ [ 0, 354 ] ] } ]

[ { "id": "NCT02509091_exc_T1", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 7, 15 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T2", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T3", "type": "Procedure", "text": [ "facial surgery" ], "offsets": [ [ 52, 66 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T4", "type": "Procedure", "text": [ "asal", "urgery" ], "offsets": [ [ 44, 48 ], [ 60, 66 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T5", "type": "Condition", "text": [ "cardio-pulmonary dysfunction" ], "offsets": [ [ 89, 117 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T6", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 82, 88 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T7", "type": "Condition", "text": [ "left heart failure" ], "offsets": [ [ 127, 145 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T8", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 156, 166 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T9", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 147, 155 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T10", "type": "Scope", "text": [ "left heart failure, unstable arrhythmia" ], "offsets": [ [ 127, 166 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T11", "type": "Condition", "text": [ "respiratory diseases" ], "offsets": [ [ 184, 204 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T12", "type": "Condition", "text": [ "pulmonary tuberculosis" ], "offsets": [ [ 221, 243 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T13", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 214, 220 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T14", "type": "Condition", "text": [ "-tuberculosis mycobacteria (N", "monary disease, p" ], "offsets": [ [ 248, 277 ], [ 284, 301 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T15", "type": "Condition", "text": [ "NTM" ], "offsets": [ [ 276, 279 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T16", "type": "Condition", "text": [ "pulmonary aspergillosis" ], "offsets": [ [ 300, 323 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T17", "type": "Scope", "text": [ "active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis" ], "offsets": [ [ 214, 323 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T18", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 333, 341 ] ], "normalized": [] }, { "id": "NCT02509091_exc_T19", "type": "Drug", "text": [ "amikacin" ], "offsets": [ [ 345, 353 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02509091_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02509091_exc_T1", "arg2_id": "NCT02509091_exc_T2", "normalized": [] }, { "id": "NCT02509091_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02509091_exc_T5", "arg2_id": "NCT02509091_exc_T6", "normalized": [] }, { "id": "NCT02509091_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02509091_exc_T8", "arg2_id": "NCT02509091_exc_T9", "normalized": [] }, { "id": "NCT02509091_exc_R4", "type": "Subsumes", "arg1_id": "NCT02509091_exc_T5", "arg2_id": "NCT02509091_exc_T10", "normalized": [] }, { "id": "NCT02509091_exc_R5", "type": "Subsumes", "arg1_id": "NCT02509091_exc_T14", "arg2_id": "NCT02509091_exc_T15", "normalized": [] }, { "id": "NCT02509091_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02509091_exc_T12", "arg2_id": "NCT02509091_exc_T13", "normalized": [] }, { "id": "NCT02509091_exc_R7", "type": "Subsumes", "arg1_id": "NCT02509091_exc_T11", "arg2_id": "NCT02509091_exc_T17", "normalized": [] }, { "id": "NCT02509091_exc_R8", "type": "AND", "arg1_id": "NCT02509091_exc_T18", "arg2_id": "NCT02509091_exc_T19", "normalized": [] } ]

[ { "id": "NCT02509091_inc_text", "type": "inclusion", "text": [ "Age=18 years and =80 years;\nPatients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;\nAre sensitive to amikacin;\nAcute exacerbation of bronchiectasis;\nCapable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;\nWilling to join in and sign the informed consent form.\n" ], "offsets": [ [ 0, 322 ] ] } ]

[ { "id": "NCT02509091_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T2", "type": "Value", "text": [ "=18 years and =80 years" ], "offsets": [ [ 3, 26 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T3", "type": "Condition", "text": [ "non-cystic fibrosis bronchiectasis" ], "offsets": [ [ 42, 76 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T4", "type": "Procedure", "text": [ "high-resolution CT" ], "offsets": [ [ 90, 108 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T5", "type": "Condition", "text": [ "sensitive" ], "offsets": [ [ 114, 123 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T6", "type": "Drug", "text": [ "amikacin" ], "offsets": [ [ 127, 135 ] ], "normalized": [] }, { "id": "NCT02509091_inc_T7", "type": "Condition", "text": [ "Acute exacerbation of bronchiectasis" ], "offsets": [ [ 137, 173 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02509091_inc_R1", "type": "Has_value", "arg1_id": "NCT02509091_inc_T1", "arg2_id": "NCT02509091_inc_T2", "normalized": [] }, { "id": "NCT02509091_inc_R2", "type": "AND", "arg1_id": "NCT02509091_inc_T4", "arg2_id": "NCT02509091_inc_T3", "normalized": [] }, { "id": "NCT02509091_inc_R3", "type": "AND", "arg1_id": "NCT02509091_inc_T5", "arg2_id": "NCT02509091_inc_T6", "normalized": [] } ]

[ { "id": "NCT02509949_exc_text", "type": "exclusion", "text": [ "Patients with a history of drug abuse;\npreoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).\n" ], "offsets": [ [ 0, 235 ] ] } ]

[ { "id": "NCT02509949_exc_T1", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 27, 37 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T2", "type": "Observation", "text": [ "history" ], "offsets": [ [ 16, 23 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 52, 59 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T4", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 63, 76 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T5", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 39, 51 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T6", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 78, 86 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T7", "type": "Condition", "text": [ "parkinsonism" ], "offsets": [ [ 88, 100 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T8", "type": "Drug", "text": [ "cholinesterase inhibitor" ], "offsets": [ [ 109, 133 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T9", "type": "Condition", "text": [ "inability to communicate" ], "offsets": [ [ 135, 159 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T10", "type": "Condition", "text": [ "coma" ], "offsets": [ [ 188, 192 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T11", "type": "Condition", "text": [ "profound dementia" ], "offsets": [ [ 194, 211 ] ], "normalized": [] }, { "id": "NCT02509949_exc_T12", "type": "Condition", "text": [ "language barrier" ], "offsets": [ [ 216, 232 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02509949_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02509949_exc_T1", "arg2_id": "NCT02509949_exc_T2", "normalized": [] } ]

[ { "id": "NCT02509949_inc_text", "type": "inclusion", "text": [ "age > 17 and < 60 years;\nAmerican Society of Anesthesiology (ASA) I-III;\nadmitted for living donor renal transplantation.\n" ], "offsets": [ [ 0, 122 ] ] } ]

[ { "id": "NCT02509949_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02509949_inc_T2", "type": "Value", "text": [ "> 17 and < 60 years" ], "offsets": [ [ 4, 23 ] ], "normalized": [] }, { "id": "NCT02509949_inc_T3", "type": "Measurement", "text": [ "American Society of Anesthesiology (ASA)" ], "offsets": [ [ 25, 65 ] ], "normalized": [] }, { "id": "NCT02509949_inc_T4", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 66, 71 ] ], "normalized": [] }, { "id": "NCT02509949_inc_T5", "type": "Procedure", "text": [ "living donor renal transplantation" ], "offsets": [ [ 86, 120 ] ], "normalized": [] }, { "id": "NCT02509949_inc_T6", "type": "Mood", "text": [ "admitted for" ], "offsets": [ [ 73, 85 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02509949_inc_R1", "type": "Has_value", "arg1_id": "NCT02509949_inc_T1", "arg2_id": "NCT02509949_inc_T2", "normalized": [] }, { "id": "NCT02509949_inc_R2", "type": "Has_value", "arg1_id": "NCT02509949_inc_T3", "arg2_id": "NCT02509949_inc_T4", "normalized": [] }, { "id": "NCT02509949_inc_R3", "type": "Has_mood", "arg1_id": "NCT02509949_inc_T5", "arg2_id": "NCT02509949_inc_T6", "normalized": [] } ]

[ { "id": "NCT02510404_exc_text", "type": "exclusion", "text": [ "1. Patients with other uncontrolled infections (see 2.3.2 for definitions) \n2. Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies in the last 28 days \n3. Received donor lymphocyte infusion in last 28 days \n4. Diagnosis of Omenn's syndrome or MHC class I deficiency \n5. Active and uncontrolled malignancy \n6. Pregnant or lactating \n7. Unable to wean steroids to ≤0.5 mg/kg/day prednisone. \n8. Patients with Grade 3 hyperbilirubinemia \n \n" ], "offsets": [ [ 0, 486 ] ] } ]

[ { "id": "NCT02510404_exc_T9", "type": "Condition", "text": [ "other uncontrolled infections" ], "offsets": [ [ 17, 46 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T12", "type": "Drug", "text": [ "ATG" ], "offsets": [ [ 101, 104 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T13", "type": "Drug", "text": [ "Campath" ], "offsets": [ [ 106, 113 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T14", "type": "Drug", "text": [ "T cell immunosuppressive monoclonal antibodies" ], "offsets": [ [ 124, 170 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T15", "type": "Temporal", "text": [ "in the last 28 days" ], "offsets": [ [ 171, 190 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T16", "type": "Scope", "text": [ "ATG, Campath, or other T cell immunosuppressive monoclonal antibodies" ], "offsets": [ [ 101, 170 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T17", "type": "Procedure", "text": [ "donor lymphocyte infusion" ], "offsets": [ [ 204, 229 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T18", "type": "Temporal", "text": [ "in last 28 days" ], "offsets": [ [ 230, 245 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T19", "type": "Condition", "text": [ "Omenn's syndrome" ], "offsets": [ [ 263, 279 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T20", "type": "Condition", "text": [ "MHC class I deficiency" ], "offsets": [ [ 283, 305 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T21", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 334, 344 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T22", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 321, 333 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T23", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 310, 316 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T24", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 349, 357 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T25", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 361, 370 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T26", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 390, 398 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T27", "type": "Value", "text": [ "≤0.5 mg/kg/day" ], "offsets": [ [ 402, 416 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T28", "type": "Procedure", "text": [ "wean" ], "offsets": [ [ 385, 389 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T29", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 417, 427 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T30", "type": "Negation", "text": [ "Unable" ], "offsets": [ [ 375, 381 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T31", "type": "Condition", "text": [ "hyperbilirubinemia" ], "offsets": [ [ 455, 473 ] ], "normalized": [] }, { "id": "NCT02510404_exc_T32", "type": "Qualifier", "text": [ "Grade 3" ], "offsets": [ [ 447, 454 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02510404_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02510404_exc_T16", "arg2_id": "NCT02510404_exc_T15", "normalized": [] }, { "id": "NCT02510404_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02510404_exc_T17", "arg2_id": "NCT02510404_exc_T18", "normalized": [] }, { "id": "NCT02510404_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02510404_exc_T21", "arg2_id": "NCT02510404_exc_T23", "normalized": [] }, { "id": "NCT02510404_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02510404_exc_T21", "arg2_id": "NCT02510404_exc_T22", "normalized": [] }, { "id": "NCT02510404_exc_R5", "type": "AND", "arg1_id": "NCT02510404_exc_T28", "arg2_id": "NCT02510404_exc_T26", "normalized": [] }, { "id": "NCT02510404_exc_R7", "type": "Has_value", "arg1_id": "NCT02510404_exc_T29", "arg2_id": "NCT02510404_exc_T27", "normalized": [] }, { "id": "NCT02510404_exc_R6", "type": "Subsumes", "arg1_id": "NCT02510404_exc_T26", "arg2_id": "NCT02510404_exc_T29", "normalized": [] }, { "id": "NCT02510404_exc_R8", "type": "Has_negation", "arg1_id": "NCT02510404_exc_T28", "arg2_id": "NCT02510404_exc_T30", "normalized": [] }, { "id": "NCT02510404_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02510404_exc_T31", "arg2_id": "NCT02510404_exc_T32", "normalized": [] } ]

[ { "id": "NCT02510404_inc_text", "type": "inclusion", "text": [ "1. Diagnosis of primary immunodeficiency with established plan to undergo myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant for treatment thereof or diagnosis of a form of primary immunodeficiency for which hematopoietic stem cell transplantation is not indicated. \n2. Active infection with EBV, CMV, and/or Adenovirus, unable to be successfully controlled with standard therapy. \n3. Steroids less than 0.5 mg/kg/day prednisone \n4. Karnofsky/Lansky score of ≥ 50 \n5. ANC greater than 500/µL. \n6. Bilirubin <2x, AST <3x, Serum creatinine <2x upper limit of normal, Hgb >8.0 \n7. Pulse oximetry of > 90% on room air \n8. Negative pregnancy test (if female of childbearing potential) \n9. Patient or parent/guardian capable of providing informed consent. \n" ], "offsets": [ [ 0, 781 ] ] } ]

[ { "id": "NCT02510404_inc_T10", "type": "Condition", "text": [ "primary immunodeficiency" ], "offsets": [ [ 16, 40 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T11", "type": "Procedure", "text": [ "allogeneic hematopoietic stem cell transplant", "myeloablative" ], "offsets": [ [ 109, 154 ], [ 74, 87 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T12", "type": "Procedure", "text": [ "non-myeloablative allogeneic hematopoietic stem cell transplant" ], "offsets": [ [ 91, 154 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T13", "type": "Condition", "text": [ "primary immunodeficiency" ], "offsets": [ [ 203, 227 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T14", "type": "Procedure", "text": [ "hematopoietic stem cell transplantation" ], "offsets": [ [ 238, 277 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T15", "type": "Negation", "text": [ "not indicated" ], "offsets": [ [ 281, 294 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T16", "type": "Scope", "text": [ "myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant" ], "offsets": [ [ 74, 154 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T17", "type": "Condition", "text": [ "EBV" ], "offsets": [ [ 322, 325 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T18", "type": "Condition", "text": [ "CMV" ], "offsets": [ [ 327, 330 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T19", "type": "Condition", "text": [ "Adenovirus" ], "offsets": [ [ 339, 349 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T20", "type": "Qualifier", "text": [ "unable to be", "controlled" ], "offsets": [ [ 351, 363 ], [ 377, 387 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T21", "type": "Procedure", "text": [ "standard therapy" ], "offsets": [ [ 393, 409 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T22", "type": "Scope", "text": [ "EBV, CMV, and/or Adenovirus" ], "offsets": [ [ 322, 349 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T23", "type": "Drug", "text": [ "Steroids" ], "offsets": [ [ 415, 423 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T24", "type": "Multiplier", "text": [ "less than 0.5 mg/kg/day" ], "offsets": [ [ 424, 447 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T25", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 448, 458 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T26", "type": "Measurement", "text": [ "Karnofsky/Lansky score" ], "offsets": [ [ 463, 485 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T27", "type": "Value", "text": [ "≥ 50" ], "offsets": [ [ 489, 493 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T28", "type": "Measurement", "text": [ "ANC" ], "offsets": [ [ 498, 501 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T29", "type": "Value", "text": [ "greater than 500/µL" ], "offsets": [ [ 502, 521 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T30", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 527, 536 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T31", "type": "Value", "text": [ "<2x" ], "offsets": [ [ 537, 540 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T32", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 542, 545 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T33", "type": "Value", "text": [ "<3x" ], "offsets": [ [ 546, 549 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T34", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 551, 567 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T35", "type": "Value", "text": [ "<2x upper limit of normal" ], "offsets": [ [ 568, 593 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T36", "type": "Measurement", "text": [ "Hgb" ], "offsets": [ [ 595, 598 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T37", "type": "Value", "text": [ ">8.0" ], "offsets": [ [ 599, 603 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T38", "type": "Measurement", "text": [ "Pulse oximetry", "on room air" ], "offsets": [ [ 608, 622 ], [ 632, 643 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T39", "type": "Value", "text": [ "> 90%" ], "offsets": [ [ 626, 631 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T40", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 657, 671 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T41", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 648, 656 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T42", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 686, 708 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T43", "type": "Person", "text": [ "female" ], "offsets": [ [ 676, 682 ] ], "normalized": [] }, { "id": "NCT02510404_inc_T44", "type": "Scope", "text": [ "female of childbearing potential" ], "offsets": [ [ 676, 708 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02510404_inc_R1", "type": "Has_negation", "arg1_id": "NCT02510404_inc_T14", "arg2_id": "NCT02510404_inc_T15", "normalized": [] }, { "id": "NCT02510404_inc_R2", "type": "AND", "arg1_id": "NCT02510404_inc_T13", "arg2_id": "NCT02510404_inc_T14", "normalized": [] }, { "id": "NCT02510404_inc_R3", "type": "Has_scope", "arg1_id": "NCT02510404_inc_T10", "arg2_id": "NCT02510404_inc_T16", "normalized": [] }, { "id": "NCT02510404_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02510404_inc_T21", "arg2_id": "NCT02510404_inc_T20", "normalized": [] }, { "id": "NCT02510404_inc_R5", "type": "AND", "arg1_id": "NCT02510404_inc_T22", "arg2_id": "NCT02510404_inc_T21", "normalized": [] }, { "id": "NCT02510404_inc_R6", "type": "Subsumes", "arg1_id": "NCT02510404_inc_T23", "arg2_id": "NCT02510404_inc_T25", "normalized": [] }, { "id": "NCT02510404_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT02510404_inc_T25", "arg2_id": "NCT02510404_inc_T24", "normalized": [] }, { "id": "NCT02510404_inc_R8", "type": "Has_value", "arg1_id": "NCT02510404_inc_T26", "arg2_id": "NCT02510404_inc_T27", "normalized": [] }, { "id": "NCT02510404_inc_R9", "type": "Has_value", "arg1_id": "NCT02510404_inc_T28", "arg2_id": "NCT02510404_inc_T29", "normalized": [] }, { "id": "NCT02510404_inc_R10", "type": "Has_value", "arg1_id": "NCT02510404_inc_T30", "arg2_id": "NCT02510404_inc_T31", "normalized": [] }, { "id": "NCT02510404_inc_R11", "type": "Has_value", "arg1_id": "NCT02510404_inc_T32", "arg2_id": "NCT02510404_inc_T33", "normalized": [] }, { "id": "NCT02510404_inc_R12", "type": "Has_value", "arg1_id": "NCT02510404_inc_T34", "arg2_id": "NCT02510404_inc_T35", "normalized": [] }, { "id": "NCT02510404_inc_R13", "type": "Has_value", "arg1_id": "NCT02510404_inc_T36", "arg2_id": "NCT02510404_inc_T37", "normalized": [] }, { "id": "NCT02510404_inc_R14", "type": "Has_value", "arg1_id": "NCT02510404_inc_T38", "arg2_id": "NCT02510404_inc_T39", "normalized": [] }, { "id": "NCT02510404_inc_R15", "type": "Has_value", "arg1_id": "NCT02510404_inc_T40", "arg2_id": "NCT02510404_inc_T41", "normalized": [] }, { "id": "NCT02510404_inc_R16", "type": "AND", "arg1_id": "NCT02510404_inc_T44", "arg2_id": "NCT02510404_inc_T40", "normalized": [] } ]