Datasets:

bigbio

/

chia

like 2

[ { "id": "NCT02186600_exc_text", "type": "exclusion", "text": [ "Have osteoporosis \nHave a 10 yr probability of hip fracture >3% or major fracture >20% based on results of the FRAX tool \nCurrently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone \nCurrently participate in a resistance training or high impact weight bearing exercise program two or more times weekly \nWeigh >300 lbs \nHave abnormal results for the following laboratory tests: serum 25(OH)D; serum creatinine; serum calcium; PTH; TSH \nHave Paget's disease, heart disease, uncontrolled hypertension, renal disease, or other concomitant conditions that prohibit participation in exercises, risedronate therapy, or use of CaD supplements. \n \n" ], "offsets": [ [ 0, 702 ] ] } ]

[ { "id": "NCT02186600_exc_T1", "type": "Condition", "text": [ "osteoporosis" ], "offsets": [ [ 5, 17 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T2", "type": "Measurement", "text": [ "10 yr probability of hip fracture" ], "offsets": [ [ 26, 59 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T3", "type": "Condition", "text": [ "hip fracture" ], "offsets": [ [ 47, 59 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T4", "type": "Value", "text": [ ">3%" ], "offsets": [ [ 60, 63 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T5", "type": "Measurement", "text": [ "10 yr probability of", "major fracture" ], "offsets": [ [ 26, 46 ], [ 67, 81 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T6", "type": "Condition", "text": [ "major fracture" ], "offsets": [ [ 67, 81 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T8", "type": "Value", "text": [ ">20%" ], "offsets": [ [ 82, 86 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T9", "type": "Drug", "text": [ "bisphosphonates" ], "offsets": [ [ 137, 152 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T10", "type": "Procedure", "text": [ "estrogen replacement therapy" ], "offsets": [ [ 154, 182 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T11", "type": "Drug", "text": [ "glucocorticosteroids" ], "offsets": [ [ 184, 204 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T12", "type": "Drug", "text": [ "drugs affecting bone" ], "offsets": [ [ 215, 235 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T14", "type": "Condition", "text": [ "participate in a resistance training" ], "offsets": [ [ 247, 283 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T16", "type": "Condition", "text": [ "participate in", "high impact weight bearing exercise" ], "offsets": [ [ 247, 261 ], [ 287, 322 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T18", "type": "Multiplier", "text": [ "two or more times weekly" ], "offsets": [ [ 331, 355 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T19", "type": "Measurement", "text": [ "Weigh" ], "offsets": [ [ 357, 362 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T20", "type": "Value", "text": [ ">300 lbs" ], "offsets": [ [ 363, 371 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T21", "type": "Value", "text": [ "abnormal results" ], "offsets": [ [ 378, 394 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T22", "type": "Measurement", "text": [ "serum 25(OH)D" ], "offsets": [ [ 431, 444 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T23", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 446, 462 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T24", "type": "Measurement", "text": [ "serum calcium" ], "offsets": [ [ 464, 477 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T25", "type": "Measurement", "text": [ "PTH" ], "offsets": [ [ 479, 482 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T26", "type": "Measurement", "text": [ "TSH" ], "offsets": [ [ 484, 487 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T27", "type": "Condition", "text": [ "Paget's disease" ], "offsets": [ [ 494, 509 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T28", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 511, 524 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T29", "type": "Condition", "text": [ "uncontrolled hypertension" ], "offsets": [ [ 526, 551 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T30", "type": "Condition", "text": [ "renal disease" ], "offsets": [ [ 553, 566 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T31", "type": "Condition", "text": [ "other concomitant conditions that prohibit participation in exercises" ], "offsets": [ [ 571, 640 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T33", "type": "Procedure", "text": [ "risedronate therapy" ], "offsets": [ [ 642, 661 ] ], "normalized": [] }, { "id": "NCT02186600_exc_T34", "type": "Drug", "text": [ "CaD supplements" ], "offsets": [ [ 673, 688 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02186600_exc_R1", "type": "Has_value", "arg1_id": "NCT02186600_exc_T2", "arg2_id": "NCT02186600_exc_T4", "normalized": [] }, { "id": "NCT02186600_exc_R2", "type": "Has_value", "arg1_id": "NCT02186600_exc_T5", "arg2_id": "NCT02186600_exc_T8", "normalized": [] }, { "id": "NCT02186600_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT02186600_exc_T16", "arg2_id": "NCT02186600_exc_T18", "normalized": [] }, { "id": "NCT02186600_exc_R4", "type": "Has_multiplier", "arg1_id": "NCT02186600_exc_T14", "arg2_id": "NCT02186600_exc_T18", "normalized": [] }, { "id": "NCT02186600_exc_R5", "type": "Has_value", "arg1_id": "NCT02186600_exc_T19", "arg2_id": "NCT02186600_exc_T20", "normalized": [] }, { "id": "NCT02186600_exc_R6", "type": "Has_value", "arg1_id": "NCT02186600_exc_T22", "arg2_id": "NCT02186600_exc_T21", "normalized": [] }, { "id": "NCT02186600_exc_R7", "type": "Has_value", "arg1_id": "NCT02186600_exc_T23", "arg2_id": "NCT02186600_exc_T21", "normalized": [] }, { "id": "NCT02186600_exc_R8", "type": "Has_value", "arg1_id": "NCT02186600_exc_T24", "arg2_id": "NCT02186600_exc_T21", "normalized": [] }, { "id": "NCT02186600_exc_R9", "type": "Has_value", "arg1_id": "NCT02186600_exc_T25", "arg2_id": "NCT02186600_exc_T21", "normalized": [] }, { "id": "NCT02186600_exc_R10", "type": "Has_value", "arg1_id": "NCT02186600_exc_T26", "arg2_id": "NCT02186600_exc_T21", "normalized": [] } ]

[ { "id": "NCT02186600_inc_text", "type": "inclusion", "text": [ "Women who are in their first 5 years of menopause \nHave a T score between -1 and -2.49 at the femoral neck, total hip, or L1-L4 spine \nBe 19 years of age or older \nHave their health care provider's permission to enroll in the study. \n" ], "offsets": [ [ 0, 234 ] ] } ]

[ { "id": "NCT02186600_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T2", "type": "Temporal", "text": [ "n their first 5 years of menopause" ], "offsets": [ [ 15, 49 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T3", "type": "Reference_point", "text": [ "menopause" ], "offsets": [ [ 40, 49 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T4", "type": "Condition", "text": [ "menopause" ], "offsets": [ [ 40, 49 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T5", "type": "Measurement", "text": [ "T score" ], "offsets": [ [ 58, 65 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T6", "type": "Temporal", "text": [ "between -1 and -2.49" ], "offsets": [ [ 66, 86 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T7", "type": "Qualifier", "text": [ "femoral neck" ], "offsets": [ [ 94, 106 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T8", "type": "Qualifier", "text": [ "total hip" ], "offsets": [ [ 108, 117 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T9", "type": "Qualifier", "text": [ "L1-L4 spine" ], "offsets": [ [ 122, 133 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T10", "type": "Value", "text": [ "19 years of age or older" ], "offsets": [ [ 138, 162 ] ], "normalized": [] }, { "id": "NCT02186600_inc_T11", "type": "Person", "text": [ "age" ], "offsets": [ [ 150, 153 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02186600_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02186600_inc_T5", "arg2_id": "NCT02186600_inc_T6", "normalized": [] }, { "id": "NCT02186600_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02186600_inc_T5", "arg2_id": "NCT02186600_inc_T7", "normalized": [] }, { "id": "NCT02186600_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02186600_inc_T5", "arg2_id": "NCT02186600_inc_T8", "normalized": [] }, { "id": "NCT02186600_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02186600_inc_T5", "arg2_id": "NCT02186600_inc_T9", "normalized": [] }, { "id": "NCT02186600_inc_R5", "type": "Has_value", "arg1_id": "NCT02186600_inc_T11", "arg2_id": "NCT02186600_inc_T10", "normalized": [] } ]

[ { "id": "NCT02186782_exc_text", "type": "exclusion", "text": [ "Age < 20 or > 35 years.\nBody mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.\nPresence of any infertility factor other than anovulation/oligoovulation.\nPrevious history of ovarian surgery or surgical removal of one ovary.\nPrevious exposure to cytotoxic drugs or pelvic irradiation.\nMetabolic or hormonal abnormalities.\n" ], "offsets": [ [ 0, 315 ] ] } ]

[ { "id": "NCT02186782_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T2", "type": "Value", "text": [ "< 20" ], "offsets": [ [ 4, 8 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T3", "type": "Value", "text": [ "> 35 years" ], "offsets": [ [ 12, 22 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T4", "type": "Scope", "text": [ "< 20 or > 35 years" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T5", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 24, 39 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T6", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 41, 44 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T7", "type": "Value", "text": [ "< 18.5 kg/m2" ], "offsets": [ [ 46, 58 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T8", "type": "Value", "text": [ "> 25 kg/m2" ], "offsets": [ [ 62, 72 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T9", "type": "Scope", "text": [ "< 18.5 kg/m2 or > 25 kg/m2" ], "offsets": [ [ 46, 72 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T10", "type": "Condition", "text": [ "infertility factor" ], "offsets": [ [ 90, 108 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T11", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 109, 119 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T12", "type": "Condition", "text": [ "anovulation" ], "offsets": [ [ 120, 131 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T13", "type": "Condition", "text": [ "oligoovulation" ], "offsets": [ [ 132, 146 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T14", "type": "Scope", "text": [ "anovulation/oligoovulation" ], "offsets": [ [ 120, 146 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T15", "type": "Procedure", "text": [ "ovarian surgery" ], "offsets": [ [ 168, 183 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T16", "type": "Procedure", "text": [ "surgical removal" ], "offsets": [ [ 187, 203 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T17", "type": "Qualifier", "text": [ "ovary" ], "offsets": [ [ 211, 216 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T18", "type": "Multiplier", "text": [ "one" ], "offsets": [ [ 207, 210 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T20", "type": "Drug", "text": [ "cytotoxic drugs" ], "offsets": [ [ 239, 254 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T21", "type": "Procedure", "text": [ "pelvic irradiation" ], "offsets": [ [ 258, 276 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T19", "type": "Condition", "text": [ "hormonal abnormalities" ], "offsets": [ [ 291, 313 ] ], "normalized": [] }, { "id": "NCT02186782_exc_T22", "type": "Condition", "text": [ "olic or h", "malities." ], "offsets": [ [ 283, 292 ], [ 305, 314 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02186782_exc_R1", "type": "Has_scope", "arg1_id": "NCT02186782_exc_T1", "arg2_id": "NCT02186782_exc_T4", "normalized": [] }, { "id": "NCT02186782_exc_R2", "type": "Subsumes", "arg1_id": "NCT02186782_exc_T5", "arg2_id": "NCT02186782_exc_T6", "normalized": [] }, { "id": "NCT02186782_exc_R3", "type": "Has_scope", "arg1_id": "NCT02186782_exc_T5", "arg2_id": "NCT02186782_exc_T9", "normalized": [] }, { "id": "NCT02186782_exc_R4", "type": "Has_negation", "arg1_id": "NCT02186782_exc_T14", "arg2_id": "NCT02186782_exc_T11", "normalized": [] }, { "id": "NCT02186782_exc_R5", "type": "Has_multiplier", "arg1_id": "NCT02186782_exc_T17", "arg2_id": "NCT02186782_exc_T18", "normalized": [] }, { "id": "NCT02186782_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02186782_exc_T16", "arg2_id": "NCT02186782_exc_T17", "normalized": [] } ]

[ { "id": "NCT02186782_inc_text", "type": "inclusion", "text": [ "Infertile women with eugonadotrophic anovulation/oligoovulation.\nUnexplained infertility.\n" ], "offsets": [ [ 0, 90 ] ] } ]

[ { "id": "NCT02186782_inc_T1", "type": "Person", "text": [ "women" ], "offsets": [ [ 10, 15 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T2", "type": "Condition", "text": [ "Infertile" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T3", "type": "Condition", "text": [ "anovulation" ], "offsets": [ [ 37, 48 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T4", "type": "Condition", "text": [ "oligoovulation" ], "offsets": [ [ 49, 63 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T5", "type": "Qualifier", "text": [ "eugonadotrophic" ], "offsets": [ [ 21, 36 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T6", "type": "Scope", "text": [ "anovulation/oligoovulation" ], "offsets": [ [ 37, 63 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T7", "type": "Qualifier", "text": [ "Unexplained" ], "offsets": [ [ 65, 76 ] ], "normalized": [] }, { "id": "NCT02186782_inc_T8", "type": "Condition", "text": [ "infertility" ], "offsets": [ [ 77, 88 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02186782_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02186782_inc_T6", "arg2_id": "NCT02186782_inc_T5", "normalized": [] }, { "id": "NCT02186782_inc_R2", "type": "Has_scope", "arg1_id": "NCT02186782_inc_T2", "arg2_id": "NCT02186782_inc_T6", "normalized": [] }, { "id": "NCT02186782_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02186782_inc_T8", "arg2_id": "NCT02186782_inc_T7", "normalized": [] } ]

[ { "id": "NCT02195024_exc_text", "type": "exclusion", "text": [ "Pacing threshold(s) (at 0.4 or 0.5 ms) and/or sensing amplitude(s) and/or impedance(s) are not measurable\nMeet one or more of the contraindications for MRI including Psychiatric disorders, anxiety, claustrophobia Cardiac disorders that represent a contraindication to MRI\nCardiac surgery already scheduled in the next three months\nHave other medical implants that may interact with MRI, e.g. abandoned implantable cardioverter defibrillator (ICD) leads or pacemaker leads other than MRI conditional, lead extensions, other active medical devices, non-MRI compatible devices, mechanical valve\nHave other metallic artifacts/components in body that may interact with MRI\nSubjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated\nSubjects who require a legally authorized representative to obtain consent\nSubjects who are immediate candidates for an ICD\nSubjects with medical conditions that preclude the testing required by the protocol or limit study participation\nSubjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study\nBeing pregnant\nHave a life expectancy of less than three months\nSubjects with exclusion criteria required by local law (e.g. age, breastfeeding)\n" ], "offsets": [ [ 0, 1411 ] ] } ]

[ { "id": "NCT02195024_exc_T1", "type": "Procedure", "text": [ "Pacing threshold" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T2", "type": "Qualifier", "text": [ "at 0.4 or 0.5 ms" ], "offsets": [ [ 21, 37 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T3", "type": "Condition", "text": [ "not measurable" ], "offsets": [ [ 91, 105 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T4", "type": "Procedure", "text": [ "sensing amplitude" ], "offsets": [ [ 46, 63 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T5", "type": "Procedure", "text": [ "impedance" ], "offsets": [ [ 74, 83 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T6", "type": "Scope", "text": [ "Pacing threshold(s) (at 0.4 or 0.5 ms) and/or sensing amplitude(s) and/or impedance" ], "offsets": [ [ 0, 83 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T7", "type": "Multiplier", "text": [ "one or more" ], "offsets": [ [ 111, 122 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T8", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 130, 147 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T9", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 152, 155 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T10", "type": "Condition", "text": [ "Psychiatric disorders" ], "offsets": [ [ 166, 187 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T11", "type": "Condition", "text": [ "anxiety" ], "offsets": [ [ 189, 196 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T12", "type": "Condition", "text": [ "claustrophobia" ], "offsets": [ [ 198, 212 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T13", "type": "Condition", "text": [ "Cardiac disorders" ], "offsets": [ [ 213, 230 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T14", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 248, 264 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T15", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 268, 271 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T16", "type": "Scope", "text": [ "Psychiatric disorders, anxiety, claustrophobia Cardiac disorders that represent a contraindication to MRI" ], "offsets": [ [ 166, 271 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T17", "type": "Procedure", "text": [ "Cardiac surgery" ], "offsets": [ [ 272, 287 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T18", "type": "Mood", "text": [ "scheduled" ], "offsets": [ [ 296, 305 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T19", "type": "Temporal", "text": [ "in the next three months" ], "offsets": [ [ 306, 330 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T20", "type": "Reference_point", "text": [ "three months" ], "offsets": [ [ 318, 330 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T21", "type": "Device", "text": [ "medical implants" ], "offsets": [ [ 342, 358 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T22", "type": "Condition", "text": [ "interact with MRI" ], "offsets": [ [ 368, 385 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T23", "type": "Device", "text": [ "abandoned implantable cardioverter defibrillator (ICD) leads" ], "offsets": [ [ 392, 452 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T24", "type": "Device", "text": [ "pacemaker leads" ], "offsets": [ [ 456, 471 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T25", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 472, 482 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T26", "type": "Device", "text": [ "MRI conditional" ], "offsets": [ [ 483, 498 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T27", "type": "Device", "text": [ "lead extensions" ], "offsets": [ [ 500, 515 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T28", "type": "Device", "text": [ "active medical devices" ], "offsets": [ [ 523, 545 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T29", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 517, 522 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T30", "type": "Device", "text": [ "non-MRI compatible devices" ], "offsets": [ [ 547, 573 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T31", "type": "Device", "text": [ "mechanical valve" ], "offsets": [ [ 575, 591 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T32", "type": "Scope", "text": [ "abandoned implantable cardioverter defibrillator (ICD) leads or pacemaker leads other than MRI conditional, lead extensions, other active medical devices, non-MRI compatible devices, mechanical valve" ], "offsets": [ [ 392, 591 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T33", "type": "Scope", "text": [ "medical implants that may interact with MRI" ], "offsets": [ [ 342, 385 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T34", "type": "Device", "text": [ "metallic artifacts" ], "offsets": [ [ 603, 621 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T35", "type": "Device", "text": [ "llic art", "onents in" ], "offsets": [ [ 607, 615 ], [ 626, 635 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T36", "type": "Condition", "text": [ "interact" ], "offsets": [ [ 650, 658 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T37", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 664, 667 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T38", "type": "Multiplier", "text": [ "single" ], "offsets": [ [ 688, 694 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T39", "type": "Multiplier", "text": [ "dose of 1.0 milligram (mg)" ], "offsets": [ [ 695, 721 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T40", "type": "Drug", "text": [ "dexamethasone acetate" ], "offsets": [ [ 722, 743 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T41", "type": "Condition", "text": [ "contraindicated" ], "offsets": [ [ 751, 766 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T43", "type": "Temporal", "text": [ "immediate" ], "offsets": [ [ 859, 868 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T44", "type": "Mood", "text": [ "candidates for" ], "offsets": [ [ 869, 883 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T45", "type": "Procedure", "text": [ "ICD" ], "offsets": [ [ 887, 890 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T46", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 905, 923 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T47", "type": "Condition", "text": [ "preclude" ], "offsets": [ [ 929, 937 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T48", "type": "Procedure", "text": [ "testing required by the protoco" ], "offsets": [ [ 942, 973 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T49", "type": "Condition", "text": [ "limit study participation" ], "offsets": [ [ 978, 1003 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T50", "type": "Scope", "text": [ "preclude the testing required by the protocol or limit study participation" ], "offsets": [ [ 929, 1003 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T52", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1272, 1280 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T53", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 1288, 1303 ] ], "normalized": [] }, { "id": "NCT02195024_exc_T54", "type": "Value", "text": [ "less than three months" ], "offsets": [ [ 1307, 1329 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02195024_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02195024_exc_T1", "arg2_id": "NCT02195024_exc_T2", "normalized": [] }, { "id": "NCT02195024_exc_R2", "type": "AND", "arg1_id": "NCT02195024_exc_T6", "arg2_id": "NCT02195024_exc_T3", "normalized": [] }, { "id": "NCT02195024_exc_R3", "type": "AND", "arg1_id": "NCT02195024_exc_T14", "arg2_id": "NCT02195024_exc_T15", "normalized": [] }, { "id": "NCT02195024_exc_R4", "type": "AND", "arg1_id": "NCT02195024_exc_T13", "arg2_id": "NCT02195024_exc_T14", "normalized": [] }, { "id": "NCT02195024_exc_R5", "type": "AND", "arg1_id": "NCT02195024_exc_T8", "arg2_id": "NCT02195024_exc_T9", "normalized": [] }, { "id": "NCT02195024_exc_R6", "type": "Has_multiplier", "arg1_id": "NCT02195024_exc_T8", "arg2_id": "NCT02195024_exc_T7", "normalized": [] }, { "id": "NCT02195024_exc_R7", "type": "Subsumes", "arg1_id": "NCT02195024_exc_T8", "arg2_id": "NCT02195024_exc_T16", "normalized": [] }, { "id": "NCT02195024_exc_R8", "type": "Has_mood", "arg1_id": "NCT02195024_exc_T17", "arg2_id": "NCT02195024_exc_T18", "normalized": [] }, { "id": "NCT02195024_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02195024_exc_T17", "arg2_id": "NCT02195024_exc_T19", "normalized": [] }, { "id": "NCT02195024_exc_R10", "type": "Has_index", "arg1_id": "NCT02195024_exc_T19", "arg2_id": "NCT02195024_exc_T20", "normalized": [] }, { "id": "NCT02195024_exc_R11", "type": "AND", "arg1_id": "NCT02195024_exc_T21", "arg2_id": "NCT02195024_exc_T22", "normalized": [] }, { "id": "NCT02195024_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02195024_exc_T28", "arg2_id": "NCT02195024_exc_T29", "normalized": [] }, { "id": "NCT02195024_exc_R13", "type": "Has_negation", "arg1_id": "NCT02195024_exc_T26", "arg2_id": "NCT02195024_exc_T25", "normalized": [] }, { "id": "NCT02195024_exc_R14", "type": "AND", "arg1_id": "NCT02195024_exc_T24", "arg2_id": "NCT02195024_exc_T26", "normalized": [] }, { "id": "NCT02195024_exc_R15", "type": "Subsumes", "arg1_id": "NCT02195024_exc_T33", "arg2_id": "NCT02195024_exc_T32", "normalized": [] }, { "id": "NCT02195024_exc_R16", "type": "AND", "arg1_id": "NCT02195024_exc_T36", "arg2_id": "NCT02195024_exc_T37", "normalized": [] }, { "id": "NCT02195024_exc_R17", "type": "AND", "arg1_id": "NCT02195024_exc_T35", "arg2_id": "NCT02195024_exc_T36", "normalized": [] }, { "id": "NCT02195024_exc_R18", "type": "AND", "arg1_id": "NCT02195024_exc_T34", "arg2_id": "NCT02195024_exc_T36", "normalized": [] }, { "id": "NCT02195024_exc_R19", "type": "AND", "arg1_id": "NCT02195024_exc_T41", "arg2_id": "NCT02195024_exc_T40", "normalized": [] }, { "id": "NCT02195024_exc_R20", "type": "Has_multiplier", "arg1_id": "NCT02195024_exc_T40", "arg2_id": "NCT02195024_exc_T39", "normalized": [] }, { "id": "NCT02195024_exc_R21", "type": "Has_multiplier", "arg1_id": "NCT02195024_exc_T40", "arg2_id": "NCT02195024_exc_T38", "normalized": [] }, { "id": "NCT02195024_exc_R22", "type": "Has_mood", "arg1_id": "NCT02195024_exc_T45", "arg2_id": "NCT02195024_exc_T44", "normalized": [] }, { "id": "NCT02195024_exc_R23", "type": "Has_temporal", "arg1_id": "NCT02195024_exc_T45", "arg2_id": "NCT02195024_exc_T43", "normalized": [] }, { "id": "NCT02195024_exc_R24", "type": "AND", "arg1_id": "NCT02195024_exc_T47", "arg2_id": "NCT02195024_exc_T48", "normalized": [] }, { "id": "NCT02195024_exc_R25", "type": "Has_scope", "arg1_id": "NCT02195024_exc_T46", "arg2_id": "NCT02195024_exc_T50", "normalized": [] }, { "id": "NCT02195024_exc_R26", "type": "Has_value", "arg1_id": "NCT02195024_exc_T53", "arg2_id": "NCT02195024_exc_T54", "normalized": [] } ]

[ { "id": "NCT02195024_inc_text", "type": "inclusion", "text": [ "Approved clinical indication for pectoral pacemaker exchange (e.g. elective replacement indication (ERI), end of service (EOS))\na single or dual chamber MRI conditional pacemaker (BSCI) or\nAny comparable successor IPG (MRI conditional system, BSCI) compatible with\nImplanted Fineline-II-leads (BSCI), MRI conditional\nThe ascertained lead impedance is between 200 and 1500 Ohm.\nAll pacing capture thresholds (PCT) do not exceed 2.0 V @0.4 or 0.5 ms in pacemaker dependent patients\nMale or female 18 years or older\nUnderstand the nature of the procedure\nGive written informed consent\nAble to complete all testing required by the clinical protocol\nAbility to measure atrial and/or ventricular pacing threshold(s) at 0.4 or 0.5 ms\nPatient body height greater or equal to 140 cm\nPectoral implanted device\nSubjects who are able and willing to undergo elective cardiac magnetic resonance (MR) scanning without sedation (MRI-group)\nSubjects who are geographically stable and available for follow-up at the study center for the length of the study\n" ], "offsets": [ [ 0, 1039 ] ] } ]

[ { "id": "NCT02195024_inc_T3", "type": "Condition", "text": [ "elective replacement indication (ERI)" ], "offsets": [ [ 67, 104 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T4", "type": "Condition", "text": [ "end of service (EOS)" ], "offsets": [ [ 106, 126 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T5", "type": "Scope", "text": [ "elective replacement indication (ERI), end of service (EOS)" ], "offsets": [ [ 67, 126 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T1", "type": "Condition", "text": [ "clinical indication" ], "offsets": [ [ 9, 28 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T2", "type": "Procedure", "text": [ "pectoral pacemaker exchange" ], "offsets": [ [ 33, 60 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T6", "type": "Scope", "text": [ "clinical indication for pectoral pacemaker exchange" ], "offsets": [ [ 9, 60 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T7", "type": "Qualifier", "text": [ "ingle", "hamber" ], "offsets": [ [ 131, 136 ], [ 146, 152 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T8", "type": "Qualifier", "text": [ "dual chamber" ], "offsets": [ [ 140, 152 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T9", "type": "Scope", "text": [ "single or dual chamber" ], "offsets": [ [ 130, 152 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T10", "type": "Device", "text": [ "pacemaker" ], "offsets": [ [ 169, 178 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T11", "type": "Device", "text": [ "BSCI" ], "offsets": [ [ 180, 184 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T12", "type": "Scope", "text": [ "single or dual chamber MRI conditional pacemaker" ], "offsets": [ [ 130, 178 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T13", "type": "Device", "text": [ "MRI conditional system" ], "offsets": [ [ 219, 241 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T14", "type": "Device", "text": [ "BSCI" ], "offsets": [ [ 243, 247 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T15", "type": "Device", "text": [ "successor IPG" ], "offsets": [ [ 204, 217 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T16", "type": "Qualifier", "text": [ "comparable" ], "offsets": [ [ 193, 203 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T17", "type": "Scope", "text": [ "comparable successor IPG" ], "offsets": [ [ 193, 217 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T18", "type": "Scope", "text": [ "MRI conditional system, BSCI" ], "offsets": [ [ 219, 247 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T19", "type": "Device", "text": [ "Implanted Fineline-II-leads" ], "offsets": [ [ 265, 292 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T20", "type": "Device", "text": [ "BSCI" ], "offsets": [ [ 294, 298 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T21", "type": "Qualifier", "text": [ "MRI conditional" ], "offsets": [ [ 301, 316 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T22", "type": "Qualifier", "text": [ "MRI conditional" ], "offsets": [ [ 153, 168 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T23", "type": "Scope", "text": [ "Implanted Fineline-II-leads (BSCI)" ], "offsets": [ [ 265, 299 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T24", "type": "Measurement", "text": [ "ascertained lead impedance" ], "offsets": [ [ 321, 347 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T25", "type": "Value", "text": [ "between 200 and 1500 Ohm" ], "offsets": [ [ 351, 375 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T26", "type": "Measurement", "text": [ "pacing capture thresholds" ], "offsets": [ [ 381, 406 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T27", "type": "Measurement", "text": [ "PCT" ], "offsets": [ [ 408, 411 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T28", "type": "Value", "text": [ "do not exceed 2.0 V @0.4 or 0.5 ms" ], "offsets": [ [ 413, 447 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T29", "type": "Condition", "text": [ "pacemaker dependent" ], "offsets": [ [ 451, 470 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T30", "type": "Scope", "text": [ "pacing capture thresholds (PCT)" ], "offsets": [ [ 381, 412 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T31", "type": "Person", "text": [ "Male" ], "offsets": [ [ 480, 484 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T32", "type": "Person", "text": [ "female" ], "offsets": [ [ 488, 494 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T33", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 495, 512 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T34", "type": "Person", "text": [ "years or older" ], "offsets": [ [ 498, 512 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T39", "type": "Measurement", "text": [ "body height" ], "offsets": [ [ 735, 746 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T40", "type": "Value", "text": [ "greater or equal to 140 cm" ], "offsets": [ [ 747, 773 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T41", "type": "Device", "text": [ "Pectoral implanted device" ], "offsets": [ [ 774, 799 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T42", "type": "Mood", "text": [ "willing to undergo" ], "offsets": [ [ 826, 844 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T43", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 845, 853 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T44", "type": "Procedure", "text": [ "tic resonance (MR) scannin", "out seda" ], "offsets": [ [ 867, 893 ], [ 899, 907 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T45", "type": "Procedure", "text": [ "MR" ], "offsets": [ [ 882, 884 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T46", "type": "Qualifier", "text": [ "without sedation" ], "offsets": [ [ 895, 911 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T47", "type": "Person", "text": [ "geographically stable" ], "offsets": [ [ 941, 962 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T48", "type": "Observation", "text": [ "available for follow-up" ], "offsets": [ [ 967, 990 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T49", "type": "Visit", "text": [ "at the study center" ], "offsets": [ [ 991, 1010 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T50", "type": "Temporal", "text": [ "for the length of the study" ], "offsets": [ [ 1011, 1038 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T51", "type": "Scope", "text": [ "geographically stable and available for follow-up" ], "offsets": [ [ 941, 990 ] ], "normalized": [] }, { "id": "NCT02195024_inc_T52", "type": "Scope", "text": [ "at the study center for the length of the study" ], "offsets": [ [ 991, 1038 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02195024_inc_R1", "type": "AND", "arg1_id": "NCT02195024_inc_T1", "arg2_id": "NCT02195024_inc_T2", "normalized": [] }, { "id": "NCT02195024_inc_R2", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T6", "arg2_id": "NCT02195024_inc_T5", "normalized": [] }, { "id": "NCT02195024_inc_R3", "type": "Has_scope", "arg1_id": "NCT02195024_inc_T10", "arg2_id": "NCT02195024_inc_T9", "normalized": [] }, { "id": "NCT02195024_inc_R4", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T12", "arg2_id": "NCT02195024_inc_T11", "normalized": [] }, { "id": "NCT02195024_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02195024_inc_T15", "arg2_id": "NCT02195024_inc_T16", "normalized": [] }, { "id": "NCT02195024_inc_R6", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T17", "arg2_id": "NCT02195024_inc_T18", "normalized": [] }, { "id": "NCT02195024_inc_R7", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T19", "arg2_id": "NCT02195024_inc_T20", "normalized": [] }, { "id": "NCT02195024_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT02195024_inc_T10", "arg2_id": "NCT02195024_inc_T22", "normalized": [] }, { "id": "NCT02195024_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT02195024_inc_T23", "arg2_id": "NCT02195024_inc_T21", "normalized": [] }, { "id": "NCT02195024_inc_R10", "type": "Has_value", "arg1_id": "NCT02195024_inc_T24", "arg2_id": "NCT02195024_inc_T25", "normalized": [] }, { "id": "NCT02195024_inc_R11", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T26", "arg2_id": "NCT02195024_inc_T27", "normalized": [] }, { "id": "NCT02195024_inc_R12", "type": "Has_value", "arg1_id": "NCT02195024_inc_T30", "arg2_id": "NCT02195024_inc_T28", "normalized": [] }, { "id": "NCT02195024_inc_R13", "type": "Has_scope", "arg1_id": "NCT02195024_inc_T29", "arg2_id": "NCT02195024_inc_T30", "normalized": [] }, { "id": "NCT02195024_inc_R14", "type": "Has_value", "arg1_id": "NCT02195024_inc_T34", "arg2_id": "NCT02195024_inc_T33", "normalized": [] }, { "id": "NCT02195024_inc_R15", "type": "Has_value", "arg1_id": "NCT02195024_inc_T39", "arg2_id": "NCT02195024_inc_T40", "normalized": [] }, { "id": "NCT02195024_inc_R16", "type": "Subsumes", "arg1_id": "NCT02195024_inc_T44", "arg2_id": "NCT02195024_inc_T45", "normalized": [] }, { "id": "NCT02195024_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT02195024_inc_T44", "arg2_id": "NCT02195024_inc_T46", "normalized": [] }, { "id": "NCT02195024_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT02195024_inc_T44", "arg2_id": "NCT02195024_inc_T43", "normalized": [] }, { "id": "NCT02195024_inc_R19", "type": "Has_mood", "arg1_id": "NCT02195024_inc_T44", "arg2_id": "NCT02195024_inc_T42", "normalized": [] }, { "id": "NCT02195024_inc_R20", "type": "Has_scope", "arg1_id": "NCT02195024_inc_T51", "arg2_id": "NCT02195024_inc_T52", "normalized": [] } ]

[ { "id": "NCT02196285_exc_text", "type": "exclusion", "text": [ "Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and anaphylaxis; \nAcute or chronic disease, as diabetes, heart disease, systemic arterial hypertension; \nUse of anti-allergic with antigen injections in a maximum timeline of 14 days before the vaccination; \nUse of immunoglobulin in the past 12 months before the study vaccination; \nUse of blood products within 12 months before the vaccination; \nUse of any vaccine type within 30 days before the vaccination of the study; \nChronic use of any medication, except homeopathy, and trivial ones, as nasal physiologic solution and vitamins; \nPrevious immunosuppressive or cytotoxic medication, in the last 6 months. Individuals who have made use of this kind of medication in non-immunosuppressant doses, as nasal corticosteroid for allergic rhinitis of topic corticosteroid for non-complicated dermatitis, for more than 14 days, are allowed to be included in the study. \nUse of any kind of medication under investigation within one year before the vaccination. \nUnstable asthma or which may have required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid. \nCoagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause; \nConvulsions, except the ones caused by fever, before 2 years old; \nPsychiatric disease which difficults the adherence to the protocol, such as psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion; \nActive malignant (p.e. any kind of cancer) or treated disease, to which the individual may relapse during the study; \nAsplenia (absence of spleen or its removal); \nPositive HIV in the screening examination of history of any immunosuppressant disease; \nPositive serology for C hepatitis in the screening evaluation; \nPositive Antigen HBs in the screening evaluation; \nAlcoholism (CAGE criteria), used for detection of abusive drinkers or alcoholic, validated in the Brazilian population with sensibility of 88% and specificity of 83%, if two or more answers, among four possible, are afirmative(Mansur and Monteiro, 1983), or according to medical decision; \nAbuse of illicit drugs, according to medical decision; \nAcquired or congenital immunodeficiency; \nAllergy to the vaccine compounds, as egg, neomycin and gelatin. \n \n" ], "offsets": [ [ 0, 2497 ] ] } ]

[ { "id": "NCT02196285_exc_T1", "type": "Drug", "text": [ "immunoglobulin" ], "offsets": [ [ 298, 312 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T2", "type": "Temporal", "text": [ "in the past 12 months before the study vaccination" ], "offsets": [ [ 313, 363 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T3", "type": "Reference_point", "text": [ "the study vaccination" ], "offsets": [ [ 342, 363 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T4", "type": "Condition", "text": [ "adverse reaction" ], "offsets": [ [ 8, 24 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T5", "type": "Condition", "text": [ "respiratory difficulty" ], "offsets": [ [ 48, 70 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T6", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 32, 43 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T7", "type": "Condition", "text": [ "angioedema" ], "offsets": [ [ 72, 82 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T8", "type": "Condition", "text": [ "anaphylaxis" ], "offsets": [ [ 87, 98 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T9", "type": "Scope", "text": [ "respiratory difficulty, angioedema and anaphylaxis" ], "offsets": [ [ 48, 98 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T10", "type": "Condition", "text": [ "chronic disease" ], "offsets": [ [ 110, 125 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T11", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 130, 138 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T12", "type": "Condition", "text": [ "Acute", "disease" ], "offsets": [ [ 101, 106 ], [ 118, 125 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T13", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 140, 153 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T14", "type": "Condition", "text": [ "systemic arterial hypertension" ], "offsets": [ [ 155, 185 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T15", "type": "Scope", "text": [ "diabetes, heart disease, systemic arterial hypertension" ], "offsets": [ [ 130, 185 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T16", "type": "Scope", "text": [ "Acute or chronic disease" ], "offsets": [ [ 101, 125 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T17", "type": "Procedure", "text": [ "antigen injections" ], "offsets": [ [ 214, 232 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T18", "type": "Drug", "text": [ "anti-allergic" ], "offsets": [ [ 195, 208 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T19", "type": "Temporal", "text": [ "maximum timeline of 14 days before the vaccination" ], "offsets": [ [ 238, 288 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T20", "type": "Reference_point", "text": [ "the vaccination" ], "offsets": [ [ 273, 288 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T21", "type": "Drug", "text": [ "blood products" ], "offsets": [ [ 373, 387 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T22", "type": "Temporal", "text": [ "within 12 months before the vaccination" ], "offsets": [ [ 388, 427 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T23", "type": "Reference_point", "text": [ "the vaccination" ], "offsets": [ [ 412, 427 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T24", "type": "Drug", "text": [ "any vaccine type" ], "offsets": [ [ 437, 453 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T25", "type": "Temporal", "text": [ "within 30 days before the vaccination of the study" ], "offsets": [ [ 454, 504 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T26", "type": "Reference_point", "text": [ "the vaccination of the study" ], "offsets": [ [ 476, 504 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T27", "type": "Multiplier", "text": [ "Chronic use" ], "offsets": [ [ 507, 518 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T28", "type": "Drug", "text": [ "any medication" ], "offsets": [ [ 522, 536 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T31", "type": "Procedure", "text": [ "homeopathy" ], "offsets": [ [ 545, 555 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T32", "type": "Drug", "text": [ "nasal physiologic solution" ], "offsets": [ [ 578, 604 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T33", "type": "Drug", "text": [ "vitamins" ], "offsets": [ [ 609, 617 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T35", "type": "Drug", "text": [ "trivial ones" ], "offsets": [ [ 561, 573 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T38", "type": "Scope", "text": [ "nasal physiologic solution and vitamins" ], "offsets": [ [ 578, 617 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T39", "type": "Negation", "text": [ "except" ], "offsets": [ [ 538, 544 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T40", "type": "Scope", "text": [ "homeopathy, and trivial ones, as nasal physiologic solution and vitamins" ], "offsets": [ [ 545, 617 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T41", "type": "Drug", "text": [ "immunosuppressive", "medication" ], "offsets": [ [ 629, 646 ], [ 660, 670 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T42", "type": "Drug", "text": [ "cytotoxic medication" ], "offsets": [ [ 650, 670 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T45", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 672, 692 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T46", "type": "Scope", "text": [ "immunosuppressive or cytotoxic medication" ], "offsets": [ [ 629, 670 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T49", "type": "Drug", "text": [ "medication under investigation" ], "offsets": [ [ 969, 999 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T51", "type": "Temporal", "text": [ "within one year before the vaccination" ], "offsets": [ [ 1000, 1038 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T52", "type": "Reference_point", "text": [ "the vaccination" ], "offsets": [ [ 1023, 1038 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T53", "type": "Condition", "text": [ "Unstable asthma" ], "offsets": [ [ 1041, 1056 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T54", "type": "Qualifier", "text": [ "required urgent care" ], "offsets": [ [ 1075, 1095 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T55", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 1097, 1112 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T56", "type": "Procedure", "text": [ "urgent care" ], "offsets": [ [ 1084, 1095 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T57", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 1116, 1126 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T58", "type": "Qualifier", "text": [ "required", "hospitalization" ], "offsets": [ [ 1075, 1083 ], [ 1097, 1112 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T59", "type": "Qualifier", "text": [ "required", "intubation" ], "offsets": [ [ 1075, 1083 ], [ 1116, 1126 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T60", "type": "Temporal", "text": [ "within the last 2 years" ], "offsets": [ [ 1127, 1150 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T61", "type": "Drug", "text": [ "oral", "corticosteroid" ], "offsets": [ [ 1177, 1181 ], [ 1197, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T62", "type": "Drug", "text": [ "intravenous corticosteroid" ], "offsets": [ [ 1185, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T63", "type": "Scope", "text": [ "required urgent care, hospitalization or intubation" ], "offsets": [ [ 1075, 1126 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T64", "type": "Qualifier", "text": [ "requires use of oral", "corticosteroid" ], "offsets": [ [ 1161, 1181 ], [ 1197, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T65", "type": "Qualifier", "text": [ "requires use of", "intravenous corticosteroid" ], "offsets": [ [ 1161, 1176 ], [ 1185, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T66", "type": "Scope", "text": [ "requires use of oral or intravenous corticosteroid" ], "offsets": [ [ 1161, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T67", "type": "Scope", "text": [ "required urgent care, hospitalization or intubation within the last 2 years" ], "offsets": [ [ 1075, 1150 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T68", "type": "Scope", "text": [ "required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid" ], "offsets": [ [ 1075, 1211 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T69", "type": "Condition", "text": [ "Coagulopathies" ], "offsets": [ [ 1214, 1228 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T70", "type": "Condition", "text": [ "capillary fragility" ], "offsets": [ [ 1267, 1286 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T71", "type": "Condition", "text": [ "bruises" ], "offsets": [ [ 1292, 1299 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T72", "type": "Condition", "text": [ "bleedings" ], "offsets": [ [ 1303, 1312 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T73", "type": "Qualifier", "text": [ "without justifiable cause" ], "offsets": [ [ 1313, 1338 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T75", "type": "Scope", "text": [ "bruises or bleedings without justifiable cause" ], "offsets": [ [ 1292, 1338 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T76", "type": "Condition", "text": [ "Convulsions" ], "offsets": [ [ 1341, 1352 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T77", "type": "Temporal", "text": [ "before 2 years old" ], "offsets": [ [ 1387, 1405 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T78", "type": "Qualifier", "text": [ "caused by fever" ], "offsets": [ [ 1370, 1385 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T79", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1354, 1360 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T80", "type": "Condition", "text": [ "fever" ], "offsets": [ [ 1380, 1385 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T81", "type": "Reference_point", "text": [ "2 years old" ], "offsets": [ [ 1394, 1405 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T82", "type": "Condition", "text": [ "Psychiatric disease" ], "offsets": [ [ 1408, 1427 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T83", "type": "Qualifier", "text": [ "difficults the adherence to the protocol" ], "offsets": [ [ 1434, 1474 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T86", "type": "Condition", "text": [ "psychosis" ], "offsets": [ [ 1484, 1493 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T87", "type": "Condition", "text": [ "obsessive-compulsive disorders" ], "offsets": [ [ 1495, 1525 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T88", "type": "Condition", "text": [ "bipolar disease" ], "offsets": [ [ 1527, 1542 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T89", "type": "Qualifier", "text": [ "under treatment" ], "offsets": [ [ 1543, 1558 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T90", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1549, 1558 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T92", "type": "Drug", "text": [ "lithium" ], "offsets": [ [ 1598, 1605 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T93", "type": "Procedure", "text": [ "treatment with lithium" ], "offsets": [ [ 1583, 1605 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T94", "type": "Condition", "text": [ "suicidal ideas" ], "offsets": [ [ 1610, 1624 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T95", "type": "Temporal", "text": [ "in the last 5 years from the inclusion" ], "offsets": [ [ 1625, 1663 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T96", "type": "Reference_point", "text": [ "the inclusion" ], "offsets": [ [ 1650, 1663 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T97", "type": "Condition", "text": [ "diseases which require treatment with lithium" ], "offsets": [ [ 1560, 1605 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T98", "type": "Scope", "text": [ "psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion" ], "offsets": [ [ 1484, 1663 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T99", "type": "Condition", "text": [ "malignant", "disease" ], "offsets": [ [ 1673, 1682 ], [ 1720, 1727 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T100", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 1666, 1672 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T101", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 1701, 1707 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T102", "type": "Qualifier", "text": [ "any kind" ], "offsets": [ [ 1689, 1697 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T103", "type": "Condition", "text": [ "treated disease" ], "offsets": [ [ 1712, 1727 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T104", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 1712, 1719 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T105", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 1712, 1719 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T106", "type": "Qualifier", "text": [ "malignant" ], "offsets": [ [ 1673, 1682 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T110", "type": "Qualifier", "text": [ "to which the individual may relapse" ], "offsets": [ [ 1729, 1764 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T111", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 1765, 1781 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T112", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 1772, 1781 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T113", "type": "Scope", "text": [ "Active malignant (p.e. any kind of cancer) or treated disease" ], "offsets": [ [ 1666, 1727 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T114", "type": "Condition", "text": [ "Asplenia" ], "offsets": [ [ 1784, 1792 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T115", "type": "Negation", "text": [ "absence of" ], "offsets": [ [ 1794, 1804 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T116", "type": "Condition", "text": [ "spleen" ], "offsets": [ [ 1805, 1811 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T117", "type": "Procedure", "text": [ "spleen", "removal" ], "offsets": [ [ 1805, 1811 ], [ 1819, 1826 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T118", "type": "Scope", "text": [ "absence of spleen or its removal" ], "offsets": [ [ 1794, 1826 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T119", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 1839, 1842 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T120", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 1830, 1838 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T121", "type": "Temporal", "text": [ "in the screening examination" ], "offsets": [ [ 1843, 1871 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T122", "type": "Reference_point", "text": [ "screening examination" ], "offsets": [ [ 1850, 1871 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T123", "type": "Condition", "text": [ "immunosuppressant disease" ], "offsets": [ [ 1890, 1915 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T125", "type": "Measurement", "text": [ "serology for C hepatitis" ], "offsets": [ [ 1927, 1951 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T126", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 1918, 1926 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T127", "type": "Temporal", "text": [ "in the screening evaluation" ], "offsets": [ [ 1952, 1979 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T128", "type": "Reference_point", "text": [ "screening evaluation" ], "offsets": [ [ 1959, 1979 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T129", "type": "Measurement", "text": [ "Antigen HBs" ], "offsets": [ [ 1991, 2002 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T130", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 1982, 1990 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T131", "type": "Temporal", "text": [ "in the screening evaluation" ], "offsets": [ [ 2003, 2030 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T132", "type": "Reference_point", "text": [ "screening evaluation" ], "offsets": [ [ 2010, 2030 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T133", "type": "Condition", "text": [ "Alcoholism" ], "offsets": [ [ 2033, 2043 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T134", "type": "Measurement", "text": [ "CAGE criteria" ], "offsets": [ [ 2045, 2058 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T135", "type": "Value", "text": [ "Alcoholism" ], "offsets": [ [ 2033, 2043 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T137", "type": "Condition", "text": [ "Abuse of illicit drugs" ], "offsets": [ [ 2323, 2345 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T139", "type": "Condition", "text": [ "Acquired", "immunodeficiency" ], "offsets": [ [ 2379, 2387 ], [ 2402, 2418 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T140", "type": "Condition", "text": [ "congenital immunodeficiency" ], "offsets": [ [ 2391, 2418 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T141", "type": "Condition", "text": [ "Allergy to the vaccine compounds" ], "offsets": [ [ 2421, 2453 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T142", "type": "Drug", "text": [ "vaccine compounds" ], "offsets": [ [ 2436, 2453 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T143", "type": "Drug", "text": [ "egg" ], "offsets": [ [ 2458, 2461 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T144", "type": "Drug", "text": [ "neomycin" ], "offsets": [ [ 2463, 2471 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T145", "type": "Drug", "text": [ "gelatin" ], "offsets": [ [ 2476, 2483 ] ], "normalized": [] }, { "id": "NCT02196285_exc_T146", "type": "Scope", "text": [ "egg, neomycin and gelatin" ], "offsets": [ [ 2458, 2483 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02196285_exc_R1", "type": "Has_index", "arg1_id": "NCT02196285_exc_T2", "arg2_id": "NCT02196285_exc_T3", "normalized": [] }, { "id": "NCT02196285_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T1", "arg2_id": "NCT02196285_exc_T2", "normalized": [] }, { "id": "NCT02196285_exc_R3", "type": "AND", "arg1_id": "NCT02196285_exc_T4", "arg2_id": "NCT02196285_exc_T6", "normalized": [] }, { "id": "NCT02196285_exc_R4", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T4", "arg2_id": "NCT02196285_exc_T9", "normalized": [] }, { "id": "NCT02196285_exc_R5", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T16", "arg2_id": "NCT02196285_exc_T15", "normalized": [] }, { "id": "NCT02196285_exc_R6", "type": "Has_index", "arg1_id": "NCT02196285_exc_T19", "arg2_id": "NCT02196285_exc_T20", "normalized": [] }, { "id": "NCT02196285_exc_R7", "type": "AND", "arg1_id": "NCT02196285_exc_T18", "arg2_id": "NCT02196285_exc_T17", "normalized": [] }, { "id": "NCT02196285_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T18", "arg2_id": "NCT02196285_exc_T19", "normalized": [] }, { "id": "NCT02196285_exc_R9", "type": "Has_index", "arg1_id": "NCT02196285_exc_T22", "arg2_id": "NCT02196285_exc_T23", "normalized": [] }, { "id": "NCT02196285_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T21", "arg2_id": "NCT02196285_exc_T22", "normalized": [] }, { "id": "NCT02196285_exc_R11", "type": "Has_index", "arg1_id": "NCT02196285_exc_T25", "arg2_id": "NCT02196285_exc_T26", "normalized": [] }, { "id": "NCT02196285_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T24", "arg2_id": "NCT02196285_exc_T25", "normalized": [] }, { "id": "NCT02196285_exc_R13", "type": "Has_multiplier", "arg1_id": "NCT02196285_exc_T28", "arg2_id": "NCT02196285_exc_T27", "normalized": [] }, { "id": "NCT02196285_exc_R14", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T35", "arg2_id": "NCT02196285_exc_T38", "normalized": [] }, { "id": "NCT02196285_exc_R15", "type": "Has_negation", "arg1_id": "NCT02196285_exc_T40", "arg2_id": "NCT02196285_exc_T39", "normalized": [] }, { "id": "NCT02196285_exc_R16", "type": "Has_scope", "arg1_id": "NCT02196285_exc_T28", "arg2_id": "NCT02196285_exc_T40", "normalized": [] }, { "id": "NCT02196285_exc_R17", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T46", "arg2_id": "NCT02196285_exc_T45", "normalized": [] }, { "id": "NCT02196285_exc_R18", "type": "Has_index", "arg1_id": "NCT02196285_exc_T51", "arg2_id": "NCT02196285_exc_T52", "normalized": [] }, { "id": "NCT02196285_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T49", "arg2_id": "NCT02196285_exc_T51", "normalized": [] }, { "id": "NCT02196285_exc_R21", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T63", "arg2_id": "NCT02196285_exc_T60", "normalized": [] }, { "id": "NCT02196285_exc_R20", "type": "Has_scope", "arg1_id": "NCT02196285_exc_T53", "arg2_id": "NCT02196285_exc_T68", "normalized": [] }, { "id": "NCT02196285_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T72", "arg2_id": "NCT02196285_exc_T73", "normalized": [] }, { "id": "NCT02196285_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T71", "arg2_id": "NCT02196285_exc_T73", "normalized": [] }, { "id": "NCT02196285_exc_R24", "type": "Has_scope", "arg1_id": "NCT02196285_exc_T70", "arg2_id": "NCT02196285_exc_T75", "normalized": [] }, { "id": "NCT02196285_exc_R25", "type": "AND", "arg1_id": "NCT02196285_exc_T69", "arg2_id": "NCT02196285_exc_T70", "normalized": [] }, { "id": "NCT02196285_exc_R26", "type": "Has_negation", "arg1_id": "NCT02196285_exc_T78", "arg2_id": "NCT02196285_exc_T79", "normalized": [] }, { "id": "NCT02196285_exc_R27", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T76", "arg2_id": "NCT02196285_exc_T77", "normalized": [] }, { "id": "NCT02196285_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T76", "arg2_id": "NCT02196285_exc_T78", "normalized": [] }, { "id": "NCT02196285_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T82", "arg2_id": "NCT02196285_exc_T83", "normalized": [] }, { "id": "NCT02196285_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T88", "arg2_id": "NCT02196285_exc_T89", "normalized": [] }, { "id": "NCT02196285_exc_R31", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T82", "arg2_id": "NCT02196285_exc_T98", "normalized": [] }, { "id": "NCT02196285_exc_R32", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T94", "arg2_id": "NCT02196285_exc_T95", "normalized": [] }, { "id": "NCT02196285_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T101", "arg2_id": "NCT02196285_exc_T102", "normalized": [] }, { "id": "NCT02196285_exc_R34", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T99", "arg2_id": "NCT02196285_exc_T101", "normalized": [] }, { "id": "NCT02196285_exc_R35", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T99", "arg2_id": "NCT02196285_exc_T100", "normalized": [] }, { "id": "NCT02196285_exc_R36", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T110", "arg2_id": "NCT02196285_exc_T111", "normalized": [] }, { "id": "NCT02196285_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT02196285_exc_T113", "arg2_id": "NCT02196285_exc_T110", "normalized": [] }, { "id": "NCT02196285_exc_R38", "type": "Has_negation", "arg1_id": "NCT02196285_exc_T116", "arg2_id": "NCT02196285_exc_T115", "normalized": [] }, { "id": "NCT02196285_exc_R39", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T114", "arg2_id": "NCT02196285_exc_T116", "normalized": [] }, { "id": "NCT02196285_exc_R40", "type": "Has_value", "arg1_id": "NCT02196285_exc_T119", "arg2_id": "NCT02196285_exc_T120", "normalized": [] }, { "id": "NCT02196285_exc_R41", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T119", "arg2_id": "NCT02196285_exc_T121", "normalized": [] }, { "id": "NCT02196285_exc_R42", "type": "Has_value", "arg1_id": "NCT02196285_exc_T125", "arg2_id": "NCT02196285_exc_T126", "normalized": [] }, { "id": "NCT02196285_exc_R43", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T125", "arg2_id": "NCT02196285_exc_T127", "normalized": [] }, { "id": "NCT02196285_exc_R44", "type": "Has_value", "arg1_id": "NCT02196285_exc_T129", "arg2_id": "NCT02196285_exc_T130", "normalized": [] }, { "id": "NCT02196285_exc_R45", "type": "Has_temporal", "arg1_id": "NCT02196285_exc_T129", "arg2_id": "NCT02196285_exc_T131", "normalized": [] }, { "id": "NCT02196285_exc_R46", "type": "Has_value", "arg1_id": "NCT02196285_exc_T134", "arg2_id": "NCT02196285_exc_T135", "normalized": [] }, { "id": "NCT02196285_exc_R47", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T133", "arg2_id": "NCT02196285_exc_T134", "normalized": [] }, { "id": "NCT02196285_exc_R48", "type": "Subsumes", "arg1_id": "NCT02196285_exc_T142", "arg2_id": "NCT02196285_exc_T146", "normalized": [] } ]

[ { "id": "NCT02196285_inc_text", "type": "inclusion", "text": [ "Male \nAge between 18 and 49 years old; \nWilling to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications); \nWilling to strictly follow the study protocol; \nCapacity for understanding and signing in the Informed Consent Form; \nTo understand the impossibility of participating in another clinical trial during the time of participation in the study, until 6 months after its conclusion; \nIntellectual level which allows to filling in the diaries for registering of symptoms at home; \nWilling to undergo to serological testing to HIV, HBV and HCV; \nBeing in good health, with no significant medical history; \nPhysical examination at screening period without clinically significant changes; \nLab examination at screening period within the normal ranges, determined by the laboratory or abnormal values, grading below 1 or 2, according to medical decision. \n" ], "offsets": [ [ 0, 1030 ] ] } ]

[ { "id": "NCT02196285_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 6, 9 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T3", "type": "Value", "text": [ "between 18 and 49 years old" ], "offsets": [ [ 10, 37 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T15", "type": "Procedure", "text": [ "serological testing to HIV" ], "offsets": [ [ 681, 707 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T16", "type": "Procedure", "text": [ "serological testing to", "HBV" ], "offsets": [ [ 681, 703 ], [ 709, 712 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T17", "type": "Procedure", "text": [ "serological testing to", "HCV" ], "offsets": [ [ 681, 703 ], [ 717, 720 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T20", "type": "Condition", "text": [ "good health" ], "offsets": [ [ 732, 743 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T23", "type": "Procedure", "text": [ "Physical examination" ], "offsets": [ [ 783, 803 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T24", "type": "Temporal", "text": [ "at screening period" ], "offsets": [ [ 804, 823 ] ], "normalized": [] }, { "id": "NCT02196285_inc_T25", "type": "Reference_point", "text": [ "screening period" ], "offsets": [ [ 807, 823 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT02200978_exc_text", "type": "exclusion", "text": [ "Patients who have coma, convulsion or paralysis due to intracranial hemorrhage or central nervous system leukemia at diagnosis.\n" ], "offsets": [ [ 0, 128 ] ] } ]

[ { "id": "NCT02200978_exc_T1", "type": "Condition", "text": [ "coma" ], "offsets": [ [ 18, 22 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T2", "type": "Condition", "text": [ "convulsion" ], "offsets": [ [ 24, 34 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T3", "type": "Condition", "text": [ "paralysis" ], "offsets": [ [ 38, 47 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T4", "type": "Condition", "text": [ "intracranial hemorrhage" ], "offsets": [ [ 55, 78 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T5", "type": "Qualifier", "text": [ "central nervous system" ], "offsets": [ [ 82, 104 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T6", "type": "Condition", "text": [ "leukemia" ], "offsets": [ [ 105, 113 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T7", "type": "Temporal", "text": [ "at diagnosis" ], "offsets": [ [ 114, 126 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T8", "type": "Scope", "text": [ "intracranial hemorrhage or central nervous system leukemia" ], "offsets": [ [ 55, 113 ] ], "normalized": [] }, { "id": "NCT02200978_exc_T9", "type": "Scope", "text": [ "coma, convulsion or paralysis" ], "offsets": [ [ 18, 47 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02200978_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02200978_exc_T6", "arg2_id": "NCT02200978_exc_T5", "normalized": [] }, { "id": "NCT02200978_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02200978_exc_T8", "arg2_id": "NCT02200978_exc_T7", "normalized": [] }, { "id": "NCT02200978_exc_R3", "type": "Has_scope", "arg1_id": "NCT02200978_exc_T9", "arg2_id": "NCT02200978_exc_T8", "normalized": [] } ]

[ { "id": "NCT02200978_inc_text", "type": "inclusion", "text": [ "Patients less than 16 years old with newly diagnosed PML-RARa positive acute promyelocytic leukemia.\n" ], "offsets": [ [ 0, 101 ] ] } ]

[ { "id": "NCT02200978_inc_T1", "type": "Value", "text": [ "less than 16 years" ], "offsets": [ [ 9, 27 ] ], "normalized": [] }, { "id": "NCT02200978_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 28, 31 ] ], "normalized": [] }, { "id": "NCT02200978_inc_T3", "type": "Measurement", "text": [ "PML-RARa" ], "offsets": [ [ 53, 61 ] ], "normalized": [] }, { "id": "NCT02200978_inc_T4", "type": "Value", "text": [ "positive" ], "offsets": [ [ 62, 70 ] ], "normalized": [] }, { "id": "NCT02200978_inc_T5", "type": "Condition", "text": [ "acute promyelocytic leukemia" ], "offsets": [ [ 71, 99 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02200978_inc_R1", "type": "Has_value", "arg1_id": "NCT02200978_inc_T2", "arg2_id": "NCT02200978_inc_T1", "normalized": [] }, { "id": "NCT02200978_inc_R2", "type": "Has_value", "arg1_id": "NCT02200978_inc_T3", "arg2_id": "NCT02200978_inc_T4", "normalized": [] }, { "id": "NCT02200978_inc_R3", "type": "AND", "arg1_id": "NCT02200978_inc_T5", "arg2_id": "NCT02200978_inc_T3", "normalized": [] } ]

[ { "id": "NCT02201316_exc_text", "type": "exclusion", "text": [ "Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). \nHistory of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 milliliter [mL]) of beer, 1 glass (100 mL) of wine or 1 (25 mL) measure of spirits. \nHistory of sensitivity to heparin or heparin-induced thrombocytopenia. \nHistory of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. \nGastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product. \nA positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening \nUrinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. \nA positive pre-study drug/alcohol screen. \nA positive test for Human Immunodeficiency Virus (HIV) antibody. \nPregnant females as determined by positive serum hCG test at screening or prior to dosing. \nWhere participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period. \nLactating females. \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: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). \nExposure to more than four new chemical entities within 12 months prior to the first dosing day. \n \n" ], "offsets": [ [ 0, 1931 ] ] } ]

[ { "id": "NCT02201316_exc_T1", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T2", "type": "Temporal", "text": [ "chronic" ], "offsets": [ [ 11, 18 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 19, 26 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T4", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 30, 43 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T5", "type": "Scope", "text": [ "Current or chronic" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T6", "type": "Condition", "text": [ "biliary abnormalities" ], "offsets": [ [ 65, 86 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T7", "type": "Condition", "text": [ "hepatic", "abnormalities" ], "offsets": [ [ 54, 61 ], [ 73, 86 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T8", "type": "Condition", "text": [ "Gilbert's syndrome" ], "offsets": [ [ 110, 128 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T9", "type": "Negation", "text": [ "exception" ], "offsets": [ [ 97, 106 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T10", "type": "Condition", "text": [ "gallstones" ], "offsets": [ [ 145, 155 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T11", "type": "Qualifier", "text": [ "asymptomatic" ], "offsets": [ [ 132, 144 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T12", "type": "Scope", "text": [ "with the exception of Gilbert's syndrome or asymptomatic gallstones)" ], "offsets": [ [ 88, 156 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T13", "type": "Scope", "text": [ "liver disease, or known hepatic or biliary abnormalities" ], "offsets": [ [ 30, 86 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T14", "type": "Condition", "text": [ "regular alcohol consumption" ], "offsets": [ [ 170, 197 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T15", "type": "Observation", "text": [ "History" ], "offsets": [ [ 159, 166 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T16", "type": "Temporal", "text": [ "within 6 months of the study" ], "offsets": [ [ 198, 226 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T17", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 217, 226 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T18", "type": "Measurement", "text": [ "average weekly intake" ], "offsets": [ [ 242, 263 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T19", "type": "Value", "text": [ ">21 units" ], "offsets": [ [ 267, 276 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T20", "type": "Person", "text": [ "males" ], "offsets": [ [ 281, 286 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T21", "type": "Value", "text": [ ">14 units" ], "offsets": [ [ 290, 299 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T22", "type": "Person", "text": [ "females" ], "offsets": [ [ 304, 311 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T23", "type": "Scope", "text": [ ">21 units for males or >14 units for females" ], "offsets": [ [ 267, 311 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T25", "type": "Condition", "text": [ "sensitivity to heparin" ], "offsets": [ [ 485, 507 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T26", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 500, 507 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T27", "type": "Condition", "text": [ "heparin-induced thrombocytopenia" ], "offsets": [ [ 511, 543 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T28", "type": "Qualifier", "text": [ "heparin-induced" ], "offsets": [ [ 511, 526 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T29", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 511, 518 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T30", "type": "Drug", "text": [ "study medications" ], "offsets": [ [ 583, 600 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T32", "type": "Condition", "text": [ "sensitivity to any of the study medications" ], "offsets": [ [ 557, 600 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T34", "type": "Observation", "text": [ "History" ], "offsets": [ [ 546, 553 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T35", "type": "Condition", "text": [ "drug", "allergy" ], "offsets": [ [ 640, 644 ], [ 654, 661 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T36", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 654, 661 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T40", "type": "Condition", "text": [ "Gastrointestinal disease" ], "offsets": [ [ 765, 789 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T41", "type": "Observation", "text": [ "gastrointestinal surgical history" ], "offsets": [ [ 798, 831 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T42", "type": "Procedure", "text": [ "gastrointestinal surgical" ], "offsets": [ [ 798, 823 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T43", "type": "Qualifier", "text": [ "affect the absorption of the investigational product" ], "offsets": [ [ 842, 894 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T46", "type": "Measurement", "text": [ "Hepatitis B surface antigen" ], "offsets": [ [ 918, 945 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T47", "type": "Value", "text": [ "positive" ], "offsets": [ [ 899, 907 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T48", "type": "Temporal", "text": [ "pre-study" ], "offsets": [ [ 908, 917 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T49", "type": "Measurement", "text": [ "Hepatitis C antibody" ], "offsets": [ [ 958, 978 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T50", "type": "Value", "text": [ "positive" ], "offsets": [ [ 949, 957 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T51", "type": "Temporal", "text": [ "within 3 months of screening" ], "offsets": [ [ 986, 1014 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T52", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1005, 1014 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T53", "type": "Scope", "text": [ "positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody" ], "offsets": [ [ 899, 978 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T55", "type": "Measurement", "text": [ "Urinary cotinine levels" ], "offsets": [ [ 1016, 1039 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T56", "type": "Condition", "text": [ "smoking" ], "offsets": [ [ 1054, 1061 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T57", "type": "Condition", "text": [ "regular use of tobacco" ], "offsets": [ [ 1076, 1098 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T58", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1065, 1072 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T59", "type": "Condition", "text": [ "regular use of", "nicotine-containing products" ], "offsets": [ [ 1076, 1090 ], [ 1103, 1131 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T60", "type": "Temporal", "text": [ "within 6 months prior to screening" ], "offsets": [ [ 1132, 1166 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T61", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1157, 1166 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T62", "type": "Scope", "text": [ "Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products" ], "offsets": [ [ 1016, 1131 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T63", "type": "Temporal", "text": [ "pre-study" ], "offsets": [ [ 1180, 1189 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T64", "type": "Measurement", "text": [ "drug", "screen" ], "offsets": [ [ 1190, 1194 ], [ 1203, 1209 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T65", "type": "Measurement", "text": [ "alcohol screen" ], "offsets": [ [ 1195, 1209 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T66", "type": "Scope", "text": [ "drug/alcohol screen" ], "offsets": [ [ 1190, 1209 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T67", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1171, 1179 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T68", "type": "Measurement", "text": [ "Human Immunodeficiency Virus (HIV) antibody" ], "offsets": [ [ 1232, 1275 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T69", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1214, 1222 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T70", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1278, 1286 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T71", "type": "Person", "text": [ "females" ], "offsets": [ [ 1287, 1294 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T72", "type": "Measurement", "text": [ "serum hCG test" ], "offsets": [ [ 1321, 1335 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T73", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1312, 1320 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T74", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1336, 1348 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T75", "type": "Temporal", "text": [ "prior to dosing" ], "offsets": [ [ 1352, 1367 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T76", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1339, 1348 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T77", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 1361, 1367 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T78", "type": "Scope", "text": [ "at screening or prior to dosing" ], "offsets": [ [ 1336, 1367 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T82", "type": "Person", "text": [ "females" ], "offsets": [ [ 1510, 1517 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T83", "type": "Condition", "text": [ "Lactating" ], "offsets": [ [ 1500, 1509 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T86", "type": "Multiplier", "text": [ "more than four" ], "offsets": [ [ 1834, 1848 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T87", "type": "Drug", "text": [ "new chemical entities" ], "offsets": [ [ 1849, 1870 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T89", "type": "Temporal", "text": [ "within 12 months prior to the first dosing day" ], "offsets": [ [ 1871, 1917 ] ], "normalized": [] }, { "id": "NCT02201316_exc_T90", "type": "Reference_point", "text": [ "the first dosing day" ], "offsets": [ [ 1897, 1917 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02201316_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T4", "arg2_id": "NCT02201316_exc_T3", "normalized": [] }, { "id": "NCT02201316_exc_R2", "type": "Has_scope", "arg1_id": "NCT02201316_exc_T4", "arg2_id": "NCT02201316_exc_T5", "normalized": [] }, { "id": "NCT02201316_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02201316_exc_T10", "arg2_id": "NCT02201316_exc_T11", "normalized": [] }, { "id": "NCT02201316_exc_R4", "type": "Has_negation", "arg1_id": "NCT02201316_exc_T8", "arg2_id": "NCT02201316_exc_T9", "normalized": [] }, { "id": "NCT02201316_exc_R5", "type": "Has_negation", "arg1_id": "NCT02201316_exc_T10", "arg2_id": "NCT02201316_exc_T9", "normalized": [] }, { "id": "NCT02201316_exc_R6", "type": "Has_scope", "arg1_id": "NCT02201316_exc_T13", "arg2_id": "NCT02201316_exc_T12", "normalized": [] }, { "id": "NCT02201316_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T14", "arg2_id": "NCT02201316_exc_T15", "normalized": [] }, { "id": "NCT02201316_exc_R8", "type": "Has_index", "arg1_id": "NCT02201316_exc_T16", "arg2_id": "NCT02201316_exc_T17", "normalized": [] }, { "id": "NCT02201316_exc_R9", "type": "Has_value", "arg1_id": "NCT02201316_exc_T22", "arg2_id": "NCT02201316_exc_T21", "normalized": [] }, { "id": "NCT02201316_exc_R10", "type": "Has_value", "arg1_id": "NCT02201316_exc_T20", "arg2_id": "NCT02201316_exc_T19", "normalized": [] }, { "id": "NCT02201316_exc_R11", "type": "Has_scope", "arg1_id": "NCT02201316_exc_T18", "arg2_id": "NCT02201316_exc_T23", "normalized": [] }, { "id": "NCT02201316_exc_R12", "type": "AND", "arg1_id": "NCT02201316_exc_T14", "arg2_id": "NCT02201316_exc_T18", "normalized": [] }, { "id": "NCT02201316_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T14", "arg2_id": "NCT02201316_exc_T16", "normalized": [] }, { "id": "NCT02201316_exc_R14", "type": "Has_value", "arg1_id": "NCT02201316_exc_T46", "arg2_id": "NCT02201316_exc_T47", "normalized": [] }, { "id": "NCT02201316_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T46", "arg2_id": "NCT02201316_exc_T48", "normalized": [] }, { "id": "NCT02201316_exc_R16", "type": "Has_value", "arg1_id": "NCT02201316_exc_T49", "arg2_id": "NCT02201316_exc_T50", "normalized": [] }, { "id": "NCT02201316_exc_R17", "type": "Has_index", "arg1_id": "NCT02201316_exc_T51", "arg2_id": "NCT02201316_exc_T52", "normalized": [] }, { "id": "NCT02201316_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T53", "arg2_id": "NCT02201316_exc_T51", "normalized": [] }, { "id": "NCT02201316_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T57", "arg2_id": "NCT02201316_exc_T58", "normalized": [] }, { "id": "NCT02201316_exc_R20", "type": "AND", "arg1_id": "NCT02201316_exc_T56", "arg2_id": "NCT02201316_exc_T55", "normalized": [] }, { "id": "NCT02201316_exc_R22", "type": "Has_index", "arg1_id": "NCT02201316_exc_T60", "arg2_id": "NCT02201316_exc_T61", "normalized": [] }, { "id": "NCT02201316_exc_R21", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T59", "arg2_id": "NCT02201316_exc_T58", "normalized": [] }, { "id": "NCT02201316_exc_R23", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T62", "arg2_id": "NCT02201316_exc_T60", "normalized": [] }, { "id": "NCT02201316_exc_R24", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T66", "arg2_id": "NCT02201316_exc_T63", "normalized": [] }, { "id": "NCT02201316_exc_R25", "type": "Has_value", "arg1_id": "NCT02201316_exc_T66", "arg2_id": "NCT02201316_exc_T67", "normalized": [] }, { "id": "NCT02201316_exc_R26", "type": "Has_value", "arg1_id": "NCT02201316_exc_T68", "arg2_id": "NCT02201316_exc_T69", "normalized": [] }, { "id": "NCT02201316_exc_R27", "type": "Has_value", "arg1_id": "NCT02201316_exc_T72", "arg2_id": "NCT02201316_exc_T73", "normalized": [] }, { "id": "NCT02201316_exc_R28", "type": "Subsumes", "arg1_id": "NCT02201316_exc_T70", "arg2_id": "NCT02201316_exc_T72", "normalized": [] }, { "id": "NCT02201316_exc_R29", "type": "Has_index", "arg1_id": "NCT02201316_exc_T75", "arg2_id": "NCT02201316_exc_T77", "normalized": [] }, { "id": "NCT02201316_exc_R30", "type": "Has_index", "arg1_id": "NCT02201316_exc_T74", "arg2_id": "NCT02201316_exc_T76", "normalized": [] }, { "id": "NCT02201316_exc_R31", "type": "Has_scope", "arg1_id": "NCT02201316_exc_T72", "arg2_id": "NCT02201316_exc_T78", "normalized": [] }, { "id": "NCT02201316_exc_R32", "type": "Has_multiplier", "arg1_id": "NCT02201316_exc_T87", "arg2_id": "NCT02201316_exc_T86", "normalized": [] }, { "id": "NCT02201316_exc_R33", "type": "Has_index", "arg1_id": "NCT02201316_exc_T89", "arg2_id": "NCT02201316_exc_T90", "normalized": [] }, { "id": "NCT02201316_exc_R34", "type": "Has_temporal", "arg1_id": "NCT02201316_exc_T87", "arg2_id": "NCT02201316_exc_T89", "normalized": [] } ]

[ { "id": "NCT02201316_inc_text", "type": "inclusion", "text": [ "Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. \nHealthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. \nBody weight >= 50 kilogram (kg) and body mass index within the range 19 - 24.9 kg/m^2 (inclusive). \nA female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, \"documented\" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) [<147 picomole per liter] is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotrophin (hCG) test at screening or prior to dosing AND; Agrees to use one of the contraception methods listed in protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up contact visit; OR has only same-sex partners, when this is her preferred and usual lifestyle. \nMale subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Protocol. This criterion must be followed from the time of the first dose of study medication until the follow-up contact visit. \nCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form \nAlanine aminotransferase, alkaline phosphatase and bilirubin <=1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). \nBased on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms obtained over a brief recording period: QTcF < 450 msec \n" ], "offsets": [ [ 0, 3457 ] ] } ]

[ { "id": "NCT02201316_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T2", "type": "Person", "text": [ "females" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 17, 21 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T5", "type": "Value", "text": [ "between 18 and 65 years" ], "offsets": [ [ 22, 45 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 49, 52 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T7", "type": "Temporal", "text": [ "at the time of signing the informed consent" ], "offsets": [ [ 64, 107 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T8", "type": "Reference_point", "text": [ "signing the informed consent" ], "offsets": [ [ 79, 107 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T9", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 110, 117 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T10", "type": "Qualifier", "text": [ "as determined by a responsible and experienced physician" ], "offsets": [ [ 118, 174 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T13", "type": "Procedure", "text": [ "medical evaluation" ], "offsets": [ [ 187, 205 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T14", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 216, 231 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T15", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 233, 253 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T16", "type": "Procedure", "text": [ "laboratory tests" ], "offsets": [ [ 255, 271 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T17", "type": "Procedure", "text": [ "cardiac monitoring" ], "offsets": [ [ 276, 294 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T18", "type": "Condition", "text": [ "clinical abnormality" ], "offsets": [ [ 313, 333 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T20", "type": "Value", "text": [ "outside the reference range" ], "offsets": [ [ 438, 465 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T21", "type": "Measurement", "text": [ "laboratory parameter" ], "offsets": [ [ 337, 357 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T26", "type": "Measurement", "text": [ "Body weight" ], "offsets": [ [ 733, 744 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T27", "type": "Value", "text": [ ">= 50 kilogram (kg)" ], "offsets": [ [ 745, 764 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T28", "type": "Measurement", "text": [ "body mass index" ], "offsets": [ [ 769, 784 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T29", "type": "Value", "text": [ "within the range 19 - 24.9 kg/m^2" ], "offsets": [ [ 785, 818 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T30", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 895, 917 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T31", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 891, 894 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T32", "type": "Condition", "text": [ "pre-menopausal" ], "offsets": [ [ 929, 943 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T33", "type": "Person", "text": [ "females" ], "offsets": [ [ 944, 951 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T34", "type": "Person", "text": [ "female" ], "offsets": [ [ 835, 841 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T35", "type": "Procedure", "text": [ "tubal ligation" ], "offsets": [ [ 970, 984 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T36", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 988, 1000 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T37", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 1247, 1261 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T38", "type": "Temporal", "text": [ "12 months" ], "offsets": [ [ 1273, 1282 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T39", "type": "Condition", "text": [ "spontaneous amenorrhea" ], "offsets": [ [ 1286, 1308 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T40", "type": "Measurement", "text": [ "follicle stimulating hormone (FSH)" ], "offsets": [ [ 1365, 1399 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T41", "type": "Value", "text": [ "> 40 milli-international units per milliliter (MlU/mL)" ], "offsets": [ [ 1400, 1454 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T42", "type": "Measurement", "text": [ "estradiol" ], "offsets": [ [ 1459, 1468 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T43", "type": "Value", "text": [ "< 40 picograms per mililiter (pg/mL)" ], "offsets": [ [ 1469, 1505 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T44", "type": "Value", "text": [ "<147 picomole per liter" ], "offsets": [ [ 1507, 1530 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T45", "type": "Scope", "text": [ "follicle stimulating hormone (FSH) > 40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) [<147 picomole per liter" ], "offsets": [ [ 1365, 1530 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T46", "type": "Scope", "text": [ "pre-menopausal females with a documented tubal ligation or hysterectomy" ], "offsets": [ [ 929, 1000 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T47", "type": "Scope", "text": [ "pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, \"documented\" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) [<147 picomole per liter] is confirmatory]" ], "offsets": [ [ 929, 1548 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T48", "type": "Procedure", "text": [ "hormone replacement therapy (HRT)" ], "offsets": [ [ 1561, 1594 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T49", "type": "Person", "text": [ "Females" ], "offsets": [ [ 1550, 1557 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T50", "type": "Measurement", "text": [ "menopausal status" ], "offsets": [ [ 1605, 1622 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T51", "type": "Value", "text": [ "in doubt" ], "offsets": [ [ 1626, 1634 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T68", "type": "Measurement", "text": [ "Alanine aminotransferase" ], "offsets": [ [ 3107, 3131 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T69", "type": "Measurement", "text": [ "alkaline phosphatase" ], "offsets": [ [ 3133, 3153 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T70", "type": "Measurement", "text": [ "bilirubin" ], "offsets": [ [ 3158, 3167 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T71", "type": "Scope", "text": [ "Alanine aminotransferase, alkaline phosphatase and bilirubin" ], "offsets": [ [ 3107, 3167 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T72", "type": "Value", "text": [ "<=1.5x upper limit of normal (ULN)" ], "offsets": [ [ 3168, 3202 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T73", "type": "Measurement", "text": [ "bilirubin" ], "offsets": [ [ 3213, 3222 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T74", "type": "Value", "text": [ ">1.5xULN" ], "offsets": [ [ 3223, 3231 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T75", "type": "Measurement", "text": [ "direct bilirubin" ], "offsets": [ [ 3279, 3295 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T77", "type": "Measurement", "text": [ "QTcF" ], "offsets": [ [ 3440, 3444 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T78", "type": "Value", "text": [ "< 450 msec" ], "offsets": [ [ 3445, 3455 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T79", "type": "Qualifier", "text": [ "single" ], "offsets": [ [ 3313, 3319 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T80", "type": "Qualifier", "text": [ "averaged" ], "offsets": [ [ 3323, 3331 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T81", "type": "Scope", "text": [ "single or averaged" ], "offsets": [ [ 3313, 3331 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T82", "type": "Measurement", "text": [ "corrected QT interval (QTc)" ], "offsets": [ [ 3332, 3359 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T83", "type": "Procedure", "text": [ "electrocardiograms" ], "offsets": [ [ 3381, 3399 ] ], "normalized": [] }, { "id": "NCT02201316_inc_T84", "type": "Temporal", "text": [ "over a brief recording period" ], "offsets": [ [ 3409, 3438 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02201316_inc_R1", "type": "Has_value", "arg1_id": "NCT02201316_inc_T4", "arg2_id": "NCT02201316_inc_T5", "normalized": [] }, { "id": "NCT02201316_inc_R2", "type": "Has_value", "arg1_id": "NCT02201316_inc_T6", "arg2_id": "NCT02201316_inc_T5", "normalized": [] }, { "id": "NCT02201316_inc_R3", "type": "Has_index", "arg1_id": "NCT02201316_inc_T7", "arg2_id": "NCT02201316_inc_T8", "normalized": [] }, { "id": "NCT02201316_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02201316_inc_T5", "arg2_id": "NCT02201316_inc_T7", "normalized": [] }, { "id": "NCT02201316_inc_R5", "type": "AND", "arg1_id": "NCT02201316_inc_T9", "arg2_id": "NCT02201316_inc_T13", "normalized": [] }, { "id": "NCT02201316_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02201316_inc_T9", "arg2_id": "NCT02201316_inc_T14", "normalized": [] }, { "id": "NCT02201316_inc_R7", "type": "AND", "arg1_id": "NCT02201316_inc_T9", "arg2_id": "NCT02201316_inc_T15", "normalized": [] }, { "id": "NCT02201316_inc_R8", "type": "AND", "arg1_id": "NCT02201316_inc_T9", "arg2_id": "NCT02201316_inc_T16", "normalized": [] }, { "id": "NCT02201316_inc_R9", "type": "AND", "arg1_id": "NCT02201316_inc_T9", "arg2_id": "NCT02201316_inc_T17", "normalized": [] }, { "id": "NCT02201316_inc_R10", "type": "Has_value", "arg1_id": "NCT02201316_inc_T21", "arg2_id": "NCT02201316_inc_T20", "normalized": [] }, { "id": "NCT02201316_inc_R11", "type": "Has_value", "arg1_id": "NCT02201316_inc_T28", "arg2_id": "NCT02201316_inc_T29", "normalized": [] }, { "id": "NCT02201316_inc_R12", "type": "Has_value", "arg1_id": "NCT02201316_inc_T26", "arg2_id": "NCT02201316_inc_T27", "normalized": [] }, { "id": "NCT02201316_inc_R13", "type": "Has_negation", "arg1_id": "NCT02201316_inc_T30", "arg2_id": "NCT02201316_inc_T31", "normalized": [] }, { "id": "NCT02201316_inc_R14", "type": "Has_temporal", "arg1_id": "NCT02201316_inc_T39", "arg2_id": "NCT02201316_inc_T38", "normalized": [] }, { "id": "NCT02201316_inc_R15", "type": "Has_value", "arg1_id": "NCT02201316_inc_T40", "arg2_id": "NCT02201316_inc_T41", "normalized": [] }, { "id": "NCT02201316_inc_R16", "type": "Subsumes", "arg1_id": "NCT02201316_inc_T43", "arg2_id": "NCT02201316_inc_T44", "normalized": [] }, { "id": "NCT02201316_inc_R17", "type": "Has_value", "arg1_id": "NCT02201316_inc_T42", "arg2_id": "NCT02201316_inc_T43", "normalized": [] }, { "id": "NCT02201316_inc_R18", "type": "Subsumes", "arg1_id": "NCT02201316_inc_T39", "arg2_id": "NCT02201316_inc_T45", "normalized": [] }, { "id": "NCT02201316_inc_R19", "type": "Subsumes", "arg1_id": "NCT02201316_inc_T37", "arg2_id": "NCT02201316_inc_T39", "normalized": [] }, { "id": "NCT02201316_inc_R20", "type": "Subsumes", "arg1_id": "NCT02201316_inc_T30", "arg2_id": "NCT02201316_inc_T47", "normalized": [] }, { "id": "NCT02201316_inc_R21", "type": "Has_value", "arg1_id": "NCT02201316_inc_T50", "arg2_id": "NCT02201316_inc_T51", "normalized": [] }, { "id": "NCT02201316_inc_R22", "type": "Has_value", "arg1_id": "NCT02201316_inc_T71", "arg2_id": "NCT02201316_inc_T72", "normalized": [] }, { "id": "NCT02201316_inc_R23", "type": "Has_value", "arg1_id": "NCT02201316_inc_T73", "arg2_id": "NCT02201316_inc_T74", "normalized": [] }, { "id": "NCT02201316_inc_R24", "type": "Has_value", "arg1_id": "NCT02201316_inc_T77", "arg2_id": "NCT02201316_inc_T78", "normalized": [] }, { "id": "NCT02201316_inc_R25", "type": "Has_temporal", "arg1_id": "NCT02201316_inc_T83", "arg2_id": "NCT02201316_inc_T84", "normalized": [] }, { "id": "NCT02201316_inc_R26", "type": "Subsumes", "arg1_id": "NCT02201316_inc_T82", "arg2_id": "NCT02201316_inc_T77", "normalized": [] }, { "id": "NCT02201316_inc_R27", "type": "Has_value", "arg1_id": "NCT02201316_inc_T82", "arg2_id": "NCT02201316_inc_T78", "normalized": [] }, { "id": "NCT02201316_inc_R28", "type": "Has_scope", "arg1_id": "NCT02201316_inc_T82", "arg2_id": "NCT02201316_inc_T81", "normalized": [] }, { "id": "NCT02201316_inc_R29", "type": "Has_scope", "arg1_id": "NCT02201316_inc_T77", "arg2_id": "NCT02201316_inc_T81", "normalized": [] }, { "id": "NCT02201316_inc_R30", "type": "AND", "arg1_id": "NCT02201316_inc_T82", "arg2_id": "NCT02201316_inc_T83", "normalized": [] }, { "id": "NCT02201316_inc_R31", "type": "AND", "arg1_id": "NCT02201316_inc_T77", "arg2_id": "NCT02201316_inc_T83", "normalized": [] } ]

[ { "id": "NCT02202369_exc_text", "type": "exclusion", "text": [ "Patients with liver disease (documented liver function test abnormality)\nPatients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)\nPatients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.\nPatients with active alcohol dependence\nPatients with active illicit drug dependence\nPatients < 18 years of age and >70 years of age\nPatients allergic to any medication given in either arm (list medications)\nPatients who have a seizure disorder\n" ], "offsets": [ [ 0, 504 ] ] } ]

[ { "id": "NCT02202369_exc_T1", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 14, 27 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T2", "type": "Measurement", "text": [ "liver function test" ], "offsets": [ [ 40, 59 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T3", "type": "Value", "text": [ "abnormality" ], "offsets": [ [ 60, 71 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T4", "type": "Condition", "text": [ "renal disease" ], "offsets": [ [ 87, 100 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T5", "type": "Measurement", "text": [ "glomerular filtration rate" ], "offsets": [ [ 113, 139 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T6", "type": "Value", "text": [ "< 60mL/min/1.73m2" ], "offsets": [ [ 140, 157 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T7", "type": "Drug", "text": [ "opioid" ], "offsets": [ [ 200, 206 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T8", "type": "Qualifier", "text": [ "baseline" ], "offsets": [ [ 175, 183 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T9", "type": "Qualifier", "text": [ "pre-operative" ], "offsets": [ [ 185, 198 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T10", "type": "Multiplier", "text": [ "greater than 30 mg of morphine equivalents/day" ], "offsets": [ [ 211, 257 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T11", "type": "Condition", "text": [ "alcohol dependence" ], "offsets": [ [ 280, 298 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T12", "type": "Condition", "text": [ "illicit drug dependence" ], "offsets": [ [ 320, 343 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T13", "type": "Person", "text": [ "age" ], "offsets": [ [ 367, 370 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T14", "type": "Value", "text": [ "< 18 years" ], "offsets": [ [ 353, 363 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T15", "type": "Person", "text": [ "age" ], "offsets": [ [ 388, 391 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T16", "type": "Value", "text": [ ">70 years" ], "offsets": [ [ 375, 384 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T17", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 401, 409 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T18", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 417, 427 ] ], "normalized": [] }, { "id": "NCT02202369_exc_T19", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 487, 503 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02202369_exc_R1", "type": "Has_value", "arg1_id": "NCT02202369_exc_T2", "arg2_id": "NCT02202369_exc_T3", "normalized": [] }, { "id": "NCT02202369_exc_R2", "type": "AND", "arg1_id": "NCT02202369_exc_T1", "arg2_id": "NCT02202369_exc_T2", "normalized": [] }, { "id": "NCT02202369_exc_R3", "type": "AND", "arg1_id": "NCT02202369_exc_T4", "arg2_id": "NCT02202369_exc_T5", "normalized": [] }, { "id": "NCT02202369_exc_R4", "type": "Has_value", "arg1_id": "NCT02202369_exc_T5", "arg2_id": "NCT02202369_exc_T6", "normalized": [] }, { "id": "NCT02202369_exc_R5", "type": "Has_multiplier", "arg1_id": "NCT02202369_exc_T7", "arg2_id": "NCT02202369_exc_T10", "normalized": [] }, { "id": "NCT02202369_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02202369_exc_T7", "arg2_id": "NCT02202369_exc_T8", "normalized": [] }, { "id": "NCT02202369_exc_R7", "type": "Subsumes", "arg1_id": "NCT02202369_exc_T8", "arg2_id": "NCT02202369_exc_T9", "normalized": [] }, { "id": "NCT02202369_exc_R8", "type": "Has_value", "arg1_id": "NCT02202369_exc_T13", "arg2_id": "NCT02202369_exc_T14", "normalized": [] }, { "id": "NCT02202369_exc_R9", "type": "Has_value", "arg1_id": "NCT02202369_exc_T15", "arg2_id": "NCT02202369_exc_T16", "normalized": [] }, { "id": "NCT02202369_exc_R10", "type": "AND", "arg1_id": "NCT02202369_exc_T17", "arg2_id": "NCT02202369_exc_T18", "normalized": [] } ]

[ { "id": "NCT02202369_inc_text", "type": "inclusion", "text": [ "Subjects undergoing a single level lumbar decompression and fusion\n> 18 years of age and < 70 years of age\nThe subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study\n" ], "offsets": [ [ 0, 276 ] ] } ]

[ { "id": "NCT02202369_inc_T1", "type": "Procedure", "text": [ "lumbar decompression" ], "offsets": [ [ 35, 55 ] ], "normalized": [] }, { "id": "NCT02202369_inc_T2", "type": "Procedure", "text": [ "lumbar", "fusion" ], "offsets": [ [ 35, 41 ], [ 60, 66 ] ], "normalized": [] }, { "id": "NCT02202369_inc_T3", "type": "Qualifier", "text": [ "single level" ], "offsets": [ [ 22, 34 ] ], "normalized": [] }, { "id": "NCT02202369_inc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 103, 106 ] ], "normalized": [] }, { "id": "NCT02202369_inc_T6", "type": "Value", "text": [ " 18 year", "nd < 70 years" ], "offsets": [ [ 68, 76 ], [ 86, 99 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02202369_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02202369_inc_T1", "arg2_id": "NCT02202369_inc_T3", "normalized": [] }, { "id": "NCT02202369_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02202369_inc_T2", "arg2_id": "NCT02202369_inc_T3", "normalized": [] }, { "id": "NCT02202369_inc_R4", "type": "Has_value", "arg1_id": "NCT02202369_inc_T5", "arg2_id": "NCT02202369_inc_T6", "normalized": [] } ]

[ { "id": "NCT02203019_exc_text", "type": "exclusion", "text": [ "Patients with documented allergies to propofol, dexmedetomidine, fentanyl, eggs or egg products, or soy or soy products.\nA heart rate less than 50 beats/minute or grade 2 or 3 AV heart block\nMean arterial pressure less than 55 mmHg despite appropriate fluid resuscitation and vasopressor support.\nCurrent triglyceride level > 400 mg/dl\n" ], "offsets": [ [ 0, 336 ] ] } ]

[ { "id": "NCT02203019_exc_T1", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T2", "type": "Drug", "text": [ "propofol" ], "offsets": [ [ 38, 46 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T3", "type": "Drug", "text": [ "dexmedetomidine" ], "offsets": [ [ 48, 63 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T4", "type": "Drug", "text": [ "fentanyl" ], "offsets": [ [ 65, 73 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T5", "type": "Observation", "text": [ "eggs" ], "offsets": [ [ 75, 79 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T6", "type": "Observation", "text": [ "egg products" ], "offsets": [ [ 83, 95 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T7", "type": "Observation", "text": [ "soy" ], "offsets": [ [ 100, 103 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T8", "type": "Observation", "text": [ "soy products" ], "offsets": [ [ 107, 119 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T9", "type": "Scope", "text": [ "propofol, dexmedetomidine, fentanyl, eggs or egg products, or soy or soy products" ], "offsets": [ [ 38, 119 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T10", "type": "Measurement", "text": [ "heart rate" ], "offsets": [ [ 123, 133 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T11", "type": "Value", "text": [ "less than 50 beats/minute" ], "offsets": [ [ 134, 159 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T12", "type": "Condition", "text": [ "AV heart block" ], "offsets": [ [ 176, 190 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T13", "type": "Qualifier", "text": [ "grade 2" ], "offsets": [ [ 163, 170 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T14", "type": "Qualifier", "text": [ "rade", "" ], "offsets": [ [ 164, 168 ], [ 175, 175 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T15", "type": "Scope", "text": [ "grade 2 or 3" ], "offsets": [ [ 163, 175 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T16", "type": "Measurement", "text": [ "Mean arterial pressure" ], "offsets": [ [ 191, 213 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T17", "type": "Value", "text": [ "less than 55 mmHg" ], "offsets": [ [ 214, 231 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T18", "type": "Procedure", "text": [ "fluid resuscitation" ], "offsets": [ [ 252, 271 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T19", "type": "Procedure", "text": [ "vasopressor" ], "offsets": [ [ 276, 287 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T20", "type": "Measurement", "text": [ "triglyceride level" ], "offsets": [ [ 305, 323 ] ], "normalized": [] }, { "id": "NCT02203019_exc_T21", "type": "Value", "text": [ "> 400 mg/dl" ], "offsets": [ [ 324, 335 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02203019_exc_R1", "type": "Has_scope", "arg1_id": "NCT02203019_exc_T1", "arg2_id": "NCT02203019_exc_T9", "normalized": [] }, { "id": "NCT02203019_exc_R2", "type": "Has_scope", "arg1_id": "NCT02203019_exc_T12", "arg2_id": "NCT02203019_exc_T15", "normalized": [] }, { "id": "NCT02203019_exc_R3", "type": "Has_value", "arg1_id": "NCT02203019_exc_T10", "arg2_id": "NCT02203019_exc_T11", "normalized": [] }, { "id": "NCT02203019_exc_R4", "type": "Has_value", "arg1_id": "NCT02203019_exc_T16", "arg2_id": "NCT02203019_exc_T17", "normalized": [] }, { "id": "NCT02203019_exc_R5", "type": "Has_value", "arg1_id": "NCT02203019_exc_T20", "arg2_id": "NCT02203019_exc_T21", "normalized": [] } ]

[ { "id": "NCT02203019_inc_text", "type": "inclusion", "text": [ "Men and women 18-89 years old\nwith the diagnosis of sepsis (as specified below) within the previous 24 hours\nwho require mechanical ventilation, and\nprovide informed consent either personally or by an authorized representative.\n" ], "offsets": [ [ 0, 228 ] ] } ]

[ { "id": "NCT02203019_inc_T1", "type": "Person", "text": [ "Men" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 8, 13 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T3", "type": "Person", "text": [ "old" ], "offsets": [ [ 26, 29 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T4", "type": "Value", "text": [ "18-89 years" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T5", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 52, 58 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T6", "type": "Temporal", "text": [ "within the previous 24 hours" ], "offsets": [ [ 80, 108 ] ], "normalized": [] }, { "id": "NCT02203019_inc_T7", "type": "Procedure", "text": [ "mechanical ventilation" ], "offsets": [ [ 121, 143 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02203019_inc_R1", "type": "Has_value", "arg1_id": "NCT02203019_inc_T3", "arg2_id": "NCT02203019_inc_T4", "normalized": [] }, { "id": "NCT02203019_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02203019_inc_T5", "arg2_id": "NCT02203019_inc_T6", "normalized": [] } ]

[ { "id": "NCT02205502_exc_text", "type": "exclusion", "text": [ "contraindication to ketamine and lidocaine\npatients involved to other studies\nmore or equal to American Society of Anesthesiologist (ASA) class III\nnot alert\n" ], "offsets": [ [ 0, 158 ] ] } ]

[ { "id": "NCT02205502_exc_T1", "type": "Drug", "text": [ "ketamine" ], "offsets": [ [ 20, 28 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T2", "type": "Drug", "text": [ "lidocaine" ], "offsets": [ [ 33, 42 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T3", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T4", "type": "Scope", "text": [ "ketamine and lidocaine" ], "offsets": [ [ 20, 42 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T6", "type": "Measurement", "text": [ "American Society of Anesthesiologist (ASA) class" ], "offsets": [ [ 95, 143 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T7", "type": "Value", "text": [ "I\nn", "re or equal to A" ], "offsets": [ [ 146, 149 ], [ 80, 96 ] ], "normalized": [] }, { "id": "NCT02205502_exc_T8", "type": "Observation", "text": [ "not alert" ], "offsets": [ [ 148, 157 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02205502_exc_R1", "type": "Has_scope", "arg1_id": "NCT02205502_exc_T3", "arg2_id": "NCT02205502_exc_T4", "normalized": [] }, { "id": "NCT02205502_exc_R2", "type": "Has_value", "arg1_id": "NCT02205502_exc_T6", "arg2_id": "NCT02205502_exc_T7", "normalized": [] } ]

[ { "id": "NCT02205502_inc_text", "type": "inclusion", "text": [ "patients who need suturing for laceration under procedural anesthesia using ketamine\n" ], "offsets": [ [ 0, 85 ] ] } ]

[ { "id": "NCT02205502_inc_T1", "type": "Procedure", "text": [ "suturing" ], "offsets": [ [ 18, 26 ] ], "normalized": [] }, { "id": "NCT02205502_inc_T2", "type": "Condition", "text": [ "laceration" ], "offsets": [ [ 31, 41 ] ], "normalized": [] }, { "id": "NCT02205502_inc_T3", "type": "Procedure", "text": [ "procedural anesthesia" ], "offsets": [ [ 48, 69 ] ], "normalized": [] }, { "id": "NCT02205502_inc_T4", "type": "Drug", "text": [ "ketamine" ], "offsets": [ [ 76, 84 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02205502_inc_R1", "type": "AND", "arg1_id": "NCT02205502_inc_T3", "arg2_id": "NCT02205502_inc_T4", "normalized": [] }, { "id": "NCT02205502_inc_R2", "type": "AND", "arg1_id": "NCT02205502_inc_T1", "arg2_id": "NCT02205502_inc_T3", "normalized": [] }, { "id": "NCT02205502_inc_R3", "type": "AND", "arg1_id": "NCT02205502_inc_T1", "arg2_id": "NCT02205502_inc_T2", "normalized": [] } ]

[ { "id": "NCT02205931_exc_text", "type": "exclusion", "text": [ "Age <1m or > 24 months of age\nNo secure diagnosis of epilepsy\n< 4 seizures/week on average in baseline period\nTrial of < 2 AEDs\nContinues on corticosteroids in previous 3 months prior to randomisation\nMetabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline.\nProgressive neurological disease\nSevere gastroesophageal reflux\nPrevious treatment with the ketogenic diet\nConcurrent participation in another clinical trial of an investigational medicinal product.\nPatients who are prescribed AEDs not listed in the trial IMPs\n" ], "offsets": [ [ 0, 629 ] ] } ]

[ { "id": "NCT02205931_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T2", "type": "Value", "text": [ "<1m or > 24 months of age" ], "offsets": [ [ 4, 29 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T3", "type": "Negation", "text": [ "No" ], "offsets": [ [ 30, 32 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T4", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 53, 61 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T5", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 66, 74 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T6", "type": "Multiplier", "text": [ "4 s", "eek o" ], "offsets": [ [ 64, 67 ], [ 76, 81 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T7", "type": "Drug", "text": [ "AEDs" ], "offsets": [ [ 123, 127 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T8", "type": "Multiplier", "text": [ "< 2" ], "offsets": [ [ 119, 122 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T9", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 141, 156 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T10", "type": "Temporal", "text": [ "previous 3 months prior to randomisation" ], "offsets": [ [ 160, 200 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T11", "type": "Reference_point", "text": [ "randomisation" ], "offsets": [ [ 187, 200 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T12", "type": "Condition", "text": [ "Metabolic disease" ], "offsets": [ [ 201, 218 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T13", "type": "Condition", "text": [ "contraindicating" ], "offsets": [ [ 219, 235 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T14", "type": "Procedure", "text": [ "ketogenic diet" ], "offsets": [ [ 247, 261 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T15", "type": "Condition", "text": [ "pyruvate carboxylase deficiency," ], "offsets": [ [ 267, 299 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T16", "type": "Condition", "text": [ "MCAD" ], "offsets": [ [ 300, 304 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T17", "type": "Scope", "text": [ "pyruvate carboxylase deficiency, MCAD" ], "offsets": [ [ 267, 304 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T18", "type": "Condition", "text": [ "neurological disease" ], "offsets": [ [ 380, 400 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T19", "type": "Qualifier", "text": [ "Progressive" ], "offsets": [ [ 368, 379 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T20", "type": "Condition", "text": [ "gastroesophageal reflux" ], "offsets": [ [ 408, 431 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T21", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 401, 407 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T22", "type": "Procedure", "text": [ "ketogenic diet" ], "offsets": [ [ 460, 474 ] ], "normalized": [] }, { "id": "NCT02205931_exc_T23", "type": "Qualifier", "text": [ "Previous" ], "offsets": [ [ 432, 440 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02205931_exc_R1", "type": "Has_value", "arg1_id": "NCT02205931_exc_T1", "arg2_id": "NCT02205931_exc_T2", "normalized": [] }, { "id": "NCT02205931_exc_R2", "type": "Has_negation", "arg1_id": "NCT02205931_exc_T4", "arg2_id": "NCT02205931_exc_T3", "normalized": [] }, { "id": "NCT02205931_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT02205931_exc_T5", "arg2_id": "NCT02205931_exc_T6", "normalized": [] }, { "id": "NCT02205931_exc_R4", "type": "Has_multiplier", "arg1_id": "NCT02205931_exc_T7", "arg2_id": "NCT02205931_exc_T8", "normalized": [] }, { "id": "NCT02205931_exc_R5", "type": "Has_index", "arg1_id": "NCT02205931_exc_T10", "arg2_id": "NCT02205931_exc_T11", "normalized": [] }, { "id": "NCT02205931_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02205931_exc_T9", "arg2_id": "NCT02205931_exc_T10", "normalized": [] }, { "id": "NCT02205931_exc_R7", "type": "AND", "arg1_id": "NCT02205931_exc_T12", "arg2_id": "NCT02205931_exc_T13", "normalized": [] }, { "id": "NCT02205931_exc_R8", "type": "AND", "arg1_id": "NCT02205931_exc_T13", "arg2_id": "NCT02205931_exc_T14", "normalized": [] }, { "id": "NCT02205931_exc_R9", "type": "Has_scope", "arg1_id": "NCT02205931_exc_T12", "arg2_id": "NCT02205931_exc_T17", "normalized": [] }, { "id": "NCT02205931_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT02205931_exc_T18", "arg2_id": "NCT02205931_exc_T19", "normalized": [] }, { "id": "NCT02205931_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02205931_exc_T20", "arg2_id": "NCT02205931_exc_T21", "normalized": [] }, { "id": "NCT02205931_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02205931_exc_T22", "arg2_id": "NCT02205931_exc_T23", "normalized": [] } ]

[ { "id": "NCT02205931_inc_text", "type": "inclusion", "text": [ "Age between 1 month and 24 months of age (not beyond second birthday at baseline).\nDiagnosis of epilepsy confirmed.\nAt least an average of 4 seizures/week in baseline period.\nFailed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids.\nChildren with written informed consent from parent/guardian.\n" ], "offsets": [ [ 0, 378 ] ] } ]

[ { "id": "NCT02205931_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T2", "type": "Value", "text": [ "between 1 month and 24 months of age" ], "offsets": [ [ 4, 40 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T3", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 96, 104 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T4", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 141, 149 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T5", "type": "Multiplier", "text": [ " least an average of 4 ", "eek i" ], "offsets": [ [ 118, 141 ], [ 151, 156 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T6", "type": "Drug", "text": [ "anti-epileptic drugs" ], "offsets": [ [ 216, 236 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T7", "type": "Multiplier", "text": [ "two" ], "offsets": [ [ 212, 215 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T8", "type": "Condition", "text": [ "response" ], "offsets": [ [ 182, 190 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T9", "type": "Qualifier", "text": [ "Failed" ], "offsets": [ [ 175, 181 ] ], "normalized": [] }, { "id": "NCT02205931_inc_T10", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 300, 315 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02205931_inc_R1", "type": "Has_value", "arg1_id": "NCT02205931_inc_T1", "arg2_id": "NCT02205931_inc_T2", "normalized": [] }, { "id": "NCT02205931_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02205931_inc_T4", "arg2_id": "NCT02205931_inc_T5", "normalized": [] }, { "id": "NCT02205931_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02205931_inc_T6", "arg2_id": "NCT02205931_inc_T7", "normalized": [] }, { "id": "NCT02205931_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02205931_inc_T8", "arg2_id": "NCT02205931_inc_T9", "normalized": [] }, { "id": "NCT02205931_inc_R5", "type": "AND", "arg1_id": "NCT02205931_inc_T8", "arg2_id": "NCT02205931_inc_T6", "normalized": [] }, { "id": "NCT02205931_inc_R6", "type": "AND", "arg1_id": "NCT02205931_inc_T6", "arg2_id": "NCT02205931_inc_T10", "normalized": [] } ]

[ { "id": "NCT02208739_exc_text", "type": "exclusion", "text": [ "Patients who had history of systemic antibiotic usage over the previous 4 months \nPatients who were pregnant \nPatients who had received non-surgical periodontal treatment within the past 6 months \nPatients who had received surgical periodontal treatment within the past 12 months \nPatients who were smokers \nPatients with a history of stroke or an acute cardiovascular event over the previous 12 months. \n \n" ], "offsets": [ [ 0, 416 ] ] } ]

[ { "id": "NCT02208739_exc_T1", "type": "Drug", "text": [ "systemic antibiotic" ], "offsets": [ [ 28, 47 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T2", "type": "Temporal", "text": [ "over the previous 4 months" ], "offsets": [ [ 54, 80 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 17, 24 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T4", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 100, 108 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T5", "type": "Procedure", "text": [ "non-surgical periodontal treatment" ], "offsets": [ [ 136, 170 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T6", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 171, 195 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T7", "type": "Procedure", "text": [ "surgical periodontal treatment" ], "offsets": [ [ 223, 253 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T8", "type": "Temporal", "text": [ "within the past 12 months" ], "offsets": [ [ 254, 279 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T9", "type": "Condition", "text": [ "smokers" ], "offsets": [ [ 299, 306 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T10", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 335, 341 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T11", "type": "Procedure", "text": [ "acute cardiovascular event" ], "offsets": [ [ 348, 374 ] ], "normalized": [] }, { "id": "NCT02208739_exc_T12", "type": "Temporal", "text": [ "over the previous 12 months" ], "offsets": [ [ 375, 402 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02208739_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02208739_exc_T1", "arg2_id": "NCT02208739_exc_T2", "normalized": [] }, { "id": "NCT02208739_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02208739_exc_T1", "arg2_id": "NCT02208739_exc_T3", "normalized": [] }, { "id": "NCT02208739_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02208739_exc_T5", "arg2_id": "NCT02208739_exc_T6", "normalized": [] }, { "id": "NCT02208739_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02208739_exc_T7", "arg2_id": "NCT02208739_exc_T8", "normalized": [] }, { "id": "NCT02208739_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02208739_exc_T11", "arg2_id": "NCT02208739_exc_T12", "normalized": [] } ]

[ { "id": "NCT02208739_inc_text", "type": "inclusion", "text": [ "Patients should have at least 12 teeth present \nPatients with Moderate to Advanced Chronic periodontitis \nPatients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing. \n" ], "offsets": [ [ 0, 331 ] ] } ]

[ { "id": "NCT02208739_inc_T1", "type": "Condition", "text": [ "Chronic periodontitis" ], "offsets": [ [ 83, 104 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T2", "type": "Qualifier", "text": [ "Advanced" ], "offsets": [ [ 74, 82 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T3", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 62, 70 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T4", "type": "Scope", "text": [ "Moderate to Advanced" ], "offsets": [ [ 62, 82 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T5", "type": "Condition", "text": [ "teeth present" ], "offsets": [ [ 33, 46 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T6", "type": "Multiplier", "text": [ "at least 12" ], "offsets": [ [ 21, 32 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T7", "type": "Multiplier", "text": [ "2 or more" ], "offsets": [ [ 120, 129 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T8", "type": "Condition", "text": [ "interproximal sites", "with probing pocket depths of 5mm or more" ], "offsets": [ [ 130, 149 ], [ 170, 211 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T9", "type": "Value", "text": [ "5mm or more" ], "offsets": [ [ 200, 211 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T10", "type": "Multiplier", "text": [ "2 or more" ], "offsets": [ [ 216, 225 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T11", "type": "Condition", "text": [ "interproximal sites", "of probing attachment loss of 4mm or more" ], "offsets": [ [ 226, 245 ], [ 265, 306 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T12", "type": "Value", "text": [ "4mm or more" ], "offsets": [ [ 295, 306 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T13", "type": "Qualifier", "text": [ "bled on probing" ], "offsets": [ [ 313, 328 ] ], "normalized": [] }, { "id": "NCT02208739_inc_T14", "type": "Procedure", "text": [ "probing" ], "offsets": [ [ 321, 328 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02208739_inc_R1", "type": "Has_scope", "arg1_id": "NCT02208739_inc_T1", "arg2_id": "NCT02208739_inc_T4", "normalized": [] }, { "id": "NCT02208739_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02208739_inc_T5", "arg2_id": "NCT02208739_inc_T6", "normalized": [] }, { "id": "NCT02208739_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02208739_inc_T11", "arg2_id": "NCT02208739_inc_T10", "normalized": [] }, { "id": "NCT02208739_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02208739_inc_T11", "arg2_id": "NCT02208739_inc_T13", "normalized": [] }, { "id": "NCT02208739_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT02208739_inc_T8", "arg2_id": "NCT02208739_inc_T7", "normalized": [] } ]

[ { "id": "NCT02209545_exc_text", "type": "exclusion", "text": [ "Patients who have had a prior abdominal myomectomy\nPost-menopausal women\nPatients with known bleeding/clotting disorders\nPatients with a history of gynecologic malignancy\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol\nAny cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n" ], "offsets": [ [ 0, 729 ] ] } ]

[ { "id": "NCT02209545_exc_T1", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 24, 29 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T2", "type": "Procedure", "text": [ "abdominal myomectomy" ], "offsets": [ [ 30, 50 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T3", "type": "Observation", "text": [ "Post-menopausal" ], "offsets": [ [ 51, 66 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T4", "type": "Person", "text": [ "women" ], "offsets": [ [ 67, 72 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T5", "type": "Condition", "text": [ "clotting disorders" ], "offsets": [ [ 102, 120 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T6", "type": "Condition", "text": [ "sorders\nP", "eeding/c" ], "offsets": [ [ 113, 122 ], [ 95, 103 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T7", "type": "Condition", "text": [ "gynecologic malignancy" ], "offsets": [ [ 148, 170 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T8", "type": "Observation", "text": [ "history" ], "offsets": [ [ 137, 144 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T9", "type": "Observation", "text": [ "History" ], "offsets": [ [ 171, 178 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T10", "type": "Condition", "text": [ "allergic reactions" ], "offsets": [ [ 182, 200 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T11", "type": "Drug", "text": [ "compounds of similar chemical or biologic composition to misoprostol" ], "offsets": [ [ 215, 283 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T12", "type": "Drug", "text": [ "misoprostol" ], "offsets": [ [ 272, 283 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T13", "type": "Procedure", "text": [ "abdominal hysterectomy" ], "offsets": [ [ 307, 329 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T14", "type": "Mood", "text": [ "converted to" ], "offsets": [ [ 294, 306 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T15", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 350, 358 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T16", "type": "Procedure", "text": [ "surgical procedures" ], "offsets": [ [ 359, 378 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T17", "type": "Temporal", "text": [ "at time of abdominal myomectomy" ], "offsets": [ [ 389, 420 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T18", "type": "Reference_point", "text": [ "abdominal myomectomy" ], "offsets": [ [ 400, 420 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T19", "type": "Procedure", "text": [ "abdominal myomectomy" ], "offsets": [ [ 400, 420 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T20", "type": "Qualifier", "text": [ "additional" ], "offsets": [ [ 339, 349 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T21", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 333, 338 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T22", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 457, 469 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T23", "type": "Condition", "text": [ "intercurrent illness" ], "offsets": [ [ 470, 490 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T24", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 533, 539 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T25", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 522, 529 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T26", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 540, 549 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T27", "type": "Scope", "text": [ "ongoing or active" ], "offsets": [ [ 522, 539 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T28", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 551, 562 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T29", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 563, 587 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T30", "type": "Condition", "text": [ "unstable angina pectoris" ], "offsets": [ [ 589, 613 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T31", "type": "Condition", "text": [ "cardiac arrhythmia" ], "offsets": [ [ 615, 633 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T32", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 638, 657 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T33", "type": "Observation", "text": [ "social situations that would limit compliance with study requirements" ], "offsets": [ [ 658, 727 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T34", "type": "Scope", "text": [ "ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements" ], "offsets": [ [ 522, 727 ] ], "normalized": [] }, { "id": "NCT02209545_exc_T35", "type": "Scope", "text": [ "Uncontrolled intercurrent illness" ], "offsets": [ [ 457, 490 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02209545_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02209545_exc_T2", "arg2_id": "NCT02209545_exc_T1", "normalized": [] }, { "id": "NCT02209545_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02209545_exc_T7", "arg2_id": "NCT02209545_exc_T8", "normalized": [] }, { "id": "NCT02209545_exc_R4", "type": "AND", "arg1_id": "NCT02209545_exc_T10", "arg2_id": "NCT02209545_exc_T11", "normalized": [] }, { "id": "NCT02209545_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02209545_exc_T10", "arg2_id": "NCT02209545_exc_T9", "normalized": [] }, { "id": "NCT02209545_exc_R6", "type": "Has_mood", "arg1_id": "NCT02209545_exc_T13", "arg2_id": "NCT02209545_exc_T14", "normalized": [] }, { "id": "NCT02209545_exc_R7", "type": "Has_index", "arg1_id": "NCT02209545_exc_T17", "arg2_id": "NCT02209545_exc_T18", "normalized": [] }, { "id": "NCT02209545_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02209545_exc_T16", "arg2_id": "NCT02209545_exc_T15", "normalized": [] }, { "id": "NCT02209545_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02209545_exc_T16", "arg2_id": "NCT02209545_exc_T17", "normalized": [] }, { "id": "NCT02209545_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02209545_exc_T16", "arg2_id": "NCT02209545_exc_T20", "normalized": [] }, { "id": "NCT02209545_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02209545_exc_T16", "arg2_id": "NCT02209545_exc_T21", "normalized": [] }, { "id": "NCT02209545_exc_R13", "type": "Has_scope", "arg1_id": "NCT02209545_exc_T26", "arg2_id": "NCT02209545_exc_T27", "normalized": [] }, { "id": "NCT02209545_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02209545_exc_T29", "arg2_id": "NCT02209545_exc_T28", "normalized": [] }, { "id": "NCT02209545_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT02209545_exc_T23", "arg2_id": "NCT02209545_exc_T22", "normalized": [] }, { "id": "NCT02209545_exc_R16", "type": "Subsumes", "arg1_id": "NCT02209545_exc_T35", "arg2_id": "NCT02209545_exc_T34", "normalized": [] } ]

[ { "id": "NCT02209545_inc_text", "type": "inclusion", "text": [ "Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months\nAge = 18 years and = 50 years\nPre-operative hemoglobin >8 g/dl\nWilling to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.\nAbility to understand and the willingness to sign a written informed consent.\nAdmissible medical/surgical history\nCan be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills\nIntraoperative use of vasopressin and uterine tourniquet is permissible\nCan have had prior Cesarean delivery\n" ], "offsets": [ [ 0, 619 ] ] } ]

[ { "id": "NCT02209545_inc_T1", "type": "Procedure", "text": [ "abdominal myomectomy" ], "offsets": [ [ 24, 44 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T2", "type": "Condition", "text": [ "uterine fibroids" ], "offsets": [ [ 61, 77 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T3", "type": "Procedure", "text": [ "pelvic imaging" ], "offsets": [ [ 81, 95 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T4", "type": "Procedure", "text": [ "pelvic ultrasound" ], "offsets": [ [ 97, 114 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T5", "type": "Procedure", "text": [ "MRI", "pelvic" ], "offsets": [ [ 118, 121 ], [ 97, 103 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T6", "type": "Scope", "text": [ "pelvic ultrasound or MRI" ], "offsets": [ [ 97, 121 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T7", "type": "Scope", "text": [ "pelvic imaging (pelvic ultrasound or MRI)" ], "offsets": [ [ 81, 122 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T8", "type": "Temporal", "text": [ "within in last 12 months" ], "offsets": [ [ 123, 147 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T9", "type": "Person", "text": [ "Age" ], "offsets": [ [ 148, 151 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T10", "type": "Value", "text": [ "= 18 years and = 50 years" ], "offsets": [ [ 152, 177 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T11", "type": "Temporal", "text": [ "Pre-operative" ], "offsets": [ [ 178, 191 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T12", "type": "Reference_point", "text": [ "operative" ], "offsets": [ [ 182, 191 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T13", "type": "Procedure", "text": [ "operative" ], "offsets": [ [ 182, 191 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T14", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 192, 202 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T15", "type": "Value", "text": [ ">8 g/dl" ], "offsets": [ [ 203, 210 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T16", "type": "Procedure", "text": [ "buccal administration" ], "offsets": [ [ 227, 248 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T17", "type": "Drug", "text": [ "misoprostol" ], "offsets": [ [ 252, 263 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T18", "type": "Qualifier", "text": [ "buccal administration" ], "offsets": [ [ 227, 248 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T19", "type": "Drug", "text": [ "placebo" ], "offsets": [ [ 269, 276 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T20", "type": "Temporal", "text": [ "at least one hour pre-procedure" ], "offsets": [ [ 277, 308 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T21", "type": "Mood", "text": [ "Willing to have" ], "offsets": [ [ 211, 226 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T22", "type": "Scope", "text": [ "misoprostol or a placebo" ], "offsets": [ [ 252, 276 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T25", "type": "Observation", "text": [ "ity to understand and", "itten informed consent.\nAd" ], "offsets": [ [ 314, 335 ], [ 364, 390 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T23", "type": "Observation", "text": [ "willingness to sign a written informed consent" ], "offsets": [ [ 340, 386 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T24", "type": "Observation", "text": [ "surgical history" ], "offsets": [ [ 407, 423 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T26", "type": "Observation", "text": [ "al/surg", "ry\nCan" ], "offsets": [ [ 404, 411 ], [ 421, 427 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T27", "type": "Qualifier", "text": [ "Admissible" ], "offsets": [ [ 388, 398 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T28", "type": "Drug", "text": [ "Depo-Lupron" ], "offsets": [ [ 455, 466 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T29", "type": "Drug", "text": [ "Depo-Provera" ], "offsets": [ [ 468, 480 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T30", "type": "Drug", "text": [ "Oral Contraceptive pills" ], "offsets": [ [ 485, 509 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T31", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 442, 449 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T32", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 431, 441 ] ], "normalized": [] }, { "id": "NCT02209545_inc_T33", "type": "Scope", "text": [ "Depo-Lupron, Depo-Provera, or Oral Contraceptive pills" ], "offsets": [ [ 455, 509 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02209545_inc_R1", "type": "Subsumes", "arg1_id": "NCT02209545_inc_T3", "arg2_id": "NCT02209545_inc_T6", "normalized": [] }, { "id": "NCT02209545_inc_R2", "type": "AND", "arg1_id": "NCT02209545_inc_T7", "arg2_id": "NCT02209545_inc_T2", "normalized": [] }, { "id": "NCT02209545_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02209545_inc_T7", "arg2_id": "NCT02209545_inc_T8", "normalized": [] }, { "id": "NCT02209545_inc_R4", "type": "Has_scope", "arg1_id": "NCT02209545_inc_T1", "arg2_id": "NCT02209545_inc_T7", "normalized": [] }, { "id": "NCT02209545_inc_R5", "type": "Has_value", "arg1_id": "NCT02209545_inc_T9", "arg2_id": "NCT02209545_inc_T10", "normalized": [] }, { "id": "NCT02209545_inc_R7", "type": "AND", "arg1_id": "NCT02209545_inc_T11", "arg2_id": "NCT02209545_inc_T13", "normalized": [] }, { "id": "NCT02209545_inc_R8", "type": "Has_value", "arg1_id": "NCT02209545_inc_T14", "arg2_id": "NCT02209545_inc_T15", "normalized": [] }, { "id": "NCT02209545_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02209545_inc_T14", "arg2_id": "NCT02209545_inc_T11", "normalized": [] }, { "id": "NCT02209545_inc_R11", "type": "Has_scope", "arg1_id": "NCT02209545_inc_T16", "arg2_id": "NCT02209545_inc_T22", "normalized": [] }, { "id": "NCT02209545_inc_R12", "type": "Has_mood", "arg1_id": "NCT02209545_inc_T16", "arg2_id": "NCT02209545_inc_T21", "normalized": [] }, { "id": "NCT02209545_inc_R13", "type": "Has_temporal", "arg1_id": "NCT02209545_inc_T16", "arg2_id": "NCT02209545_inc_T20", "normalized": [] }, { "id": "NCT02209545_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT02209545_inc_T26", "arg2_id": "NCT02209545_inc_T27", "normalized": [] }, { "id": "NCT02209545_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT02209545_inc_T24", "arg2_id": "NCT02209545_inc_T27", "normalized": [] }, { "id": "NCT02209545_inc_R16", "type": "Has_temporal", "arg1_id": "NCT02209545_inc_T31", "arg2_id": "NCT02209545_inc_T32", "normalized": [] }, { "id": "NCT02209545_inc_R17", "type": "Has_scope", "arg1_id": "NCT02209545_inc_T31", "arg2_id": "NCT02209545_inc_T33", "normalized": [] } ]

[ { "id": "NCT02219880_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02219880_inc_text", "type": "inclusion", "text": [ "Aged between 18-70 years\nMeets the Diagnostic and Statistical Manual (DSM) IV and DSM-V diagnostic criteria for generalised anxiety disorder (GAD) based on structured interview (Mini International Neuropsychiatric Interview-Plus 6 [MINI-Plus 6]. Note that while the MINI-Plus 6 uses the DSM-IV criteria, the same criteria are used in the DSM-V).\nPresents with anxiety (Hamilton Anxiety Rating Scale = 18) at the time of study entry\nFluent in written and spoken English\nProvides a signed copy of the consent form\nPrimary diagnosis other than GAD\nPresentation of moderate to severe depressive symptoms (Montgomery-Asberg Rating Scale: MADRS = 18 at time of study entry or = 24 at any time during study)\nPresentation of suicidal ideation (= 3 on MADRS suicidal thoughts domain at time of study entry or at any time during study)\nCurrent diagnosis of bipolar disorder or schizophrenia on structured interview (MINI Plus)\nCurrent substance/alcohol use disorder on structured interview (MINI Plus) Page 21 of 39 Commercial-in-Confidence\nCurrently taking an antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin or thyroxin, or current regular use (more than 2 days per week) of a benzodiazepine or opioid-based analgesic\nCurrent use of a psychotropic nutraceutical (e.g. St John's wort)\nPrevious intolerance to kava\nThree or more failed trials of pharmacotherapy for the current GAD episode\nRecently commenced psychotherapy (within four weeks of study entry)\nKnown or suspected clinically unstable systemic medical disorder\nDiagnosed hepato-biliary disease/inflammation\nElevated liver enzymes at baseline blood test\nPregnancy or breastfeeding, or trying to conceive\nNot using medically approved contraception (including abstinence) if female and of childbearing age\nUnable to participate in all scheduled visits, treatment plan, or other trial procedures according to the protocol (except for the optional genetic component)\n" ], "offsets": [ [ 0, 1938 ] ] } ]

[ { "id": "NCT02219880_inc_T1", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T2", "type": "Value", "text": [ "between 18-70 years" ], "offsets": [ [ 5, 24 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T3", "type": "Measurement", "text": [ "Diagnostic and Statistical Manual (DSM) IV and DSM-V diagnostic criteria" ], "offsets": [ [ 35, 107 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T4", "type": "Scope", "text": [ "Meets" ], "offsets": [ [ 25, 30 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T5", "type": "Condition", "text": [ "generalised anxiety disorder" ], "offsets": [ [ 112, 140 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T6", "type": "Condition", "text": [ "GAD" ], "offsets": [ [ 142, 145 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T7", "type": "Procedure", "text": [ "structured interview" ], "offsets": [ [ 156, 176 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T8", "type": "Procedure", "text": [ "Mini International Neuropsychiatric Interview-Plus 6 [MINI-Plus 6]" ], "offsets": [ [ 178, 244 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T9", "type": "Condition", "text": [ "anxiety" ], "offsets": [ [ 360, 367 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T10", "type": "Measurement", "text": [ "Hamilton Anxiety Rating Scale" ], "offsets": [ [ 369, 398 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T11", "type": "Value", "text": [ "= 18" ], "offsets": [ [ 399, 403 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T12", "type": "Temporal", "text": [ "at the time of study entry" ], "offsets": [ [ 405, 431 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T13", "type": "Reference_point", "text": [ "time of study entry" ], "offsets": [ [ 412, 431 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T16", "type": "Condition", "text": [ "GAD" ], "offsets": [ [ 541, 544 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T17", "type": "Condition", "text": [ "Primary diagnosis" ], "offsets": [ [ 512, 529 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T18", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 530, 540 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T19", "type": "Qualifier", "text": [ "moderate to severe" ], "offsets": [ [ 561, 579 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T20", "type": "Condition", "text": [ "depressive symptoms" ], "offsets": [ [ 580, 599 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T21", "type": "Scope", "text": [ "moderate to severe depressive symptoms" ], "offsets": [ [ 561, 599 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T22", "type": "Measurement", "text": [ "Montgomery-Asberg Rating Scale" ], "offsets": [ [ 601, 631 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T23", "type": "Measurement", "text": [ "MADRS" ], "offsets": [ [ 633, 638 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T24", "type": "Value", "text": [ "= 18" ], "offsets": [ [ 639, 643 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T25", "type": "Temporal", "text": [ "at time of study entry" ], "offsets": [ [ 644, 666 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T26", "type": "Value", "text": [ "= 24" ], "offsets": [ [ 670, 674 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T27", "type": "Temporal", "text": [ "at any time during study" ], "offsets": [ [ 675, 699 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T28", "type": "Scope", "text": [ "= 18 at time of study entry or = 24 at any time during study" ], "offsets": [ [ 639, 699 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T29", "type": "Scope", "text": [ "Montgomery-Asberg Rating Scale: MADRS" ], "offsets": [ [ 601, 638 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T30", "type": "Scope", "text": [ "Montgomery-Asberg Rating Scale: MADRS = 18 at time of study entry or = 24 at any time during study" ], "offsets": [ [ 601, 699 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T31", "type": "Condition", "text": [ "suicidal ideation" ], "offsets": [ [ 717, 734 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T32", "type": "Value", "text": [ "= 3" ], "offsets": [ [ 736, 739 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T33", "type": "Measurement", "text": [ "MADRS suicidal thoughts domain" ], "offsets": [ [ 743, 773 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T34", "type": "Temporal", "text": [ "at time of study entry" ], "offsets": [ [ 774, 796 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T35", "type": "Temporal", "text": [ "at any time during study" ], "offsets": [ [ 800, 824 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T36", "type": "Scope", "text": [ "at time of study entry or at any time during study" ], "offsets": [ [ 774, 824 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T37", "type": "Scope", "text": [ "= 3 on MADRS suicidal thoughts domain at time of study entry or at any time during study" ], "offsets": [ [ 736, 824 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T38", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 847, 863 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T39", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 867, 880 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T40", "type": "Measurement", "text": [ "structured interview" ], "offsets": [ [ 884, 904 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T41", "type": "Measurement", "text": [ "MINI Plus" ], "offsets": [ [ 906, 915 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T42", "type": "Scope", "text": [ "bipolar disorder or schizophrenia" ], "offsets": [ [ 847, 880 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T43", "type": "Condition", "text": [ "alcohol use disorder" ], "offsets": [ [ 935, 955 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T44", "type": "Condition", "text": [ "/alcohol", "der on struc" ], "offsets": [ [ 934, 942 ], [ 952, 964 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T45", "type": "Measurement", "text": [ "structured interview" ], "offsets": [ [ 959, 979 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T46", "type": "Measurement", "text": [ "MINI Plus" ], "offsets": [ [ 981, 990 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T47", "type": "Scope", "text": [ "substance/alcohol use disorder" ], "offsets": [ [ 925, 955 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T48", "type": "Drug", "text": [ "antidepressant" ], "offsets": [ [ 1051, 1065 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T49", "type": "Condition", "text": [ "taking" ], "offsets": [ [ 1041, 1047 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T50", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 1031, 1040 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T51", "type": "Drug", "text": [ "mood stabiliser" ], "offsets": [ [ 1067, 1082 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T52", "type": "Drug", "text": [ "antipsychotic" ], "offsets": [ [ 1084, 1097 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T53", "type": "Drug", "text": [ "anticonvulsant" ], "offsets": [ [ 1099, 1113 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T54", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 1115, 1123 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T55", "type": "Drug", "text": [ "thyroxin" ], "offsets": [ [ 1127, 1135 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T56", "type": "Drug", "text": [ "benzodiazepine" ], "offsets": [ [ 1193, 1207 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T57", "type": "Drug", "text": [ "opioid-based analgesic" ], "offsets": [ [ 1211, 1233 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T58", "type": "Multiplier", "text": [ "more than 2 days per week" ], "offsets": [ [ 1161, 1186 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T59", "type": "Multiplier", "text": [ "regular" ], "offsets": [ [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T60", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1140, 1147 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T61", "type": "Scope", "text": [ "benzodiazepine or opioid-based analgesic" ], "offsets": [ [ 1193, 1233 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T62", "type": "Scope", "text": [ "antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin or thyroxin" ], "offsets": [ [ 1051, 1135 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T63", "type": "Procedure", "text": [ "use" ], "offsets": [ [ 1156, 1159 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T64", "type": "Drug", "text": [ "psychotropic nutraceutical" ], "offsets": [ [ 1251, 1277 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T65", "type": "Condition", "text": [ "St John's wort" ], "offsets": [ [ 1284, 1298 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T66", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 1234, 1241 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T67", "type": "Procedure", "text": [ "use" ], "offsets": [ [ 1242, 1245 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T68", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 1309, 1320 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T69", "type": "Drug", "text": [ "kava" ], "offsets": [ [ 1324, 1328 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T70", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 1300, 1308 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T71", "type": "Multiplier", "text": [ "Three or more" ], "offsets": [ [ 1329, 1342 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T72", "type": "Procedure", "text": [ "trials of pharmacotherapy" ], "offsets": [ [ 1350, 1375 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T73", "type": "Qualifier", "text": [ "failed" ], "offsets": [ [ 1343, 1349 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T74", "type": "Condition", "text": [ "GAD episode" ], "offsets": [ [ 1392, 1403 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T75", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1384, 1391 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T76", "type": "Procedure", "text": [ "psychotherapy" ], "offsets": [ [ 1423, 1436 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T77", "type": "Temporal", "text": [ "within four weeks of study entry" ], "offsets": [ [ 1438, 1470 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T78", "type": "Temporal", "text": [ "Recently" ], "offsets": [ [ 1404, 1412 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T79", "type": "Qualifier", "text": [ "clinically unstable" ], "offsets": [ [ 1491, 1510 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T80", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 1511, 1519 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T81", "type": "Condition", "text": [ "medical disorder" ], "offsets": [ [ 1520, 1536 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T82", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 1481, 1490 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T83", "type": "Mood", "text": [ "Known" ], "offsets": [ [ 1472, 1477 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T84", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 1472, 1490 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T85", "type": "Condition", "text": [ "hepato-biliary disease" ], "offsets": [ [ 1547, 1569 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T86", "type": "Condition", "text": [ "isease/inflamm", "vated liver" ], "offsets": [ [ 1563, 1577 ], [ 1586, 1597 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T87", "type": "Value", "text": [ "Elevated" ], "offsets": [ [ 1583, 1591 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T88", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 1592, 1605 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T89", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 1609, 1617 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T90", "type": "Procedure", "text": [ "blood test" ], "offsets": [ [ 1618, 1628 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T91", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 1629, 1638 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T92", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 1642, 1655 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T93", "type": "Condition", "text": [ "trying to conceive" ], "offsets": [ [ 1660, 1678 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T94", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 1679, 1682 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T96", "type": "Qualifier", "text": [ "medically approved" ], "offsets": [ [ 1689, 1707 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T97", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 1708, 1721 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T98", "type": "Procedure", "text": [ "abstinence" ], "offsets": [ [ 1733, 1743 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T99", "type": "Person", "text": [ "female" ], "offsets": [ [ 1748, 1754 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T100", "type": "Person", "text": [ "childbearing age" ], "offsets": [ [ 1762, 1778 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T101", "type": "Observation", "text": [ "age" ], "offsets": [ [ 1775, 1778 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T102", "type": "Value", "text": [ "childbearing" ], "offsets": [ [ 1762, 1774 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T103", "type": "Scope", "text": [ "childbearing age" ], "offsets": [ [ 1762, 1778 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T104", "type": "Scope", "text": [ "female and of childbearing age" ], "offsets": [ [ 1748, 1778 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T105", "type": "Scope", "text": [ "Not using medically approved contraception (including abstinence)" ], "offsets": [ [ 1679, 1744 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T95", "type": "Observation", "text": [ "Unable to participate" ], "offsets": [ [ 1779, 1800 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T106", "type": "Visit", "text": [ "scheduled visits" ], "offsets": [ [ 1808, 1824 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T107", "type": "Observation", "text": [ "treatment plan" ], "offsets": [ [ 1826, 1840 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T108", "type": "Procedure", "text": [ "trial procedures" ], "offsets": [ [ 1851, 1867 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T109", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 1895, 1905 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T110", "type": "Observation", "text": [ "genetic component" ], "offsets": [ [ 1919, 1936 ] ], "normalized": [] }, { "id": "NCT02219880_inc_T111", "type": "Scope", "text": [ "scheduled visits, treatment plan, or other trial procedures" ], "offsets": [ [ 1808, 1867 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02219880_inc_R1", "type": "Has_value", "arg1_id": "NCT02219880_inc_T1", "arg2_id": "NCT02219880_inc_T2", "normalized": [] }, { "id": "NCT02219880_inc_R2", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T3", "arg2_id": "NCT02219880_inc_T4", "normalized": [] }, { "id": "NCT02219880_inc_R3", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T5", "arg2_id": "NCT02219880_inc_T6", "normalized": [] }, { "id": "NCT02219880_inc_R4", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T7", "arg2_id": "NCT02219880_inc_T8", "normalized": [] }, { "id": "NCT02219880_inc_R5", "type": "AND", "arg1_id": "NCT02219880_inc_T7", "arg2_id": "NCT02219880_inc_T3", "normalized": [] }, { "id": "NCT02219880_inc_R6", "type": "AND", "arg1_id": "NCT02219880_inc_T5", "arg2_id": "NCT02219880_inc_T7", "normalized": [] }, { "id": "NCT02219880_inc_R7", "type": "Has_value", "arg1_id": "NCT02219880_inc_T10", "arg2_id": "NCT02219880_inc_T11", "normalized": [] }, { "id": "NCT02219880_inc_R8", "type": "AND", "arg1_id": "NCT02219880_inc_T9", "arg2_id": "NCT02219880_inc_T10", "normalized": [] }, { "id": "NCT02219880_inc_R9", "type": "Has_index", "arg1_id": "NCT02219880_inc_T12", "arg2_id": "NCT02219880_inc_T13", "normalized": [] }, { "id": "NCT02219880_inc_R10", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T9", "arg2_id": "NCT02219880_inc_T12", "normalized": [] }, { "id": "NCT02219880_inc_R11", "type": "Has_negation", "arg1_id": "NCT02219880_inc_T16", "arg2_id": "NCT02219880_inc_T18", "normalized": [] }, { "id": "NCT02219880_inc_R12", "type": "AND", "arg1_id": "NCT02219880_inc_T17", "arg2_id": "NCT02219880_inc_T16", "normalized": [] }, { "id": "NCT02219880_inc_R13", "type": "Has_qualifier", "arg1_id": "NCT02219880_inc_T20", "arg2_id": "NCT02219880_inc_T19", "normalized": [] }, { "id": "NCT02219880_inc_R14", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T22", "arg2_id": "NCT02219880_inc_T23", "normalized": [] }, { "id": "NCT02219880_inc_R15", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T24", "arg2_id": "NCT02219880_inc_T25", "normalized": [] }, { "id": "NCT02219880_inc_R16", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T26", "arg2_id": "NCT02219880_inc_T27", "normalized": [] }, { "id": "NCT02219880_inc_R17", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T29", "arg2_id": "NCT02219880_inc_T28", "normalized": [] }, { "id": "NCT02219880_inc_R18", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T21", "arg2_id": "NCT02219880_inc_T30", "normalized": [] }, { "id": "NCT02219880_inc_R19", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T33", "arg2_id": "NCT02219880_inc_T36", "normalized": [] }, { "id": "NCT02219880_inc_R20", "type": "Has_value", "arg1_id": "NCT02219880_inc_T33", "arg2_id": "NCT02219880_inc_T32", "normalized": [] }, { "id": "NCT02219880_inc_R21", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T31", "arg2_id": "NCT02219880_inc_T37", "normalized": [] }, { "id": "NCT02219880_inc_R22", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T40", "arg2_id": "NCT02219880_inc_T41", "normalized": [] }, { "id": "NCT02219880_inc_R23", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T40", "arg2_id": "NCT02219880_inc_T42", "normalized": [] }, { "id": "NCT02219880_inc_R24", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T45", "arg2_id": "NCT02219880_inc_T46", "normalized": [] }, { "id": "NCT02219880_inc_R25", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T45", "arg2_id": "NCT02219880_inc_T47", "normalized": [] }, { "id": "NCT02219880_inc_R27", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T49", "arg2_id": "NCT02219880_inc_T50", "normalized": [] }, { "id": "NCT02219880_inc_R29", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T59", "arg2_id": "NCT02219880_inc_T58", "normalized": [] }, { "id": "NCT02219880_inc_R26", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T49", "arg2_id": "NCT02219880_inc_T62", "normalized": [] }, { "id": "NCT02219880_inc_R31", "type": "Has_multiplier", "arg1_id": "NCT02219880_inc_T63", "arg2_id": "NCT02219880_inc_T59", "normalized": [] }, { "id": "NCT02219880_inc_R28", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T63", "arg2_id": "NCT02219880_inc_T60", "normalized": [] }, { "id": "NCT02219880_inc_R30", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T63", "arg2_id": "NCT02219880_inc_T61", "normalized": [] }, { "id": "NCT02219880_inc_R32", "type": "AND", "arg1_id": "NCT02219880_inc_T67", "arg2_id": "NCT02219880_inc_T64", "normalized": [] }, { "id": "NCT02219880_inc_R33", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T67", "arg2_id": "NCT02219880_inc_T66", "normalized": [] }, { "id": "NCT02219880_inc_R34", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T64", "arg2_id": "NCT02219880_inc_T65", "normalized": [] }, { "id": "NCT02219880_inc_R35", "type": "AND", "arg1_id": "NCT02219880_inc_T68", "arg2_id": "NCT02219880_inc_T69", "normalized": [] }, { "id": "NCT02219880_inc_R36", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T68", "arg2_id": "NCT02219880_inc_T70", "normalized": [] }, { "id": "NCT02219880_inc_R37", "type": "Has_qualifier", "arg1_id": "NCT02219880_inc_T72", "arg2_id": "NCT02219880_inc_T73", "normalized": [] }, { "id": "NCT02219880_inc_R38", "type": "Has_multiplier", "arg1_id": "NCT02219880_inc_T72", "arg2_id": "NCT02219880_inc_T71", "normalized": [] }, { "id": "NCT02219880_inc_R39", "type": "AND", "arg1_id": "NCT02219880_inc_T72", "arg2_id": "NCT02219880_inc_T74", "normalized": [] }, { "id": "NCT02219880_inc_R40", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T74", "arg2_id": "NCT02219880_inc_T75", "normalized": [] }, { "id": "NCT02219880_inc_R41", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T78", "arg2_id": "NCT02219880_inc_T77", "normalized": [] }, { "id": "NCT02219880_inc_R42", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T76", "arg2_id": "NCT02219880_inc_T78", "normalized": [] }, { "id": "NCT02219880_inc_R43", "type": "Has_qualifier", "arg1_id": "NCT02219880_inc_T81", "arg2_id": "NCT02219880_inc_T80", "normalized": [] }, { "id": "NCT02219880_inc_R44", "type": "Has_qualifier", "arg1_id": "NCT02219880_inc_T81", "arg2_id": "NCT02219880_inc_T79", "normalized": [] }, { "id": "NCT02219880_inc_R45", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T81", "arg2_id": "NCT02219880_inc_T84", "normalized": [] }, { "id": "NCT02219880_inc_R46", "type": "Has_temporal", "arg1_id": "NCT02219880_inc_T90", "arg2_id": "NCT02219880_inc_T89", "normalized": [] }, { "id": "NCT02219880_inc_R47", "type": "Has_value", "arg1_id": "NCT02219880_inc_T88", "arg2_id": "NCT02219880_inc_T87", "normalized": [] }, { "id": "NCT02219880_inc_R48", "type": "AND", "arg1_id": "NCT02219880_inc_T88", "arg2_id": "NCT02219880_inc_T90", "normalized": [] }, { "id": "NCT02219880_inc_R49", "type": "Has_qualifier", "arg1_id": "NCT02219880_inc_T97", "arg2_id": "NCT02219880_inc_T96", "normalized": [] }, { "id": "NCT02219880_inc_R50", "type": "Subsumes", "arg1_id": "NCT02219880_inc_T97", "arg2_id": "NCT02219880_inc_T98", "normalized": [] }, { "id": "NCT02219880_inc_R51", "type": "Has_value", "arg1_id": "NCT02219880_inc_T101", "arg2_id": "NCT02219880_inc_T102", "normalized": [] }, { "id": "NCT02219880_inc_R53", "type": "Has_negation", "arg1_id": "NCT02219880_inc_T97", "arg2_id": "NCT02219880_inc_T94", "normalized": [] }, { "id": "NCT02219880_inc_R54", "type": "Has_scope", "arg1_id": "NCT02219880_inc_T104", "arg2_id": "NCT02219880_inc_T105", "normalized": [] }, { "id": "NCT02219880_inc_R55", "type": "Has_negation", "arg1_id": "NCT02219880_inc_T110", "arg2_id": "NCT02219880_inc_T109", "normalized": [] } ]

[ { "id": "NCT02222272_exc_text", "type": "exclusion", "text": [ " \n" ], "offsets": [ [ 0, 5 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02222272_inc_text", "type": "inclusion", "text": [ "All adult patients with chronic myeloid leukaemia in any phase (chronic, accelerated or blastic) who undergo allogeneic stem cell transplantation between 01/01/2010 and 30/09/2013 and have been previously treated with Nilotinib or Dasatinib, regardless of their response to these drugs. \n" ], "offsets": [ [ 0, 288 ] ] } ]

[ { "id": "NCT02222272_inc_T1", "type": "Condition", "text": [ "chronic myeloid leukaemia" ], "offsets": [ [ 24, 49 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T2", "type": "Procedure", "text": [ "allogeneic stem cell transplantation" ], "offsets": [ [ 109, 145 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T3", "type": "Temporal", "text": [ "between 01/01/2010 and 30/09/2013" ], "offsets": [ [ 146, 179 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T4", "type": "Drug", "text": [ "Nilotinib" ], "offsets": [ [ 218, 227 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T5", "type": "Drug", "text": [ "Dasatinib" ], "offsets": [ [ 231, 240 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T6", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 194, 204 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T7", "type": "Scope", "text": [ "Nilotinib or Dasatinib" ], "offsets": [ [ 218, 240 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T8", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 64, 71 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T9", "type": "Qualifier", "text": [ "accelerated" ], "offsets": [ [ 73, 84 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T10", "type": "Qualifier", "text": [ "blastic" ], "offsets": [ [ 88, 95 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T11", "type": "Qualifier", "text": [ "any phase" ], "offsets": [ [ 53, 62 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T12", "type": "Scope", "text": [ "chronic, accelerated or blastic" ], "offsets": [ [ 64, 95 ] ], "normalized": [] }, { "id": "NCT02222272_inc_T13", "type": "Person", "text": [ "adult" ], "offsets": [ [ 4, 9 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02222272_inc_R1", "type": "Has_temporal", "arg1_id": "NCT02222272_inc_T7", "arg2_id": "NCT02222272_inc_T6", "normalized": [] }, { "id": "NCT02222272_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02222272_inc_T2", "arg2_id": "NCT02222272_inc_T3", "normalized": [] }, { "id": "NCT02222272_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02222272_inc_T1", "arg2_id": "NCT02222272_inc_T11", "normalized": [] }, { "id": "NCT02222272_inc_R4", "type": "Subsumes", "arg1_id": "NCT02222272_inc_T11", "arg2_id": "NCT02222272_inc_T12", "normalized": [] } ]

[ { "id": "NCT02224040_exc_text", "type": "exclusion", "text": [ "Allergy to ceftriaxone or macrolides \nMajor typhoid fever-associated complications \nInability to swallow oral medication \nUnderlying illness \nPregnancy \nLactation \nTreatment within the past 4 days with an antibiotic that may be effective against typhoid fever \n \n" ], "offsets": [ [ 0, 272 ] ] } ]

[ { "id": "NCT02224040_exc_T1", "type": "Drug", "text": [ "ceftriaxone" ], "offsets": [ [ 11, 22 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T2", "type": "Drug", "text": [ "macrolides" ], "offsets": [ [ 26, 36 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T3", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T4", "type": "Scope", "text": [ "ceftriaxone or macrolides" ], "offsets": [ [ 11, 36 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T5", "type": "Qualifier", "text": [ "typhoid fever-associated" ], "offsets": [ [ 44, 68 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T6", "type": "Condition", "text": [ "typhoid fever" ], "offsets": [ [ 44, 57 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T7", "type": "Condition", "text": [ "complications" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T8", "type": "Qualifier", "text": [ "Major" ], "offsets": [ [ 38, 43 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T10", "type": "Drug", "text": [ "oral medication" ], "offsets": [ [ 105, 120 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T11", "type": "Condition", "text": [ "Inability to swallow oral medication" ], "offsets": [ [ 84, 120 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T12", "type": "Condition", "text": [ "Underlying illness" ], "offsets": [ [ 122, 140 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T14", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 142, 151 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T15", "type": "Condition", "text": [ "Lactation" ], "offsets": [ [ 153, 162 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T16", "type": "Temporal", "text": [ "within the past 4 days" ], "offsets": [ [ 174, 196 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T17", "type": "Drug", "text": [ "antibiotic" ], "offsets": [ [ 205, 215 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T18", "type": "Qualifier", "text": [ "effective against typhoid fever" ], "offsets": [ [ 228, 259 ] ], "normalized": [] }, { "id": "NCT02224040_exc_T19", "type": "Condition", "text": [ "typhoid fever" ], "offsets": [ [ 246, 259 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02224040_exc_R1", "type": "Has_scope", "arg1_id": "NCT02224040_exc_T3", "arg2_id": "NCT02224040_exc_T4", "normalized": [] }, { "id": "NCT02224040_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02224040_exc_T7", "arg2_id": "NCT02224040_exc_T5", "normalized": [] }, { "id": "NCT02224040_exc_R3", "type": "AND", "arg1_id": "NCT02224040_exc_T5", "arg2_id": "NCT02224040_exc_T6", "normalized": [] }, { "id": "NCT02224040_exc_R4", "type": "AND", "arg1_id": "NCT02224040_exc_T11", "arg2_id": "NCT02224040_exc_T10", "normalized": [] }, { "id": "NCT02224040_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02224040_exc_T17", "arg2_id": "NCT02224040_exc_T16", "normalized": [] }, { "id": "NCT02224040_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02224040_exc_T17", "arg2_id": "NCT02224040_exc_T18", "normalized": [] }, { "id": "NCT02224040_exc_R7", "type": "AND", "arg1_id": "NCT02224040_exc_T18", "arg2_id": "NCT02224040_exc_T19", "normalized": [] } ]

[ { "id": "NCT02224040_inc_text", "type": "inclusion", "text": [ "Blood culture-proven typhoid fever (S. typhi or S. paratyphi) \nSigned informed consent to participate in the study. \n" ], "offsets": [ [ 0, 117 ] ] } ]

[ { "id": "NCT02224040_inc_T1", "type": "Measurement", "text": [ "Blood culture" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT02224040_inc_T2", "type": "Value", "text": [ "proven" ], "offsets": [ [ 14, 20 ] ], "normalized": [] }, { "id": "NCT02224040_inc_T3", "type": "Condition", "text": [ "typhoid fever" ], "offsets": [ [ 21, 34 ] ], "normalized": [] }, { "id": "NCT02224040_inc_T4", "type": "Condition", "text": [ "S. typhi" ], "offsets": [ [ 36, 44 ] ], "normalized": [] }, { "id": "NCT02224040_inc_T5", "type": "Condition", "text": [ "S. paratyphi" ], "offsets": [ [ 48, 60 ] ], "normalized": [] }, { "id": "NCT02224040_inc_T6", "type": "Scope", "text": [ "S. typhi or S. paratyphi" ], "offsets": [ [ 36, 60 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02224040_inc_R1", "type": "Has_value", "arg1_id": "NCT02224040_inc_T1", "arg2_id": "NCT02224040_inc_T2", "normalized": [] }, { "id": "NCT02224040_inc_R2", "type": "AND", "arg1_id": "NCT02224040_inc_T3", "arg2_id": "NCT02224040_inc_T1", "normalized": [] }, { "id": "NCT02224040_inc_R3", "type": "Subsumes", "arg1_id": "NCT02224040_inc_T3", "arg2_id": "NCT02224040_inc_T6", "normalized": [] } ]

[ { "id": "NCT02225548_exc_text", "type": "exclusion", "text": [ "Subject unwilling to cease use of any treatment for erectile dysfunction during the study, including oral medication, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or nonprescription medications, and products purchased via the internet\nSubject receiving dopamine agonists, nitrates, alpha-receptor blocking agents, or antihypertensive medication (see other exclusionary medications listed below)\nSubject with a history of syncope within the last 6 months prior to screening\nSubject with symptomatic postural hypotension (severe dizziness or fainting\nSubject with hypotension and a resting systolic blood pressure of < 90 mmHG or hypertension with a resting systolic blood pressure > 170 mmHG or a resting diastolic blood pressure > 110 mmHG\nSubject with any underlying cardiovascular condition, including unstable angina pectoris, which preclude sexual activity\nSubject with a history of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening\nSubject with uncontrolled atrial fibrillation/flutter at screening (defined as ventricular response rate = 100 bpm)\nSubject with a bleeding disorder\nSubject with a history of prostatectomy because of prostate cancer, including nerve sparing techniques. Subjects with a history of surgical procedures for the treatment of benign prostate hypertrophy are permitted, with the exception of cryosurgery, cryotherapy or cryoablation\nSubject with hereditary degenerative retinal disorders such as retinitis pigmentosa\nSubject with a history of loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), history of temporary or permanent loss of vision, including unilateral loss of vision\nSubject with a history of congenital QT prolongation\nSubject with a penile anatomical abnormality (e.g., penile fibrosis, fractures, or Peyronie's disease) which, in the investigator's opinion, could significantly impair sexual performance. This will be based on subject's reported medical history (penile exam not required)\nSubject with primary hypoactive sexual desire.\nSubject with a spinal cord injury\nSubject with a severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment\nSubject with clinically significant chronic hematological disease which could lead to priapism such as sickle cell anemia, multiple myeloma, and leukemia\nSubject with active peptic ulceration\nSubject with a history of malignancy within the past 5 years (other than squamous or basal cell skin cancer)\nSubject with a history of a positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C\nSubject with a known hypersensitivity to any component of the investigational medications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors or phenylethylamines\nSubjects with a history of drug or alcohol abuse within the past 6 months\nSubjects currently consuming =5 units of alcohol per day\nSubject who is illiterate or unable to understand the Informed Consent Form, questionnaires or subject diary\nSubject who, in the opinion of the investigator, will be noncompliant with the visit schedule or study procedures\nSubject with any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or preclude the subject's participation in the study\nDiagnosis of any other neurologic disease\nUncontrolled Diabetes (Hemoglobin A1C > 7.5)\n" ], "offsets": [ [ 0, 3536 ] ] } ]

[ { "id": "NCT02225548_exc_T1", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 38, 47 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T2", "type": "Condition", "text": [ "erectile dysfunction" ], "offsets": [ [ 52, 72 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T3", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 73, 89 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T4", "type": "Procedure", "text": [ "oral medication" ], "offsets": [ [ 101, 116 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T5", "type": "Device", "text": [ "vacuum devices" ], "offsets": [ [ 118, 132 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T6", "type": "Device", "text": [ "constrictive devices" ], "offsets": [ [ 134, 154 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T7", "type": "Procedure", "text": [ "injections" ], "offsets": [ [ 156, 166 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T8", "type": "Device", "text": [ "urethral suppositories" ], "offsets": [ [ 168, 190 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T9", "type": "Procedure", "text": [ "gels" ], "offsets": [ [ 192, 196 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T10", "type": "Qualifier", "text": [ "over-the-counter" ], "offsets": [ [ 202, 218 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T11", "type": "Qualifier", "text": [ "nonprescription" ], "offsets": [ [ 222, 237 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T12", "type": "Procedure", "text": [ "medications" ], "offsets": [ [ 238, 249 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T13", "type": "Scope", "text": [ "over-the-counter or nonprescription" ], "offsets": [ [ 202, 237 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T14", "type": "Scope", "text": [ "oral medication, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or nonprescription medications," ], "offsets": [ [ 101, 250 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T15", "type": "Drug", "text": [ "dopamine agonists" ], "offsets": [ [ 309, 326 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T16", "type": "Drug", "text": [ "nitrates" ], "offsets": [ [ 328, 336 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T17", "type": "Drug", "text": [ "alpha-receptor blocking agents" ], "offsets": [ [ 338, 368 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T18", "type": "Drug", "text": [ "antihypertensive medication" ], "offsets": [ [ 373, 400 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T19", "type": "Condition", "text": [ "syncope" ], "offsets": [ [ 477, 484 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T20", "type": "Temporal", "text": [ "within the last 6 months prior to screening" ], "offsets": [ [ 485, 528 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T21", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 519, 528 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T22", "type": "Condition", "text": [ "postural hypotension" ], "offsets": [ [ 554, 574 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T23", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 542, 553 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T24", "type": "Condition", "text": [ "dizziness" ], "offsets": [ [ 583, 592 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T25", "type": "Condition", "text": [ "fainting" ], "offsets": [ [ 596, 604 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T26", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 576, 582 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T27", "type": "Scope", "text": [ "dizziness or fainting" ], "offsets": [ [ 583, 604 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T28", "type": "Condition", "text": [ "hypotension" ], "offsets": [ [ 618, 629 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T29", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 644, 667 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T30", "type": "Value", "text": [ "< 90 mmHG" ], "offsets": [ [ 671, 680 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T31", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 684, 696 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T32", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 712, 735 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T33", "type": "Value", "text": [ "> 170 mmHG" ], "offsets": [ [ 736, 746 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T34", "type": "Measurement", "text": [ "diastolic blood pressure" ], "offsets": [ [ 760, 784 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T35", "type": "Value", "text": [ "> 110 mmHG" ], "offsets": [ [ 785, 795 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T36", "type": "Scope", "text": [ "systolic blood pressure > 170 mmHG or a resting diastolic blood pressure > 110 mmHG" ], "offsets": [ [ 712, 795 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T37", "type": "Condition", "text": [ "cardiovascular condition" ], "offsets": [ [ 824, 848 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T38", "type": "Condition", "text": [ "unstable angina pectoris" ], "offsets": [ [ 860, 884 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T39", "type": "Observation", "text": [ "sexual activity" ], "offsets": [ [ 901, 916 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T40", "type": "Negation", "text": [ "preclude" ], "offsets": [ [ 892, 900 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T41", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 943, 964 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T42", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 966, 972 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T43", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 993, 1003 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T44", "type": "Qualifier", "text": [ "life-threatening" ], "offsets": [ [ 976, 992 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T45", "type": "Temporal", "text": [ "within 6 months prior to screening" ], "offsets": [ [ 1004, 1038 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T46", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1029, 1038 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T47", "type": "Scope", "text": [ "myocardial infarction, stroke or life-threatening arrhythmia" ], "offsets": [ [ 943, 1003 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T48", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 1065, 1084 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T49", "type": "Condition", "text": [ "fibril", " at sc" ], "offsets": [ [ 1072, 1078 ], [ 1092, 1098 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T50", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1052, 1064 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T51", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1093, 1105 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T52", "type": "Scope", "text": [ "atrial fibrillation/flutter" ], "offsets": [ [ 1065, 1092 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T53", "type": "Condition", "text": [ "bleeding disorder" ], "offsets": [ [ 1170, 1187 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T54", "type": "Procedure", "text": [ "prostatectomy" ], "offsets": [ [ 1214, 1227 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T55", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 1239, 1254 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T56", "type": "Procedure", "text": [ "nerve sparing techniques" ], "offsets": [ [ 1266, 1290 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T57", "type": "Procedure", "text": [ "surgical procedures" ], "offsets": [ [ 1319, 1338 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T58", "type": "Condition", "text": [ "benign prostate hypertrophy" ], "offsets": [ [ 1360, 1387 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T59", "type": "Negation", "text": [ "permitted" ], "offsets": [ [ 1392, 1401 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T60", "type": "Procedure", "text": [ "cryosurgery" ], "offsets": [ [ 1425, 1436 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T61", "type": "Procedure", "text": [ "cryotherapy" ], "offsets": [ [ 1438, 1449 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T62", "type": "Procedure", "text": [ "cryoablation" ], "offsets": [ [ 1453, 1465 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T63", "type": "Scope", "text": [ "cryosurgery, cryotherapy or cryoablation" ], "offsets": [ [ 1425, 1465 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T64", "type": "Condition", "text": [ "hereditary degenerative retinal disorders" ], "offsets": [ [ 1479, 1520 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T65", "type": "Condition", "text": [ "retinitis pigmentosa" ], "offsets": [ [ 1529, 1549 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T66", "type": "Condition", "text": [ "non-arteritic anterior ischemic optic neuropathy" ], "offsets": [ [ 1602, 1650 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T67", "type": "Condition", "text": [ "NAION" ], "offsets": [ [ 1652, 1657 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T68", "type": "Condition", "text": [ "loss of vision" ], "offsets": [ [ 1576, 1590 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T69", "type": "Condition", "text": [ "loss of vision" ], "offsets": [ [ 1694, 1708 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T70", "type": "Qualifier", "text": [ "temporary" ], "offsets": [ [ 1671, 1680 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T71", "type": "Qualifier", "text": [ "permanent" ], "offsets": [ [ 1684, 1693 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T72", "type": "Scope", "text": [ "temporary or permanent" ], "offsets": [ [ 1671, 1693 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T73", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 1720, 1730 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T74", "type": "Condition", "text": [ "loss of vision" ], "offsets": [ [ 1731, 1745 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T75", "type": "Condition", "text": [ "congenital QT prolongation" ], "offsets": [ [ 1772, 1798 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T76", "type": "Condition", "text": [ "penile anatomical abnormality" ], "offsets": [ [ 1814, 1843 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T77", "type": "Condition", "text": [ "penile fibrosis" ], "offsets": [ [ 1851, 1866 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T78", "type": "Condition", "text": [ "is, fr", " Peyroni" ], "offsets": [ [ 1864, 1870 ], [ 1881, 1889 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T79", "type": "Condition", "text": [ "Peyronie's disease)" ], "offsets": [ [ 1882, 1901 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T81", "type": "Scope", "text": [ "penile fibrosis, fractures, or Peyronie's disease" ], "offsets": [ [ 1851, 1900 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T82", "type": "Observation", "text": [ "primary hypoactive sexual desire" ], "offsets": [ [ 2084, 2116 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T83", "type": "Condition", "text": [ "spinal cord injury" ], "offsets": [ [ 2133, 2151 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T84", "type": "Condition", "text": [ "ase,", "istory of mod" ], "offsets": [ [ 2201, 2205 ], [ 2207, 2220 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T85", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2167, 2173 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T86", "type": "Condition", "text": [ " live", "istory of mod" ], "offsets": [ [ 2190, 2195 ], [ 2207, 2220 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T87", "type": "Condition", "text": [ "hepatic impairment" ], "offsets": [ [ 2267, 2285 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T88", "type": "Measurement", "text": [ "Child-Pugh" ], "offsets": [ [ 2253, 2263 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T89", "type": "Measurement", "text": [ "Child-Pugh" ], "offsets": [ [ 2253, 2263 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T90", "type": "Value", "text": [ "B" ], "offsets": [ [ 2238, 2239 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T91", "type": "Value", "text": [ "C" ], "offsets": [ [ 2264, 2265 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T92", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 2217, 2225 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T93", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2245, 2251 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T94", "type": "Scope", "text": [ "chronic or acute liver disease" ], "offsets": [ [ 2174, 2204 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T95", "type": "Condition", "text": [ "hepatic impairment" ], "offsets": [ [ 2267, 2285 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T96", "type": "Condition", "text": [ "hematological disease" ], "offsets": [ [ 2330, 2351 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T80", "type": "Scope", "text": [ "cardiovascular condition, including unstable angina pectoris" ], "offsets": [ [ 824, 884 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T97", "type": "Measurement", "text": [ "ventricular response rate" ], "offsets": [ [ 1118, 1143 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T98", "type": "Value", "text": [ "= 100 bpm" ], "offsets": [ [ 1144, 1153 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T99", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1308, 1318 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T100", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 1403, 1424 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T101", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1565, 1575 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T102", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1761, 1771 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T104", "type": "Qualifier", "text": [ "could significantly impair sexual performance" ], "offsets": [ [ 1940, 1985 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T106", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 2322, 2329 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T107", "type": "Qualifier", "text": [ "could lead to priapism" ], "offsets": [ [ 2358, 2380 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T108", "type": "Condition", "text": [ "sickle cell anemia" ], "offsets": [ [ 2389, 2407 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T109", "type": "Condition", "text": [ "multiple myeloma" ], "offsets": [ [ 2409, 2425 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T110", "type": "Condition", "text": [ "leukemia" ], "offsets": [ [ 2431, 2439 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T111", "type": "Scope", "text": [ "sickle cell anemia, multiple myeloma, and leukemia" ], "offsets": [ [ 2389, 2439 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T105", "type": "Procedure", "text": [ "penile exam" ], "offsets": [ [ 2045, 2056 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T112", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 2299, 2321 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T113", "type": "Condition", "text": [ "impair sexual performance" ], "offsets": [ [ 1960, 1985 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T114", "type": "Condition", "text": [ "priapism" ], "offsets": [ [ 2372, 2380 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T115", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 2453, 2459 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T116", "type": "Condition", "text": [ "peptic ulceration" ], "offsets": [ [ 2460, 2477 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T117", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 2493, 2503 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T118", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 2504, 2514 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T119", "type": "Temporal", "text": [ "within the past 5 years" ], "offsets": [ [ 2515, 2538 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T120", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 2540, 2550 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T121", "type": "Condition", "text": [ "ell skin", "t with a hi" ], "offsets": [ [ 2570, 2578 ], [ 2593, 2604 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T122", "type": "Condition", "text": [ "basal cell skin cancer" ], "offsets": [ [ 2563, 2585 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T123", "type": "Scope", "text": [ "squamous or basal cell skin cancer" ], "offsets": [ [ 2551, 2585 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T124", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 2602, 2612 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T125", "type": "Value", "text": [ "positive" ], "offsets": [ [ 2615, 2623 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T126", "type": "Measurement", "text": [ "test for Hepatitis B surface antigen (HbsAg)" ], "offsets": [ [ 2624, 2668 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T127", "type": "Measurement", "text": [ " surfac", "with a know" ], "offsets": [ [ 2644, 2651 ], [ 2692, 2703 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T128", "type": "Scope", "text": [ "test for Hepatitis B surface antigen (HbsAg) or Hepatitis C" ], "offsets": [ [ 2624, 2683 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T129", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 2705, 2721 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T130", "type": "Qualifier", "text": [ "investigational" ], "offsets": [ [ 2746, 2761 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T131", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 2762, 2773 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T132", "type": "Drug", "text": [ "monoamine oxidase inhibitors" ], "offsets": [ [ 2775, 2803 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T133", "type": "Drug", "text": [ "phosphodiesterase type 5 inhibitors" ], "offsets": [ [ 2805, 2840 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T134", "type": "Drug", "text": [ "phenylethylamines" ], "offsets": [ [ 2844, 2861 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T135", "type": "Scope", "text": [ "investigational medications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors or phenylethylamines" ], "offsets": [ [ 2746, 2861 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T136", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 2878, 2888 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T137", "type": "Condition", "text": [ "with", "6 mon" ], "offsets": [ [ 2911, 2915 ], [ 2927, 2932 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T138", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 2897, 2910 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T139", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 2911, 2935 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T140", "type": "Reference_point", "text": [ "the past 6 months" ], "offsets": [ [ 2918, 2935 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T141", "type": "Scope", "text": [ "drug or alcohol abuse" ], "offsets": [ [ 2889, 2910 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T142", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 2945, 2954 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T143", "type": "Observation", "text": [ "lcohol pe", " who is illite" ], "offsets": [ [ 2978, 2987 ], [ 3000, 3014 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T144", "type": "Value", "text": [ "=5 units" ], "offsets": [ [ 2965, 2973 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T145", "type": "Observation", "text": [ "illiterate" ], "offsets": [ [ 3008, 3018 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T146", "type": "Negation", "text": [ "unable to" ], "offsets": [ [ 3022, 3031 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T150", "type": "Scope", "text": [ "understand the Informed Consent Form, questionnaires or subject diary" ], "offsets": [ [ 3032, 3101 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T153", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 3233, 3241 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T154", "type": "Condition", "text": [ "ubstanc", "on of th" ], "offsets": [ [ 3268, 3275 ], [ 3309, 3317 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T155", "type": "Condition", "text": [ "abuse disor", "on of th" ], "offsets": [ [ 3277, 3288 ], [ 3309, 3317 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T156", "type": "Condition", "text": [ "substance abuse disorder" ], "offsets": [ [ 3267, 3291 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T157", "type": "Scope", "text": [ "medical, psychiatric, or substance abuse disorder" ], "offsets": [ [ 3242, 3291 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T159", "type": "Qualifier", "text": [ "likely to affect the subject's ability to complete the study" ], "offsets": [ [ 3335, 3395 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T160", "type": "Qualifier", "text": [ "preclude the subject's participation in the study" ], "offsets": [ [ 3399, 3448 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T161", "type": "Scope", "text": [ "likely to affect the subject's ability to complete the study or preclude the subject's participation in the study" ], "offsets": [ [ 3335, 3448 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T162", "type": "Condition", "text": [ "neurologic disease" ], "offsets": [ [ 3472, 3490 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T163", "type": "Qualifier", "text": [ "any other" ], "offsets": [ [ 3462, 3471 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T164", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 3491, 3503 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T165", "type": "Condition", "text": [ "Diabetes" ], "offsets": [ [ 3504, 3512 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T166", "type": "Measurement", "text": [ "Hemoglobin A1C" ], "offsets": [ [ 3514, 3528 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T167", "type": "Value", "text": [ "> 7.5" ], "offsets": [ [ 3529, 3534 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T168", "type": "Scope", "text": [ "Hemoglobin A1C > 7.5" ], "offsets": [ [ 3514, 3534 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T169", "type": "Scope", "text": [ "Uncontrolled Diabetes" ], "offsets": [ [ 3491, 3512 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T170", "type": "Negation", "text": [ "unwilling" ], "offsets": [ [ 8, 17 ] ], "normalized": [] }, { "id": "NCT02225548_exc_T171", "type": "Mood", "text": [ "cease use of" ], "offsets": [ [ 21, 33 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02225548_exc_R1", "type": "AND", "arg1_id": "NCT02225548_exc_T1", "arg2_id": "NCT02225548_exc_T2", "normalized": [] }, { "id": "NCT02225548_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T1", "arg2_id": "NCT02225548_exc_T3", "normalized": [] }, { "id": "NCT02225548_exc_R3", "type": "Has_scope", "arg1_id": "NCT02225548_exc_T12", "arg2_id": "NCT02225548_exc_T13", "normalized": [] }, { "id": "NCT02225548_exc_R4", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T1", "arg2_id": "NCT02225548_exc_T14", "normalized": [] }, { "id": "NCT02225548_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T19", "arg2_id": "NCT02225548_exc_T20", "normalized": [] }, { "id": "NCT02225548_exc_R6", "type": "Has_index", "arg1_id": "NCT02225548_exc_T20", "arg2_id": "NCT02225548_exc_T21", "normalized": [] }, { "id": "NCT02225548_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T22", "arg2_id": "NCT02225548_exc_T23", "normalized": [] }, { "id": "NCT02225548_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T27", "arg2_id": "NCT02225548_exc_T26", "normalized": [] }, { "id": "NCT02225548_exc_R9", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T22", "arg2_id": "NCT02225548_exc_T27", "normalized": [] }, { "id": "NCT02225548_exc_R10", "type": "Has_value", "arg1_id": "NCT02225548_exc_T29", "arg2_id": "NCT02225548_exc_T30", "normalized": [] }, { "id": "NCT02225548_exc_R11", "type": "AND", "arg1_id": "NCT02225548_exc_T28", "arg2_id": "NCT02225548_exc_T29", "normalized": [] }, { "id": "NCT02225548_exc_R12", "type": "Has_value", "arg1_id": "NCT02225548_exc_T32", "arg2_id": "NCT02225548_exc_T33", "normalized": [] }, { "id": "NCT02225548_exc_R13", "type": "Has_value", "arg1_id": "NCT02225548_exc_T34", "arg2_id": "NCT02225548_exc_T35", "normalized": [] }, { "id": "NCT02225548_exc_R14", "type": "Has_scope", "arg1_id": "NCT02225548_exc_T31", "arg2_id": "NCT02225548_exc_T36", "normalized": [] }, { "id": "NCT02225548_exc_R15", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T37", "arg2_id": "NCT02225548_exc_T38", "normalized": [] }, { "id": "NCT02225548_exc_R16", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T39", "arg2_id": "NCT02225548_exc_T40", "normalized": [] }, { "id": "NCT02225548_exc_R17", "type": "Has_index", "arg1_id": "NCT02225548_exc_T45", "arg2_id": "NCT02225548_exc_T46", "normalized": [] }, { "id": "NCT02225548_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T43", "arg2_id": "NCT02225548_exc_T44", "normalized": [] }, { "id": "NCT02225548_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T47", "arg2_id": "NCT02225548_exc_T45", "normalized": [] }, { "id": "NCT02225548_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T52", "arg2_id": "NCT02225548_exc_T50", "normalized": [] }, { "id": "NCT02225548_exc_R21", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T52", "arg2_id": "NCT02225548_exc_T51", "normalized": [] }, { "id": "NCT02225548_exc_R22", "type": "AND", "arg1_id": "NCT02225548_exc_T54", "arg2_id": "NCT02225548_exc_T55", "normalized": [] }, { "id": "NCT02225548_exc_R23", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T54", "arg2_id": "NCT02225548_exc_T56", "normalized": [] }, { "id": "NCT02225548_exc_R24", "type": "AND", "arg1_id": "NCT02225548_exc_T57", "arg2_id": "NCT02225548_exc_T58", "normalized": [] }, { "id": "NCT02225548_exc_R25", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T57", "arg2_id": "NCT02225548_exc_T59", "normalized": [] }, { "id": "NCT02225548_exc_R26", "type": "AND", "arg1_id": "NCT02225548_exc_T63", "arg2_id": "NCT02225548_exc_T58", "normalized": [] }, { "id": "NCT02225548_exc_R27", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T64", "arg2_id": "NCT02225548_exc_T65", "normalized": [] }, { "id": "NCT02225548_exc_R28", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T66", "arg2_id": "NCT02225548_exc_T67", "normalized": [] }, { "id": "NCT02225548_exc_R29", "type": "AND", "arg1_id": "NCT02225548_exc_T68", "arg2_id": "NCT02225548_exc_T66", "normalized": [] }, { "id": "NCT02225548_exc_R30", "type": "Has_scope", "arg1_id": "NCT02225548_exc_T69", "arg2_id": "NCT02225548_exc_T72", "normalized": [] }, { "id": "NCT02225548_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T74", "arg2_id": "NCT02225548_exc_T73", "normalized": [] }, { "id": "NCT02225548_exc_R32", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T69", "arg2_id": "NCT02225548_exc_T74", "normalized": [] }, { "id": "NCT02225548_exc_R33", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T76", "arg2_id": "NCT02225548_exc_T81", "normalized": [] }, { "id": "NCT02225548_exc_R34", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T94", "arg2_id": "NCT02225548_exc_T85", "normalized": [] }, { "id": "NCT02225548_exc_R35", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T95", "arg2_id": "NCT02225548_exc_T93", "normalized": [] }, { "id": "NCT02225548_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T87", "arg2_id": "NCT02225548_exc_T92", "normalized": [] }, { "id": "NCT02225548_exc_R37", "type": "AND", "arg1_id": "NCT02225548_exc_T87", "arg2_id": "NCT02225548_exc_T88", "normalized": [] }, { "id": "NCT02225548_exc_R38", "type": "Has_value", "arg1_id": "NCT02225548_exc_T88", "arg2_id": "NCT02225548_exc_T90", "normalized": [] }, { "id": "NCT02225548_exc_R39", "type": "AND", "arg1_id": "NCT02225548_exc_T95", "arg2_id": "NCT02225548_exc_T89", "normalized": [] }, { "id": "NCT02225548_exc_R40", "type": "Has_value", "arg1_id": "NCT02225548_exc_T89", "arg2_id": "NCT02225548_exc_T91", "normalized": [] }, { "id": "NCT02225548_exc_R42", "type": "Has_value", "arg1_id": "NCT02225548_exc_T97", "arg2_id": "NCT02225548_exc_T98", "normalized": [] }, { "id": "NCT02225548_exc_R43", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T52", "arg2_id": "NCT02225548_exc_T97", "normalized": [] }, { "id": "NCT02225548_exc_R44", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T57", "arg2_id": "NCT02225548_exc_T99", "normalized": [] }, { "id": "NCT02225548_exc_R45", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T63", "arg2_id": "NCT02225548_exc_T100", "normalized": [] }, { "id": "NCT02225548_exc_R46", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T68", "arg2_id": "NCT02225548_exc_T101", "normalized": [] }, { "id": "NCT02225548_exc_R47", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T75", "arg2_id": "NCT02225548_exc_T102", "normalized": [] }, { "id": "NCT02225548_exc_R50", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T96", "arg2_id": "NCT02225548_exc_T106", "normalized": [] }, { "id": "NCT02225548_exc_R49", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T76", "arg2_id": "NCT02225548_exc_T104", "normalized": [] }, { "id": "NCT02225548_exc_R51", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T96", "arg2_id": "NCT02225548_exc_T112", "normalized": [] }, { "id": "NCT02225548_exc_R54", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T107", "arg2_id": "NCT02225548_exc_T111", "normalized": [] }, { "id": "NCT02225548_exc_R55", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T96", "arg2_id": "NCT02225548_exc_T107", "normalized": [] }, { "id": "NCT02225548_exc_R56", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T116", "arg2_id": "NCT02225548_exc_T115", "normalized": [] }, { "id": "NCT02225548_exc_R57", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T123", "arg2_id": "NCT02225548_exc_T120", "normalized": [] }, { "id": "NCT02225548_exc_R58", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T118", "arg2_id": "NCT02225548_exc_T119", "normalized": [] }, { "id": "NCT02225548_exc_R59", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T118", "arg2_id": "NCT02225548_exc_T117", "normalized": [] }, { "id": "NCT02225548_exc_R60", "type": "Has_scope", "arg1_id": "NCT02225548_exc_T118", "arg2_id": "NCT02225548_exc_T123", "normalized": [] }, { "id": "NCT02225548_exc_R61", "type": "Has_value", "arg1_id": "NCT02225548_exc_T128", "arg2_id": "NCT02225548_exc_T125", "normalized": [] }, { "id": "NCT02225548_exc_R62", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T128", "arg2_id": "NCT02225548_exc_T124", "normalized": [] }, { "id": "NCT02225548_exc_R63", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T131", "arg2_id": "NCT02225548_exc_T130", "normalized": [] }, { "id": "NCT02225548_exc_R64", "type": "AND", "arg1_id": "NCT02225548_exc_T135", "arg2_id": "NCT02225548_exc_T129", "normalized": [] }, { "id": "NCT02225548_exc_R65", "type": "Has_index", "arg1_id": "NCT02225548_exc_T139", "arg2_id": "NCT02225548_exc_T140", "normalized": [] }, { "id": "NCT02225548_exc_R66", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T141", "arg2_id": "NCT02225548_exc_T136", "normalized": [] }, { "id": "NCT02225548_exc_R67", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T141", "arg2_id": "NCT02225548_exc_T139", "normalized": [] }, { "id": "NCT02225548_exc_R68", "type": "Has_value", "arg1_id": "NCT02225548_exc_T143", "arg2_id": "NCT02225548_exc_T144", "normalized": [] }, { "id": "NCT02225548_exc_R69", "type": "Has_temporal", "arg1_id": "NCT02225548_exc_T143", "arg2_id": "NCT02225548_exc_T142", "normalized": [] }, { "id": "NCT02225548_exc_R70", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T150", "arg2_id": "NCT02225548_exc_T146", "normalized": [] }, { "id": "NCT02225548_exc_R73", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T157", "arg2_id": "NCT02225548_exc_T153", "normalized": [] }, { "id": "NCT02225548_exc_R75", "type": "Has_scope", "arg1_id": "NCT02225548_exc_T157", "arg2_id": "NCT02225548_exc_T161", "normalized": [] }, { "id": "NCT02225548_exc_R76", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T162", "arg2_id": "NCT02225548_exc_T163", "normalized": [] }, { "id": "NCT02225548_exc_R77", "type": "Has_value", "arg1_id": "NCT02225548_exc_T166", "arg2_id": "NCT02225548_exc_T167", "normalized": [] }, { "id": "NCT02225548_exc_R78", "type": "Has_qualifier", "arg1_id": "NCT02225548_exc_T165", "arg2_id": "NCT02225548_exc_T164", "normalized": [] }, { "id": "NCT02225548_exc_R79", "type": "Subsumes", "arg1_id": "NCT02225548_exc_T169", "arg2_id": "NCT02225548_exc_T168", "normalized": [] }, { "id": "NCT02225548_exc_R80", "type": "Has_negation", "arg1_id": "NCT02225548_exc_T171", "arg2_id": "NCT02225548_exc_T170", "normalized": [] }, { "id": "NCT02225548_exc_R81", "type": "Has_mood", "arg1_id": "NCT02225548_exc_T1", "arg2_id": "NCT02225548_exc_T171", "normalized": [] } ]

[ { "id": "NCT02225548_inc_text", "type": "inclusion", "text": [ "Diagnosis of idiopathic Parkinson's disease that is optimally treated (motor fluctuations <20% of subject's awake time). Subjects may be on levodopa therapy but must be stable at the time of entry into the study\nSexually active (i.e. =1 attempt/week) males, 40 - 64 years of age (inclusive) at time of screening\nDiagnosis of moderate erectile dysfunction (defined according to the NIH Consensus Development Panel on Impotence) for more than 6 months and demonstrating and incomplete response to tadalafil alone\nSubject demonstrating an IIEF-5 drug-free baseline score that is = 10 but = 16, and an IIEF-5 tadalafil-alone baseline score that is = 18\nSubject in a stable heterosexual relationship for at least 6 months. (2)\nSubject motivated to seek treatment for erectile dysfunction.\nSubject with a total serum testosterone level = 300 ng/dL, with or without supplementation\nHoehn and Yahr Scale score of 1 - 3\nPatient able to consent and comply with protocol requirements\n" ], "offsets": [ [ 0, 973 ] ] } ]

[ { "id": "NCT02225548_inc_T1", "type": "Condition", "text": [ "idiopathic Parkinson's disease" ], "offsets": [ [ 13, 43 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T2", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 62, 69 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T3", "type": "Measurement", "text": [ "motor fluctuations" ], "offsets": [ [ 71, 89 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T4", "type": "Value", "text": [ "<20% of subject's awake time" ], "offsets": [ [ 90, 118 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T5", "type": "Observation", "text": [ "Sexually active" ], "offsets": [ [ 212, 227 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T6", "type": "Person", "text": [ "males" ], "offsets": [ [ 251, 256 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T7", "type": "Person", "text": [ "age" ], "offsets": [ [ 275, 278 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T8", "type": "Value", "text": [ "40 - 64 years" ], "offsets": [ [ 258, 271 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T9", "type": "Multiplier", "text": [ "=1 attempt/week" ], "offsets": [ [ 234, 249 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T10", "type": "Condition", "text": [ "erectile dysfunction" ], "offsets": [ [ 334, 354 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T11", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 325, 333 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T12", "type": "Temporal", "text": [ "for more than 6 months" ], "offsets": [ [ 427, 449 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T13", "type": "Drug", "text": [ "tadalafil" ], "offsets": [ [ 495, 504 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T14", "type": "Condition", "text": [ "response" ], "offsets": [ [ 483, 491 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T15", "type": "Qualifier", "text": [ "incomplete" ], "offsets": [ [ 472, 482 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T16", "type": "Measurement", "text": [ "IIEF-5 drug-free baseline score" ], "offsets": [ [ 536, 567 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T17", "type": "Value", "text": [ "= 10 but = 16" ], "offsets": [ [ 576, 589 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T18", "type": "Measurement", "text": [ "IIEF-5 tadalafil-alone baseline score" ], "offsets": [ [ 598, 635 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T19", "type": "Value", "text": [ "= 18" ], "offsets": [ [ 644, 648 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T20", "type": "Observation", "text": [ "heterosexual relationship" ], "offsets": [ [ 669, 694 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T21", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 662, 668 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T22", "type": "Temporal", "text": [ "at least 6 months" ], "offsets": [ [ 699, 716 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T23", "type": "Condition", "text": [ "erectile dysfunction" ], "offsets": [ [ 762, 782 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T24", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 748, 757 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T26", "type": "Measurement", "text": [ "total serum testosterone level" ], "offsets": [ [ 799, 829 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T27", "type": "Value", "text": [ "= 300 ng/dL" ], "offsets": [ [ 830, 841 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T28", "type": "Measurement", "text": [ "Hoehn and Yahr Scale score" ], "offsets": [ [ 875, 901 ] ], "normalized": [] }, { "id": "NCT02225548_inc_T29", "type": "Value", "text": [ "1 - 3" ], "offsets": [ [ 905, 910 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02225548_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02225548_inc_T1", "arg2_id": "NCT02225548_inc_T2", "normalized": [] }, { "id": "NCT02225548_inc_R2", "type": "Has_value", "arg1_id": "NCT02225548_inc_T3", "arg2_id": "NCT02225548_inc_T4", "normalized": [] }, { "id": "NCT02225548_inc_R3", "type": "Has_value", "arg1_id": "NCT02225548_inc_T7", "arg2_id": "NCT02225548_inc_T8", "normalized": [] }, { "id": "NCT02225548_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT02225548_inc_T5", "arg2_id": "NCT02225548_inc_T9", "normalized": [] }, { "id": "NCT02225548_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02225548_inc_T10", "arg2_id": "NCT02225548_inc_T11", "normalized": [] }, { "id": "NCT02225548_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02225548_inc_T10", "arg2_id": "NCT02225548_inc_T12", "normalized": [] }, { "id": "NCT02225548_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02225548_inc_T14", "arg2_id": "NCT02225548_inc_T15", "normalized": [] }, { "id": "NCT02225548_inc_R8", "type": "AND", "arg1_id": "NCT02225548_inc_T14", "arg2_id": "NCT02225548_inc_T13", "normalized": [] }, { "id": "NCT02225548_inc_R9", "type": "Has_value", "arg1_id": "NCT02225548_inc_T16", "arg2_id": "NCT02225548_inc_T17", "normalized": [] }, { "id": "NCT02225548_inc_R10", "type": "Has_value", "arg1_id": "NCT02225548_inc_T18", "arg2_id": "NCT02225548_inc_T19", "normalized": [] }, { "id": "NCT02225548_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT02225548_inc_T20", "arg2_id": "NCT02225548_inc_T21", "normalized": [] }, { "id": "NCT02225548_inc_R12", "type": "Has_temporal", "arg1_id": "NCT02225548_inc_T20", "arg2_id": "NCT02225548_inc_T22", "normalized": [] }, { "id": "NCT02225548_inc_R13", "type": "Has_value", "arg1_id": "NCT02225548_inc_T26", "arg2_id": "NCT02225548_inc_T27", "normalized": [] }, { "id": "NCT02225548_inc_R14", "type": "Has_value", "arg1_id": "NCT02225548_inc_T28", "arg2_id": "NCT02225548_inc_T29", "normalized": [] } ]

[ { "id": "NCT02226887_exc_text", "type": "exclusion", "text": [ "Patients under 18\nPregnancy and Lactation\nPatients allergic to polyglycolic / trimethylene carbonate\nCarrier of prosthetic mesh in the ostomy\nPatients presenting midline hernia.\nPatients affected by inflammatory bowel disease\n" ], "offsets": [ [ 0, 226 ] ] } ]

[ { "id": "NCT02226887_exc_T1", "type": "Person", "text": [ "under 18" ], "offsets": [ [ 9, 17 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T2", "type": "Value", "text": [ "under 18" ], "offsets": [ [ 9, 17 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T3", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 18, 27 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T4", "type": "Condition", "text": [ "Lactation" ], "offsets": [ [ 32, 41 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T5", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 51, 59 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T6", "type": "Drug", "text": [ "lyglycolic /", "rbonate\nC" ], "offsets": [ [ 65, 77 ], [ 93, 102 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T7", "type": "Drug", "text": [ "trimethylene carbonate" ], "offsets": [ [ 78, 100 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T8", "type": "Scope", "text": [ "polyglycolic / trimethylene carbonate" ], "offsets": [ [ 63, 100 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T9", "type": "Device", "text": [ "prosthetic mesh" ], "offsets": [ [ 112, 127 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T10", "type": "Procedure", "text": [ "ostomy" ], "offsets": [ [ 135, 141 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T11", "type": "Condition", "text": [ "midline hernia" ], "offsets": [ [ 162, 176 ] ], "normalized": [] }, { "id": "NCT02226887_exc_T12", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 199, 225 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02226887_exc_R1", "type": "Has_value", "arg1_id": "NCT02226887_exc_T1", "arg2_id": "NCT02226887_exc_T2", "normalized": [] }, { "id": "NCT02226887_exc_R2", "type": "Has_scope", "arg1_id": "NCT02226887_exc_T5", "arg2_id": "NCT02226887_exc_T8", "normalized": [] }, { "id": "NCT02226887_exc_R3", "type": "AND", "arg1_id": "NCT02226887_exc_T10", "arg2_id": "NCT02226887_exc_T9", "normalized": [] } ]

[ { "id": "NCT02226887_inc_text", "type": "inclusion", "text": [ "Patients undergoing a loop ileostomy closure\n" ], "offsets": [ [ 0, 45 ] ] } ]

[ { "id": "NCT02226887_inc_T1", "type": "Procedure", "text": [ "loop ileostomy closure" ], "offsets": [ [ 22, 44 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT02227992_exc_text", "type": "exclusion", "text": [ "Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;\nFemale subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;\nSubject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;\nSubjects who are known, current alcohol and/or drug abusers\nSubjects admitted for trauma surgery\nSubjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure.\nSubject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)\nTBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the EVARREST™ or SURGICEL® to blood flow and pressure during healing and absorption of the product;\nTBS with major arterial bleeding requiring suture or mechanical ligation;\nBleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.\n" ], "offsets": [ [ 0, 1149 ] ] } ]

[ { "id": "NCT02227992_exc_T1", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T2", "type": "Procedure", "text": [ "blood products" ], "offsets": [ [ 35, 49 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T6", "type": "Person", "text": [ "drug abusers" ], "offsets": [ [ 426, 438 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T7", "type": "Person", "text": [ "ohol an", "sers\nSu" ], "offsets": [ [ 414, 421 ], [ 434, 441 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T8", "type": "Procedure", "text": [ "trauma surgery" ], "offsets": [ [ 461, 475 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T10", "type": "Condition", "text": [ "TBS" ], "offsets": [ [ 615, 618 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T11", "type": "Qualifier", "text": [ "Class III Contaminated" ], "offsets": [ [ 650, 672 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T12", "type": "Qualifier", "text": [ "Class IV Dirty or Infected" ], "offsets": [ [ 676, 702 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T13", "type": "Scope", "text": [ "Class III Contaminated or Class IV Dirty or Infected" ], "offsets": [ [ 650, 702 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T15", "type": "Condition", "text": [ "TBS" ], "offsets": [ [ 983, 986 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T16", "type": "Condition", "text": [ "major arterial bleeding" ], "offsets": [ [ 992, 1015 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T17", "type": "Procedure", "text": [ "mechanical ligation" ], "offsets": [ [ 1036, 1055 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T18", "type": "Procedure", "text": [ "suture" ], "offsets": [ [ 1026, 1032 ] ], "normalized": [] }, { "id": "NCT02227992_exc_T19", "type": "Scope", "text": [ "suture or mechanical ligation" ], "offsets": [ [ 1026, 1055 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02227992_exc_R1", "type": "AND", "arg1_id": "NCT02227992_exc_T1", "arg2_id": "NCT02227992_exc_T2", "normalized": [] }, { "id": "NCT02227992_exc_R2", "type": "Has_scope", "arg1_id": "NCT02227992_exc_T10", "arg2_id": "NCT02227992_exc_T13", "normalized": [] }, { "id": "NCT02227992_exc_R3", "type": "AND", "arg1_id": "NCT02227992_exc_T15", "arg2_id": "NCT02227992_exc_T16", "normalized": [] }, { "id": "NCT02227992_exc_R4", "type": "Has_scope", "arg1_id": "NCT02227992_exc_T16", "arg2_id": "NCT02227992_exc_T19", "normalized": [] } ]

[ { "id": "NCT02227992_inc_text", "type": "inclusion", "text": [ "Paediatric subjects aged =28 days (= 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects aged =1 years to <18 years. ii) The next 4 subjects to be enrolled will be subjects aged =28 days to <1 year.\nThe subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study.\nPresence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;\nAbility to firmly press trial treatment at TBS until 4 minutes after randomisation\n" ], "offsets": [ [ 0, 1209 ] ] } ]

[ { "id": "NCT02227992_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 20, 24 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T2", "type": "Value", "text": [ "=28 days (= 1 month) to <18 years" ], "offsets": [ [ 25, 58 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T3", "type": "Procedure", "text": [ "surgical procedures" ], "offsets": [ [ 158, 177 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T4", "type": "Qualifier", "text": [ "thoracic" ], "offsets": [ [ 135, 143 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T5", "type": "Qualifier", "text": [ "pelvic" ], "offsets": [ [ 125, 131 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T6", "type": "Qualifier", "text": [ "retroperitoneal" ], "offsets": [ [ 108, 123 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T7", "type": "Qualifier", "text": [ "abdominal" ], "offsets": [ [ 97, 106 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T8", "type": "Qualifier", "text": [ "hepatic" ], "offsets": [ [ 88, 95 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T9", "type": "Qualifier", "text": [ "open" ], "offsets": [ [ 83, 87 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T10", "type": "Qualifier", "text": [ "non-emergent" ], "offsets": [ [ 70, 82 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T11", "type": "Qualifier", "text": [ "non-cardiac" ], "offsets": [ [ 145, 156 ] ], "normalized": [] }, { "id": "NCT02227992_inc_T12", "type": "Scope", "text": [ "hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac)" ], "offsets": [ [ 88, 157 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02227992_inc_R1", "type": "Has_value", "arg1_id": "NCT02227992_inc_T1", "arg2_id": "NCT02227992_inc_T2", "normalized": [] }, { "id": "NCT02227992_inc_R2", "type": "Has_scope", "arg1_id": "NCT02227992_inc_T3", "arg2_id": "NCT02227992_inc_T12", "normalized": [] }, { "id": "NCT02227992_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02227992_inc_T3", "arg2_id": "NCT02227992_inc_T9", "normalized": [] }, { "id": "NCT02227992_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02227992_inc_T3", "arg2_id": "NCT02227992_inc_T10", "normalized": [] } ]

[ { "id": "NCT02231892_exc_text", "type": "exclusion", "text": [ "1. Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days. \nJustification: Stroke or head trauma can lower the seizure threshold, and are therefore contra-indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. \nScreening tool: TMS adult safety questionnaire, Medical History. \n2. First-degree family history of any neurological disorder with a potentially hereditary basis, including migraines, epilepsy, or multiple sclerosis. \n1. Justification: Neurological disorders can lower the seizure threshold, and are therefore contra-indications for TMS. First-degree family history of certain neurological disorders with a hereditary component increases the risk of the subject having an undiagnosed condition that is associated with lowered seizure threshold. \n2. Screening tool: TMS adult safety screening, Medical History. \n3. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that precludes MRI scanning. \n1. Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field. \n2. Screening tool: TMS adult safety screening, MRI safety screening, Medical History. \n4. Noise-induced hearing loss or tinnitus. \n1. Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment. \n2. Screening tools: TMS adult safety screening. \n5. Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action. \n1. Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contra-indicated for TMS. \n2. Screening tools: MRI safety screening questionnaire, Medical history, Medical Assessments: Urine toxicology analyzes for presence of a broad range of prescription and nonprescription drugs. \n6. Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania. \n1. Justification: The population of interest here is a healthy control population with no psychiatric disorders. In subjects with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. \n2. Screening tools: SCID Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counsellor. \n7. Meet current DSM V criteria for moderate to severe substance use disorder (excluding nicotine), smoke daily, or urine toxicology positive for any illicit substance inconsistent with history given. \n1. Justification: The population of interest here is a healthy control population with no substance use disorder. Current use of illicit substances could impact on seizure threshold and is therefore contra-indicated for TMS. \n2. Screening tools: SCID Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counsellor, Drug Use Survey (DUS), Substance Use Disorder Evaluation, Medical Assessments: urine qualitative drug screen is performed for methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, opiates, barbiturates, and tetrahydrocannabinol. \n8. Have met DSM V criteria for moderate to severe substance use disorder (excluding nicotine, alcohol and cannabis) in the past, or have met DSM V criteria for moderate to severe substance use disorder for cannabis or alcohol in the past 5 years. \n1. Justification: the population of interest here is a healthy control population with no present or past substance use disorder. \n2. Screening tools: SCID Screen Patient Questionnaire. Potential diagnoses will be further evaluated by a counselor. Drug Use Survey (DUS), Substance Use Disorder Evaluation. \n9. History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care. \n1. Justifications: the risk of TMS for individuals with a heart condition is unknown. \n2. Screening tool: physical assessment (EKG), medical history. \n10. Pregnant women or women with reproductive potential who are sexually active and not using an acceptable form of contraception. \n1. Justification: it is unknown whether TMS poses a risk to fetuses. \n2. Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI. \n11. History of learning disability or current ADHD \n1. Justification: Subjects should be able to perform cognitive tasks to a high degree of accuracy, both in the MRI scanner and outside the scanner. Subjects with ADHD/LD may engage different neural circuitry even if they can perform the tasks. \n2. Screening tool: Wechsler Abbreviated Scale of Intelligence, Medical history, Adult ADHD Self-Report Scale. \n12. Participation in an rTMS session less than two weeks ago. \n1. Justification: in order to limit exposure to TMS, we will not enroll subjects who have received TMS less than two weeks ago. \n2. Screening tool: TMS safety screening questionnaire. \n \n" ], "offsets": [ [ 0, 5576 ] ] } ]

[ { "id": "NCT02231892_exc_T35", "type": "Procedure", "text": [ "TMS safety screening questionnaire" ], "offsets": [ [ 5528, 5562 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T38", "type": "Procedure", "text": [ "rTMS session" ], "offsets": [ [ 5341, 5353 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T39", "type": "Temporal", "text": [ "less than two weeks ago" ], "offsets": [ [ 5354, 5377 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T40", "type": "Procedure", "text": [ "Wechsler Abbreviated Scale of Intelligence" ], "offsets": [ [ 5225, 5267 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T41", "type": "Observation", "text": [ "Medical history" ], "offsets": [ [ 5269, 5284 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T42", "type": "Procedure", "text": [ "Adult ADHD Self-Report Scale" ], "offsets": [ [ 5286, 5314 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T45", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 5123, 5127 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T46", "type": "Condition", "text": [ "LD" ], "offsets": [ [ 5128, 5130 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T52", "type": "Condition", "text": [ "learning disability" ], "offsets": [ [ 4924, 4943 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T53", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 4947, 4954 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T54", "type": "Observation", "text": [ "History" ], "offsets": [ [ 4913, 4920 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T55", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 4955, 4959 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T56", "type": "Measurement", "text": [ "urine pregnancy test" ], "offsets": [ [ 4829, 4849 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T57", "type": "Procedure", "text": [ "Medical assessments" ], "offsets": [ [ 4808, 4827 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T58", "type": "Temporal", "text": [ "at the beginning of each visit" ], "offsets": [ [ 4851, 4881 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T59", "type": "Reference_point", "text": [ "the beginning of each visit" ], "offsets": [ [ 4854, 4881 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T60", "type": "Procedure", "text": [ "TMS" ], "offsets": [ [ 4896, 4899 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T61", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 4903, 4906 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T62", "type": "Scope", "text": [ "TMS or MRI" ], "offsets": [ [ 4896, 4906 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T65", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 4591, 4599 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T66", "type": "Person", "text": [ "women" ], "offsets": [ [ 4600, 4605 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T67", "type": "Person", "text": [ "women" ], "offsets": [ [ 4609, 4614 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T68", "type": "Condition", "text": [ "reproductive potential" ], "offsets": [ [ 4620, 4642 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T69", "type": "Condition", "text": [ "sexually active" ], "offsets": [ [ 4651, 4666 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T70", "type": "Condition", "text": [ "contraception" ], "offsets": [ [ 4703, 4716 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T71", "type": "Qualifier", "text": [ "acceptable form of" ], "offsets": [ [ 4684, 4702 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T73", "type": "Negation", "text": [ "not" ], "offsets": [ [ 4671, 4674 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T74", "type": "Scope", "text": [ "Pregnant women" ], "offsets": [ [ 4591, 4605 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T75", "type": "Scope", "text": [ "women with reproductive potential who are sexually active and not using an acceptable form of contraception" ], "offsets": [ [ 4609, 4716 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T80", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 4272, 4293 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T81", "type": "Condition", "text": [ "angina" ], "offsets": [ [ 4295, 4301 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T82", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 4303, 4327 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T83", "type": "Condition", "text": [ "cardiomyopathy" ], "offsets": [ [ 4329, 4343 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T84", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 4345, 4351 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T85", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 4355, 4380 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T86", "type": "Condition", "text": [ "heart condition" ], "offsets": [ [ 4389, 4404 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T87", "type": "Qualifier", "text": [ "under medical care" ], "offsets": [ [ 4415, 4433 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T88", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 4405, 4414 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T90", "type": "Observation", "text": [ "History" ], "offsets": [ [ 4261, 4268 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T91", "type": "Scope", "text": [ "myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack" ], "offsets": [ [ 4272, 4380 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T97", "type": "Measurement", "text": [ "DSM V criteria" ], "offsets": [ [ 2932, 2946 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T98", "type": "Qualifier", "text": [ "moderate to severe" ], "offsets": [ [ 2951, 2969 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T99", "type": "Condition", "text": [ "substance use disorder" ], "offsets": [ [ 2970, 2992 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T100", "type": "Drug", "text": [ "nicotine" ], "offsets": [ [ 3004, 3012 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T101", "type": "Negation", "text": [ "excluding" ], "offsets": [ [ 2994, 3003 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T102", "type": "Observation", "text": [ "smoke daily" ], "offsets": [ [ 3015, 3026 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T103", "type": "Measurement", "text": [ "urine toxicology" ], "offsets": [ [ 3031, 3047 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T104", "type": "Value", "text": [ "positive" ], "offsets": [ [ 3048, 3056 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T105", "type": "Drug", "text": [ "illicit substance" ], "offsets": [ [ 3065, 3082 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T106", "type": "Qualifier", "text": [ "inconsistent with history" ], "offsets": [ [ 3083, 3108 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T112", "type": "Value", "text": [ "Meet" ], "offsets": [ [ 2919, 2923 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T115", "type": "Procedure", "text": [ "Drug Use Survey (DUS)" ], "offsets": [ [ 4199, 4220 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T116", "type": "Procedure", "text": [ "Substance Use Disorder Evaluation" ], "offsets": [ [ 4222, 4255 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T120", "type": "Procedure", "text": [ "SCID Screen Patient Questionnaire" ], "offsets": [ [ 4102, 4135 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T125", "type": "Measurement", "text": [ "DSM V criteria" ], "offsets": [ [ 3715, 3729 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T126", "type": "Value", "text": [ "met" ], "offsets": [ [ 3711, 3714 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T127", "type": "Qualifier", "text": [ "moderate to severe" ], "offsets": [ [ 3734, 3752 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T128", "type": "Condition", "text": [ "substance use disorder" ], "offsets": [ [ 3753, 3775 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T129", "type": "Drug", "text": [ "nicotine" ], "offsets": [ [ 3787, 3795 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T130", "type": "Drug", "text": [ "alcohol" ], "offsets": [ [ 3797, 3804 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T131", "type": "Drug", "text": [ "cannabis" ], "offsets": [ [ 3809, 3817 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T132", "type": "Negation", "text": [ "excluding" ], "offsets": [ [ 3777, 3786 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T133", "type": "Temporal", "text": [ "in the past" ], "offsets": [ [ 3819, 3830 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T134", "type": "Measurement", "text": [ "DSM V criteria" ], "offsets": [ [ 3844, 3858 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T135", "type": "Value", "text": [ "met" ], "offsets": [ [ 3840, 3843 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T136", "type": "Scope", "text": [ "excluding nicotine, alcohol and cannabis" ], "offsets": [ [ 3777, 3817 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T137", "type": "Qualifier", "text": [ "moderate to severe" ], "offsets": [ [ 3863, 3881 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T138", "type": "Condition", "text": [ "substance use disorder" ], "offsets": [ [ 3882, 3904 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T139", "type": "Drug", "text": [ "cannabis" ], "offsets": [ [ 3909, 3917 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T140", "type": "Drug", "text": [ "alcohol" ], "offsets": [ [ 3921, 3928 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T141", "type": "Temporal", "text": [ "in the past 5 years" ], "offsets": [ [ 3929, 3948 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T142", "type": "Scope", "text": [ "cannabis or alcohol" ], "offsets": [ [ 3909, 3928 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T147", "type": "Procedure", "text": [ "SCID Screen Patient Questionnaire" ], "offsets": [ [ 3363, 3396 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T148", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 12, 22 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T149", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 23, 29 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T150", "type": "Condition", "text": [ "brain lesions" ], "offsets": [ [ 31, 44 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T151", "type": "Condition", "text": [ "neurosurgery" ], "offsets": [ [ 55, 67 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T152", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 46, 54 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T153", "type": "Observation", "text": [ "personal history of" ], "offsets": [ [ 73, 92 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T154", "type": "Condition", "text": [ "seizure" ], "offsets": [ [ 93, 100 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T155", "type": "Condition", "text": [ "fainting episode" ], "offsets": [ [ 104, 120 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T156", "type": "Qualifier", "text": [ "unknown cause" ], "offsets": [ [ 124, 137 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T157", "type": "Condition", "text": [ "head trauma resulting in loss of consciousness" ], "offsets": [ [ 142, 188 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T158", "type": "Qualifier", "text": [ "lasting over 30 minutes" ], "offsets": [ [ 190, 213 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T159", "type": "Condition", "text": [ "sequela" ], "offsets": [ [ 222, 229 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T160", "type": "Measurement", "text": [ "lasting" ], "offsets": [ [ 230, 237 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T161", "type": "Value", "text": [ "longer than two days" ], "offsets": [ [ 238, 258 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T162", "type": "Scope", "text": [ "lasting over 30 minutes or with sequela lasting longer than two days" ], "offsets": [ [ 190, 258 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T163", "type": "Scope", "text": [ "seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days" ], "offsets": [ [ 93, 258 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T164", "type": "Scope", "text": [ "stroke, brain lesions, previous neurosurgery" ], "offsets": [ [ 23, 67 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T166", "type": "Procedure", "text": [ "TMS adult safety questionnaire" ], "offsets": [ [ 506, 536 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T167", "type": "Observation", "text": [ "Medical History" ], "offsets": [ [ 538, 553 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T168", "type": "Procedure", "text": [ "Screening" ], "offsets": [ [ 490, 499 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T169", "type": "Scope", "text": [ "TMS adult safety questionnaire, Medical History" ], "offsets": [ [ 506, 553 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T170", "type": "Qualifier", "text": [ "First-degree" ], "offsets": [ [ 559, 571 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T171", "type": "Observation", "text": [ "family history of" ], "offsets": [ [ 572, 589 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T172", "type": "Condition", "text": [ "neurological disorder" ], "offsets": [ [ 594, 615 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T173", "type": "Qualifier", "text": [ "potentially hereditary basis" ], "offsets": [ [ 623, 651 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T174", "type": "Condition", "text": [ "migraines" ], "offsets": [ [ 663, 672 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T175", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 674, 682 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T176", "type": "Condition", "text": [ "multiple sclerosis" ], "offsets": [ [ 687, 705 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T177", "type": "Scope", "text": [ "migraines, epilepsy, or multiple sclerosis" ], "offsets": [ [ 663, 705 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T178", "type": "Scope", "text": [ "neurological disorder with a potentially hereditary basis" ], "offsets": [ [ 594, 651 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T180", "type": "Procedure", "text": [ "Screening" ], "offsets": [ [ 1039, 1048 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T181", "type": "Procedure", "text": [ "TMS adult safety screening" ], "offsets": [ [ 1055, 1081 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T182", "type": "Observation", "text": [ "Medical History" ], "offsets": [ [ 1083, 1098 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T183", "type": "Scope", "text": [ "TMS adult safety screening, Medical History" ], "offsets": [ [ 1055, 1098 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T184", "type": "Device", "text": [ "Cardiac pacemakers" ], "offsets": [ [ 1104, 1122 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T185", "type": "Device", "text": [ "neural stimulators" ], "offsets": [ [ 1124, 1142 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T186", "type": "Device", "text": [ "implantable defibrillator" ], "offsets": [ [ 1144, 1169 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T187", "type": "Device", "text": [ "implanted medication pumps" ], "offsets": [ [ 1171, 1197 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T188", "type": "Device", "text": [ "intracardiac lines" ], "offsets": [ [ 1199, 1217 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T189", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 1222, 1227 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T190", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 1229, 1237 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T191", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 1238, 1253 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T192", "type": "Device", "text": [ "intracranial implants" ], "offsets": [ [ 1260, 1281 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T193", "type": "Device", "text": [ "aneurysm clips" ], "offsets": [ [ 1288, 1302 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T194", "type": "Device", "text": [ "shunts" ], "offsets": [ [ 1304, 1310 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T195", "type": "Device", "text": [ "stimulators" ], "offsets": [ [ 1312, 1323 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T196", "type": "Device", "text": [ "cochlear implants" ], "offsets": [ [ 1325, 1342 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T197", "type": "Device", "text": [ "electrodes" ], "offsets": [ [ 1347, 1357 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T198", "type": "Device", "text": [ "metal object within or near the head" ], "offsets": [ [ 1372, 1408 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T199", "type": "Qualifier", "text": [ "precludes MRI scanning" ], "offsets": [ [ 1414, 1436 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T200", "type": "Negation", "text": [ "precludes" ], "offsets": [ [ 1414, 1423 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T201", "type": "Procedure", "text": [ "MRI scanning" ], "offsets": [ [ 1424, 1436 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T202", "type": "Scope", "text": [ "aneurysm clips, shunts, stimulators, cochlear implants, or electrodes" ], "offsets": [ [ 1288, 1357 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T207", "type": "Procedure", "text": [ "Screening" ], "offsets": [ [ 1603, 1612 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T208", "type": "Procedure", "text": [ "TMS adult safety screening" ], "offsets": [ [ 1619, 1645 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T209", "type": "Procedure", "text": [ "MRI safety screening" ], "offsets": [ [ 1647, 1667 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T210", "type": "Observation", "text": [ "Medical History" ], "offsets": [ [ 1669, 1684 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T211", "type": "Scope", "text": [ "TMS adult safety screening, MRI safety screening, Medical History" ], "offsets": [ [ 1619, 1684 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T212", "type": "Condition", "text": [ "Noise-induced hearing loss" ], "offsets": [ [ 1690, 1716 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T213", "type": "Condition", "text": [ "tinnitus" ], "offsets": [ [ 1720, 1728 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T214", "type": "Procedure", "text": [ "Screening" ], "offsets": [ [ 1890, 1899 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T215", "type": "Procedure", "text": [ "TMS adult safety screening" ], "offsets": [ [ 1907, 1933 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T216", "type": "Qualifier", "text": [ "Current use" ], "offsets": [ [ 1939, 1950 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T217", "type": "Temporal", "text": [ "in the past 4 weeks" ], "offsets": [ [ 1960, 1979 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T218", "type": "Qualifier", "text": [ "any use" ], "offsets": [ [ 1952, 1959 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T219", "type": "Qualifier", "text": [ "chronic use" ], "offsets": [ [ 1981, 1992 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T220", "type": "Temporal", "text": [ "within 6 past six months" ], "offsets": [ [ 1993, 2017 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T221", "type": "Scope", "text": [ "any use in the past 4 weeks, chronic use within 6 past six months" ], "offsets": [ [ 1952, 2017 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T222", "type": "Temporal", "text": [ "Current use" ], "offsets": [ [ 1939, 1950 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T223", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 2026, 2046 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T224", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 2057, 2068 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T225", "type": "Qualifier", "text": [ "psychotropic", "action" ], "offsets": [ [ 2074, 2086 ], [ 2111, 2117 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T226", "type": "Qualifier", "text": [ "pro-convulsive action" ], "offsets": [ [ 2096, 2117 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T227", "type": "Scope", "text": [ "psychotropic, anti or pro-convulsive action" ], "offsets": [ [ 2074, 2117 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T228", "type": "Scope", "text": [ "investigational drug or of any medications with psychotropic, anti or pro-convulsive action" ], "offsets": [ [ 2026, 2117 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T229", "type": "Procedure", "text": [ "Screening" ], "offsets": [ [ 2253, 2262 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T230", "type": "Procedure", "text": [ "MRI safety screening questionnaire" ], "offsets": [ [ 2270, 2304 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T231", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 2270, 2273 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T232", "type": "Procedure", "text": [ "safety screening questionnaire" ], "offsets": [ [ 2274, 2304 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T233", "type": "Procedure", "text": [ "Medical history" ], "offsets": [ [ 2306, 2321 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T234", "type": "Procedure", "text": [ "Urine toxicology analyzes" ], "offsets": [ [ 2344, 2369 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T235", "type": "Qualifier", "text": [ "prescription" ], "offsets": [ [ 2403, 2415 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T236", "type": "Qualifier", "text": [ "nonprescription" ], "offsets": [ [ 2420, 2435 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T237", "type": "Drug", "text": [ "drugs" ], "offsets": [ [ 2436, 2441 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T238", "type": "Scope", "text": [ "prescription and nonprescription" ], "offsets": [ [ 2403, 2435 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T239", "type": "Scope", "text": [ "MRI safety screening questionnaire, Medical history, Medical Assessments: Urine toxicology analyzes for presence of a broad range of prescription and nonprescription drugs" ], "offsets": [ [ 2270, 2441 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T240", "type": "Observation", "text": [ "Lifetime history of" ], "offsets": [ [ 2447, 2466 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T241", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 2467, 2492 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T242", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 2494, 2507 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T243", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 2509, 2525 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T244", "type": "Condition", "text": [ "mania" ], "offsets": [ [ 2527, 2532 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T245", "type": "Condition", "text": [ "hypomania" ], "offsets": [ [ 2537, 2546 ] ], "normalized": [] }, { "id": "NCT02231892_exc_T246", "type": "Scope", "text": [ "major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania" ], "offsets": [ [ 2467, 2546 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02231892_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T38", "arg2_id": "NCT02231892_exc_T39", "normalized": [] }, { "id": "NCT02231892_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T55", "arg2_id": "NCT02231892_exc_T53", "normalized": [] }, { "id": "NCT02231892_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T52", "arg2_id": "NCT02231892_exc_T54", "normalized": [] }, { "id": "NCT02231892_exc_R4", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T57", "arg2_id": "NCT02231892_exc_T56", "normalized": [] }, { "id": "NCT02231892_exc_R5", "type": "Has_index", "arg1_id": "NCT02231892_exc_T58", "arg2_id": "NCT02231892_exc_T59", "normalized": [] }, { "id": "NCT02231892_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T57", "arg2_id": "NCT02231892_exc_T58", "normalized": [] }, { "id": "NCT02231892_exc_R7", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T57", "arg2_id": "NCT02231892_exc_T62", "normalized": [] }, { "id": "NCT02231892_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T70", "arg2_id": "NCT02231892_exc_T71", "normalized": [] }, { "id": "NCT02231892_exc_R9", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T70", "arg2_id": "NCT02231892_exc_T73", "normalized": [] }, { "id": "NCT02231892_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T87", "arg2_id": "NCT02231892_exc_T88", "normalized": [] }, { "id": "NCT02231892_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T86", "arg2_id": "NCT02231892_exc_T87", "normalized": [] }, { "id": "NCT02231892_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T91", "arg2_id": "NCT02231892_exc_T90", "normalized": [] }, { "id": "NCT02231892_exc_R13", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T100", "arg2_id": "NCT02231892_exc_T101", "normalized": [] }, { "id": "NCT02231892_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T105", "arg2_id": "NCT02231892_exc_T106", "normalized": [] }, { "id": "NCT02231892_exc_R15", "type": "Has_value", "arg1_id": "NCT02231892_exc_T103", "arg2_id": "NCT02231892_exc_T104", "normalized": [] }, { "id": "NCT02231892_exc_R16", "type": "AND", "arg1_id": "NCT02231892_exc_T103", "arg2_id": "NCT02231892_exc_T105", "normalized": [] }, { "id": "NCT02231892_exc_R17", "type": "AND", "arg1_id": "NCT02231892_exc_T99", "arg2_id": "NCT02231892_exc_T100", "normalized": [] }, { "id": "NCT02231892_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T99", "arg2_id": "NCT02231892_exc_T98", "normalized": [] }, { "id": "NCT02231892_exc_R19", "type": "AND", "arg1_id": "NCT02231892_exc_T97", "arg2_id": "NCT02231892_exc_T99", "normalized": [] }, { "id": "NCT02231892_exc_R20", "type": "Has_value", "arg1_id": "NCT02231892_exc_T97", "arg2_id": "NCT02231892_exc_T112", "normalized": [] }, { "id": "NCT02231892_exc_R21", "type": "Has_value", "arg1_id": "NCT02231892_exc_T125", "arg2_id": "NCT02231892_exc_T126", "normalized": [] }, { "id": "NCT02231892_exc_R22", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T129", "arg2_id": "NCT02231892_exc_T132", "normalized": [] }, { "id": "NCT02231892_exc_R23", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T130", "arg2_id": "NCT02231892_exc_T132", "normalized": [] }, { "id": "NCT02231892_exc_R24", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T131", "arg2_id": "NCT02231892_exc_T132", "normalized": [] }, { "id": "NCT02231892_exc_R25", "type": "Has_value", "arg1_id": "NCT02231892_exc_T134", "arg2_id": "NCT02231892_exc_T135", "normalized": [] }, { "id": "NCT02231892_exc_R26", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T128", "arg2_id": "NCT02231892_exc_T136", "normalized": [] }, { "id": "NCT02231892_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T128", "arg2_id": "NCT02231892_exc_T127", "normalized": [] }, { "id": "NCT02231892_exc_R28", "type": "AND", "arg1_id": "NCT02231892_exc_T125", "arg2_id": "NCT02231892_exc_T128", "normalized": [] }, { "id": "NCT02231892_exc_R29", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T128", "arg2_id": "NCT02231892_exc_T133", "normalized": [] }, { "id": "NCT02231892_exc_R30", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T138", "arg2_id": "NCT02231892_exc_T142", "normalized": [] }, { "id": "NCT02231892_exc_R31", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T138", "arg2_id": "NCT02231892_exc_T141", "normalized": [] }, { "id": "NCT02231892_exc_R32", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T138", "arg2_id": "NCT02231892_exc_T137", "normalized": [] }, { "id": "NCT02231892_exc_R33", "type": "AND", "arg1_id": "NCT02231892_exc_T134", "arg2_id": "NCT02231892_exc_T138", "normalized": [] }, { "id": "NCT02231892_exc_R34", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T151", "arg2_id": "NCT02231892_exc_T152", "normalized": [] }, { "id": "NCT02231892_exc_R35", "type": "Has_value", "arg1_id": "NCT02231892_exc_T160", "arg2_id": "NCT02231892_exc_T161", "normalized": [] }, { "id": "NCT02231892_exc_R36", "type": "AND", "arg1_id": "NCT02231892_exc_T159", "arg2_id": "NCT02231892_exc_T160", "normalized": [] }, { "id": "NCT02231892_exc_R37", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T157", "arg2_id": "NCT02231892_exc_T162", "normalized": [] }, { "id": "NCT02231892_exc_R38", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T155", "arg2_id": "NCT02231892_exc_T156", "normalized": [] }, { "id": "NCT02231892_exc_R39", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T163", "arg2_id": "NCT02231892_exc_T153", "normalized": [] }, { "id": "NCT02231892_exc_R40", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T164", "arg2_id": "NCT02231892_exc_T148", "normalized": [] }, { "id": "NCT02231892_exc_R41", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T168", "arg2_id": "NCT02231892_exc_T169", "normalized": [] }, { "id": "NCT02231892_exc_R42", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T172", "arg2_id": "NCT02231892_exc_T173", "normalized": [] }, { "id": "NCT02231892_exc_R43", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T178", "arg2_id": "NCT02231892_exc_T177", "normalized": [] }, { "id": "NCT02231892_exc_R45", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T171", "arg2_id": "NCT02231892_exc_T170", "normalized": [] }, { "id": "NCT02231892_exc_R46", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T180", "arg2_id": "NCT02231892_exc_T183", "normalized": [] }, { "id": "NCT02231892_exc_R47", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T191", "arg2_id": "NCT02231892_exc_T190", "normalized": [] }, { "id": "NCT02231892_exc_R48", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T191", "arg2_id": "NCT02231892_exc_T189", "normalized": [] }, { "id": "NCT02231892_exc_R49", "type": "Has_negation", "arg1_id": "NCT02231892_exc_T201", "arg2_id": "NCT02231892_exc_T200", "normalized": [] }, { "id": "NCT02231892_exc_R51", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T198", "arg2_id": "NCT02231892_exc_T199", "normalized": [] }, { "id": "NCT02231892_exc_R52", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T192", "arg2_id": "NCT02231892_exc_T202", "normalized": [] }, { "id": "NCT02231892_exc_R53", "type": "AND", "arg1_id": "NCT02231892_exc_T191", "arg2_id": "NCT02231892_exc_T192", "normalized": [] }, { "id": "NCT02231892_exc_R54", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T207", "arg2_id": "NCT02231892_exc_T211", "normalized": [] }, { "id": "NCT02231892_exc_R55", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T214", "arg2_id": "NCT02231892_exc_T215", "normalized": [] }, { "id": "NCT02231892_exc_R56", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T218", "arg2_id": "NCT02231892_exc_T217", "normalized": [] }, { "id": "NCT02231892_exc_R57", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T219", "arg2_id": "NCT02231892_exc_T220", "normalized": [] }, { "id": "NCT02231892_exc_R59", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T216", "arg2_id": "NCT02231892_exc_T221", "normalized": [] }, { "id": "NCT02231892_exc_R60", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T224", "arg2_id": "NCT02231892_exc_T227", "normalized": [] }, { "id": "NCT02231892_exc_R61", "type": "Has_qualifier", "arg1_id": "NCT02231892_exc_T228", "arg2_id": "NCT02231892_exc_T216", "normalized": [] }, { "id": "NCT02231892_exc_R62", "type": "AND", "arg1_id": "NCT02231892_exc_T232", "arg2_id": "NCT02231892_exc_T231", "normalized": [] }, { "id": "NCT02231892_exc_R64", "type": "Has_scope", "arg1_id": "NCT02231892_exc_T237", "arg2_id": "NCT02231892_exc_T238", "normalized": [] }, { "id": "NCT02231892_exc_R65", "type": "AND", "arg1_id": "NCT02231892_exc_T234", "arg2_id": "NCT02231892_exc_T237", "normalized": [] }, { "id": "NCT02231892_exc_R66", "type": "Subsumes", "arg1_id": "NCT02231892_exc_T229", "arg2_id": "NCT02231892_exc_T239", "normalized": [] }, { "id": "NCT02231892_exc_R67", "type": "Has_temporal", "arg1_id": "NCT02231892_exc_T246", "arg2_id": "NCT02231892_exc_T240", "normalized": [] } ]

[ { "id": "NCT02231892_inc_text", "type": "inclusion", "text": [ "Subjects must: \n1. Be able to give valid informed consent \n2. Be 18 55 years of age. \n1. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. \n2. Screening tool: History. Government-issued forms of identification (e.g. driver s license, birth certificate) will be required when participant appears to be out of age range. \n3. Be in good health. \n1. Justification: Many illnesses may alter neural functioning as well as fMRI signals. \n2. Screening tools: Medical Assessment, Medical History and Physical Examination. Medical assessments include: Vital Signs, EKG, oral HIV test, height/weight measurements, urinalysis and blood sample. Tests on the blood sample include CBC, complete metabolic profile, TSH, ESR, STS and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Cholesterol >250 mg/dl, Hemoglobin < 10.5 g/dl, WBC < 2400/microl, LFTs > 3Xnormal, HCG positive, Casual serum glucose > 200 mg/dl, Urine protein > 1+. The MAI will retain discretion to exclude at less extreme values, depending on the clinical presentation. (Serum glucose over 140 mg/dl will be followed up with a fasting serum glucose assessment. Those with fasting glucose below 100 mg/dl may be considered for the protocol. Others will be rejected and referred for work-up.) MAI will make the final judgment on any questionable lab results. \n4. Right-handed. \n1. Justification: Using right-handed individuals will reduce variability in BOLD MRI data. \n2. Screening tool: Edinburgh Handedness Inventory. \n5. Estimated IQ greater than or equal to 85 \n1. Justification: Subjects must be able to perform a cognitively challenging task to a high standard. \n2. Screening tool: Wechsler Abbreviated Scale of Intelligence. \n" ], "offsets": [ [ 0, 2000 ] ] } ]

[ { "id": "NCT02231892_inc_T18", "type": "Person", "text": [ "age" ], "offsets": [ [ 80, 83 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T19", "type": "Value", "text": [ "18 55 years" ], "offsets": [ [ 65, 76 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T24", "type": "Observation", "text": [ "History" ], "offsets": [ [ 374, 381 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T26", "type": "Condition", "text": [ "good health" ], "offsets": [ [ 544, 555 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T29", "type": "Procedure", "text": [ "Medical Assessment" ], "offsets": [ [ 666, 684 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T30", "type": "Observation", "text": [ "Medical History" ], "offsets": [ [ 686, 701 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T31", "type": "Procedure", "text": [ "Physical Examination" ], "offsets": [ [ 706, 726 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T32", "type": "Measurement", "text": [ "Vital Signs" ], "offsets": [ [ 757, 768 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T33", "type": "Procedure", "text": [ "EKG" ], "offsets": [ [ 770, 773 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T34", "type": "Procedure", "text": [ "oral HIV test" ], "offsets": [ [ 775, 788 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T35", "type": "Measurement", "text": [ "height", "measurement" ], "offsets": [ [ 790, 796 ], [ 804, 815 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T36", "type": "Measurement", "text": [ "weight measurement" ], "offsets": [ [ 797, 815 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T37", "type": "Procedure", "text": [ "urinalysis" ], "offsets": [ [ 818, 828 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T38", "type": "Procedure", "text": [ "blood sample" ], "offsets": [ [ 833, 845 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T39", "type": "Procedure", "text": [ "CBC" ], "offsets": [ [ 881, 884 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T40", "type": "Procedure", "text": [ "complete metabolic profile" ], "offsets": [ [ 886, 912 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T41", "type": "Procedure", "text": [ "TSH" ], "offsets": [ [ 914, 917 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T42", "type": "Procedure", "text": [ "ESR" ], "offsets": [ [ 919, 922 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T43", "type": "Procedure", "text": [ "STS" ], "offsets": [ [ 924, 927 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T44", "type": "Procedure", "text": [ "HIV" ], "offsets": [ [ 932, 935 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T45", "type": "Measurement", "text": [ "salivary test for HIV" ], "offsets": [ [ 969, 990 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T46", "type": "Value", "text": [ "positive" ], "offsets": [ [ 960, 968 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T48", "type": "Measurement", "text": [ "Cholesterol" ], "offsets": [ [ 1080, 1091 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T49", "type": "Value", "text": [ ">250 mg/dl" ], "offsets": [ [ 1092, 1102 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T50", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 1104, 1114 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T51", "type": "Value", "text": [ "< 10.5 g/dl" ], "offsets": [ [ 1115, 1126 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T52", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 1128, 1131 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T53", "type": "Value", "text": [ "< 2400/microl" ], "offsets": [ [ 1132, 1145 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T54", "type": "Measurement", "text": [ "LFTs" ], "offsets": [ [ 1147, 1151 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T55", "type": "Value", "text": [ "> 3Xnormal" ], "offsets": [ [ 1152, 1162 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T56", "type": "Measurement", "text": [ "HCG" ], "offsets": [ [ 1164, 1167 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T57", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1168, 1176 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T58", "type": "Measurement", "text": [ "serum glucose" ], "offsets": [ [ 1185, 1198 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T59", "type": "Value", "text": [ "> 200 mg/dl" ], "offsets": [ [ 1199, 1210 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T60", "type": "Measurement", "text": [ "Urine protein" ], "offsets": [ [ 1212, 1225 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T61", "type": "Value", "text": [ "> 1+" ], "offsets": [ [ 1226, 1230 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T62", "type": "Negation", "text": [ "disqualify" ], "offsets": [ [ 1056, 1066 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T63", "type": "Scope", "text": [ "Cholesterol >250 mg/dl, Hemoglobin < 10.5 g/dl, WBC < 2400/microl, LFTs > 3Xnormal, HCG positive, Casual serum glucose > 200 mg/dl, Urine protein > 1+" ], "offsets": [ [ 1080, 1230 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T66", "type": "Measurement", "text": [ "Serum glucose" ], "offsets": [ [ 1339, 1352 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T67", "type": "Value", "text": [ "over 140 mg/dl" ], "offsets": [ [ 1353, 1367 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T68", "type": "Procedure", "text": [ "fasting serum glucose assessment" ], "offsets": [ [ 1395, 1427 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T69", "type": "Scope", "text": [ "Serum glucose over 140 mg/dl" ], "offsets": [ [ 1339, 1367 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T70", "type": "Condition", "text": [ "Right-handed" ], "offsets": [ [ 1629, 1641 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T73", "type": "Procedure", "text": [ "Edinburgh Handedness Inventory" ], "offsets": [ [ 1755, 1785 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T74", "type": "Measurement", "text": [ "Estimated IQ" ], "offsets": [ [ 1791, 1803 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T75", "type": "Value", "text": [ "greater than or equal to 85" ], "offsets": [ [ 1804, 1831 ] ], "normalized": [] }, { "id": "NCT02231892_inc_T77", "type": "Procedure", "text": [ "Wechsler Abbreviated Scale of Intelligence" ], "offsets": [ [ 1955, 1997 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02231892_inc_R1", "type": "Has_value", "arg1_id": "NCT02231892_inc_T18", "arg2_id": "NCT02231892_inc_T19", "normalized": [] }, { "id": "NCT02231892_inc_R2", "type": "Has_value", "arg1_id": "NCT02231892_inc_T45", "arg2_id": "NCT02231892_inc_T46", "normalized": [] }, { "id": "NCT02231892_inc_R3", "type": "Has_value", "arg1_id": "NCT02231892_inc_T48", "arg2_id": "NCT02231892_inc_T49", "normalized": [] }, { "id": "NCT02231892_inc_R4", "type": "Has_value", "arg1_id": "NCT02231892_inc_T50", "arg2_id": "NCT02231892_inc_T51", "normalized": [] }, { "id": "NCT02231892_inc_R5", "type": "Has_value", "arg1_id": "NCT02231892_inc_T52", "arg2_id": "NCT02231892_inc_T53", "normalized": [] }, { "id": "NCT02231892_inc_R6", "type": "Has_value", "arg1_id": "NCT02231892_inc_T54", "arg2_id": "NCT02231892_inc_T55", "normalized": [] }, { "id": "NCT02231892_inc_R7", "type": "Has_value", "arg1_id": "NCT02231892_inc_T56", "arg2_id": "NCT02231892_inc_T57", "normalized": [] }, { "id": "NCT02231892_inc_R8", "type": "Has_value", "arg1_id": "NCT02231892_inc_T58", "arg2_id": "NCT02231892_inc_T59", "normalized": [] }, { "id": "NCT02231892_inc_R9", "type": "Has_value", "arg1_id": "NCT02231892_inc_T60", "arg2_id": "NCT02231892_inc_T61", "normalized": [] }, { "id": "NCT02231892_inc_R10", "type": "Has_negation", "arg1_id": "NCT02231892_inc_T63", "arg2_id": "NCT02231892_inc_T62", "normalized": [] }, { "id": "NCT02231892_inc_R11", "type": "Has_value", "arg1_id": "NCT02231892_inc_T66", "arg2_id": "NCT02231892_inc_T67", "normalized": [] }, { "id": "NCT02231892_inc_R12", "type": "AND", "arg1_id": "NCT02231892_inc_T69", "arg2_id": "NCT02231892_inc_T68", "normalized": [] }, { "id": "NCT02231892_inc_R13", "type": "Has_value", "arg1_id": "NCT02231892_inc_T74", "arg2_id": "NCT02231892_inc_T75", "normalized": [] } ]

[ { "id": "NCT02242188_exc_text", "type": "exclusion", "text": [ "preterm delivery (<37 weeks of gestation)\nbirth weight < 2500 g\nmultiple pregnancy\nmajor illness or congenital anomaly\nbeing <50% breastfed at the time of inclusion\nfood allergy\nanaemia (Hb <105 g/L [10.5 g/dL]) at inclusion, lack of informed consent\n" ], "offsets": [ [ 0, 251 ] ] } ]

[ { "id": "NCT02242188_exc_T1", "type": "Condition", "text": [ "preterm delivery" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T2", "type": "Value", "text": [ "<37 weeks" ], "offsets": [ [ 18, 27 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T3", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 31, 40 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T4", "type": "Scope", "text": [ "<37 weeks of gestation" ], "offsets": [ [ 18, 40 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T5", "type": "Measurement", "text": [ "birth weight" ], "offsets": [ [ 42, 54 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T6", "type": "Value", "text": [ "< 2500 g" ], "offsets": [ [ 55, 63 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T7", "type": "Condition", "text": [ "multiple pregnancy" ], "offsets": [ [ 64, 82 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T8", "type": "Condition", "text": [ "major illness" ], "offsets": [ [ 83, 96 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T9", "type": "Condition", "text": [ "congenital anomaly" ], "offsets": [ [ 100, 118 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T10", "type": "Multiplier", "text": [ "<50%" ], "offsets": [ [ 125, 129 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T11", "type": "Observation", "text": [ "breastfed" ], "offsets": [ [ 130, 139 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T12", "type": "Temporal", "text": [ "at the time of inclusion" ], "offsets": [ [ 140, 164 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T13", "type": "Condition", "text": [ "food allergy" ], "offsets": [ [ 165, 177 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T14", "type": "Condition", "text": [ "anaemia" ], "offsets": [ [ 178, 185 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T15", "type": "Measurement", "text": [ "Hb" ], "offsets": [ [ 187, 189 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T16", "type": "Value", "text": [ "<105 g/L" ], "offsets": [ [ 190, 198 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T17", "type": "Value", "text": [ "10.5 g/dL" ], "offsets": [ [ 200, 209 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T18", "type": "Scope", "text": [ "Hb <105 g/L [10.5 g/dL]" ], "offsets": [ [ 187, 210 ] ], "normalized": [] }, { "id": "NCT02242188_exc_T19", "type": "Temporal", "text": [ "at inclusion" ], "offsets": [ [ 212, 224 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02242188_exc_R1", "type": "Has_value", "arg1_id": "NCT02242188_exc_T3", "arg2_id": "NCT02242188_exc_T2", "normalized": [] }, { "id": "NCT02242188_exc_R2", "type": "Subsumes", "arg1_id": "NCT02242188_exc_T1", "arg2_id": "NCT02242188_exc_T4", "normalized": [] }, { "id": "NCT02242188_exc_R3", "type": "Has_value", "arg1_id": "NCT02242188_exc_T5", "arg2_id": "NCT02242188_exc_T6", "normalized": [] }, { "id": "NCT02242188_exc_R4", "type": "Has_multiplier", "arg1_id": "NCT02242188_exc_T11", "arg2_id": "NCT02242188_exc_T10", "normalized": [] }, { "id": "NCT02242188_exc_R5", "type": "Subsumes", "arg1_id": "NCT02242188_exc_T11", "arg2_id": "NCT02242188_exc_T12", "normalized": [] }, { "id": "NCT02242188_exc_R6", "type": "Subsumes", "arg1_id": "NCT02242188_exc_T16", "arg2_id": "NCT02242188_exc_T17", "normalized": [] }, { "id": "NCT02242188_exc_R7", "type": "Has_value", "arg1_id": "NCT02242188_exc_T15", "arg2_id": "NCT02242188_exc_T16", "normalized": [] }, { "id": "NCT02242188_exc_R8", "type": "Subsumes", "arg1_id": "NCT02242188_exc_T14", "arg2_id": "NCT02242188_exc_T18", "normalized": [] }, { "id": "NCT02242188_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02242188_exc_T14", "arg2_id": "NCT02242188_exc_T19", "normalized": [] } ]

[ { "id": "NCT02242188_inc_text", "type": "inclusion", "text": [ "Term singleton infants (>37 weeks gestational age)\nBirth weight > 2500g\nHealthy at inclusion\nBreastfed exclusively or predominantly (>50% meals) at inclusion\nNo previous iron supplementation\nNo previous blood transfusion\nInformed consent given\n" ], "offsets": [ [ 0, 244 ] ] } ]

[ { "id": "NCT02242188_inc_T1", "type": "Condition", "text": [ "singleton infants" ], "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T2", "type": "Condition", "text": [ "Term", "infants" ], "offsets": [ [ 0, 4 ], [ 15, 22 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T3", "type": "Value", "text": [ ">37 weeks" ], "offsets": [ [ 24, 33 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T4", "type": "Measurement", "text": [ "gestational age" ], "offsets": [ [ 34, 49 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T5", "type": "Scope", "text": [ "Term singleton infants" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T6", "type": "Scope", "text": [ ">37 weeks gestational age" ], "offsets": [ [ 24, 49 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T7", "type": "Measurement", "text": [ "Birth weight" ], "offsets": [ [ 51, 63 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T8", "type": "Value", "text": [ "> 2500g" ], "offsets": [ [ 64, 71 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T9", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 72, 79 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T10", "type": "Temporal", "text": [ "at inclusion" ], "offsets": [ [ 80, 92 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T11", "type": "Condition", "text": [ "Breastfed" ], "offsets": [ [ 93, 102 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T12", "type": "Qualifier", "text": [ "exclusively" ], "offsets": [ [ 103, 114 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T13", "type": "Qualifier", "text": [ "predominantly" ], "offsets": [ [ 118, 131 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T14", "type": "Multiplier", "text": [ ">50% meals" ], "offsets": [ [ 133, 143 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T15", "type": "Temporal", "text": [ "at inclusion" ], "offsets": [ [ 145, 157 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T16", "type": "Scope", "text": [ "exclusively or predominantly" ], "offsets": [ [ 103, 131 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T17", "type": "Negation", "text": [ "No" ], "offsets": [ [ 158, 160 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T18", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 161, 169 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T19", "type": "Procedure", "text": [ "iron supplementation" ], "offsets": [ [ 170, 190 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T20", "type": "Negation", "text": [ "No" ], "offsets": [ [ 191, 193 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T21", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 194, 202 ] ], "normalized": [] }, { "id": "NCT02242188_inc_T22", "type": "Procedure", "text": [ "blood transfusion" ], "offsets": [ [ 203, 220 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02242188_inc_R1", "type": "Has_value", "arg1_id": "NCT02242188_inc_T4", "arg2_id": "NCT02242188_inc_T3", "normalized": [] }, { "id": "NCT02242188_inc_R2", "type": "Has_scope", "arg1_id": "NCT02242188_inc_T5", "arg2_id": "NCT02242188_inc_T6", "normalized": [] }, { "id": "NCT02242188_inc_R3", "type": "Has_value", "arg1_id": "NCT02242188_inc_T7", "arg2_id": "NCT02242188_inc_T8", "normalized": [] }, { "id": "NCT02242188_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02242188_inc_T9", "arg2_id": "NCT02242188_inc_T10", "normalized": [] }, { "id": "NCT02242188_inc_R5", "type": "Subsumes", "arg1_id": "NCT02242188_inc_T16", "arg2_id": "NCT02242188_inc_T14", "normalized": [] }, { "id": "NCT02242188_inc_R6", "type": "Has_scope", "arg1_id": "NCT02242188_inc_T11", "arg2_id": "NCT02242188_inc_T16", "normalized": [] }, { "id": "NCT02242188_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02242188_inc_T11", "arg2_id": "NCT02242188_inc_T15", "normalized": [] }, { "id": "NCT02242188_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02242188_inc_T19", "arg2_id": "NCT02242188_inc_T18", "normalized": [] }, { "id": "NCT02242188_inc_R9", "type": "Has_negation", "arg1_id": "NCT02242188_inc_T19", "arg2_id": "NCT02242188_inc_T17", "normalized": [] }, { "id": "NCT02242188_inc_R10", "type": "Has_temporal", "arg1_id": "NCT02242188_inc_T22", "arg2_id": "NCT02242188_inc_T21", "normalized": [] }, { "id": "NCT02242188_inc_R11", "type": "Has_negation", "arg1_id": "NCT02242188_inc_T22", "arg2_id": "NCT02242188_inc_T20", "normalized": [] } ]

[ { "id": "NCT02243553_exc_text", "type": "exclusion", "text": [ "1. History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation \n2. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance \n3. History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders \n4. Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed) \n5. Clinically relevant laboratory abnormalities (e.g. Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2) \n6. History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease \n7. History of alcohol abuse or use of any illicit drugs \n8. Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study \n9. Use of tobacco products and/or history of smoking within the past 2 months \n10. Pregnant or breast feeding \n11. Sexually active women of childbearing age who do not use an acceptable barrier method of birth control \n12. Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients \n13. Concomitant treatment with other experimental compounds \n14. Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity \n15. Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity \n16. Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges \n17. Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin) \n18. Concomitant administration of oral contraceptives (may be included with 7-day washout period) \n19. Concomitant administration of any herbal medications \n20. Inadequate venous access \n21. Renal or hepatic insufficiency \n22. Clinically unacceptable result at the screening physical examination \n23. Use of investigational medications within 30 days before study entry \n24. HIV-positive \n25. Body Mass Index (BMI) > 30 kg/m² \n \n" ], "offsets": [ [ 0, 2838 ] ] } ]

[ { "id": "NCT02243553_exc_T26", "type": "Measurement", "text": [ "Body Mass Index (BMI)" ], "offsets": [ [ 2793, 2814 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T27", "type": "Value", "text": [ "> 30 kg/m²" ], "offsets": [ [ 2815, 2825 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T28", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 2775, 2778 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T29", "type": "Value", "text": [ "positive" ], "offsets": [ [ 2779, 2787 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T30", "type": "Drug", "text": [ "investigational medications" ], "offsets": [ [ 2708, 2735 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T32", "type": "Temporal", "text": [ "within 30 days before study entry" ], "offsets": [ [ 2736, 2769 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T33", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 2758, 2769 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T34", "type": "Condition", "text": [ "Clinically unacceptable result" ], "offsets": [ [ 2627, 2657 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T35", "type": "Temporal", "text": [ "at the screening physical examination" ], "offsets": [ [ 2658, 2695 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T36", "type": "Reference_point", "text": [ "the screening physical examination" ], "offsets": [ [ 2661, 2695 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T37", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 2675, 2695 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T38", "type": "Qualifier", "text": [ "Clinically unacceptable" ], "offsets": [ [ 2627, 2650 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T41", "type": "Condition", "text": [ "hepatic insufficiency" ], "offsets": [ [ 2600, 2621 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T42", "type": "Condition", "text": [ "Renal", "insufficiency" ], "offsets": [ [ 2591, 2596 ], [ 2608, 2621 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T43", "type": "Device", "text": [ "venous access" ], "offsets": [ [ 2572, 2585 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T44", "type": "Qualifier", "text": [ "Inadequate" ], "offsets": [ [ 2561, 2571 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T45", "type": "Drug", "text": [ "herbal medications" ], "offsets": [ [ 2537, 2555 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T46", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 2503, 2514 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T47", "type": "Drug", "text": [ "oral contraceptives" ], "offsets": [ [ 2434, 2453 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T48", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 2404, 2415 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T50", "type": "Drug", "text": [ "drug that could affect bleeding" ], "offsets": [ [ 2276, 2307 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T52", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 2315, 2322 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T53", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 2324, 2335 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T54", "type": "Drug", "text": [ "ticlopidine" ], "offsets": [ [ 2337, 2348 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T55", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 2350, 2358 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T56", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 2360, 2367 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T57", "type": "Drug", "text": [ "low-molecular weight heparin" ], "offsets": [ [ 2369, 2397 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T58", "type": "Scope", "text": [ "aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin" ], "offsets": [ [ 2315, 2397 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T59", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 2104, 2115 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T60", "type": "Drug", "text": [ "food product known to alter P450 enzyme", "activity" ], "offsets": [ [ 2138, 2177 ], [ 2186, 2194 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T61", "type": "Drug", "text": [ "food product known to alter", "P-gp activity" ], "offsets": [ [ 2138, 2165 ], [ 2181, 2194 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T62", "type": "Drug", "text": [ "grapefruit juice" ], "offsets": [ [ 2203, 2219 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T63", "type": "Drug", "text": [ "Seville oranges" ], "offsets": [ [ 2221, 2236 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T64", "type": "Scope", "text": [ "grapefruit juice, Seville oranges" ], "offsets": [ [ 2203, 2236 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T65", "type": "Scope", "text": [ "food product known to alter P450 enzyme or P-gp activity" ], "offsets": [ [ 2138, 2194 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T66", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 1871, 1882 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T67", "type": "Drug", "text": [ "medications known to be highly dependent on P450", "for clearance" ], "offsets": [ [ 1938, 1986 ], [ 1995, 2008 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T68", "type": "Drug", "text": [ "medications known to be highly dependent on", "P-gp for clearance" ], "offsets": [ [ 1938, 1981 ], [ 1990, 2008 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T69", "type": "Measurement", "text": [ "plasma concentrations" ], "offsets": [ [ 2028, 2049 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T70", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 2019, 2027 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T71", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 2090, 2098 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T72", "type": "Scope", "text": [ "medications known to be highly dependent on P450 or P-gp for clearance" ], "offsets": [ [ 1938, 2008 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T73", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2082, 2089 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T74", "type": "Scope", "text": [ "elevated plasma concentrations" ], "offsets": [ [ 2019, 2049 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T75", "type": "Drug", "text": [ "medications known to alter P450 enzyme", "activity" ], "offsets": [ [ 1810, 1848 ], [ 1857, 1865 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T76", "type": "Drug", "text": [ "medications known to alter", "P-gp activity" ], "offsets": [ [ 1810, 1836 ], [ 1852, 1865 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T80", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 1743, 1754 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T81", "type": "Scope", "text": [ "medications known to alter P450 enzyme or P-gp activity" ], "offsets": [ [ 1810, 1865 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T82", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 1682, 1693 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T83", "type": "Drug", "text": [ "experimental compounds" ], "offsets": [ [ 1715, 1737 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T84", "type": "Drug", "text": [ "caffeine" ], "offsets": [ [ 1563, 1571 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T85", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 1573, 1581 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T86", "type": "Drug", "text": [ "vitamin K" ], "offsets": [ [ 1583, 1592 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T87", "type": "Drug", "text": [ "omeprazole" ], "offsets": [ [ 1594, 1604 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T88", "type": "Drug", "text": [ "dextromethorphan" ], "offsets": [ [ 1606, 1622 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T89", "type": "Drug", "text": [ "midazolam" ], "offsets": [ [ 1624, 1633 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T90", "type": "Drug", "text": [ "tipranavir" ], "offsets": [ [ 1635, 1645 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T91", "type": "Drug", "text": [ "ritonavir" ], "offsets": [ [ 1647, 1656 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T92", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 1543, 1559 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T93", "type": "Scope", "text": [ "caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir" ], "offsets": [ [ 1563, 1656 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T94", "type": "Person", "text": [ "women" ], "offsets": [ [ 1451, 1456 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T95", "type": "Condition", "text": [ "Sexually active" ], "offsets": [ [ 1435, 1450 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T96", "type": "Value", "text": [ "childbearing" ], "offsets": [ [ 1460, 1472 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T97", "type": "Person", "text": [ "age" ], "offsets": [ [ 1473, 1476 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T98", "type": "Device", "text": [ "barrier method of birth control" ], "offsets": [ [ 1506, 1537 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T99", "type": "Qualifier", "text": [ "acceptable" ], "offsets": [ [ 1495, 1505 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T100", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1484, 1487 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T101", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1403, 1411 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T102", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 1415, 1429 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T103", "type": "Drug", "text": [ "tobacco products" ], "offsets": [ [ 1330, 1346 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T105", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 1365, 1372 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T106", "type": "Temporal", "text": [ "within the past 2 months" ], "offsets": [ [ 1373, 1397 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T104", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1354, 1361 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T108", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 1171, 1184 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T109", "type": "Condition", "text": [ "use of", "illicit drugs" ], "offsets": [ [ 1188, 1194 ], [ 1199, 1212 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T110", "type": "Condition", "text": [ "collagen disease" ], "offsets": [ [ 1139, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T111", "type": "Condition", "text": [ "vascular", "disease" ], "offsets": [ [ 1127, 1135 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T112", "type": "Condition", "text": [ "hematological", "disease" ], "offsets": [ [ 1112, 1125 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T113", "type": "Condition", "text": [ "gastrointestinal", "disease" ], "offsets": [ [ 1094, 1110 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T114", "type": "Condition", "text": [ "immunological", "disease" ], "offsets": [ [ 1079, 1092 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T115", "type": "Condition", "text": [ "endocrine", "disease" ], "offsets": [ [ 1068, 1077 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T116", "type": "Condition", "text": [ "pulmonary", "disease" ], "offsets": [ [ 1057, 1066 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T117", "type": "Condition", "text": [ "cardiac", "disease" ], "offsets": [ [ 1048, 1055 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T118", "type": "Condition", "text": [ "hepatic", "disease" ], "offsets": [ [ 1039, 1046 ], [ 1148, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T120", "type": "Scope", "text": [ "hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease" ], "offsets": [ [ 1039, 1155 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T121", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1016, 1038 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T122", "type": "Observation", "text": [ "History" ], "offsets": [ [ 993, 1000 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T123", "type": "Qualifier", "text": [ "Clinically relevant" ], "offsets": [ [ 737, 756 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T125", "type": "Condition", "text": [ "laboratory abnormalities" ], "offsets": [ [ 757, 781 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T126", "type": "Measurement", "text": [ "Hgb" ], "offsets": [ [ 788, 791 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T127", "type": "Value", "text": [ "<11g/dL" ], "offsets": [ [ 791, 798 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T128", "type": "Measurement", "text": [ "Hct" ], "offsets": [ [ 800, 803 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T129", "type": "Measurement", "text": [ "total cholesterol" ], "offsets": [ [ 812, 829 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T130", "type": "Measurement", "text": [ "triglycerides" ], "offsets": [ [ 841, 854 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T131", "type": "Measurement", "text": [ "fasting glucose" ], "offsets": [ [ 866, 881 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T132", "type": "Measurement", "text": [ "liver function tests" ], "offsets": [ [ 893, 913 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T133", "type": "Value", "text": [ ">2.5x upper limit of normal" ], "offsets": [ [ 914, 941 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T134", "type": "Measurement", "text": [ "international normalized ratio" ], "offsets": [ [ 952, 982 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T135", "type": "Value", "text": [ ">1.2" ], "offsets": [ [ 983, 987 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T136", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 943, 951 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T137", "type": "Value", "text": [ ">130mg/dL" ], "offsets": [ [ 882, 891 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T138", "type": "Value", "text": [ ">500mg/dL" ], "offsets": [ [ 855, 864 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T139", "type": "Value", "text": [ ">240mg/dL" ], "offsets": [ [ 830, 839 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T140", "type": "Value", "text": [ "<30g/dL" ], "offsets": [ [ 803, 810 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T141", "type": "Scope", "text": [ "Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2" ], "offsets": [ [ 788, 987 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T142", "type": "Scope", "text": [ "Clinically relevant laboratory abnormalities" ], "offsets": [ [ 737, 781 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T143", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 650, 663 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T144", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 641, 649 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T147", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 419, 437 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T150", "type": "Condition", "text": [ "hormonal disorders" ], "offsets": [ [ 612, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T151", "type": "Condition", "text": [ "oncological", "disorders" ], "offsets": [ [ 597, 608 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T152", "type": "Condition", "text": [ "neurological", "disorders" ], "offsets": [ [ 583, 595 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T153", "type": "Condition", "text": [ "psychiatric", "disorders" ], "offsets": [ [ 570, 581 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T154", "type": "Condition", "text": [ "hematological", "disorders" ], "offsets": [ [ 555, 568 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T155", "type": "Condition", "text": [ "immunologic", "disorders" ], "offsets": [ [ 542, 553 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T156", "type": "Condition", "text": [ "metabolic", "disorders" ], "offsets": [ [ 531, 540 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T157", "type": "Condition", "text": [ "cardiovascular", "disorders" ], "offsets": [ [ 515, 529 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T158", "type": "Condition", "text": [ "respiratory", "disorders" ], "offsets": [ [ 502, 513 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T159", "type": "Condition", "text": [ "renal", "disorders" ], "offsets": [ [ 495, 500 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T160", "type": "Condition", "text": [ "hepatic", "disorders" ], "offsets": [ [ 486, 493 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T161", "type": "Condition", "text": [ "gastrointestinal", "disorders" ], "offsets": [ [ 468, 484 ], [ 621, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T162", "type": "Scope", "text": [ "gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders" ], "offsets": [ [ 468, 630 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T163", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 407, 418 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T167", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 26, 33 ] ], "normalized": [] }, { "id": "NCT02243553_exc_T168", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 41, 52 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02243553_exc_R1", "type": "Has_value", "arg1_id": "NCT02243553_exc_T26", "arg2_id": "NCT02243553_exc_T27", "normalized": [] }, { "id": "NCT02243553_exc_R2", "type": "Has_value", "arg1_id": "NCT02243553_exc_T28", "arg2_id": "NCT02243553_exc_T29", "normalized": [] }, { "id": "NCT02243553_exc_R3", "type": "Has_index", "arg1_id": "NCT02243553_exc_T32", "arg2_id": "NCT02243553_exc_T33", "normalized": [] }, { "id": "NCT02243553_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T30", "arg2_id": "NCT02243553_exc_T32", "normalized": [] }, { "id": "NCT02243553_exc_R5", "type": "Has_index", "arg1_id": "NCT02243553_exc_T35", "arg2_id": "NCT02243553_exc_T36", "normalized": [] }, { "id": "NCT02243553_exc_R6", "type": "AND", "arg1_id": "NCT02243553_exc_T36", "arg2_id": "NCT02243553_exc_T37", "normalized": [] }, { "id": "NCT02243553_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T34", "arg2_id": "NCT02243553_exc_T38", "normalized": [] }, { "id": "NCT02243553_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T43", "arg2_id": "NCT02243553_exc_T44", "normalized": [] }, { "id": "NCT02243553_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T45", "arg2_id": "NCT02243553_exc_T46", "normalized": [] }, { "id": "NCT02243553_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T47", "arg2_id": "NCT02243553_exc_T48", "normalized": [] }, { "id": "NCT02243553_exc_R11", "type": "Subsumes", "arg1_id": "NCT02243553_exc_T50", "arg2_id": "NCT02243553_exc_T58", "normalized": [] }, { "id": "NCT02243553_exc_R12", "type": "Subsumes", "arg1_id": "NCT02243553_exc_T65", "arg2_id": "NCT02243553_exc_T64", "normalized": [] }, { "id": "NCT02243553_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T65", "arg2_id": "NCT02243553_exc_T59", "normalized": [] }, { "id": "NCT02243553_exc_R14", "type": "Has_value", "arg1_id": "NCT02243553_exc_T69", "arg2_id": "NCT02243553_exc_T70", "normalized": [] }, { "id": "NCT02243553_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T72", "arg2_id": "NCT02243553_exc_T66", "normalized": [] }, { "id": "NCT02243553_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T71", "arg2_id": "NCT02243553_exc_T73", "normalized": [] }, { "id": "NCT02243553_exc_R16", "type": "Has_scope", "arg1_id": "NCT02243553_exc_T72", "arg2_id": "NCT02243553_exc_T74", "normalized": [] }, { "id": "NCT02243553_exc_R18", "type": "AND", "arg1_id": "NCT02243553_exc_T74", "arg2_id": "NCT02243553_exc_T71", "normalized": [] }, { "id": "NCT02243553_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T81", "arg2_id": "NCT02243553_exc_T80", "normalized": [] }, { "id": "NCT02243553_exc_R20", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T83", "arg2_id": "NCT02243553_exc_T82", "normalized": [] }, { "id": "NCT02243553_exc_R21", "type": "Has_scope", "arg1_id": "NCT02243553_exc_T92", "arg2_id": "NCT02243553_exc_T93", "normalized": [] }, { "id": "NCT02243553_exc_R22", "type": "Has_value", "arg1_id": "NCT02243553_exc_T97", "arg2_id": "NCT02243553_exc_T96", "normalized": [] }, { "id": "NCT02243553_exc_R23", "type": "Has_negation", "arg1_id": "NCT02243553_exc_T98", "arg2_id": "NCT02243553_exc_T100", "normalized": [] }, { "id": "NCT02243553_exc_R24", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T98", "arg2_id": "NCT02243553_exc_T99", "normalized": [] }, { "id": "NCT02243553_exc_R25", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T105", "arg2_id": "NCT02243553_exc_T104", "normalized": [] }, { "id": "NCT02243553_exc_R26", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T105", "arg2_id": "NCT02243553_exc_T106", "normalized": [] }, { "id": "NCT02243553_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T120", "arg2_id": "NCT02243553_exc_T121", "normalized": [] }, { "id": "NCT02243553_exc_R28", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T120", "arg2_id": "NCT02243553_exc_T122", "normalized": [] }, { "id": "NCT02243553_exc_R29", "type": "Has_value", "arg1_id": "NCT02243553_exc_T126", "arg2_id": "NCT02243553_exc_T127", "normalized": [] }, { "id": "NCT02243553_exc_R30", "type": "Has_value", "arg1_id": "NCT02243553_exc_T134", "arg2_id": "NCT02243553_exc_T135", "normalized": [] }, { "id": "NCT02243553_exc_R31", "type": "Has_temporal", "arg1_id": "NCT02243553_exc_T134", "arg2_id": "NCT02243553_exc_T136", "normalized": [] }, { "id": "NCT02243553_exc_R32", "type": "Has_value", "arg1_id": "NCT02243553_exc_T132", "arg2_id": "NCT02243553_exc_T133", "normalized": [] }, { "id": "NCT02243553_exc_R33", "type": "Has_value", "arg1_id": "NCT02243553_exc_T131", "arg2_id": "NCT02243553_exc_T137", "normalized": [] }, { "id": "NCT02243553_exc_R34", "type": "Has_value", "arg1_id": "NCT02243553_exc_T130", "arg2_id": "NCT02243553_exc_T138", "normalized": [] }, { "id": "NCT02243553_exc_R35", "type": "Has_value", "arg1_id": "NCT02243553_exc_T129", "arg2_id": "NCT02243553_exc_T139", "normalized": [] }, { "id": "NCT02243553_exc_R36", "type": "Has_value", "arg1_id": "NCT02243553_exc_T128", "arg2_id": "NCT02243553_exc_T140", "normalized": [] }, { "id": "NCT02243553_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T125", "arg2_id": "NCT02243553_exc_T123", "normalized": [] }, { "id": "NCT02243553_exc_R38", "type": "Subsumes", "arg1_id": "NCT02243553_exc_T142", "arg2_id": "NCT02243553_exc_T141", "normalized": [] }, { "id": "NCT02243553_exc_R39", "type": "Has_value", "arg1_id": "NCT02243553_exc_T143", "arg2_id": "NCT02243553_exc_T144", "normalized": [] }, { "id": "NCT02243553_exc_R40", "type": "Subsumes", "arg1_id": "NCT02243553_exc_T147", "arg2_id": "NCT02243553_exc_T162", "normalized": [] }, { "id": "NCT02243553_exc_R41", "type": "Has_qualifier", "arg1_id": "NCT02243553_exc_T147", "arg2_id": "NCT02243553_exc_T163", "normalized": [] }, { "id": "NCT02243553_exc_R42", "type": "AND", "arg1_id": "NCT02243553_exc_T167", "arg2_id": "NCT02243553_exc_T168", "normalized": [] } ]

[ { "id": "NCT02243553_inc_text", "type": "inclusion", "text": [ "1. Signed informed consent \n2. Healthy subjects aged between 18 years and 45 years inclusive \n3. Weighing at least 50 kg \n4. Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20) \n5. Volunteers must be willing to complete all study-related activities \n6. Each volunteer must have a valid social security number \n7. Each volunteer must have acceptable medical history, physical examination and laboratory test \n" ], "offsets": [ [ 0, 498 ] ] } ]

[ { "id": "NCT02243553_inc_T10", "type": "Person", "text": [ "aged" ], "offsets": [ [ 48, 52 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T11", "type": "Value", "text": [ "between 18 years and 45 years inclusive" ], "offsets": [ [ 53, 92 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T12", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 31, 38 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T13", "type": "Measurement", "text": [ "Weighing" ], "offsets": [ [ 97, 105 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T14", "type": "Value", "text": [ "at least 50 kg" ], "offsets": [ [ 106, 120 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T21", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 439, 454 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T22", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 456, 476 ] ], "normalized": [] }, { "id": "NCT02243553_inc_T23", "type": "Measurement", "text": [ "laboratory test" ], "offsets": [ [ 481, 496 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02243553_inc_R1", "type": "Has_value", "arg1_id": "NCT02243553_inc_T10", "arg2_id": "NCT02243553_inc_T11", "normalized": [] }, { "id": "NCT02243553_inc_R2", "type": "Has_value", "arg1_id": "NCT02243553_inc_T13", "arg2_id": "NCT02243553_inc_T14", "normalized": [] } ]

[ { "id": "NCT02245256_exc_text", "type": "exclusion", "text": [ "Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine\n" ], "offsets": [ [ 0, 170 ] ] } ]

[ { "id": "NCT02245256_exc_T1", "type": "Person", "text": [ "Pediatric" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T2", "type": "Value", "text": [ "under 18 years" ], "offsets": [ [ 20, 34 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 29, 34 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T4", "type": "Scope", "text": [ "under 18 years" ], "offsets": [ [ 20, 34 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T7", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 36, 45 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T9", "type": "Observation", "text": [ "unresponsive" ], "offsets": [ [ 63, 75 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T10", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 76, 87 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T11", "type": "Condition", "text": [ "neurologic deficits" ], "offsets": [ [ 98, 117 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T12", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 118, 129 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T13", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 142, 150 ] ], "normalized": [] }, { "id": "NCT02245256_exc_T14", "type": "Drug", "text": [ "dexmedetomidine" ], "offsets": [ [ 154, 169 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02245256_exc_R1", "type": "Has_value", "arg1_id": "NCT02245256_exc_T3", "arg2_id": "NCT02245256_exc_T2", "normalized": [] }, { "id": "NCT02245256_exc_R2", "type": "Subsumes", "arg1_id": "NCT02245256_exc_T1", "arg2_id": "NCT02245256_exc_T4", "normalized": [] }, { "id": "NCT02245256_exc_R3", "type": "AND", "arg1_id": "NCT02245256_exc_T13", "arg2_id": "NCT02245256_exc_T14", "normalized": [] }, { "id": "NCT02245256_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02245256_exc_T11", "arg2_id": "NCT02245256_exc_T12", "normalized": [] }, { "id": "NCT02245256_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02245256_exc_T9", "arg2_id": "NCT02245256_exc_T10", "normalized": [] } ]

[ { "id": "NCT02245256_inc_text", "type": "inclusion", "text": [ "Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation\n" ], "offsets": [ [ 0, 102 ] ] } ]

[ { "id": "NCT02245256_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02245256_inc_T2", "type": "Value", "text": [ "18years old or older" ], "offsets": [ [ 16, 36 ] ], "normalized": [] }, { "id": "NCT02245256_inc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 18, 23 ] ], "normalized": [] }, { "id": "NCT02245256_inc_T4", "type": "Scope", "text": [ "18years old or older" ], "offsets": [ [ 16, 36 ] ], "normalized": [] }, { "id": "NCT02245256_inc_T5", "type": "Procedure", "text": [ "living-donor", "liver transplantation" ], "offsets": [ [ 49, 61 ], [ 80, 101 ] ], "normalized": [] }, { "id": "NCT02245256_inc_T6", "type": "Procedure", "text": [ "deceased-donor liver transplantation" ], "offsets": [ [ 65, 101 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02245256_inc_R1", "type": "Has_value", "arg1_id": "NCT02245256_inc_T3", "arg2_id": "NCT02245256_inc_T2", "normalized": [] }, { "id": "NCT02245256_inc_R2", "type": "Subsumes", "arg1_id": "NCT02245256_inc_T1", "arg2_id": "NCT02245256_inc_T4", "normalized": [] } ]

[ { "id": "NCT02247128_exc_text", "type": "exclusion", "text": [ "Need for long-term oral anticoagulation;\nDrug-eluting stent implantation within 3 months prior to TAVI procedure;\nBare-metal stent implantation within 1 month prior to TAVI procedure;\nAllergy or intolerance to aspirin or clopidogrel.\nDrug-eluting stent implantation within 3 months prior to TAVI procedure;\nBare-metal stent implantation within 1 month prior to TAVI procedure;\nAllergy or intolerance to (N)OAC or clopidogrel.\n" ], "offsets": [ [ 0, 426 ] ] } ]

[ { "id": "NCT02247128_exc_T1", "type": "Mood", "text": [ "Need for" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T2", "type": "Procedure", "text": [ "long-term oral anticoagulation" ], "offsets": [ [ 9, 39 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T3", "type": "Device", "text": [ "Drug-eluting stent" ], "offsets": [ [ 41, 59 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T4", "type": "Procedure", "text": [ "implantation" ], "offsets": [ [ 60, 72 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T5", "type": "Temporal", "text": [ "within 3 months prior to TAVI procedure" ], "offsets": [ [ 73, 112 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T6", "type": "Reference_point", "text": [ "TAVI procedure" ], "offsets": [ [ 98, 112 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T7", "type": "Procedure", "text": [ "TAVI procedure" ], "offsets": [ [ 98, 112 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T8", "type": "Device", "text": [ "Bare-metal stent" ], "offsets": [ [ 114, 130 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T9", "type": "Procedure", "text": [ "implantation" ], "offsets": [ [ 131, 143 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T10", "type": "Temporal", "text": [ "within 1 month prior to TAVI procedure" ], "offsets": [ [ 144, 182 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T11", "type": "Procedure", "text": [ "TAVI procedure" ], "offsets": [ [ 168, 182 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T12", "type": "Reference_point", "text": [ "TAVI procedure" ], "offsets": [ [ 168, 182 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T13", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 184, 191 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T14", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 195, 206 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T15", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 210, 217 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T16", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 221, 232 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T17", "type": "Scope", "text": [ "Allergy or intolerance" ], "offsets": [ [ 184, 206 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T18", "type": "Scope", "text": [ "aspirin or clopidogrel" ], "offsets": [ [ 210, 232 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T19", "type": "Device", "text": [ "Drug-eluting stent" ], "offsets": [ [ 234, 252 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T20", "type": "Procedure", "text": [ "implantation" ], "offsets": [ [ 253, 265 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T21", "type": "Temporal", "text": [ "within 3 months prior to TAVI procedure" ], "offsets": [ [ 266, 305 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T22", "type": "Reference_point", "text": [ "TAVI procedure" ], "offsets": [ [ 291, 305 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T23", "type": "Procedure", "text": [ "TAVI procedure" ], "offsets": [ [ 291, 305 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T24", "type": "Device", "text": [ "Bare-metal stent" ], "offsets": [ [ 307, 323 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T25", "type": "Procedure", "text": [ "implantation" ], "offsets": [ [ 324, 336 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T26", "type": "Temporal", "text": [ "within 1 month prior to TAVI procedure" ], "offsets": [ [ 337, 375 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T27", "type": "Reference_point", "text": [ "TAVI procedure" ], "offsets": [ [ 361, 375 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T28", "type": "Procedure", "text": [ "TAVI procedure" ], "offsets": [ [ 361, 375 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T29", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 377, 384 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T30", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 388, 399 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T31", "type": "Drug", "text": [ "(N)OAC" ], "offsets": [ [ 403, 409 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T32", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 413, 424 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T33", "type": "Scope", "text": [ "Allergy or intolerance" ], "offsets": [ [ 377, 399 ] ], "normalized": [] }, { "id": "NCT02247128_exc_T34", "type": "Scope", "text": [ "(N)OAC or clopidogrel" ], "offsets": [ [ 403, 424 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02247128_exc_R1", "type": "Has_mood", "arg1_id": "NCT02247128_exc_T2", "arg2_id": "NCT02247128_exc_T1", "normalized": [] }, { "id": "NCT02247128_exc_R4", "type": "AND", "arg1_id": "NCT02247128_exc_T4", "arg2_id": "NCT02247128_exc_T3", "normalized": [] }, { "id": "NCT02247128_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02247128_exc_T4", "arg2_id": "NCT02247128_exc_T5", "normalized": [] }, { "id": "NCT02247128_exc_R7", "type": "AND", "arg1_id": "NCT02247128_exc_T10", "arg2_id": "NCT02247128_exc_T11", "normalized": [] }, { "id": "NCT02247128_exc_R8", "type": "AND", "arg1_id": "NCT02247128_exc_T9", "arg2_id": "NCT02247128_exc_T8", "normalized": [] }, { "id": "NCT02247128_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02247128_exc_T9", "arg2_id": "NCT02247128_exc_T10", "normalized": [] }, { "id": "NCT02247128_exc_R10", "type": "Has_scope", "arg1_id": "NCT02247128_exc_T17", "arg2_id": "NCT02247128_exc_T18", "normalized": [] }, { "id": "NCT02247128_exc_R12", "type": "Has_index", "arg1_id": "NCT02247128_exc_T21", "arg2_id": "NCT02247128_exc_T22", "normalized": [] }, { "id": "NCT02247128_exc_R13", "type": "AND", "arg1_id": "NCT02247128_exc_T20", "arg2_id": "NCT02247128_exc_T19", "normalized": [] }, { "id": "NCT02247128_exc_R14", "type": "Has_temporal", "arg1_id": "NCT02247128_exc_T20", "arg2_id": "NCT02247128_exc_T21", "normalized": [] }, { "id": "NCT02247128_exc_R15", "type": "Has_index", "arg1_id": "NCT02247128_exc_T26", "arg2_id": "NCT02247128_exc_T27", "normalized": [] }, { "id": "NCT02247128_exc_R16", "type": "AND", "arg1_id": "NCT02247128_exc_T25", "arg2_id": "NCT02247128_exc_T24", "normalized": [] }, { "id": "NCT02247128_exc_R17", "type": "Has_temporal", "arg1_id": "NCT02247128_exc_T25", "arg2_id": "NCT02247128_exc_T26", "normalized": [] }, { "id": "NCT02247128_exc_R18", "type": "Has_scope", "arg1_id": "NCT02247128_exc_T33", "arg2_id": "NCT02247128_exc_T34", "normalized": [] }, { "id": "NCT02247128_exc_R3", "type": "Has_index", "arg1_id": "NCT02247128_exc_T5", "arg2_id": "NCT02247128_exc_T6", "normalized": [] } ]

[ { "id": "NCT02247128_inc_text", "type": "inclusion", "text": [ "Need for long-term oral anticoagulation;\nPatient has provided written informed consent.\n" ], "offsets": [ [ 0, 88 ] ] } ]

[ { "id": "NCT02247128_inc_T1", "type": "Mood", "text": [ "Need for" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02247128_inc_T2", "type": "Procedure", "text": [ "long-term oral anticoagulation" ], "offsets": [ [ 9, 39 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02247128_inc_R1", "type": "Has_mood", "arg1_id": "NCT02247128_inc_T2", "arg2_id": "NCT02247128_inc_T1", "normalized": [] } ]

[ { "id": "NCT02251249_exc_text", "type": "exclusion", "text": [ "Allergy or contraindication to paracetamol, Prasugrel or Ticagrelor\nParacetamol ingestion in the previous 48 hours\nPatient treated with drugs supposed to alter gastric emptying times (calcium antagonists, Alimentary tract treatments, opioid analgesics, tricyclic antidepressants, antibiotics).\nConditions or pathologies supposed to alter gastric emptying times (Thyroid dysfunction, chronic renal failure, Parkinson's disease, scleroderma, amyloidosis, any gastrointestinal disease, any not cured malignancy, and any advanced psychiatric or neurological disease).\nPresence of vomiting\nCardiogenic shock, ventricular arrhythmia or resuscitated cardiac arrest\nHepatic insufficiency\nSevere respiratory disease\nPregnant or breastfeeding women\n" ], "offsets": [ [ 0, 739 ] ] } ]

[ { "id": "NCT02251249_exc_T1", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T2", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 11, 27 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T3", "type": "Drug", "text": [ "paracetamol" ], "offsets": [ [ 31, 42 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T4", "type": "Drug", "text": [ "Prasugrel" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T5", "type": "Drug", "text": [ "Ticagrelor" ], "offsets": [ [ 57, 67 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T6", "type": "Scope", "text": [ "paracetamol, Prasugrel or Ticagrelor" ], "offsets": [ [ 31, 67 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T7", "type": "Scope", "text": [ "Allergy or contraindication" ], "offsets": [ [ 0, 27 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T8", "type": "Drug", "text": [ "Paracetamol" ], "offsets": [ [ 68, 79 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T9", "type": "Temporal", "text": [ "in the previous 48 hours" ], "offsets": [ [ 90, 114 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T10", "type": "Drug", "text": [ "calcium antagonists" ], "offsets": [ [ 184, 203 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T11", "type": "Procedure", "text": [ "Alimentary tract treatments" ], "offsets": [ [ 205, 232 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T12", "type": "Drug", "text": [ "opioid analgesics" ], "offsets": [ [ 234, 251 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T13", "type": "Drug", "text": [ "tricyclic antidepressants" ], "offsets": [ [ 253, 278 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T14", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 280, 291 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T15", "type": "Condition", "text": [ "Thyroid dysfunction" ], "offsets": [ [ 362, 381 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T16", "type": "Condition", "text": [ "chronic renal failure" ], "offsets": [ [ 383, 404 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T17", "type": "Condition", "text": [ "Parkinson's disease" ], "offsets": [ [ 406, 425 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T18", "type": "Condition", "text": [ "scleroderma" ], "offsets": [ [ 427, 438 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T19", "type": "Condition", "text": [ "amyloidosis" ], "offsets": [ [ 440, 451 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T20", "type": "Condition", "text": [ "gastrointestinal disease" ], "offsets": [ [ 457, 481 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T21", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 497, 507 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T22", "type": "Condition", "text": [ "chiatric or", "ease)." ], "offsets": [ [ 529, 540 ], [ 557, 563 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T23", "type": "Condition", "text": [ "neurological disease" ], "offsets": [ [ 541, 561 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T24", "type": "Qualifier", "text": [ "advanced" ], "offsets": [ [ 517, 525 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T25", "type": "Scope", "text": [ "psychiatric or neurological disease" ], "offsets": [ [ 526, 561 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T26", "type": "Condition", "text": [ "vomiting" ], "offsets": [ [ 576, 584 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T27", "type": "Condition", "text": [ "Cardiogenic shock" ], "offsets": [ [ 585, 602 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T28", "type": "Condition", "text": [ "ventricular arrhythmia" ], "offsets": [ [ 604, 626 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T29", "type": "Condition", "text": [ "cardiac arrest" ], "offsets": [ [ 643, 657 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T30", "type": "Qualifier", "text": [ "resuscitated" ], "offsets": [ [ 630, 642 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T31", "type": "Condition", "text": [ "Hepatic insufficiency" ], "offsets": [ [ 658, 679 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T32", "type": "Condition", "text": [ "respiratory disease" ], "offsets": [ [ 687, 706 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T33", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 680, 686 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T35", "type": "Drug", "text": [ "drugs supposed to alter gastric emptying times" ], "offsets": [ [ 136, 182 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T36", "type": "Scope", "text": [ "calcium antagonists, Alimentary tract treatments, opioid analgesics, tricyclic antidepressants, antibiotics" ], "offsets": [ [ 184, 291 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T37", "type": "Condition", "text": [ "pathologies supposed to alter gastric emptying times" ], "offsets": [ [ 308, 360 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T38", "type": "Condition", "text": [ "ditions or", "posed to alter gastric emptying times (T" ], "offsets": [ [ 297, 307 ], [ 323, 363 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T39", "type": "Scope", "text": [ "Conditions or pathologies supposed to alter gastric emptying times" ], "offsets": [ [ 294, 360 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T40", "type": "Scope", "text": [ "Thyroid dysfunction, chronic renal failure, Parkinson's disease, scleroderma, amyloidosis, any gastrointestinal disease, any not cured malignancy, and any advanced psychiatric or neurological disease" ], "offsets": [ [ 362, 561 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T34", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 707, 715 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T41", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 719, 732 ] ], "normalized": [] }, { "id": "NCT02251249_exc_T42", "type": "Person", "text": [ "women" ], "offsets": [ [ 733, 738 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02251249_exc_R1", "type": "Has_scope", "arg1_id": "NCT02251249_exc_T7", "arg2_id": "NCT02251249_exc_T6", "normalized": [] }, { "id": "NCT02251249_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02251249_exc_T8", "arg2_id": "NCT02251249_exc_T9", "normalized": [] }, { "id": "NCT02251249_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02251249_exc_T25", "arg2_id": "NCT02251249_exc_T24", "normalized": [] }, { "id": "NCT02251249_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02251249_exc_T29", "arg2_id": "NCT02251249_exc_T30", "normalized": [] }, { "id": "NCT02251249_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02251249_exc_T32", "arg2_id": "NCT02251249_exc_T33", "normalized": [] }, { "id": "NCT02251249_exc_R6", "type": "Subsumes", "arg1_id": "NCT02251249_exc_T35", "arg2_id": "NCT02251249_exc_T36", "normalized": [] }, { "id": "NCT02251249_exc_R7", "type": "Subsumes", "arg1_id": "NCT02251249_exc_T39", "arg2_id": "NCT02251249_exc_T40", "normalized": [] } ]

[ { "id": "NCT02251249_inc_text", "type": "inclusion", "text": [ "Patient over 18 years weighing between 65 and 85 Kg\nReferred for STEMI within 6 hours from beginning of chest pain or stable coronary artery disease requiring a loading dose of Prasugrel or Ticagrelor according to the international recommendations.\nNo previous treatment with Clopidogrel, Prasugrel or Ticagrelor.\nPatient fasting for at least 6 hours.\nAffiliate or receiving a social security system.\nWritten informed consent.\n" ], "offsets": [ [ 0, 427 ] ] } ]

[ { "id": "NCT02251249_inc_T1", "type": "Person", "text": [ "years" ], "offsets": [ [ 16, 21 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T2", "type": "Value", "text": [ "over 18" ], "offsets": [ [ 8, 15 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T3", "type": "Measurement", "text": [ "weighing" ], "offsets": [ [ 22, 30 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T4", "type": "Value", "text": [ "between 65 and 85 Kg" ], "offsets": [ [ 31, 51 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T5", "type": "Condition", "text": [ "STEMI" ], "offsets": [ [ 65, 70 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T7", "type": "Multiplier", "text": [ "loading dose" ], "offsets": [ [ 161, 173 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T8", "type": "Drug", "text": [ "Prasugrel" ], "offsets": [ [ 177, 186 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T9", "type": "Drug", "text": [ "Ticagrelor" ], "offsets": [ [ 190, 200 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T10", "type": "Scope", "text": [ "Prasugrel or Ticagrelor" ], "offsets": [ [ 177, 200 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T11", "type": "Temporal", "text": [ "within 6 hours from beginning of chest pain" ], "offsets": [ [ 71, 114 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T12", "type": "Reference_point", "text": [ "beginning of chest pain" ], "offsets": [ [ 91, 114 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T13", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 125, 148 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T14", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 118, 124 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T15", "type": "Negation", "text": [ "No" ], "offsets": [ [ 249, 251 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T16", "type": "Drug", "text": [ "Clopidogrel" ], "offsets": [ [ 276, 287 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T17", "type": "Drug", "text": [ "Prasugrel" ], "offsets": [ [ 289, 298 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T18", "type": "Drug", "text": [ "Ticagrelor" ], "offsets": [ [ 302, 312 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T19", "type": "Scope", "text": [ "Clopidogrel, Prasugrel or Ticagrelor" ], "offsets": [ [ 276, 312 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T20", "type": "Observation", "text": [ "fasting" ], "offsets": [ [ 322, 329 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T21", "type": "Temporal", "text": [ "for at least 6 hours." ], "offsets": [ [ 330, 351 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T6", "type": "Condition", "text": [ "chest pain" ], "offsets": [ [ 104, 114 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T24", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 252, 260 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T25", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 261, 270 ] ], "normalized": [] }, { "id": "NCT02251249_inc_T23", "type": "Observation", "text": [ "Written informed consent" ], "offsets": [ [ 401, 425 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02251249_inc_R1", "type": "Has_value", "arg1_id": "NCT02251249_inc_T1", "arg2_id": "NCT02251249_inc_T2", "normalized": [] }, { "id": "NCT02251249_inc_R2", "type": "Has_value", "arg1_id": "NCT02251249_inc_T3", "arg2_id": "NCT02251249_inc_T4", "normalized": [] }, { "id": "NCT02251249_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02251249_inc_T10", "arg2_id": "NCT02251249_inc_T7", "normalized": [] }, { "id": "NCT02251249_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02251249_inc_T5", "arg2_id": "NCT02251249_inc_T11", "normalized": [] }, { "id": "NCT02251249_inc_R5", "type": "Has_index", "arg1_id": "NCT02251249_inc_T11", "arg2_id": "NCT02251249_inc_T12", "normalized": [] }, { "id": "NCT02251249_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02251249_inc_T13", "arg2_id": "NCT02251249_inc_T14", "normalized": [] }, { "id": "NCT02251249_inc_R7", "type": "Has_scope", "arg1_id": "NCT02251249_inc_T13", "arg2_id": "NCT02251249_inc_T10", "normalized": [] }, { "id": "NCT02251249_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02251249_inc_T20", "arg2_id": "NCT02251249_inc_T21", "normalized": [] }, { "id": "NCT02251249_inc_R8", "type": "Has_scope", "arg1_id": "NCT02251249_inc_T25", "arg2_id": "NCT02251249_inc_T19", "normalized": [] }, { "id": "NCT02251249_inc_R11", "type": "Has_temporal", "arg1_id": "NCT02251249_inc_T25", "arg2_id": "NCT02251249_inc_T24", "normalized": [] }, { "id": "NCT02251249_inc_R12", "type": "Has_negation", "arg1_id": "NCT02251249_inc_T25", "arg2_id": "NCT02251249_inc_T15", "normalized": [] } ]

[ { "id": "NCT02254668_exc_text", "type": "exclusion", "text": [ "Renal insufficiency (> 265 µmol/l)\nIncapability to give informed consent\nCardiogenic shock of patient with KILLIP III or IV\npregnant or breast feeding females\ninsufficient contraception (only for substudy 3)\n" ], "offsets": [ [ 0, 208 ] ] } ]

[ { "id": "NCT02254668_exc_T1", "type": "Condition", "text": [ "Renal insufficiency" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T3", "type": "Condition", "text": [ "Cardiogenic shock" ], "offsets": [ [ 73, 90 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T4", "type": "Measurement", "text": [ "KILLIP" ], "offsets": [ [ 107, 113 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T5", "type": "Value", "text": [ "III or IV" ], "offsets": [ [ 114, 123 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T6", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 124, 132 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T7", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 136, 150 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T8", "type": "Person", "text": [ "females" ], "offsets": [ [ 151, 158 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T9", "type": "Qualifier", "text": [ "insufficient" ], "offsets": [ [ 159, 171 ] ], "normalized": [] }, { "id": "NCT02254668_exc_T10", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 172, 185 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02254668_exc_R1", "type": "Has_value", "arg1_id": "NCT02254668_exc_T4", "arg2_id": "NCT02254668_exc_T5", "normalized": [] }, { "id": "NCT02254668_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02254668_exc_T10", "arg2_id": "NCT02254668_exc_T9", "normalized": [] } ]

[ { "id": "NCT02254668_inc_text", "type": "inclusion", "text": [ "Patients with heart transplantation\nPatient with coronary artery disease\nAge between 18 and 80 years\n" ], "offsets": [ [ 0, 101 ] ] } ]

[ { "id": "NCT02254668_inc_T1", "type": "Procedure", "text": [ "heart transplantation" ], "offsets": [ [ 14, 35 ] ], "normalized": [] }, { "id": "NCT02254668_inc_T2", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 49, 72 ] ], "normalized": [] }, { "id": "NCT02254668_inc_T3", "type": "Person", "text": [ "Age" ], "offsets": [ [ 73, 76 ] ], "normalized": [] }, { "id": "NCT02254668_inc_T4", "type": "Value", "text": [ "between 18 and 80 years" ], "offsets": [ [ 77, 100 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02254668_inc_R1", "type": "Has_value", "arg1_id": "NCT02254668_inc_T3", "arg2_id": "NCT02254668_inc_T4", "normalized": [] } ]

[ { "id": "NCT02256943_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02256943_inc_text", "type": "inclusion", "text": [ "Healthy\nMale\n>7 Metabolic Equivalents\nWritten informed consent\nChronic pain syndrome\nDrug abuse\nAlcohol abuse\nSuspicion of neurologic dysfunction at tested sites\nOngoing treatment with antidepressants\nOngoing treatment with analgesics\nPretreatment with any CYP3A inducers or inhibitors\nKnown allergy to tested drugs\nElevated eye pressure\nObstructive uropathy\nHeart disease\nPulmonary disease\nNeurological disease\nPsychiatric illness\n" ], "offsets": [ [ 0, 432 ] ] } ]

[ { "id": "NCT02256943_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T2", "type": "Person", "text": [ "Male" ], "offsets": [ [ 8, 12 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T3", "type": "Value", "text": [ ">7" ], "offsets": [ [ 13, 15 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T4", "type": "Measurement", "text": [ "Metabolic Equivalents" ], "offsets": [ [ 16, 37 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T6", "type": "Condition", "text": [ "Chronic pain syndrome" ], "offsets": [ [ 63, 84 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T7", "type": "Condition", "text": [ "Drug abuse" ], "offsets": [ [ 85, 95 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T8", "type": "Condition", "text": [ "Alcohol abuse" ], "offsets": [ [ 96, 109 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T9", "type": "Mood", "text": [ "Suspicion" ], "offsets": [ [ 110, 119 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T10", "type": "Condition", "text": [ "neurologic dysfunction" ], "offsets": [ [ 123, 145 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T11", "type": "Qualifier", "text": [ "tested sites" ], "offsets": [ [ 149, 161 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T12", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 162, 169 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T13", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 170, 179 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T14", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 185, 200 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T15", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 201, 208 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T16", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 209, 218 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T17", "type": "Drug", "text": [ "analgesics" ], "offsets": [ [ 224, 234 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T18", "type": "Procedure", "text": [ "Pretreatment" ], "offsets": [ [ 235, 247 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T19", "type": "Drug", "text": [ "CYP3A inducers" ], "offsets": [ [ 257, 271 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T20", "type": "Drug", "text": [ "cers", "\nKnown al" ], "offsets": [ [ 267, 271 ], [ 285, 294 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T21", "type": "Scope", "text": [ "CYP3A inducers or inhibitors" ], "offsets": [ [ 257, 285 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T22", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 292, 299 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T23", "type": "Drug", "text": [ "tested drugs" ], "offsets": [ [ 303, 315 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T24", "type": "Condition", "text": [ "Elevated eye pressure" ], "offsets": [ [ 316, 337 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T25", "type": "Condition", "text": [ "Obstructive uropathy" ], "offsets": [ [ 338, 358 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T26", "type": "Condition", "text": [ "Heart disease" ], "offsets": [ [ 359, 372 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T27", "type": "Condition", "text": [ "Pulmonary disease" ], "offsets": [ [ 373, 390 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T28", "type": "Condition", "text": [ "Neurological disease" ], "offsets": [ [ 391, 411 ] ], "normalized": [] }, { "id": "NCT02256943_inc_T29", "type": "Condition", "text": [ "Psychiatric illness" ], "offsets": [ [ 412, 431 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02256943_inc_R1", "type": "Has_value", "arg1_id": "NCT02256943_inc_T4", "arg2_id": "NCT02256943_inc_T3", "normalized": [] }, { "id": "NCT02256943_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02256943_inc_T10", "arg2_id": "NCT02256943_inc_T11", "normalized": [] }, { "id": "NCT02256943_inc_R3", "type": "Has_mood", "arg1_id": "NCT02256943_inc_T10", "arg2_id": "NCT02256943_inc_T9", "normalized": [] }, { "id": "NCT02256943_inc_R4", "type": "AND", "arg1_id": "NCT02256943_inc_T13", "arg2_id": "NCT02256943_inc_T14", "normalized": [] }, { "id": "NCT02256943_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02256943_inc_T13", "arg2_id": "NCT02256943_inc_T12", "normalized": [] }, { "id": "NCT02256943_inc_R6", "type": "AND", "arg1_id": "NCT02256943_inc_T16", "arg2_id": "NCT02256943_inc_T17", "normalized": [] }, { "id": "NCT02256943_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02256943_inc_T16", "arg2_id": "NCT02256943_inc_T15", "normalized": [] }, { "id": "NCT02256943_inc_R8", "type": "Has_scope", "arg1_id": "NCT02256943_inc_T18", "arg2_id": "NCT02256943_inc_T21", "normalized": [] }, { "id": "NCT02256943_inc_R9", "type": "AND", "arg1_id": "NCT02256943_inc_T22", "arg2_id": "NCT02256943_inc_T23", "normalized": [] } ]

[ { "id": "NCT02256956_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02256956_inc_text", "type": "inclusion", "text": [ "Healthy\nMale\n>7 Metabolic Equivalents\nWritten informed consent\nChronic pain syndrome\nDrug abuse\nAlcohol abuse\nSuspicion of neurologic dysfunction at tested sites\nOngoing treatment with antidepressants\nOngoing treatment with analgesics\nPretreatment with any CYP3A inducers or inhibitors\nKnown allergy to tested drugs\nElevated eye pressure\nObstructive uropathy\nHeart disease\nPulmonary disease\nNeurological disease\nPsychiatric illness\n" ], "offsets": [ [ 0, 432 ] ] } ]

[ { "id": "NCT02256956_inc_T1", "type": "Value", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T2", "type": "Person", "text": [ "Male" ], "offsets": [ [ 8, 12 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T3", "type": "Value", "text": [ ">7" ], "offsets": [ [ 13, 15 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T4", "type": "Measurement", "text": [ "Metabolic Equivalents" ], "offsets": [ [ 16, 37 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T5", "type": "Condition", "text": [ "Drug abuse" ], "offsets": [ [ 85, 95 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T6", "type": "Condition", "text": [ "Alcohol abuse" ], "offsets": [ [ 96, 109 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T7", "type": "Condition", "text": [ "Chronic pain syndrome" ], "offsets": [ [ 63, 84 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T9", "type": "Mood", "text": [ "Suspicion" ], "offsets": [ [ 110, 119 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T10", "type": "Condition", "text": [ "neurologic dysfunction" ], "offsets": [ [ 123, 145 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T11", "type": "Qualifier", "text": [ "tested sites" ], "offsets": [ [ 149, 161 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T12", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 162, 169 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T13", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 170, 179 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T14", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 185, 200 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T15", "type": "Temporal", "text": [ "Ongoing" ], "offsets": [ [ 201, 208 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T16", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 209, 218 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T17", "type": "Drug", "text": [ "analgesics" ], "offsets": [ [ 224, 234 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T18", "type": "Procedure", "text": [ "Pretreatment" ], "offsets": [ [ 235, 247 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T19", "type": "Drug", "text": [ "CYP3A inducers" ], "offsets": [ [ 257, 271 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T20", "type": "Drug", "text": [ "cers", "\nKnown al" ], "offsets": [ [ 267, 271 ], [ 285, 294 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T21", "type": "Scope", "text": [ "CYP3A inducers or inhibitors" ], "offsets": [ [ 257, 285 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T22", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 292, 299 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T23", "type": "Condition", "text": [ "Obstructive uropathy" ], "offsets": [ [ 338, 358 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T24", "type": "Drug", "text": [ "tested drugs" ], "offsets": [ [ 303, 315 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T25", "type": "Condition", "text": [ "Elevated eye pressure" ], "offsets": [ [ 316, 337 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T26", "type": "Condition", "text": [ "Heart disease" ], "offsets": [ [ 359, 372 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T27", "type": "Condition", "text": [ "Pulmonary disease" ], "offsets": [ [ 373, 390 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T28", "type": "Condition", "text": [ "Neurological disease" ], "offsets": [ [ 391, 411 ] ], "normalized": [] }, { "id": "NCT02256956_inc_T29", "type": "Condition", "text": [ "Psychiatric illness" ], "offsets": [ [ 412, 431 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02256956_inc_R1", "type": "Has_value", "arg1_id": "NCT02256956_inc_T4", "arg2_id": "NCT02256956_inc_T3", "normalized": [] }, { "id": "NCT02256956_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02256956_inc_T10", "arg2_id": "NCT02256956_inc_T11", "normalized": [] }, { "id": "NCT02256956_inc_R3", "type": "Has_mood", "arg1_id": "NCT02256956_inc_T10", "arg2_id": "NCT02256956_inc_T9", "normalized": [] }, { "id": "NCT02256956_inc_R4", "type": "AND", "arg1_id": "NCT02256956_inc_T13", "arg2_id": "NCT02256956_inc_T14", "normalized": [] }, { "id": "NCT02256956_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02256956_inc_T13", "arg2_id": "NCT02256956_inc_T12", "normalized": [] }, { "id": "NCT02256956_inc_R6", "type": "AND", "arg1_id": "NCT02256956_inc_T16", "arg2_id": "NCT02256956_inc_T17", "normalized": [] }, { "id": "NCT02256956_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02256956_inc_T16", "arg2_id": "NCT02256956_inc_T15", "normalized": [] }, { "id": "NCT02256956_inc_R8", "type": "Has_scope", "arg1_id": "NCT02256956_inc_T18", "arg2_id": "NCT02256956_inc_T21", "normalized": [] }, { "id": "NCT02256956_inc_R9", "type": "AND", "arg1_id": "NCT02256956_inc_T22", "arg2_id": "NCT02256956_inc_T24", "normalized": [] } ]

[ { "id": "NCT02257580_exc_text", "type": "exclusion", "text": [ "Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)\nHistory of hypersensitivity to EACA\nHistory of thromboembolic event (e.g., PE or DVT)\nHistory of renal insufficiency or failure\nCongenital or acquired coagulopathy as evidence by INR >1.4 or PTT > 1.4 times normal, or Platelets <150,000/mm3 on preoperative laboratory testing\nUse of hormone replacement therapy or hormonal contraceptive agents within days prior to surgery\nUse of acetylsalicylic acid (ASA), antiplatelet agents within 7 days prior to surgery\nPregnant\nBreastfeeding\nNot received neuraxial anesthesia\n" ], "offsets": [ [ 0, 587 ] ] } ]

[ { "id": "NCT02257580_exc_T1", "type": "Temporal", "text": [ "Preoperative" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T2", "type": "Drug", "text": [ "anticoagulant" ], "offsets": [ [ 23, 36 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T3", "type": "Drug", "text": [ "Plavix" ], "offsets": [ [ 38, 44 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T4", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 46, 54 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T5", "type": "Drug", "text": [ "lovenox" ], "offsets": [ [ 56, 63 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T6", "type": "Scope", "text": [ "Plavix, warfarin, lovenox" ], "offsets": [ [ 38, 63 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T7", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 82, 98 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T8", "type": "Drug", "text": [ "EACA" ], "offsets": [ [ 102, 106 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T9", "type": "Condition", "text": [ "thromboembolic event" ], "offsets": [ [ 118, 138 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T10", "type": "Condition", "text": [ "renal insufficiency" ], "offsets": [ [ 168, 187 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T11", "type": "Condition", "text": [ "PE" ], "offsets": [ [ 146, 148 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T12", "type": "Condition", "text": [ "DVT" ], "offsets": [ [ 152, 155 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T13", "type": "Scope", "text": [ "PE or DVT" ], "offsets": [ [ 146, 155 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T14", "type": "Condition", "text": [ "al in", "lure\nCo" ], "offsets": [ [ 171, 176 ], [ 194, 201 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T15", "type": "Qualifier", "text": [ "Congenital" ], "offsets": [ [ 199, 209 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T16", "type": "Qualifier", "text": [ "acquired" ], "offsets": [ [ 213, 221 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T17", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 222, 234 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T18", "type": "Scope", "text": [ "Congenital or acquired" ], "offsets": [ [ 199, 221 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T19", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 250, 253 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T20", "type": "Value", "text": [ " o", "s normal, or" ], "offsets": [ [ 258, 260 ], [ 276, 288 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T21", "type": "Measurement", "text": [ "PTT" ], "offsets": [ [ 262, 265 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T22", "type": "Value", "text": [ "> 1.4 times normal" ], "offsets": [ [ 266, 284 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T23", "type": "Scope", "text": [ "INR >1.4 or PTT > 1.4 times normal" ], "offsets": [ [ 250, 284 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T24", "type": "Measurement", "text": [ "Platelets" ], "offsets": [ [ 289, 298 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T25", "type": "Value", "text": [ "<150,000/mm3" ], "offsets": [ [ 299, 311 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T26", "type": "Procedure", "text": [ "preoperative laboratory testing" ], "offsets": [ [ 315, 346 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T27", "type": "Procedure", "text": [ "hormone replacement therapy" ], "offsets": [ [ 354, 381 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T28", "type": "Drug", "text": [ "hormonal contraceptive agents" ], "offsets": [ [ 385, 414 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T29", "type": "Temporal", "text": [ "within days prior to surgery" ], "offsets": [ [ 415, 443 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T30", "type": "Reference_point", "text": [ "surgery" ], "offsets": [ [ 436, 443 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T31", "type": "Scope", "text": [ "hormone replacement therapy or hormonal contraceptive agents" ], "offsets": [ [ 354, 414 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T32", "type": "Drug", "text": [ "acetylsalicylic acid" ], "offsets": [ [ 451, 471 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T33", "type": "Drug", "text": [ "ASA" ], "offsets": [ [ 473, 476 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T34", "type": "Drug", "text": [ "antiplatelet agents" ], "offsets": [ [ 479, 498 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T35", "type": "Temporal", "text": [ "within 7 days prior to surgery" ], "offsets": [ [ 499, 529 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T36", "type": "Reference_point", "text": [ "surgery" ], "offsets": [ [ 522, 529 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T37", "type": "Scope", "text": [ "acetylsalicylic acid (ASA), antiplatelet agents" ], "offsets": [ [ 451, 498 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T38", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 530, 538 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T39", "type": "Observation", "text": [ "Breastfeeding" ], "offsets": [ [ 539, 552 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T40", "type": "Procedure", "text": [ "neuraxial anesthesia" ], "offsets": [ [ 566, 586 ] ], "normalized": [] }, { "id": "NCT02257580_exc_T41", "type": "Negation", "text": [ "Not received" ], "offsets": [ [ 553, 565 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02257580_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02257580_exc_T2", "arg2_id": "NCT02257580_exc_T1", "normalized": [] }, { "id": "NCT02257580_exc_R2", "type": "Subsumes", "arg1_id": "NCT02257580_exc_T2", "arg2_id": "NCT02257580_exc_T6", "normalized": [] }, { "id": "NCT02257580_exc_R3", "type": "AND", "arg1_id": "NCT02257580_exc_T7", "arg2_id": "NCT02257580_exc_T8", "normalized": [] }, { "id": "NCT02257580_exc_R4", "type": "Subsumes", "arg1_id": "NCT02257580_exc_T9", "arg2_id": "NCT02257580_exc_T13", "normalized": [] }, { "id": "NCT02257580_exc_R5", "type": "Has_scope", "arg1_id": "NCT02257580_exc_T17", "arg2_id": "NCT02257580_exc_T18", "normalized": [] }, { "id": "NCT02257580_exc_R6", "type": "Has_value", "arg1_id": "NCT02257580_exc_T21", "arg2_id": "NCT02257580_exc_T22", "normalized": [] }, { "id": "NCT02257580_exc_R7", "type": "Has_value", "arg1_id": "NCT02257580_exc_T19", "arg2_id": "NCT02257580_exc_T20", "normalized": [] }, { "id": "NCT02257580_exc_R8", "type": "Has_scope", "arg1_id": "NCT02257580_exc_T17", "arg2_id": "NCT02257580_exc_T23", "normalized": [] }, { "id": "NCT02257580_exc_R9", "type": "Has_value", "arg1_id": "NCT02257580_exc_T24", "arg2_id": "NCT02257580_exc_T25", "normalized": [] }, { "id": "NCT02257580_exc_R10", "type": "AND", "arg1_id": "NCT02257580_exc_T26", "arg2_id": "NCT02257580_exc_T24", "normalized": [] }, { "id": "NCT02257580_exc_R11", "type": "Has_index", "arg1_id": "NCT02257580_exc_T29", "arg2_id": "NCT02257580_exc_T30", "normalized": [] }, { "id": "NCT02257580_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02257580_exc_T31", "arg2_id": "NCT02257580_exc_T29", "normalized": [] }, { "id": "NCT02257580_exc_R13", "type": "Subsumes", "arg1_id": "NCT02257580_exc_T32", "arg2_id": "NCT02257580_exc_T33", "normalized": [] }, { "id": "NCT02257580_exc_R14", "type": "Has_index", "arg1_id": "NCT02257580_exc_T35", "arg2_id": "NCT02257580_exc_T36", "normalized": [] }, { "id": "NCT02257580_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02257580_exc_T37", "arg2_id": "NCT02257580_exc_T35", "normalized": [] }, { "id": "NCT02257580_exc_R16", "type": "Has_negation", "arg1_id": "NCT02257580_exc_T40", "arg2_id": "NCT02257580_exc_T41", "normalized": [] } ]

[ { "id": "NCT02257580_inc_text", "type": "inclusion", "text": [ "Scheduled for bilateral varus rotational osteotomy (VRO) with or without associated soft tissue and osseous procedures\n" ], "offsets": [ [ 0, 119 ] ] } ]

[ { "id": "NCT02257580_inc_T1", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 14, 23 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T2", "type": "Mood", "text": [ "Scheduled for" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T3", "type": "Procedure", "text": [ "varus rotational osteotomy" ], "offsets": [ [ 24, 50 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T4", "type": "Procedure", "text": [ "VRO" ], "offsets": [ [ 52, 55 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T5", "type": "Procedure", "text": [ "osseous procedures" ], "offsets": [ [ 100, 118 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T6", "type": "Procedure", "text": [ "procedures", "soft tissue" ], "offsets": [ [ 108, 118 ], [ 84, 95 ] ], "normalized": [] }, { "id": "NCT02257580_inc_T7", "type": "Scope", "text": [ "soft tissue and osseous procedures" ], "offsets": [ [ 84, 118 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02257580_inc_R1", "type": "Subsumes", "arg1_id": "NCT02257580_inc_T3", "arg2_id": "NCT02257580_inc_T4", "normalized": [] }, { "id": "NCT02257580_inc_R2", "type": "Has_scope", "arg1_id": "NCT02257580_inc_T3", "arg2_id": "NCT02257580_inc_T7", "normalized": [] }, { "id": "NCT02257580_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02257580_inc_T3", "arg2_id": "NCT02257580_inc_T1", "normalized": [] }, { "id": "NCT02257580_inc_R4", "type": "Has_mood", "arg1_id": "NCT02257580_inc_T3", "arg2_id": "NCT02257580_inc_T2", "normalized": [] } ]

[ { "id": "NCT02260206_exc_text", "type": "exclusion", "text": [ "Hypersensitivity on Colchicine\nThe existence of intra-cardiac thrombus on trans-esophageal echocardiography\nPregnancy\n" ], "offsets": [ [ 0, 118 ] ] } ]

[ { "id": "NCT02260206_exc_T1", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02260206_exc_T2", "type": "Drug", "text": [ "Colchicine" ], "offsets": [ [ 20, 30 ] ], "normalized": [] }, { "id": "NCT02260206_exc_T3", "type": "Condition", "text": [ "intra-cardiac thrombus" ], "offsets": [ [ 48, 70 ] ], "normalized": [] }, { "id": "NCT02260206_exc_T4", "type": "Procedure", "text": [ "trans-esophageal echocardiography" ], "offsets": [ [ 74, 107 ] ], "normalized": [] }, { "id": "NCT02260206_exc_T5", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 108, 117 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02260206_exc_R1", "type": "AND", "arg1_id": "NCT02260206_exc_T1", "arg2_id": "NCT02260206_exc_T2", "normalized": [] }, { "id": "NCT02260206_exc_R2", "type": "AND", "arg1_id": "NCT02260206_exc_T4", "arg2_id": "NCT02260206_exc_T3", "normalized": [] } ]

[ { "id": "NCT02260206_inc_text", "type": "inclusion", "text": [ "Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.\n" ], "offsets": [ [ 0, 100 ] ] } ]

[ { "id": "NCT02260206_inc_T1", "type": "Procedure", "text": [ "pericardiocentesis" ], "offsets": [ [ 19, 37 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T2", "type": "Temporal", "text": [ "during RFCA" ], "offsets": [ [ 38, 49 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T3", "type": "Reference_point", "text": [ "RFCA" ], "offsets": [ [ 45, 49 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T4", "type": "Procedure", "text": [ "RFCA" ], "offsets": [ [ 45, 49 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T5", "type": "Qualifier", "text": [ "paroxysmal" ], "offsets": [ [ 54, 64 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T6", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 68, 78 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T7", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 79, 98 ] ], "normalized": [] }, { "id": "NCT02260206_inc_T8", "type": "Scope", "text": [ "paroxysmal or persistent" ], "offsets": [ [ 54, 78 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02260206_inc_R2", "type": "Has_index", "arg1_id": "NCT02260206_inc_T2", "arg2_id": "NCT02260206_inc_T3", "normalized": [] }, { "id": "NCT02260206_inc_R3", "type": "Has_scope", "arg1_id": "NCT02260206_inc_T7", "arg2_id": "NCT02260206_inc_T8", "normalized": [] }, { "id": "NCT02260206_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02260206_inc_T1", "arg2_id": "NCT02260206_inc_T2", "normalized": [] }, { "id": "NCT02260206_inc_R5", "type": "AND", "arg1_id": "NCT02260206_inc_T1", "arg2_id": "NCT02260206_inc_T7", "normalized": [] } ]

[ { "id": "NCT02260700_exc_text", "type": "exclusion", "text": [ "Participant has a clinically significant abnormal physical examination, vital signs or 12 lead ECG (including QTc greater than (>) 450msec, Left Bundle Branch Block, permanent pacemaker or implantable cardioverter defibrillator) at Screening or admission \nParticipant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances \nUse of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to study drug administration (not including paracetamol). Medication for chronic use in age related disease will be allowed after approval by both the investigator and to the sponsor. No change in dose or regimen will be permitted during the study that is, from the Screening visit until the follow-up visit \nParticipant has a history of spontaneous, prolonged or severe bleeding of unclear origin \nParticipant has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse \n \n" ], "offsets": [ [ 0, 1119 ] ] } ]

[ { "id": "NCT02260700_exc_T2", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 18, 40 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T3", "type": "Condition", "text": [ "abnormal physical examination" ], "offsets": [ [ 41, 70 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T5", "type": "Condition", "text": [ "abnormal", "vital signs" ], "offsets": [ [ 41, 49 ], [ 72, 83 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T6", "type": "Condition", "text": [ "abnormal", "12 lead ECG" ], "offsets": [ [ 41, 49 ], [ 87, 98 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T7", "type": "Measurement", "text": [ "QTc" ], "offsets": [ [ 110, 113 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T8", "type": "Value", "text": [ "greater than (>) 450msec" ], "offsets": [ [ 114, 138 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T9", "type": "Condition", "text": [ "Left Bundle Branch Block" ], "offsets": [ [ 140, 164 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T10", "type": "Device", "text": [ "permanent pacemaker" ], "offsets": [ [ 166, 185 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T11", "type": "Condition", "text": [ "implantable cardioverter defibrillator" ], "offsets": [ [ 189, 227 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T12", "type": "Scope", "text": [ "QTc greater than (>) 450msec, Left Bundle Branch Block, permanent pacemaker or implantable cardioverter defibrillator" ], "offsets": [ [ 110, 227 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T13", "type": "Temporal", "text": [ "at Screening or admission" ], "offsets": [ [ 229, 254 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T14", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 232, 241 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T15", "type": "Reference_point", "text": [ "admission" ], "offsets": [ [ 245, 254 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T16", "type": "Scope", "text": [ "Screening or admission" ], "offsets": [ [ 232, 254 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T17", "type": "Scope", "text": [ "abnormal physical examination, vital signs or 12 lead ECG" ], "offsets": [ [ 41, 98 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T18", "type": "Condition", "text": [ "renal insufficiency" ], "offsets": [ [ 305, 324 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T19", "type": "Condition", "text": [ "liver", "insufficiency" ], "offsets": [ [ 296, 301 ], [ 311, 324 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T20", "type": "Observation", "text": [ "history" ], "offsets": [ [ 274, 281 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T21", "type": "Condition", "text": [ "metabolic disturbances" ], "offsets": [ [ 453, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T22", "type": "Condition", "text": [ "psychiatric", "disturbances" ], "offsets": [ [ 437, 448 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T23", "type": "Condition", "text": [ "rheumatologic", "disturbances" ], "offsets": [ [ 422, 435 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T24", "type": "Condition", "text": [ "hematologic", "disturbances" ], "offsets": [ [ 409, 420 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T25", "type": "Condition", "text": [ "neurologic", "disturbances" ], "offsets": [ [ 397, 407 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T26", "type": "Condition", "text": [ "endocrine", "disturbances" ], "offsets": [ [ 386, 395 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T27", "type": "Condition", "text": [ "gastrointestinal", "disturbances" ], "offsets": [ [ 368, 384 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T28", "type": "Condition", "text": [ "pulmonary", "disturbances" ], "offsets": [ [ 357, 366 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T29", "type": "Condition", "text": [ "vascular", "disturbances" ], "offsets": [ [ 347, 355 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T30", "type": "Condition", "text": [ "cardiac", "disturbances" ], "offsets": [ [ 338, 345 ], [ 463, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T31", "type": "Scope", "text": [ "cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances" ], "offsets": [ [ 338, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T32", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 326, 337 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T35", "type": "Scope", "text": [ "liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances" ], "offsets": [ [ 296, 475 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T36", "type": "Drug", "text": [ "any prescription" ], "offsets": [ [ 484, 500 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T38", "type": "Drug", "text": [ "over-the-counter medication" ], "offsets": [ [ 504, 531 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T40", "type": "Drug", "text": [ "herbal medication" ], "offsets": [ [ 533, 550 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T41", "type": "Drug", "text": [ "vitamins" ], "offsets": [ [ 552, 560 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T42", "type": "Drug", "text": [ "mineral supplements" ], "offsets": [ [ 565, 584 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T43", "type": "Temporal", "text": [ "within 14 days prior to study drug administration" ], "offsets": [ [ 585, 634 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T44", "type": "Reference_point", "text": [ "study drug administration" ], "offsets": [ [ 609, 634 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T45", "type": "Drug", "text": [ "paracetamol" ], "offsets": [ [ 650, 661 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T46", "type": "Negation", "text": [ "not" ], "offsets": [ [ 636, 639 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T47", "type": "Scope", "text": [ "any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements" ], "offsets": [ [ 484, 584 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T48", "type": "Drug", "text": [ "Medication" ], "offsets": [ [ 664, 674 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T49", "type": "Condition", "text": [ "age related disease" ], "offsets": [ [ 694, 713 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T51", "type": "Multiplier", "text": [ "chronic use" ], "offsets": [ [ 679, 690 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T56", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 977, 985 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T57", "type": "Qualifier", "text": [ "unclear origin" ], "offsets": [ [ 989, 1003 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T58", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 970, 976 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T59", "type": "Qualifier", "text": [ "prolonged" ], "offsets": [ [ 957, 966 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T60", "type": "Qualifier", "text": [ "spontaneous" ], "offsets": [ [ 944, 955 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T61", "type": "Observation", "text": [ "history" ], "offsets": [ [ 933, 940 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T62", "type": "Scope", "text": [ "spontaneous, prolonged or severe" ], "offsets": [ [ 944, 976 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T64", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 1034, 1042 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T65", "type": "Condition", "text": [ "fits" ], "offsets": [ [ 1046, 1050 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T66", "type": "Condition", "text": [ "black-outs" ], "offsets": [ [ 1066, 1076 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T67", "type": "Qualifier", "text": [ "unexplained" ], "offsets": [ [ 1054, 1065 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T68", "type": "Condition", "text": [ "vasovagal collapse" ], "offsets": [ [ 1088, 1106 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T69", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1077, 1087 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T70", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1023, 1030 ] ], "normalized": [] }, { "id": "NCT02260700_exc_T71", "type": "Scope", "text": [ "epilepsy or fits or unexplained black-outs other than vasovagal collapse" ], "offsets": [ [ 1034, 1106 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02260700_exc_R2", "type": "Has_value", "arg1_id": "NCT02260700_exc_T7", "arg2_id": "NCT02260700_exc_T8", "normalized": [] }, { "id": "NCT02260700_exc_R3", "type": "Subsumes", "arg1_id": "NCT02260700_exc_T6", "arg2_id": "NCT02260700_exc_T12", "normalized": [] }, { "id": "NCT02260700_exc_R4", "type": "Has_scope", "arg1_id": "NCT02260700_exc_T13", "arg2_id": "NCT02260700_exc_T16", "normalized": [] }, { "id": "NCT02260700_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02260700_exc_T17", "arg2_id": "NCT02260700_exc_T2", "normalized": [] }, { "id": "NCT02260700_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02260700_exc_T17", "arg2_id": "NCT02260700_exc_T13", "normalized": [] }, { "id": "NCT02260700_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02260700_exc_T31", "arg2_id": "NCT02260700_exc_T32", "normalized": [] }, { "id": "NCT02260700_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02260700_exc_T35", "arg2_id": "NCT02260700_exc_T20", "normalized": [] }, { "id": "NCT02260700_exc_R8", "type": "Has_index", "arg1_id": "NCT02260700_exc_T43", "arg2_id": "NCT02260700_exc_T44", "normalized": [] }, { "id": "NCT02260700_exc_R9", "type": "Has_negation", "arg1_id": "NCT02260700_exc_T45", "arg2_id": "NCT02260700_exc_T46", "normalized": [] }, { "id": "NCT02260700_exc_R10", "type": "AND", "arg1_id": "NCT02260700_exc_T47", "arg2_id": "NCT02260700_exc_T45", "normalized": [] }, { "id": "NCT02260700_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02260700_exc_T47", "arg2_id": "NCT02260700_exc_T43", "normalized": [] }, { "id": "NCT02260700_exc_R12", "type": "Has_multiplier", "arg1_id": "NCT02260700_exc_T48", "arg2_id": "NCT02260700_exc_T51", "normalized": [] }, { "id": "NCT02260700_exc_R13", "type": "AND", "arg1_id": "NCT02260700_exc_T48", "arg2_id": "NCT02260700_exc_T49", "normalized": [] }, { "id": "NCT02260700_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02260700_exc_T56", "arg2_id": "NCT02260700_exc_T57", "normalized": [] }, { "id": "NCT02260700_exc_R15", "type": "Has_scope", "arg1_id": "NCT02260700_exc_T56", "arg2_id": "NCT02260700_exc_T62", "normalized": [] }, { "id": "NCT02260700_exc_R16", "type": "Has_temporal", "arg1_id": "NCT02260700_exc_T56", "arg2_id": "NCT02260700_exc_T61", "normalized": [] }, { "id": "NCT02260700_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT02260700_exc_T66", "arg2_id": "NCT02260700_exc_T67", "normalized": [] }, { "id": "NCT02260700_exc_R18", "type": "Has_negation", "arg1_id": "NCT02260700_exc_T68", "arg2_id": "NCT02260700_exc_T69", "normalized": [] }, { "id": "NCT02260700_exc_R19", "type": "AND", "arg1_id": "NCT02260700_exc_T66", "arg2_id": "NCT02260700_exc_T68", "normalized": [] }, { "id": "NCT02260700_exc_R20", "type": "Has_temporal", "arg1_id": "NCT02260700_exc_T71", "arg2_id": "NCT02260700_exc_T70", "normalized": [] } ]

[ { "id": "NCT02260700_inc_text", "type": "inclusion", "text": [ "Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between 18 and 30 kg/m^2, (inclusive) \nBe healthy for their age group with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or admission. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable \nBe healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel [including liver enzymes], hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participants' source documents and initialed by the investigator \nMen who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control for example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration \nParticipants' must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study \n" ], "offsets": [ [ 0, 1666 ] ] } ]

[ { "id": "NCT02260700_inc_T1", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T2", "type": "Value", "text": [ "between 18 and 30 kg/m^2" ], "offsets": [ [ 75, 99 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T3", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T4", "type": "Measurement", "text": [ "weight [kilogram(kg)]/height^2 [meter square (m^2)]" ], "offsets": [ [ 22, 73 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T6", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 188, 208 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T7", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 210, 225 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T8", "type": "Measurement", "text": [ "vital signs" ], "offsets": [ [ 227, 238 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T9", "type": "Scope", "text": [ "12-lead electrocardiogram (ECG)" ], "offsets": [ [ 244, 275 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T10", "type": "Temporal", "text": [ "performed at Screening or admission" ], "offsets": [ [ 276, 311 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T11", "type": "Reference_point", "text": [ "Screening" ], "offsets": [ [ 289, 298 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T12", "type": "Reference_point", "text": [ "admission" ], "offsets": [ [ 302, 311 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T13", "type": "Scope", "text": [ "Screening or admission" ], "offsets": [ [ 289, 311 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T14", "type": "Scope", "text": [ "physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)" ], "offsets": [ [ 188, 275 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T15", "type": "Condition", "text": [ "deviations in ECG" ], "offsets": [ [ 319, 336 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T16", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 333, 336 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T19", "type": "Qualifier", "text": [ "which are not considered to be of clinical significance to the investigator" ], "offsets": [ [ 338, 413 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T20", "type": "Procedure", "text": [ "clinical laboratory tests" ], "offsets": [ [ 458, 483 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T21", "type": "Temporal", "text": [ "performed at Screening" ], "offsets": [ [ 484, 506 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T22", "type": "Reference_point", "text": [ "at Screening" ], "offsets": [ [ 494, 506 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T24", "type": "Condition", "text": [ "healthy" ], "offsets": [ [ 434, 441 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T25", "type": "Measurement", "text": [ "serum chemistry panel" ], "offsets": [ [ 530, 551 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T26", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 563, 576 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T27", "type": "Measurement", "text": [ "hematology" ], "offsets": [ [ 579, 589 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T28", "type": "Procedure", "text": [ "urinalysis" ], "offsets": [ [ 594, 604 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T29", "type": "Value", "text": [ "outside the normal reference range" ], "offsets": [ [ 609, 643 ] ], "normalized": [] }, { "id": "NCT02260700_inc_T30", "type": "Scope", "text": [ "serum chemistry panel [including liver enzymes], hematology, or urinalysis" ], "offsets": [ [ 530, 604 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02260700_inc_R1", "type": "Subsumes", "arg1_id": "NCT02260700_inc_T1", "arg2_id": "NCT02260700_inc_T3", "normalized": [] }, { "id": "NCT02260700_inc_R2", "type": "Subsumes", "arg1_id": "NCT02260700_inc_T1", "arg2_id": "NCT02260700_inc_T4", "normalized": [] }, { "id": "NCT02260700_inc_R3", "type": "Has_value", "arg1_id": "NCT02260700_inc_T1", "arg2_id": "NCT02260700_inc_T2", "normalized": [] }, { "id": "NCT02260700_inc_R4", "type": "Has_scope", "arg1_id": "NCT02260700_inc_T10", "arg2_id": "NCT02260700_inc_T13", "normalized": [] }, { "id": "NCT02260700_inc_R5", "type": "Has_scope", "arg1_id": "NCT02260700_inc_T14", "arg2_id": "NCT02260700_inc_T13", "normalized": [] }, { "id": "NCT02260700_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02260700_inc_T15", "arg2_id": "NCT02260700_inc_T19", "normalized": [] }, { "id": "NCT02260700_inc_R7", "type": "AND", "arg1_id": "NCT02260700_inc_T15", "arg2_id": "NCT02260700_inc_T16", "normalized": [] }, { "id": "NCT02260700_inc_R8", "type": "Has_index", "arg1_id": "NCT02260700_inc_T21", "arg2_id": "NCT02260700_inc_T22", "normalized": [] }, { "id": "NCT02260700_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02260700_inc_T20", "arg2_id": "NCT02260700_inc_T21", "normalized": [] }, { "id": "NCT02260700_inc_R10", "type": "AND", "arg1_id": "NCT02260700_inc_T24", "arg2_id": "NCT02260700_inc_T20", "normalized": [] }, { "id": "NCT02260700_inc_R11", "type": "Has_value", "arg1_id": "NCT02260700_inc_T30", "arg2_id": "NCT02260700_inc_T29", "normalized": [] } ]

[ { "id": "NCT02267616_exc_text", "type": "exclusion", "text": [ "Have history of female sterilization procedure\nDesire for conception in the next 12 months\nNot sexually active with a male partner\n" ], "offsets": [ [ 0, 131 ] ] } ]

[ { "id": "NCT02267616_exc_T1", "type": "Procedure", "text": [ "female sterilization procedure" ], "offsets": [ [ 16, 46 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T2", "type": "Mood", "text": [ "Desire" ], "offsets": [ [ 47, 53 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T3", "type": "Observation", "text": [ "conception" ], "offsets": [ [ 58, 68 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T4", "type": "Temporal", "text": [ "in the next 12 months" ], "offsets": [ [ 69, 90 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T5", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 91, 94 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T6", "type": "Observation", "text": [ "sexually active" ], "offsets": [ [ 95, 110 ] ], "normalized": [] }, { "id": "NCT02267616_exc_T7", "type": "Qualifier", "text": [ "male partner" ], "offsets": [ [ 118, 130 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02267616_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02267616_exc_T3", "arg2_id": "NCT02267616_exc_T4", "normalized": [] }, { "id": "NCT02267616_exc_R2", "type": "Has_mood", "arg1_id": "NCT02267616_exc_T3", "arg2_id": "NCT02267616_exc_T2", "normalized": [] }, { "id": "NCT02267616_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02267616_exc_T6", "arg2_id": "NCT02267616_exc_T7", "normalized": [] }, { "id": "NCT02267616_exc_R4", "type": "Has_negation", "arg1_id": "NCT02267616_exc_T6", "arg2_id": "NCT02267616_exc_T5", "normalized": [] } ]

[ { "id": "NCT02267616_inc_text", "type": "inclusion", "text": [ "Women age 18-45\nWithin 6 months of expiration or beyond the end of the FDA-approved duration of use of the levonorgestrel intrauterine device (LNG-IUD = 5 years) OR the etonogestrel-releasing subdermal implant (ENG implant = 3 years)\nAble to consent in English or Spanish.\nNot pregnant at the time of enrollment\n" ], "offsets": [ [ 0, 312 ] ] } ]

[ { "id": "NCT02267616_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02267616_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 6, 9 ] ], "normalized": [] }, { "id": "NCT02267616_inc_T3", "type": "Value", "text": [ "18-45" ], "offsets": [ [ 10, 15 ] ], "normalized": [] }, { "id": "NCT02267616_inc_T6", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 273, 276 ] ], "normalized": [] }, { "id": "NCT02267616_inc_T7", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 277, 285 ] ], "normalized": [] }, { "id": "NCT02267616_inc_T8", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 286, 311 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02267616_inc_R1", "type": "Has_value", "arg1_id": "NCT02267616_inc_T2", "arg2_id": "NCT02267616_inc_T3", "normalized": [] }, { "id": "NCT02267616_inc_R2", "type": "Has_negation", "arg1_id": "NCT02267616_inc_T7", "arg2_id": "NCT02267616_inc_T6", "normalized": [] }, { "id": "NCT02267616_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02267616_inc_T7", "arg2_id": "NCT02267616_inc_T8", "normalized": [] } ]

[ { "id": "NCT02269137_exc_text", "type": "exclusion", "text": [ "hypoglycemia SE;psychogenic SE;any other pseudo-SE \n \n" ], "offsets": [ [ 0, 63 ] ] } ]

[ { "id": "NCT02269137_exc_T1", "type": "Condition", "text": [ "hypoglycemia SE" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02269137_exc_T2", "type": "Condition", "text": [ "psychogenic SE" ], "offsets": [ [ 16, 30 ] ], "normalized": [] }, { "id": "NCT02269137_exc_T3", "type": "Condition", "text": [ "pseudo-SE" ], "offsets": [ [ 41, 50 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT02269137_inc_text", "type": "inclusion", "text": [ "30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures; \nclinical data is complete. \n" ], "offsets": [ [ 0, 183 ] ] } ]

[ { "id": "NCT02269137_inc_T1", "type": "Multiplier", "text": [ "30 min or more" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T2", "type": "Condition", "text": [ "seizure" ], "offsets": [ [ 42, 49 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T3", "type": "Condition", "text": [ "seizure" ], "offsets": [ [ 78, 85 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T4", "type": "Temporal", "text": [ "continuous" ], "offsets": [ [ 22, 32 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T5", "type": "Temporal", "text": [ "recurrent" ], "offsets": [ [ 68, 77 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T6", "type": "Qualifier", "text": [ "without recovery" ], "offsets": [ [ 97, 113 ] ], "normalized": [] }, { "id": "NCT02269137_inc_T7", "type": "Scope", "text": [ "recurrent seizure" ], "offsets": [ [ 68, 85 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02269137_inc_R1", "type": "Has_temporal", "arg1_id": "NCT02269137_inc_T2", "arg2_id": "NCT02269137_inc_T4", "normalized": [] }, { "id": "NCT02269137_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02269137_inc_T3", "arg2_id": "NCT02269137_inc_T5", "normalized": [] } ]

[ { "id": "NCT02270970_exc_text", "type": "exclusion", "text": [ "NA\n\n" ], "offsets": [ [ 0, 4 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02270970_inc_text", "type": "inclusion", "text": [ "Patients who meet 1987 ACR criteria for SLE with 1996 modifications\nSLEDAI >/= 6 at screening visit\nPositive ANA OR anti-dsDNA within one year of screening\nIn the opinion of the investigator there is intent to treat with a biologic (e.g. patient failed standard of care treatment) however there is no organ threatening disease\n" ], "offsets": [ [ 0, 327 ] ] } ]

[ { "id": "NCT02270970_inc_T1", "type": "Measurement", "text": [ "1987 ACR criteria", "with 1996 modifications" ], "offsets": [ [ 18, 35 ], [ 44, 67 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T2", "type": "Condition", "text": [ "SLE" ], "offsets": [ [ 40, 43 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T3", "type": "Measurement", "text": [ "SLEDAI" ], "offsets": [ [ 68, 74 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T4", "type": "Value", "text": [ ">/= 6" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T5", "type": "Temporal", "text": [ "at screening visit" ], "offsets": [ [ 81, 99 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T6", "type": "Reference_point", "text": [ "screening visit" ], "offsets": [ [ 84, 99 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T7", "type": "Measurement", "text": [ "ANA" ], "offsets": [ [ 109, 112 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T8", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 100, 108 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T9", "type": "Measurement", "text": [ "anti-dsDNA" ], "offsets": [ [ 116, 126 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T10", "type": "Temporal", "text": [ "within one year of screening" ], "offsets": [ [ 127, 155 ] ], "normalized": [] }, { "id": "NCT02270970_inc_T11", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 146, 155 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02270970_inc_R1", "type": "AND", "arg1_id": "NCT02270970_inc_T2", "arg2_id": "NCT02270970_inc_T1", "normalized": [] }, { "id": "NCT02270970_inc_R2", "type": "Has_index", "arg1_id": "NCT02270970_inc_T5", "arg2_id": "NCT02270970_inc_T6", "normalized": [] }, { "id": "NCT02270970_inc_R3", "type": "Has_value", "arg1_id": "NCT02270970_inc_T3", "arg2_id": "NCT02270970_inc_T4", "normalized": [] }, { "id": "NCT02270970_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02270970_inc_T3", "arg2_id": "NCT02270970_inc_T5", "normalized": [] }, { "id": "NCT02270970_inc_R5", "type": "Has_index", "arg1_id": "NCT02270970_inc_T10", "arg2_id": "NCT02270970_inc_T11", "normalized": [] }, { "id": "NCT02270970_inc_R6", "type": "Has_value", "arg1_id": "NCT02270970_inc_T7", "arg2_id": "NCT02270970_inc_T8", "normalized": [] }, { "id": "NCT02270970_inc_R7", "type": "Has_value", "arg1_id": "NCT02270970_inc_T9", "arg2_id": "NCT02270970_inc_T8", "normalized": [] }, { "id": "NCT02270970_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02270970_inc_T9", "arg2_id": "NCT02270970_inc_T10", "normalized": [] }, { "id": "NCT02270970_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02270970_inc_T7", "arg2_id": "NCT02270970_inc_T10", "normalized": [] } ]

[ { "id": "NCT02273791_exc_text", "type": "exclusion", "text": [ "Moderate or severe endometriosis.\nHydrosalpinx.\nUterine abnormalities or myoma.\nPrevious uterine surgery.\n" ], "offsets": [ [ 0, 106 ] ] } ]

[ { "id": "NCT02273791_exc_T1", "type": "Condition", "text": [ "endometriosis" ], "offsets": [ [ 19, 32 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T2", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T3", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T4", "type": "Scope", "text": [ "Moderate or severe" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T5", "type": "Condition", "text": [ "Hydrosalpinx" ], "offsets": [ [ 34, 46 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T6", "type": "Condition", "text": [ "Uterine abnormalities" ], "offsets": [ [ 48, 69 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T7", "type": "Condition", "text": [ "myoma" ], "offsets": [ [ 73, 78 ] ], "normalized": [] }, { "id": "NCT02273791_exc_T8", "type": "Procedure", "text": [ "uterine surgery" ], "offsets": [ [ 89, 104 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02273791_exc_R1", "type": "Has_scope", "arg1_id": "NCT02273791_exc_T1", "arg2_id": "NCT02273791_exc_T4", "normalized": [] } ]

[ { "id": "NCT02273791_inc_text", "type": "inclusion", "text": [ "Women with PCOS as defined by the Rotterdam criteria.\nPresence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).\n" ], "offsets": [ [ 0, 278 ] ] } ]

[ { "id": "NCT02273791_inc_T1", "type": "Condition", "text": [ "PCOS" ], "offsets": [ [ 11, 15 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T2", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T3", "type": "Measurement", "text": [ "Rotterdam criteria" ], "offsets": [ [ 34, 52 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T4", "type": "Multiplier", "text": [ "at least 2" ], "offsets": [ [ 66, 76 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T5", "type": "Observation", "text": [ "cleavage-stage embryo" ], "offsets": [ [ 104, 125 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T6", "type": "Qualifier", "text": [ "good" ], "offsets": [ [ 91, 95 ] ], "normalized": [] }, { "id": "NCT02273791_inc_T7", "type": "Qualifier", "text": [ "cryopreserved" ], "offsets": [ [ 77, 90 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02273791_inc_R1", "type": "AND", "arg1_id": "NCT02273791_inc_T3", "arg2_id": "NCT02273791_inc_T1", "normalized": [] }, { "id": "NCT02273791_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02273791_inc_T5", "arg2_id": "NCT02273791_inc_T6", "normalized": [] }, { "id": "NCT02273791_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02273791_inc_T5", "arg2_id": "NCT02273791_inc_T7", "normalized": [] }, { "id": "NCT02273791_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT02273791_inc_T5", "arg2_id": "NCT02273791_inc_T4", "normalized": [] } ]

[ { "id": "NCT02277041_exc_text", "type": "exclusion", "text": [ "women undergoing caesarean section at less than 37 weeks of gestation.\nHypertension with pregnancy.\nCardiac and coronary diseases with pregnancy\n" ], "offsets": [ [ 0, 145 ] ] } ]

[ { "id": "NCT02277041_exc_T1", "type": "Person", "text": [ "women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T2", "type": "Procedure", "text": [ "caesarean section" ], "offsets": [ [ 17, 34 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T3", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 6, 16 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T4", "type": "Value", "text": [ "less than 37 weeks" ], "offsets": [ [ 38, 56 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T5", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 60, 69 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T6", "type": "Condition", "text": [ "Hypertension" ], "offsets": [ [ 71, 83 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T7", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 89, 98 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T8", "type": "Condition", "text": [ "coronary diseases" ], "offsets": [ [ 112, 129 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T9", "type": "Condition", "text": [ "rdiac a", "seases w" ], "offsets": [ [ 102, 109 ], [ 123, 131 ] ], "normalized": [] }, { "id": "NCT02277041_exc_T10", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 135, 144 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02277041_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02277041_exc_T2", "arg2_id": "NCT02277041_exc_T3", "normalized": [] }, { "id": "NCT02277041_exc_R2", "type": "Has_value", "arg1_id": "NCT02277041_exc_T5", "arg2_id": "NCT02277041_exc_T4", "normalized": [] }, { "id": "NCT02277041_exc_R3", "type": "AND", "arg1_id": "NCT02277041_exc_T2", "arg2_id": "NCT02277041_exc_T5", "normalized": [] }, { "id": "NCT02277041_exc_R4", "type": "AND", "arg1_id": "NCT02277041_exc_T6", "arg2_id": "NCT02277041_exc_T7", "normalized": [] } ]

[ { "id": "NCT02277041_inc_text", "type": "inclusion", "text": [ "Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.\n" ], "offsets": [ [ 0, 90 ] ] } ]

[ { "id": "NCT02277041_inc_T1", "type": "Condition", "text": [ "singleton pregnancy" ], "offsets": [ [ 13, 32 ] ], "normalized": [] }, { "id": "NCT02277041_inc_T2", "type": "Procedure", "text": [ "cesarean section" ], "offsets": [ [ 44, 60 ] ], "normalized": [] }, { "id": "NCT02277041_inc_T3", "type": "Value", "text": [ "after 37 weeks" ], "offsets": [ [ 61, 75 ] ], "normalized": [] }, { "id": "NCT02277041_inc_T4", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 79, 88 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02277041_inc_R1", "type": "Has_value", "arg1_id": "NCT02277041_inc_T4", "arg2_id": "NCT02277041_inc_T3", "normalized": [] }, { "id": "NCT02277041_inc_R2", "type": "AND", "arg1_id": "NCT02277041_inc_T2", "arg2_id": "NCT02277041_inc_T4", "normalized": [] } ]

[ { "id": "NCT02277067_exc_text", "type": "exclusion", "text": [ "Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.\nwomen undergoing cesarean section at less than 37 weeks of gestation.\n" ], "offsets": [ [ 0, 217 ] ] } ]

[ { "id": "NCT02277067_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 147, 152 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T3", "type": "Procedure", "text": [ "cesarean section" ], "offsets": [ [ 17, 33 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T4", "type": "Qualifier", "text": [ "general anesthesia" ], "offsets": [ [ 39, 57 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T6", "type": "Procedure", "text": [ "cesarean section" ], "offsets": [ [ 164, 180 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T7", "type": "Temporal", "text": [ "less than 37 weeks" ], "offsets": [ [ 184, 202 ] ], "normalized": [] }, { "id": "NCT02277067_exc_T8", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 206, 215 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02277067_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02277067_exc_T8", "arg2_id": "NCT02277067_exc_T7", "normalized": [] }, { "id": "NCT02277067_exc_R2", "type": "AND", "arg1_id": "NCT02277067_exc_T6", "arg2_id": "NCT02277067_exc_T8", "normalized": [] } ]

[ { "id": "NCT02277067_inc_text", "type": "inclusion", "text": [ "Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.\n" ], "offsets": [ [ 0, 90 ] ] } ]

[ { "id": "NCT02277067_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02277067_inc_T2", "type": "Condition", "text": [ "singleton pregnancy" ], "offsets": [ [ 13, 32 ] ], "normalized": [] }, { "id": "NCT02277067_inc_T3", "type": "Procedure", "text": [ "cesarean section" ], "offsets": [ [ 44, 60 ] ], "normalized": [] }, { "id": "NCT02277067_inc_T4", "type": "Value", "text": [ "after 37 weeks" ], "offsets": [ [ 61, 75 ] ], "normalized": [] }, { "id": "NCT02277067_inc_T5", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 79, 88 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02277067_inc_R1", "type": "Has_value", "arg1_id": "NCT02277067_inc_T5", "arg2_id": "NCT02277067_inc_T4", "normalized": [] }, { "id": "NCT02277067_inc_R2", "type": "AND", "arg1_id": "NCT02277067_inc_T3", "arg2_id": "NCT02277067_inc_T5", "normalized": [] } ]

[ { "id": "NCT02281643_exc_text", "type": "exclusion", "text": [ "Known intolerance to the doxycycline Body weight <40 kg Pregnancy or breastfeeding History of severe allergic reaction or anaphylaxis Alcohol or drug abuse \n \n" ], "offsets": [ [ 0, 168 ] ] } ]

[ { "id": "NCT02281643_exc_T1", "type": "Condition", "text": [ "intolerance to the doxycycline" ], "offsets": [ [ 6, 36 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T2", "type": "Drug", "text": [ "doxycycline" ], "offsets": [ [ 25, 36 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T3", "type": "Measurement", "text": [ "Body weight" ], "offsets": [ [ 37, 48 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T4", "type": "Value", "text": [ "<40 kg" ], "offsets": [ [ 49, 55 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T5", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 56, 65 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T6", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T7", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 101, 118 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T8", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T9", "type": "Condition", "text": [ "anaphylaxis" ], "offsets": [ [ 122, 133 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T10", "type": "Condition", "text": [ "Alcohol", "abuse" ], "offsets": [ [ 134, 141 ], [ 150, 155 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T11", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 145, 155 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T12", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 83, 93 ] ], "normalized": [] }, { "id": "NCT02281643_exc_T13", "type": "Scope", "text": [ "severe allergic reaction or anaphylaxis Alcohol or drug abuse" ], "offsets": [ [ 94, 155 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02281643_exc_R1", "type": "AND", "arg1_id": "NCT02281643_exc_T1", "arg2_id": "NCT02281643_exc_T2", "normalized": [] }, { "id": "NCT02281643_exc_R2", "type": "Has_value", "arg1_id": "NCT02281643_exc_T3", "arg2_id": "NCT02281643_exc_T4", "normalized": [] }, { "id": "NCT02281643_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02281643_exc_T7", "arg2_id": "NCT02281643_exc_T8", "normalized": [] }, { "id": "NCT02281643_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02281643_exc_T13", "arg2_id": "NCT02281643_exc_T12", "normalized": [] } ]

[ { "id": "NCT02281643_inc_text", "type": "inclusion", "text": [ "M. perstans mg-positive status Good general health without any clinical condition requiring long-term medication. \nNormal renal and hepatic laboratory profiles \n" ], "offsets": [ [ 0, 161 ] ] } ]

[ { "id": "NCT02281643_inc_T1", "type": "Measurement", "text": [ "hepatic laboratory profile" ], "offsets": [ [ 132, 158 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T2", "type": "Value", "text": [ "Normal" ], "offsets": [ [ 115, 121 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T3", "type": "Measurement", "text": [ "renal", "laboratory profile" ], "offsets": [ [ 122, 127 ], [ 140, 158 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T4", "type": "Measurement", "text": [ "M. perstans mg" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T5", "type": "Value", "text": [ "positive" ], "offsets": [ [ 15, 23 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T6", "type": "Condition", "text": [ "Good general health" ], "offsets": [ [ 31, 50 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T7", "type": "Condition", "text": [ "clinical condition requiring long-term medication" ], "offsets": [ [ 63, 112 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T8", "type": "Drug", "text": [ "long-term medication" ], "offsets": [ [ 92, 112 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T9", "type": "Qualifier", "text": [ "requiring long-term medication" ], "offsets": [ [ 82, 112 ] ], "normalized": [] }, { "id": "NCT02281643_inc_T11", "type": "Negation", "text": [ "without" ], "offsets": [ [ 51, 58 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02281643_inc_R1", "type": "Has_value", "arg1_id": "NCT02281643_inc_T3", "arg2_id": "NCT02281643_inc_T2", "normalized": [] }, { "id": "NCT02281643_inc_R2", "type": "Has_value", "arg1_id": "NCT02281643_inc_T1", "arg2_id": "NCT02281643_inc_T2", "normalized": [] }, { "id": "NCT02281643_inc_R3", "type": "Has_value", "arg1_id": "NCT02281643_inc_T4", "arg2_id": "NCT02281643_inc_T5", "normalized": [] }, { "id": "NCT02281643_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02281643_inc_T7", "arg2_id": "NCT02281643_inc_T9", "normalized": [] }, { "id": "NCT02281643_inc_R5", "type": "AND", "arg1_id": "NCT02281643_inc_T9", "arg2_id": "NCT02281643_inc_T8", "normalized": [] }, { "id": "NCT02281643_inc_R6", "type": "Has_negation", "arg1_id": "NCT02281643_inc_T7", "arg2_id": "NCT02281643_inc_T11", "normalized": [] } ]

[ { "id": "NCT02282319_exc_text", "type": "exclusion", "text": [ "micturition problems,\nneurological history or\nprevious lower abdominal surgery with an abnormal micturition\n" ], "offsets": [ [ 0, 108 ] ] } ]

[ { "id": "NCT02282319_exc_T1", "type": "Condition", "text": [ "micturition" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT02282319_exc_T2", "type": "Observation", "text": [ "neurological history" ], "offsets": [ [ 22, 42 ] ], "normalized": [] }, { "id": "NCT02282319_exc_T3", "type": "Procedure", "text": [ "lower abdominal surgery" ], "offsets": [ [ 55, 78 ] ], "normalized": [] }, { "id": "NCT02282319_exc_T4", "type": "Condition", "text": [ "micturition" ], "offsets": [ [ 96, 107 ] ], "normalized": [] }, { "id": "NCT02282319_exc_T5", "type": "Qualifier", "text": [ "abnormal" ], "offsets": [ [ 87, 95 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02282319_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02282319_exc_T4", "arg2_id": "NCT02282319_exc_T5", "normalized": [] } ]

[ { "id": "NCT02282319_inc_text", "type": "inclusion", "text": [ "ASA (American Society of Anesthesiologists) class 1 & 2,\nundergoing day-case knee arthroscopy\n" ], "offsets": [ [ 0, 94 ] ] } ]

[ { "id": "NCT02282319_inc_T1", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02282319_inc_T2", "type": "Value", "text": [ "class 1 & 2" ], "offsets": [ [ 44, 55 ] ], "normalized": [] }, { "id": "NCT02282319_inc_T3", "type": "Procedure", "text": [ "knee arthroscopy" ], "offsets": [ [ 77, 93 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02282319_inc_R1", "type": "Has_value", "arg1_id": "NCT02282319_inc_T1", "arg2_id": "NCT02282319_inc_T2", "normalized": [] } ]

[ { "id": "NCT02283905_exc_text", "type": "exclusion", "text": [ "The patient's data will be excluded if they die within 3 days of hospital admission.\n" ], "offsets": [ [ 0, 85 ] ] } ]

[ { "id": "NCT02283905_exc_T1", "type": "Observation", "text": [ "die" ], "offsets": [ [ 44, 47 ] ], "normalized": [] }, { "id": "NCT02283905_exc_T2", "type": "Temporal", "text": [ "within 3 days of hospital admission" ], "offsets": [ [ 48, 83 ] ], "normalized": [] }, { "id": "NCT02283905_exc_T3", "type": "Reference_point", "text": [ "hospital admission" ], "offsets": [ [ 65, 83 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02283905_exc_R1", "type": "Has_index", "arg1_id": "NCT02283905_exc_T2", "arg2_id": "NCT02283905_exc_T3", "normalized": [] }, { "id": "NCT02283905_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02283905_exc_T1", "arg2_id": "NCT02283905_exc_T2", "normalized": [] } ]

[ { "id": "NCT02283905_inc_text", "type": "inclusion", "text": [ "All adult patients 18 years of age or older admitted to the intensive care units of St. Boniface General Hospital with a diagnosis of acute pulmonary blastomycosis requiring mechanical ventilation.\n" ], "offsets": [ [ 0, 198 ] ] } ]

[ { "id": "NCT02283905_inc_T1", "type": "Person", "text": [ "adult" ], "offsets": [ [ 4, 9 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T2", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 19, 27 ], [ 35, 43 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 31, 34 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T4", "type": "Visit", "text": [ "intensive care units" ], "offsets": [ [ 60, 80 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T5", "type": "Visit", "text": [ "St. Boniface General Hospital" ], "offsets": [ [ 84, 113 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T6", "type": "Procedure", "text": [ "admitted" ], "offsets": [ [ 44, 52 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T7", "type": "Scope", "text": [ "intensive care units of St. Boniface General Hospital" ], "offsets": [ [ 60, 113 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T8", "type": "Condition", "text": [ "acute pulmonary blastomycosis" ], "offsets": [ [ 134, 163 ] ], "normalized": [] }, { "id": "NCT02283905_inc_T9", "type": "Procedure", "text": [ "mechanical ventilation" ], "offsets": [ [ 174, 196 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02283905_inc_R1", "type": "Has_value", "arg1_id": "NCT02283905_inc_T3", "arg2_id": "NCT02283905_inc_T2", "normalized": [] }, { "id": "NCT02283905_inc_R2", "type": "Has_scope", "arg1_id": "NCT02283905_inc_T6", "arg2_id": "NCT02283905_inc_T7", "normalized": [] }, { "id": "NCT02283905_inc_R3", "type": "AND", "arg1_id": "NCT02283905_inc_T8", "arg2_id": "NCT02283905_inc_T9", "normalized": [] } ]

[ { "id": "NCT02283996_exc_text", "type": "exclusion", "text": [ "Non-English speaking patients\nPregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)\nPatients who had previously undergone operative therapy for the condition\n" ], "offsets": [ [ 0, 206 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT02283996_inc_text", "type": "inclusion", "text": [ "Patient must be 18 years or older\nMust meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder\nMust be amenable to randomization into either cohort\n" ], "offsets": [ [ 0, 406 ] ] } ]

[ { "id": "NCT02283996_inc_T1", "type": "Person", "text": [ "years" ], "offsets": [ [ 19, 24 ] ], "normalized": [] }, { "id": "NCT02283996_inc_T2", "type": "Value", "text": [ "18", "or older" ], "offsets": [ [ 16, 18 ], [ 25, 33 ] ], "normalized": [] }, { "id": "NCT02283996_inc_T3", "type": "Condition", "text": [ "adhesive capsulitis" ], "offsets": [ [ 73, 92 ] ], "normalized": [] }, { "id": "NCT02283996_inc_T4", "type": "Measurement", "text": [ "American Academy of Orthopedic Surgeons" ], "offsets": [ [ 111, 150 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02283996_inc_R1", "type": "Has_value", "arg1_id": "NCT02283996_inc_T1", "arg2_id": "NCT02283996_inc_T2", "normalized": [] }, { "id": "NCT02283996_inc_R2", "type": "AND", "arg1_id": "NCT02283996_inc_T4", "arg2_id": "NCT02283996_inc_T3", "normalized": [] } ]

[ { "id": "NCT02284737_exc_text", "type": "exclusion", "text": [ "Pregnancy and breast feeding mother;\nEstimated life expectancy <12 months;\nScheduled major surgery in the next 6 months;\nInability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;\nPrevious enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.\nWHO group II, III, IV, V PH\nSevere Renal dysfunction (Ccr<30 ml/min)\nBlood platelet count<100,000/L\nExpected life span<6-month\nSystematical inflammation\nMalignant cancer(s)\nTricuspid valve stenosis, Supra-pulmonary valve stenosis\nAllergic to studied drugs or metal materials.\n" ], "offsets": [ [ 0, 695 ] ] } ]

[ { "id": "NCT02284737_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T2", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T3", "type": "Observation", "text": [ "Estimated life expectancy" ], "offsets": [ [ 37, 62 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T4", "type": "Value", "text": [ "<12 months" ], "offsets": [ [ 63, 73 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T5", "type": "Mood", "text": [ "Scheduled" ], "offsets": [ [ 75, 84 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T6", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 85, 98 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T7", "type": "Temporal", "text": [ "in the next 6 months" ], "offsets": [ [ 99, 119 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T10", "type": "Measurement", "text": [ "WHO" ], "offsets": [ [ 419, 422 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T11", "type": "Value", "text": [ "group II, III, IV, V" ], "offsets": [ [ 423, 443 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T12", "type": "Condition", "text": [ "PH" ], "offsets": [ [ 444, 446 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T13", "type": "Condition", "text": [ "Renal dysfunction" ], "offsets": [ [ 454, 471 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T14", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 447, 453 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T15", "type": "Measurement", "text": [ "Ccr" ], "offsets": [ [ 473, 476 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T16", "type": "Value", "text": [ "<30 ml/min" ], "offsets": [ [ 476, 486 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T17", "type": "Scope", "text": [ "Severe Renal dysfunction" ], "offsets": [ [ 447, 471 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T18", "type": "Measurement", "text": [ "Blood platelet count" ], "offsets": [ [ 488, 508 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T19", "type": "Value", "text": [ "<100,000/L" ], "offsets": [ [ 508, 518 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T20", "type": "Observation", "text": [ "Expected life span" ], "offsets": [ [ 519, 537 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T21", "type": "Value", "text": [ "<6-month" ], "offsets": [ [ 537, 545 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T22", "type": "Condition", "text": [ "Systematical inflammation" ], "offsets": [ [ 546, 571 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T23", "type": "Condition", "text": [ "Malignant cancer" ], "offsets": [ [ 572, 588 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T24", "type": "Condition", "text": [ "Tricuspid valve stenosis" ], "offsets": [ [ 592, 616 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T25", "type": "Condition", "text": [ "Supra-pulmonary valve stenosis" ], "offsets": [ [ 618, 648 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T26", "type": "Condition", "text": [ "Allergic" ], "offsets": [ [ 649, 657 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T27", "type": "Drug", "text": [ "studied drugs" ], "offsets": [ [ 661, 674 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T28", "type": "Drug", "text": [ "s or me", "als." ], "offsets": [ [ 673, 680 ], [ 690, 694 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T29", "type": "Scope", "text": [ "studied drugs or metal materials" ], "offsets": [ [ 661, 693 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T9", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 284, 292 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T30", "type": "Procedure", "text": [ "treatment with an investigational drug" ], "offsets": [ [ 320, 358 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T31", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 338, 358 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T32", "type": "Observation", "text": [ "enrolment in this study" ], "offsets": [ [ 293, 316 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T33", "type": "Device", "text": [ "device" ], "offsets": [ [ 362, 368 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T8", "type": "Observation", "text": [ "Inability to follow the protocol" ], "offsets": [ [ 121, 153 ] ], "normalized": [] }, { "id": "NCT02284737_exc_T34", "type": "Observation", "text": [ "bility to fo", "ply with follow-up requirements or" ], "offsets": [ [ 124, 136 ], [ 161, 195 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02284737_exc_R1", "type": "Has_value", "arg1_id": "NCT02284737_exc_T3", "arg2_id": "NCT02284737_exc_T4", "normalized": [] }, { "id": "NCT02284737_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02284737_exc_T6", "arg2_id": "NCT02284737_exc_T7", "normalized": [] }, { "id": "NCT02284737_exc_R3", "type": "Has_mood", "arg1_id": "NCT02284737_exc_T6", "arg2_id": "NCT02284737_exc_T5", "normalized": [] }, { "id": "NCT02284737_exc_R4", "type": "Has_value", "arg1_id": "NCT02284737_exc_T10", "arg2_id": "NCT02284737_exc_T11", "normalized": [] }, { "id": "NCT02284737_exc_R5", "type": "AND", "arg1_id": "NCT02284737_exc_T12", "arg2_id": "NCT02284737_exc_T10", "normalized": [] }, { "id": "NCT02284737_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02284737_exc_T13", "arg2_id": "NCT02284737_exc_T14", "normalized": [] }, { "id": "NCT02284737_exc_R7", "type": "Subsumes", "arg1_id": "NCT02284737_exc_T17", "arg2_id": "NCT02284737_exc_T15", "normalized": [] }, { "id": "NCT02284737_exc_R8", "type": "Has_value", "arg1_id": "NCT02284737_exc_T15", "arg2_id": "NCT02284737_exc_T16", "normalized": [] }, { "id": "NCT02284737_exc_R9", "type": "Has_value", "arg1_id": "NCT02284737_exc_T18", "arg2_id": "NCT02284737_exc_T19", "normalized": [] }, { "id": "NCT02284737_exc_R10", "type": "Has_value", "arg1_id": "NCT02284737_exc_T20", "arg2_id": "NCT02284737_exc_T21", "normalized": [] }, { "id": "NCT02284737_exc_R11", "type": "Has_scope", "arg1_id": "NCT02284737_exc_T26", "arg2_id": "NCT02284737_exc_T29", "normalized": [] }, { "id": "NCT02284737_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02284737_exc_T30", "arg2_id": "NCT02284737_exc_T9", "normalized": [] }, { "id": "NCT02284737_exc_R14", "type": "Has_temporal", "arg1_id": "NCT02284737_exc_T32", "arg2_id": "NCT02284737_exc_T9", "normalized": [] }, { "id": "NCT02284737_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02284737_exc_T33", "arg2_id": "NCT02284737_exc_T9", "normalized": [] } ]

[ { "id": "NCT02284737_inc_text", "type": "inclusion", "text": [ "Provision of informed consent prior to any study specific procedures;\nMen and women 18 years and older;\nGroup I PAH, defined as a mPAP=25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.\n" ], "offsets": [ [ 0, 204 ] ] } ]

[ { "id": "NCT02284737_inc_T2", "type": "Person", "text": [ "Men" ], "offsets": [ [ 70, 73 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T3", "type": "Person", "text": [ "women" ], "offsets": [ [ 78, 83 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T4", "type": "Value", "text": [ "18 years and older" ], "offsets": [ [ 84, 102 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T5", "type": "Person", "text": [ "years" ], "offsets": [ [ 87, 92 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T6", "type": "Qualifier", "text": [ "Group I" ], "offsets": [ [ 104, 111 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T7", "type": "Condition", "text": [ "PAH" ], "offsets": [ [ 112, 115 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T8", "type": "Measurement", "text": [ "mPAP" ], "offsets": [ [ 130, 134 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T9", "type": "Value", "text": [ "=25mmHg" ], "offsets": [ [ 134, 141 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T10", "type": "Measurement", "text": [ "PCWP" ], "offsets": [ [ 143, 147 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T11", "type": "Value", "text": [ "<15mmHg" ], "offsets": [ [ 147, 154 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T12", "type": "Measurement", "text": [ "PVR" ], "offsets": [ [ 159, 162 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T13", "type": "Measurement", "text": [ "(mPAP-PCWP)/CO" ], "offsets": [ [ 172, 186 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T14", "type": "Value", "text": [ ">3.0 Woods unit" ], "offsets": [ [ 187, 202 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T15", "type": "Scope", "text": [ "PVR[The PVR =(mPAP-PCWP)/CO]" ], "offsets": [ [ 159, 187 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T16", "type": "Scope", "text": [ "mPAP=25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit" ], "offsets": [ [ 130, 202 ] ], "normalized": [] }, { "id": "NCT02284737_inc_T17", "type": "Scope", "text": [ "Group I PAH" ], "offsets": [ [ 104, 115 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02284737_inc_R1", "type": "Has_value", "arg1_id": "NCT02284737_inc_T5", "arg2_id": "NCT02284737_inc_T4", "normalized": [] }, { "id": "NCT02284737_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02284737_inc_T7", "arg2_id": "NCT02284737_inc_T6", "normalized": [] }, { "id": "NCT02284737_inc_R3", "type": "Has_value", "arg1_id": "NCT02284737_inc_T8", "arg2_id": "NCT02284737_inc_T9", "normalized": [] }, { "id": "NCT02284737_inc_R4", "type": "Has_value", "arg1_id": "NCT02284737_inc_T10", "arg2_id": "NCT02284737_inc_T11", "normalized": [] }, { "id": "NCT02284737_inc_R5", "type": "Subsumes", "arg1_id": "NCT02284737_inc_T12", "arg2_id": "NCT02284737_inc_T13", "normalized": [] }, { "id": "NCT02284737_inc_R6", "type": "Has_value", "arg1_id": "NCT02284737_inc_T15", "arg2_id": "NCT02284737_inc_T14", "normalized": [] }, { "id": "NCT02284737_inc_R7", "type": "Subsumes", "arg1_id": "NCT02284737_inc_T17", "arg2_id": "NCT02284737_inc_T16", "normalized": [] } ]

[ { "id": "NCT02287259_exc_text", "type": "exclusion", "text": [ "don't have Diabetes and abnormal metabolism of sugar\nnot noticed as bipolar disorder\nhave an organic brain disease\npregnant or breastfeeding women\ndon't have heart disease\nhave actively suicidal thought(Suicidal ideation score of MADRS is 6)\nwho are judged by the investigator to should be excluded from the study\n" ], "offsets": [ [ 0, 314 ] ] } ]

[ { "id": "NCT02287259_exc_T1", "type": "Negation", "text": [ "don't have" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T2", "type": "Condition", "text": [ "Diabetes" ], "offsets": [ [ 11, 19 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T3", "type": "Condition", "text": [ "abnormal metabolism of sugar" ], "offsets": [ [ 24, 52 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T4", "type": "Scope", "text": [ "Diabetes and abnormal metabolism of sugar" ], "offsets": [ [ 11, 52 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T5", "type": "Negation", "text": [ "not" ], "offsets": [ [ 53, 56 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T6", "type": "Mood", "text": [ "noticed" ], "offsets": [ [ 57, 64 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T7", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 68, 84 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T8", "type": "Condition", "text": [ "organic brain disease" ], "offsets": [ [ 93, 114 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T9", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 115, 123 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T10", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 127, 140 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T11", "type": "Person", "text": [ "women" ], "offsets": [ [ 141, 146 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T12", "type": "Negation", "text": [ "don't have" ], "offsets": [ [ 147, 157 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T13", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 158, 171 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T14", "type": "Condition", "text": [ "actively suicidal thought" ], "offsets": [ [ 177, 202 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T15", "type": "Measurement", "text": [ "Suicidal ideation score of MADRS" ], "offsets": [ [ 203, 235 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T16", "type": "Value", "text": [ "6" ], "offsets": [ [ 239, 240 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T17", "type": "Scope", "text": [ "Suicidal ideation score of MADRS is 6" ], "offsets": [ [ 203, 240 ] ], "normalized": [] }, { "id": "NCT02287259_exc_T18", "type": "Observation", "text": [ "judged by the investigator to should be excluded from the study" ], "offsets": [ [ 250, 313 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02287259_exc_R1", "type": "Has_negation", "arg1_id": "NCT02287259_exc_T4", "arg2_id": "NCT02287259_exc_T1", "normalized": [] }, { "id": "NCT02287259_exc_R2", "type": "Has_mood", "arg1_id": "NCT02287259_exc_T7", "arg2_id": "NCT02287259_exc_T6", "normalized": [] }, { "id": "NCT02287259_exc_R3", "type": "Has_negation", "arg1_id": "NCT02287259_exc_T7", "arg2_id": "NCT02287259_exc_T5", "normalized": [] }, { "id": "NCT02287259_exc_R4", "type": "Has_negation", "arg1_id": "NCT02287259_exc_T13", "arg2_id": "NCT02287259_exc_T12", "normalized": [] }, { "id": "NCT02287259_exc_R5", "type": "Has_value", "arg1_id": "NCT02287259_exc_T15", "arg2_id": "NCT02287259_exc_T16", "normalized": [] }, { "id": "NCT02287259_exc_R6", "type": "Subsumes", "arg1_id": "NCT02287259_exc_T14", "arg2_id": "NCT02287259_exc_T17", "normalized": [] } ]

[ { "id": "NCT02287259_inc_text", "type": "inclusion", "text": [ "major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)\n18years to 65years\nsubjects who sign the informed consent document\n" ], "offsets": [ [ 0, 169 ] ] } ]

[ { "id": "NCT02287259_inc_T1", "type": "Condition", "text": [ "major depressive episode" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T2", "type": "Condition", "text": [ "type2 bipolar disorder" ], "offsets": [ [ 28, 50 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T3", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 54, 70 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T4", "type": "Qualifier", "text": [ "NOS" ], "offsets": [ [ 71, 74 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T5", "type": "Measurement", "text": [ "MADRS" ], "offsets": [ [ 76, 81 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T6", "type": "Value", "text": [ "more than 20 point" ], "offsets": [ [ 82, 100 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T7", "type": "Scope", "text": [ "MADRS more than 20 point" ], "offsets": [ [ 76, 100 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T8", "type": "Scope", "text": [ "type2 bipolar disorder or bipolar disorder NOS" ], "offsets": [ [ 28, 74 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T9", "type": "Value", "text": [ "18years to 65years" ], "offsets": [ [ 102, 120 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T10", "type": "Person", "text": [ "years" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT02287259_inc_T11", "type": "Observation", "text": [ "sign the informed consent" ], "offsets": [ [ 134, 159 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02287259_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02287259_inc_T3", "arg2_id": "NCT02287259_inc_T4", "normalized": [] }, { "id": "NCT02287259_inc_R2", "type": "Has_value", "arg1_id": "NCT02287259_inc_T5", "arg2_id": "NCT02287259_inc_T6", "normalized": [] }, { "id": "NCT02287259_inc_R3", "type": "Subsumes", "arg1_id": "NCT02287259_inc_T1", "arg2_id": "NCT02287259_inc_T7", "normalized": [] }, { "id": "NCT02287259_inc_R4", "type": "Has_scope", "arg1_id": "NCT02287259_inc_T1", "arg2_id": "NCT02287259_inc_T8", "normalized": [] }, { "id": "NCT02287259_inc_R5", "type": "Has_value", "arg1_id": "NCT02287259_inc_T10", "arg2_id": "NCT02287259_inc_T9", "normalized": [] } ]

[ { "id": "NCT02295202_exc_text", "type": "exclusion", "text": [ "Smokers\nPatients under chronic use of medications\nNeurological diseases\nCoronary artery disease\nAcute heart failure\nChronic renal failure (GFR < 30 ml/min)\nChronic obstructive pulmonary disease\nMild OSA and patients with BMI over 40 kg/m2.\n" ], "offsets": [ [ 0, 240 ] ] } ]

[ { "id": "NCT02295202_exc_T1", "type": "Condition", "text": [ "Smokers" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T2", "type": "Multiplier", "text": [ "chronic use" ], "offsets": [ [ 23, 34 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T3", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 38, 49 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T4", "type": "Condition", "text": [ "Neurological diseases" ], "offsets": [ [ 50, 71 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T5", "type": "Condition", "text": [ "Coronary artery disease" ], "offsets": [ [ 72, 95 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T6", "type": "Condition", "text": [ "Acute heart failure" ], "offsets": [ [ 96, 115 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T7", "type": "Condition", "text": [ "renal failure" ], "offsets": [ [ 124, 137 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T8", "type": "Multiplier", "text": [ "Chronic" ], "offsets": [ [ 116, 123 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T9", "type": "Measurement", "text": [ "GFR" ], "offsets": [ [ 139, 142 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T10", "type": "Value", "text": [ "< 30 ml/min" ], "offsets": [ [ 143, 154 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T11", "type": "Scope", "text": [ "Chronic renal failure" ], "offsets": [ [ 116, 137 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T12", "type": "Condition", "text": [ "obstructive pulmonary disease" ], "offsets": [ [ 164, 193 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T13", "type": "Multiplier", "text": [ "Chronic" ], "offsets": [ [ 156, 163 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T14", "type": "Condition", "text": [ "Mild OSA" ], "offsets": [ [ 194, 202 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T15", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 221, 224 ] ], "normalized": [] }, { "id": "NCT02295202_exc_T16", "type": "Value", "text": [ "over 40 kg/m2" ], "offsets": [ [ 225, 238 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02295202_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT02295202_exc_T3", "arg2_id": "NCT02295202_exc_T2", "normalized": [] }, { "id": "NCT02295202_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT02295202_exc_T7", "arg2_id": "NCT02295202_exc_T8", "normalized": [] }, { "id": "NCT02295202_exc_R3", "type": "Has_value", "arg1_id": "NCT02295202_exc_T9", "arg2_id": "NCT02295202_exc_T10", "normalized": [] }, { "id": "NCT02295202_exc_R4", "type": "Subsumes", "arg1_id": "NCT02295202_exc_T11", "arg2_id": "NCT02295202_exc_T9", "normalized": [] }, { "id": "NCT02295202_exc_R5", "type": "Has_multiplier", "arg1_id": "NCT02295202_exc_T12", "arg2_id": "NCT02295202_exc_T13", "normalized": [] }, { "id": "NCT02295202_exc_R6", "type": "Has_value", "arg1_id": "NCT02295202_exc_T15", "arg2_id": "NCT02295202_exc_T16", "normalized": [] } ]

[ { "id": "NCT02295202_inc_text", "type": "inclusion", "text": [ "Metabolic Syndrome (ATP III)\nModerate to severe OSA\n" ], "offsets": [ [ 0, 52 ] ] } ]

[ { "id": "NCT02295202_inc_T1", "type": "Condition", "text": [ "Metabolic Syndrome" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02295202_inc_T2", "type": "Measurement", "text": [ "ATP" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT02295202_inc_T3", "type": "Value", "text": [ "III" ], "offsets": [ [ 24, 27 ] ], "normalized": [] }, { "id": "NCT02295202_inc_T4", "type": "Qualifier", "text": [ "Moderate to severe" ], "offsets": [ [ 29, 47 ] ], "normalized": [] }, { "id": "NCT02295202_inc_T5", "type": "Condition", "text": [ "OSA" ], "offsets": [ [ 48, 51 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02295202_inc_R1", "type": "Has_value", "arg1_id": "NCT02295202_inc_T2", "arg2_id": "NCT02295202_inc_T3", "normalized": [] }, { "id": "NCT02295202_inc_R2", "type": "Subsumes", "arg1_id": "NCT02295202_inc_T1", "arg2_id": "NCT02295202_inc_T2", "normalized": [] }, { "id": "NCT02295202_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02295202_inc_T5", "arg2_id": "NCT02295202_inc_T4", "normalized": [] } ]

[ { "id": "NCT02298504_exc_text", "type": "exclusion", "text": [ "Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection\nChildren with systemic illness that contraindicated vital pulp treatment such a sickle cell disease\nTeeth that are not restorable\n" ], "offsets": [ [ 0, 227 ] ] } ]

[ { "id": "NCT02298504_exc_T1", "type": "Condition", "text": [ "irriversible pulpitis" ], "offsets": [ [ 32, 53 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T2", "type": "Condition", "text": [ "pulp necrosis" ], "offsets": [ [ 57, 70 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T3", "type": "Condition", "text": [ "acute dental infection" ], "offsets": [ [ 74, 96 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T4", "type": "Qualifier", "text": [ "Teeth" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T5", "type": "Condition", "text": [ "systemic illness" ], "offsets": [ [ 111, 127 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T6", "type": "Condition", "text": [ "contraindicated" ], "offsets": [ [ 133, 148 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T7", "type": "Procedure", "text": [ "vital pulp treatment" ], "offsets": [ [ 149, 169 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T8", "type": "Condition", "text": [ "sickle cell disease" ], "offsets": [ [ 177, 196 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T9", "type": "Scope", "text": [ "systemic illness that contraindicated vital pulp treatment" ], "offsets": [ [ 111, 169 ] ], "normalized": [] }, { "id": "NCT02298504_exc_T10", "type": "Observation", "text": [ "Teeth that are not restorable" ], "offsets": [ [ 197, 226 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02298504_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02298504_exc_T1", "arg2_id": "NCT02298504_exc_T4", "normalized": [] }, { "id": "NCT02298504_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02298504_exc_T2", "arg2_id": "NCT02298504_exc_T4", "normalized": [] }, { "id": "NCT02298504_exc_R3", "type": "AND", "arg1_id": "NCT02298504_exc_T6", "arg2_id": "NCT02298504_exc_T7", "normalized": [] }, { "id": "NCT02298504_exc_R4", "type": "AND", "arg1_id": "NCT02298504_exc_T5", "arg2_id": "NCT02298504_exc_T6", "normalized": [] }, { "id": "NCT02298504_exc_R5", "type": "Subsumes", "arg1_id": "NCT02298504_exc_T9", "arg2_id": "NCT02298504_exc_T8", "normalized": [] } ]

[ { "id": "NCT02298504_inc_text", "type": "inclusion", "text": [ "Pediatric patients with deep dental decay in primary molars\nTeeth with signs and symptoms of reversible pulpitis\n" ], "offsets": [ [ 0, 113 ] ] } ]

[ { "id": "NCT02298504_inc_T1", "type": "Person", "text": [ "Pediatric" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02298504_inc_T2", "type": "Condition", "text": [ "deep dental decay" ], "offsets": [ [ 24, 41 ] ], "normalized": [] }, { "id": "NCT02298504_inc_T3", "type": "Qualifier", "text": [ "primary molars" ], "offsets": [ [ 45, 59 ] ], "normalized": [] }, { "id": "NCT02298504_inc_T4", "type": "Qualifier", "text": [ "Teeth" ], "offsets": [ [ 60, 65 ] ], "normalized": [] }, { "id": "NCT02298504_inc_T5", "type": "Condition", "text": [ "reversible pulpitis" ], "offsets": [ [ 93, 112 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02298504_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02298504_inc_T2", "arg2_id": "NCT02298504_inc_T3", "normalized": [] }, { "id": "NCT02298504_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02298504_inc_T5", "arg2_id": "NCT02298504_inc_T4", "normalized": [] } ]

[ { "id": "NCT02299063_exc_text", "type": "exclusion", "text": [ "recent surgery (< 3 months)\nprevious chemotherapy\nprevious transfusion of blood products\nneurodevelopmental disorders (including Trisomy 21)\nsupplemental oxygen requirement (< 3 months)\nasthma requiring regular therapy\nobstructive sleep apnea\nthe presence of concurrent infection or inflammation\na known allergy to dexmedetomidine hydrochloride\n" ], "offsets": [ [ 0, 345 ] ] } ]

[ { "id": "NCT02299063_exc_T1", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 7, 14 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T2", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T3", "type": "Temporal", "text": [ "< 3 months" ], "offsets": [ [ 16, 26 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T4", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 28, 36 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T5", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 37, 49 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T6", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 50, 58 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T7", "type": "Procedure", "text": [ "transfusion of blood products" ], "offsets": [ [ 59, 88 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T8", "type": "Condition", "text": [ "neurodevelopmental disorders" ], "offsets": [ [ 89, 117 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T9", "type": "Condition", "text": [ "Trisomy 21" ], "offsets": [ [ 129, 139 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T10", "type": "Procedure", "text": [ "supplemental oxygen" ], "offsets": [ [ 141, 160 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T11", "type": "Mood", "text": [ "requirement" ], "offsets": [ [ 161, 172 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T12", "type": "Temporal", "text": [ "< 3 months" ], "offsets": [ [ 174, 184 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T13", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 186, 192 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T14", "type": "Procedure", "text": [ "regular therapy" ], "offsets": [ [ 203, 218 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T15", "type": "Condition", "text": [ "obstructive sleep apnea" ], "offsets": [ [ 219, 242 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T16", "type": "Temporal", "text": [ "concurrent" ], "offsets": [ [ 259, 269 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T17", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 270, 279 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T18", "type": "Condition", "text": [ "inflammation" ], "offsets": [ [ 283, 295 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T19", "type": "Scope", "text": [ "infection or inflammation" ], "offsets": [ [ 270, 295 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T20", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 304, 311 ] ], "normalized": [] }, { "id": "NCT02299063_exc_T21", "type": "Drug", "text": [ "dexmedetomidine hydrochloride" ], "offsets": [ [ 315, 344 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02299063_exc_R1", "type": "Subsumes", "arg1_id": "NCT02299063_exc_T2", "arg2_id": "NCT02299063_exc_T3", "normalized": [] }, { "id": "NCT02299063_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02299063_exc_T1", "arg2_id": "NCT02299063_exc_T2", "normalized": [] }, { "id": "NCT02299063_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02299063_exc_T5", "arg2_id": "NCT02299063_exc_T4", "normalized": [] }, { "id": "NCT02299063_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02299063_exc_T7", "arg2_id": "NCT02299063_exc_T6", "normalized": [] }, { "id": "NCT02299063_exc_R5", "type": "Subsumes", "arg1_id": "NCT02299063_exc_T8", "arg2_id": "NCT02299063_exc_T9", "normalized": [] }, { "id": "NCT02299063_exc_R6", "type": "Has_mood", "arg1_id": "NCT02299063_exc_T10", "arg2_id": "NCT02299063_exc_T11", "normalized": [] }, { "id": "NCT02299063_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02299063_exc_T10", "arg2_id": "NCT02299063_exc_T12", "normalized": [] }, { "id": "NCT02299063_exc_R8", "type": "AND", "arg1_id": "NCT02299063_exc_T13", "arg2_id": "NCT02299063_exc_T14", "normalized": [] }, { "id": "NCT02299063_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02299063_exc_T19", "arg2_id": "NCT02299063_exc_T16", "normalized": [] }, { "id": "NCT02299063_exc_R10", "type": "AND", "arg1_id": "NCT02299063_exc_T20", "arg2_id": "NCT02299063_exc_T21", "normalized": [] } ]

[ { "id": "NCT02299063_inc_text", "type": "inclusion", "text": [ "aged between 3 - 36 months\nhaving primary corrective heart surgery\n" ], "offsets": [ [ 0, 67 ] ] } ]

[ { "id": "NCT02299063_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02299063_inc_T2", "type": "Value", "text": [ "between 3 - 36 months" ], "offsets": [ [ 5, 26 ] ], "normalized": [] }, { "id": "NCT02299063_inc_T3", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 34, 41 ] ], "normalized": [] }, { "id": "NCT02299063_inc_T4", "type": "Procedure", "text": [ "corrective heart surgery" ], "offsets": [ [ 42, 66 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02299063_inc_R1", "type": "Has_value", "arg1_id": "NCT02299063_inc_T1", "arg2_id": "NCT02299063_inc_T2", "normalized": [] }, { "id": "NCT02299063_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02299063_inc_T4", "arg2_id": "NCT02299063_inc_T3", "normalized": [] } ]

[ { "id": "NCT02299947_exc_text", "type": "exclusion", "text": [ "Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration <1g/L\n" ], "offsets": [ [ 0, 196 ] ] } ]

[ { "id": "NCT02299947_exc_T1", "type": "Condition", "text": [ "trombosis" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T2", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T3", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 19, 40 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T4", "type": "Condition", "text": [ "congenital coagulation disorder" ], "offsets": [ [ 42, 73 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T5", "type": "Drug", "text": [ "anti-coagulants" ], "offsets": [ [ 82, 97 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T6", "type": "Temporal", "text": [ "prior to surgery" ], "offsets": [ [ 98, 114 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T7", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 116, 121 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T8", "type": "Procedure", "text": [ "thoracic surgery" ], "offsets": [ [ 122, 138 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T9", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 140, 149 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T10", "type": "Temporal", "text": [ "pre-operative" ], "offsets": [ [ 151, 164 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T11", "type": "Measurement", "text": [ "fibrinogen concentration" ], "offsets": [ [ 165, 189 ] ], "normalized": [] }, { "id": "NCT02299947_exc_T12", "type": "Value", "text": [ "<1g/L" ], "offsets": [ [ 190, 195 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02299947_exc_R1", "type": "Has_value", "arg1_id": "NCT02299947_exc_T11", "arg2_id": "NCT02299947_exc_T12", "normalized": [] }, { "id": "NCT02299947_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02299947_exc_T11", "arg2_id": "NCT02299947_exc_T10", "normalized": [] }, { "id": "NCT02299947_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02299947_exc_T8", "arg2_id": "NCT02299947_exc_T7", "normalized": [] }, { "id": "NCT02299947_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02299947_exc_T5", "arg2_id": "NCT02299947_exc_T6", "normalized": [] }, { "id": "NCT02299947_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02299947_exc_T1", "arg2_id": "NCT02299947_exc_T2", "normalized": [] } ]

[ { "id": "NCT02299947_inc_text", "type": "inclusion", "text": [ "Elective surgery for thoracic aneurysm\n" ], "offsets": [ [ 0, 39 ] ] } ]

[ { "id": "NCT02299947_inc_T1", "type": "Procedure", "text": [ "Elective surgery" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02299947_inc_T2", "type": "Condition", "text": [ "thoracic aneurysm" ], "offsets": [ [ 21, 38 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02299947_inc_R1", "type": "AND", "arg1_id": "NCT02299947_inc_T1", "arg2_id": "NCT02299947_inc_T2", "normalized": [] } ]

[ { "id": "NCT02301039_exc_text", "type": "exclusion", "text": [ "Prior systemic therapy targeting PD-1: PD-L1 axis. \nPatients who are curable by conventional multidisciplinary management. \nPatients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol. \nPatients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy. \nPatients who have active infections requiring therapy. \nPatients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA [qualitative] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing. \nPatients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial. \nPatients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames: \nPatients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study. \nWomen who are pregnant or nursing/breastfeeding. \nKnown hypersensitivity to pembrolizumab or another mAb. \nHas a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. \nPatients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible. \nInability to comply with protocol required procedures. \nPatients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening. \nPatients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis). \nPatients who have received a live vaccine within 30 days prior to the first dose of trial treatment. \n \n" ], "offsets": [ [ 0, 2776 ] ] } ]

[ { "id": "NCT02301039_exc_T1", "type": "Procedure", "text": [ "systemic therapy targeting PD-1: PD-L1 axis" ], "offsets": [ [ 6, 49 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T2", "type": "Procedure", "text": [ "conventional multidisciplinary management" ], "offsets": [ [ 80, 121 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T3", "type": "Qualifier", "text": [ "curable" ], "offsets": [ [ 69, 76 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T5", "type": "Condition", "text": [ "medical disease" ], "offsets": [ [ 176, 191 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T7", "type": "Temporal", "text": [ "concurrent" ], "offsets": [ [ 165, 175 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T8", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 152, 164 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 138, 144 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T10", "type": "Scope", "text": [ "severe and/or uncontrolled" ], "offsets": [ [ 138, 164 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T13", "type": "Procedure", "text": [ "wide field radiotherapy" ], "offsets": [ [ 342, 365 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T14", "type": "Temporal", "text": [ "≤ 4 weeks" ], "offsets": [ [ 366, 375 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T15", "type": "Procedure", "text": [ "limited field radiation for palliation" ], "offsets": [ [ 379, 417 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T16", "type": "Temporal", "text": [ "< 2 weeks prior to screening" ], "offsets": [ [ 418, 446 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T17", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 437, 446 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T18", "type": "Condition", "text": [ "recovered" ], "offsets": [ [ 463, 472 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T19", "type": "Qualifier", "text": [ "adequately" ], "offsets": [ [ 473, 483 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T20", "type": "Negation", "text": [ "not" ], "offsets": [ [ 459, 462 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T21", "type": "Condition", "text": [ "side effects of such therapy" ], "offsets": [ [ 489, 517 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T23", "type": "Procedure", "text": [ "such therapy" ], "offsets": [ [ 505, 517 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T24", "type": "Condition", "text": [ "infections" ], "offsets": [ [ 545, 555 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T25", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 566, 573 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T26", "type": "Qualifier", "text": [ "requiring therapy" ], "offsets": [ [ 556, 573 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T27", "type": "Measurement", "text": [ "Human Immunodeficiency Virus (HIV)" ], "offsets": [ [ 619, 653 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T28", "type": "Value", "text": [ "positive" ], "offsets": [ [ 606, 614 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T29", "type": "Qualifier", "text": [ "HIV 1/2 antibodies" ], "offsets": [ [ 655, 673 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T30", "type": "Condition", "text": [ "active Hepatitis B" ], "offsets": [ [ 676, 694 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T31", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 696, 701 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T32", "type": "Value", "text": [ "reactive" ], "offsets": [ [ 702, 710 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T33", "type": "Condition", "text": [ "Hepatitis C" ], "offsets": [ [ 716, 727 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T34", "type": "Measurement", "text": [ "HCV RNA [qualitative]" ], "offsets": [ [ 729, 750 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T35", "type": "Value", "text": [ "detected" ], "offsets": [ [ 754, 762 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T36", "type": "Measurement", "text": [ "Hepatitis C antibody" ], "offsets": [ [ 788, 808 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T37", "type": "Value", "text": [ "negative" ], "offsets": [ [ 779, 787 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T40", "type": "Condition", "text": [ "psychiatric", "disorder" ], "offsets": [ [ 871, 882 ], [ 902, 910 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T41", "type": "Condition", "text": [ "substance abuse disorder" ], "offsets": [ [ 886, 910 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T43", "type": "Procedure", "text": [ "systemic anti-cancer treatment" ], "offsets": [ [ 1008, 1038 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T44", "type": "Temporal", "text": [ "prior to the first dose of study drug" ], "offsets": [ [ 1039, 1076 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T45", "type": "Reference_point", "text": [ "the first dose of study drug" ], "offsets": [ [ 1048, 1076 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T47", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1133, 1151 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T48", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 1126, 1132 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T49", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1179, 1197 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T50", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1168, 1175 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T51", "type": "Condition", "text": [ "syndrome that requires systemic steroids" ], "offsets": [ [ 1201, 1241 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T52", "type": "Drug", "text": [ "systemic steroids" ], "offsets": [ [ 1224, 1241 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T54", "type": "Drug", "text": [ "immunosuppressive agents" ], "offsets": [ [ 1245, 1269 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T55", "type": "Condition", "text": [ "syndrome that requires", "immunosuppressive agents" ], "offsets": [ [ 1201, 1223 ], [ 1245, 1269 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T56", "type": "Condition", "text": [ "childhood asthma" ], "offsets": [ [ 1306, 1322 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T57", "type": "Qualifier", "text": [ "resolved" ], "offsets": [ [ 1297, 1305 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T58", "type": "Condition", "text": [ "vitiligo" ], "offsets": [ [ 1285, 1293 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T59", "type": "Condition", "text": [ "atopy" ], "offsets": [ [ 1323, 1328 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T63", "type": "Condition", "text": [ "hypothyroidism" ], "offsets": [ [ 1481, 1495 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T64", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1505, 1523 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T65", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1496, 1499 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T66", "type": "Qualifier", "text": [ "stable on hormone replacement" ], "offsets": [ [ 1532, 1561 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T67", "type": "Procedure", "text": [ "hormone replacement" ], "offsets": [ [ 1542, 1561 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T70", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1600, 1605 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T71", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1614, 1622 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T72", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 1626, 1633 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T73", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 1634, 1647 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T74", "type": "Condition", "text": [ "hypersensitivity to pembrolizumab" ], "offsets": [ [ 1656, 1689 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T75", "type": "Drug", "text": [ "pembrolizumab" ], "offsets": [ [ 1676, 1689 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T76", "type": "Condition", "text": [ "hypersensitivity to", "mAb" ], "offsets": [ [ 1656, 1675 ], [ 1701, 1704 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T77", "type": "Drug", "text": [ "mAb" ], "offsets": [ [ 1701, 1704 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T78", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 1767, 1775 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T79", "type": "Condition", "text": [ "pneumonitis" ], "offsets": [ [ 1787, 1798 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T80", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1779, 1786 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T81", "type": "Condition", "text": [ "pneumonitis" ], "offsets": [ [ 1741, 1752 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T82", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1713, 1720 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T83", "type": "Qualifier", "text": [ "required steroids" ], "offsets": [ [ 1758, 1775 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T84", "type": "Condition", "text": [ "central nervous system disease" ], "offsets": [ [ 1825, 1855 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T86", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 1815, 1824 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T87", "type": "Condition", "text": [ "CNS lesions" ], "offsets": [ [ 1890, 1901 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T88", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1921, 1928 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T89", "type": "Procedure", "text": [ "stereotactic radiosurgery" ], "offsets": [ [ 1932, 1957 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T90", "type": "Temporal", "text": [ "for 4 weeks" ], "offsets": [ [ 1969, 1980 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T91", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 1962, 1968 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T92", "type": "Scope", "text": [ "surgery or stereotactic radiosurgery" ], "offsets": [ [ 1921, 1957 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T93", "type": "Qualifier", "text": [ "controlled" ], "offsets": [ [ 1871, 1881 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T94", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 1882, 1889 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T95", "type": "Condition", "text": [ "Inability to comply with protocol required procedures." ], "offsets": [ [ 1996, 2050 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T99", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 2066, 2084 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T100", "type": "Procedure", "text": [ "systemic corticosteroid therapy" ], "offsets": [ [ 2106, 2137 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T101", "type": "Temporal", "text": [ "chronic" ], "offsets": [ [ 2098, 2105 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T102", "type": "Drug", "text": [ "immunosuppressive medication" ], "offsets": [ [ 2167, 2195 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T104", "type": "Qualifier", "text": [ "require chronic systemic corticosteroid therapy" ], "offsets": [ [ 2090, 2137 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T105", "type": "Qualifier", "text": [ "require", "immunosuppressive medication" ], "offsets": [ [ 2141, 2148 ], [ 2167, 2195 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T106", "type": "Scope", "text": [ "require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication" ], "offsets": [ [ 2090, 2195 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T107", "type": "Multiplier", "text": [ "physiologic replacement doses" ], "offsets": [ [ 2221, 2250 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T108", "type": "Drug", "text": [ "hydrocortisone" ], "offsets": [ [ 2254, 2268 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T109", "type": "Drug", "text": [ "hydrocortisone" ], "offsets": [ [ 2345, 2359 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T110", "type": "Multiplier", "text": [ "up to 20 mg" ], "offsets": [ [ 2333, 2344 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T111", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 2372, 2382 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T112", "type": "Multiplier", "text": [ "5 mg" ], "offsets": [ [ 2364, 2368 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T113", "type": "Drug", "text": [ "hydrocortisone" ], "offsets": [ [ 2409, 2423 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T114", "type": "Multiplier", "text": [ "10 mg" ], "offsets": [ [ 2403, 2408 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T115", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 2435, 2445 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T116", "type": "Multiplier", "text": [ "2.5 mg" ], "offsets": [ [ 2428, 2434 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T117", "type": "Multiplier", "text": [ "in the morning" ], "offsets": [ [ 2384, 2398 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T118", "type": "Multiplier", "text": [ "in the evening" ], "offsets": [ [ 2447, 2461 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T119", "type": "Scope", "text": [ "up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening" ], "offsets": [ [ 2333, 2461 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T120", "type": "Scope", "text": [ "physiologic replacement doses of hydrocortisone" ], "offsets": [ [ 2221, 2268 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T121", "type": "Condition", "text": [ "bowel obstruction" ], "offsets": [ [ 2499, 2516 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T122", "type": "Condition", "text": [ "bowel perforation" ], "offsets": [ [ 2520, 2537 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T123", "type": "Condition", "text": [ "risk factors for bowel obstruction" ], "offsets": [ [ 2482, 2516 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T124", "type": "Condition", "text": [ "risk factors for", "bowel perforation" ], "offsets": [ [ 2482, 2498 ], [ 2520, 2537 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T125", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2577, 2584 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T126", "type": "Condition", "text": [ "acute diverticulitis" ], "offsets": [ [ 2588, 2608 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T127", "type": "Condition", "text": [ "intra-abdominal abscess" ], "offsets": [ [ 2610, 2633 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T128", "type": "Condition", "text": [ "abdominal carcinomatosis" ], "offsets": [ [ 2635, 2659 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T129", "type": "Scope", "text": [ "acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis" ], "offsets": [ [ 2588, 2659 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T130", "type": "Scope", "text": [ "risk factors for bowel obstruction or bowel perforation" ], "offsets": [ [ 2482, 2537 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T131", "type": "Drug", "text": [ "live vaccine" ], "offsets": [ [ 2692, 2704 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T132", "type": "Temporal", "text": [ "within 30 days prior to the first dose of trial treatment" ], "offsets": [ [ 2705, 2762 ] ], "normalized": [] }, { "id": "NCT02301039_exc_T133", "type": "Reference_point", "text": [ "the first dose of trial treatment" ], "offsets": [ [ 2729, 2762 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02301039_exc_R1", "type": "AND", "arg1_id": "NCT02301039_exc_T3", "arg2_id": "NCT02301039_exc_T2", "normalized": [] }, { "id": "NCT02301039_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T5", "arg2_id": "NCT02301039_exc_T7", "normalized": [] }, { "id": "NCT02301039_exc_R3", "type": "Has_scope", "arg1_id": "NCT02301039_exc_T5", "arg2_id": "NCT02301039_exc_T10", "normalized": [] }, { "id": "NCT02301039_exc_R4", "type": "Has_index", "arg1_id": "NCT02301039_exc_T16", "arg2_id": "NCT02301039_exc_T17", "normalized": [] }, { "id": "NCT02301039_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T15", "arg2_id": "NCT02301039_exc_T16", "normalized": [] }, { "id": "NCT02301039_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T13", "arg2_id": "NCT02301039_exc_T14", "normalized": [] }, { "id": "NCT02301039_exc_R7", "type": "Has_negation", "arg1_id": "NCT02301039_exc_T18", "arg2_id": "NCT02301039_exc_T20", "normalized": [] }, { "id": "NCT02301039_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T18", "arg2_id": "NCT02301039_exc_T19", "normalized": [] }, { "id": "NCT02301039_exc_R9", "type": "AND", "arg1_id": "NCT02301039_exc_T21", "arg2_id": "NCT02301039_exc_T23", "normalized": [] }, { "id": "NCT02301039_exc_R10", "type": "AND", "arg1_id": "NCT02301039_exc_T18", "arg2_id": "NCT02301039_exc_T21", "normalized": [] }, { "id": "NCT02301039_exc_R11", "type": "AND", "arg1_id": "NCT02301039_exc_T26", "arg2_id": "NCT02301039_exc_T25", "normalized": [] }, { "id": "NCT02301039_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T24", "arg2_id": "NCT02301039_exc_T26", "normalized": [] }, { "id": "NCT02301039_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T27", "arg2_id": "NCT02301039_exc_T29", "normalized": [] }, { "id": "NCT02301039_exc_R14", "type": "Has_value", "arg1_id": "NCT02301039_exc_T27", "arg2_id": "NCT02301039_exc_T28", "normalized": [] }, { "id": "NCT02301039_exc_R15", "type": "Has_value", "arg1_id": "NCT02301039_exc_T31", "arg2_id": "NCT02301039_exc_T32", "normalized": [] }, { "id": "NCT02301039_exc_R16", "type": "Subsumes", "arg1_id": "NCT02301039_exc_T30", "arg2_id": "NCT02301039_exc_T31", "normalized": [] }, { "id": "NCT02301039_exc_R17", "type": "Has_value", "arg1_id": "NCT02301039_exc_T34", "arg2_id": "NCT02301039_exc_T35", "normalized": [] }, { "id": "NCT02301039_exc_R18", "type": "AND", "arg1_id": "NCT02301039_exc_T33", "arg2_id": "NCT02301039_exc_T34", "normalized": [] }, { "id": "NCT02301039_exc_R19", "type": "Has_value", "arg1_id": "NCT02301039_exc_T36", "arg2_id": "NCT02301039_exc_T37", "normalized": [] }, { "id": "NCT02301039_exc_R20", "type": "Has_index", "arg1_id": "NCT02301039_exc_T44", "arg2_id": "NCT02301039_exc_T45", "normalized": [] }, { "id": "NCT02301039_exc_R21", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T43", "arg2_id": "NCT02301039_exc_T44", "normalized": [] }, { "id": "NCT02301039_exc_R22", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T47", "arg2_id": "NCT02301039_exc_T48", "normalized": [] }, { "id": "NCT02301039_exc_R23", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T49", "arg2_id": "NCT02301039_exc_T50", "normalized": [] }, { "id": "NCT02301039_exc_R24", "type": "AND", "arg1_id": "NCT02301039_exc_T51", "arg2_id": "NCT02301039_exc_T52", "normalized": [] }, { "id": "NCT02301039_exc_R25", "type": "AND", "arg1_id": "NCT02301039_exc_T55", "arg2_id": "NCT02301039_exc_T54", "normalized": [] }, { "id": "NCT02301039_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T56", "arg2_id": "NCT02301039_exc_T57", "normalized": [] }, { "id": "NCT02301039_exc_R27", "type": "Has_negation", "arg1_id": "NCT02301039_exc_T64", "arg2_id": "NCT02301039_exc_T65", "normalized": [] }, { "id": "NCT02301039_exc_R28", "type": "AND", "arg1_id": "NCT02301039_exc_T63", "arg2_id": "NCT02301039_exc_T64", "normalized": [] }, { "id": "NCT02301039_exc_R29", "type": "AND", "arg1_id": "NCT02301039_exc_T66", "arg2_id": "NCT02301039_exc_T67", "normalized": [] }, { "id": "NCT02301039_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T63", "arg2_id": "NCT02301039_exc_T66", "normalized": [] }, { "id": "NCT02301039_exc_R31", "type": "AND", "arg1_id": "NCT02301039_exc_T74", "arg2_id": "NCT02301039_exc_T75", "normalized": [] }, { "id": "NCT02301039_exc_R32", "type": "AND", "arg1_id": "NCT02301039_exc_T76", "arg2_id": "NCT02301039_exc_T77", "normalized": [] }, { "id": "NCT02301039_exc_R33", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T79", "arg2_id": "NCT02301039_exc_T80", "normalized": [] }, { "id": "NCT02301039_exc_R34", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T81", "arg2_id": "NCT02301039_exc_T82", "normalized": [] }, { "id": "NCT02301039_exc_R35", "type": "AND", "arg1_id": "NCT02301039_exc_T83", "arg2_id": "NCT02301039_exc_T78", "normalized": [] }, { "id": "NCT02301039_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T81", "arg2_id": "NCT02301039_exc_T83", "normalized": [] }, { "id": "NCT02301039_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T84", "arg2_id": "NCT02301039_exc_T86", "normalized": [] }, { "id": "NCT02301039_exc_R38", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T91", "arg2_id": "NCT02301039_exc_T90", "normalized": [] }, { "id": "NCT02301039_exc_R39", "type": "Has_scope", "arg1_id": "NCT02301039_exc_T87", "arg2_id": "NCT02301039_exc_T92", "normalized": [] }, { "id": "NCT02301039_exc_R40", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T87", "arg2_id": "NCT02301039_exc_T91", "normalized": [] }, { "id": "NCT02301039_exc_R41", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T87", "arg2_id": "NCT02301039_exc_T94", "normalized": [] }, { "id": "NCT02301039_exc_R42", "type": "Has_qualifier", "arg1_id": "NCT02301039_exc_T87", "arg2_id": "NCT02301039_exc_T93", "normalized": [] }, { "id": "NCT02301039_exc_R43", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T100", "arg2_id": "NCT02301039_exc_T101", "normalized": [] }, { "id": "NCT02301039_exc_R44", "type": "AND", "arg1_id": "NCT02301039_exc_T105", "arg2_id": "NCT02301039_exc_T102", "normalized": [] }, { "id": "NCT02301039_exc_R45", "type": "AND", "arg1_id": "NCT02301039_exc_T104", "arg2_id": "NCT02301039_exc_T100", "normalized": [] }, { "id": "NCT02301039_exc_R46", "type": "Has_scope", "arg1_id": "NCT02301039_exc_T99", "arg2_id": "NCT02301039_exc_T106", "normalized": [] }, { "id": "NCT02301039_exc_R47", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T108", "arg2_id": "NCT02301039_exc_T107", "normalized": [] }, { "id": "NCT02301039_exc_R48", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T109", "arg2_id": "NCT02301039_exc_T110", "normalized": [] }, { "id": "NCT02301039_exc_R49", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T111", "arg2_id": "NCT02301039_exc_T112", "normalized": [] }, { "id": "NCT02301039_exc_R50", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T113", "arg2_id": "NCT02301039_exc_T114", "normalized": [] }, { "id": "NCT02301039_exc_R51", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T115", "arg2_id": "NCT02301039_exc_T116", "normalized": [] }, { "id": "NCT02301039_exc_R52", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T113", "arg2_id": "NCT02301039_exc_T118", "normalized": [] }, { "id": "NCT02301039_exc_R53", "type": "Has_multiplier", "arg1_id": "NCT02301039_exc_T109", "arg2_id": "NCT02301039_exc_T117", "normalized": [] }, { "id": "NCT02301039_exc_R54", "type": "Subsumes", "arg1_id": "NCT02301039_exc_T120", "arg2_id": "NCT02301039_exc_T119", "normalized": [] }, { "id": "NCT02301039_exc_R55", "type": "AND", "arg1_id": "NCT02301039_exc_T123", "arg2_id": "NCT02301039_exc_T121", "normalized": [] }, { "id": "NCT02301039_exc_R56", "type": "AND", "arg1_id": "NCT02301039_exc_T124", "arg2_id": "NCT02301039_exc_T122", "normalized": [] }, { "id": "NCT02301039_exc_R57", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T129", "arg2_id": "NCT02301039_exc_T125", "normalized": [] }, { "id": "NCT02301039_exc_R58", "type": "Subsumes", "arg1_id": "NCT02301039_exc_T130", "arg2_id": "NCT02301039_exc_T129", "normalized": [] }, { "id": "NCT02301039_exc_R59", "type": "Has_index", "arg1_id": "NCT02301039_exc_T132", "arg2_id": "NCT02301039_exc_T133", "normalized": [] }, { "id": "NCT02301039_exc_R60", "type": "Has_temporal", "arg1_id": "NCT02301039_exc_T131", "arg2_id": "NCT02301039_exc_T132", "normalized": [] } ]

[ { "id": "NCT02301039_inc_text", "type": "inclusion", "text": [ "Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas). \nHistologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]). \nECOG Performance Status of 0 or 1. \nAt least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing. \nAt least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts. \nPatients may have received 1-3 prior systemic therapies in the metastatic setting. \nAdequate organ function within 14 days of dosing \nMust be willing to provide and have available archival tissue for PD-L1 testing. \nWritten, voluntary informed consent. \nFertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study. \nEffective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence. \nLife expectancy of >12 weeks. \nPatients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab. \n" ], "offsets": [ [ 0, 2061 ] ] } ]

[ { "id": "NCT02301039_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T2", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 4, 14 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T3", "type": "Person", "text": [ "Age" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T4", "type": "Value", "text": [ "≥ 12 years" ], "offsets": [ [ 20, 30 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T5", "type": "Condition", "text": [ "bone sarcomas" ], "offsets": [ [ 49, 62 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T6", "type": "Procedure", "text": [ "Histologically" ], "offsets": [ [ 66, 80 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T7", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 81, 90 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T8", "type": "Condition", "text": [ "soft-tissue", "sarcoma" ], "offsets": [ [ 158, 169 ], [ 178, 185 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T9", "type": "Qualifier", "text": [ "high grade" ], "offsets": [ [ 147, 157 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T10", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 136, 146 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T11", "type": "Temporal", "text": [ "recurrent" ], "offsets": [ [ 118, 127 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T12", "type": "Qualifier", "text": [ "unresectable" ], "offsets": [ [ 104, 116 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T13", "type": "Condition", "text": [ "bone sarcoma" ], "offsets": [ [ 173, 185 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T14", "type": "Scope", "text": [ "soft-tissue or bone sarcoma" ], "offsets": [ [ 158, 185 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T15", "type": "Scope", "text": [ "unresectable, recurrent, and/or metastatic high grade" ], "offsets": [ [ 104, 157 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T16", "type": "Condition", "text": [ "soft tissue sarcomas" ], "offsets": [ [ 220, 240 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T17", "type": "Condition", "text": [ "leiomyosarcoma" ], "offsets": [ [ 242, 256 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T18", "type": "Condition", "text": [ "liposarcoma" ], "offsets": [ [ 298, 309 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T19", "type": "Qualifier", "text": [ "poorly differentiated" ], "offsets": [ [ 258, 279 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T20", "type": "Qualifier", "text": [ "de-differentiated" ], "offsets": [ [ 280, 297 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T21", "type": "Scope", "text": [ "poorly differentiated/de-differentiated" ], "offsets": [ [ 258, 297 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T22", "type": "Condition", "text": [ "sarcoma" ], "offsets": [ [ 351, 358 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T23", "type": "Qualifier", "text": [ "undifferentiated" ], "offsets": [ [ 334, 350 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T24", "type": "Qualifier", "text": [ "pleomorphic" ], "offsets": [ [ 322, 333 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T25", "type": "Qualifier", "text": [ "high grade" ], "offsets": [ [ 311, 321 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T26", "type": "Condition", "text": [ "MFH" ], "offsets": [ [ 359, 362 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T27", "type": "Condition", "text": [ "synovial sarcoma" ], "offsets": [ [ 367, 383 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T28", "type": "Scope", "text": [ "sarcoma/MFH and synovial sarcoma" ], "offsets": [ [ 351, 383 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T29", "type": "Scope", "text": [ "high grade pleomorphic undifferentiated" ], "offsets": [ [ 311, 350 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T30", "type": "Condition", "text": [ "bone sarcomas" ], "offsets": [ [ 390, 403 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T31", "type": "Condition", "text": [ "Ewing sarcoma" ], "offsets": [ [ 405, 418 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T32", "type": "Condition", "text": [ "osteosarcoma" ], "offsets": [ [ 420, 432 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T33", "type": "Condition", "text": [ "chondrosarcoma" ], "offsets": [ [ 438, 452 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T34", "type": "Qualifier", "text": [ "de-differentiated" ], "offsets": [ [ 454, 471 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T35", "type": "Qualifier", "text": [ "mesenchymal" ], "offsets": [ [ 475, 486 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T36", "type": "Scope", "text": [ "de-differentiated or mesenchymal" ], "offsets": [ [ 454, 486 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T37", "type": "Scope", "text": [ "(Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal])" ], "offsets": [ [ 404, 488 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T38", "type": "Scope", "text": [ "leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma" ], "offsets": [ [ 242, 383 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T40", "type": "Scope", "text": [ "soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal])" ], "offsets": [ [ 220, 488 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T41", "type": "Measurement", "text": [ "ECOG Performance Status" ], "offsets": [ [ 491, 514 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T42", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 518, 524 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T43", "type": "Condition", "text": [ "measurable disease" ], "offsets": [ [ 548, 566 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T44", "type": "Procedure", "text": [ "CT", "scans" ], "offsets": [ [ 570, 572 ], [ 577, 582 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T45", "type": "Procedure", "text": [ "MRI scans" ], "offsets": [ [ 573, 582 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T46", "type": "Scope", "text": [ "CT/MRI scans" ], "offsets": [ [ 570, 582 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T47", "type": "Procedure", "text": [ "imaging" ], "offsets": [ [ 618, 625 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T48", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 609, 617 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T49", "type": "Temporal", "text": [ "within 30 days of dosing" ], "offsets": [ [ 644, 668 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T50", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 662, 668 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T52", "type": "Multiplier", "text": [ "1-3" ], "offsets": [ [ 840, 843 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T53", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 844, 849 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T54", "type": "Procedure", "text": [ "systemic therapies" ], "offsets": [ [ 850, 868 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T55", "type": "Qualifier", "text": [ "metastatic setting" ], "offsets": [ [ 876, 894 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T56", "type": "Condition", "text": [ "Adequate organ function" ], "offsets": [ [ 897, 920 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T57", "type": "Temporal", "text": [ "within 14 days of dosing" ], "offsets": [ [ 921, 945 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T58", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 939, 945 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T62", "type": "Person", "text": [ "women" ], "offsets": [ [ 1083, 1088 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T63", "type": "Person", "text": [ "men" ], "offsets": [ [ 1075, 1078 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T64", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1092, 1114 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T65", "type": "Procedure", "text": [ "birth control" ], "offsets": [ [ 1156, 1169 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T66", "type": "Temporal", "text": [ "from providing signed consent" ], "offsets": [ [ 1170, 1199 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T67", "type": "Reference_point", "text": [ "providing signed consent" ], "offsets": [ [ 1175, 1199 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T68", "type": "Temporal", "text": [ "for 120 days after last study drug administration" ], "offsets": [ [ 1204, 1253 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T69", "type": "Reference_point", "text": [ "last study drug administration" ], "offsets": [ [ 1223, 1253 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T70", "type": "Scope", "text": [ "men and women of childbearing potential" ], "offsets": [ [ 1075, 1114 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T73", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1255, 1260 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T74", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1264, 1286 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T75", "type": "Condition", "text": [ "pre-menopausal" ], "offsets": [ [ 1295, 1309 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T76", "type": "Person", "text": [ "women" ], "offsets": [ [ 1310, 1315 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T77", "type": "Person", "text": [ "women" ], "offsets": [ [ 1320, 1325 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T78", "type": "Temporal", "text": [ "within the first 2 years of the onset of menopause" ], "offsets": [ [ 1326, 1376 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T79", "type": "Reference_point", "text": [ "the onset of menopause" ], "offsets": [ [ 1354, 1376 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T80", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1387, 1409 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T81", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1378, 1383 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T82", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 1431, 1445 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T83", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1422, 1430 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T84", "type": "Temporal", "text": [ "≤ 72 hours prior to Day 1" ], "offsets": [ [ 1446, 1471 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T85", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 1466, 1471 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T86", "type": "Scope", "text": [ "Women of childbearing potential" ], "offsets": [ [ 1378, 1409 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T87", "type": "Procedure", "text": [ "birth control" ], "offsets": [ [ 1504, 1517 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T88", "type": "Condition", "text": [ "surgically sterile" ], "offsets": [ [ 1527, 1545 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T89", "type": "Device", "text": [ "barrier device" ], "offsets": [ [ 1547, 1561 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T90", "type": "Device", "text": [ "condom" ], "offsets": [ [ 1563, 1569 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T91", "type": "Device", "text": [ "diaphragm" ], "offsets": [ [ 1571, 1580 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T92", "type": "Scope", "text": [ "condom, diaphragm" ], "offsets": [ [ 1563, 1580 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T93", "type": "Device", "text": [ "contraceptive coil" ], "offsets": [ [ 1583, 1601 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T94", "type": "Device", "text": [ "intrauterine device (IUD)" ], "offsets": [ [ 1603, 1628 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T95", "type": "Procedure", "text": [ "abstinence" ], "offsets": [ [ 1634, 1644 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T97", "type": "Scope", "text": [ "surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence" ], "offsets": [ [ 1527, 1644 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T98", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 1647, 1662 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T99", "type": "Value", "text": [ ">12 weeks" ], "offsets": [ [ 1666, 1675 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T100", "type": "Condition", "text": [ "central nervous system disease" ], "offsets": [ [ 1692, 1722 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T101", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 1779, 1791 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T102", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1795, 1802 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T103", "type": "Condition", "text": [ "CNS metastatic disease" ], "offsets": [ [ 1815, 1837 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T104", "type": "Condition", "text": [ "clinical progression" ], "offsets": [ [ 1866, 1886 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T105", "type": "Negation", "text": [ "without" ], "offsets": [ [ 1846, 1853 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T106", "type": "Temporal", "text": [ "for at least 4 weeks prior to screening" ], "offsets": [ [ 1887, 1926 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T107", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 1917, 1926 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T108", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 1965, 1981 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T109", "type": "Qualifier", "text": [ "enlarging" ], "offsets": [ [ 1955, 1964 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T110", "type": "Qualifier", "text": [ "new" ], "offsets": [ [ 1948, 1951 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T111", "type": "Scope", "text": [ "new or enlarging" ], "offsets": [ [ 1948, 1964 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T112", "type": "Negation", "text": [ "no" ], "offsets": [ [ 1933, 1935 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T113", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 1995, 2003 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T114", "type": "Negation", "text": [ "off" ], "offsets": [ [ 1991, 1994 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T115", "type": "Temporal", "text": [ "for at least 7 days before first dose of pembrolizumab" ], "offsets": [ [ 2004, 2058 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T116", "type": "Reference_point", "text": [ "first dose of pembrolizumab" ], "offsets": [ [ 2031, 2058 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T117", "type": "Drug", "text": [ "pembrolizumab" ], "offsets": [ [ 2045, 2058 ] ], "normalized": [] }, { "id": "NCT02301039_inc_T118", "type": "Scope", "text": [ "radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab" ], "offsets": [ [ 1779, 2058 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02301039_inc_R1", "type": "Has_value", "arg1_id": "NCT02301039_inc_T1", "arg2_id": "NCT02301039_inc_T2", "normalized": [] }, { "id": "NCT02301039_inc_R2", "type": "Has_value", "arg1_id": "NCT02301039_inc_T3", "arg2_id": "NCT02301039_inc_T4", "normalized": [] }, { "id": "NCT02301039_inc_R3", "type": "AND", "arg1_id": "NCT02301039_inc_T5", "arg2_id": "NCT02301039_inc_T3", "normalized": [] }, { "id": "NCT02301039_inc_R4", "type": "Has_value", "arg1_id": "NCT02301039_inc_T6", "arg2_id": "NCT02301039_inc_T7", "normalized": [] }, { "id": "NCT02301039_inc_R5", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T14", "arg2_id": "NCT02301039_inc_T15", "normalized": [] }, { "id": "NCT02301039_inc_R6", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T18", "arg2_id": "NCT02301039_inc_T21", "normalized": [] }, { "id": "NCT02301039_inc_R7", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T28", "arg2_id": "NCT02301039_inc_T29", "normalized": [] }, { "id": "NCT02301039_inc_R8", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T33", "arg2_id": "NCT02301039_inc_T36", "normalized": [] }, { "id": "NCT02301039_inc_R9", "type": "Subsumes", "arg1_id": "NCT02301039_inc_T30", "arg2_id": "NCT02301039_inc_T37", "normalized": [] }, { "id": "NCT02301039_inc_R10", "type": "Subsumes", "arg1_id": "NCT02301039_inc_T16", "arg2_id": "NCT02301039_inc_T38", "normalized": [] }, { "id": "NCT02301039_inc_R11", "type": "Subsumes", "arg1_id": "NCT02301039_inc_T14", "arg2_id": "NCT02301039_inc_T40", "normalized": [] }, { "id": "NCT02301039_inc_R12", "type": "AND", "arg1_id": "NCT02301039_inc_T14", "arg2_id": "NCT02301039_inc_T6", "normalized": [] }, { "id": "NCT02301039_inc_R13", "type": "Has_value", "arg1_id": "NCT02301039_inc_T41", "arg2_id": "NCT02301039_inc_T42", "normalized": [] }, { "id": "NCT02301039_inc_R14", "type": "AND", "arg1_id": "NCT02301039_inc_T46", "arg2_id": "NCT02301039_inc_T43", "normalized": [] }, { "id": "NCT02301039_inc_R15", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T47", "arg2_id": "NCT02301039_inc_T48", "normalized": [] }, { "id": "NCT02301039_inc_R16", "type": "Has_index", "arg1_id": "NCT02301039_inc_T49", "arg2_id": "NCT02301039_inc_T50", "normalized": [] }, { "id": "NCT02301039_inc_R17", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T47", "arg2_id": "NCT02301039_inc_T49", "normalized": [] }, { "id": "NCT02301039_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT02301039_inc_T54", "arg2_id": "NCT02301039_inc_T55", "normalized": [] }, { "id": "NCT02301039_inc_R19", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T54", "arg2_id": "NCT02301039_inc_T53", "normalized": [] }, { "id": "NCT02301039_inc_R20", "type": "Has_multiplier", "arg1_id": "NCT02301039_inc_T54", "arg2_id": "NCT02301039_inc_T52", "normalized": [] }, { "id": "NCT02301039_inc_R21", "type": "Has_index", "arg1_id": "NCT02301039_inc_T57", "arg2_id": "NCT02301039_inc_T58", "normalized": [] }, { "id": "NCT02301039_inc_R22", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T56", "arg2_id": "NCT02301039_inc_T57", "normalized": [] }, { "id": "NCT02301039_inc_R23", "type": "Has_index", "arg1_id": "NCT02301039_inc_T66", "arg2_id": "NCT02301039_inc_T67", "normalized": [] }, { "id": "NCT02301039_inc_R24", "type": "Has_index", "arg1_id": "NCT02301039_inc_T68", "arg2_id": "NCT02301039_inc_T69", "normalized": [] }, { "id": "NCT02301039_inc_R25", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T65", "arg2_id": "NCT02301039_inc_T66", "normalized": [] }, { "id": "NCT02301039_inc_R26", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T65", "arg2_id": "NCT02301039_inc_T68", "normalized": [] }, { "id": "NCT02301039_inc_R27", "type": "AND", "arg1_id": "NCT02301039_inc_T70", "arg2_id": "NCT02301039_inc_T65", "normalized": [] }, { "id": "NCT02301039_inc_R28", "type": "Has_index", "arg1_id": "NCT02301039_inc_T78", "arg2_id": "NCT02301039_inc_T79", "normalized": [] }, { "id": "NCT02301039_inc_R29", "type": "Has_value", "arg1_id": "NCT02301039_inc_T82", "arg2_id": "NCT02301039_inc_T83", "normalized": [] }, { "id": "NCT02301039_inc_R30", "type": "Has_index", "arg1_id": "NCT02301039_inc_T84", "arg2_id": "NCT02301039_inc_T85", "normalized": [] }, { "id": "NCT02301039_inc_R31", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T82", "arg2_id": "NCT02301039_inc_T84", "normalized": [] }, { "id": "NCT02301039_inc_R32", "type": "AND", "arg1_id": "NCT02301039_inc_T86", "arg2_id": "NCT02301039_inc_T82", "normalized": [] }, { "id": "NCT02301039_inc_R33", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T89", "arg2_id": "NCT02301039_inc_T92", "normalized": [] }, { "id": "NCT02301039_inc_R34", "type": "Subsumes", "arg1_id": "NCT02301039_inc_T87", "arg2_id": "NCT02301039_inc_T97", "normalized": [] }, { "id": "NCT02301039_inc_R35", "type": "Has_value", "arg1_id": "NCT02301039_inc_T98", "arg2_id": "NCT02301039_inc_T99", "normalized": [] }, { "id": "NCT02301039_inc_R36", "type": "AND", "arg1_id": "NCT02301039_inc_T102", "arg2_id": "NCT02301039_inc_T103", "normalized": [] }, { "id": "NCT02301039_inc_R37", "type": "AND", "arg1_id": "NCT02301039_inc_T101", "arg2_id": "NCT02301039_inc_T103", "normalized": [] }, { "id": "NCT02301039_inc_R38", "type": "Has_negation", "arg1_id": "NCT02301039_inc_T104", "arg2_id": "NCT02301039_inc_T105", "normalized": [] }, { "id": "NCT02301039_inc_R39", "type": "Has_index", "arg1_id": "NCT02301039_inc_T106", "arg2_id": "NCT02301039_inc_T107", "normalized": [] }, { "id": "NCT02301039_inc_R40", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T104", "arg2_id": "NCT02301039_inc_T106", "normalized": [] }, { "id": "NCT02301039_inc_R41", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T108", "arg2_id": "NCT02301039_inc_T111", "normalized": [] }, { "id": "NCT02301039_inc_R42", "type": "Has_negation", "arg1_id": "NCT02301039_inc_T108", "arg2_id": "NCT02301039_inc_T112", "normalized": [] }, { "id": "NCT02301039_inc_R43", "type": "Has_negation", "arg1_id": "NCT02301039_inc_T113", "arg2_id": "NCT02301039_inc_T114", "normalized": [] }, { "id": "NCT02301039_inc_R44", "type": "AND", "arg1_id": "NCT02301039_inc_T116", "arg2_id": "NCT02301039_inc_T117", "normalized": [] }, { "id": "NCT02301039_inc_R45", "type": "Has_index", "arg1_id": "NCT02301039_inc_T115", "arg2_id": "NCT02301039_inc_T116", "normalized": [] }, { "id": "NCT02301039_inc_R46", "type": "Has_temporal", "arg1_id": "NCT02301039_inc_T113", "arg2_id": "NCT02301039_inc_T115", "normalized": [] }, { "id": "NCT02301039_inc_R47", "type": "Has_scope", "arg1_id": "NCT02301039_inc_T100", "arg2_id": "NCT02301039_inc_T118", "normalized": [] } ]

[ { "id": "NCT02301962_exc_text", "type": "exclusion", "text": [ "History or known presence of central nervous system metastases.\nHistory of another malignancy except: Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer.\nKnown immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panitumumab or excipients that contraindicates their participation.\nPrior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib).\nAntitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy <=30 days before first dose of study treatment or not recovered from any acute toxicity.\nOther investigational procedure <=30 days before study entry.\nHistory of interstitial lung disease (ILD) e.g., interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computer tomography.\nSubject previously enrolled to this study.\nHistory of keratitis, ulcerative keratitis or severe dry eye.\nMajor surgery (e.g., requiring general anesthesia) <=30 days before first dose of study treatment. Subjects must have recovered from any surgery related toxicities.\nMinor surgical procedure (e.g., open biopsy) <=7 days before first dose of study treatment, or not yet recovered from prior minor surgery Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis >=3 days prior to first dose of study treatment is acceptable.\nClinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=6 months prior to enrolment.\nHistory of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration, compliance with the study procedures or may interfere with the interpretation of the results.\nUnstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event <=30 days before first dose of study treatment. If on anticoagulation, subject must be on stable therapeutic dose prior to first dose of study treatment.\nSubject who is pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the discontinuation of study treatment.\nKnown positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion).\nActive infection requiring systemic treatment or any uncontrolled infection <=14 days prior to first dose of study treatment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).\nSubject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements.\n" ], "offsets": [ [ 0, 3421 ] ] } ]

[ { "id": "NCT02301962_exc_T1", "type": "Condition", "text": [ "central nervous system metastases" ], "offsets": [ [ 29, 62 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T2", "type": "Qualifier", "text": [ "another" ], "offsets": [ [ 75, 82 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T3", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 83, 93 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T4", "type": "Condition", "text": [ "Malignancy" ], "offsets": [ [ 102, 112 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T5", "type": "Procedure", "text": [ "treated with curative intent" ], "offsets": [ [ 113, 141 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T6", "type": "Negation", "text": [ "no" ], "offsets": [ [ 151, 153 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T7", "type": "Condition", "text": [ "active disease" ], "offsets": [ [ 160, 174 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T8", "type": "Temporal", "text": [ "for >=5 years prior to enrolment" ], "offsets": [ [ 183, 215 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T9", "type": "Reference_point", "text": [ "enrolment" ], "offsets": [ [ 206, 215 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T10", "type": "Mood", "text": [ "felt to be at low risk" ], "offsets": [ [ 220, 242 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T11", "type": "Condition", "text": [ "recurrence" ], "offsets": [ [ 247, 257 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T12", "type": "Qualifier", "text": [ "Adequately" ], "offsets": [ [ 285, 295 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T13", "type": "Condition", "text": [ "non-melanomatous skin cancer" ], "offsets": [ [ 304, 332 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T14", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 296, 303 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T15", "type": "Condition", "text": [ "lentigo maligna" ], "offsets": [ [ 336, 351 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T16", "type": "Condition", "text": [ "evidence of disease" ], "offsets": [ [ 360, 379 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T17", "type": "Negation", "text": [ "without" ], "offsets": [ [ 352, 359 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T18", "type": "Qualifier", "text": [ "Adequately" ], "offsets": [ [ 381, 391 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T19", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 392, 399 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T20", "type": "Condition", "text": [ "cervical carcinoma in situ" ], "offsets": [ [ 400, 426 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T21", "type": "Negation", "text": [ "without" ], "offsets": [ [ 427, 434 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T22", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 447, 454 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T23", "type": "Scope", "text": [ "non-melanomatous skin cancer or lentigo maligna" ], "offsets": [ [ 304, 351 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T24", "type": "Condition", "text": [ "Prostatic intraepithelial neoplasia" ], "offsets": [ [ 456, 491 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T25", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 512, 527 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T26", "type": "Negation", "text": [ "without" ], "offsets": [ [ 492, 499 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T27", "type": "Mood", "text": [ "evidence of" ], "offsets": [ [ 435, 446 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T28", "type": "Mood", "text": [ "evidence of" ], "offsets": [ [ 500, 511 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T29", "type": "Negation", "text": [ "except" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T30", "type": "Scope", "text": [ "Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer" ], "offsets": [ [ 102, 527 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T31", "type": "Condition", "text": [ "delayed hypersensitivity reaction" ], "offsets": [ [ 548, 581 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T32", "type": "Condition", "text": [ "mediate o", "persensitivity reaction o" ], "offsets": [ [ 537, 546 ], [ 558, 583 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T33", "type": "Condition", "text": [ "idiosyncrasy" ], "offsets": [ [ 585, 597 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T34", "type": "Drug", "text": [ "drugs chemically related to panitumumab" ], "offsets": [ [ 601, 640 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T35", "type": "Drug", "text": [ "ugs chemically related to panitumumab o", "cipients t" ], "offsets": [ [ 603, 642 ], [ 646, 656 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T36", "type": "Scope", "text": [ "drugs chemically related to panitumumab or excipients" ], "offsets": [ [ 601, 654 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T37", "type": "Procedure", "text": [ "i-epidermal growth factor receptor (E", "ibody therapy (e" ], "offsets": [ [ 706, 743 ], [ 751, 767 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T38", "type": "Drug", "text": [ "panitumumab" ], "offsets": [ [ 772, 783 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T39", "type": "Drug", "text": [ "cetuximab" ], "offsets": [ [ 787, 796 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T40", "type": "Scope", "text": [ "panitumumab or cetuximab" ], "offsets": [ [ 772, 796 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T41", "type": "Procedure", "text": [ "EGFr" ], "offsets": [ [ 742, 746 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T42", "type": "Procedure", "text": [ "treatment with small molecule EGFr inhibitors" ], "offsets": [ [ 801, 846 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T43", "type": "Drug", "text": [ "gefitinib" ], "offsets": [ [ 854, 863 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T44", "type": "Drug", "text": [ "erlotinib" ], "offsets": [ [ 865, 874 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T45", "type": "Drug", "text": [ "lapatinib" ], "offsets": [ [ 876, 885 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T46", "type": "Scope", "text": [ "gefitinib, erlotinib, lapatinib" ], "offsets": [ [ 854, 885 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T47", "type": "Procedure", "text": [ "Antitumor therapy" ], "offsets": [ [ 888, 905 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T48", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 913, 925 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T49", "type": "Procedure", "text": [ "hormonal therapy" ], "offsets": [ [ 927, 943 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T50", "type": "Procedure", "text": [ "immunotherapy" ], "offsets": [ [ 945, 958 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T51", "type": "Procedure", "text": [ "antibody therapy" ], "offsets": [ [ 960, 976 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T52", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 978, 990 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T53", "type": "Scope", "text": [ "chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy" ], "offsets": [ [ 913, 990 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T54", "type": "Drug", "text": [ "investigational agent" ], "offsets": [ [ 996, 1017 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T55", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 1021, 1028 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T56", "type": "Temporal", "text": [ "<=30 days before first dose of study treatment" ], "offsets": [ [ 1029, 1075 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T57", "type": "Condition", "text": [ "not recovered from any acute toxicity" ], "offsets": [ [ 1079, 1116 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T58", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 1046, 1075 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T59", "type": "Scope", "text": [ "Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy" ], "offsets": [ [ 888, 1028 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T60", "type": "Temporal", "text": [ "<=30 days before study entry" ], "offsets": [ [ 1150, 1178 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T61", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 1118, 1123 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T62", "type": "Procedure", "text": [ "investigational procedure" ], "offsets": [ [ 1124, 1149 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T63", "type": "Condition", "text": [ "interstitial lung disease" ], "offsets": [ [ 1191, 1216 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T64", "type": "Condition", "text": [ "ILD" ], "offsets": [ [ 1218, 1221 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T65", "type": "Condition", "text": [ "interstitial pneumonitis" ], "offsets": [ [ 1229, 1253 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T66", "type": "Condition", "text": [ "pulmonary fibrosis" ], "offsets": [ [ 1255, 1273 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T67", "type": "Mood", "text": [ "evidence of" ], "offsets": [ [ 1277, 1288 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T68", "type": "Condition", "text": [ "ILD" ], "offsets": [ [ 1289, 1292 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T69", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 1296, 1304 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T70", "type": "Procedure", "text": [ "chest computer tomography" ], "offsets": [ [ 1305, 1330 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T71", "type": "Scope", "text": [ "interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computer tomography" ], "offsets": [ [ 1229, 1330 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T72", "type": "Scope", "text": [ "interstitial lung disease (ILD)" ], "offsets": [ [ 1191, 1222 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T74", "type": "Condition", "text": [ "keratitis" ], "offsets": [ [ 1386, 1395 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T75", "type": "Condition", "text": [ "ulcerative keratitis" ], "offsets": [ [ 1397, 1417 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T76", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1421, 1427 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T77", "type": "Condition", "text": [ "dry eye" ], "offsets": [ [ 1428, 1435 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T78", "type": "Procedure", "text": [ "Major surgery" ], "offsets": [ [ 1437, 1450 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T79", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 1468, 1486 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T80", "type": "Temporal", "text": [ "<=30 days before first dose of study treatment" ], "offsets": [ [ 1488, 1534 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T81", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 1505, 1534 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T83", "type": "Procedure", "text": [ "Minor surgical procedure" ], "offsets": [ [ 1602, 1626 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T84", "type": "Procedure", "text": [ "open biopsy" ], "offsets": [ [ 1634, 1645 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T85", "type": "Temporal", "text": [ "<=7 days before first dose of study treatment" ], "offsets": [ [ 1647, 1692 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T86", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 1663, 1692 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T87", "type": "Negation", "text": [ "not yet" ], "offsets": [ [ 1697, 1704 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T88", "type": "Condition", "text": [ "recovered" ], "offsets": [ [ 1705, 1714 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T89", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 1720, 1725 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T90", "type": "Procedure", "text": [ "minor surgery" ], "offsets": [ [ 1726, 1739 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T91", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 1916, 1938 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T92", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 1939, 1961 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T93", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 1973, 1994 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T94", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 1996, 2011 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T95", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 2025, 2049 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T96", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 2013, 2024 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T97", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2051, 2058 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T98", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 2059, 2071 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T99", "type": "Condition", "text": [ "cardiac arrhythmia" ], "offsets": [ [ 2072, 2090 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T100", "type": "Temporal", "text": [ "<=6 months prior to enrolment" ], "offsets": [ [ 2092, 2121 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T101", "type": "Reference_point", "text": [ "enrolment" ], "offsets": [ [ 2112, 2121 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T102", "type": "Scope", "text": [ "myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia" ], "offsets": [ [ 1973, 2090 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T103", "type": "Scope", "text": [ "Clinically significant cardiovascular disease" ], "offsets": [ [ 1916, 1961 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T105", "type": "Qualifier", "text": [ "Unstable" ], "offsets": [ [ 2436, 2444 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T106", "type": "Condition", "text": [ "pulmonary embolism" ], "offsets": [ [ 2445, 2463 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T107", "type": "Condition", "text": [ "deep vein thrombosis" ], "offsets": [ [ 2465, 2485 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T108", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 2490, 2495 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T109", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2496, 2507 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T110", "type": "Condition", "text": [ "us throm", "c event <=30 days be" ], "offsets": [ [ 2521, 2529 ], [ 2537, 2557 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T111", "type": "Condition", "text": [ "venous thromboembolic event" ], "offsets": [ [ 2517, 2544 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T112", "type": "Temporal", "text": [ "<=30 days before first dose of study treatment" ], "offsets": [ [ 2545, 2591 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T113", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 2562, 2591 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T114", "type": "Scope", "text": [ "arterial/venous thromboembolic event" ], "offsets": [ [ 2508, 2544 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T115", "type": "Scope", "text": [ "Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event" ], "offsets": [ [ 2436, 2544 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T116", "type": "Procedure", "text": [ "anticoagulation" ], "offsets": [ [ 2599, 2614 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T117", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 2635, 2641 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T118", "type": "Multiplier", "text": [ "therapeutic dose" ], "offsets": [ [ 2642, 2658 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T119", "type": "Temporal", "text": [ "prior to first dose of study treatment" ], "offsets": [ [ 2659, 2697 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T120", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 2668, 2697 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T121", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 2714, 2722 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T122", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 2726, 2740 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T123", "type": "Observation", "text": [ "become pregnant" ], "offsets": [ [ 2757, 2772 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T124", "type": "Temporal", "text": [ "during treatment" ], "offsets": [ [ 2773, 2789 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T125", "type": "Temporal", "text": [ "within 2 months after the discontinuation of study treatment" ], "offsets": [ [ 2794, 2854 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T126", "type": "Reference_point", "text": [ "the discontinuation of study treatment" ], "offsets": [ [ 2816, 2854 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T127", "type": "Reference_point", "text": [ "treatment" ], "offsets": [ [ 2780, 2789 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T128", "type": "Scope", "text": [ "during treatment and within 2 months after the discontinuation of study treatment" ], "offsets": [ [ 2773, 2854 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T129", "type": "Scope", "text": [ "pregnant or breast feeding, or planning to become pregnant" ], "offsets": [ [ 2714, 2772 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T130", "type": "Measurement", "text": [ "test(s) for human immunodeficiency virus infection" ], "offsets": [ [ 2871, 2921 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T131", "type": "Value", "text": [ "positive" ], "offsets": [ [ 2862, 2870 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T132", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 2993, 3002 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T133", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 2986, 2992 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T134", "type": "Procedure", "text": [ "systemic treatment" ], "offsets": [ [ 3013, 3031 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T135", "type": "Condition", "text": [ "uncontrolled infection" ], "offsets": [ [ 3039, 3061 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T136", "type": "Temporal", "text": [ "<=14 days prior to first dose of study treatment" ], "offsets": [ [ 3062, 3110 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T137", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 3081, 3110 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T138", "type": "Qualifier", "text": [ "any" ], "offsets": [ [ 3035, 3038 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T139", "type": "Scope", "text": [ "Active infection requiring systemic treatment or any uncontrolled infection" ], "offsets": [ [ 2986, 3061 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T140", "type": "Condition", "text": [ "urinary tract infection" ], "offsets": [ [ 3148, 3171 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T141", "type": "Qualifier", "text": [ "uncomplicated" ], "offsets": [ [ 3134, 3147 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T142", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 3112, 3133 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T143", "type": "Condition", "text": [ "upper respiratory tract infection" ], "offsets": [ [ 3175, 3208 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T144", "type": "Scope", "text": [ "uncomplicated urinary tract infection or upper respiratory tract infection" ], "offsets": [ [ 3134, 3208 ] ], "normalized": [] }, { "id": "NCT02301962_exc_T146", "type": "Mood", "text": [ "planning to" ], "offsets": [ [ 2745, 2756 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02301962_exc_R1", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T7", "arg2_id": "NCT02301962_exc_T6", "normalized": [] }, { "id": "NCT02301962_exc_R2", "type": "Has_index", "arg1_id": "NCT02301962_exc_T8", "arg2_id": "NCT02301962_exc_T9", "normalized": [] }, { "id": "NCT02301962_exc_R3", "type": "Has_mood", "arg1_id": "NCT02301962_exc_T11", "arg2_id": "NCT02301962_exc_T10", "normalized": [] }, { "id": "NCT02301962_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T14", "arg2_id": "NCT02301962_exc_T12", "normalized": [] }, { "id": "NCT02301962_exc_R5", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T16", "arg2_id": "NCT02301962_exc_T17", "normalized": [] }, { "id": "NCT02301962_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T19", "arg2_id": "NCT02301962_exc_T18", "normalized": [] }, { "id": "NCT02301962_exc_R7", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T22", "arg2_id": "NCT02301962_exc_T21", "normalized": [] }, { "id": "NCT02301962_exc_R8", "type": "AND", "arg1_id": "NCT02301962_exc_T23", "arg2_id": "NCT02301962_exc_T14", "normalized": [] }, { "id": "NCT02301962_exc_R9", "type": "AND", "arg1_id": "NCT02301962_exc_T23", "arg2_id": "NCT02301962_exc_T16", "normalized": [] }, { "id": "NCT02301962_exc_R10", "type": "AND", "arg1_id": "NCT02301962_exc_T20", "arg2_id": "NCT02301962_exc_T19", "normalized": [] }, { "id": "NCT02301962_exc_R11", "type": "AND", "arg1_id": "NCT02301962_exc_T20", "arg2_id": "NCT02301962_exc_T22", "normalized": [] }, { "id": "NCT02301962_exc_R12", "type": "Has_mood", "arg1_id": "NCT02301962_exc_T22", "arg2_id": "NCT02301962_exc_T27", "normalized": [] }, { "id": "NCT02301962_exc_R13", "type": "Has_mood", "arg1_id": "NCT02301962_exc_T25", "arg2_id": "NCT02301962_exc_T28", "normalized": [] }, { "id": "NCT02301962_exc_R14", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T25", "arg2_id": "NCT02301962_exc_T26", "normalized": [] }, { "id": "NCT02301962_exc_R15", "type": "AND", "arg1_id": "NCT02301962_exc_T24", "arg2_id": "NCT02301962_exc_T25", "normalized": [] }, { "id": "NCT02301962_exc_R16", "type": "AND", "arg1_id": "NCT02301962_exc_T4", "arg2_id": "NCT02301962_exc_T5", "normalized": [] }, { "id": "NCT02301962_exc_R17", "type": "AND", "arg1_id": "NCT02301962_exc_T4", "arg2_id": "NCT02301962_exc_T7", "normalized": [] }, { "id": "NCT02301962_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T7", "arg2_id": "NCT02301962_exc_T8", "normalized": [] }, { "id": "NCT02301962_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T3", "arg2_id": "NCT02301962_exc_T2", "normalized": [] }, { "id": "NCT02301962_exc_R20", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T30", "arg2_id": "NCT02301962_exc_T29", "normalized": [] }, { "id": "NCT02301962_exc_R21", "type": "Has_scope", "arg1_id": "NCT02301962_exc_T3", "arg2_id": "NCT02301962_exc_T30", "normalized": [] }, { "id": "NCT02301962_exc_R22", "type": "AND", "arg1_id": "NCT02301962_exc_T36", "arg2_id": "NCT02301962_exc_T33", "normalized": [] }, { "id": "NCT02301962_exc_R23", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T37", "arg2_id": "NCT02301962_exc_T40", "normalized": [] }, { "id": "NCT02301962_exc_R24", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T37", "arg2_id": "NCT02301962_exc_T41", "normalized": [] }, { "id": "NCT02301962_exc_R25", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T42", "arg2_id": "NCT02301962_exc_T46", "normalized": [] }, { "id": "NCT02301962_exc_R26", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T47", "arg2_id": "NCT02301962_exc_T53", "normalized": [] }, { "id": "NCT02301962_exc_R27", "type": "Has_index", "arg1_id": "NCT02301962_exc_T56", "arg2_id": "NCT02301962_exc_T58", "normalized": [] }, { "id": "NCT02301962_exc_R28", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T59", "arg2_id": "NCT02301962_exc_T56", "normalized": [] }, { "id": "NCT02301962_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T62", "arg2_id": "NCT02301962_exc_T61", "normalized": [] }, { "id": "NCT02301962_exc_R30", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T62", "arg2_id": "NCT02301962_exc_T60", "normalized": [] }, { "id": "NCT02301962_exc_R31", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T63", "arg2_id": "NCT02301962_exc_T64", "normalized": [] }, { "id": "NCT02301962_exc_R32", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T70", "arg2_id": "NCT02301962_exc_T69", "normalized": [] }, { "id": "NCT02301962_exc_R33", "type": "Has_mood", "arg1_id": "NCT02301962_exc_T68", "arg2_id": "NCT02301962_exc_T67", "normalized": [] }, { "id": "NCT02301962_exc_R34", "type": "AND", "arg1_id": "NCT02301962_exc_T70", "arg2_id": "NCT02301962_exc_T68", "normalized": [] }, { "id": "NCT02301962_exc_R35", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T72", "arg2_id": "NCT02301962_exc_T71", "normalized": [] }, { "id": "NCT02301962_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T77", "arg2_id": "NCT02301962_exc_T76", "normalized": [] }, { "id": "NCT02301962_exc_R37", "type": "Has_index", "arg1_id": "NCT02301962_exc_T80", "arg2_id": "NCT02301962_exc_T81", "normalized": [] }, { "id": "NCT02301962_exc_R38", "type": "AND", "arg1_id": "NCT02301962_exc_T78", "arg2_id": "NCT02301962_exc_T79", "normalized": [] }, { "id": "NCT02301962_exc_R39", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T78", "arg2_id": "NCT02301962_exc_T80", "normalized": [] }, { "id": "NCT02301962_exc_R40", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T83", "arg2_id": "NCT02301962_exc_T84", "normalized": [] }, { "id": "NCT02301962_exc_R41", "type": "Has_index", "arg1_id": "NCT02301962_exc_T85", "arg2_id": "NCT02301962_exc_T86", "normalized": [] }, { "id": "NCT02301962_exc_R42", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T83", "arg2_id": "NCT02301962_exc_T85", "normalized": [] }, { "id": "NCT02301962_exc_R43", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T90", "arg2_id": "NCT02301962_exc_T89", "normalized": [] }, { "id": "NCT02301962_exc_R44", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T88", "arg2_id": "NCT02301962_exc_T87", "normalized": [] }, { "id": "NCT02301962_exc_R45", "type": "AND", "arg1_id": "NCT02301962_exc_T88", "arg2_id": "NCT02301962_exc_T90", "normalized": [] }, { "id": "NCT02301962_exc_R46", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T95", "arg2_id": "NCT02301962_exc_T96", "normalized": [] }, { "id": "NCT02301962_exc_R47", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T99", "arg2_id": "NCT02301962_exc_T98", "normalized": [] }, { "id": "NCT02301962_exc_R48", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T99", "arg2_id": "NCT02301962_exc_T97", "normalized": [] }, { "id": "NCT02301962_exc_R49", "type": "Has_index", "arg1_id": "NCT02301962_exc_T100", "arg2_id": "NCT02301962_exc_T101", "normalized": [] }, { "id": "NCT02301962_exc_R50", "type": "Subsumes", "arg1_id": "NCT02301962_exc_T103", "arg2_id": "NCT02301962_exc_T102", "normalized": [] }, { "id": "NCT02301962_exc_R51", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T103", "arg2_id": "NCT02301962_exc_T100", "normalized": [] }, { "id": "NCT02301962_exc_R52", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T106", "arg2_id": "NCT02301962_exc_T105", "normalized": [] }, { "id": "NCT02301962_exc_R53", "type": "Has_index", "arg1_id": "NCT02301962_exc_T112", "arg2_id": "NCT02301962_exc_T113", "normalized": [] }, { "id": "NCT02301962_exc_R54", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T114", "arg2_id": "NCT02301962_exc_T109", "normalized": [] }, { "id": "NCT02301962_exc_R55", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T114", "arg2_id": "NCT02301962_exc_T108", "normalized": [] }, { "id": "NCT02301962_exc_R56", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T115", "arg2_id": "NCT02301962_exc_T112", "normalized": [] }, { "id": "NCT02301962_exc_R57", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T118", "arg2_id": "NCT02301962_exc_T117", "normalized": [] }, { "id": "NCT02301962_exc_R58", "type": "Has_multiplier", "arg1_id": "NCT02301962_exc_T116", "arg2_id": "NCT02301962_exc_T118", "normalized": [] }, { "id": "NCT02301962_exc_R59", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T116", "arg2_id": "NCT02301962_exc_T119", "normalized": [] }, { "id": "NCT02301962_exc_R60", "type": "Has_index", "arg1_id": "NCT02301962_exc_T125", "arg2_id": "NCT02301962_exc_T126", "normalized": [] }, { "id": "NCT02301962_exc_R61", "type": "Has_index", "arg1_id": "NCT02301962_exc_T124", "arg2_id": "NCT02301962_exc_T127", "normalized": [] }, { "id": "NCT02301962_exc_R62", "type": "Has_scope", "arg1_id": "NCT02301962_exc_T129", "arg2_id": "NCT02301962_exc_T128", "normalized": [] }, { "id": "NCT02301962_exc_R63", "type": "Has_value", "arg1_id": "NCT02301962_exc_T130", "arg2_id": "NCT02301962_exc_T131", "normalized": [] }, { "id": "NCT02301962_exc_R64", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T132", "arg2_id": "NCT02301962_exc_T133", "normalized": [] }, { "id": "NCT02301962_exc_R65", "type": "Has_index", "arg1_id": "NCT02301962_exc_T136", "arg2_id": "NCT02301962_exc_T137", "normalized": [] }, { "id": "NCT02301962_exc_R66", "type": "AND", "arg1_id": "NCT02301962_exc_T132", "arg2_id": "NCT02301962_exc_T134", "normalized": [] }, { "id": "NCT02301962_exc_R67", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T135", "arg2_id": "NCT02301962_exc_T138", "normalized": [] }, { "id": "NCT02301962_exc_R68", "type": "Has_temporal", "arg1_id": "NCT02301962_exc_T139", "arg2_id": "NCT02301962_exc_T136", "normalized": [] }, { "id": "NCT02301962_exc_R69", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T140", "arg2_id": "NCT02301962_exc_T141", "normalized": [] }, { "id": "NCT02301962_exc_R70", "type": "Has_qualifier", "arg1_id": "NCT02301962_exc_T143", "arg2_id": "NCT02301962_exc_T141", "normalized": [] }, { "id": "NCT02301962_exc_R71", "type": "Has_negation", "arg1_id": "NCT02301962_exc_T144", "arg2_id": "NCT02301962_exc_T142", "normalized": [] }, { "id": "NCT02301962_exc_R72", "type": "Has_scope", "arg1_id": "NCT02301962_exc_T139", "arg2_id": "NCT02301962_exc_T144", "normalized": [] }, { "id": "NCT02301962_exc_R73", "type": "Has_mood", "arg1_id": "NCT02301962_exc_T123", "arg2_id": "NCT02301962_exc_T146", "normalized": [] } ]

[ { "id": "NCT02301962_inc_text", "type": "inclusion", "text": [ "Subject or subject's legally acceptable representative has provided informed consent.\nMale or female >=18 years of age.\nHistologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.\nWild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\nMeasurable or non-measurable disease per RECIST Version 1.1.\nMust have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens for metastatic disease. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ function defined by (<=7 days prior to first dose of study treatment).\nHematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).\nRenal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).\nHepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.\nMetabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium within normal limits. Serum Potassium within normal limits.\nAll prior treatment related toxicities common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.\nWomen of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use adequate contraception, during the study and for 2 months following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use adequate contraception, from time of signing informed consent until 5 months after the last dose of study treatment.\n" ], "offsets": [ [ 0, 2313 ] ] } ]

[ { "id": "NCT02301962_inc_T2", "type": "Person", "text": [ "Male" ], "offsets": [ [ 86, 90 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T3", "type": "Person", "text": [ "female" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T4", "type": "Value", "text": [ ">=18 years" ], "offsets": [ [ 101, 111 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 115, 118 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T6", "type": "Procedure", "text": [ "Histologically" ], "offsets": [ [ 120, 134 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T7", "type": "Procedure", "text": [ "cytologically" ], "offsets": [ [ 138, 151 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T8", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 152, 161 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T9", "type": "Condition", "text": [ "adenocarcinoma" ], "offsets": [ [ 175, 189 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T10", "type": "Qualifier", "text": [ "colon" ], "offsets": [ [ 197, 202 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T11", "type": "Qualifier", "text": [ "rectum" ], "offsets": [ [ 206, 212 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T12", "type": "Scope", "text": [ "colon or rectum" ], "offsets": [ [ 197, 212 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T13", "type": "Scope", "text": [ "Histologically or cytologically" ], "offsets": [ [ 120, 151 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T15", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group (ECOG) performance status" ], "offsets": [ [ 478, 538 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T16", "type": "Value", "text": [ "0, 1 or 2" ], "offsets": [ [ 542, 551 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T17", "type": "Condition", "text": [ "non-measurable disease" ], "offsets": [ [ 567, 589 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T18", "type": "Condition", "text": [ "rable or n", "se per" ], "offsets": [ [ 558, 568 ], [ 587, 593 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T19", "type": "Procedure", "text": [ "RECIST Version 1.1" ], "offsets": [ [ 594, 612 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T20", "type": "Scope", "text": [ "Measurable or non-measurable disease" ], "offsets": [ [ 553, 589 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T21", "type": "Qualifier", "text": [ "failed" ], "offsets": [ [ 624, 630 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T22", "type": "Procedure", "text": [ "pyrimidine-, oxal", "ning chemotherapy regim" ], "offsets": [ [ 643, 660 ], [ 691, 714 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T23", "type": "Procedure", "text": [ "latin-, and", "ning chemotherapy regim" ], "offsets": [ [ 662, 673 ], [ 691, 714 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T24", "type": "Procedure", "text": [ "irinotecan-containing chemotherapy" ], "offsets": [ [ 674, 708 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T25", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 722, 740 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T26", "type": "Scope", "text": [ "fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy" ], "offsets": [ [ 637, 708 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T27", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 771, 790 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T28", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 821, 832 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T29", "type": "Procedure", "text": [ "the regimen" ], "offsets": [ [ 836, 847 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T30", "type": "Condition", "text": [ "Metastatic relapse" ], "offsets": [ [ 849, 867 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T31", "type": "Temporal", "text": [ "within 6 months after completing adjuvant chemotherapy" ], "offsets": [ [ 868, 922 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T32", "type": "Reference_point", "text": [ "after completing adjuvant chemotherapy" ], "offsets": [ [ 884, 922 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T33", "type": "Procedure", "text": [ "ecan or ox", "ning regimen) will" ], "offsets": [ [ 945, 955 ], [ 971, 989 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T34", "type": "Procedure", "text": [ "oxaliplatin containing regimen" ], "offsets": [ [ 953, 983 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T35", "type": "Scope", "text": [ "irinotecan or oxaliplatin containing regimen" ], "offsets": [ [ 939, 983 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T36", "type": "Condition", "text": [ "Adequate baseline organ function" ], "offsets": [ [ 1085, 1117 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T37", "type": "Temporal", "text": [ "<=7 days prior to first dose of study treatment" ], "offsets": [ [ 1130, 1177 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T38", "type": "Reference_point", "text": [ "first dose of study treatment" ], "offsets": [ [ 1148, 1177 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T39", "type": "Scope", "text": [ "Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease." ], "offsets": [ [ 742, 1072 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T40", "type": "Measurement", "text": [ "Absolute neutrophil count (ANC)" ], "offsets": [ [ 1214, 1245 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T41", "type": "Value", "text": [ ">=1.5 x 10^9/Liter (L)" ], "offsets": [ [ 1246, 1268 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T42", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 1270, 1284 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T43", "type": "Value", "text": [ ">=75 x 10^9/L" ], "offsets": [ [ 1285, 1298 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T44", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 1300, 1310 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T45", "type": "Value", "text": [ ">=8.0 gram/deciliter (g/dL)" ], "offsets": [ [ 1311, 1338 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T46", "type": "Measurement", "text": [ "Creatinine" ], "offsets": [ [ 1368, 1378 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T47", "type": "Value", "text": [ "<=1.5 x upper limit of normal (ULN)" ], "offsets": [ [ 1379, 1414 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T48", "type": "Measurement", "text": [ "spartate aminotransferase (AST)" ], "offsets": [ [ 1447, 1478 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T49", "type": "Value", "text": [ "<=3 x ULN" ], "offsets": [ [ 1479, 1488 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T50", "type": "Measurement", "text": [ "Alanine aminotransferase (ALT)" ], "offsets": [ [ 1490, 1520 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T51", "type": "Value", "text": [ "<=3 x ULN" ], "offsets": [ [ 1521, 1530 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T52", "type": "Measurement", "text": [ "Total Bilirubin" ], "offsets": [ [ 1532, 1547 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T53", "type": "Value", "text": [ "<=1.5 x ULN" ], "offsets": [ [ 1548, 1559 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T54", "type": "Measurement", "text": [ "Serum Magnesium" ], "offsets": [ [ 1593, 1608 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T55", "type": "Value", "text": [ "within normal limits" ], "offsets": [ [ 1609, 1629 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T56", "type": "Measurement", "text": [ "Serum Calcium" ], "offsets": [ [ 1631, 1644 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T57", "type": "Value", "text": [ "within normal limits" ], "offsets": [ [ 1645, 1665 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T58", "type": "Measurement", "text": [ "Serum Potassium" ], "offsets": [ [ 1667, 1682 ] ], "normalized": [] }, { "id": "NCT02301962_inc_T59", "type": "Value", "text": [ "within normal limits" ], "offsets": [ [ 1683, 1703 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02301962_inc_R1", "type": "Has_value", "arg1_id": "NCT02301962_inc_T5", "arg2_id": "NCT02301962_inc_T4", "normalized": [] }, { "id": "NCT02301962_inc_R2", "type": "Has_scope", "arg1_id": "NCT02301962_inc_T9", "arg2_id": "NCT02301962_inc_T12", "normalized": [] }, { "id": "NCT02301962_inc_R3", "type": "Has_value", "arg1_id": "NCT02301962_inc_T13", "arg2_id": "NCT02301962_inc_T8", "normalized": [] }, { "id": "NCT02301962_inc_R4", "type": "Has_scope", "arg1_id": "NCT02301962_inc_T9", "arg2_id": "NCT02301962_inc_T13", "normalized": [] }, { "id": "NCT02301962_inc_R5", "type": "Has_value", "arg1_id": "NCT02301962_inc_T15", "arg2_id": "NCT02301962_inc_T16", "normalized": [] }, { "id": "NCT02301962_inc_R6", "type": "AND", "arg1_id": "NCT02301962_inc_T20", "arg2_id": "NCT02301962_inc_T19", "normalized": [] }, { "id": "NCT02301962_inc_R7", "type": "AND", "arg1_id": "NCT02301962_inc_T26", "arg2_id": "NCT02301962_inc_T25", "normalized": [] }, { "id": "NCT02301962_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT02301962_inc_T26", "arg2_id": "NCT02301962_inc_T21", "normalized": [] }, { "id": "NCT02301962_inc_R9", "type": "AND", "arg1_id": "NCT02301962_inc_T28", "arg2_id": "NCT02301962_inc_T29", "normalized": [] }, { "id": "NCT02301962_inc_R10", "type": "Has_temporal", "arg1_id": "NCT02301962_inc_T30", "arg2_id": "NCT02301962_inc_T31", "normalized": [] }, { "id": "NCT02301962_inc_R11", "type": "Has_scope", "arg1_id": "NCT02301962_inc_T30", "arg2_id": "NCT02301962_inc_T35", "normalized": [] }, { "id": "NCT02301962_inc_R12", "type": "Has_index", "arg1_id": "NCT02301962_inc_T37", "arg2_id": "NCT02301962_inc_T38", "normalized": [] }, { "id": "NCT02301962_inc_R13", "type": "Has_temporal", "arg1_id": "NCT02301962_inc_T36", "arg2_id": "NCT02301962_inc_T37", "normalized": [] }, { "id": "NCT02301962_inc_R14", "type": "Subsumes", "arg1_id": "NCT02301962_inc_T21", "arg2_id": "NCT02301962_inc_T39", "normalized": [] }, { "id": "NCT02301962_inc_R15", "type": "Has_value", "arg1_id": "NCT02301962_inc_T40", "arg2_id": "NCT02301962_inc_T41", "normalized": [] }, { "id": "NCT02301962_inc_R16", "type": "Has_value", "arg1_id": "NCT02301962_inc_T42", "arg2_id": "NCT02301962_inc_T43", "normalized": [] }, { "id": "NCT02301962_inc_R17", "type": "Has_value", "arg1_id": "NCT02301962_inc_T44", "arg2_id": "NCT02301962_inc_T45", "normalized": [] }, { "id": "NCT02301962_inc_R18", "type": "Has_value", "arg1_id": "NCT02301962_inc_T46", "arg2_id": "NCT02301962_inc_T47", "normalized": [] }, { "id": "NCT02301962_inc_R19", "type": "Has_value", "arg1_id": "NCT02301962_inc_T48", "arg2_id": "NCT02301962_inc_T49", "normalized": [] }, { "id": "NCT02301962_inc_R20", "type": "Has_value", "arg1_id": "NCT02301962_inc_T50", "arg2_id": "NCT02301962_inc_T51", "normalized": [] }, { "id": "NCT02301962_inc_R21", "type": "Has_value", "arg1_id": "NCT02301962_inc_T52", "arg2_id": "NCT02301962_inc_T53", "normalized": [] }, { "id": "NCT02301962_inc_R22", "type": "Has_value", "arg1_id": "NCT02301962_inc_T54", "arg2_id": "NCT02301962_inc_T55", "normalized": [] }, { "id": "NCT02301962_inc_R23", "type": "Has_value", "arg1_id": "NCT02301962_inc_T56", "arg2_id": "NCT02301962_inc_T57", "normalized": [] }, { "id": "NCT02301962_inc_R24", "type": "Has_value", "arg1_id": "NCT02301962_inc_T58", "arg2_id": "NCT02301962_inc_T59", "normalized": [] } ]

[ { "id": "NCT02303171_exc_text", "type": "exclusion", "text": [ "Women with systemic lupus erythematosus (SLE)\nWomen with active thromboembolic disorders\nWomen with history of previous thromboembolic disorders\n" ], "offsets": [ [ 0, 145 ] ] } ]

[ { "id": "NCT02303171_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T2", "type": "Condition", "text": [ "systemic lupus erythematosus (SLE)" ], "offsets": [ [ 11, 45 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T3", "type": "Person", "text": [ "Women" ], "offsets": [ [ 46, 51 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T4", "type": "Person", "text": [ "Women" ], "offsets": [ [ 89, 94 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T5", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 57, 63 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T6", "type": "Condition", "text": [ "thromboembolic disorders" ], "offsets": [ [ 64, 88 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T7", "type": "Observation", "text": [ "history" ], "offsets": [ [ 100, 107 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T8", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 111, 119 ] ], "normalized": [] }, { "id": "NCT02303171_exc_T9", "type": "Condition", "text": [ "thromboembolic disorders" ], "offsets": [ [ 120, 144 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02303171_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02303171_exc_T6", "arg2_id": "NCT02303171_exc_T5", "normalized": [] }, { "id": "NCT02303171_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02303171_exc_T9", "arg2_id": "NCT02303171_exc_T8", "normalized": [] }, { "id": "NCT02303171_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02303171_exc_T9", "arg2_id": "NCT02303171_exc_T7", "normalized": [] } ]

[ { "id": "NCT02303171_inc_text", "type": "inclusion", "text": [ "Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia\nEarly pregnancy body weight is 50-90 Kg\n" ], "offsets": [ [ 0, 160 ] ] } ]

[ { "id": "NCT02303171_inc_T1", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 9, 14 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T3", "type": "Condition", "text": [ "APS" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T4", "type": "Qualifier", "text": [ "revised classification criteria for APS in 2006 in Sydney, Australia" ], "offsets": [ [ 51, 119 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T5", "type": "Temporal", "text": [ "Early pregnancy" ], "offsets": [ [ 120, 135 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T6", "type": "Measurement", "text": [ "body weight" ], "offsets": [ [ 136, 147 ] ], "normalized": [] }, { "id": "NCT02303171_inc_T7", "type": "Value", "text": [ "50-90 Kg" ], "offsets": [ [ 151, 159 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02303171_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02303171_inc_T3", "arg2_id": "NCT02303171_inc_T4", "normalized": [] }, { "id": "NCT02303171_inc_R2", "type": "Has_value", "arg1_id": "NCT02303171_inc_T6", "arg2_id": "NCT02303171_inc_T7", "normalized": [] }, { "id": "NCT02303171_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02303171_inc_T6", "arg2_id": "NCT02303171_inc_T5", "normalized": [] } ]

[ { "id": "NCT02312076_exc_text", "type": "exclusion", "text": [ "Moderate or severe endometriosis.\nHydrosalpinx.\nUterine abnormalities.\nMyoma.\nPrevious uterine surgery.\n" ], "offsets": [ [ 0, 104 ] ] } ]

[ { "id": "NCT02312076_exc_T1", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T2", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T3", "type": "Condition", "text": [ "endometriosis" ], "offsets": [ [ 19, 32 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T4", "type": "Scope", "text": [ "Moderate or severe" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T5", "type": "Condition", "text": [ "Hydrosalpinx" ], "offsets": [ [ 34, 46 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T6", "type": "Condition", "text": [ "Uterine abnormalities" ], "offsets": [ [ 48, 69 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T7", "type": "Condition", "text": [ "Myoma" ], "offsets": [ [ 71, 76 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T8", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 78, 86 ] ], "normalized": [] }, { "id": "NCT02312076_exc_T9", "type": "Procedure", "text": [ "uterine surgery" ], "offsets": [ [ 87, 102 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02312076_exc_R1", "type": "Has_scope", "arg1_id": "NCT02312076_exc_T3", "arg2_id": "NCT02312076_exc_T4", "normalized": [] } ]

[ { "id": "NCT02312076_inc_text", "type": "inclusion", "text": [ "Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.\n" ], "offsets": [ [ 0, 114 ] ] } ]

[ { "id": "NCT02312076_inc_T1", "type": "Procedure", "text": [ "ICSI" ], "offsets": [ [ 19, 23 ] ], "normalized": [] }, { "id": "NCT02312076_inc_T2", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02312076_inc_T3", "type": "Procedure", "text": [ "controlled ovarian hyperstimulation (COH)" ], "offsets": [ [ 32, 73 ] ], "normalized": [] }, { "id": "NCT02312076_inc_T4", "type": "Procedure", "text": [ "pituitary downregulation by GnRHa" ], "offsets": [ [ 79, 112 ] ], "normalized": [] }, { "id": "NCT02312076_inc_T5", "type": "Scope", "text": [ "controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa" ], "offsets": [ [ 32, 112 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02312076_inc_R1", "type": "Subsumes", "arg1_id": "NCT02312076_inc_T1", "arg2_id": "NCT02312076_inc_T5", "normalized": [] } ]