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[ { "id": "NCT01991743_exc_text", "type": "exclusion", "text": [ "Refusal\nContraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.\nDrop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.\n" ], "offsets": [ [ 0, 306 ] ] } ]

[ { "id": "NCT01991743_exc_T2", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 8, 24 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T3", "type": "Procedure", "text": [ "neuraxial" ], "offsets": [ [ 28, 37 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T4", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 39, 51 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T5", "type": "Drug", "text": [ "anticoagulant" ], "offsets": [ [ 53, 66 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T6", "type": "Condition", "text": [ "local infection" ], "offsets": [ [ 72, 87 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T7", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 89, 95 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T8", "type": "Condition", "text": [ "Rupture of membranes" ], "offsets": [ [ 102, 122 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T9", "type": "Scope", "text": [ "oagulopathy, anticoagulant use, local infection, sepsis" ], "offsets": [ [ 40, 95 ] ], "normalized": [] }, { "id": "NCT01991743_exc_T10", "type": "Scope", "text": [ "Contraindication to neuraxial" ], "offsets": [ [ 8, 37 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01991743_exc_R1", "type": "AND", "arg1_id": "NCT01991743_exc_T2", "arg2_id": "NCT01991743_exc_T3", "normalized": [] }, { "id": "NCT01991743_exc_R2", "type": "Has_scope", "arg1_id": "NCT01991743_exc_T10", "arg2_id": "NCT01991743_exc_T9", "normalized": [] } ]

[ { "id": "NCT01991743_inc_text", "type": "inclusion", "text": [ "Healthy patients age 18 and older\nBreech presentation\nSingleton gestation .scheduled for ECV desiring CSE.\n" ], "offsets": [ [ 0, 107 ] ] } ]

[ { "id": "NCT01991743_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T3", "type": "Value", "text": [ "18 and older" ], "offsets": [ [ 21, 33 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T4", "type": "Observation", "text": [ "Breech presentation" ], "offsets": [ [ 34, 53 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T5", "type": "Condition", "text": [ "Singleton gestation" ], "offsets": [ [ 54, 73 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T6", "type": "Procedure", "text": [ "ECV" ], "offsets": [ [ 89, 92 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T7", "type": "Procedure", "text": [ "CSE" ], "offsets": [ [ 102, 105 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T8", "type": "Mood", "text": [ "desiring" ], "offsets": [ [ 93, 101 ] ], "normalized": [] }, { "id": "NCT01991743_inc_T9", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 75, 88 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01991743_inc_R1", "type": "Has_value", "arg1_id": "NCT01991743_inc_T2", "arg2_id": "NCT01991743_inc_T3", "normalized": [] }, { "id": "NCT01991743_inc_R2", "type": "Has_mood", "arg1_id": "NCT01991743_inc_T7", "arg2_id": "NCT01991743_inc_T8", "normalized": [] }, { "id": "NCT01991743_inc_R3", "type": "AND", "arg1_id": "NCT01991743_inc_T6", "arg2_id": "NCT01991743_inc_T7", "normalized": [] }, { "id": "NCT01991743_inc_R4", "type": "Has_mood", "arg1_id": "NCT01991743_inc_T6", "arg2_id": "NCT01991743_inc_T9", "normalized": [] } ]

[ { "id": "NCT01993836_exc_text", "type": "exclusion", "text": [ "Inmate of a correctional facility (i.e. prisoners).\nPregnancy\nDocumented or suspected family or personal history of malignant hyperthermia.\nPatient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.\n" ], "offsets": [ [ 0, 247 ] ] } ]

[ { "id": "NCT01993836_exc_T1", "type": "Person", "text": [ "Inmate of a correctional facility" ], "offsets": [ [ 0, 33 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T2", "type": "Person", "text": [ "prisoners" ], "offsets": [ [ 40, 49 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T3", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 52, 61 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T4", "type": "Condition", "text": [ "malignant hyperthermia" ], "offsets": [ [ 116, 138 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T5", "type": "Observation", "text": [ "story o", "mily o" ], "offsets": [ [ 107, 114 ], [ 88, 94 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T6", "type": "Observation", "text": [ "personal history" ], "offsets": [ [ 96, 112 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T7", "type": "Drug", "text": [ "propofol" ], "offsets": [ [ 173, 181 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T8", "type": "Drug", "text": [ "isoflurane" ], "offsets": [ [ 185, 195 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T9", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 203, 210 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T10", "type": "Condition", "text": [ "unable to receive" ], "offsets": [ [ 148, 165 ] ], "normalized": [] }, { "id": "NCT01993836_exc_T11", "type": "Scope", "text": [ "propofol or isoflurane" ], "offsets": [ [ 173, 195 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01993836_exc_R1", "type": "Subsumes", "arg1_id": "NCT01993836_exc_T1", "arg2_id": "NCT01993836_exc_T2", "normalized": [] }, { "id": "NCT01993836_exc_R2", "type": "Has_scope", "arg1_id": "NCT01993836_exc_T10", "arg2_id": "NCT01993836_exc_T11", "normalized": [] }, { "id": "NCT01993836_exc_R3", "type": "AND", "arg1_id": "NCT01993836_exc_T10", "arg2_id": "NCT01993836_exc_T9", "normalized": [] } ]

[ { "id": "NCT01993836_inc_text", "type": "inclusion", "text": [ "Surgical patients 60 years of age or older\nSurgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)\nEnglish speaking ability.\nAbility to give informed consent\n" ], "offsets": [ [ 0, 192 ] ] } ]

[ { "id": "NCT01993836_inc_T1", "type": "Value", "text": [ "60 years", "or older" ], "offsets": [ [ 18, 26 ], [ 34, 42 ] ], "normalized": [] }, { "id": "NCT01993836_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 30, 33 ] ], "normalized": [] }, { "id": "NCT01993836_inc_T3", "type": "Procedure", "text": [ "Surgery" ], "offsets": [ [ 43, 50 ] ], "normalized": [] }, { "id": "NCT01993836_inc_T5", "type": "Qualifier", "text": [ "scheduled to last at least 2 hours" ], "offsets": [ [ 51, 85 ] ], "normalized": [] }, { "id": "NCT01993836_inc_T6", "type": "Observation", "text": [ "English speaking ability" ], "offsets": [ [ 133, 157 ] ], "normalized": [] }, { "id": "NCT01993836_inc_T7", "type": "Observation", "text": [ "Ability to give informed consent" ], "offsets": [ [ 159, 191 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01993836_inc_R1", "type": "Has_value", "arg1_id": "NCT01993836_inc_T2", "arg2_id": "NCT01993836_inc_T1", "normalized": [] }, { "id": "NCT01993836_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01993836_inc_T3", "arg2_id": "NCT01993836_inc_T5", "normalized": [] } ]

[ { "id": "NCT01994382_exc_text", "type": "exclusion", "text": [ "Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from Follicular NHL are eligible). \nPrior transplant with stem cell infusion 90 days or active graft-versus-host treatment within 8 weeks of Day 1. \nPrior therapy with SYK inhibitors. \nChronic treatment with strong CYP3A4 inhibitor/ inducer, acid reducing agent, Proton pump inhibitors \nKnown lymphomatous involvement of the CNS. \nPersistent, unresolved NCI CTCAE v4.0 ≥ Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy). \nPrior monoclonal antibody, radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks or for alemtuzumab 8 weeks of Day 1. \nFor CTCL: (TSEBT) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. (Stable topical ≥ 4 weeks prior to Day 1 allowed). \nKnown carrier or infection for HIV/Hep B or C. HCV ab+ must be PCR-. HBV ab+ must be HBsAg- or undetectable DNA \nActive infection requiring systemic treatment, \nSignificant GI disease, previous major gastric/bowel surgery, difficulty swallowing or malabsorption syndrome. \nMajor surgery within 4 weeks \nPrevious malignancies within 2 yrs. unless relapse risk is small (< 5%). \nCurrent use of systemic steroids >20 mg QD prednisone (or equivalent) \nBreastfeeding or pregnant (intention to become) females or participation in other clinical trials \n \n" ], "offsets": [ [ 0, 1530 ] ] } ]

[ { "id": "NCT01994382_exc_T1", "type": "Condition", "text": [ "Richter's syndrome" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T2", "type": "Condition", "text": [ "Burkitt's lymphoma" ], "offsets": [ [ 20, 38 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T3", "type": "Condition", "text": [ "Burkitt-like Lymphoma" ], "offsets": [ [ 43, 64 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T4", "type": "Condition", "text": [ "DLBCL" ], "offsets": [ [ 78, 83 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T5", "type": "Condition", "text": [ "Follicular NHL" ], "offsets": [ [ 89, 103 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T6", "type": "Procedure", "text": [ "transplant" ], "offsets": [ [ 126, 136 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T7", "type": "Procedure", "text": [ "stem cell infusion" ], "offsets": [ [ 142, 160 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T8", "type": "Temporal", "text": [ "90 days", "of Day 1" ], "offsets": [ [ 161, 168 ], [ 222, 230 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T9", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 172, 178 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T10", "type": "Procedure", "text": [ "graft-versus-host treatment" ], "offsets": [ [ 179, 206 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T11", "type": "Temporal", "text": [ "within 8 weeks of Day 1" ], "offsets": [ [ 207, 230 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T12", "type": "Drug", "text": [ "SYK inhibitors" ], "offsets": [ [ 252, 266 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T13", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 239, 246 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T14", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 233, 238 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T15", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 120, 125 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T16", "type": "Drug", "text": [ "strong CYP3A4 inhibitor" ], "offsets": [ [ 292, 315 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T17", "type": "Drug", "text": [ "strong CYP3A4", "inducer" ], "offsets": [ [ 292, 305 ], [ 317, 324 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T18", "type": "Drug", "text": [ "acid reducing agent" ], "offsets": [ [ 326, 345 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T19", "type": "Drug", "text": [ "Proton pump inhibitors" ], "offsets": [ [ 347, 369 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T20", "type": "Condition", "text": [ "lymphomatous involvement of the CNS" ], "offsets": [ [ 377, 412 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T22", "type": "Measurement", "text": [ "NCI CTCAE v4.0" ], "offsets": [ [ 438, 452 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T23", "type": "Value", "text": [ "≥ Grade 2" ], "offsets": [ [ 453, 462 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T24", "type": "Condition", "text": [ "drug-related toxicity" ], "offsets": [ [ 473, 494 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T25", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 464, 472 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T26", "type": "Condition", "text": [ "alopecia" ], "offsets": [ [ 503, 511 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T27", "type": "Negation", "text": [ "except" ], "offsets": [ [ 496, 502 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T28", "type": "Condition", "text": [ "erectile impotence" ], "offsets": [ [ 513, 531 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T29", "type": "Condition", "text": [ "hot flashes" ], "offsets": [ [ 533, 544 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T30", "type": "Condition", "text": [ "libido" ], "offsets": [ [ 546, 552 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T31", "type": "Condition", "text": [ "neuropathy" ], "offsets": [ [ 554, 564 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T32", "type": "Scope", "text": [ "alopecia, erectile impotence, hot flashes, libido, neuropathy" ], "offsets": [ [ 503, 564 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T33", "type": "Drug", "text": [ "monoclonal antibody" ], "offsets": [ [ 574, 593 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T34", "type": "Drug", "text": [ "radioimmunoconjugate" ], "offsets": [ [ 595, 615 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T35", "type": "Drug", "text": [ "antibody drug conjugate" ], "offsets": [ [ 617, 640 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T36", "type": "Procedure", "text": [ "phototherapy" ], "offsets": [ [ 642, 654 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T37", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 656, 668 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T38", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 670, 682 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T39", "type": "Procedure", "text": [ "immunotherapy" ], "offsets": [ [ 684, 697 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T40", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 699, 724 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T41", "type": "Temporal", "text": [ "within 3 weeks", "of Day 1" ], "offsets": [ [ 744, 758 ], [ 786, 794 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T42", "type": "Drug", "text": [ "alemtuzumab" ], "offsets": [ [ 766, 777 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T43", "type": "Temporal", "text": [ "8 weeks of Day 1" ], "offsets": [ [ 778, 794 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T44", "type": "Scope", "text": [ "monoclonal antibody, radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy" ], "offsets": [ [ 574, 724 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T45", "type": "Scope", "text": [ "within 3 weeks or for alemtuzumab 8 weeks of Day 1" ], "offsets": [ [ 744, 794 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T46", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 789, 794 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T47", "type": "Condition", "text": [ "CTCL" ], "offsets": [ [ 801, 805 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T48", "type": "Procedure", "text": [ "TSEBT" ], "offsets": [ [ 808, 813 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T49", "type": "Temporal", "text": [ "within 12 weeks" ], "offsets": [ [ 815, 830 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T50", "type": "Drug", "text": [ "topical steroid" ], "offsets": [ [ 849, 864 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T51", "type": "Observation", "text": [ "initiation" ], "offsets": [ [ 835, 845 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T52", "type": "Drug", "text": [ "nitrogen mustard" ], "offsets": [ [ 866, 882 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T53", "type": "Drug", "text": [ "topical retinoid" ], "offsets": [ [ 887, 903 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T54", "type": "Temporal", "text": [ "within 2 weeks" ], "offsets": [ [ 904, 918 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T55", "type": "Scope", "text": [ "topical steroid, nitrogen mustard, or topical retinoid" ], "offsets": [ [ 849, 903 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T56", "type": "Temporal", "text": [ "≥ 4 weeks prior to Day 1" ], "offsets": [ [ 936, 960 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T57", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 955, 960 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T59", "type": "Condition", "text": [ "infection for HIV" ], "offsets": [ [ 989, 1006 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T60", "type": "Condition", "text": [ "Hep B", "infection for" ], "offsets": [ [ 1007, 1012 ], [ 989, 1002 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T61", "type": "Condition", "text": [ "Hep", "C", "infection for" ], "offsets": [ [ 1007, 1010 ], [ 1016, 1017 ], [ 989, 1002 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T62", "type": "Condition", "text": [ "HCV ab+" ], "offsets": [ [ 1019, 1026 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T63", "type": "Qualifier", "text": [ "PCR-" ], "offsets": [ [ 1035, 1039 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T64", "type": "Condition", "text": [ "HBV ab+" ], "offsets": [ [ 1041, 1048 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T65", "type": "Qualifier", "text": [ "HBsAg-" ], "offsets": [ [ 1057, 1063 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T66", "type": "Condition", "text": [ "undetectable DNA" ], "offsets": [ [ 1067, 1083 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T67", "type": "Scope", "text": [ "infection for HIV/Hep B or C" ], "offsets": [ [ 989, 1017 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T68", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 1092, 1101 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T69", "type": "Procedure", "text": [ "systemic treatment" ], "offsets": [ [ 1112, 1130 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T70", "type": "Qualifier", "text": [ "requiring systemic treatment" ], "offsets": [ [ 1102, 1130 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T71", "type": "Condition", "text": [ "GI disease" ], "offsets": [ [ 1145, 1155 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T72", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 1133, 1144 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T74", "type": "Procedure", "text": [ "bowel surgery" ], "offsets": [ [ 1180, 1193 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T75", "type": "Procedure", "text": [ "gastric", "surgery" ], "offsets": [ [ 1172, 1179 ], [ 1186, 1193 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T76", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 1166, 1171 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T78", "type": "Condition", "text": [ "difficulty swallowing" ], "offsets": [ [ 1195, 1216 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T79", "type": "Condition", "text": [ "malabsorption syndrome" ], "offsets": [ [ 1220, 1242 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T80", "type": "Scope", "text": [ "gastric/bowel surgery" ], "offsets": [ [ 1172, 1193 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T81", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1251, 1258 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T82", "type": "Qualifier", "text": [ "Major" ], "offsets": [ [ 1245, 1250 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T85", "type": "Temporal", "text": [ "within 4 weeks" ], "offsets": [ [ 1259, 1273 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T86", "type": "Condition", "text": [ "malignancies" ], "offsets": [ [ 1284, 1296 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T87", "type": "Temporal", "text": [ "within 2 yrs." ], "offsets": [ [ 1297, 1310 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T91", "type": "Drug", "text": [ "systemic steroids" ], "offsets": [ [ 1364, 1381 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T92", "type": "Multiplier", "text": [ ">20 mg QD" ], "offsets": [ [ 1382, 1391 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T93", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 1392, 1402 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T94", "type": "Observation", "text": [ "Breastfeeding" ], "offsets": [ [ 1420, 1433 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T95", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1437, 1445 ] ], "normalized": [] }, { "id": "NCT01994382_exc_T96", "type": "Person", "text": [ "females" ], "offsets": [ [ 1468, 1475 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT01994382_inc_text", "type": "inclusion", "text": [ "Phase 1 Specific Patient at least 18yrs of age with histologically confirmed CLL/SLL or B-cell Non-Hodgkin lymphoma (DLBCL, FL, MCL, MZL, lymphoplasmacytic lymphoma). \nPhase 2a Inclusion \nHistological evidence: FL Grade 1-3A/iNHL, with relapsed or refractory disease (iNHL includes LPL/WM, MZL); aNHL, defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, PTCL, or CTCL (with MF/SS) with relapsed or refractory. \nReceived BCR and/or BCL2 inhibitors were intolerant or had relapsed/refractory disease afterwards. \nPrior treatment for lymphoid malignancy for progressive /refractory disease \n≥ 1 prior regimen (min 2 cycles) with antibody conjugate, cytotoxic chemotherapy, or TKI alone or in combination. \nMeasureable disease defined as: ≥ 1 lesion ≥ 1.5 cm single dimension via CT, CT/PET with nodal or mass lesions; Quantifiable circulating tumor cells; or for Waldenström's macroglobulinemia presence of IgM l > 2X ULN; For CTCL: mSWAT > 0 \nAbility to provide diagnostic reports \nGeneral Inclusion \nECOG Score of 0 or 1. \nHematologic ANC > 1000/uL and platelet > 75,000/uL, \nSerum creatinine of < 1.5 ULN or calculated CrCl of > 50 mL/min \nBilirubin < 20.0mg/dL (if Gilberts then < 2.5 mg/dL) and AST/AST < 2.5 ULN \n" ], "offsets": [ [ 0, 1252 ] ] } ]

[ { "id": "NCT01994382_inc_T1", "type": "Condition", "text": [ "CLL" ], "offsets": [ [ 77, 80 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T2", "type": "Condition", "text": [ "SLL" ], "offsets": [ [ 81, 84 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T3", "type": "Condition", "text": [ "B-cell Non-Hodgkin lymphoma" ], "offsets": [ [ 88, 115 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T4", "type": "Condition", "text": [ "DLBCL" ], "offsets": [ [ 117, 122 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T5", "type": "Condition", "text": [ "FL" ], "offsets": [ [ 124, 126 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T6", "type": "Condition", "text": [ "MCL" ], "offsets": [ [ 128, 131 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T7", "type": "Condition", "text": [ "MZL" ], "offsets": [ [ 133, 136 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T8", "type": "Condition", "text": [ "lymphoplasmacytic lymphoma" ], "offsets": [ [ 138, 164 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T9", "type": "Scope", "text": [ "DLBCL, FL, MCL, MZL, lymphoplasmacytic lymphoma" ], "offsets": [ [ 117, 164 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T10", "type": "Scope", "text": [ "CLL/SLL or B-cell Non-Hodgkin lymphoma" ], "offsets": [ [ 77, 115 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T11", "type": "Value", "text": [ "at least 18yrs" ], "offsets": [ [ 25, 39 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T12", "type": "Person", "text": [ "age" ], "offsets": [ [ 43, 46 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T13", "type": "Procedure", "text": [ "histologically" ], "offsets": [ [ 52, 66 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T14", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 67, 76 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T16", "type": "Procedure", "text": [ "Histological" ], "offsets": [ [ 188, 200 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T17", "type": "Condition", "text": [ "FL" ], "offsets": [ [ 211, 213 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T18", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 214, 219 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T19", "type": "Value", "text": [ "1-3A" ], "offsets": [ [ 220, 224 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T20", "type": "Condition", "text": [ "iNHL" ], "offsets": [ [ 225, 229 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T21", "type": "Condition", "text": [ "refractory disease" ], "offsets": [ [ 248, 266 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T22", "type": "Condition", "text": [ "relapsed", "disease" ], "offsets": [ [ 236, 244 ], [ 259, 266 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T23", "type": "Condition", "text": [ "iNHL" ], "offsets": [ [ 268, 272 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T24", "type": "Condition", "text": [ "LPL" ], "offsets": [ [ 282, 285 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T25", "type": "Condition", "text": [ "WM" ], "offsets": [ [ 286, 288 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T26", "type": "Condition", "text": [ "MZL" ], "offsets": [ [ 290, 293 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T27", "type": "Scope", "text": [ "LPL/WM, MZL" ], "offsets": [ [ 282, 293 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T28", "type": "Scope", "text": [ "relapsed or refractory disease" ], "offsets": [ [ 236, 266 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T29", "type": "Condition", "text": [ "aNHL" ], "offsets": [ [ 296, 300 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T30", "type": "Condition", "text": [ "DLBCL" ], "offsets": [ [ 313, 318 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T31", "type": "Condition", "text": [ "FL" ], "offsets": [ [ 320, 322 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T32", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 323, 328 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T33", "type": "Value", "text": [ "3B" ], "offsets": [ [ 329, 331 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T34", "type": "Condition", "text": [ "MCL" ], "offsets": [ [ 333, 336 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T35", "type": "Condition", "text": [ "transformed NHL" ], "offsets": [ [ 342, 357 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T36", "type": "Condition", "text": [ "relapsed disease" ], "offsets": [ [ 363, 379 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T37", "type": "Condition", "text": [ "CLL" ], "offsets": [ [ 381, 384 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T38", "type": "Condition", "text": [ "SLL" ], "offsets": [ [ 385, 388 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T39", "type": "Condition", "text": [ "PTCL" ], "offsets": [ [ 390, 394 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T40", "type": "Condition", "text": [ "CTCL" ], "offsets": [ [ 399, 403 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T41", "type": "Condition", "text": [ "MF" ], "offsets": [ [ 410, 412 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T42", "type": "Condition", "text": [ "SS" ], "offsets": [ [ 413, 415 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T43", "type": "Scope", "text": [ "MF/SS" ], "offsets": [ [ 410, 415 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T44", "type": "Scope", "text": [ "DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease" ], "offsets": [ [ 313, 379 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T45", "type": "Drug", "text": [ "BCL2 inhibitors" ], "offsets": [ [ 467, 482 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T46", "type": "Drug", "text": [ "BCR", "inhibitors" ], "offsets": [ [ 456, 459 ], [ 472, 482 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T47", "type": "Condition", "text": [ "intolerant" ], "offsets": [ [ 488, 498 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T48", "type": "Scope", "text": [ "BCR and/or BCL2 inhibitors" ], "offsets": [ [ 456, 482 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T49", "type": "Condition", "text": [ "relapsed" ], "offsets": [ [ 506, 514 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T50", "type": "Condition", "text": [ "refractory disease" ], "offsets": [ [ 515, 533 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T51", "type": "Temporal", "text": [ "afterwards" ], "offsets": [ [ 534, 544 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T52", "type": "Scope", "text": [ "relapsed/refractory disease" ], "offsets": [ [ 506, 533 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T53", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 547, 552 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T54", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 553, 562 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T55", "type": "Condition", "text": [ "lymphoid malignancy" ], "offsets": [ [ 567, 586 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T56", "type": "Condition", "text": [ "refractory disease" ], "offsets": [ [ 604, 622 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T57", "type": "Condition", "text": [ "progressive", "disease" ], "offsets": [ [ 591, 602 ], [ 615, 622 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T58", "type": "Drug", "text": [ "antibody conjugate" ], "offsets": [ [ 662, 680 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T59", "type": "Procedure", "text": [ "cytotoxic chemotherapy" ], "offsets": [ [ 682, 704 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T60", "type": "Drug", "text": [ "TKI" ], "offsets": [ [ 709, 712 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T61", "type": "Multiplier", "text": [ "≥ 1 prior regimen" ], "offsets": [ [ 624, 641 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T62", "type": "Multiplier", "text": [ "min 2 cycles" ], "offsets": [ [ 643, 655 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T63", "type": "Scope", "text": [ "antibody conjugate, cytotoxic chemotherapy, or TKI" ], "offsets": [ [ 662, 712 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T64", "type": "Condition", "text": [ "Measureable disease" ], "offsets": [ [ 739, 758 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T65", "type": "Multiplier", "text": [ "≥ 1 lesion" ], "offsets": [ [ 771, 781 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T66", "type": "Measurement", "text": [ "≥ 1.5 cm single dimension" ], "offsets": [ [ 782, 807 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T67", "type": "Value", "text": [ "≥ 1.5 cm" ], "offsets": [ [ 782, 790 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T68", "type": "Procedure", "text": [ "CT" ], "offsets": [ [ 812, 814 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T69", "type": "Procedure", "text": [ "CT/PET" ], "offsets": [ [ 816, 822 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T70", "type": "Condition", "text": [ "mass lesions" ], "offsets": [ [ 837, 849 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T71", "type": "Condition", "text": [ "nodal", "lesions" ], "offsets": [ [ 828, 833 ], [ 842, 849 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T72", "type": "Condition", "text": [ "circulating tumor cells" ], "offsets": [ [ 864, 887 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T73", "type": "Condition", "text": [ "Waldenström's macroglobulinemia" ], "offsets": [ [ 896, 927 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T74", "type": "Measurement", "text": [ "IgM l" ], "offsets": [ [ 940, 945 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T75", "type": "Value", "text": [ "> 2X ULN" ], "offsets": [ [ 946, 954 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T76", "type": "Condition", "text": [ "CTCL" ], "offsets": [ [ 960, 964 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T77", "type": "Measurement", "text": [ "mSWAT" ], "offsets": [ [ 966, 971 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T78", "type": "Value", "text": [ "> 0" ], "offsets": [ [ 972, 975 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T79", "type": "Scope", "text": [ "nodal or mass lesions" ], "offsets": [ [ 828, 849 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T80", "type": "Scope", "text": [ "CT, CT/PET" ], "offsets": [ [ 812, 822 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T81", "type": "Scope", "text": [ "≥ 1 lesion ≥ 1.5 cm single dimension via CT, CT/PET with nodal or mass lesions; Quantifiable circulating tumor cells; or for Waldenström's macroglobulinemia presence of IgM l > 2X ULN; For CTCL: mSWAT > 0" ], "offsets": [ [ 771, 975 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T84", "type": "Measurement", "text": [ "ECOG Score" ], "offsets": [ [ 1035, 1045 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T85", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 1049, 1055 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T86", "type": "Measurement", "text": [ "Hematologic ANC" ], "offsets": [ [ 1058, 1073 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T87", "type": "Value", "text": [ "> 1000/uL" ], "offsets": [ [ 1074, 1083 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T88", "type": "Measurement", "text": [ "platelet" ], "offsets": [ [ 1088, 1096 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T89", "type": "Value", "text": [ "> 75,000/uL" ], "offsets": [ [ 1097, 1108 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T90", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 1111, 1127 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T91", "type": "Value", "text": [ "< 1.5 ULN" ], "offsets": [ [ 1131, 1140 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T92", "type": "Measurement", "text": [ "calculated CrCl" ], "offsets": [ [ 1144, 1159 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T93", "type": "Value", "text": [ "> 50 mL/min" ], "offsets": [ [ 1163, 1174 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T94", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 1176, 1185 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T95", "type": "Value", "text": [ "< 20.0mg/dL" ], "offsets": [ [ 1186, 1197 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T96", "type": "Condition", "text": [ "Gilberts" ], "offsets": [ [ 1202, 1210 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T97", "type": "Value", "text": [ "< 2.5 mg/dL" ], "offsets": [ [ 1216, 1227 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T98", "type": "Scope", "text": [ "< 20.0mg/dL (if Gilberts then < 2.5 mg/dL)" ], "offsets": [ [ 1186, 1228 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T99", "type": "Measurement", "text": [ "AST/AST" ], "offsets": [ [ 1233, 1240 ] ], "normalized": [] }, { "id": "NCT01994382_inc_T100", "type": "Value", "text": [ "< 2.5 ULN" ], "offsets": [ [ 1241, 1250 ] ], "normalized": [] } ]

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[ { "id": "NCT01994382_inc_R1", "type": "Subsumes", "arg1_id": "NCT01994382_inc_T10", "arg2_id": "NCT01994382_inc_T9", "normalized": [] }, { "id": "NCT01994382_inc_R2", "type": "Has_value", "arg1_id": "NCT01994382_inc_T12", "arg2_id": "NCT01994382_inc_T11", "normalized": [] }, { "id": "NCT01994382_inc_R3", "type": "Has_value", "arg1_id": "NCT01994382_inc_T13", "arg2_id": "NCT01994382_inc_T14", "normalized": [] }, { "id": "NCT01994382_inc_R4", "type": "AND", "arg1_id": "NCT01994382_inc_T10", "arg2_id": "NCT01994382_inc_T13", "normalized": [] }, { "id": "NCT01994382_inc_R5", "type": "Has_value", "arg1_id": "NCT01994382_inc_T18", "arg2_id": "NCT01994382_inc_T19", "normalized": [] }, { "id": "NCT01994382_inc_R6", "type": "AND", "arg1_id": "NCT01994382_inc_T17", "arg2_id": "NCT01994382_inc_T18", "normalized": [] }, { "id": "NCT01994382_inc_R7", "type": "Subsumes", "arg1_id": "NCT01994382_inc_T23", "arg2_id": "NCT01994382_inc_T27", "normalized": [] }, { "id": "NCT01994382_inc_R8", "type": "Subsumes", "arg1_id": "NCT01994382_inc_T28", "arg2_id": "NCT01994382_inc_T23", "normalized": [] }, { "id": "NCT01994382_inc_R9", "type": "Has_value", "arg1_id": "NCT01994382_inc_T32", "arg2_id": "NCT01994382_inc_T33", "normalized": [] }, { "id": "NCT01994382_inc_R10", "type": "Has_scope", "arg1_id": "NCT01994382_inc_T40", "arg2_id": "NCT01994382_inc_T43", "normalized": [] }, { "id": "NCT01994382_inc_R11", "type": "AND", "arg1_id": "NCT01994382_inc_T35", "arg2_id": "NCT01994382_inc_T36", "normalized": [] }, { "id": "NCT01994382_inc_R12", "type": "Subsumes", "arg1_id": "NCT01994382_inc_T29", "arg2_id": "NCT01994382_inc_T44", "normalized": [] }, { "id": "NCT01994382_inc_R13", "type": "Has_scope", "arg1_id": "NCT01994382_inc_T47", "arg2_id": "NCT01994382_inc_T48", "normalized": [] }, { "id": "NCT01994382_inc_R14", "type": "Has_temporal", "arg1_id": "NCT01994382_inc_T52", "arg2_id": "NCT01994382_inc_T51", "normalized": [] }, { "id": "NCT01994382_inc_R15", "type": "Has_multiplier", "arg1_id": "NCT01994382_inc_T63", "arg2_id": "NCT01994382_inc_T61", "normalized": [] }, { "id": "NCT01994382_inc_R16", "type": "Has_multiplier", "arg1_id": "NCT01994382_inc_T61", "arg2_id": "NCT01994382_inc_T62", "normalized": [] }, { "id": "NCT01994382_inc_R17", "type": "Has_value", "arg1_id": "NCT01994382_inc_T66", "arg2_id": "NCT01994382_inc_T67", "normalized": [] }, { "id": "NCT01994382_inc_R18", "type": "Has_value", "arg1_id": "NCT01994382_inc_T74", "arg2_id": "NCT01994382_inc_T75", "normalized": [] }, { "id": "NCT01994382_inc_R19", "type": "Has_value", "arg1_id": "NCT01994382_inc_T77", "arg2_id": "NCT01994382_inc_T78", "normalized": [] }, { "id": "NCT01994382_inc_R20", "type": "AND", "arg1_id": "NCT01994382_inc_T76", "arg2_id": "NCT01994382_inc_T77", "normalized": [] }, { "id": "NCT01994382_inc_R21", "type": "AND", "arg1_id": "NCT01994382_inc_T73", "arg2_id": "NCT01994382_inc_T74", "normalized": [] }, { "id": "NCT01994382_inc_R22", "type": "Has_scope", "arg1_id": "NCT01994382_inc_T66", "arg2_id": "NCT01994382_inc_T80", "normalized": [] }, { "id": "NCT01994382_inc_R23", "type": "Has_scope", "arg1_id": "NCT01994382_inc_T80", "arg2_id": "NCT01994382_inc_T79", "normalized": [] }, { "id": "NCT01994382_inc_R24", "type": "Subsumes", "arg1_id": "NCT01994382_inc_T64", "arg2_id": "NCT01994382_inc_T81", "normalized": [] }, { "id": "NCT01994382_inc_R25", "type": "Has_value", "arg1_id": "NCT01994382_inc_T84", "arg2_id": "NCT01994382_inc_T85", "normalized": [] }, { "id": "NCT01994382_inc_R26", "type": "Has_value", "arg1_id": "NCT01994382_inc_T86", "arg2_id": "NCT01994382_inc_T87", "normalized": [] }, { "id": "NCT01994382_inc_R27", "type": "Has_value", "arg1_id": "NCT01994382_inc_T88", "arg2_id": "NCT01994382_inc_T89", "normalized": [] }, { "id": "NCT01994382_inc_R28", "type": "Has_value", "arg1_id": "NCT01994382_inc_T90", "arg2_id": "NCT01994382_inc_T91", "normalized": [] }, { "id": "NCT01994382_inc_R29", "type": "Has_value", "arg1_id": "NCT01994382_inc_T92", "arg2_id": "NCT01994382_inc_T93", "normalized": [] }, { "id": "NCT01994382_inc_R30", "type": "Has_value", "arg1_id": "NCT01994382_inc_T96", "arg2_id": "NCT01994382_inc_T97", "normalized": [] }, { "id": "NCT01994382_inc_R31", "type": "Has_scope", "arg1_id": "NCT01994382_inc_T94", "arg2_id": "NCT01994382_inc_T98", "normalized": [] }, { "id": "NCT01994382_inc_R32", "type": "Has_value", "arg1_id": "NCT01994382_inc_T99", "arg2_id": "NCT01994382_inc_T100", "normalized": [] } ]

[ { "id": "NCT01996436_exc_text", "type": "exclusion", "text": [ "Inability to obtain consent from patient or patients kin\nPregnant women\nless than 18 years of age of more than 80 years of age\nHunt Hess Grade 5 SAH\n" ], "offsets": [ [ 0, 149 ] ] } ]

[ { "id": "NCT01996436_exc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 94, 97 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T4", "type": "Value", "text": [ "less than 18 years" ], "offsets": [ [ 72, 90 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 123, 126 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T6", "type": "Value", "text": [ "more than 80 years" ], "offsets": [ [ 101, 119 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T7", "type": "Measurement", "text": [ "Hunt Hess Grade" ], "offsets": [ [ 127, 142 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T8", "type": "Value", "text": [ "5" ], "offsets": [ [ 143, 144 ] ], "normalized": [] }, { "id": "NCT01996436_exc_T9", "type": "Condition", "text": [ "SAH" ], "offsets": [ [ 145, 148 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01996436_exc_R1", "type": "Has_value", "arg1_id": "NCT01996436_exc_T3", "arg2_id": "NCT01996436_exc_T4", "normalized": [] }, { "id": "NCT01996436_exc_R2", "type": "Has_value", "arg1_id": "NCT01996436_exc_T5", "arg2_id": "NCT01996436_exc_T6", "normalized": [] }, { "id": "NCT01996436_exc_R3", "type": "Has_value", "arg1_id": "NCT01996436_exc_T7", "arg2_id": "NCT01996436_exc_T8", "normalized": [] }, { "id": "NCT01996436_exc_R4", "type": "AND", "arg1_id": "NCT01996436_exc_T9", "arg2_id": "NCT01996436_exc_T7", "normalized": [] } ]

[ { "id": "NCT01996436_inc_text", "type": "inclusion", "text": [ "Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.\n" ], "offsets": [ [ 0, 131 ] ] } ]

[ { "id": "NCT01996436_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 15, 18 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T3", "type": "Value", "text": [ "18-80 years old" ], "offsets": [ [ 19, 34 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T4", "type": "Condition", "text": [ "ruptured aneurysm" ], "offsets": [ [ 41, 58 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T5", "type": "Condition", "text": [ "cerebral vasospasm" ], "offsets": [ [ 77, 95 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T6", "type": "Temporal", "text": [ "post operatively within 3-21 days" ], "offsets": [ [ 96, 129 ] ], "normalized": [] }, { "id": "NCT01996436_inc_T7", "type": "Reference_point", "text": [ "post operatively" ], "offsets": [ [ 96, 112 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01996436_inc_R1", "type": "Has_value", "arg1_id": "NCT01996436_inc_T2", "arg2_id": "NCT01996436_inc_T3", "normalized": [] }, { "id": "NCT01996436_inc_R2", "type": "Has_index", "arg1_id": "NCT01996436_inc_T6", "arg2_id": "NCT01996436_inc_T7", "normalized": [] }, { "id": "NCT01996436_inc_R3", "type": "AND", "arg1_id": "NCT01996436_inc_T4", "arg2_id": "NCT01996436_inc_T5", "normalized": [] }, { "id": "NCT01996436_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01996436_inc_T5", "arg2_id": "NCT01996436_inc_T6", "normalized": [] } ]

[ { "id": "NCT01997112_exc_text", "type": "exclusion", "text": [ "History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease.\nHistory of overdose or suicidal ideation\nPatients weighing <55kgs.\nPatients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.\n" ], "offsets": [ [ 0, 399 ] ] } ]

[ { "id": "NCT01997112_exc_T1", "type": "Condition", "text": [ "ischaemic heart disease" ], "offsets": [ [ 11, 34 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T2", "type": "Condition", "text": [ "cardiac failure" ], "offsets": [ [ 36, 51 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T3", "type": "Condition", "text": [ "cerebrovascular disease" ], "offsets": [ [ 53, 76 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T4", "type": "Condition", "text": [ "liver impairment" ], "offsets": [ [ 78, 94 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T5", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 96, 99 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T6", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 100, 103 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T7", "type": "Value", "text": [ ">50IU/L" ], "offsets": [ [ 103, 110 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T8", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T9", "type": "Value", "text": [ "3-5" ], "offsets": [ [ 121, 124 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T10", "type": "Condition", "text": [ "chronic kidney disease" ], "offsets": [ [ 125, 147 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T11", "type": "Scope", "text": [ "ALT/AST>50IU/L" ], "offsets": [ [ 96, 110 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T12", "type": "Condition", "text": [ "overdose" ], "offsets": [ [ 160, 168 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T13", "type": "Condition", "text": [ "suicidal ideation" ], "offsets": [ [ 172, 189 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T14", "type": "Measurement", "text": [ "weighing" ], "offsets": [ [ 199, 207 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T15", "type": "Value", "text": [ "<55kgs" ], "offsets": [ [ 208, 214 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T16", "type": "Condition", "text": [ "chronic pain" ], "offsets": [ [ 230, 242 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T17", "type": "Qualifier", "text": [ "requiring treatment" ], "offsets": [ [ 243, 262 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T18", "type": "Condition", "text": [ "known allergy" ], "offsets": [ [ 271, 284 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T19", "type": "Drug", "text": [ "paracetamol" ], "offsets": [ [ 288, 299 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T20", "type": "Drug", "text": [ "non-steroidal anti-inflammatories" ], "offsets": [ [ 323, 356 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T21", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 304, 315 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T22", "type": "Drug", "text": [ "oral anticoagulants" ], "offsets": [ [ 359, 378 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T23", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 382, 397 ] ], "normalized": [] }, { "id": "NCT01997112_exc_T24", "type": "Scope", "text": [ "non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids" ], "offsets": [ [ 323, 397 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01997112_exc_R1", "type": "Has_value", "arg1_id": "NCT01997112_exc_T6", "arg2_id": "NCT01997112_exc_T7", "normalized": [] }, { "id": "NCT01997112_exc_R2", "type": "Has_value", "arg1_id": "NCT01997112_exc_T5", "arg2_id": "NCT01997112_exc_T7", "normalized": [] }, { "id": "NCT01997112_exc_R3", "type": "Has_value", "arg1_id": "NCT01997112_exc_T8", "arg2_id": "NCT01997112_exc_T9", "normalized": [] }, { "id": "NCT01997112_exc_R4", "type": "AND", "arg1_id": "NCT01997112_exc_T10", "arg2_id": "NCT01997112_exc_T8", "normalized": [] }, { "id": "NCT01997112_exc_R5", "type": "Subsumes", "arg1_id": "NCT01997112_exc_T4", "arg2_id": "NCT01997112_exc_T11", "normalized": [] }, { "id": "NCT01997112_exc_R6", "type": "Has_value", "arg1_id": "NCT01997112_exc_T14", "arg2_id": "NCT01997112_exc_T15", "normalized": [] }, { "id": "NCT01997112_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01997112_exc_T16", "arg2_id": "NCT01997112_exc_T17", "normalized": [] }, { "id": "NCT01997112_exc_R8", "type": "AND", "arg1_id": "NCT01997112_exc_T18", "arg2_id": "NCT01997112_exc_T19", "normalized": [] }, { "id": "NCT01997112_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01997112_exc_T24", "arg2_id": "NCT01997112_exc_T21", "normalized": [] } ]

[ { "id": "NCT01997112_inc_text", "type": "inclusion", "text": [ "=18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)\nTreated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM =135/85 but <150/95.\n" ], "offsets": [ [ 0, 497 ] ] } ]

[ { "id": "NCT01997112_inc_T1", "type": "Value", "text": [ "=18" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T2", "type": "Person", "text": [ "years old" ], "offsets": [ [ 4, 13 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T3", "type": "Person", "text": [ "men" ], "offsets": [ [ 15, 18 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T4", "type": "Condition", "text": [ "post-menopausal" ], "offsets": [ [ 22, 37 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T5", "type": "Person", "text": [ "women" ], "offsets": [ [ 38, 43 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T6", "type": "Condition", "text": [ "no periods" ], "offsets": [ [ 56, 66 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T7", "type": "Temporal", "text": [ "for 12 months or more" ], "offsets": [ [ 67, 88 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T8", "type": "Procedure", "text": [ "surgical" ], "offsets": [ [ 114, 122 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T9", "type": "Condition", "text": [ "menopause" ], "offsets": [ [ 123, 132 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T10", "type": "Scope", "text": [ "no periods for 12 months or more, or those who have had a surgical menopause" ], "offsets": [ [ 56, 132 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T11", "type": "Condition", "text": [ "hypertensive" ], "offsets": [ [ 142, 154 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T12", "type": "Qualifier", "text": [ "Treated" ], "offsets": [ [ 134, 141 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T13", "type": "Measurement", "text": [ "average daytime ambulatory blood pressure measurement (ABPM)" ], "offsets": [ [ 172, 232 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T14", "type": "Value", "text": [ "<150/95mmHg" ], "offsets": [ [ 233, 244 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T15", "type": "Qualifier", "text": [ "stable doses" ], "offsets": [ [ 248, 260 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T16", "type": "Drug", "text": [ "antihypertensive medication" ], "offsets": [ [ 276, 303 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T17", "type": "Multiplier", "text": [ "one or more" ], "offsets": [ [ 264, 275 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T18", "type": "Drug", "text": [ "ACE inhibitor" ], "offsets": [ [ 341, 354 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T19", "type": "Drug", "text": [ "angiotensin receptor blocker" ], "offsets": [ [ 356, 384 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T20", "type": "Drug", "text": [ "diuretic" ], "offsets": [ [ 388, 396 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T21", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 305, 317 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T22", "type": "Scope", "text": [ "ACE inhibitor, angiotensin receptor blocker or diuretic" ], "offsets": [ [ 341, 396 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T23", "type": "Temporal", "text": [ "for 3 months" ], "offsets": [ [ 398, 410 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T24", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 415, 424 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T25", "type": "Condition", "text": [ "hypertensive patients" ], "offsets": [ [ 425, 446 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T26", "type": "Measurement", "text": [ "average daytime ABPM" ], "offsets": [ [ 455, 475 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T27", "type": "Value", "text": [ "=135/85 but <150/95" ], "offsets": [ [ 476, 495 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T28", "type": "Scope", "text": [ "Treated hypertensive" ], "offsets": [ [ 134, 154 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T29", "type": "Scope", "text": [ "untreated hypertensive patients" ], "offsets": [ [ 415, 446 ] ], "normalized": [] }, { "id": "NCT01997112_inc_T30", "type": "Scope", "text": [ "average daytime ambulatory blood pressure measurement (ABPM) <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months" ], "offsets": [ [ 172, 410 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01997112_inc_R1", "type": "Has_value", "arg1_id": "NCT01997112_inc_T2", "arg2_id": "NCT01997112_inc_T1", "normalized": [] }, { "id": "NCT01997112_inc_R2", "type": "AND", "arg1_id": "NCT01997112_inc_T5", "arg2_id": "NCT01997112_inc_T4", "normalized": [] }, { "id": "NCT01997112_inc_R3", "type": "AND", "arg1_id": "NCT01997112_inc_T9", "arg2_id": "NCT01997112_inc_T8", "normalized": [] }, { "id": "NCT01997112_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01997112_inc_T6", "arg2_id": "NCT01997112_inc_T7", "normalized": [] }, { "id": "NCT01997112_inc_R5", "type": "Subsumes", "arg1_id": "NCT01997112_inc_T4", "arg2_id": "NCT01997112_inc_T10", "normalized": [] }, { "id": "NCT01997112_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01997112_inc_T11", "arg2_id": "NCT01997112_inc_T12", "normalized": [] }, { "id": "NCT01997112_inc_R7", "type": "Has_value", "arg1_id": "NCT01997112_inc_T13", "arg2_id": "NCT01997112_inc_T14", "normalized": [] }, { "id": "NCT01997112_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT01997112_inc_T16", "arg2_id": "NCT01997112_inc_T17", "normalized": [] }, { "id": "NCT01997112_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT01997112_inc_T16", "arg2_id": "NCT01997112_inc_T15", "normalized": [] }, { "id": "NCT01997112_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT01997112_inc_T22", "arg2_id": "NCT01997112_inc_T21", "normalized": [] }, { "id": "NCT01997112_inc_R11", "type": "Subsumes", "arg1_id": "NCT01997112_inc_T16", "arg2_id": "NCT01997112_inc_T22", "normalized": [] }, { "id": "NCT01997112_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01997112_inc_T15", "arg2_id": "NCT01997112_inc_T23", "normalized": [] }, { "id": "NCT01997112_inc_R13", "type": "Has_value", "arg1_id": "NCT01997112_inc_T26", "arg2_id": "NCT01997112_inc_T27", "normalized": [] }, { "id": "NCT01997112_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT01997112_inc_T25", "arg2_id": "NCT01997112_inc_T24", "normalized": [] }, { "id": "NCT01997112_inc_R15", "type": "AND", "arg1_id": "NCT01997112_inc_T29", "arg2_id": "NCT01997112_inc_T26", "normalized": [] }, { "id": "NCT01997112_inc_R16", "type": "Has_scope", "arg1_id": "NCT01997112_inc_T28", "arg2_id": "NCT01997112_inc_T30", "normalized": [] } ]

[ { "id": "NCT01997580_exc_text", "type": "exclusion", "text": [ "DSM-IV-TR substance-related disorders (except nicotine)\nsignificant medical or neurological conditions\nmental retardation or organic brain damage\n" ], "offsets": [ [ 0, 146 ] ] } ]

[ { "id": "NCT01997580_exc_T1", "type": "Qualifier", "text": [ "DSM-IV-TR" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT01997580_exc_T2", "type": "Condition", "text": [ "substance-related disorders" ], "offsets": [ [ 10, 37 ] ], "normalized": [] }, { "id": "NCT01997580_exc_T3", "type": "Drug", "text": [ "nicotine" ], "offsets": [ [ 46, 54 ] ], "normalized": [] }, { "id": "NCT01997580_exc_T4", "type": "Negation", "text": [ "except" ], "offsets": [ [ 39, 45 ] ], "normalized": [] }, { "id": "NCT01997580_exc_T6", "type": "Condition", "text": [ "mental retardation" ], "offsets": [ [ 103, 121 ] ], "normalized": [] }, { "id": "NCT01997580_exc_T7", "type": "Condition", "text": [ "organic brain damage" ], "offsets": [ [ 125, 145 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01997580_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01997580_exc_T2", "arg2_id": "NCT01997580_exc_T1", "normalized": [] }, { "id": "NCT01997580_exc_R2", "type": "Has_negation", "arg1_id": "NCT01997580_exc_T3", "arg2_id": "NCT01997580_exc_T4", "normalized": [] }, { "id": "NCT01997580_exc_R3", "type": "AND", "arg1_id": "NCT01997580_exc_T2", "arg2_id": "NCT01997580_exc_T3", "normalized": [] } ]

[ { "id": "NCT01997580_inc_text", "type": "inclusion", "text": [ "DSM-IV-TR major depressive disorder\naged between 20 and 80\ndurg-naive or drug-free\n" ], "offsets": [ [ 0, 83 ] ] } ]

[ { "id": "NCT01997580_inc_T1", "type": "Qualifier", "text": [ "DSM-IV-TR" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T2", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 10, 35 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 36, 40 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T4", "type": "Value", "text": [ "between 20 and 80" ], "offsets": [ [ 41, 58 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T5", "type": "Drug", "text": [ "durg" ], "offsets": [ [ 59, 63 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T6", "type": "Negation", "text": [ "naive" ], "offsets": [ [ 64, 69 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T7", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 73, 77 ] ], "normalized": [] }, { "id": "NCT01997580_inc_T8", "type": "Negation", "text": [ "free" ], "offsets": [ [ 78, 82 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01997580_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01997580_inc_T2", "arg2_id": "NCT01997580_inc_T1", "normalized": [] }, { "id": "NCT01997580_inc_R2", "type": "Has_value", "arg1_id": "NCT01997580_inc_T3", "arg2_id": "NCT01997580_inc_T4", "normalized": [] }, { "id": "NCT01997580_inc_R3", "type": "Has_negation", "arg1_id": "NCT01997580_inc_T7", "arg2_id": "NCT01997580_inc_T8", "normalized": [] }, { "id": "NCT01997580_inc_R4", "type": "Has_negation", "arg1_id": "NCT01997580_inc_T5", "arg2_id": "NCT01997580_inc_T6", "normalized": [] } ]

[ { "id": "NCT02003339_exc_text", "type": "exclusion", "text": [ "Invasive hepatocellular carcinoma without any isolated tumor \nDisease needing 2 injections of Therasphere \nThrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis \nPrevious treatment by chemoembolization, radiofrequency less than 3 months before radioembolization \nNo antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib \nAssociated disease which could prevent patient from receiving treatment \nRMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy) \nPatient already participating in an other therapeutic trial with an experimental drug \nPregnant or childbearing potential women or breastfeeding women \nminors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons \nUnable to sign an informed consent \n \n" ], "offsets": [ [ 0, 1046 ] ] } ]

[ { "id": "NCT02003339_exc_T1", "type": "Condition", "text": [ "hepatocellular carcinoma" ], "offsets": [ [ 9, 33 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T2", "type": "Qualifier", "text": [ "Invasive" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T3", "type": "Condition", "text": [ "isolated tumor" ], "offsets": [ [ 46, 60 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T4", "type": "Negation", "text": [ "without" ], "offsets": [ [ 34, 41 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T6", "type": "Condition", "text": [ "Thrombosis" ], "offsets": [ [ 107, 117 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T7", "type": "Qualifier", "text": [ "extending into the porta" ], "offsets": [ [ 118, 142 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T8", "type": "Condition", "text": [ "thrombosis" ], "offsets": [ [ 143, 153 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T9", "type": "Qualifier", "text": [ "left", "branch" ], "offsets": [ [ 164, 168 ], [ 178, 184 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T10", "type": "Qualifier", "text": [ "right branch" ], "offsets": [ [ 172, 184 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T11", "type": "Scope", "text": [ "left or right branch" ], "offsets": [ [ 164, 184 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T13", "type": "Negation", "text": [ "authorized" ], "offsets": [ [ 185, 195 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T14", "type": "Condition", "text": [ "extra hepatic metastasis" ], "offsets": [ [ 198, 222 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T15", "type": "Procedure", "text": [ "chemoembolization" ], "offsets": [ [ 246, 263 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T16", "type": "Procedure", "text": [ "radiofrequency" ], "offsets": [ [ 265, 279 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T17", "type": "Temporal", "text": [ "less than 3 months before radioembolization" ], "offsets": [ [ 280, 323 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T18", "type": "Reference_point", "text": [ "radioembolization" ], "offsets": [ [ 306, 323 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T19", "type": "Scope", "text": [ "chemoembolization, radiofrequency" ], "offsets": [ [ 246, 279 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T20", "type": "Temporal", "text": [ "15 days before", "radioembolization" ], "offsets": [ [ 366, 380 ], [ 399, 416 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T21", "type": "Temporal", "text": [ "15 days after radioembolization" ], "offsets": [ [ 385, 416 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T22", "type": "Negation", "text": [ "No" ], "offsets": [ [ 325, 327 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T23", "type": "Procedure", "text": [ "antiangiogenic", "treatment" ], "offsets": [ [ 328, 342 ], [ 355, 364 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T24", "type": "Drug", "text": [ "Sorafenib" ], "offsets": [ [ 428, 437 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T25", "type": "Condition", "text": [ "Associated disease" ], "offsets": [ [ 439, 457 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T26", "type": "Qualifier", "text": [ "could prevent patient from receiving treatment" ], "offsets": [ [ 464, 510 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T28", "type": "Procedure", "text": [ "RMI" ], "offsets": [ [ 512, 515 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T29", "type": "Condition", "text": [ "RMI contre-indication" ], "offsets": [ [ 512, 533 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T32", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 727, 735 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T33", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 739, 761 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T34", "type": "Person", "text": [ "women" ], "offsets": [ [ 762, 767 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T35", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 771, 784 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T36", "type": "Person", "text": [ "women" ], "offsets": [ [ 785, 790 ] ], "normalized": [] }, { "id": "NCT02003339_exc_T38", "type": "Person", "text": [ "minors" ], "offsets": [ [ 792, 798 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02003339_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02003339_exc_T1", "arg2_id": "NCT02003339_exc_T2", "normalized": [] }, { "id": "NCT02003339_exc_R2", "type": "Has_negation", "arg1_id": "NCT02003339_exc_T3", "arg2_id": "NCT02003339_exc_T4", "normalized": [] }, { "id": "NCT02003339_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02003339_exc_T6", "arg2_id": "NCT02003339_exc_T7", "normalized": [] }, { "id": "NCT02003339_exc_R4", "type": "Has_scope", "arg1_id": "NCT02003339_exc_T8", "arg2_id": "NCT02003339_exc_T11", "normalized": [] }, { "id": "NCT02003339_exc_R5", "type": "Has_negation", "arg1_id": "NCT02003339_exc_T8", "arg2_id": "NCT02003339_exc_T13", "normalized": [] }, { "id": "NCT02003339_exc_R6", "type": "Has_index", "arg1_id": "NCT02003339_exc_T17", "arg2_id": "NCT02003339_exc_T18", "normalized": [] }, { "id": "NCT02003339_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02003339_exc_T19", "arg2_id": "NCT02003339_exc_T17", "normalized": [] }, { "id": "NCT02003339_exc_R8", "type": "Has_negation", "arg1_id": "NCT02003339_exc_T23", "arg2_id": "NCT02003339_exc_T22", "normalized": [] }, { "id": "NCT02003339_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02003339_exc_T23", "arg2_id": "NCT02003339_exc_T20", "normalized": [] }, { "id": "NCT02003339_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02003339_exc_T23", "arg2_id": "NCT02003339_exc_T21", "normalized": [] }, { "id": "NCT02003339_exc_R11", "type": "Subsumes", "arg1_id": "NCT02003339_exc_T23", "arg2_id": "NCT02003339_exc_T24", "normalized": [] }, { "id": "NCT02003339_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02003339_exc_T25", "arg2_id": "NCT02003339_exc_T26", "normalized": [] } ]

[ { "id": "NCT02003339_inc_text", "type": "inclusion", "text": [ "Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting. \nIsolated target on initial imagery (invasive hepatocellular carcinoma excluded) \nWHO (World Health organization) Performance status: 0, 1 or 2 \nIf cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter \nCreatinine clearance more or equal to 30 mL/min \nPatient informed and consent signature obtained \n" ], "offsets": [ [ 0, 485 ] ] } ]

[ { "id": "NCT02003339_inc_T1", "type": "Condition", "text": [ "Hepatocellular Carcinoma" ], "offsets": [ [ 46, 70 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T2", "type": "Negation", "text": [ "non" ], "offsets": [ [ 31, 34 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T3", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 35, 45 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T4", "type": "Qualifier", "text": [ "advanced" ], "offsets": [ [ 21, 29 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T5", "type": "Qualifier", "text": [ "intermediate" ], "offsets": [ [ 7, 19 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T6", "type": "Qualifier", "text": [ "Early" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T7", "type": "Scope", "text": [ "Early, intermediate, advanced" ], "offsets": [ [ 0, 29 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T8", "type": "Procedure", "text": [ "radioembolization" ], "offsets": [ [ 87, 104 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T9", "type": "Observation", "text": [ "Indication" ], "offsets": [ [ 72, 82 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T13", "type": "Measurement", "text": [ "WHO (World Health organization) Performance status" ], "offsets": [ [ 240, 290 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T14", "type": "Value", "text": [ "0, 1 or 2" ], "offsets": [ [ 292, 301 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T15", "type": "Condition", "text": [ "cirrhosis" ], "offsets": [ [ 306, 315 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T16", "type": "Measurement", "text": [ "Child", "score" ], "offsets": [ [ 317, 322 ], [ 325, 330 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T17", "type": "Value", "text": [ "A" ], "offsets": [ [ 323, 324 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T18", "type": "Measurement", "text": [ "total bilirubin" ], "offsets": [ [ 336, 351 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T19", "type": "Value", "text": [ "less than 30 micromoles per liter" ], "offsets": [ [ 352, 385 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T20", "type": "Scope", "text": [ "Child A score with total bilirubin less than 30 micromoles per liter" ], "offsets": [ [ 317, 385 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T21", "type": "Measurement", "text": [ "Creatinine clearance" ], "offsets": [ [ 387, 407 ] ], "normalized": [] }, { "id": "NCT02003339_inc_T22", "type": "Value", "text": [ "more or equal to 30 mL/min" ], "offsets": [ [ 408, 434 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02003339_inc_R1", "type": "Has_negation", "arg1_id": "NCT02003339_inc_T3", "arg2_id": "NCT02003339_inc_T2", "normalized": [] }, { "id": "NCT02003339_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02003339_inc_T1", "arg2_id": "NCT02003339_inc_T3", "normalized": [] }, { "id": "NCT02003339_inc_R3", "type": "Has_scope", "arg1_id": "NCT02003339_inc_T1", "arg2_id": "NCT02003339_inc_T7", "normalized": [] }, { "id": "NCT02003339_inc_R5", "type": "Has_value", "arg1_id": "NCT02003339_inc_T13", "arg2_id": "NCT02003339_inc_T14", "normalized": [] }, { "id": "NCT02003339_inc_R6", "type": "Has_value", "arg1_id": "NCT02003339_inc_T16", "arg2_id": "NCT02003339_inc_T17", "normalized": [] }, { "id": "NCT02003339_inc_R7", "type": "Has_value", "arg1_id": "NCT02003339_inc_T18", "arg2_id": "NCT02003339_inc_T19", "normalized": [] }, { "id": "NCT02003339_inc_R8", "type": "Has_scope", "arg1_id": "NCT02003339_inc_T15", "arg2_id": "NCT02003339_inc_T20", "normalized": [] }, { "id": "NCT02003339_inc_R9", "type": "Has_value", "arg1_id": "NCT02003339_inc_T21", "arg2_id": "NCT02003339_inc_T22", "normalized": [] } ]

[ { "id": "NCT02015494_exc_text", "type": "exclusion", "text": [ "Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period \nHas received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection \nHistory of excessive alcohol use, drug abuse or significant psychiatric illness \nTobacco use within 3 months of enrollment and throughout first 6 months of the study \nHas a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results \nClinically significant abnormal liver function tests at screening \nPositive serology for HBsAg, HCV or HIV antibodies \nPregnant or lactating female \nHaving cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding minor skin cancers, which are allowed unless located at the vaccination site \nPersons with impaired immune responsiveness (of any cause), including diabetes mellitus and autoimmune disorders \nPersons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed. \nPersons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component \nPersons with a history of Guillain-Barré Syndrome \nReceipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination \nDonation of blood or blood products within 8 weeks prior to vaccination or during the three week study period following \nAn oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever. \nBody Mass Index >29.9 \nAny disorder of coagulation \nA clinical diagnosis of influenza within the previous 12 months \nAny other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study \n \n" ], "offsets": [ [ 0, 2824 ] ] } ]

[ { "id": "NCT02015494_exc_T1", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 45, 49 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T2", "type": "Drug", "text": [ "vaccine product" ], "offsets": [ [ 53, 68 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T3", "type": "Qualifier", "text": [ "investigational" ], "offsets": [ [ 11, 26 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T4", "type": "Qualifier", "text": [ "non-registered" ], "offsets": [ [ 30, 44 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T5", "type": "Scope", "text": [ "investigational or non-registered" ], "offsets": [ [ 11, 44 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T6", "type": "Temporal", "text": [ "within 30 days preceding the administration of the study vaccine" ], "offsets": [ [ 69, 133 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T7", "type": "Reference_point", "text": [ "the administration of the study vaccine" ], "offsets": [ [ 94, 133 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T9", "type": "Temporal", "text": [ "within the first six weeks of the study period" ], "offsets": [ [ 149, 195 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T10", "type": "Observation", "text": [ "planned use" ], "offsets": [ [ 137, 148 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T11", "type": "Reference_point", "text": [ "the study period" ], "offsets": [ [ 179, 195 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T12", "type": "Scope", "text": [ "within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period" ], "offsets": [ [ 69, 195 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T13", "type": "Scope", "text": [ "drug or vaccine product" ], "offsets": [ [ 45, 68 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T15", "type": "Drug", "text": [ "influenza vaccine" ], "offsets": [ [ 248, 265 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T16", "type": "Qualifier", "text": [ "licensed" ], 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"offsets": [ [ 365, 382 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T25", "type": "Reference_point", "text": [ "Day 21" ], "offsets": [ [ 376, 382 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T26", "type": "Observation", "text": [ "History" ], "offsets": [ [ 401, 408 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T27", "type": "Condition", "text": [ "excessive alcohol use" ], "offsets": [ [ 412, 433 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T28", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 435, 445 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T29", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 461, 480 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T31", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 449, 460 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T32", "type": "Scope", "text": [ "excessive alcohol use, drug abuse or significant psychiatric illness" ], "offsets": [ [ 412, 480 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T33", "type": "Condition", "text": [ "Tobacco use" ], "offsets": [ [ 482, 493 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T34", "type": "Temporal", "text": [ "within 3 months of enrollment" ], "offsets": [ [ 494, 523 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T35", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 513, 523 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T36", "type": "Temporal", "text": [ "throughout first 6 months of the study" ], "offsets": [ [ 528, 566 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T37", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 557, 566 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T38", "type": "Condition", "text": [ "chronic illness" ], "offsets": [ [ 574, 589 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T40", "type": "Condition", "text": [ "liver", "disease" ], "offsets": [ [ 597, 602 ], [ 613, 620 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T41", "type": "Condition", "text": [ "kidney disease" ], "offsets": [ [ 606, 620 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T42", "type": "Scope", "text": [ "liver or kidney disease" ], "offsets": [ [ 597, 620 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T43", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 647, 654 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T44", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 635, 646 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T46", "type": "Condition", "text": [ "any other condition" ], "offsets": [ [ 663, 682 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T47", "type": "Qualifier", "text": [ "could interfere with the subject's participation in the study" ], "offsets": [ [ 688, 749 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T48", "type": "Measurement", "text": [ "liver function tests" ], "offsets": [ [ 829, 849 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T49", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 820, 828 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T50", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 797, 819 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T52", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 850, 862 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T53", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 853, 862 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T54", "type": "Measurement", "text": [ "HBsAg", "antibodies" ], "offsets": [ [ 886, 891 ], [ 904, 914 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T55", "type": "Measurement", "text": [ "HCV", "antibodies" ], "offsets": [ [ 893, 896 ], [ 904, 914 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T56", "type": "Measurement", "text": [ "HIV antibodies" ], "offsets": [ [ 900, 914 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T57", "type": "Scope", "text": [ "HBsAg, HCV or HIV antibodies" ], "offsets": [ [ 886, 914 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T58", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 864, 872 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T59", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 916, 924 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T60", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 928, 937 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T61", "type": "Person", "text": [ "female" ], "offsets": [ [ 938, 944 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T62", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 953, 959 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T63", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 991, 997 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T64", "type": "Procedure", "text": [ "treatment for cancer" ], "offsets": [ [ 977, 997 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T65", "type": "Temporal", "text": [ "within three years" ], "offsets": [ [ 998, 1016 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T66", "type": "Scope", "text": [ "cancer or have received treatment for cancer" ], "offsets": [ [ 953, 997 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T67", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 1044, 1050 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T68", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1033, 1040 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T69", "type": "Condition", "text": [ "disease-free" ], "offsets": [ [ 1059, 1071 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T70", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1080, 1089 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T71", "type": "Negation", "text": [ "without" ], "offsets": [ [ 1072, 1079 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T72", "type": "Temporal", "text": [ "for three years or more" ], "offsets": [ [ 1090, 1113 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T74", "type": "Scope", "text": [ "history of cancer who are disease-free without treatment for three years or more are eligible" ], "offsets": [ [ 1033, 1126 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T75", "type": "Condition", "text": [ "impaired immune responsiveness" ], "offsets": [ [ 1230, 1260 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T76", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 1287, 1304 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T77", "type": "Condition", "text": [ "autoimmune disorders" ], "offsets": [ [ 1309, 1329 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T78", "type": "Scope", "text": [ "diabetes mellitus and autoimmune disorders" ], "offsets": [ [ 1287, 1329 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T79", "type": "Temporal", "text": [ "within the past six months" ], "offsets": [ [ 1400, 1426 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T80", "type": "Drug", "text": [ "any medication" ], "offsets": [ [ 1428, 1442 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T81", "type": "Procedure", "text": [ "therapeutic modality" ], "offsets": [ [ 1446, 1466 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T82", "type": "Qualifier", "text": [ "affects the immune system" ], "offsets": [ [ 1472, 1497 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T83", "type": "Drug", "text": [ "allergy shots" ], "offsets": [ [ 1506, 1519 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T84", "type": "Drug", "text": [ "immune globulin" ], "offsets": [ [ 1521, 1536 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T85", "type": "Drug", "text": [ "interferon" ], "offsets": [ [ 1538, 1548 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T86", "type": "Drug", "text": [ "immunomodulators" ], "offsets": [ [ 1550, 1566 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T87", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 1568, 1585 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T88", "type": "Drug", "text": [ "cytotoxic drugs" ], "offsets": [ [ 1587, 1602 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T89", "type": "Drug", "text": [ "drugs known to be frequently associated with significant major organ toxicity" ], "offsets": [ [ 1606, 1683 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T90", "type": "Qualifier", "text": [ "known to be frequently associated with significant major organ toxicity" ], "offsets": [ [ 1612, 1683 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T91", "type": "Drug", "text": [ "systemic corticosteroids" ], "offsets": [ [ 1688, 1712 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T92", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 1714, 1718 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T93", "type": "Qualifier", "text": [ "injectable" ], "offsets": [ [ 1722, 1732 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T94", "type": "Scope", "text": [ "oral or injectable" ], "offsets": [ [ 1714, 1732 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T96", "type": "Scope", "text": [ "any medication or therapeutic modality that affects the immune system" ], "offsets": [ [ 1428, 1497 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T97", "type": "Scope", "text": [ "allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable)" ], "offsets": [ [ 1506, 1733 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T98", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 1818, 1835 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T99", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1811, 1817 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T100", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1800, 1807 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T101", "type": "Temporal", "text": [ "after previous vaccinations" ], "offsets": [ [ 1836, 1863 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T102", "type": "Reference_point", "text": [ "previous vaccinations" ], "offsets": [ [ 1842, 1863 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T103", "type": "Condition", "text": [ "hypersensitivity to any seasonal influenza vaccine component" ], "offsets": [ [ 1867, 1927 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T104", "type": "Drug", "text": [ "seasonal influenza vaccine component" ], "offsets": [ [ 1891, 1927 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T105", "type": "Condition", "text": [ "Guillain-Barré Syndrome" ], "offsets": [ [ 1955, 1978 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T106", "type": "Procedure", "text": [ "Receipt of blood" ], "offsets": [ [ 1980, 1996 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T107", "type": "Procedure", "text": [ "Receipt of", "blood products" ], "offsets": [ [ 1980, 1990 ], [ 2000, 2014 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T108", "type": "Temporal", "text": [ "8 weeks prior to vaccination" ], "offsets": [ [ 2015, 2043 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T109", "type": "Reference_point", "text": [ "vaccination" ], "offsets": [ [ 2032, 2043 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T110", "type": "Temporal", "text": [ "during the three week study period following vaccination" ], "offsets": [ [ 2070, 2126 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T111", "type": "Reference_point", "text": [ "three week study period following vaccination" ], "offsets": [ [ 2081, 2126 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T112", "type": "Observation", "text": [ "planned administration" ], "offsets": [ [ 2047, 2069 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T113", "type": "Scope", "text": [ "Receipt of blood or blood products" ], "offsets": [ [ 1980, 2014 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T114", "type": "Scope", "text": [ "8 weeks prior to vaccination or planned administration during the three week study period following vaccination" ], "offsets": [ [ 2015, 2126 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T115", "type": "Procedure", "text": [ "Donation of blood" ], "offsets": [ [ 2128, 2145 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T116", "type": "Procedure", "text": [ "Donation of", "blood products" ], "offsets": [ [ 2128, 2139 ], [ 2149, 2163 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T117", "type": "Temporal", "text": [ "within 8 weeks prior to vaccination" ], "offsets": [ [ 2164, 2199 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T118", "type": "Reference_point", "text": [ "vaccination" ], "offsets": [ [ 2188, 2199 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T119", "type": "Temporal", "text": [ "during the three week study period" ], "offsets": [ [ 2203, 2237 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T120", "type": "Reference_point", "text": [ "the three week study period" ], "offsets": [ [ 2210, 2237 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T121", "type": "Scope", "text": [ "within 8 weeks prior to vaccination or during the three week study period" ], "offsets": [ [ 2164, 2237 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T122", "type": "Scope", "text": [ "Donation of blood or blood products" ], "offsets": [ [ 2128, 2163 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T123", "type": "Measurement", "text": [ "oral temperature" ], "offsets": [ [ 2252, 2268 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T124", "type": "Value", "text": [ ">100.4°" ], "offsets": [ [ 2269, 2276 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T125", "type": "Condition", "text": [ "acute disease" ], "offsets": [ [ 2280, 2293 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T126", "type": "Temporal", "text": [ "within 72 hours prior to vaccination" ], "offsets": [ [ 2294, 2330 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T127", "type": "Reference_point", "text": [ "vaccination" ], "offsets": [ [ 2319, 2330 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T128", "type": "Scope", "text": [ "oral temperature >100.4° or acute disease" ], "offsets": [ [ 2252, 2293 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T129", "type": "Condition", "text": [ "moderate", "illness" ], "offsets": [ [ 2361, 2369 ], [ 2380, 2387 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T130", "type": "Condition", "text": [ "severe illness" ], "offsets": [ [ 2373, 2387 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T131", "type": "Measurement", "text": [ "Body Mass Index" ], "offsets": [ [ 2548, 2563 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T132", "type": "Value", "text": [ ">29.9" ], "offsets": [ [ 2564, 2569 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T133", "type": "Condition", "text": [ "disorder of coagulation" ], "offsets": [ [ 2575, 2598 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T134", "type": "Condition", "text": [ "influenza" ], "offsets": [ [ 2624, 2633 ] ], "normalized": [] }, { "id": "NCT02015494_exc_T135", "type": "Temporal", "text": [ "within the previous 12 months" ], "offsets": [ [ 2634, 2663 ] ], "normalized": [] } ]

[]

[]

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"Has_index", "arg1_id": "NCT02015494_exc_T52", "arg2_id": "NCT02015494_exc_T53", "normalized": [] }, { "id": "NCT02015494_exc_R24", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T48", "arg2_id": "NCT02015494_exc_T52", "normalized": [] }, { "id": "NCT02015494_exc_R25", "type": "Has_value", "arg1_id": "NCT02015494_exc_T57", "arg2_id": "NCT02015494_exc_T58", "normalized": [] }, { "id": "NCT02015494_exc_R26", "type": "AND", "arg1_id": "NCT02015494_exc_T64", "arg2_id": "NCT02015494_exc_T63", "normalized": [] }, { "id": "NCT02015494_exc_R27", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T66", "arg2_id": "NCT02015494_exc_T65", "normalized": [] }, { "id": "NCT02015494_exc_R28", "type": "Has_negation", "arg1_id": "NCT02015494_exc_T70", "arg2_id": "NCT02015494_exc_T71", "normalized": [] }, { "id": "NCT02015494_exc_R29", "type": "AND", "arg1_id": "NCT02015494_exc_T67", "arg2_id": "NCT02015494_exc_T70", "normalized": [] }, { "id": "NCT02015494_exc_R30", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T67", "arg2_id": "NCT02015494_exc_T68", "normalized": [] }, { "id": "NCT02015494_exc_R31", "type": "AND", "arg1_id": "NCT02015494_exc_T67", "arg2_id": "NCT02015494_exc_T69", "normalized": [] }, { "id": "NCT02015494_exc_R32", "type": "Subsumes", "arg1_id": "NCT02015494_exc_T75", "arg2_id": "NCT02015494_exc_T78", "normalized": [] }, { "id": "NCT02015494_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT02015494_exc_T89", "arg2_id": "NCT02015494_exc_T90", "normalized": [] }, { "id": "NCT02015494_exc_R34", "type": "Has_scope", "arg1_id": "NCT02015494_exc_T91", "arg2_id": "NCT02015494_exc_T94", "normalized": [] }, { "id": "NCT02015494_exc_R35", "type": "Has_qualifier", "arg1_id": "NCT02015494_exc_T96", "arg2_id": "NCT02015494_exc_T82", "normalized": [] }, { "id": "NCT02015494_exc_R36", "type": "Subsumes", "arg1_id": "NCT02015494_exc_T96", "arg2_id": "NCT02015494_exc_T97", "normalized": [] }, { "id": "NCT02015494_exc_R37", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T96", "arg2_id": "NCT02015494_exc_T79", "normalized": [] }, { "id": "NCT02015494_exc_R38", "type": "Has_qualifier", "arg1_id": "NCT02015494_exc_T98", "arg2_id": "NCT02015494_exc_T99", "normalized": [] }, { "id": "NCT02015494_exc_R39", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T98", "arg2_id": "NCT02015494_exc_T100", "normalized": [] }, { "id": "NCT02015494_exc_R40", "type": "Has_index", "arg1_id": "NCT02015494_exc_T101", "arg2_id": "NCT02015494_exc_T102", "normalized": [] }, { "id": "NCT02015494_exc_R41", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T98", "arg2_id": "NCT02015494_exc_T101", "normalized": [] }, { "id": "NCT02015494_exc_R42", "type": "Has_index", "arg1_id": "NCT02015494_exc_T108", "arg2_id": "NCT02015494_exc_T109", "normalized": [] }, { "id": "NCT02015494_exc_R43", "type": "Has_index", "arg1_id": "NCT02015494_exc_T110", "arg2_id": "NCT02015494_exc_T111", "normalized": [] }, { "id": "NCT02015494_exc_R44", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T112", "arg2_id": "NCT02015494_exc_T110", "normalized": [] }, { "id": "NCT02015494_exc_R45", "type": "Has_scope", "arg1_id": "NCT02015494_exc_T113", "arg2_id": "NCT02015494_exc_T114", "normalized": [] }, { "id": "NCT02015494_exc_R46", "type": "Has_index", "arg1_id": "NCT02015494_exc_T117", "arg2_id": "NCT02015494_exc_T118", "normalized": [] }, { "id": "NCT02015494_exc_R47", "type": "Has_index", "arg1_id": "NCT02015494_exc_T119", "arg2_id": "NCT02015494_exc_T120", "normalized": [] }, { "id": "NCT02015494_exc_R48", "type": "Has_scope", "arg1_id": "NCT02015494_exc_T122", "arg2_id": "NCT02015494_exc_T121", "normalized": [] }, { "id": "NCT02015494_exc_R49", "type": "Has_value", "arg1_id": "NCT02015494_exc_T123", "arg2_id": "NCT02015494_exc_T124", "normalized": [] }, { "id": "NCT02015494_exc_R50", "type": "Has_index", "arg1_id": "NCT02015494_exc_T126", "arg2_id": "NCT02015494_exc_T127", "normalized": [] }, { "id": "NCT02015494_exc_R51", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T128", "arg2_id": "NCT02015494_exc_T126", "normalized": [] }, { "id": "NCT02015494_exc_R52", "type": "Has_value", "arg1_id": "NCT02015494_exc_T131", "arg2_id": "NCT02015494_exc_T132", "normalized": [] }, { "id": "NCT02015494_exc_R53", "type": "Has_temporal", "arg1_id": "NCT02015494_exc_T134", "arg2_id": "NCT02015494_exc_T135", "normalized": [] } ]

[ { "id": "NCT02015494_inc_text", "type": "inclusion", "text": [ "Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator \nAble to provide informed consent indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol \nIf the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential. \nWilling to receive the unlicensed vaccine given as an IM injection \nWilling to provide multiple blood specimens collected by venipuncture \n" ], "offsets": [ [ 0, 1057 ] ] } ]

[ { "id": "NCT02015494_inc_T1", "type": "Person", "text": [ "Males" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T2", "type": "Person", "text": [ "females" ], "offsets": [ [ 10, 17 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 18, 22 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T4", "type": "Value", "text": [ "18-40 years" ], "offsets": [ [ 23, 34 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 38, 41 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T6", "type": "Temporal", "text": [ "at the time of vaccination" ], "offsets": [ [ 42, 68 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T7", "type": "Reference_point", "text": [ "time of vaccination" ], "offsets": [ [ 49, 68 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T8", "type": "Condition", "text": [ "good health" ], "offsets": [ [ 72, 83 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T10", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 101, 116 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T11", "type": "Procedure", "text": [ "physical exam" ], "offsets": [ [ 118, 131 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T12", "type": "Procedure", "text": [ "laboratory assessments" ], "offsets": [ [ 133, 155 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T14", "type": "Scope", "text": [ "medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator" ], "offsets": [ [ 101, 211 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T18", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 952, 959 ] ], "normalized": [] }, { "id": "NCT02015494_inc_T19", "type": "Procedure", "text": [ "IM injection" ], "offsets": [ [ 972, 984 ] ], "normalized": [] } ]

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[ { "id": "NCT02015494_inc_R1", "type": "Has_value", "arg1_id": "NCT02015494_inc_T5", "arg2_id": "NCT02015494_inc_T4", "normalized": [] }, { "id": "NCT02015494_inc_R2", "type": "Has_value", "arg1_id": "NCT02015494_inc_T3", "arg2_id": "NCT02015494_inc_T4", "normalized": [] }, { "id": "NCT02015494_inc_R3", "type": "Has_index", "arg1_id": "NCT02015494_inc_T6", "arg2_id": "NCT02015494_inc_T7", "normalized": [] }, { "id": "NCT02015494_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02015494_inc_T4", "arg2_id": "NCT02015494_inc_T6", "normalized": [] }, { "id": "NCT02015494_inc_R5", "type": "Subsumes", "arg1_id": "NCT02015494_inc_T8", "arg2_id": "NCT02015494_inc_T14", "normalized": [] } ]

[ { "id": "NCT02015923_exc_text", "type": "exclusion", "text": [ "Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.\nMultiple bone metastasis or central nervous system metastasis\nOther neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical \"in situ\" carcinoma\nSignificant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months\nPeripheral neuropathy\nPatients who do not give informed consent\n" ], "offsets": [ [ 0, 514 ] ] } ]

[ { "id": "NCT02015923_exc_T1", "type": "Condition", "text": [ "rectal tumours" ], "offsets": [ [ 9, 23 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T2", "type": "Qualifier", "text": [ "below 12cm from anal verge" ], "offsets": [ [ 24, 50 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T3", "type": "Condition", "text": [ "locally advanced tumours" ], "offsets": [ [ 55, 79 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T4", "type": "Condition", "text": [ "invading blood vessels" ], "offsets": [ [ 80, 102 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T5", "type": "Condition", "text": [ "nerves", "invading" ], "offsets": [ [ 104, 110 ], [ 80, 88 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T6", "type": "Condition", "text": [ "bone", "invading" ], "offsets": [ [ 114, 118 ], [ 80, 88 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T7", "type": "Scope", "text": [ "invading blood vessels, nerves or bone" ], "offsets": [ [ 80, 118 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T8", "type": "Condition", "text": [ "Multiple bone metastasis" ], "offsets": [ [ 120, 144 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T9", "type": "Condition", "text": [ "central nervous system metastasis" ], "offsets": [ [ 148, 181 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T10", "type": "Condition", "text": [ "neoplastic disease" ], "offsets": [ [ 188, 206 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T11", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 182, 187 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T12", "type": "Temporal", "text": [ "in the 5 previous years" ], "offsets": [ [ 207, 230 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T13", "type": "Condition", "text": [ "basal cell skin carcinoma" ], "offsets": [ [ 251, 276 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T14", "type": "Condition", "text": [ "uamous o", "ll skin carcinoma o" ], "offsets": [ [ 241, 249 ], [ 259, 278 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T15", "type": "Condition", "text": [ "cervical \"in situ\" carcinoma" ], "offsets": [ [ 280, 308 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T16", "type": "Negation", "text": [ "except" ], "offsets": [ [ 232, 238 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T17", "type": "Scope", "text": [ "squamous or basal cell skin carcinoma or cervical \"in situ\" carcinoma" ], "offsets": [ [ 239, 308 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T18", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 321, 334 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T19", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 309, 320 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T20", "type": "Condition", "text": [ "chronic congestive heart failure" ], "offsets": [ [ 336, 368 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T21", "type": "Condition", "text": [ "symptomatic coronary disease" ], "offsets": [ [ 370, 398 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T22", "type": "Scope", "text": [ "chronic congestive heart failure, symptomatic coronary disease" ], "offsets": [ [ 336, 398 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T23", "type": "Scope", "text": [ "Significant heart disease" ], "offsets": [ [ 309, 334 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T24", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 403, 424 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T25", "type": "Temporal", "text": [ "in the previous 6 months" ], "offsets": [ [ 425, 449 ] ], "normalized": [] }, { "id": "NCT02015923_exc_T26", "type": "Condition", "text": [ "Peripheral neuropathy" ], "offsets": [ [ 450, 471 ] ], "normalized": [] } ]

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[ { "id": "NCT02015923_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02015923_exc_T1", "arg2_id": "NCT02015923_exc_T2", "normalized": [] }, { "id": "NCT02015923_exc_R2", "type": "Has_scope", "arg1_id": "NCT02015923_exc_T3", "arg2_id": "NCT02015923_exc_T7", "normalized": [] }, { "id": "NCT02015923_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02015923_exc_T10", "arg2_id": "NCT02015923_exc_T11", "normalized": [] }, { "id": "NCT02015923_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02015923_exc_T10", "arg2_id": "NCT02015923_exc_T12", "normalized": [] }, { "id": "NCT02015923_exc_R5", "type": "Has_negation", "arg1_id": "NCT02015923_exc_T17", "arg2_id": "NCT02015923_exc_T16", "normalized": [] }, { "id": "NCT02015923_exc_R6", "type": "Has_scope", "arg1_id": "NCT02015923_exc_T10", "arg2_id": "NCT02015923_exc_T17", "normalized": [] }, { "id": "NCT02015923_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02015923_exc_T18", "arg2_id": "NCT02015923_exc_T19", "normalized": [] }, { "id": "NCT02015923_exc_R8", "type": "Subsumes", "arg1_id": "NCT02015923_exc_T23", "arg2_id": "NCT02015923_exc_T22", "normalized": [] }, { "id": "NCT02015923_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02015923_exc_T24", "arg2_id": "NCT02015923_exc_T25", "normalized": [] } ]

[ { "id": "NCT02015923_inc_text", "type": "inclusion", "text": [ "colorectal cancer above to 12 cm from the anal verge\nunresectable synchronous metastases\nno contraindications for chemotherapy\nabsence of peritoneal carcinomatosis, central nervous system o bone metastasis.\nperformance status ECOG = 2 (Eastern Cooperative Oncology Group)\nuncontrolled concomitant medical conditions that may compromise to chemotherapy\nsignificant symptomatic cardiac disease\nnot pregnancy or breastfeeding\n" ], "offsets": [ [ 0, 423 ] ] } ]

[ { "id": "NCT02015923_inc_T1", "type": "Condition", "text": [ "colorectal cancer" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T2", "type": "Qualifier", "text": [ "above to 12 cm from the anal verge" ], "offsets": [ [ 18, 52 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T3", "type": "Qualifier", "text": [ "unresectable" ], "offsets": [ [ 53, 65 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T4", "type": "Qualifier", "text": [ "synchronous" ], "offsets": [ [ 66, 77 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T5", "type": "Condition", "text": [ "metastases" ], "offsets": [ [ 78, 88 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T6", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 114, 126 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T7", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 92, 109 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T8", "type": "Negation", "text": [ "no" ], "offsets": [ [ 89, 91 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T9", "type": "Condition", "text": [ "peritoneal carcinomatosis" ], "offsets": [ [ 138, 163 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T10", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 127, 134 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T11", "type": "Condition", "text": [ "tral nervous system o", "astasis.\np" ], "offsets": [ [ 168, 189 ], [ 198, 208 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T12", "type": "Condition", "text": [ "bone metastasis" ], "offsets": [ [ 190, 205 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T13", "type": "Scope", "text": [ "peritoneal carcinomatosis, central nervous system o bone metastasis" ], "offsets": [ [ 138, 205 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T14", "type": "Measurement", "text": [ "ECOG" ], "offsets": [ [ 226, 230 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T15", "type": "Value", "text": [ "= 2" ], "offsets": [ [ 231, 234 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T16", "type": "Measurement", "text": [ "performance status" ], "offsets": [ [ 207, 225 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T17", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group" ], "offsets": [ [ 236, 270 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T18", "type": "Scope", "text": [ "ormance status ECOG = 2", "ern Cooperative Oncology Group)\nun" ], "offsets": [ [ 211, 234 ], [ 240, 274 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T19", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 272, 284 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T20", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 285, 296 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T21", "type": "Condition", "text": [ "medical conditions that may compromise to chemotherapy" ], "offsets": [ [ 297, 351 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T22", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 364, 375 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T23", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 376, 391 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T24", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 352, 363 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T25", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 396, 405 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T26", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 409, 422 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T27", "type": "Negation", "text": [ "not" ], "offsets": [ [ 392, 395 ] ], "normalized": [] }, { "id": "NCT02015923_inc_T28", "type": "Scope", "text": [ "pregnancy or breastfeeding" ], "offsets": [ [ 396, 422 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02015923_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T1", "arg2_id": "NCT02015923_inc_T2", "normalized": [] }, { "id": "NCT02015923_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T5", "arg2_id": "NCT02015923_inc_T4", "normalized": [] }, { "id": "NCT02015923_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T5", "arg2_id": "NCT02015923_inc_T3", "normalized": [] }, { "id": "NCT02015923_inc_R4", "type": "Has_negation", "arg1_id": "NCT02015923_inc_T7", "arg2_id": "NCT02015923_inc_T8", "normalized": [] }, { "id": "NCT02015923_inc_R5", "type": "AND", "arg1_id": "NCT02015923_inc_T7", "arg2_id": "NCT02015923_inc_T6", "normalized": [] }, { "id": "NCT02015923_inc_R6", "type": "Has_negation", "arg1_id": "NCT02015923_inc_T13", "arg2_id": "NCT02015923_inc_T10", "normalized": [] }, { "id": "NCT02015923_inc_R7", "type": "Subsumes", "arg1_id": "NCT02015923_inc_T14", "arg2_id": "NCT02015923_inc_T17", "normalized": [] }, { "id": "NCT02015923_inc_R8", "type": "Has_value", "arg1_id": "NCT02015923_inc_T14", "arg2_id": "NCT02015923_inc_T15", "normalized": [] }, { "id": "NCT02015923_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02015923_inc_T21", "arg2_id": "NCT02015923_inc_T20", "normalized": [] }, { "id": "NCT02015923_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T21", "arg2_id": "NCT02015923_inc_T19", "normalized": [] }, { "id": "NCT02015923_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T23", "arg2_id": "NCT02015923_inc_T24", "normalized": [] }, { "id": "NCT02015923_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT02015923_inc_T23", "arg2_id": "NCT02015923_inc_T22", "normalized": [] }, { "id": "NCT02015923_inc_R13", "type": "Has_negation", "arg1_id": "NCT02015923_inc_T28", "arg2_id": "NCT02015923_inc_T27", "normalized": [] } ]

[ { "id": "NCT02019160_exc_text", "type": "exclusion", "text": [ "Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded. \n \n" ], "offsets": [ [ 0, 147 ] ] } ]

[ { "id": "NCT02019160_exc_T1", "type": "Condition", "text": [ "uncooperative" ], "offsets": [ [ 17, 30 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T2", "type": "Observation", "text": [ "difficult to manage" ], "offsets": [ [ 35, 54 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T4", "type": "Condition", "text": [ "systemic diseases" ], "offsets": [ [ 67, 84 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T5", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 61, 66 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T6", "type": "Temporal", "text": [ "long-term" ], "offsets": [ [ 96, 105 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T7", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 106, 116 ] ], "normalized": [] }, { "id": "NCT02019160_exc_T8", "type": "Scope", "text": [ "uncooperative and difficult to manage" ], "offsets": [ [ 17, 54 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02019160_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02019160_exc_T4", "arg2_id": "NCT02019160_exc_T5", "normalized": [] }, { "id": "NCT02019160_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02019160_exc_T7", "arg2_id": "NCT02019160_exc_T6", "normalized": [] } ]

[ { "id": "NCT02019160_inc_text", "type": "inclusion", "text": [ "Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study. \n" ], "offsets": [ [ 0, 237 ] ] } ]

[ { "id": "NCT02019160_inc_T1", "type": "Person", "text": [ "Kindergarteners" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02019160_inc_T2", "type": "Person", "text": [ "Preschool children" ], "offsets": [ [ 96, 114 ] ], "normalized": [] }, { "id": "NCT02019160_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 115, 119 ] ], "normalized": [] }, { "id": "NCT02019160_inc_T4", "type": "Value", "text": [ "3-4 years" ], "offsets": [ [ 120, 129 ] ], "normalized": [] }, { "id": "NCT02019160_inc_T5", "type": "Condition", "text": [ "tooth decay" ], "offsets": [ [ 139, 150 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02019160_inc_R1", "type": "Has_value", "arg1_id": "NCT02019160_inc_T3", "arg2_id": "NCT02019160_inc_T4", "normalized": [] } ]

[ { "id": "NCT02019628_exc_text", "type": "exclusion", "text": [ "1. Currently enrolled in another research trial for investigative nutritional or other therapies thought to have an impact on immune system functioning. \n2. Unable to consent to the study. \n3. Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion. \n4. Other medical complications that might preclude one from participating in the study, i.e., recent heart attack or stroke or chronic kidney disease. \n5. Currently taking immunomodulatory medication, i.e. interferon. \n6. Currently taking other medications thought to have an impact on immune system functioning, i.e., chemotherapeutic agents. \n7. Known allergy to rice, rice bran, or related food products. \n8. Known allergy to mushrooms or related food products. \n9. History of malignancies related to the NK cell line, including: NK cell leukemias and T-cell large granular lymphocyte leukemias, NK-cell lymphoproliferative disease of granular lymphocytes, and NK cell lymphomas, e.g., nasal and nasal-like NK/T-cell lymphomas. \n10. Current smoker. \n \n" ], "offsets": [ [ 0, 1086 ] ] } ]

[ { "id": "NCT02019628_exc_T5", "type": "Person", "text": [ "Women" ], "offsets": [ [ 193, 198 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T6", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 207, 215 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T7", "type": "Condition", "text": [ "spontaneous abortion" ], "offsets": [ [ 299, 319 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T8", "type": "Temporal", "text": [ "recurrent" ], "offsets": [ [ 289, 298 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T9", "type": "Condition", "text": [ "heart attack" ], "offsets": [ [ 423, 435 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T10", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 416, 422 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T11", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 439, 445 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T12", "type": "Condition", "text": [ "chronic kidney disease" ], "offsets": [ [ 449, 471 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T13", "type": "Drug", "text": [ "immunomodulatory medication" ], "offsets": [ [ 494, 521 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T15", "type": "Drug", "text": [ "interferon" ], "offsets": [ [ 528, 538 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T16", "type": "Drug", "text": [ "chemotherapeutic agents" ], "offsets": [ [ 641, 664 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T18", "type": "Condition", "text": [ "allergy to rice" ], "offsets": [ [ 676, 691 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T19", "type": "Drug", "text": [ "rice" ], "offsets": [ [ 687, 691 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T20", "type": "Condition", "text": [ "allergy to", "rice bran" ], "offsets": [ [ 676, 686 ], [ 693, 702 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T21", "type": "Drug", "text": [ "rice bran" ], "offsets": [ [ 693, 702 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T23", "type": "Condition", "text": [ "allergy to mushrooms" ], "offsets": [ [ 740, 760 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T24", "type": "Condition", "text": [ "malignancies" ], "offsets": [ [ 802, 814 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T25", "type": "Observation", "text": [ "History" ], "offsets": [ [ 791, 798 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T26", "type": "Qualifier", "text": [ "related to the NK cell line" ], "offsets": [ [ 815, 842 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T27", "type": "Condition", "text": [ "NK cell leukemias" ], "offsets": [ [ 855, 872 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T28", "type": "Condition", "text": [ "T-cell large granular lymphocyte leukemias" ], "offsets": [ [ 877, 919 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T30", "type": "Condition", "text": [ "NK-cell lymphoproliferative disease of granular lymphocytes" ], "offsets": [ [ 921, 980 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T31", "type": "Condition", "text": [ "NK cell lymphomas" ], "offsets": [ [ 986, 1003 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T32", "type": "Condition", "text": [ "nasal-like NK/T-cell lymphomas" ], "offsets": [ [ 1021, 1051 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T33", "type": "Condition", "text": [ "nasal", "NK/T-cell lymphomas" ], "offsets": [ [ 1011, 1016 ], [ 1032, 1051 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T36", "type": "Scope", "text": [ "NK cell leukemias and T-cell large granular lymphocyte leukemias, NK-cell lymphoproliferative disease of granular lymphocytes, and NK cell lymphomas, e.g., nasal and nasal-like NK/T-cell lymphomas" ], "offsets": [ [ 855, 1051 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T37", "type": "Scope", "text": [ "malignancies related to the NK cell line" ], "offsets": [ [ 802, 842 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T38", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 325, 330 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T39", "type": "Condition", "text": [ "medical complications" ], "offsets": [ [ 331, 352 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T40", "type": "Negation", "text": [ "preclude" ], "offsets": [ [ 364, 372 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T42", "type": "Scope", "text": [ "Other medical complications that might preclude one from participating in the study" ], "offsets": [ [ 325, 408 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T43", "type": "Scope", "text": [ "recent heart attack or stroke or chronic kidney disease" ], "offsets": [ [ 416, 471 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T44", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 544, 553 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T45", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 561, 566 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T46", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 567, 578 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T47", "type": "Qualifier", "text": [ "impact on immune system functioning" ], "offsets": [ [ 598, 633 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T48", "type": "Scope", "text": [ "other medications thought to have an impact on immune system functioning" ], "offsets": [ [ 561, 633 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T49", "type": "Condition", "text": [ "allergy to", "food products" ], "offsets": [ [ 740, 750 ], [ 772, 785 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T50", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 1058, 1065 ] ], "normalized": [] }, { "id": "NCT02019628_exc_T51", "type": "Observation", "text": [ "smoker" ], "offsets": [ [ 1066, 1072 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02019628_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02019628_exc_T7", "arg2_id": "NCT02019628_exc_T8", "normalized": [] }, { "id": "NCT02019628_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02019628_exc_T9", "arg2_id": "NCT02019628_exc_T10", "normalized": [] }, { "id": "NCT02019628_exc_R3", "type": "Subsumes", "arg1_id": "NCT02019628_exc_T13", "arg2_id": "NCT02019628_exc_T15", "normalized": [] }, { "id": "NCT02019628_exc_R4", "type": "AND", "arg1_id": "NCT02019628_exc_T18", "arg2_id": "NCT02019628_exc_T19", "normalized": [] }, { "id": "NCT02019628_exc_R5", "type": "AND", "arg1_id": "NCT02019628_exc_T20", "arg2_id": "NCT02019628_exc_T21", "normalized": [] }, { "id": "NCT02019628_exc_R6", "type": "Subsumes", "arg1_id": "NCT02019628_exc_T37", "arg2_id": "NCT02019628_exc_T36", "normalized": [] }, { "id": "NCT02019628_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02019628_exc_T37", "arg2_id": "NCT02019628_exc_T25", "normalized": [] }, { "id": "NCT02019628_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02019628_exc_T39", "arg2_id": "NCT02019628_exc_T38", "normalized": [] }, { "id": "NCT02019628_exc_R11", "type": "Has_scope", "arg1_id": "NCT02019628_exc_T42", "arg2_id": "NCT02019628_exc_T43", "normalized": [] }, { "id": "NCT02019628_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02019628_exc_T46", "arg2_id": "NCT02019628_exc_T45", "normalized": [] }, { "id": "NCT02019628_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT02019628_exc_T46", "arg2_id": "NCT02019628_exc_T47", "normalized": [] }, { "id": "NCT02019628_exc_R14", "type": "Subsumes", "arg1_id": "NCT02019628_exc_T46", "arg2_id": "NCT02019628_exc_T16", "normalized": [] }, { "id": "NCT02019628_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02019628_exc_T48", "arg2_id": "NCT02019628_exc_T44", "normalized": [] }, { "id": "NCT02019628_exc_R16", "type": "Has_temporal", "arg1_id": "NCT02019628_exc_T51", "arg2_id": "NCT02019628_exc_T50", "normalized": [] } ]

[ { "id": "NCT02019628_inc_text", "type": "inclusion", "text": [ "1. Women and men ages 18 years and over. \n2. Interest in participating in a novel nutritional supplement program. \n3. Willingness to follow recommendations. \n" ], "offsets": [ [ 0, 158 ] ] } ]

[ { "id": "NCT02019628_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT02019628_inc_T2", "type": "Person", "text": [ "men" ], "offsets": [ [ 13, 16 ] ], "normalized": [] }, { "id": "NCT02019628_inc_T3", "type": "Person", "text": [ "ages" ], "offsets": [ [ 17, 21 ] ], "normalized": [] }, { "id": "NCT02019628_inc_T4", "type": "Value", "text": [ "18 years and over" ], "offsets": [ [ 22, 39 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02019628_inc_R1", "type": "Has_value", "arg1_id": "NCT02019628_inc_T3", "arg2_id": "NCT02019628_inc_T4", "normalized": [] } ]

[ { "id": "NCT02022709_exc_text", "type": "exclusion", "text": [ "Having significant medical illnesses that would interfere with the conduct of the study\nClinically significant abnormal laboratory finding\nHaving comorbid psychiatric conditions according to the criteria set forth in the DSM-IV(administered by the Mini-International Neuropsychiatric Interview (MINI))\nThe current OCD symptoms are too severe that the patient cannot finish the evaluation or receive the ERP\nBeing currently at risk for suicide\nBeing pregnant or having the intention to be pregnant before the end of the study\nA history of having inadequate response to adequate SSRIs or CBT treatment\nSubjects who are unable to undergo the MRI\n" ], "offsets": [ [ 0, 643 ] ] } ]

[ { "id": "NCT02022709_exc_T3", "type": "Condition", "text": [ "psychiatric conditions" ], "offsets": [ [ 155, 177 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T4", "type": "Qualifier", "text": [ "comorbid" ], "offsets": [ [ 146, 154 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T5", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 221, 227 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T6", "type": "Condition", "text": [ "OCD symptoms" ], "offsets": [ [ 314, 326 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T7", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 335, 341 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T8", "type": "Observation", "text": [ "risk for suicide" ], "offsets": [ [ 426, 442 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T10", "type": "Drug", "text": [ "SSRIs" ], "offsets": [ [ 577, 582 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T11", "type": "Drug", "text": [ "CBT" ], "offsets": [ [ 586, 589 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T12", "type": "Condition", "text": [ "response" ], "offsets": [ [ 556, 564 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T13", "type": "Scope", "text": [ "SSRIs or CBT" ], "offsets": [ [ 577, 589 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T14", "type": "Qualifier", "text": [ "inadequate" ], "offsets": [ [ 545, 555 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T15", "type": "Mood", "text": [ "unable to" ], "offsets": [ [ 617, 626 ] ], "normalized": [] }, { "id": "NCT02022709_exc_T16", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 639, 642 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02022709_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02022709_exc_T3", "arg2_id": "NCT02022709_exc_T4", "normalized": [] }, { "id": "NCT02022709_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02022709_exc_T3", "arg2_id": "NCT02022709_exc_T5", "normalized": [] }, { "id": "NCT02022709_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02022709_exc_T6", "arg2_id": "NCT02022709_exc_T7", "normalized": [] }, { "id": "NCT02022709_exc_R4", "type": "Has_scope", "arg1_id": "NCT02022709_exc_T12", "arg2_id": "NCT02022709_exc_T13", "normalized": [] }, { "id": "NCT02022709_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02022709_exc_T12", "arg2_id": "NCT02022709_exc_T14", "normalized": [] }, { "id": "NCT02022709_exc_R6", "type": "Has_mood", "arg1_id": "NCT02022709_exc_T16", "arg2_id": "NCT02022709_exc_T15", "normalized": [] } ]

[ { "id": "NCT02022709_inc_text", "type": "inclusion", "text": [ "Having been diagnosed with primary OCD as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-) criteria;Cleaning or checking as primary OCD symptoms\nYale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of = 16\nNever receiving adequate treatment or stop receiving treatment for at least 8 weeks\nHaving an education degree of high school or above\nAccepting to participate in the study\n" ], "offsets": [ [ 0, 409 ] ] } ]

[ { "id": "NCT02022709_inc_T1", "type": "Condition", "text": [ "primary OCD" ], "offsets": [ [ 27, 38 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T2", "type": "Measurement", "text": [ "DSM-IV" ], "offsets": [ [ 112, 118 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T3", "type": "Measurement", "text": [ "Diagnostic and Statistical Manual of Mental Disorders" ], "offsets": [ [ 57, 110 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T4", "type": "Measurement", "text": [ "Yale-Brown Obsessive-Compulsive Scale" ], "offsets": [ [ 175, 212 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T5", "type": "Measurement", "text": [ "Y-BOCS" ], "offsets": [ [ 214, 220 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T6", "type": "Value", "text": [ "score of = 16" ], "offsets": [ [ 222, 235 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T7", "type": "Negation", "text": [ "Never" ], "offsets": [ [ 236, 241 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T8", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 261, 270 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T9", "type": "Qualifier", "text": [ "adequate" ], "offsets": [ [ 252, 260 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T10", "type": "Negation", "text": [ "stop" ], "offsets": [ [ 274, 278 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T11", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 289, 298 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T12", "type": "Temporal", "text": [ "for at least 8 weeks" ], "offsets": [ [ 299, 319 ] ], "normalized": [] }, { "id": "NCT02022709_inc_T13", "type": "Person", "text": [ "degree of high school" ], "offsets": [ [ 340, 361 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02022709_inc_R1", "type": "Subsumes", "arg1_id": "NCT02022709_inc_T3", "arg2_id": "NCT02022709_inc_T2", "normalized": [] }, { "id": "NCT02022709_inc_R2", "type": "AND", "arg1_id": "NCT02022709_inc_T3", "arg2_id": "NCT02022709_inc_T1", "normalized": [] }, { "id": "NCT02022709_inc_R3", "type": "Subsumes", "arg1_id": "NCT02022709_inc_T4", "arg2_id": "NCT02022709_inc_T5", "normalized": [] }, { "id": "NCT02022709_inc_R4", "type": "Has_negation", "arg1_id": "NCT02022709_inc_T8", "arg2_id": "NCT02022709_inc_T7", "normalized": [] }, { "id": "NCT02022709_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02022709_inc_T8", "arg2_id": "NCT02022709_inc_T9", "normalized": [] }, { "id": "NCT02022709_inc_R6", "type": "Has_negation", "arg1_id": "NCT02022709_inc_T11", "arg2_id": "NCT02022709_inc_T10", "normalized": [] }, { "id": "NCT02022709_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02022709_inc_T11", "arg2_id": "NCT02022709_inc_T12", "normalized": [] } ]

[ { "id": "NCT02034019_exc_text", "type": "exclusion", "text": [ "Any intraocular inflammation in the study eye present during the screening slit lamp examination \nScore greater than \"0\" on the Ocular Pain Assessment in the study eye at Screening \nAny intraocular inflammation in the study eye present during the screening slit lamp examination \n \n" ], "offsets": [ [ 0, 291 ] ] } ]

[ { "id": "NCT02034019_exc_T1", "type": "Value", "text": [ "intraocular inflammation" ], "offsets": [ [ 4, 28 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T2", "type": "Temporal", "text": [ "during the screening slit lamp examination" ], "offsets": [ [ 54, 96 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T3", "type": "Reference_point", "text": [ "the screening slit lamp examination" ], "offsets": [ [ 61, 96 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T4", "type": "Procedure", "text": [ "slit lamp examination" ], "offsets": [ [ 75, 96 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T5", "type": "Condition", "text": [ "intraocular inflammation" ], "offsets": [ [ 4, 28 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T6", "type": "Measurement", "text": [ "Ocular Pain Assessment" ], "offsets": [ [ 128, 150 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T7", "type": "Value", "text": [ "greater than \"0\"" ], "offsets": [ [ 104, 120 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T8", "type": "Temporal", "text": [ "at Screening" ], "offsets": [ [ 168, 180 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T9", "type": "Condition", "text": [ "intraocular inflammation" ], "offsets": [ [ 186, 210 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T10", "type": "Temporal", "text": [ "during the screening slit lamp examination" ], "offsets": [ [ 236, 278 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T11", "type": "Reference_point", "text": [ "the screening slit lamp examination" ], "offsets": [ [ 243, 278 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T12", "type": "Procedure", "text": [ "slit lamp examination" ], "offsets": [ [ 257, 278 ] ], "normalized": [] }, { "id": "NCT02034019_exc_T13", "type": "Value", "text": [ "intraocular inflammation" ], "offsets": [ [ 186, 210 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02034019_exc_R1", "type": "Has_index", "arg1_id": "NCT02034019_exc_T2", "arg2_id": "NCT02034019_exc_T3", "normalized": [] }, { "id": "NCT02034019_exc_R2", "type": "Has_value", "arg1_id": "NCT02034019_exc_T4", "arg2_id": "NCT02034019_exc_T1", "normalized": [] }, { "id": "NCT02034019_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02034019_exc_T4", "arg2_id": "NCT02034019_exc_T2", "normalized": [] }, { "id": "NCT02034019_exc_R4", "type": "Has_value", "arg1_id": "NCT02034019_exc_T6", "arg2_id": "NCT02034019_exc_T7", "normalized": [] }, { "id": "NCT02034019_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02034019_exc_T6", "arg2_id": "NCT02034019_exc_T8", "normalized": [] }, { "id": "NCT02034019_exc_R6", "type": "Has_value", "arg1_id": "NCT02034019_exc_T12", "arg2_id": "NCT02034019_exc_T13", "normalized": [] }, { "id": "NCT02034019_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02034019_exc_T12", "arg2_id": "NCT02034019_exc_T10", "normalized": [] } ]

[ { "id": "NCT02034019_inc_text", "type": "inclusion", "text": [ "Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens \nHas a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes \n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT02034019_inc_T1", "type": "Condition", "text": [ "cataract" ], "offsets": [ [ 6, 14 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T2", "type": "Procedure", "text": [ "clear corneal cataract surgery" ], "offsets": [ [ 42, 72 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T3", "type": "Qualifier", "text": [ "with phacoemulsification" ], "offsets": [ [ 73, 97 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T4", "type": "Qualifier", "text": [ "implantation of a posterior chamber intraocular lens" ], "offsets": [ [ 102, 154 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T5", "type": "Measurement", "text": [ "pinhole corrected Snellen VA" ], "offsets": [ [ 187, 215 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T6", "type": "Value", "text": [ "at least 20/200 or better" ], "offsets": [ [ 219, 244 ] ], "normalized": [] }, { "id": "NCT02034019_inc_T7", "type": "Qualifier", "text": [ "both eyes" ], "offsets": [ [ 248, 257 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02034019_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02034019_inc_T2", "arg2_id": "NCT02034019_inc_T3", "normalized": [] }, { "id": "NCT02034019_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02034019_inc_T2", "arg2_id": "NCT02034019_inc_T4", "normalized": [] }, { "id": "NCT02034019_inc_R3", "type": "Has_value", "arg1_id": "NCT02034019_inc_T5", "arg2_id": "NCT02034019_inc_T6", "normalized": [] }, { "id": "NCT02034019_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02034019_inc_T6", "arg2_id": "NCT02034019_inc_T7", "normalized": [] } ]

[ { "id": "NCT02035800_exc_text", "type": "exclusion", "text": [ "Patients not capable or willing to provide informed consent\nPatients starting Adalimumab less than five half-lives after the interruption of a previous anti-TNF therapy.\n" ], "offsets": [ [ 0, 170 ] ] } ]

[ { "id": "NCT02035800_exc_T2", "type": "Drug", "text": [ "Adalimumab" ], "offsets": [ [ 78, 88 ] ], "normalized": [] }, { "id": "NCT02035800_exc_T3", "type": "Temporal", "text": [ "less than five half-lives after the interruption of a previous anti-TNF therapy" ], "offsets": [ [ 89, 168 ] ], "normalized": [] }, { "id": "NCT02035800_exc_T4", "type": "Reference_point", "text": [ "the interruption of a previous anti-TNF therapy" ], "offsets": [ [ 121, 168 ] ], "normalized": [] }, { "id": "NCT02035800_exc_T5", "type": "Procedure", "text": [ "anti-TNF therapy" ], "offsets": [ [ 152, 168 ] ], "normalized": [] }, { "id": "NCT02035800_exc_T6", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 143, 151 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02035800_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02035800_exc_T5", "arg2_id": "NCT02035800_exc_T6", "normalized": [] }, { "id": "NCT02035800_exc_R3", "type": "Has_index", "arg1_id": "NCT02035800_exc_T3", "arg2_id": "NCT02035800_exc_T4", "normalized": [] }, { "id": "NCT02035800_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02035800_exc_T2", "arg2_id": "NCT02035800_exc_T3", "normalized": [] } ]

[ { "id": "NCT02035800_inc_text", "type": "inclusion", "text": [ "Patients aged of 18 and over,\nSatisfying the 1987 American College of Rheumatology (ACR) criteria for RA\nReceiving a prescription of Adalimumab 40 mg subcutaneous every two weeks.\n" ], "offsets": [ [ 0, 180 ] ] } ]

[ { "id": "NCT02035800_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T2", "type": "Value", "text": [ "18 and over" ], "offsets": [ [ 17, 28 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T3", "type": "Qualifier", "text": [ "1987 American College of Rheumatology (ACR) criteria" ], "offsets": [ [ 45, 97 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T4", "type": "Condition", "text": [ "RA" ], "offsets": [ [ 102, 104 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T5", "type": "Drug", "text": [ "Adalimumab" ], "offsets": [ [ 133, 143 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T6", "type": "Multiplier", "text": [ " mg ", "ery two weeks." ], "offsets": [ [ 146, 150 ], [ 165, 179 ] ], "normalized": [] }, { "id": "NCT02035800_inc_T7", "type": "Qualifier", "text": [ "subcutaneous" ], "offsets": [ [ 150, 162 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02035800_inc_R1", "type": "Has_value", "arg1_id": "NCT02035800_inc_T1", "arg2_id": "NCT02035800_inc_T2", "normalized": [] }, { "id": "NCT02035800_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02035800_inc_T4", "arg2_id": "NCT02035800_inc_T3", "normalized": [] }, { "id": "NCT02035800_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02035800_inc_T5", "arg2_id": "NCT02035800_inc_T6", "normalized": [] }, { "id": "NCT02035800_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02035800_inc_T5", "arg2_id": "NCT02035800_inc_T7", "normalized": [] } ]

[ { "id": "NCT02035904_exc_text", "type": "exclusion", "text": [ "preexisting pectoral, axillar, thoracic homolateral pain\nhabitual opioid consumption;\ndrug-alcoholics addiction ;\nICU postoperative recovery;\nkidney failure (creatinin > 2 g/dl, creatinin <clearance 30 ml/h) and/or hepatic failure (cholinesterase < 2000 UI);\ncardiac arrhythmias o;\nEpilepsy;\nPsychiatric, cognitive disorders, mental retardation;\nCoagulopathies (INR > 2, activated partial thromboplastin time - aPTT>44 sec);\nplatelet count less than 100.000/mm3;\nBMI > 30;\nAllergies to study drugs.\n" ], "offsets": [ [ 0, 499 ] ] } ]

[ { "id": "NCT02035904_exc_T1", "type": "Condition", "text": [ "thoracic", "pain" ], "offsets": [ [ 31, 39 ], [ 52, 56 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T2", "type": "Qualifier", "text": [ "homolateral" ], "offsets": [ [ 40, 51 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T3", "type": "Condition", "text": [ "axillar", "pain" ], "offsets": [ [ 22, 29 ], [ 52, 56 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T4", "type": "Condition", "text": [ "pectoral", "pain" ], "offsets": [ [ 12, 20 ], [ 52, 56 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T5", "type": "Scope", "text": [ "pectoral, axillar, thoracic", "pain" ], "offsets": [ [ 12, 39 ], [ 52, 56 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T6", "type": "Observation", "text": [ "opioid consumption" ], "offsets": [ [ 66, 84 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T7", "type": "Qualifier", "text": [ "habitual" ], "offsets": [ [ 57, 65 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T8", "type": "Condition", "text": [ "alcoholics addiction" ], "offsets": [ [ 91, 111 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T9", "type": "Condition", "text": [ "diction ;", "ug-a" ], "offsets": [ [ 104, 113 ], [ 88, 92 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T10", "type": "Observation", "text": [ "ICU postoperative recovery" ], "offsets": [ [ 114, 140 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T11", "type": "Condition", "text": [ "kidney failure" ], "offsets": [ [ 142, 156 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T12", "type": "Measurement", "text": [ "creatinin" ], "offsets": [ [ 158, 167 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T13", "type": "Measurement", "text": [ "creatinin <clearance" ], "offsets": [ [ 178, 198 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T14", "type": "Value", "text": [ "30 ml/h" ], "offsets": [ [ 199, 206 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T15", "type": "Value", "text": [ "> 2 g/dl" ], "offsets": [ [ 168, 176 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T16", "type": "Condition", "text": [ "hepatic failure" ], "offsets": [ [ 215, 230 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T17", "type": "Measurement", "text": [ "cholinesterase" ], "offsets": [ [ 232, 246 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T18", "type": "Value", "text": [ "< 2000 UI" ], "offsets": [ [ 247, 256 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T19", "type": "Scope", "text": [ "creatinin > 2 g/dl, creatinin <clearance 30 ml/h" ], "offsets": [ [ 158, 206 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T20", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 259, 278 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T21", "type": "Condition", "text": [ "Epilepsy" ], "offsets": [ [ 282, 290 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T22", "type": "Condition", "text": [ "Psychiatric, cognitive disorders" ], "offsets": [ [ 292, 324 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T23", "type": "Condition", "text": [ "mental retardation" ], "offsets": [ [ 326, 344 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T24", "type": "Condition", "text": [ "Coagulopathies" ], "offsets": [ [ 346, 360 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T25", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 362, 365 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T26", "type": "Value", "text": [ "> 2" ], "offsets": [ [ 366, 369 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T27", "type": "Measurement", "text": [ "activated partial thromboplastin time - aPTT" ], "offsets": [ [ 371, 415 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T28", "type": "Value", "text": [ ">44 sec" ], "offsets": [ [ 415, 422 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T29", "type": "Scope", "text": [ "INR > 2, activated partial thromboplastin time - aPTT>44 sec" ], "offsets": [ [ 362, 422 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T30", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 425, 439 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T31", "type": "Value", "text": [ "less than 100.000/mm3" ], "offsets": [ [ 440, 461 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T32", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 463, 466 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T33", "type": "Value", "text": [ "> 30" ], "offsets": [ [ 467, 471 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T34", "type": "Condition", "text": [ "Allergies" ], "offsets": [ [ 473, 482 ] ], "normalized": [] }, { "id": "NCT02035904_exc_T35", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 486, 497 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02035904_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02035904_exc_T5", "arg2_id": "NCT02035904_exc_T2", "normalized": [] }, { "id": "NCT02035904_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02035904_exc_T6", "arg2_id": "NCT02035904_exc_T7", "normalized": [] }, { "id": "NCT02035904_exc_R3", "type": "Has_value", "arg1_id": "NCT02035904_exc_T12", "arg2_id": "NCT02035904_exc_T15", "normalized": [] }, { "id": "NCT02035904_exc_R4", "type": "Has_value", "arg1_id": "NCT02035904_exc_T13", "arg2_id": "NCT02035904_exc_T14", "normalized": [] }, { "id": "NCT02035904_exc_R5", "type": "Has_value", "arg1_id": "NCT02035904_exc_T17", "arg2_id": "NCT02035904_exc_T18", "normalized": [] }, { "id": "NCT02035904_exc_R6", "type": "Subsumes", "arg1_id": "NCT02035904_exc_T16", "arg2_id": "NCT02035904_exc_T17", "normalized": [] }, { "id": "NCT02035904_exc_R7", "type": "Subsumes", "arg1_id": "NCT02035904_exc_T11", "arg2_id": "NCT02035904_exc_T19", "normalized": [] }, { "id": "NCT02035904_exc_R8", "type": "Has_value", "arg1_id": "NCT02035904_exc_T25", "arg2_id": "NCT02035904_exc_T26", "normalized": [] }, { "id": "NCT02035904_exc_R9", "type": "Has_value", "arg1_id": "NCT02035904_exc_T27", "arg2_id": "NCT02035904_exc_T28", "normalized": [] }, { "id": "NCT02035904_exc_R10", "type": "Subsumes", "arg1_id": "NCT02035904_exc_T24", "arg2_id": "NCT02035904_exc_T29", "normalized": [] }, { "id": "NCT02035904_exc_R11", "type": "Has_value", "arg1_id": "NCT02035904_exc_T30", "arg2_id": "NCT02035904_exc_T31", "normalized": [] }, { "id": "NCT02035904_exc_R12", "type": "Has_value", "arg1_id": "NCT02035904_exc_T32", "arg2_id": "NCT02035904_exc_T33", "normalized": [] }, { "id": "NCT02035904_exc_R13", "type": "AND", "arg1_id": "NCT02035904_exc_T34", "arg2_id": "NCT02035904_exc_T35", "normalized": [] } ]

[ { "id": "NCT02035904_inc_text", "type": "inclusion", "text": [ "F; age 18 to 70\nAmerican Society of Anesthesiologists (ASA) I e II;\nbreast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;\nimmediate sub-pectoral prosthetic reconstruction;\nsigned informed consent.\n" ], "offsets": [ [ 0, 353 ] ] } ]

[ { "id": "NCT02035904_inc_T1", "type": "Person", "text": [ "F" ], "offsets": [ [ 0, 1 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 3, 6 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T3", "type": "Value", "text": [ "18 to 70" ], "offsets": [ [ 7, 15 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T4", "type": "Measurement", "text": [ "American Society of Anesthesiologists (ASA)" ], "offsets": [ [ 16, 59 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T5", "type": "Value", "text": [ "I e II" ], "offsets": [ [ 60, 66 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T6", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 68, 81 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T7", "type": "Measurement", "text": [ "DIN" ], "offsets": [ [ 84, 87 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T8", "type": "Value", "text": [ "2 e 3" ], "offsets": [ [ 88, 93 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T9", "type": "Measurement", "text": [ "LIN" ], "offsets": [ [ 97, 100 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T10", "type": "Value", "text": [ "2 e 3 sec" ], "offsets": [ [ 101, 110 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T11", "type": "Condition", "text": [ "nipple-sparing mastectomy" ], "offsets": [ [ 137, 162 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T12", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 123, 136 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T13", "type": "Condition", "text": [ "simple mastectomy" ], "offsets": [ [ 164, 181 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T14", "type": "Condition", "text": [ "skin-sparing mastectomy" ], "offsets": [ [ 183, 206 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T15", "type": "Condition", "text": [ "skin-reducing mastectomy" ], "offsets": [ [ 208, 232 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T16", "type": "Condition", "text": [ "lymphnode biopsy" ], "offsets": [ [ 236, 252 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T17", "type": "Condition", "text": [ "axillary dissection" ], "offsets": [ [ 257, 276 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T18", "type": "Scope", "text": [ "DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli" ], "offsets": [ [ 84, 121 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T19", "type": "Procedure", "text": [ "sub-pectoral prosthetic reconstruction" ], "offsets": [ [ 288, 326 ] ], "normalized": [] }, { "id": "NCT02035904_inc_T20", "type": "Qualifier", "text": [ "immediate" ], "offsets": [ [ 278, 287 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02035904_inc_R1", "type": "Has_value", "arg1_id": "NCT02035904_inc_T2", "arg2_id": "NCT02035904_inc_T3", "normalized": [] }, { "id": "NCT02035904_inc_R2", "type": "Has_value", "arg1_id": "NCT02035904_inc_T4", "arg2_id": "NCT02035904_inc_T5", "normalized": [] }, { "id": "NCT02035904_inc_R3", "type": "Has_value", "arg1_id": "NCT02035904_inc_T7", "arg2_id": "NCT02035904_inc_T8", "normalized": [] }, { "id": "NCT02035904_inc_R4", "type": "Has_value", "arg1_id": "NCT02035904_inc_T9", "arg2_id": "NCT02035904_inc_T10", "normalized": [] }, { "id": "NCT02035904_inc_R5", "type": "Has_mood", "arg1_id": "NCT02035904_inc_T11", "arg2_id": "NCT02035904_inc_T12", "normalized": [] }, { "id": "NCT02035904_inc_R6", "type": "Subsumes", "arg1_id": "NCT02035904_inc_T6", "arg2_id": "NCT02035904_inc_T18", "normalized": [] }, { "id": "NCT02035904_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02035904_inc_T19", "arg2_id": "NCT02035904_inc_T20", "normalized": [] } ]

[ { "id": "NCT02041299_exc_text", "type": "exclusion", "text": [ "Thalassemia syndromes;\nMyelodysplastic syndrome (MDS) or myelofibrosis;\nDiamond Blackfan anemia;\nPrimary bone marrow failure;\nBaseline LIC >30 mg/g dw (measured by MRI);\nUnable or unwilling to undergo a 7 day washout period if currently being treated with deferiprone or deferoxamine or deferasirox;\nPrevious discontinuation of treatment with deferiprone or deferoxamine due to adverse events;\nHistory or presence of hypersensitivity or idiosyncratic reaction to deferiprone or deferoxamine;\nTreated with hydroxyurea within 30 days;\nHistory of malignancy;\nEvidence of abnormal liver function (serum ALT level(s) > 5 times upper limit of normal at screening or creatinine levels >2 times upper limit of normal at screening);\nA serious, unstable illness, as judged by the Investigator, during the past 3 months before screening/baseline visit including but not limited to: hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease;\nClinically significant abnormal 12-lead ECG findings;\nCardiac MRI T2* <10ms;\nMyocardial infarction, cardiac arrest or cardiac failure within 1 year before screening/baseline visit;\nUnable to undergo MRI\nPresence of metallic objects such as artificial joints, inner ear (cochlear) implants, brain aneurysm clips, pacemakers, and metallic foreign bodies in the eye or other body areas that would prevent use of MRI imaging\n" ], "offsets": [ [ 0, 1408 ] ] } ]

[ { "id": "NCT02041299_exc_T1", "type": "Condition", "text": [ "Thalassemia syndromes" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T2", "type": "Condition", "text": [ "Myelodysplastic syndrome (MDS)" ], "offsets": [ [ 23, 53 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T3", "type": "Condition", "text": [ "myelofibrosis" ], "offsets": [ [ 57, 70 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T4", "type": "Condition", "text": [ "Diamond Blackfan anemia" ], "offsets": [ [ 72, 95 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T5", "type": "Condition", "text": [ "Primary bone marrow failure" ], "offsets": [ [ 97, 124 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T6", "type": "Measurement", "text": [ "LIC" ], "offsets": [ [ 135, 138 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T7", "type": "Value", "text": [ ">30 mg/g" ], "offsets": [ [ 139, 147 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T8", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 126, 134 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T9", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 164, 167 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T10", "type": "Mood", "text": [ "measured by" ], "offsets": [ [ 152, 163 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T12", "type": "Procedure", "text": [ "discontinuation of treatment" ], "offsets": [ [ 309, 337 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T13", "type": "Condition", "text": [ "deferiprone" ], "offsets": [ [ 343, 354 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T14", "type": "Condition", "text": [ "deferoxamine" ], "offsets": [ [ 358, 370 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T15", "type": "Scope", "text": [ "deferiprone or deferoxamine" ], "offsets": [ [ 343, 370 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T16", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 417, 433 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T17", "type": "Condition", "text": [ "idiosyncratic reaction" ], "offsets": [ [ 437, 459 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T18", "type": "Drug", "text": [ "deferiprone" ], "offsets": [ [ 463, 474 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T19", "type": "Drug", "text": [ "deferoxamine" ], "offsets": [ [ 478, 490 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T20", "type": "Scope", "text": [ "deferiprone or deferoxamine" ], "offsets": [ [ 463, 490 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T21", "type": "Scope", "text": [ "hypersensitivity or idiosyncratic reaction" ], "offsets": [ [ 417, 459 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T22", "type": "Drug", "text": [ "hydroxyurea" ], "offsets": [ [ 505, 516 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T23", "type": "Temporal", "text": [ "within 30 days" ], "offsets": [ [ 517, 531 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T24", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 544, 554 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T25", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 568, 576 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T26", "type": "Measurement", "text": [ "liver function" ], "offsets": [ [ 577, 591 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T27", "type": "Measurement", "text": [ "serum ALT level(s)" ], "offsets": [ [ 593, 611 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T28", "type": "Value", "text": [ "> 5 times upper limit of normal" ], "offsets": [ [ 612, 643 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T29", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 644, 656 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T30", "type": "Measurement", "text": [ "creatinine levels" ], "offsets": [ [ 660, 677 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T31", "type": "Value", "text": [ ">2 times upper limit of normal" ], "offsets": [ [ 678, 708 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T32", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 709, 721 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T33", "type": "Scope", "text": [ "serum ALT level(s) > 5 times upper limit of normal at screening or creatinine levels >2 times upper limit of normal at screening" ], "offsets": [ [ 593, 721 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T34", "type": "Scope", "text": [ "abnormal liver function" ], "offsets": [ [ 568, 591 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T35", "type": "Condition", "text": [ "unstable illness" ], "offsets": [ [ 735, 751 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T36", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 726, 733 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T37", "type": "Qualifier", "text": [ "as judged by the Investigator" ], "offsets": [ [ 753, 782 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T38", "type": "Temporal", "text": [ "during the past 3 months before screening/baseline visit" ], "offsets": [ [ 784, 840 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T39", "type": "Condition", "text": [ "immunologic disease" ], "offsets": [ [ 966, 985 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T40", "type": "Condition", "text": [ "or immunol", "inicall" ], "offsets": [ [ 963, 973 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T41", "type": "Condition", "text": [ "gic, neurologi", "inicall" ], "offsets": [ [ 947, 961 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T42", "type": "Condition", "text": [ "lar, endocrino", "inicall" ], "offsets": [ [ 931, 945 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T43", "type": "Condition", "text": [ ", cardiovas", "inicall" ], "offsets": [ [ 918, 929 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T44", "type": "Condition", "text": [ "rologic, respirato", "inicall" ], "offsets": [ [ 898, 916 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T45", "type": "Condition", "text": [ "ro-en", "inicall" ], "offsets": [ [ 891, 896 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T46", "type": "Condition", "text": [ "nal, ga", "inicall" ], "offsets": [ [ 882, 889 ], [ 989, 996 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T47", "type": "Scope", "text": [ "hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease" ], "offsets": [ [ 871, 985 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T48", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 987, 1009 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T49", "type": "Qualifier", "text": [ "abnormal" ], "offsets": [ [ 1010, 1018 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T50", "type": "Procedure", "text": [ "12-lead ECG" ], "offsets": [ [ 1019, 1030 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T51", "type": "Condition", "text": [ "findings" ], "offsets": [ [ 1031, 1039 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T52", "type": "Measurement", "text": [ "Cardiac MRI T2*" ], "offsets": [ [ 1041, 1056 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T53", "type": "Value", "text": [ "<10ms" ], "offsets": [ [ 1057, 1062 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T54", "type": "Condition", "text": [ "Myocardial infarction" ], "offsets": [ [ 1064, 1085 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T55", "type": "Condition", "text": [ "cardiac arrest" ], "offsets": [ [ 1087, 1101 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T56", "type": "Condition", "text": [ "cardiac failure" ], "offsets": [ [ 1105, 1120 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T57", "type": "Temporal", "text": [ "within 1 year before screening/baseline visit" ], "offsets": [ [ 1121, 1166 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T58", "type": "Scope", "text": [ "Myocardial infarction, cardiac arrest or cardiac failure" ], "offsets": [ [ 1064, 1120 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T59", "type": "Condition", "text": [ "Unable to undergo" ], "offsets": [ [ 1168, 1185 ] ], "normalized": [] }, { "id": "NCT02041299_exc_T60", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 1186, 1189 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02041299_exc_R1", "type": "Has_value", "arg1_id": "NCT02041299_exc_T6", "arg2_id": "NCT02041299_exc_T7", "normalized": [] }, { "id": "NCT02041299_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T6", "arg2_id": "NCT02041299_exc_T8", "normalized": [] }, { "id": "NCT02041299_exc_R3", "type": "Has_mood", "arg1_id": "NCT02041299_exc_T9", "arg2_id": "NCT02041299_exc_T10", "normalized": [] }, { "id": "NCT02041299_exc_R4", "type": "AND", "arg1_id": "NCT02041299_exc_T6", "arg2_id": "NCT02041299_exc_T9", "normalized": [] }, { "id": "NCT02041299_exc_R5", "type": "Has_scope", "arg1_id": "NCT02041299_exc_T12", "arg2_id": "NCT02041299_exc_T15", "normalized": [] }, { "id": "NCT02041299_exc_R6", "type": "Has_scope", "arg1_id": "NCT02041299_exc_T21", "arg2_id": "NCT02041299_exc_T20", "normalized": [] }, { "id": "NCT02041299_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T22", "arg2_id": "NCT02041299_exc_T23", "normalized": [] }, { "id": "NCT02041299_exc_R8", "type": "Has_value", "arg1_id": "NCT02041299_exc_T27", "arg2_id": "NCT02041299_exc_T28", "normalized": [] }, { "id": "NCT02041299_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T27", "arg2_id": "NCT02041299_exc_T29", "normalized": [] }, { "id": "NCT02041299_exc_R10", "type": "Has_value", "arg1_id": "NCT02041299_exc_T30", "arg2_id": "NCT02041299_exc_T31", "normalized": [] }, { "id": "NCT02041299_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T30", "arg2_id": "NCT02041299_exc_T32", "normalized": [] }, { "id": "NCT02041299_exc_R12", "type": "Has_value", "arg1_id": "NCT02041299_exc_T26", "arg2_id": "NCT02041299_exc_T25", "normalized": [] }, { "id": "NCT02041299_exc_R13", "type": "Subsumes", "arg1_id": "NCT02041299_exc_T34", "arg2_id": "NCT02041299_exc_T33", "normalized": [] }, { "id": "NCT02041299_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02041299_exc_T35", "arg2_id": "NCT02041299_exc_T36", "normalized": [] }, { "id": "NCT02041299_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT02041299_exc_T36", "arg2_id": "NCT02041299_exc_T37", "normalized": [] }, { "id": "NCT02041299_exc_R16", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T35", "arg2_id": "NCT02041299_exc_T38", "normalized": [] }, { "id": "NCT02041299_exc_R17", "type": "Subsumes", "arg1_id": "NCT02041299_exc_T35", "arg2_id": "NCT02041299_exc_T47", "normalized": [] }, { "id": "NCT02041299_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02041299_exc_T51", "arg2_id": "NCT02041299_exc_T49", "normalized": [] }, { "id": "NCT02041299_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT02041299_exc_T51", "arg2_id": "NCT02041299_exc_T48", "normalized": [] }, { "id": "NCT02041299_exc_R20", "type": "AND", "arg1_id": "NCT02041299_exc_T50", "arg2_id": "NCT02041299_exc_T51", "normalized": [] }, { "id": "NCT02041299_exc_R21", "type": "Has_value", "arg1_id": "NCT02041299_exc_T52", "arg2_id": "NCT02041299_exc_T53", "normalized": [] }, { "id": "NCT02041299_exc_R22", "type": "Has_temporal", "arg1_id": "NCT02041299_exc_T58", "arg2_id": "NCT02041299_exc_T57", "normalized": [] }, { "id": "NCT02041299_exc_R23", "type": "AND", "arg1_id": "NCT02041299_exc_T59", "arg2_id": "NCT02041299_exc_T60", "normalized": [] } ]

[ { "id": "NCT02041299_inc_text", "type": "inclusion", "text": [ "Male or female = 2 years of age;\nHave sickle cell disease (confirmed by Hb electrophoresis or more specific tests) or other conditions with iron overload from repeated blood transfusions (see exclusion criteria for exceptions);\nBaseline LIC >7 mg/g dw (measured by MRI);\nPatients who have received no less than 20 transfusions of RBCs;\nPatients who have received at least 1 transfusion per year in the last 2 years and who are expected to have a continuing requirement (based on Investigator's judgement) during the duration of the trial\n" ], "offsets": [ [ 0, 538 ] ] } ]

[ { "id": "NCT02041299_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T3", "type": "Value", "text": [ "= 2 years" ], "offsets": [ [ 15, 24 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 28, 31 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T5", "type": "Condition", "text": [ "sickle cell disease" ], "offsets": [ [ 38, 57 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T6", "type": "Procedure", "text": [ "Hb electrophoresis" ], "offsets": [ [ 72, 90 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T7", "type": "Procedure", "text": [ "more specific tests" ], "offsets": [ [ 94, 113 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T8", "type": "Scope", "text": [ "Hb electrophoresis or more specific tests" ], "offsets": [ [ 72, 113 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T10", "type": "Condition", "text": [ "other conditions with iron overload" ], "offsets": [ [ 118, 153 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T9", "type": "Multiplier", "text": [ "repeated" ], "offsets": [ [ 159, 167 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T11", "type": "Procedure", "text": [ "blood transfusions" ], "offsets": [ [ 168, 186 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T12", "type": "Measurement", "text": [ "Baseline LIC" ], "offsets": [ [ 228, 240 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T13", "type": "Value", "text": [ ">7 mg/g" ], "offsets": [ [ 241, 248 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T14", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 265, 268 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T15", "type": "Multiplier", "text": [ "no less than 20" ], "offsets": [ [ 298, 313 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T16", "type": "Procedure", "text": [ "transfusions of RBCs" ], "offsets": [ [ 314, 334 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T17", "type": "Multiplier", "text": [ "east 1 tra", "year in" ], "offsets": [ [ 367, 377 ], [ 390, 397 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T18", "type": "Temporal", "text": [ "in the last 2 years" ], "offsets": [ [ 395, 414 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T19", "type": "Procedure", "text": [ "transfusion" ], "offsets": [ [ 374, 385 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T20", "type": "Condition", "text": [ "expected to have a continuing requirement" ], "offsets": [ [ 427, 468 ] ], "normalized": [] }, { "id": "NCT02041299_inc_T21", "type": "Temporal", "text": [ "during the duration of the trial" ], "offsets": [ [ 505, 537 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02041299_inc_R1", "type": "Has_value", "arg1_id": "NCT02041299_inc_T4", "arg2_id": "NCT02041299_inc_T3", "normalized": [] }, { "id": "NCT02041299_inc_R2", "type": "Has_scope", "arg1_id": "NCT02041299_inc_T5", "arg2_id": "NCT02041299_inc_T8", "normalized": [] }, { "id": "NCT02041299_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02041299_inc_T11", "arg2_id": "NCT02041299_inc_T9", "normalized": [] }, { "id": "NCT02041299_inc_R4", "type": "AND", "arg1_id": "NCT02041299_inc_T10", "arg2_id": "NCT02041299_inc_T11", "normalized": [] }, { "id": "NCT02041299_inc_R5", "type": "Has_value", "arg1_id": "NCT02041299_inc_T12", "arg2_id": "NCT02041299_inc_T13", "normalized": [] }, { "id": "NCT02041299_inc_R6", "type": "AND", "arg1_id": "NCT02041299_inc_T12", "arg2_id": "NCT02041299_inc_T14", "normalized": [] }, { "id": "NCT02041299_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT02041299_inc_T16", "arg2_id": "NCT02041299_inc_T15", "normalized": [] }, { "id": "NCT02041299_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT02041299_inc_T19", "arg2_id": "NCT02041299_inc_T17", "normalized": [] }, { "id": "NCT02041299_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02041299_inc_T19", "arg2_id": "NCT02041299_inc_T18", "normalized": [] }, { "id": "NCT02041299_inc_R10", "type": "Has_temporal", "arg1_id": "NCT02041299_inc_T20", "arg2_id": "NCT02041299_inc_T21", "normalized": [] } ]

[ { "id": "NCT02042287_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

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[ { "id": "NCT02042287_inc_text", "type": "inclusion", "text": [ "> 18 years old\nAcute symptomatic BV\nSigned informed consent\nInsufficient knowledge of German\nIlliteracy\nPregnancy\nAcute illness\nKnown allergies against ingredients of the investigational products\n" ], "offsets": [ [ 0, 196 ] ] } ]

[ { "id": "NCT02042287_inc_T1", "type": "Value", "text": [ "18 years" ], "offsets": [ [ 2, 10 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 11, 14 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T3", "type": "Temporal", "text": [ "Acute" ], "offsets": [ [ 15, 20 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T4", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 21, 32 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T5", "type": "Condition", "text": [ "BV" ], "offsets": [ [ 33, 35 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T7", "type": "Observation", "text": [ "Insufficient knowledge of German" ], "offsets": [ [ 60, 92 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T8", "type": "Observation", "text": [ "Illiteracy" ], "offsets": [ [ 93, 103 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T9", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 104, 113 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T10", "type": "Condition", "text": [ "Acute illness" ], "offsets": [ [ 114, 127 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T11", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 134, 143 ] ], "normalized": [] }, { "id": "NCT02042287_inc_T12", "type": "Drug", "text": [ "ingredients of the investigational products" ], "offsets": [ [ 152, 195 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02042287_inc_R1", "type": "Has_value", "arg1_id": "NCT02042287_inc_T2", "arg2_id": "NCT02042287_inc_T1", "normalized": [] }, { "id": "NCT02042287_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02042287_inc_T5", "arg2_id": "NCT02042287_inc_T4", "normalized": [] }, { "id": "NCT02042287_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02042287_inc_T5", "arg2_id": "NCT02042287_inc_T3", "normalized": [] }, { "id": "NCT02042287_inc_R4", "type": "AND", "arg1_id": "NCT02042287_inc_T11", "arg2_id": "NCT02042287_inc_T12", "normalized": [] } ]

[ { "id": "NCT02046395_exc_text", "type": "exclusion", "text": [ "Pregnancy\nPatients with chronic kidney disease stage with eGFR < 30 ml/min (CKD stage IV and V)\nNephrotic range proteinuria (urinary protein > 3.5 gm/day)\nHistory or renal transplantation\nHistory of multiple myeloma\nKnown history of hypersensitivity reaction or intolerability to Ace Inh or ARB.\n" ], "offsets": [ [ 0, 296 ] ] } ]

[ { "id": "NCT02046395_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T2", "type": "Condition", "text": [ "chronic kidney disease" ], "offsets": [ [ 24, 46 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T3", "type": "Measurement", "text": [ "eGFR" ], "offsets": [ [ 58, 62 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T4", "type": "Value", "text": [ "< 30 ml/min" ], "offsets": [ [ 63, 74 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T5", "type": "Condition", "text": [ "CKD" ], "offsets": [ [ 76, 79 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T6", "type": "Qualifier", "text": [ "stage IV" ], "offsets": [ [ 80, 88 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T7", "type": "Qualifier", "text": [ "tage", ")" ], "offsets": [ [ 81, 85 ], [ 94, 95 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T8", "type": "Scope", "text": [ "stage IV and V" ], "offsets": [ [ 80, 94 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T9", "type": "Qualifier", "text": [ "Nephrotic range" ], "offsets": [ [ 96, 111 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T10", "type": "Condition", "text": [ "proteinuria" ], "offsets": [ [ 112, 123 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T11", "type": "Measurement", "text": [ "urinary protein" ], "offsets": [ [ 125, 140 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T12", "type": "Value", "text": [ "> 3.5 gm/day" ], "offsets": [ [ 141, 153 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T13", "type": "Measurement", "text": [ "renal transplantation" ], "offsets": [ [ 166, 187 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T14", "type": "Condition", "text": [ "multiple myeloma" ], "offsets": [ [ 199, 215 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T15", "type": "Observation", "text": [ "History" ], "offsets": [ [ 155, 162 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T16", "type": "Observation", "text": [ "History" ], "offsets": [ [ 188, 195 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T17", "type": "Condition", "text": [ "hypersensitivity reaction" ], "offsets": [ [ 233, 258 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T18", "type": "Condition", "text": [ "intolerability" ], "offsets": [ [ 262, 276 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T19", "type": "Drug", "text": [ "Ace Inh" ], "offsets": [ [ 280, 287 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T20", "type": "Drug", "text": [ "ARB" ], "offsets": [ [ 291, 294 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T21", "type": "Scope", "text": [ "Ace Inh or ARB" ], "offsets": [ [ 280, 294 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T22", "type": "Scope", "text": [ "hypersensitivity reaction or intolerability" ], "offsets": [ [ 233, 276 ] ], "normalized": [] }, { "id": "NCT02046395_exc_T23", "type": "Observation", "text": [ "history" ], "offsets": [ [ 222, 229 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02046395_exc_R1", "type": "Has_value", "arg1_id": "NCT02046395_exc_T3", "arg2_id": "NCT02046395_exc_T4", "normalized": [] }, { "id": "NCT02046395_exc_R2", "type": "Has_scope", "arg1_id": "NCT02046395_exc_T5", "arg2_id": "NCT02046395_exc_T8", "normalized": [] }, { "id": "NCT02046395_exc_R3", "type": "AND", "arg1_id": "NCT02046395_exc_T2", "arg2_id": "NCT02046395_exc_T3", "normalized": [] }, { "id": "NCT02046395_exc_R4", "type": "Has_value", "arg1_id": "NCT02046395_exc_T11", "arg2_id": "NCT02046395_exc_T12", "normalized": [] }, { "id": "NCT02046395_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02046395_exc_T10", "arg2_id": "NCT02046395_exc_T9", "normalized": [] }, { "id": "NCT02046395_exc_R6", "type": "AND", "arg1_id": "NCT02046395_exc_T10", "arg2_id": "NCT02046395_exc_T11", "normalized": [] }, { "id": "NCT02046395_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02046395_exc_T13", "arg2_id": "NCT02046395_exc_T15", "normalized": [] }, { "id": "NCT02046395_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02046395_exc_T14", "arg2_id": "NCT02046395_exc_T16", "normalized": [] }, { "id": "NCT02046395_exc_R9", "type": "Has_scope", "arg1_id": "NCT02046395_exc_T22", "arg2_id": "NCT02046395_exc_T21", "normalized": [] }, { "id": "NCT02046395_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02046395_exc_T22", "arg2_id": "NCT02046395_exc_T23", "normalized": [] } ]

[ { "id": "NCT02046395_inc_text", "type": "inclusion", "text": [ "Type 2 Diabetes\nHypertension\nEstimated glomerular filtration rate (eGFR) > 30 ml/min\nUse of Ace Inh and ARB for control of blood pressure who are willing to be placed on alternate drug(s) in the washout period for blood pressure control\n" ], "offsets": [ [ 0, 237 ] ] } ]

[ { "id": "NCT02046395_inc_T1", "type": "Condition", "text": [ "Type 2 Diabetes" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T2", "type": "Condition", "text": [ "Hypertension" ], "offsets": [ [ 16, 28 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T3", "type": "Measurement", "text": [ "Estimated glomerular filtration rate (eGFR)" ], "offsets": [ [ 29, 72 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T4", "type": "Value", "text": [ "> 30 ml/min" ], "offsets": [ [ 73, 84 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T5", "type": "Drug", "text": [ "Ace Inh" ], "offsets": [ [ 92, 99 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T6", "type": "Drug", "text": [ "ARB" ], "offsets": [ [ 104, 107 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T7", "type": "Procedure", "text": [ "control of blood pressure" ], "offsets": [ [ 112, 137 ] ], "normalized": [] }, { "id": "NCT02046395_inc_T8", "type": "Scope", "text": [ "Ace Inh and ARB" ], "offsets": [ [ 92, 107 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02046395_inc_R1", "type": "Has_value", "arg1_id": "NCT02046395_inc_T3", "arg2_id": "NCT02046395_inc_T4", "normalized": [] }, { "id": "NCT02046395_inc_R2", "type": "AND", "arg1_id": "NCT02046395_inc_T8", "arg2_id": "NCT02046395_inc_T7", "normalized": [] } ]

[ { "id": "NCT02053246_exc_text", "type": "exclusion", "text": [ "Other causes of heart failure other than diastolic dysfunction, such as restrictive cardiomyopathy or infiltrative cardiomyopathy\nWomen who are pregnant or nursing\nLiver cirrhosis,\nPrimary valvular disease\nAcute coronary syndrome\nCauses of PH other than that of heart failure, such as: chronic thromboembolic PH, sickle-cell disease, or sarcoidosis\nSevere bradycardia or greater than 1st degree heart block\nDecompensated heart failure\nCurrent use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol) or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or equivalent)\n" ], "offsets": [ [ 0, 611 ] ] } ]

[ { "id": "NCT02053246_exc_T1", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 16, 29 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T2", "type": "Condition", "text": [ "diastolic dysfunction" ], "offsets": [ [ 41, 62 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T3", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 30, 40 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T4", "type": "Condition", "text": [ "restrictive cardiomyopathy" ], "offsets": [ [ 72, 98 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T5", "type": "Condition", "text": [ "infiltrative cardiomyopathy" ], "offsets": [ [ 102, 129 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T6", "type": "Scope", "text": [ "restrictive cardiomyopathy or infiltrative cardiomyopathy" ], "offsets": [ [ 72, 129 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T7", "type": "Scope", "text": [ "heart failure other than diastolic dysfunction" ], "offsets": [ [ 16, 62 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T8", "type": "Person", "text": [ "Women" ], "offsets": [ [ 130, 135 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T9", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 144, 152 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T10", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 156, 163 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T11", "type": "Condition", "text": [ "Liver cirrhosis" ], "offsets": [ [ 164, 179 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T12", "type": "Condition", "text": [ "Primary valvular disease" ], "offsets": [ [ 181, 205 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T13", "type": "Condition", "text": [ "Acute coronary syndrome" ], "offsets": [ [ 206, 229 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T14", "type": "Condition", "text": [ "Causes of PH" ], "offsets": [ [ 230, 242 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T15", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 243, 253 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T16", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 262, 275 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T17", "type": "Condition", "text": [ "chronic thromboembolic PH" ], "offsets": [ [ 286, 311 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T18", "type": "Condition", "text": [ "sickle-cell disease" ], "offsets": [ [ 313, 332 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T19", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 337, 348 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T20", "type": "Scope", "text": [ "chronic thromboembolic PH, sickle-cell disease, or sarcoidosis" ], "offsets": [ [ 286, 348 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T21", "type": "Condition", "text": [ "bradycardia" ], "offsets": [ [ 356, 367 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T22", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 349, 355 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T23", "type": "Qualifier", "text": [ "greater than 1st degree" ], "offsets": [ [ 371, 394 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T24", "type": "Condition", "text": [ "heart block" ], "offsets": [ [ 395, 406 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T25", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 421, 434 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T26", "type": "Qualifier", "text": [ "Decompensated" ], "offsets": [ [ 407, 420 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T27", "type": "Drug", "text": [ "third generation beta-blocker" ], "offsets": [ [ 452, 481 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T28", "type": "Drug", "text": [ "nebivolol" ], "offsets": [ [ 483, 492 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T29", "type": "Drug", "text": [ "carvedilol" ], "offsets": [ [ 494, 504 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T30", "type": "Drug", "text": [ "labetalol" ], "offsets": [ [ 509, 518 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T31", "type": "Scope", "text": [ "nebivolol, carvedilol, or labetalol" ], "offsets": [ [ 483, 518 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T32", "type": "Multiplier", "text": [ "high dose" ], "offsets": [ [ 523, 532 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T33", "type": "Drug", "text": [ "any beta-blockers" ], "offsets": [ [ 536, 553 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T34", "type": "Multiplier", "text": [ "greater than 100 mg daily" ], "offsets": [ [ 555, 580 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T35", "type": "Drug", "text": [ "metoprolol" ], "offsets": [ [ 584, 594 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T36", "type": "Scope", "text": [ "greater than 100 mg daily of metoprolol" ], "offsets": [ [ 555, 594 ] ], "normalized": [] }, { "id": "NCT02053246_exc_T37", "type": "Scope", "text": [ "high dose of any beta-blockers" ], "offsets": [ [ 523, 553 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02053246_exc_R1", "type": "Has_negation", "arg1_id": "NCT02053246_exc_T2", "arg2_id": "NCT02053246_exc_T3", "normalized": [] }, { "id": "NCT02053246_exc_R2", "type": "AND", "arg1_id": "NCT02053246_exc_T1", "arg2_id": "NCT02053246_exc_T2", "normalized": [] }, { "id": "NCT02053246_exc_R3", "type": "Subsumes", "arg1_id": "NCT02053246_exc_T7", "arg2_id": "NCT02053246_exc_T6", "normalized": [] }, { "id": "NCT02053246_exc_R4", "type": "Has_negation", "arg1_id": "NCT02053246_exc_T16", "arg2_id": "NCT02053246_exc_T15", "normalized": [] }, { "id": "NCT02053246_exc_R5", "type": "AND", "arg1_id": "NCT02053246_exc_T14", "arg2_id": "NCT02053246_exc_T16", "normalized": [] }, { "id": "NCT02053246_exc_R6", "type": "Has_scope", "arg1_id": "NCT02053246_exc_T16", "arg2_id": "NCT02053246_exc_T20", "normalized": [] }, { "id": "NCT02053246_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02053246_exc_T21", "arg2_id": "NCT02053246_exc_T22", "normalized": [] }, { "id": "NCT02053246_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02053246_exc_T24", "arg2_id": "NCT02053246_exc_T23", "normalized": [] }, { "id": "NCT02053246_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02053246_exc_T25", "arg2_id": "NCT02053246_exc_T26", "normalized": [] }, { "id": "NCT02053246_exc_R10", "type": "Subsumes", "arg1_id": "NCT02053246_exc_T27", "arg2_id": "NCT02053246_exc_T31", "normalized": [] }, { "id": "NCT02053246_exc_R11", "type": "Has_multiplier", "arg1_id": "NCT02053246_exc_T35", "arg2_id": "NCT02053246_exc_T34", "normalized": [] }, { "id": "NCT02053246_exc_R12", "type": "Has_multiplier", "arg1_id": "NCT02053246_exc_T33", "arg2_id": "NCT02053246_exc_T32", "normalized": [] }, { "id": "NCT02053246_exc_R13", "type": "Subsumes", "arg1_id": "NCT02053246_exc_T37", "arg2_id": "NCT02053246_exc_T36", "normalized": [] } ]

[ { "id": "NCT02053246_inc_text", "type": "inclusion", "text": [ "Adults (= 18 years of age) with World Health Organization Group 2 Pulmonary Hypertension (Mean pulmonary artery pressure = 25 mmHg and pulmonary capillary wedge pressure = 15 mmHg)\nNew York Heart Association class II-IV symptoms\nLeft ventricular ejection fraction (LVEF) = 45%\n" ], "offsets": [ [ 0, 277 ] ] } ]

[ { "id": "NCT02053246_inc_T1", "type": "Person", "text": [ "Adults" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T2", "type": "Value", "text": [ "= 18 years" ], "offsets": [ [ 8, 18 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T4", "type": "Condition", "text": [ "Pulmonary Hypertension" ], "offsets": [ [ 66, 88 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T5", "type": "Qualifier", "text": [ "World Health Organization Group 2" ], "offsets": [ [ 32, 65 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T6", "type": "Measurement", "text": [ "(Mean pulmonary artery pressure" ], "offsets": [ [ 89, 120 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T7", "type": "Value", "text": [ "= 25 mmHg" ], "offsets": [ [ 121, 130 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T8", "type": "Measurement", "text": [ "pulmonary capillary wedge pressure" ], "offsets": [ [ 135, 169 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T9", "type": "Value", "text": [ "= 15 mmHg" ], "offsets": [ [ 170, 179 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T10", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 181, 207 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T11", "type": "Value", "text": [ "class II-IV" ], "offsets": [ [ 208, 219 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T12", "type": "Condition", "text": [ "symptoms" ], "offsets": [ [ 220, 228 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T13", "type": "Measurement", "text": [ "Left ventricular ejection fraction (LVEF)" ], "offsets": [ [ 229, 270 ] ], "normalized": [] }, { "id": "NCT02053246_inc_T14", "type": "Value", "text": [ "= 45%" ], "offsets": [ [ 271, 276 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02053246_inc_R1", "type": "Has_value", "arg1_id": "NCT02053246_inc_T3", "arg2_id": "NCT02053246_inc_T2", "normalized": [] }, { "id": "NCT02053246_inc_R2", "type": "Subsumes", "arg1_id": "NCT02053246_inc_T1", "arg2_id": "NCT02053246_inc_T3", "normalized": [] }, { "id": "NCT02053246_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02053246_inc_T4", "arg2_id": "NCT02053246_inc_T5", "normalized": [] }, { "id": "NCT02053246_inc_R4", "type": "Has_value", "arg1_id": "NCT02053246_inc_T6", "arg2_id": "NCT02053246_inc_T7", "normalized": [] }, { "id": "NCT02053246_inc_R5", "type": "Has_value", "arg1_id": "NCT02053246_inc_T8", "arg2_id": "NCT02053246_inc_T9", "normalized": [] }, { "id": "NCT02053246_inc_R6", "type": "Has_value", "arg1_id": "NCT02053246_inc_T10", "arg2_id": "NCT02053246_inc_T11", "normalized": [] }, { "id": "NCT02053246_inc_R7", "type": "AND", "arg1_id": "NCT02053246_inc_T12", "arg2_id": "NCT02053246_inc_T10", "normalized": [] }, { "id": "NCT02053246_inc_R8", "type": "Has_value", "arg1_id": "NCT02053246_inc_T13", "arg2_id": "NCT02053246_inc_T14", "normalized": [] } ]

[ { "id": "NCT02055053_exc_text", "type": "exclusion", "text": [ "Conversion from laparoscopic to open surgery\nHistory of Chronic pain or ongoing treatment for chronic pain\nAge less than 18 yrs\nAllergy to local anesthetics\n" ], "offsets": [ [ 0, 157 ] ] } ]

[ { "id": "NCT02055053_exc_T2", "type": "Observation", "text": [ "History" ], "offsets": [ [ 45, 52 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T3", "type": "Condition", "text": [ "Chronic pain" ], "offsets": [ [ 56, 68 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T4", "type": "Condition", "text": [ "chronic pain" ], "offsets": [ [ 94, 106 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T5", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 72, 79 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T6", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 80, 89 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T7", "type": "Person", "text": [ "Age" ], "offsets": [ [ 107, 110 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T8", "type": "Value", "text": [ "less than 18 yrs" ], "offsets": [ [ 111, 127 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T9", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 128, 135 ] ], "normalized": [] }, { "id": "NCT02055053_exc_T10", "type": "Drug", "text": [ "local anesthetics" ], "offsets": [ [ 139, 156 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02055053_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02055053_exc_T6", "arg2_id": "NCT02055053_exc_T5", "normalized": [] }, { "id": "NCT02055053_exc_R2", "type": "AND", "arg1_id": "NCT02055053_exc_T6", "arg2_id": "NCT02055053_exc_T4", "normalized": [] }, { "id": "NCT02055053_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02055053_exc_T3", "arg2_id": "NCT02055053_exc_T2", "normalized": [] }, { "id": "NCT02055053_exc_R4", "type": "AND", "arg1_id": "NCT02055053_exc_T3", "arg2_id": "NCT02055053_exc_T6", "normalized": [] }, { "id": "NCT02055053_exc_R5", "type": "Has_value", "arg1_id": "NCT02055053_exc_T7", "arg2_id": "NCT02055053_exc_T8", "normalized": [] }, { "id": "NCT02055053_exc_R6", "type": "AND", "arg1_id": "NCT02055053_exc_T9", "arg2_id": "NCT02055053_exc_T10", "normalized": [] } ]

[ { "id": "NCT02055053_inc_text", "type": "inclusion", "text": [ "Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair\nAmerican Society of Anesthesiology (ASA) Class I and II\n" ], "offsets": [ [ 0, 140 ] ] } ]

[ { "id": "NCT02055053_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T2", "type": "Value", "text": [ "18 or older" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T3", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 21, 31 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T4", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 35, 44 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T5", "type": "Condition", "text": [ "inguinal herna" ], "offsets": [ [ 45, 59 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T7", "type": "Scope", "text": [ "unilateral or bilateral" ], "offsets": [ [ 21, 44 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T8", "type": "Measurement", "text": [ "American Society of Anesthesiology (ASA) Class" ], "offsets": [ [ 84, 130 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T9", "type": "Value", "text": [ "I and II" ], "offsets": [ [ 131, 139 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T6", "type": "Qualifier", "text": [ "for laparoscopic repair" ], "offsets": [ [ 60, 83 ] ], "normalized": [] }, { "id": "NCT02055053_inc_T10", "type": "Procedure", "text": [ "laparoscopic repair" ], "offsets": [ [ 64, 83 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02055053_inc_R1", "type": "Has_value", "arg1_id": "NCT02055053_inc_T1", "arg2_id": "NCT02055053_inc_T2", "normalized": [] }, { "id": "NCT02055053_inc_R2", "type": "Has_scope", "arg1_id": "NCT02055053_inc_T5", "arg2_id": "NCT02055053_inc_T7", "normalized": [] }, { "id": "NCT02055053_inc_R3", "type": "Has_value", "arg1_id": "NCT02055053_inc_T8", "arg2_id": "NCT02055053_inc_T9", "normalized": [] }, { "id": "NCT02055053_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02055053_inc_T5", "arg2_id": "NCT02055053_inc_T6", "normalized": [] } ]

[ { "id": "NCT02056288_exc_text", "type": "exclusion", "text": [ "Pulseless extremity\nCompromised neurologic status on exam (specifically assessment of radial, ulnar, and median nerve)\nKnown allergy to local anesthetics (7) Not scheduled for closed reduction with percutaneous pinning under general anesthesia\nBleeding diathesis\nAmerican Society of Anesthesiologist (ASA) status 4 or higher.\nSleep apnea by polysomnography\n" ], "offsets": [ [ 0, 357 ] ] } ]

[ { "id": "NCT02056288_exc_T1", "type": "Condition", "text": [ "Pulseless extremity" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T2", "type": "Condition", "text": [ "Compromised neurologic status" ], "offsets": [ [ 20, 49 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T3", "type": "Qualifier", "text": [ "erve)", "adial," ], "offsets": [ [ 113, 118 ], [ 87, 93 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T4", "type": "Qualifier", "text": [ "erve)", "lnar," ], "offsets": [ [ 113, 118 ], [ 95, 100 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T5", "type": "Qualifier", "text": [ "median nerve" ], "offsets": [ [ 105, 117 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T6", "type": "Scope", "text": [ "radial, ulnar, and median nerve" ], "offsets": [ [ 86, 117 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T7", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T8", "type": "Drug", "text": [ "local anesthetics" ], "offsets": [ [ 136, 153 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T9", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 158, 161 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T10", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 162, 175 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T11", "type": "Procedure", "text": [ "closed reduction with percutaneous pinning" ], "offsets": [ [ 176, 218 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T12", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 225, 243 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T13", "type": "Condition", "text": [ "Bleeding diathesis" ], "offsets": [ [ 244, 262 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T14", "type": "Measurement", "text": [ "American Society of Anesthesiologist (ASA) status" ], "offsets": [ [ 263, 312 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T15", "type": "Value", "text": [ "4 or higher" ], "offsets": [ [ 313, 324 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T16", "type": "Condition", "text": [ "Sleep apnea" ], "offsets": [ [ 326, 337 ] ], "normalized": [] }, { "id": "NCT02056288_exc_T17", "type": "Procedure", "text": [ "polysomnography" ], "offsets": [ [ 341, 356 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056288_exc_R1", "type": "Has_scope", "arg1_id": "NCT02056288_exc_T2", "arg2_id": "NCT02056288_exc_T6", "normalized": [] }, { "id": "NCT02056288_exc_R2", "type": "AND", "arg1_id": "NCT02056288_exc_T7", "arg2_id": "NCT02056288_exc_T8", "normalized": [] }, { "id": "NCT02056288_exc_R3", "type": "AND", "arg1_id": "NCT02056288_exc_T11", "arg2_id": "NCT02056288_exc_T12", "normalized": [] }, { "id": "NCT02056288_exc_R4", "type": "Has_mood", "arg1_id": "NCT02056288_exc_T11", "arg2_id": "NCT02056288_exc_T10", "normalized": [] }, { "id": "NCT02056288_exc_R5", "type": "Has_negation", "arg1_id": "NCT02056288_exc_T10", "arg2_id": "NCT02056288_exc_T9", "normalized": [] }, { "id": "NCT02056288_exc_R6", "type": "Has_value", "arg1_id": "NCT02056288_exc_T14", "arg2_id": "NCT02056288_exc_T15", "normalized": [] }, { "id": "NCT02056288_exc_R7", "type": "AND", "arg1_id": "NCT02056288_exc_T17", "arg2_id": "NCT02056288_exc_T16", "normalized": [] } ]

[ { "id": "NCT02056288_inc_text", "type": "inclusion", "text": [ "Supracondylar fracture\nAge 2-17 years\nAmerican Society of Anesthesiologists Status 1 -3\nScheduled for closed reduction with percutaneous pinning under general anesthesia\n" ], "offsets": [ [ 0, 170 ] ] } ]

[ { "id": "NCT02056288_inc_T1", "type": "Condition", "text": [ "Supracondylar fracture" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 23, 26 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T3", "type": "Value", "text": [ "2-17 years" ], "offsets": [ [ 27, 37 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T4", "type": "Measurement", "text": [ "American Society of Anesthesiologists Status" ], "offsets": [ [ 38, 82 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T5", "type": "Value", "text": [ "1 -3" ], "offsets": [ [ 83, 87 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T6", "type": "Procedure", "text": [ "closed reduction with percutaneous pinning" ], "offsets": [ [ 102, 144 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T7", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 151, 169 ] ], "normalized": [] }, { "id": "NCT02056288_inc_T8", "type": "Mood", "text": [ "Scheduled for" ], "offsets": [ [ 88, 101 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056288_inc_R1", "type": "Has_value", "arg1_id": "NCT02056288_inc_T2", "arg2_id": "NCT02056288_inc_T3", "normalized": [] }, { "id": "NCT02056288_inc_R2", "type": "Has_value", "arg1_id": "NCT02056288_inc_T4", "arg2_id": "NCT02056288_inc_T5", "normalized": [] }, { "id": "NCT02056288_inc_R3", "type": "AND", "arg1_id": "NCT02056288_inc_T6", "arg2_id": "NCT02056288_inc_T7", "normalized": [] }, { "id": "NCT02056288_inc_R4", "type": "Has_mood", "arg1_id": "NCT02056288_inc_T6", "arg2_id": "NCT02056288_inc_T8", "normalized": [] } ]

[ { "id": "NCT02056301_exc_text", "type": "exclusion", "text": [ "1) Refusal of epidural catheter 2) Pregnancy 3) Bleeding History 4) Inability to understand how to use the PCA device 5) Medication interfering with blood coagulation 6) Patients allergic to local anesthetics 7) Patient refusal to participate in study 8) Developmental delay\n" ], "offsets": [ [ 0, 275 ] ] } ]

[ { "id": "NCT02056301_exc_T1", "type": "Mood", "text": [ "Refusal" ], "offsets": [ [ 3, 10 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T2", "type": "Device", "text": [ "epidural catheter" ], "offsets": [ [ 14, 31 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T3", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 35, 44 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T4", "type": "Condition", "text": [ "Bleeding" ], "offsets": [ [ 48, 56 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T5", "type": "Observation", "text": [ "History" ], "offsets": [ [ 57, 64 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T7", "type": "Drug", "text": [ "Medication" ], "offsets": [ [ 121, 131 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T8", "type": "Qualifier", "text": [ "interfering with blood coagulation" ], "offsets": [ [ 132, 166 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T9", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 179, 187 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T10", "type": "Drug", "text": [ "local anesthetics" ], "offsets": [ [ 191, 208 ] ], "normalized": [] }, { "id": "NCT02056301_exc_T20", "type": "Condition", "text": [ "Developmental delay" ], "offsets": [ [ 255, 274 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056301_exc_R1", "type": "Has_mood", "arg1_id": "NCT02056301_exc_T2", "arg2_id": "NCT02056301_exc_T1", "normalized": [] }, { "id": "NCT02056301_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02056301_exc_T4", "arg2_id": "NCT02056301_exc_T5", "normalized": [] }, { "id": "NCT02056301_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02056301_exc_T7", "arg2_id": "NCT02056301_exc_T8", "normalized": [] }, { "id": "NCT02056301_exc_R4", "type": "AND", "arg1_id": "NCT02056301_exc_T9", "arg2_id": "NCT02056301_exc_T10", "normalized": [] } ]

[ { "id": "NCT02056301_inc_text", "type": "inclusion", "text": [ "Patients age 8- 18 years 2) Patients undergoing minimally invasive pectus excavatum repair via Nuss procedure 3) American Society of Anesthesiology Status I-III\n" ], "offsets": [ [ 0, 161 ] ] } ]

[ { "id": "NCT02056301_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 9, 12 ] ], "normalized": [] }, { "id": "NCT02056301_inc_T2", "type": "Value", "text": [ "8- 18 years" ], "offsets": [ [ 13, 24 ] ], "normalized": [] }, { "id": "NCT02056301_inc_T5", "type": "Procedure", "text": [ "minimally invasive pectus excavatum repair" ], "offsets": [ [ 48, 90 ] ], "normalized": [] }, { "id": "NCT02056301_inc_T6", "type": "Qualifier", "text": [ "Nuss procedure" ], "offsets": [ [ 95, 109 ] ], "normalized": [] }, { "id": "NCT02056301_inc_T7", "type": "Measurement", "text": [ "American Society of Anesthesiology Status" ], "offsets": [ [ 113, 154 ] ], "normalized": [] }, { "id": "NCT02056301_inc_T8", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 155, 160 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056301_inc_R1", "type": "Has_value", "arg1_id": "NCT02056301_inc_T1", "arg2_id": "NCT02056301_inc_T2", "normalized": [] }, { "id": "NCT02056301_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02056301_inc_T5", "arg2_id": "NCT02056301_inc_T6", "normalized": [] }, { "id": "NCT02056301_inc_R3", "type": "Has_value", "arg1_id": "NCT02056301_inc_T7", "arg2_id": "NCT02056301_inc_T8", "normalized": [] } ]

[ { "id": "NCT02056626_exc_text", "type": "exclusion", "text": [ "abnormal renal function\ncurrently pregnant, or trying to become pregnant\nbeing treated with a beta-blocker\nuse of illicit drugs\n" ], "offsets": [ [ 0, 128 ] ] } ]

[ { "id": "NCT02056626_exc_T1", "type": "Condition", "text": [ "abnormal renal function" ], "offsets": [ [ 0, 23 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T2", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 24, 33 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T3", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T4", "type": "Mood", "text": [ "trying to become" ], "offsets": [ [ 47, 63 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T5", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 64, 72 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T6", "type": "Drug", "text": [ "beta-blocker" ], "offsets": [ [ 94, 106 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T7", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 79, 86 ] ], "normalized": [] }, { "id": "NCT02056626_exc_T8", "type": "Drug", "text": [ "illicit drugs" ], "offsets": [ [ 114, 127 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056626_exc_R1", "type": "Has_mood", "arg1_id": "NCT02056626_exc_T5", "arg2_id": "NCT02056626_exc_T4", "normalized": [] }, { "id": "NCT02056626_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02056626_exc_T3", "arg2_id": "NCT02056626_exc_T2", "normalized": [] }, { "id": "NCT02056626_exc_R3", "type": "AND", "arg1_id": "NCT02056626_exc_T7", "arg2_id": "NCT02056626_exc_T6", "normalized": [] } ]

[ { "id": "NCT02056626_inc_text", "type": "inclusion", "text": [ "systolic blood pressure between 140-160 mmHG\nbetween 18-80 years old\n" ], "offsets": [ [ 0, 69 ] ] } ]

[ { "id": "NCT02056626_inc_T1", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 0, 23 ] ], "normalized": [] }, { "id": "NCT02056626_inc_T2", "type": "Value", "text": [ "between 140-160 mmHG" ], "offsets": [ [ 24, 44 ] ], "normalized": [] }, { "id": "NCT02056626_inc_T3", "type": "Value", "text": [ "between 18-80 years" ], "offsets": [ [ 45, 64 ] ], "normalized": [] }, { "id": "NCT02056626_inc_T4", "type": "Person", "text": [ "old" ], "offsets": [ [ 65, 68 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02056626_inc_R1", "type": "Has_value", "arg1_id": "NCT02056626_inc_T1", "arg2_id": "NCT02056626_inc_T2", "normalized": [] }, { "id": "NCT02056626_inc_R2", "type": "Has_value", "arg1_id": "NCT02056626_inc_T4", "arg2_id": "NCT02056626_inc_T3", "normalized": [] } ]

[ { "id": "NCT02062489_exc_text", "type": "exclusion", "text": [ "The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;\nThe patients have active infections that were not suitable for chemotherapy;\nThe patients have severe non-cancerous diseases.\nThe patients have history of neoadjuvant hormone therapy.\nThe patients have bilateral breast cancers or DCIS or metastatic breast cancers.\nThe patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.\nThe patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.\nThe patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.\nThe patients have allergic history or contraindication of tamoxifen.\n" ], "offsets": [ [ 0, 898 ] ] } ]

[ { "id": "NCT02062489_exc_T1", "type": "Condition", "text": [ "other cancers" ], "offsets": [ [ 18, 31 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T2", "type": "Temporal", "text": [ "at the same time" ], "offsets": [ [ 32, 48 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T3", "type": "Condition", "text": [ "other cancers" ], "offsets": [ [ 72, 85 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T4", "type": "Negation", "text": [ "except" ], "offsets": [ [ 86, 92 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T5", "type": "Condition", "text": [ "controlled skin basal cell carcinoma" ], "offsets": [ [ 93, 129 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T6", "type": "Condition", "text": [ "skin squamous cell carcinoma" ], "offsets": [ [ 133, 161 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T7", "type": "Condition", "text": [ "carcinoma in situ of cervix uterus" ], "offsets": [ [ 165, 199 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T8", "type": "Scope", "text": [ "controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus" ], "offsets": [ [ 93, 199 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T9", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 219, 225 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T10", "type": "Condition", "text": [ "infections" ], "offsets": [ [ 226, 236 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T11", "type": "Negation", "text": [ "not" ], "offsets": [ [ 247, 250 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T12", "type": "Qualifier", "text": [ "suitable for chemotherapy" ], "offsets": [ [ 251, 276 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T13", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 296, 302 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T14", "type": "Condition", "text": [ "non-cancerous diseases" ], "offsets": [ [ 303, 325 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T15", "type": "Procedure", "text": [ "neoadjuvant hormone therapy" ], "offsets": [ [ 356, 383 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T16", "type": "Condition", "text": [ "bilateral breast cancers" ], "offsets": [ [ 403, 427 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T17", "type": "Condition", "text": [ "DCIS" ], "offsets": [ [ 431, 435 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T18", "type": "Condition", "text": [ "metastatic breast cancers" ], "offsets": [ [ 439, 464 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T19", "type": "Procedure", "text": [ "anti-cancer therapies" ], "offsets": [ [ 520, 541 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T20", "type": "Observation", "text": [ "attending other clinical trials" ], "offsets": [ [ 550, 581 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T21", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 600, 608 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T22", "type": "Condition", "text": [ "lactational" ], "offsets": [ [ 612, 623 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T23", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 652, 665 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T24", "type": "Negation", "text": [ "refuse to practice" ], "offsets": [ [ 633, 651 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T25", "type": "Temporal", "text": [ "during the whole trial" ], "offsets": [ [ 666, 688 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T27", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 847, 855 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T28", "type": "Drug", "text": [ "tamoxifen" ], "offsets": [ [ 887, 896 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T29", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 867, 883 ] ], "normalized": [] }, { "id": "NCT02062489_exc_T30", "type": "Scope", "text": [ "allergic history or contraindication" ], "offsets": [ [ 847, 883 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02062489_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02062489_exc_T1", "arg2_id": "NCT02062489_exc_T2", "normalized": [] }, { "id": "NCT02062489_exc_R2", "type": "Has_negation", "arg1_id": "NCT02062489_exc_T8", "arg2_id": "NCT02062489_exc_T4", "normalized": [] }, { "id": "NCT02062489_exc_R3", "type": "Has_scope", "arg1_id": "NCT02062489_exc_T3", "arg2_id": "NCT02062489_exc_T8", "normalized": [] }, { "id": "NCT02062489_exc_R4", "type": "Has_negation", "arg1_id": "NCT02062489_exc_T12", "arg2_id": "NCT02062489_exc_T11", "normalized": [] }, { "id": "NCT02062489_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02062489_exc_T10", "arg2_id": "NCT02062489_exc_T12", "normalized": [] }, { "id": "NCT02062489_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02062489_exc_T10", "arg2_id": "NCT02062489_exc_T9", "normalized": [] }, { "id": "NCT02062489_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT02062489_exc_T14", "arg2_id": "NCT02062489_exc_T13", "normalized": [] }, { "id": "NCT02062489_exc_R8", "type": "Has_negation", "arg1_id": "NCT02062489_exc_T23", "arg2_id": "NCT02062489_exc_T24", "normalized": [] }, { "id": "NCT02062489_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02062489_exc_T23", "arg2_id": "NCT02062489_exc_T25", "normalized": [] }, { "id": "NCT02062489_exc_R10", "type": "AND", "arg1_id": "NCT02062489_exc_T30", "arg2_id": "NCT02062489_exc_T28", "normalized": [] } ]

[ { "id": "NCT02062489_inc_text", "type": "inclusion", "text": [ "The patients signed the written informed consent\nThe patients present with operable unilateral invasive breast cancers without distant metastasis(stage I, II, and III)\nThe breast tumor's positive ER/PR rate is <1%, and positive ER-beta1 rate is =10% by IHC.\nThe patients have no history of neoadjuvant hormone therapy.\nThe patients have normal cardiac functions by echocardiography.\nThe patients' ECOG scores are =0-2.\nFemale patient who is = 18yrs, and = 65yrs.\nThe patients are non-pregnant, and disposed to practice contraception during the whole trial.\nThe patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.\nThe patients underwent chemotherapy, radiation therapy or targeted therapy(herceptin) after surgery according to the 2013 NCCN guideline.\nThe results of patients' blood tests are as follows:\n" ], "offsets": [ [ 0, 980 ] ] } ]

[ { "id": "NCT02062489_inc_T2", "type": "Qualifier", "text": [ "operable" ], "offsets": [ [ 75, 83 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T3", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 84, 94 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T4", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 95, 103 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T5", "type": "Condition", "text": [ "breast cancers" ], "offsets": [ [ 104, 118 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T6", "type": "Condition", "text": [ "distant metastasis" ], "offsets": [ [ 127, 145 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T7", "type": "Negation", "text": [ "without" ], "offsets": [ [ 119, 126 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T8", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 146, 151 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T9", "type": "Value", "text": [ "I, II, and III" ], "offsets": [ [ 152, 166 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T10", "type": "Scope", "text": [ "without distant metastasis" ], "offsets": [ [ 119, 145 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T11", "type": "Condition", "text": [ "breast tumor" ], "offsets": [ [ 172, 184 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T12", "type": "Measurement", "text": [ "positive ER/PR rate" ], "offsets": [ [ 187, 206 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T13", "type": "Value", "text": [ "<1%" ], "offsets": [ [ 210, 213 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T14", "type": "Measurement", "text": [ "positive ER-beta1 rate" ], "offsets": [ [ 219, 241 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T15", "type": "Value", "text": [ "=10%" ], "offsets": [ [ 245, 249 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T16", "type": "Procedure", "text": [ "IHC" ], "offsets": [ [ 253, 256 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T17", "type": "Scope", "text": [ "positive ER/PR rate is <1%, and positive ER-beta1 rate is =10%" ], "offsets": [ [ 187, 249 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T18", "type": "Procedure", "text": [ "neoadjuvant hormone therapy" ], "offsets": [ [ 290, 317 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T19", "type": "Negation", "text": [ "no history" ], "offsets": [ [ 276, 286 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T21", "type": "Condition", "text": [ "normal cardiac functions" ], "offsets": [ [ 337, 361 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T20", "type": "Procedure", "text": [ "echocardiography" ], "offsets": [ [ 365, 381 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T22", "type": "Measurement", "text": [ "ECOG scores" ], "offsets": [ [ 397, 408 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T23", "type": "Value", "text": [ "=0-2" ], "offsets": [ [ 413, 417 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T24", "type": "Person", "text": [ "Female" ], "offsets": [ [ 419, 425 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T25", "type": "Value", "text": [ "= 18yrs" ], "offsets": [ [ 441, 448 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T26", "type": "Value", "text": [ "= 65yrs" ], "offsets": [ [ 454, 461 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T27", "type": "Scope", "text": [ "= 18yrs, and = 65yrs" ], "offsets": [ [ 441, 461 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T29", "type": "Procedure", "text": [ "neoadjuvant chemotherapy" ], "offsets": [ [ 580, 604 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T30", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 610, 617 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T31", "type": "Procedure", "text": [ "radical mastectomy" ], "offsets": [ [ 639, 657 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T32", "type": "Qualifier", "text": [ "directly modified" ], "offsets": [ [ 621, 638 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T33", "type": "Scope", "text": [ "neoadjuvant chemotherapy plus surgery" ], "offsets": [ [ 580, 617 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T34", "type": "Procedure", "text": [ "breast-conserving surgery" ], "offsets": [ [ 661, 686 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T35", "type": "Procedure", "text": [ "sentinel lymph node biopsy" ], "offsets": [ [ 693, 719 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T36", "type": "Procedure", "text": [ "axillary lymph node dissection" ], "offsets": [ [ 723, 753 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T37", "type": "Temporal", "text": [ "after diagnosis of breast cancer" ], "offsets": [ [ 755, 787 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T38", "type": "Reference_point", "text": [ "diagnosis of breast cancer" ], "offsets": [ [ 761, 787 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T39", "type": "Scope", "text": [ "neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection)" ], "offsets": [ [ 580, 754 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T40", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 812, 824 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T41", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 826, 843 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T42", "type": "Procedure", "text": [ "targeted therapy" ], "offsets": [ [ 847, 863 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T43", "type": "Drug", "text": [ "herceptin" ], "offsets": [ [ 864, 873 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T44", "type": "Reference_point", "text": [ "surgery" ], "offsets": [ [ 881, 888 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T45", "type": "Temporal", "text": [ "after surgery" ], "offsets": [ [ 875, 888 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T46", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 881, 888 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T47", "type": "Qualifier", "text": [ "2013 NCCN guideline" ], "offsets": [ [ 906, 925 ] ], "normalized": [] }, { "id": "NCT02062489_inc_T48", "type": "Scope", "text": [ "chemotherapy, radiation therapy or targeted therapy(herceptin)" ], "offsets": [ [ 812, 874 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02062489_inc_R1", "type": "Has_negation", "arg1_id": "NCT02062489_inc_T6", "arg2_id": "NCT02062489_inc_T7", "normalized": [] }, { "id": "NCT02062489_inc_R2", "type": "Has_value", "arg1_id": "NCT02062489_inc_T8", "arg2_id": "NCT02062489_inc_T9", "normalized": [] }, { "id": "NCT02062489_inc_R3", "type": "Subsumes", "arg1_id": "NCT02062489_inc_T10", "arg2_id": "NCT02062489_inc_T8", "normalized": [] }, { "id": "NCT02062489_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02062489_inc_T5", "arg2_id": "NCT02062489_inc_T4", "normalized": [] }, { "id": "NCT02062489_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02062489_inc_T5", "arg2_id": "NCT02062489_inc_T3", "normalized": [] }, { "id": "NCT02062489_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02062489_inc_T5", "arg2_id": "NCT02062489_inc_T2", "normalized": [] }, { "id": "NCT02062489_inc_R7", "type": "Has_scope", "arg1_id": "NCT02062489_inc_T5", "arg2_id": "NCT02062489_inc_T10", "normalized": [] }, { "id": "NCT02062489_inc_R8", "type": "Has_value", "arg1_id": "NCT02062489_inc_T12", "arg2_id": "NCT02062489_inc_T13", "normalized": [] }, { "id": "NCT02062489_inc_R10", "type": "Has_value", "arg1_id": "NCT02062489_inc_T14", "arg2_id": "NCT02062489_inc_T15", "normalized": [] }, { "id": "NCT02062489_inc_R9", "type": "Has_scope", "arg1_id": "NCT02062489_inc_T11", "arg2_id": "NCT02062489_inc_T17", "normalized": [] }, { "id": "NCT02062489_inc_R11", "type": "AND", "arg1_id": "NCT02062489_inc_T17", "arg2_id": "NCT02062489_inc_T16", "normalized": [] }, { "id": "NCT02062489_inc_R12", "type": "Has_negation", "arg1_id": "NCT02062489_inc_T18", "arg2_id": "NCT02062489_inc_T19", "normalized": [] }, { "id": "NCT02062489_inc_R13", "type": "AND", "arg1_id": "NCT02062489_inc_T21", "arg2_id": "NCT02062489_inc_T20", "normalized": [] }, { "id": "NCT02062489_inc_R14", "type": "Has_value", "arg1_id": "NCT02062489_inc_T22", "arg2_id": "NCT02062489_inc_T23", "normalized": [] }, { "id": "NCT02062489_inc_R15", "type": "Has_scope", "arg1_id": "NCT02062489_inc_T24", "arg2_id": "NCT02062489_inc_T27", "normalized": [] }, { "id": "NCT02062489_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT02062489_inc_T31", "arg2_id": "NCT02062489_inc_T32", "normalized": [] }, { "id": "NCT02062489_inc_R17", "type": "Has_index", "arg1_id": "NCT02062489_inc_T37", "arg2_id": "NCT02062489_inc_T38", "normalized": [] }, { "id": "NCT02062489_inc_R18", "type": "Has_temporal", "arg1_id": "NCT02062489_inc_T39", "arg2_id": "NCT02062489_inc_T37", "normalized": [] }, { "id": "NCT02062489_inc_R19", "type": "Subsumes", "arg1_id": "NCT02062489_inc_T42", "arg2_id": "NCT02062489_inc_T43", "normalized": [] }, { "id": "NCT02062489_inc_R20", "type": "Has_index", "arg1_id": "NCT02062489_inc_T45", "arg2_id": "NCT02062489_inc_T44", "normalized": [] }, { "id": "NCT02062489_inc_R21", "type": "Has_temporal", "arg1_id": "NCT02062489_inc_T48", "arg2_id": "NCT02062489_inc_T45", "normalized": [] }, { "id": "NCT02062489_inc_R22", "type": "Has_qualifier", "arg1_id": "NCT02062489_inc_T48", "arg2_id": "NCT02062489_inc_T47", "normalized": [] } ]

[ { "id": "NCT02068365_exc_text", "type": "exclusion", "text": [ "Evidence of decompensated liver disease (Childs B-C), hepato-cellular carcinoma, pre-existing severe depression or other psychiatric disease, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy.\nreceived telbivudine as the antiviral therapy or have received more than one NA in the past.\nreceived interferon or peginterferon treatment in the past.\nreceived antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) within the past 6 months.\nPositive test at screening for anti-HIV, anti-HCV.\nPatients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited (<=7 days) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.\nSerum total bilirubin > 3 times the upper limit of normal at screening.\nHistory or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.\nHistory or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia).\nWomen with ongoing pregnancy or who are breast feeding.\nNeutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening.\nHemoglobin < 11.5 g/dL for females and < 12.5 g/dL for men at screening.\nSerum creatinine level >120 umol/ml for men and >105 umol/ml for women at screening.\nHistory of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis, a period of treatment with an antidepressant medication or major tranquilizer at therapeutic doses for depression or psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.\nHistory of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).\nHistory or other evidence of chronic pulmonary disease associated with functional limitation. Severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).\nHistory of a severe seizure disorder or current anticonvulsant use.\nEvidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >=20% within 2 years. Patients with a lesion suspicious of hepatic malignancy on a screening imaging study will only be eligible if the likelihood of carcinoma is <=10% following an appropriate evaluation.\nHistory of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.\nMajor organ transplantation.\nThyroid disease with thyroid function poorly controlled on prescribed medications. Patients with abnormal thyroid stimulating hormone or T4 concentrations, with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.\nHistory or other evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension\nInability or unwillingness to provide informed consent or abide by the requirements of the study.\nHistory or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.\nPatients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.\nEvidence of drug and/or alcohol abuse (20g/day for women & 30g/day for men).\nPatients included in another trial or having been given investigational drugs within 12 weeks prior to screening\nAny known history of hypersensitivity to interferon.\n" ], "offsets": [ [ 0, 4500 ] ] } ]

[ { "id": "NCT02068365_exc_T1", "type": "Qualifier", "text": [ "decompensated" ], "offsets": [ [ 12, 25 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T2", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 26, 39 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T3", "type": "Measurement", "text": [ "Childs" ], "offsets": [ [ 41, 47 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T4", "type": "Value", "text": [ "B-C" ], "offsets": [ [ 48, 51 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T5", "type": "Scope", "text": [ "decompensated liver disease" ], "offsets": [ [ 12, 39 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T6", "type": "Scope", "text": [ "Childs B-C" ], "offsets": [ [ 41, 51 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T7", "type": "Condition", "text": [ "hepato-cellular carcinoma" ], "offsets": [ [ 54, 79 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T8", "type": "Temporal", "text": [ "pre-existing" ], "offsets": [ [ 81, 93 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T10", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 101, 111 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T11", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 121, 140 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T12", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T13", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 154, 169 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T14", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 142, 153 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T15", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 171, 182 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T16", "type": "Condition", "text": [ "renal disease" ], "offsets": [ [ 183, 196 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T17", "type": "Condition", "text": [ "seizure disorders" ], "offsets": [ [ 198, 215 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T18", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 219, 225 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T19", "type": "Condition", "text": [ "retinopathy" ], "offsets": [ [ 226, 237 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T20", "type": "Scope", "text": [ "severe depression or other psychiatric disease" ], "offsets": [ [ 94, 140 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T21", "type": "Drug", "text": [ "telbivudine" ], "offsets": [ [ 248, 259 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T22", "type": "Procedure", "text": [ "antiviral therapy" ], "offsets": [ [ 267, 284 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T23", "type": "Multiplier", "text": [ "more than one" ], "offsets": [ [ 302, 315 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T24", "type": "Condition", "text": [ "NA" ], "offsets": [ [ 316, 318 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T25", "type": "Temporal", "text": [ "in the past" ], "offsets": [ [ 319, 330 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T26", "type": "Drug", "text": [ "interferon" ], "offsets": [ [ 341, 351 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T27", "type": "Drug", "text": [ "peginterferon" ], "offsets": [ [ 355, 368 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T28", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 369, 378 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T29", "type": "Temporal", "text": [ "in the past" ], "offsets": [ [ 379, 390 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T30", "type": "Scope", "text": [ "interferon or peginterferon" ], "offsets": [ [ 341, 368 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T31", "type": "Procedure", "text": [ "antiviral therapy" ], "offsets": [ [ 401, 418 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T32", "type": "Drug", "text": [ "systemic anti-viral" ], "offsets": [ [ 427, 446 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T33", "type": "Procedure", "text": [ "i-neoplastic or", "atment (i" ], "offsets": [ [ 451, 466 ], [ 488, 497 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T34", "type": "Procedure", "text": [ "immuno-modulatory treatment" ], "offsets": [ [ 467, 494 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T35", "type": "Multiplier", "text": [ "supraphysiologic doses" ], "offsets": [ [ 506, 528 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T36", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 532, 540 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T37", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 545, 554 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T38", "type": "Scope", "text": [ "supraphysiologic doses of steroids and radiation" ], "offsets": [ [ 506, 554 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T39", "type": "Scope", "text": [ "antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment" ], "offsets": [ [ 401, 494 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T40", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 556, 580 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T41", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 582, 590 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T42", "type": "Measurement", "text": [ " a", "anti-HIV, an" ], "offsets": [ [ 595, 597 ], [ 613, 625 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T43", "type": "Measurement", "text": [ " a", "ant", "-HCV.\nPa" ], "offsets": [ [ 595, 597 ], [ 613, 616 ], [ 627, 635 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T44", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 596, 608 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T45", "type": "Scope", "text": [ " a", "anti-HIV, anti-HCV.\nPa" ], "offsets": [ [ 595, 597 ], [ 613, 635 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T46", "type": "Mood", "text": [ "expected to need" ], "offsets": [ [ 650, 666 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T47", "type": "Procedure", "text": [ "systemic antiviral therapy" ], "offsets": [ [ 667, 693 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T48", "type": "Temporal", "text": [ "at any time during their participation in the study" ], "offsets": [ [ 732, 783 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T49", "type": "Reference_point", "text": [ "their participation in the study" ], "offsets": [ [ 751, 783 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T50", "type": "Drug", "text": [ "acyclovir" ], "offsets": [ [ 867, 876 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T51", "type": "Multiplier", "text": [ "ed (<=7", "e of a" ], "offsets": [ [ 843, 850 ], [ 862, 868 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T52", "type": "Multiplier", "text": [ "<=7 days" ], "offsets": [ [ 847, 855 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T53", "type": "Condition", "text": [ "herpetic lesions" ], "offsets": [ [ 881, 897 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T54", "type": "Temporal", "text": [ "more than 1 month prior to the first administration of test drug" ], "offsets": [ [ 898, 962 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T55", "type": "Reference_point", "text": [ "the first administration of test drug" ], "offsets": [ [ 925, 962 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T56", "type": "Mood", "text": [ "not excluded" ], "offsets": [ [ 967, 979 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T57", "type": "Negation", "text": [ "Exception" ], "offsets": [ [ 803, 812 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T58", "type": "Measurement", "text": [ "Serum total bilirubin" ], "offsets": [ [ 981, 1002 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T59", "type": "Value", "text": [ "> 3 times the upper limit of normal" ], "offsets": [ [ 1003, 1038 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T60", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1039, 1051 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T61", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 1082, 1090 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T62", "type": "Condition", "text": [ "esophageal varices" ], "offsets": [ [ 1096, 1114 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T63", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 1118, 1123 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T64", "type": "Condition", "text": [ "conditions consistent with decompensated liver disease" ], "offsets": [ [ 1124, 1178 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T65", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 1211, 1228 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T66", "type": "Condition", "text": [ "chronic liver disease" ], "offsets": [ [ 1245, 1266 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T67", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1267, 1277 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T68", "type": "Condition", "text": [ "HBV" ], "offsets": [ [ 1278, 1281 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T69", "type": "Scope", "text": [ "other than HBV" ], "offsets": [ [ 1267, 1281 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T70", "type": "Condition", "text": [ "hemochromatosis" ], "offsets": [ [ 1289, 1304 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T71", "type": "Condition", "text": [ "autoimmune hepatitis" ], "offsets": [ [ 1306, 1326 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T72", "type": "Condition", "text": [ "metabolic liver diseases" ], "offsets": [ [ 1328, 1352 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T73", "type": "Condition", "text": [ "Wilson's" ], "offsets": [ [ 1363, 1371 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T74", "type": "Condition", "text": [ "alpha1-antitrypsin deficiency" ], "offsets": [ [ 1376, 1405 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T75", "type": "Condition", "text": [ "alcoholic liver disease" ], "offsets": [ [ 1407, 1430 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T76", "type": "Condition", "text": [ "toxin exposures" ], "offsets": [ [ 1432, 1447 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T77", "type": "Condition", "text": [ "thalassemia" ], "offsets": [ [ 1449, 1460 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T78", "type": "Scope", "text": [ "Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia" ], "offsets": [ [ 1363, 1460 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T79", "type": "Scope", "text": [ "hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia" ], "offsets": [ [ 1289, 1460 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T80", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1463, 1468 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T81", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 1482, 1491 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T82", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 1474, 1481 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T83", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 1503, 1517 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T84", "type": "Measurement", "text": [ "Neutrophil count" ], "offsets": [ [ 1519, 1535 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T85", "type": "Value", "text": [ "<1500 cells/mm3" ], "offsets": [ [ 1536, 1551 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T86", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 1555, 1569 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T87", "type": "Value", "text": [ "<90,000 cells/mm3" ], "offsets": [ [ 1570, 1587 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T88", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1588, 1600 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T89", "type": "Scope", "text": [ "Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3" ], "offsets": [ [ 1519, 1587 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T90", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 1602, 1612 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T91", "type": "Value", "text": [ "< 11.5 g/dL" ], "offsets": [ [ 1613, 1624 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T92", "type": "Person", "text": [ "females" ], "offsets": [ [ 1629, 1636 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T93", "type": "Value", "text": [ "< 12.5 g/dL" ], "offsets": [ [ 1641, 1652 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T94", "type": "Person", "text": [ "men" ], "offsets": [ [ 1657, 1660 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T95", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1661, 1673 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T96", "type": "Scope", "text": [ "< 11.5 g/dL for females and < 12.5 g/dL for men" ], "offsets": [ [ 1613, 1660 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T97", "type": "Measurement", "text": [ "Serum creatinine level" ], "offsets": [ [ 1675, 1697 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T98", "type": "Value", "text": [ ">120 umol/ml" ], "offsets": [ [ 1698, 1710 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T99", "type": "Person", "text": [ "men" ], "offsets": [ [ 1715, 1718 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T100", "type": "Value", "text": [ ">105 umol/ml" ], "offsets": [ [ 1723, 1735 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T101", "type": "Person", "text": [ "women" ], "offsets": [ [ 1740, 1745 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T102", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 1746, 1758 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T103", "type": "Scope", "text": [ ">120 umol/ml for men and >105 umol/ml for women" ], "offsets": [ [ 1698, 1745 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T104", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 1778, 1797 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T105", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1771, 1777 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T106", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 1810, 1820 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T107", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 1822, 1828 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T108", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 1829, 1848 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T109", "type": "Condition", "text": [ "major depression" ], "offsets": [ [ 1863, 1879 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T110", "type": "Condition", "text": [ "psychosis" ], "offsets": [ [ 1883, 1892 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T111", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1906, 1915 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T112", "type": "Drug", "text": [ "antidepressant medication" ], "offsets": [ [ 1924, 1949 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T113", "type": "Drug", "text": [ "major tranquilizer" ], "offsets": [ [ 1953, 1971 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T114", "type": "Multiplier", "text": [ "therapeutic doses" ], "offsets": [ [ 1975, 1992 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T115", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 1997, 2007 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T116", "type": "Condition", "text": [ "psychosis" ], "offsets": [ [ 2011, 2020 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T117", "type": "Temporal", "text": [ "for at least 3 months" ], "offsets": [ [ 2021, 2042 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T118", "type": "Condition", "text": [ "suicidal attempt" ], "offsets": [ [ 2046, 2062 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T119", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 2064, 2079 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T120", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 2084, 2103 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T121", "type": "Condition", "text": [ "disability" ], "offsets": [ [ 2120, 2130 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T122", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 2140, 2159 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T123", "type": "Scope", "text": [ "antidepressant medication or major tranquilizer" ], "offsets": [ [ 1924, 1971 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T124", "type": "Scope", "text": [ "major depression or psychosis, a period of treatment with an antidepressant medication or major tranquilizer at therapeutic doses for depression or psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease" ], "offsets": [ [ 1863, 2159 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T125", "type": "Scope", "text": [ "Severe psychiatric disease" ], "offsets": [ [ 1822, 1848 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T126", "type": "Scope", "text": [ "severe psychiatric disease, especially depression" ], "offsets": [ [ 1771, 1820 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T127", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 2212, 2238 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T128", "type": "Condition", "text": [ "immunologically mediated disease" ], "offsets": [ [ 2172, 2204 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T129", "type": "Condition", "text": [ "idiopathic thrombocytopenic purpura" ], "offsets": [ [ 2240, 2275 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T130", "type": "Condition", "text": [ "lupus erythematosus" ], "offsets": [ [ 2277, 2296 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T131", "type": "Condition", "text": [ "autoimmune hemolytic anemia" ], "offsets": [ [ 2298, 2325 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T132", "type": "Condition", "text": [ "scleroderma" ], "offsets": [ [ 2327, 2338 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T133", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2340, 2346 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T134", "type": "Condition", "text": [ "psoriasis" ], "offsets": [ [ 2347, 2356 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T135", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 2358, 2378 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T136", "type": "Scope", "text": [ "inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis" ], "offsets": [ [ 2212, 2378 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T137", "type": "Condition", "text": [ "chronic pulmonary disease" ], "offsets": [ [ 2410, 2435 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T138", "type": "Condition", "text": [ "functional limitation" ], "offsets": [ [ 2452, 2473 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T139", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 2475, 2481 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T140", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 2482, 2497 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T141", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 2505, 2509 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T142", "type": "Value", "text": [ "Functional Class III or IV" ], "offsets": [ [ 2510, 2536 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T143", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 2538, 2559 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T144", "type": "Temporal", "text": [ "within 6 months" ], "offsets": [ [ 2560, 2575 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T145", "type": "Condition", "text": [ "ventricular tachyarrhythmias" ], "offsets": [ [ 2577, 2605 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T146", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 2616, 2623 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T147", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2624, 2633 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T148", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 2635, 2650 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T149", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 2654, 2659 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T150", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2660, 2671 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T151", "type": "Condition", "text": [ "cardiovascular diseases" ], "offsets": [ [ 2672, 2695 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T152", "type": "Scope", "text": [ "Severe cardiac disease" ], "offsets": [ [ 2475, 2497 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T153", "type": "Scope", "text": [ "NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases" ], "offsets": [ [ 2505, 2695 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T154", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 2711, 2717 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T155", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 2718, 2734 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T156", "type": "Drug", "text": [ "anticonvulsant" ], "offsets": [ [ 2746, 2760 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T157", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 2738, 2745 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T158", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 2781, 2787 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T159", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 2791, 2800 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T160", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 2801, 2807 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T161", "type": "Scope", "text": [ "active or suspected" ], "offsets": [ [ 2781, 2800 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T162", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 2824, 2834 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T163", "type": "Measurement", "text": [ "risk of recurrence" ], "offsets": [ [ 2845, 2863 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T164", "type": "Value", "text": [ ">=20% within 2 years" ], "offsets": [ [ 2867, 2887 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T165", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 2905, 2911 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T166", "type": "Mood", "text": [ "suspicious" ], "offsets": [ [ 2912, 2922 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T167", "type": "Condition", "text": [ "hepatic malignancy" ], "offsets": [ [ 2926, 2944 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T168", "type": "Procedure", "text": [ "screening imaging study" ], "offsets": [ [ 2950, 2973 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T169", "type": "Measurement", "text": [ "likelihood of carcinoma" ], "offsets": [ [ 3003, 3026 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T170", "type": "Value", "text": [ "<=10%" ], "offsets": [ [ 3030, 3035 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T171", "type": "Scope", "text": [ "lesion suspicious of hepatic malignancy on a screening imaging study" ], "offsets": [ [ 2905, 2973 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T172", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 3104, 3112 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T173", "type": "Procedure", "text": [ "ncluding radiat", "ng system" ], "offsets": [ [ 3131, 3146 ], [ 3189, 3198 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T174", "type": "Procedure", "text": [ "immunomodulatory treatment" ], "offsets": [ [ 3154, 3180 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T175", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 3140, 3149 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T176", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 3192, 3200 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T177", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 3201, 3216 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T178", "type": "Scope", "text": [ "anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids)" ], "offsets": [ [ 3113, 3217 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T179", "type": "Temporal", "text": [ "<=6 months prior to the first dose of study drug" ], "offsets": [ [ 3218, 3266 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T180", "type": "Reference_point", "text": [ "the first dose of study drug" ], "offsets": [ [ 3238, 3266 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T181", "type": "Mood", "text": [ "expectation" ], "offsets": [ [ 3274, 3285 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T182", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 3296, 3305 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T183", "type": "Mood", "text": [ "will be needed" ], "offsets": [ [ 3306, 3320 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T184", "type": "Temporal", "text": [ "at any time during the study" ], "offsets": [ [ 3321, 3349 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T185", "type": "Procedure", "text": [ "Major organ transplantation" ], "offsets": [ [ 3351, 3378 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T186", "type": "Condition", "text": [ "Thyroid disease" ], "offsets": [ [ 3380, 3395 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T187", "type": "Measurement", "text": [ "thyroid function" ], "offsets": [ [ 3401, 3417 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T188", "type": "Value", "text": [ "poorly controlled" ], "offsets": [ [ 3418, 3435 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T189", "type": "Qualifier", "text": [ "on prescribed medications" ], "offsets": [ [ 3436, 3461 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T190", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 3477, 3485 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T191", "type": "Measurement", "text": [ "thyroid stimulating hormone" ], "offsets": [ [ 3486, 3513 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T192", "type": "Measurement", "text": [ "T4 concentrations" ], "offsets": [ [ 3517, 3534 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T193", "type": "Scope", "text": [ "abnormal thyroid stimulating hormone or T4 concentrations" ], "offsets": [ [ 3477, 3534 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T194", "type": "Scope", "text": [ "abnormal thyroid stimulating hormone or T4 concentrations" ], "offsets": [ [ 3477, 3534 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T195", "type": "Measurement", "text": [ "antibodies to thyroid peroxidase" ], "offsets": [ [ 3554, 3586 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T196", "type": "Value", "text": [ "elevation" ], "offsets": [ [ 3541, 3550 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T197", "type": "Condition", "text": [ "clinical manifestations of thyroid disease" ], "offsets": [ [ 3595, 3637 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T198", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 3681, 3687 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T199", "type": "Condition", "text": [ "retinopathy" ], "offsets": [ [ 3688, 3699 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T200", "type": "Condition", "text": [ "CMV retinitis" ], "offsets": [ [ 3706, 3719 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T201", "type": "Condition", "text": [ "macula degeneration" ], "offsets": [ [ 3721, 3740 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T202", "type": "Scope", "text": [ "CMV retinitis, macula degeneration" ], "offsets": [ [ 3706, 3740 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T203", "type": "Scope", "text": [ "severe retinopathy" ], "offsets": [ [ 3681, 3699 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T204", "type": "Qualifier", "text": [ "clinically relevant" ], "offsets": [ [ 3745, 3764 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T205", "type": "Condition", "text": [ "ophthalmological disorder" ], "offsets": [ [ 3765, 3790 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T206", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 3798, 3815 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T207", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 3819, 3831 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T208", "type": "Scope", "text": [ "diabetes mellitus or hypertension" ], "offsets": [ [ 3798, 3831 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T211", "type": "Measurement", "text": [ "alpha-fetoprotein" ], "offsets": [ [ 4115, 4132 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T212", "type": "Value", "text": [ ">100 ng/mL" ], "offsets": [ [ 4133, 4143 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T213", "type": "Temporal", "text": [ "at least the previous 3 months" ], "offsets": [ [ 4225, 4255 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T214", "type": "Reference_point", "text": [ "the previous 3 months" ], "offsets": [ [ 4234, 4255 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T215", "type": "Condition", "text": [ "stability" ], "offsets": [ [ 4165, 4174 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T216", "type": "Value", "text": [ "less than 10%" ], "offsets": [ [ 4176, 4189 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T217", "type": "Measurement", "text": [ "increase" ], "offsets": [ [ 4190, 4198 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T218", "type": "Scope", "text": [ "less than 10% increase" ], "offsets": [ [ 4176, 4198 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T219", "type": "Negation", "text": [ "unless" ], "offsets": [ [ 4158, 4164 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T220", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 4281, 4294 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T221", "type": "Condition", "text": [ " (2", "& 30g" ], "offsets": [ [ 4294, 4297 ], [ 4314, 4319 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T222", "type": "Multiplier", "text": [ "20g/day" ], "offsets": [ [ 4296, 4303 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T223", "type": "Multiplier", "text": [ "30g/day" ], "offsets": [ [ 4316, 4323 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T224", "type": "Person", "text": [ "men" ], "offsets": [ [ 4328, 4331 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T225", "type": "Person", "text": [ "women" ], "offsets": [ [ 4308, 4313 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T226", "type": "Scope", "text": [ "20g/day for women & 30g/day for men" ], "offsets": [ [ 4296, 4331 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T228", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 4468, 4484 ] ], "normalized": [] }, { "id": "NCT02068365_exc_T229", "type": "Drug", "text": [ "interferon" ], "offsets": [ [ 4488, 4498 ] ], "normalized": [] } ]

[]

[]

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"NCT02068365_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T20", "arg2_id": "NCT02068365_exc_T8", "normalized": [] }, { "id": "NCT02068365_exc_R9", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T22", "arg2_id": "NCT02068365_exc_T21", "normalized": [] }, { "id": "NCT02068365_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T24", "arg2_id": "NCT02068365_exc_T25", "normalized": [] }, { "id": "NCT02068365_exc_R11", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T28", "arg2_id": "NCT02068365_exc_T30", "normalized": [] }, { "id": "NCT02068365_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T28", "arg2_id": "NCT02068365_exc_T29", "normalized": [] }, { "id": "NCT02068365_exc_R13", "type": "AND", "arg1_id": "NCT02068365_exc_T31", "arg2_id": "NCT02068365_exc_T32", "normalized": [] }, { "id": "NCT02068365_exc_R14", "type": "Has_multiplier", "arg1_id": "NCT02068365_exc_T36", "arg2_id": "NCT02068365_exc_T35", "normalized": [] }, { "id": "NCT02068365_exc_R15", "type": "Has_multiplier", "arg1_id": "NCT02068365_exc_T37", "arg2_id": "NCT02068365_exc_T35", "normalized": [] }, { "id": "NCT02068365_exc_R16", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T39", "arg2_id": "NCT02068365_exc_T38", "normalized": [] }, { "id": "NCT02068365_exc_R17", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T39", "arg2_id": "NCT02068365_exc_T40", "normalized": [] }, { "id": "NCT02068365_exc_R18", "type": "Has_value", "arg1_id": "NCT02068365_exc_T45", "arg2_id": "NCT02068365_exc_T41", "normalized": [] }, { "id": "NCT02068365_exc_R19", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T45", "arg2_id": "NCT02068365_exc_T44", "normalized": [] }, { "id": "NCT02068365_exc_R20", "type": "Has_mood", "arg1_id": "NCT02068365_exc_T47", "arg2_id": "NCT02068365_exc_T46", "normalized": [] }, { "id": "NCT02068365_exc_R21", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T47", "arg2_id": "NCT02068365_exc_T48", "normalized": [] }, { "id": "NCT02068365_exc_R22", "type": "Has_index", "arg1_id": "NCT02068365_exc_T48", "arg2_id": "NCT02068365_exc_T49", "normalized": [] }, { "id": "NCT02068365_exc_R23", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T51", "arg2_id": "NCT02068365_exc_T52", "normalized": [] }, { "id": "NCT02068365_exc_R24", "type": "Has_multiplier", "arg1_id": "NCT02068365_exc_T50", "arg2_id": "NCT02068365_exc_T51", "normalized": [] }, { "id": "NCT02068365_exc_R25", "type": "Has_index", "arg1_id": "NCT02068365_exc_T54", "arg2_id": "NCT02068365_exc_T55", "normalized": [] }, { "id": "NCT02068365_exc_R26", "type": "AND", "arg1_id": "NCT02068365_exc_T50", "arg2_id": "NCT02068365_exc_T53", "normalized": [] }, { "id": "NCT02068365_exc_R27", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T50", "arg2_id": "NCT02068365_exc_T54", "normalized": [] }, { "id": "NCT02068365_exc_R28", "type": "Has_mood", "arg1_id": "NCT02068365_exc_T50", "arg2_id": "NCT02068365_exc_T56", "normalized": [] }, { "id": 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"type": "Has_value", "arg1_id": "NCT02068365_exc_T92", "arg2_id": "NCT02068365_exc_T91", "normalized": [] }, { "id": "NCT02068365_exc_R44", "type": "Has_value", "arg1_id": "NCT02068365_exc_T94", "arg2_id": "NCT02068365_exc_T93", "normalized": [] }, { "id": "NCT02068365_exc_R45", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T90", "arg2_id": "NCT02068365_exc_T96", "normalized": [] }, { "id": "NCT02068365_exc_R46", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T90", "arg2_id": "NCT02068365_exc_T95", "normalized": [] }, { "id": "NCT02068365_exc_R47", "type": "Has_value", "arg1_id": "NCT02068365_exc_T101", "arg2_id": "NCT02068365_exc_T100", "normalized": [] }, { "id": "NCT02068365_exc_R48", "type": "Has_value", "arg1_id": "NCT02068365_exc_T99", "arg2_id": "NCT02068365_exc_T98", "normalized": [] }, { "id": "NCT02068365_exc_R49", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T97", "arg2_id": "NCT02068365_exc_T103", "normalized": [] }, { "id": "NCT02068365_exc_R50", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T97", "arg2_id": "NCT02068365_exc_T102", "normalized": [] }, { "id": "NCT02068365_exc_R51", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T104", "arg2_id": "NCT02068365_exc_T105", "normalized": [] }, { "id": "NCT02068365_exc_R52", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T104", "arg2_id": "NCT02068365_exc_T106", "normalized": [] }, { "id": "NCT02068365_exc_R53", "type": "AND", "arg1_id": "NCT02068365_exc_T119", "arg2_id": "NCT02068365_exc_T120", "normalized": [] }, { "id": "NCT02068365_exc_R54", "type": "AND", "arg1_id": "NCT02068365_exc_T121", "arg2_id": "NCT02068365_exc_T122", "normalized": [] }, { "id": "NCT02068365_exc_R56", "type": "Has_multiplier", "arg1_id": "NCT02068365_exc_T123", "arg2_id": "NCT02068365_exc_T114", "normalized": [] }, { "id": "NCT02068365_exc_R57", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T116", "arg2_id": "NCT02068365_exc_T117", "normalized": [] }, { "id": "NCT02068365_exc_R58", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T111", "arg2_id": "NCT02068365_exc_T123", "normalized": [] }, { "id": "NCT02068365_exc_R55", "type": "AND", "arg1_id": "NCT02068365_exc_T111", "arg2_id": "NCT02068365_exc_T115", "normalized": [] }, { "id": "NCT02068365_exc_R59", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T125", "arg2_id": "NCT02068365_exc_T124", "normalized": [] }, { "id": "NCT02068365_exc_R60", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T126", "arg2_id": "NCT02068365_exc_T125", "normalized": [] }, { "id": "NCT02068365_exc_R61", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T134", "arg2_id": "NCT02068365_exc_T133", "normalized": [] }, { "id": "NCT02068365_exc_R62", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T128", "arg2_id": "NCT02068365_exc_T136", "normalized": [] }, { "id": "NCT02068365_exc_R63", "type": "AND", "arg1_id": "NCT02068365_exc_T137", "arg2_id": "NCT02068365_exc_T138", "normalized": [] }, { "id": "NCT02068365_exc_R64", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T140", "arg2_id": "NCT02068365_exc_T139", "normalized": [] }, { "id": "NCT02068365_exc_R65", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T143", "arg2_id": "NCT02068365_exc_T144", "normalized": [] }, { "id": "NCT02068365_exc_R66", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T147", "arg2_id": "NCT02068365_exc_T146", "normalized": [] }, { "id": "NCT02068365_exc_R67", "type": "AND", "arg1_id": "NCT02068365_exc_T145", "arg2_id": "NCT02068365_exc_T147", "normalized": [] }, { "id": "NCT02068365_exc_R68", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T151", "arg2_id": "NCT02068365_exc_T150", "normalized": [] }, { "id": "NCT02068365_exc_R69", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T151", "arg2_id": "NCT02068365_exc_T149", "normalized": [] }, { "id": "NCT02068365_exc_R70", "type": "Has_value", "arg1_id": "NCT02068365_exc_T141", "arg2_id": "NCT02068365_exc_T142", "normalized": [] }, { "id": "NCT02068365_exc_R71", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T152", "arg2_id": "NCT02068365_exc_T153", "normalized": [] }, { "id": "NCT02068365_exc_R72", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T156", "arg2_id": "NCT02068365_exc_T157", "normalized": [] }, { "id": "NCT02068365_exc_R73", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T155", "arg2_id": "NCT02068365_exc_T154", "normalized": [] }, { "id": "NCT02068365_exc_R74", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T160", "arg2_id": "NCT02068365_exc_T161", "normalized": [] }, { "id": "NCT02068365_exc_R75", "type": "Has_value", "arg1_id": "NCT02068365_exc_T163", "arg2_id": "NCT02068365_exc_T164", "normalized": [] }, { "id": "NCT02068365_exc_R76", "type": "AND", "arg1_id": "NCT02068365_exc_T162", "arg2_id": "NCT02068365_exc_T163", "normalized": [] }, { "id": "NCT02068365_exc_R77", "type": "Has_mood", "arg1_id": "NCT02068365_exc_T167", "arg2_id": "NCT02068365_exc_T166", "normalized": [] }, { "id": "NCT02068365_exc_R78", "type": "AND", "arg1_id": "NCT02068365_exc_T165", "arg2_id": "NCT02068365_exc_T167", "normalized": [] }, { "id": "NCT02068365_exc_R79", "type": "Has_value", "arg1_id": "NCT02068365_exc_T169", "arg2_id": "NCT02068365_exc_T170", "normalized": [] }, { "id": "NCT02068365_exc_R80", "type": "AND", "arg1_id": "NCT02068365_exc_T165", "arg2_id": "NCT02068365_exc_T168", "normalized": [] }, { "id": "NCT02068365_exc_R81", "type": "AND", "arg1_id": "NCT02068365_exc_T171", "arg2_id": "NCT02068365_exc_T169", "normalized": [] }, { "id": "NCT02068365_exc_R82", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T173", "arg2_id": "NCT02068365_exc_T175", "normalized": [] }, { "id": "NCT02068365_exc_R83", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T177", "arg2_id": "NCT02068365_exc_T176", "normalized": [] }, { "id": "NCT02068365_exc_R84", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T178", "arg2_id": "NCT02068365_exc_T172", "normalized": [] }, { "id": "NCT02068365_exc_R85", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T174", "arg2_id": "NCT02068365_exc_T177", "normalized": [] }, { "id": "NCT02068365_exc_R86", "type": "Has_index", "arg1_id": "NCT02068365_exc_T179", "arg2_id": "NCT02068365_exc_T180", "normalized": [] }, { "id": "NCT02068365_exc_R87", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T178", "arg2_id": "NCT02068365_exc_T179", "normalized": [] }, { "id": "NCT02068365_exc_R88", "type": "Has_mood", "arg1_id": "NCT02068365_exc_T182", "arg2_id": "NCT02068365_exc_T181", "normalized": [] }, { "id": "NCT02068365_exc_R89", "type": "Has_mood", "arg1_id": "NCT02068365_exc_T182", "arg2_id": "NCT02068365_exc_T183", "normalized": [] }, { "id": "NCT02068365_exc_R90", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T182", "arg2_id": "NCT02068365_exc_T184", "normalized": [] }, { "id": "NCT02068365_exc_R91", "type": "Has_value", "arg1_id": "NCT02068365_exc_T187", "arg2_id": "NCT02068365_exc_T188", "normalized": [] }, { "id": "NCT02068365_exc_R92", "type": "AND", "arg1_id": "NCT02068365_exc_T186", "arg2_id": "NCT02068365_exc_T187", "normalized": [] }, { "id": "NCT02068365_exc_R93", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T187", "arg2_id": "NCT02068365_exc_T189", "normalized": [] }, { "id": "NCT02068365_exc_R94", "type": "Has_value", "arg1_id": "NCT02068365_exc_T193", "arg2_id": "NCT02068365_exc_T190", "normalized": [] }, { "id": "NCT02068365_exc_R95", "type": "Has_value", "arg1_id": "NCT02068365_exc_T195", "arg2_id": "NCT02068365_exc_T196", "normalized": [] }, { "id": "NCT02068365_exc_R96", "type": "Has_qualifier", "arg1_id": "NCT02068365_exc_T199", "arg2_id": "NCT02068365_exc_T198", "normalized": [] }, { "id": "NCT02068365_exc_R97", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T203", "arg2_id": "NCT02068365_exc_T202", "normalized": [] }, { "id": "NCT02068365_exc_R98", "type": "Has_scope", "arg1_id": "NCT02068365_exc_T205", "arg2_id": "NCT02068365_exc_T208", "normalized": [] }, { "id": "NCT02068365_exc_R99", "type": "Has_value", "arg1_id": "NCT02068365_exc_T211", "arg2_id": "NCT02068365_exc_T212", "normalized": [] }, { "id": "NCT02068365_exc_R100", "type": "Has_index", "arg1_id": "NCT02068365_exc_T213", "arg2_id": "NCT02068365_exc_T214", "normalized": [] }, { "id": "NCT02068365_exc_R101", "type": "Has_value", "arg1_id": "NCT02068365_exc_T217", "arg2_id": "NCT02068365_exc_T216", "normalized": [] }, { "id": "NCT02068365_exc_R102", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T215", "arg2_id": "NCT02068365_exc_T218", "normalized": [] }, { "id": "NCT02068365_exc_R103", "type": "Has_temporal", "arg1_id": "NCT02068365_exc_T215", "arg2_id": "NCT02068365_exc_T213", "normalized": [] }, { "id": "NCT02068365_exc_R104", "type": "Has_negation", "arg1_id": "NCT02068365_exc_T215", "arg2_id": "NCT02068365_exc_T219", "normalized": [] }, { "id": "NCT02068365_exc_R105", "type": "AND", "arg1_id": "NCT02068365_exc_T222", "arg2_id": "NCT02068365_exc_T225", "normalized": [] }, { "id": "NCT02068365_exc_R106", "type": "AND", "arg1_id": "NCT02068365_exc_T223", "arg2_id": "NCT02068365_exc_T224", "normalized": [] }, { "id": "NCT02068365_exc_R107", "type": "Subsumes", "arg1_id": "NCT02068365_exc_T220", "arg2_id": "NCT02068365_exc_T226", "normalized": [] }, { "id": "NCT02068365_exc_R108", "type": "AND", "arg1_id": "NCT02068365_exc_T228", "arg2_id": "NCT02068365_exc_T229", "normalized": [] } ]

[ { "id": "NCT02068365_inc_text", "type": "inclusion", "text": [ "Male & female patients >= 18 and < 70 years of age\nPositive HBeAg before starting NA treatment\nTreated by a single NA (lamivudine, adefovir, entecavir or tenofovir) for 6 months to 5 years\nDeveloped HBeAg seroconversion (HBeAg negative and ant-HBe negative) with undetectable HBV DNA by PCR based assay on NA treatment.\nNegative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all females must be using reliable contraception during the study and for 3 months after treatment completion\n" ], "offsets": [ [ 0, 596 ] ] } ]

[ { "id": "NCT02068365_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 7, 13 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T3", "type": "Value", "text": [ ">= 18 and < 70 years" ], "offsets": [ [ 23, 43 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 47, 50 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T5", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 60, 65 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T6", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 51, 59 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T7", "type": "Temporal", "text": [ "before starting NA treatment" ], "offsets": [ [ 66, 94 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T8", "type": "Reference_point", "text": [ "starting NA treatment" ], "offsets": [ [ 73, 94 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T9", "type": "Drug", "text": [ "lamivudine" ], "offsets": [ [ 119, 129 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T10", "type": "Drug", "text": [ "adefovir" ], "offsets": [ [ 131, 139 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T11", "type": "Drug", "text": [ "entecavir" ], "offsets": [ [ 141, 150 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T12", "type": "Drug", "text": [ "tenofovir" ], "offsets": [ [ 154, 163 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T13", "type": "Multiplier", "text": [ "single" ], "offsets": [ [ 108, 114 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T14", "type": "Drug", "text": [ "NA" ], "offsets": [ [ 115, 117 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T15", "type": "Procedure", "text": [ "Treated" ], "offsets": [ [ 95, 102 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T16", "type": "Scope", "text": [ "lamivudine, adefovir, entecavir or tenofovir" ], "offsets": [ [ 119, 163 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T17", "type": "Temporal", "text": [ "for 6 months to 5 years" ], "offsets": [ [ 165, 188 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T18", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 199, 204 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T19", "type": "Value", "text": [ "seroconversion" ], "offsets": [ [ 205, 219 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T20", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 221, 226 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T21", "type": "Measurement", "text": [ "ant-HBe" ], "offsets": [ [ 240, 247 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T22", "type": "Value", "text": [ "negative" ], "offsets": [ [ 227, 235 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T23", "type": "Value", "text": [ "negative" ], "offsets": [ [ 248, 256 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T24", "type": "Scope", "text": [ "HBeAg negative and ant-HBe negative" ], "offsets": [ [ 221, 256 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T25", "type": "Value", "text": [ "undetectable" ], "offsets": [ [ 263, 275 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T26", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 276, 283 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T27", "type": "Procedure", "text": [ "PCR based assay" ], "offsets": [ [ 287, 302 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T28", "type": "Drug", "text": [ "NA" ], "offsets": [ [ 306, 308 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T29", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 309, 318 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T30", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 320, 328 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T31", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 338, 358 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T32", "type": "Measurement", "text": [ "e or", "nancy test (fo" ], "offsets": [ [ 333, 337 ], [ 348, 362 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T33", "type": "Scope", "text": [ "urine or serum pregnancy test" ], "offsets": [ [ 329, 358 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T34", "type": "Person", "text": [ "women" ], "offsets": [ [ 364, 369 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T35", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 373, 395 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T36", "type": "Scope", "text": [ "women of childbearing potential" ], "offsets": [ [ 364, 395 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T37", "type": "Temporal", "text": [ "within the 24-hour period prior to the first dose of test drug" ], "offsets": [ [ 408, 470 ] ], "normalized": [] }, { "id": "NCT02068365_inc_T38", "type": "Reference_point", "text": [ "the first dose of test drug" ], "offsets": [ [ 443, 470 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02068365_inc_R1", "type": "Has_value", "arg1_id": "NCT02068365_inc_T4", "arg2_id": "NCT02068365_inc_T3", "normalized": [] }, { "id": "NCT02068365_inc_R2", "type": "Has_value", "arg1_id": "NCT02068365_inc_T5", "arg2_id": "NCT02068365_inc_T6", "normalized": [] }, { "id": "NCT02068365_inc_R3", "type": "Has_index", "arg1_id": "NCT02068365_inc_T7", "arg2_id": "NCT02068365_inc_T8", "normalized": [] }, { "id": "NCT02068365_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02068365_inc_T5", "arg2_id": "NCT02068365_inc_T7", "normalized": [] }, { "id": "NCT02068365_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT02068365_inc_T14", "arg2_id": "NCT02068365_inc_T13", "normalized": [] }, { "id": "NCT02068365_inc_R6", "type": "AND", "arg1_id": "NCT02068365_inc_T15", "arg2_id": "NCT02068365_inc_T14", "normalized": [] }, { "id": "NCT02068365_inc_R7", "type": "Subsumes", "arg1_id": "NCT02068365_inc_T14", "arg2_id": "NCT02068365_inc_T16", "normalized": [] }, { "id": "NCT02068365_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02068365_inc_T15", "arg2_id": "NCT02068365_inc_T17", "normalized": [] }, { "id": "NCT02068365_inc_R9", "type": "Subsumes", "arg1_id": "NCT02068365_inc_T19", "arg2_id": "NCT02068365_inc_T24", "normalized": [] }, { "id": "NCT02068365_inc_R10", "type": "AND", "arg1_id": "NCT02068365_inc_T29", "arg2_id": "NCT02068365_inc_T28", "normalized": [] }, { "id": "NCT02068365_inc_R11", "type": "Has_value", "arg1_id": "NCT02068365_inc_T26", "arg2_id": "NCT02068365_inc_T25", "normalized": [] }, { "id": "NCT02068365_inc_R12", "type": "AND", "arg1_id": "NCT02068365_inc_T27", "arg2_id": "NCT02068365_inc_T26", "normalized": [] }, { "id": "NCT02068365_inc_R13", "type": "AND", "arg1_id": "NCT02068365_inc_T27", "arg2_id": "NCT02068365_inc_T29", "normalized": [] }, { "id": "NCT02068365_inc_R14", "type": "Has_value", "arg1_id": "NCT02068365_inc_T33", "arg2_id": "NCT02068365_inc_T30", "normalized": [] }, { "id": "NCT02068365_inc_R15", "type": "Has_scope", "arg1_id": "NCT02068365_inc_T36", "arg2_id": "NCT02068365_inc_T33", "normalized": [] }, { "id": "NCT02068365_inc_R16", "type": "Has_index", "arg1_id": "NCT02068365_inc_T37", "arg2_id": "NCT02068365_inc_T38", "normalized": [] }, { "id": "NCT02068365_inc_R17", "type": "Has_temporal", "arg1_id": "NCT02068365_inc_T33", "arg2_id": "NCT02068365_inc_T37", "normalized": [] } ]

[ { "id": "NCT02072811_exc_text", "type": "exclusion", "text": [ "No informed consent for participation in the study, mental illness, which don't allow to obtain informed consent and conduct the treatment according to the protocol \nPregnancy \nHIV infection \nActive cancer \nActive hepatitis virus infection \n \n" ], "offsets": [ [ 0, 252 ] ] } ]

[ { "id": "NCT02072811_exc_T2", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 166, 175 ] ], "normalized": [] }, { "id": "NCT02072811_exc_T3", "type": "Condition", "text": [ "HIV infection" ], "offsets": [ [ 177, 190 ] ], "normalized": [] }, { "id": "NCT02072811_exc_T4", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 199, 205 ] ], "normalized": [] }, { "id": "NCT02072811_exc_T5", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 192, 198 ] ], "normalized": [] }, { "id": "NCT02072811_exc_T6", "type": "Condition", "text": [ "hepatitis virus infection" ], "offsets": [ [ 214, 239 ] ], "normalized": [] }, { "id": "NCT02072811_exc_T7", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 207, 213 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02072811_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02072811_exc_T4", "arg2_id": "NCT02072811_exc_T5", "normalized": [] }, { "id": "NCT02072811_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02072811_exc_T6", "arg2_id": "NCT02072811_exc_T7", "normalized": [] } ]

[ { "id": "NCT02072811_inc_text", "type": "inclusion", "text": [ "Adult acute myeloid leukemia \nAge: ≥18 and ≤ 60 \nClinical condition of the patient allows to carry out induction therapy: ECOG performance status: ≤ 2 and the Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3 \nInformed consent to participate in the study (ICF signed) \nThe second early induction start criteria is in addition to the listed above, the percentage of the blasts on the level >10% on 7th day. \n" ], "offsets": [ [ 0, 418 ] ] } ]

[ { "id": "NCT02072811_inc_T1", "type": "Condition", "text": [ "Adult acute myeloid leukemia" ], "offsets": [ [ 0, 28 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 30, 33 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T3", "type": "Value", "text": [ "≥18 and ≤ 60" ], "offsets": [ [ 35, 47 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T4", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 122, 145 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T5", "type": "Value", "text": [ "≤ 2" ], "offsets": [ [ 147, 150 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T6", "type": "Measurement", "text": [ "Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I)" ], "offsets": [ [ 159, 215 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T7", "type": "Value", "text": [ "≤3" ], "offsets": [ [ 217, 219 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T9", "type": "Measurement", "text": [ "percentage of the blasts" ], "offsets": [ [ 362, 386 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T10", "type": "Value", "text": [ ">10%" ], "offsets": [ [ 400, 404 ] ], "normalized": [] }, { "id": "NCT02072811_inc_T11", "type": "Temporal", "text": [ "on 7th day" ], "offsets": [ [ 405, 415 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02072811_inc_R1", "type": "Has_value", "arg1_id": "NCT02072811_inc_T2", "arg2_id": "NCT02072811_inc_T3", "normalized": [] }, { "id": "NCT02072811_inc_R2", "type": "Has_value", "arg1_id": "NCT02072811_inc_T4", "arg2_id": "NCT02072811_inc_T5", "normalized": [] }, { "id": "NCT02072811_inc_R3", "type": "Has_value", "arg1_id": "NCT02072811_inc_T6", "arg2_id": "NCT02072811_inc_T7", "normalized": [] }, { "id": "NCT02072811_inc_R4", "type": "Has_value", "arg1_id": "NCT02072811_inc_T9", "arg2_id": "NCT02072811_inc_T10", "normalized": [] }, { "id": "NCT02072811_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02072811_inc_T9", "arg2_id": "NCT02072811_inc_T11", "normalized": [] } ]

[ { "id": "NCT02077556_exc_text", "type": "exclusion", "text": [ "Pregnancy\nTuberculosis\nHepatitis B or C carrier status\nHuman immunodeficiency virus-positive status\nRetransplantation or multiorgan transplantation\nHistory of rheumatoid arthritis\nUse of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity\n" ], "offsets": [ [ 0, 255 ] ] } ]

[ { "id": "NCT02077556_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T2", "type": "Condition", "text": [ "Tuberculosis" ], "offsets": [ [ 10, 22 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T3", "type": "Condition", "text": [ "patitis B o", "rrier s" ], "offsets": [ [ 25, 36 ], [ 42, 49 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T4", "type": "Condition", "text": [ "patitis B", "carrier s" ], "offsets": [ [ 25, 34 ], [ 40, 49 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T5", "type": "Measurement", "text": [ "Human immunodeficiency virus" ], "offsets": [ [ 55, 83 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T6", "type": "Value", "text": [ "positive" ], "offsets": [ [ 84, 92 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T7", "type": "Procedure", "text": [ "Retransplantation" ], "offsets": [ [ 100, 117 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T8", "type": "Procedure", "text": [ "transplantation" ], "offsets": [ [ 132, 147 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T9", "type": "Qualifier", "text": [ "multiorgan" ], "offsets": [ [ 121, 131 ] ], "normalized": [] }, { "id": "NCT02077556_exc_T10", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 159, 179 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02077556_exc_R1", "type": "Has_value", "arg1_id": "NCT02077556_exc_T5", "arg2_id": "NCT02077556_exc_T6", "normalized": [] }, { "id": "NCT02077556_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02077556_exc_T8", "arg2_id": "NCT02077556_exc_T9", "normalized": [] } ]

[ { "id": "NCT02077556_inc_text", "type": "inclusion", "text": [ "De novo kidney transplants\n20 - 65 years old\naspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range\n" ], "offsets": [ [ 0, 144 ] ] } ]

[ { "id": "NCT02077556_inc_T1", "type": "Procedure", "text": [ "kidney transplants" ], "offsets": [ [ 8, 26 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T2", "type": "Qualifier", "text": [ "De novo" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T3", "type": "Person", "text": [ "old" ], "offsets": [ [ 41, 44 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T4", "type": "Value", "text": [ "20 - 65 years" ], "offsets": [ [ 27, 40 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T5", "type": "Measurement", "text": [ "alanine aminotransferase" ], "offsets": [ [ 72, 96 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T6", "type": "Measurement", "text": [ "aspartate aminotransferase" ], "offsets": [ [ 45, 71 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T7", "type": "Value", "text": [ "within 2 times the upper limit of normal range" ], "offsets": [ [ 97, 143 ] ], "normalized": [] }, { "id": "NCT02077556_inc_T8", "type": "Scope", "text": [ "aspartate aminotransferase/alanine aminotransferase" ], "offsets": [ [ 45, 96 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02077556_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02077556_inc_T1", "arg2_id": "NCT02077556_inc_T2", "normalized": [] }, { "id": "NCT02077556_inc_R2", "type": "Has_value", "arg1_id": "NCT02077556_inc_T3", "arg2_id": "NCT02077556_inc_T4", "normalized": [] }, { "id": "NCT02077556_inc_R3", "type": "Has_value", "arg1_id": "NCT02077556_inc_T8", "arg2_id": "NCT02077556_inc_T7", "normalized": [] } ]

[ { "id": "NCT02083991_exc_text", "type": "exclusion", "text": [ "Diabetes mellitus or plasma glucose >11,1 at admission.\nReceiving steroids at the time of transplantation or likely to need steroids after transplantation.\nMultiorgan transplants and/or previously transplanted with any other organ than kidney.\nPanel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.\nRenal transplants from HLA-identical sibling.\nHypersensitivity to, or disability to take immunosuppressive drugs.\nBlood group(ABO)-incompatible transplants.\nUnlikely to comply with the study requirements.\nTransplant from donor positive for HIV, HBsAg, Hepatitis C.\nFemale of childbearing potential planing/being pregnant or unwilling to use contraception.\n" ], "offsets": [ [ 0, 749 ] ] } ]

[ { "id": "NCT02083991_exc_T1", "type": "Condition", "text": [ "Diabetes mellitus" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T2", "type": "Measurement", "text": [ "plasma glucose" ], "offsets": [ [ 21, 35 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T3", "type": "Value", "text": [ ">11,1" ], "offsets": [ [ 36, 41 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T4", "type": "Temporal", "text": [ "at admission" ], "offsets": [ [ 42, 54 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T5", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 66, 74 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T6", "type": "Procedure", "text": [ "Receiving" ], "offsets": [ [ 56, 65 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T7", "type": "Temporal", "text": [ "at the time of transplantation" ], "offsets": [ [ 75, 105 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T8", "type": "Reference_point", "text": [ "transplantation" ], "offsets": [ [ 90, 105 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T9", "type": "Mood", "text": [ "likely to need" ], "offsets": [ [ 109, 123 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T10", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 124, 132 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T11", "type": "Temporal", "text": [ "after transplantation" ], "offsets": [ [ 133, 154 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T12", "type": "Reference_point", "text": [ "transplantation" ], "offsets": [ [ 139, 154 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T13", "type": "Procedure", "text": [ "Multiorgan transplants" ], "offsets": [ [ 156, 178 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T14", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 186, 196 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T15", "type": "Procedure", "text": [ "transplanted with any other organ than kidney" ], "offsets": [ [ 197, 242 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T16", "type": "Measurement", "text": [ "Panel reacting antibodies(PRA)" ], "offsets": [ [ 244, 274 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T17", "type": "Value", "text": [ ">25%" ], "offsets": [ [ 275, 279 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T18", "type": "Temporal", "text": [ "most recent test" ], "offsets": [ [ 283, 299 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T19", "type": "Mood", "text": [ "considered to be of high risk" ], "offsets": [ [ 303, 332 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T20", "type": "Condition", "text": [ "rejection" ], "offsets": [ [ 337, 346 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T21", "type": "Procedure", "text": [ "enhanced immunosuppression" ], "offsets": [ [ 365, 391 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T22", "type": "Procedure", "text": [ "Renal transplants" ], "offsets": [ [ 393, 410 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T23", "type": "Qualifier", "text": [ "HLA-identical sibling" ], "offsets": [ [ 416, 437 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T24", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 439, 455 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T25", "type": "Condition", "text": [ "disability" ], "offsets": [ [ 463, 473 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T26", "type": "Drug", "text": [ "immunosuppressive drugs" ], "offsets": [ [ 482, 505 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T27", "type": "Qualifier", "text": [ "Blood group(ABO)-incompatible" ], "offsets": [ [ 507, 536 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T28", "type": "Procedure", "text": [ "transplants" ], "offsets": [ [ 537, 548 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T30", "type": "Condition", "text": [ "positive for HIV" ], "offsets": [ [ 620, 636 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T31", "type": "Condition", "text": [ " for HIV, H", "epati" ], "offsets": [ [ 628, 639 ], [ 646, 651 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T32", "type": "Condition", "text": [ " for HIV, H", "s C.\nFemale" ], "offsets": [ [ 628, 639 ], [ 653, 664 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T33", "type": "Procedure", "text": [ "Transplant" ], "offsets": [ [ 598, 608 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T34", "type": "Qualifier", "text": [ "donor" ], "offsets": [ [ 614, 619 ] ], "normalized": [] }, { "id": "NCT02083991_exc_T35", "type": "Scope", "text": [ "positive for HIV, HBsAg, Hepatitis C" ], "offsets": [ [ 620, 656 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02083991_exc_R1", "type": "Has_value", "arg1_id": "NCT02083991_exc_T2", "arg2_id": "NCT02083991_exc_T3", "normalized": [] }, { "id": "NCT02083991_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02083991_exc_T2", "arg2_id": "NCT02083991_exc_T4", "normalized": [] }, { "id": "NCT02083991_exc_R3", "type": "AND", "arg1_id": "NCT02083991_exc_T6", "arg2_id": "NCT02083991_exc_T5", "normalized": [] }, { "id": "NCT02083991_exc_R4", "type": "Has_index", "arg1_id": "NCT02083991_exc_T7", "arg2_id": "NCT02083991_exc_T8", "normalized": [] }, { "id": "NCT02083991_exc_R5", "type": "Has_index", "arg1_id": "NCT02083991_exc_T11", "arg2_id": "NCT02083991_exc_T12", "normalized": [] }, { "id": "NCT02083991_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02083991_exc_T10", "arg2_id": "NCT02083991_exc_T11", "normalized": [] }, { "id": "NCT02083991_exc_R7", "type": "Has_mood", "arg1_id": "NCT02083991_exc_T10", "arg2_id": "NCT02083991_exc_T9", "normalized": [] }, { "id": "NCT02083991_exc_R8", "type": "Has_temporal", "arg1_id": "NCT02083991_exc_T6", "arg2_id": "NCT02083991_exc_T7", "normalized": [] }, { "id": "NCT02083991_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02083991_exc_T15", "arg2_id": "NCT02083991_exc_T14", "normalized": [] }, { "id": "NCT02083991_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02083991_exc_T16", "arg2_id": "NCT02083991_exc_T18", "normalized": [] }, { "id": "NCT02083991_exc_R11", "type": "Has_value", "arg1_id": "NCT02083991_exc_T16", "arg2_id": "NCT02083991_exc_T17", "normalized": [] }, { "id": "NCT02083991_exc_R12", "type": "AND", "arg1_id": "NCT02083991_exc_T20", "arg2_id": "NCT02083991_exc_T21", "normalized": [] }, { "id": "NCT02083991_exc_R13", "type": "Has_mood", "arg1_id": "NCT02083991_exc_T20", "arg2_id": "NCT02083991_exc_T19", "normalized": [] }, { "id": "NCT02083991_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT02083991_exc_T22", "arg2_id": "NCT02083991_exc_T23", "normalized": [] }, { "id": "NCT02083991_exc_R15", "type": "AND", "arg1_id": "NCT02083991_exc_T25", "arg2_id": "NCT02083991_exc_T26", "normalized": [] }, { "id": "NCT02083991_exc_R16", "type": "AND", "arg1_id": "NCT02083991_exc_T24", "arg2_id": "NCT02083991_exc_T26", "normalized": [] }, { "id": "NCT02083991_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT02083991_exc_T28", "arg2_id": "NCT02083991_exc_T27", "normalized": [] }, { "id": "NCT02083991_exc_R18", "type": "Has_scope", "arg1_id": "NCT02083991_exc_T34", "arg2_id": "NCT02083991_exc_T35", "normalized": [] }, { "id": "NCT02083991_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT02083991_exc_T33", "arg2_id": "NCT02083991_exc_T34", "normalized": [] } ]

[ { "id": "NCT02083991_inc_text", "type": "inclusion", "text": [ "First or second single kidney (cadaveric or living donors) transplant recipients.\nConsidered for a standard immunosuppressive protocol.\nMust be capable of giving written informed connect for participation in the study for 24 months.\n" ], "offsets": [ [ 0, 233 ] ] } ]

[ { "id": "NCT02083991_inc_T1", "type": "Procedure", "text": [ "transplant", "second single kidney" ], "offsets": [ [ 59, 69 ], [ 9, 29 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T2", "type": "Procedure", "text": [ "First", "single kidney", "transplant" ], "offsets": [ [ 0, 5 ], [ 16, 29 ], [ 59, 69 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T3", "type": "Qualifier", "text": [ "cadaveric", "donors" ], "offsets": [ [ 31, 40 ], [ 51, 57 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T4", "type": "Qualifier", "text": [ "living donors" ], "offsets": [ [ 44, 57 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T5", "type": "Scope", "text": [ "cadaveric or living donors" ], "offsets": [ [ 31, 57 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T6", "type": "Mood", "text": [ "Considered for" ], "offsets": [ [ 82, 96 ] ], "normalized": [] }, { "id": "NCT02083991_inc_T7", "type": "Procedure", "text": [ "standard immunosuppressive protocol" ], "offsets": [ [ 99, 134 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02083991_inc_R1", "type": "Has_scope", "arg1_id": "NCT02083991_inc_T2", "arg2_id": "NCT02083991_inc_T5", "normalized": [] }, { "id": "NCT02083991_inc_R2", "type": "Has_scope", "arg1_id": "NCT02083991_inc_T1", "arg2_id": "NCT02083991_inc_T5", "normalized": [] }, { "id": "NCT02083991_inc_R3", "type": "Has_mood", "arg1_id": "NCT02083991_inc_T7", "arg2_id": "NCT02083991_inc_T6", "normalized": [] } ]

[ { "id": "NCT02092467_exc_text", "type": "exclusion", "text": [ "Current or recent infection\nClinically significant laboratory abnormalities\nPregnancy\n" ], "offsets": [ [ 0, 86 ] ] } ]

[ { "id": "NCT02092467_exc_T1", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 11, 17 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T2", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T3", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 18, 27 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T4", "type": "Scope", "text": [ "Current or recent" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T5", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 28, 50 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T6", "type": "Condition", "text": [ "laboratory abnormalities" ], "offsets": [ [ 51, 75 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T7", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 51, 61 ] ], "normalized": [] }, { "id": "NCT02092467_exc_T8", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 76, 85 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02092467_exc_R1", "type": "Has_scope", "arg1_id": "NCT02092467_exc_T3", "arg2_id": "NCT02092467_exc_T4", "normalized": [] }, { "id": "NCT02092467_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02092467_exc_T6", "arg2_id": "NCT02092467_exc_T5", "normalized": [] } ]

[ { "id": "NCT02092467_inc_text", "type": "inclusion", "text": [ "Moderate to severe rheumatoid arthritis\nTaking methotrexate without adequate control of symptoms\nHave at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)\n" ], "offsets": [ [ 0, 323 ] ] } ]

[ { "id": "NCT02092467_inc_T1", "type": "Qualifier", "text": [ "Moderate to severe" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T2", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 19, 39 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T3", "type": "Drug", "text": [ "methotrexate" ], "offsets": [ [ 47, 59 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T4", "type": "Negation", "text": [ "without" ], "offsets": [ [ 60, 67 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T5", "type": "Observation", "text": [ "adequate control of symptoms" ], "offsets": [ [ 68, 96 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T6", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 102, 114 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T7", "type": "Condition", "text": [ "cardiovascular risk factor" ], "offsets": [ [ 115, 141 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T8", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 147, 154 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T9", "type": "Observation", "text": [ "smoker" ], "offsets": [ [ 155, 161 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T10", "type": "Condition", "text": [ "high blood pressure" ], "offsets": [ [ 163, 182 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T11", "type": "Condition", "text": [ "high cholesterol levels" ], "offsets": [ [ 184, 207 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T12", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 209, 226 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T13", "type": "Observation", "text": [ "history" ], "offsets": [ [ 228, 235 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T14", "type": "Condition", "text": [ "heart attack" ], "offsets": [ [ 239, 251 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T15", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 253, 267 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T16", "type": "Condition", "text": [ "coronary heart disease" ], "offsets": [ [ 271, 293 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T17", "type": "Qualifier", "text": [ "extra-articular" ], "offsets": [ [ 295, 310 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T18", "type": "Condition", "text": [ "RA disease" ], "offsets": [ [ 311, 321 ] ], "normalized": [] }, { "id": "NCT02092467_inc_T19", "type": "Scope", "text": [ "current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease" ], "offsets": [ [ 147, 321 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02092467_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02092467_inc_T2", "arg2_id": "NCT02092467_inc_T1", "normalized": [] }, { "id": "NCT02092467_inc_R2", "type": "Has_negation", "arg1_id": "NCT02092467_inc_T5", "arg2_id": "NCT02092467_inc_T4", "normalized": [] }, { "id": "NCT02092467_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT02092467_inc_T7", "arg2_id": "NCT02092467_inc_T6", "normalized": [] }, { "id": "NCT02092467_inc_R4", "type": "Has_temporal", "arg1_id": "NCT02092467_inc_T14", "arg2_id": "NCT02092467_inc_T13", "normalized": [] }, { "id": "NCT02092467_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02092467_inc_T18", "arg2_id": "NCT02092467_inc_T17", "normalized": [] }, { "id": "NCT02092467_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02092467_inc_T9", "arg2_id": "NCT02092467_inc_T8", "normalized": [] }, { "id": "NCT02092467_inc_R8", "type": "Subsumes", "arg1_id": "NCT02092467_inc_T7", "arg2_id": "NCT02092467_inc_T19", "normalized": [] } ]

[ { "id": "NCT02101554_exc_text", "type": "exclusion", "text": [ "Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.\nHypersensitivity to morphine, naltrexone.\nA life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.\nUndergone surgery within 3 days prior to the first day of dosing.\n" ], "offsets": [ [ 0, 325 ] ] } ]

[ { "id": "NCT02101554_exc_T1", "type": "Measurement", "text": [ "Columbia-Suicide Severity Rating Scale" ], "offsets": [ [ 0, 38 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T2", "type": "Measurement", "text": [ "C-SSRS" ], "offsets": [ [ 40, 46 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T3", "type": "Condition", "text": [ "suicidal ideation" ], "offsets": [ [ 52, 69 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T4", "type": "Condition", "text": [ "suicidal", "behavior" ], "offsets": [ [ 52, 60 ], [ 74, 82 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T5", "type": "Temporal", "text": [ "in past year" ], "offsets": [ [ 83, 95 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T6", "type": "Scope", "text": [ "suicidal ideation and behavior" ], "offsets": [ [ 52, 82 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T7", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 97, 113 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T8", "type": "Drug", "text": [ "morphine" ], "offsets": [ [ 117, 125 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T9", "type": "Drug", "text": [ "naltrexone" ], "offsets": [ [ 127, 137 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T10", "type": "Scope", "text": [ "morphine, naltrexone" ], "offsets": [ [ 117, 137 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T11", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 141, 156 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T12", "type": "Value", "text": [ "less than 6 months" ], "offsets": [ [ 187, 205 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T14", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 269, 276 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T15", "type": "Temporal", "text": [ "within 3 days prior to the first day of dosing" ], "offsets": [ [ 277, 323 ] ], "normalized": [] }, { "id": "NCT02101554_exc_T16", "type": "Reference_point", "text": [ "first day of dosing" ], "offsets": [ [ 304, 323 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02101554_exc_R1", "type": "Subsumes", "arg1_id": "NCT02101554_exc_T1", "arg2_id": "NCT02101554_exc_T2", "normalized": [] }, { "id": "NCT02101554_exc_R2", "type": "Has_scope", "arg1_id": "NCT02101554_exc_T1", "arg2_id": "NCT02101554_exc_T6", "normalized": [] }, { "id": "NCT02101554_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02101554_exc_T6", "arg2_id": "NCT02101554_exc_T5", "normalized": [] }, { "id": "NCT02101554_exc_R4", "type": "Has_scope", "arg1_id": "NCT02101554_exc_T7", "arg2_id": "NCT02101554_exc_T10", "normalized": [] }, { "id": "NCT02101554_exc_R5", "type": "Has_value", "arg1_id": "NCT02101554_exc_T11", "arg2_id": "NCT02101554_exc_T12", "normalized": [] }, { "id": "NCT02101554_exc_R6", "type": "Has_index", "arg1_id": "NCT02101554_exc_T15", "arg2_id": "NCT02101554_exc_T16", "normalized": [] }, { "id": "NCT02101554_exc_R7", "type": "Has_temporal", "arg1_id": "NCT02101554_exc_T14", "arg2_id": "NCT02101554_exc_T15", "normalized": [] } ]

[ { "id": "NCT02101554_inc_text", "type": "inclusion", "text": [ "Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.\nBe an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.\n" ], "offsets": [ [ 0, 317 ] ] } ]

[ { "id": "NCT02101554_inc_T1", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T2", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 38, 42 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T3", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 19, 27 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T4", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 31, 37 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T5", "type": "Drug", "text": [ "opioid analgesic" ], "offsets": [ [ 88, 104 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T6", "type": "Procedure", "text": [ "around the clock treatment" ], "offsets": [ [ 53, 79 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T7", "type": "Scope", "text": [ "moderate to severe" ], "offsets": [ [ 19, 37 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T8", "type": "Drug", "text": [ "opioid therapy" ], "offsets": [ [ 173, 187 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T9", "type": "Drug", "text": [ "morphine" ], "offsets": [ [ 230, 238 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T10", "type": "Multiplier", "text": [ ">20 mg per day" ], "offsets": [ [ 212, 226 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T11", "type": "Qualifier", "text": [ "equivalent" ], "offsets": [ [ 189, 199 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T12", "type": "Drug", "text": [ "morphine" ], "offsets": [ [ 230, 238 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T13", "type": "Temporal", "text": [ "3 consecutive days immediately prior to first day of dosing" ], "offsets": [ [ 256, 315 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T14", "type": "Reference_point", "text": [ "first day of dosing" ], "offsets": [ [ 296, 315 ] ], "normalized": [] }, { "id": "NCT02101554_inc_T15", "type": "Scope", "text": [ "equivalent or equal to >20 mg per day of morphine" ], "offsets": [ [ 189, 238 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02101554_inc_R1", "type": "AND", "arg1_id": "NCT02101554_inc_T6", "arg2_id": "NCT02101554_inc_T5", "normalized": [] }, { "id": "NCT02101554_inc_R2", "type": "Has_scope", "arg1_id": "NCT02101554_inc_T2", "arg2_id": "NCT02101554_inc_T7", "normalized": [] }, { "id": "NCT02101554_inc_R3", "type": "AND", "arg1_id": "NCT02101554_inc_T2", "arg2_id": "NCT02101554_inc_T6", "normalized": [] }, { "id": "NCT02101554_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02101554_inc_T9", "arg2_id": "NCT02101554_inc_T11", "normalized": [] }, { "id": "NCT02101554_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT02101554_inc_T9", "arg2_id": "NCT02101554_inc_T10", "normalized": [] }, { "id": "NCT02101554_inc_R6", "type": "Has_multiplier", "arg1_id": "NCT02101554_inc_T12", "arg2_id": "NCT02101554_inc_T10", "normalized": [] }, { "id": "NCT02101554_inc_R7", "type": "Has_index", "arg1_id": "NCT02101554_inc_T13", "arg2_id": "NCT02101554_inc_T14", "normalized": [] }, { "id": "NCT02101554_inc_R8", "type": "Has_scope", "arg1_id": "NCT02101554_inc_T8", "arg2_id": "NCT02101554_inc_T15", "normalized": [] }, { "id": "NCT02101554_inc_R9", "type": "Has_temporal", "arg1_id": "NCT02101554_inc_T8", "arg2_id": "NCT02101554_inc_T13", "normalized": [] } ]

[ { "id": "NCT02102243_exc_text", "type": "exclusion", "text": [ "Congestive heart failure or coronary artery disease\nBlood pressure averaging > 159/99 mmHg\nSerum creatinine > 1.5 mg/dL\nDiabetes mellitus or other systemic illness\nLeft ventricular hypertrophy by echocardiography or ECG\nPregnancy\nHypersensitivity to spironolactone, chlorthalidone, amlodipine, human recombinant insulin or Definity\nAny history of substance abuse (other than tobacco)\nHistory of gouty arthritis\nPatients with right-to-left, bi-directional, or transient right-to-left cardiac shunts\nHypersensitivity to perflutren, blood, blood products or albumin\n" ], "offsets": [ [ 0, 563 ] ] } ]

[ { "id": "NCT02102243_exc_T1", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T2", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 28, 51 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T3", "type": "Measurement", "text": [ "Blood pressure" ], "offsets": [ [ 52, 66 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T4", "type": "Value", "text": [ "> 159/99 mmHg" ], "offsets": [ [ 77, 90 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T5", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 91, 107 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T6", "type": "Value", "text": [ "> 1.5 mg/dL" ], "offsets": [ [ 108, 119 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T7", "type": "Condition", "text": [ "Diabetes mellitus" ], "offsets": [ [ 120, 137 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T8", "type": "Condition", "text": [ "systemic illness" ], "offsets": [ [ 147, 163 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T9", "type": "Condition", "text": [ "Left ventricular hypertrophy" ], "offsets": [ [ 164, 192 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T10", "type": "Procedure", "text": [ "echocardiography" ], "offsets": [ [ 196, 212 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T11", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 216, 219 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T12", "type": "Scope", "text": [ "echocardiography or ECG" ], "offsets": [ [ 196, 219 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T13", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 220, 229 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T14", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 230, 246 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T15", "type": "Drug", "text": [ "spironolactone" ], "offsets": [ [ 250, 264 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T16", "type": "Drug", "text": [ "chlorthalidone" ], "offsets": [ [ 266, 280 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T17", "type": "Drug", "text": [ "amlodipine" ], "offsets": [ [ 282, 292 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T18", "type": "Drug", "text": [ "human recombinant insulin" ], "offsets": [ [ 294, 319 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T19", "type": "Scope", "text": [ "spironolactone, chlorthalidone, amlodipine, human recombinant insulin" ], "offsets": [ [ 250, 319 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T20", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 347, 362 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T21", "type": "Observation", "text": [ "tobacco" ], "offsets": [ [ 375, 382 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T22", "type": "Negation", "text": [ "other" ], "offsets": [ [ 364, 369 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T23", "type": "Condition", "text": [ "gouty arthritis" ], "offsets": [ [ 395, 410 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T24", "type": "Qualifier", "text": [ "right-to-left," ], "offsets": [ [ 425, 439 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T25", "type": "Qualifier", "text": [ "bi-directional" ], "offsets": [ [ 440, 454 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T26", "type": "Qualifier", "text": [ "transient" ], "offsets": [ [ 459, 468 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T27", "type": "Qualifier", "text": [ "right-to-left" ], "offsets": [ [ 469, 482 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T28", "type": "Condition", "text": [ "cardiac shunts" ], "offsets": [ [ 483, 497 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T29", "type": "Scope", "text": [ "transient right-to-left" ], "offsets": [ [ 459, 482 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T30", "type": "Scope", "text": [ "right-to-left, bi-directional, or transient right-to-left" ], "offsets": [ [ 425, 482 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T31", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 498, 514 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T32", "type": "Drug", "text": [ "perflutren" ], "offsets": [ [ 518, 528 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T33", "type": "Procedure", "text": [ "blood" ], "offsets": [ [ 537, 542 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T34", "type": "Procedure", "text": [ "blood products" ], "offsets": [ [ 537, 551 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T35", "type": "Drug", "text": [ "albumin" ], "offsets": [ [ 555, 562 ] ], "normalized": [] }, { "id": "NCT02102243_exc_T36", "type": "Scope", "text": [ "perflutren, blood, blood products or albumin" ], "offsets": [ [ 518, 562 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02102243_exc_R1", "type": "Has_value", "arg1_id": "NCT02102243_exc_T3", "arg2_id": "NCT02102243_exc_T4", "normalized": [] }, { "id": "NCT02102243_exc_R2", "type": "Has_value", "arg1_id": "NCT02102243_exc_T5", "arg2_id": "NCT02102243_exc_T6", "normalized": [] }, { "id": "NCT02102243_exc_R3", "type": "Subsumes", "arg1_id": "NCT02102243_exc_T10", "arg2_id": "NCT02102243_exc_T11", "normalized": [] }, { "id": "NCT02102243_exc_R4", "type": "AND", "arg1_id": "NCT02102243_exc_T12", "arg2_id": "NCT02102243_exc_T9", "normalized": [] }, { "id": "NCT02102243_exc_R5", "type": "Has_scope", "arg1_id": "NCT02102243_exc_T14", "arg2_id": "NCT02102243_exc_T19", "normalized": [] }, { "id": "NCT02102243_exc_R6", "type": "Has_negation", "arg1_id": "NCT02102243_exc_T21", "arg2_id": "NCT02102243_exc_T22", "normalized": [] }, { "id": "NCT02102243_exc_R7", "type": "Has_scope", "arg1_id": "NCT02102243_exc_T28", "arg2_id": "NCT02102243_exc_T30", "normalized": [] }, { "id": "NCT02102243_exc_R8", "type": "Has_scope", "arg1_id": "NCT02102243_exc_T31", "arg2_id": "NCT02102243_exc_T36", "normalized": [] } ]

[ { "id": "NCT02102243_inc_text", "type": "inclusion", "text": [ "Normotensive controls\nStage I (140-159/90-99 mmHg) untreated subjects with essential hypertension\nPatients with PA and stage I (140-159/90-99 mmHg) hypertension\n" ], "offsets": [ [ 0, 161 ] ] } ]

[ { "id": "NCT02102243_inc_T1", "type": "Procedure", "text": [ "controls" ], "offsets": [ [ 13, 21 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T2", "type": "Qualifier", "text": [ "Normotensive" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T3", "type": "Condition", "text": [ "essential hypertension" ], "offsets": [ [ 75, 97 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T4", "type": "Qualifier", "text": [ "Stage I" ], "offsets": [ [ 22, 29 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T5", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 51, 60 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T6", "type": "Condition", "text": [ "PA" ], "offsets": [ [ 112, 114 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T7", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 148, 160 ] ], "normalized": [] }, { "id": "NCT02102243_inc_T8", "type": "Qualifier", "text": [ "stage I" ], "offsets": [ [ 119, 126 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02102243_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02102243_inc_T1", "arg2_id": "NCT02102243_inc_T2", "normalized": [] }, { "id": "NCT02102243_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02102243_inc_T3", "arg2_id": "NCT02102243_inc_T5", "normalized": [] }, { "id": "NCT02102243_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02102243_inc_T3", "arg2_id": "NCT02102243_inc_T4", "normalized": [] }, { "id": "NCT02102243_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02102243_inc_T7", "arg2_id": "NCT02102243_inc_T8", "normalized": [] } ]

[ { "id": "NCT02105090_exc_text", "type": "exclusion", "text": [ "amide and/or esther local anaesthetic allergy\nparaben allergy\nChild-Pugh grade B/C liver failure\nrenal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale )\ndementia\nthose presenting with swallowing problem\nchronic pain condition\nchronic use of pain medication\npregnancy\nlactation\n" ], "offsets": [ [ 0, 341 ] ] } ]

[ { "id": "NCT02105090_exc_T1", "type": "Drug", "text": [ "amide", "local anaesthetic" ], "offsets": [ [ 0, 5 ], [ 20, 37 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T2", "type": "Drug", "text": [ "esther local anaesthetic" ], "offsets": [ [ 13, 37 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T4", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 38, 45 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T3", "type": "Scope", "text": [ "amide and/or esther local anaesthetic" ], "offsets": [ [ 0, 37 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T5", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 54, 61 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T6", "type": "Drug", "text": [ "paraben" ], "offsets": [ [ 46, 53 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T7", "type": "Measurement", "text": [ "Child-Pugh grade" ], "offsets": [ [ 62, 78 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T8", "type": "Value", "text": [ "B" ], "offsets": [ [ 79, 80 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T9", "type": "Value", "text": [ "C" ], "offsets": [ [ 81, 82 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T10", "type": "Scope", "text": [ "B/C" ], "offsets": [ [ 79, 82 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T11", "type": "Condition", "text": [ "liver failure" ], "offsets": [ [ 83, 96 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T12", "type": "Condition", "text": [ "renal insufficiency" ], "offsets": [ [ 97, 116 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T13", "type": "Measurement", "text": [ "calculated glomerular filtration rate" ], "offsets": [ [ 118, 155 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T14", "type": "Value", "text": [ "under 60 ml/min/1.73 m2" ], "offsets": [ [ 156, 179 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T15", "type": "Qualifier", "text": [ "Cockcroft-Gault scale" ], "offsets": [ [ 193, 214 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T16", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 217, 225 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T17", "type": "Condition", "text": [ "swallowing problem" ], "offsets": [ [ 248, 266 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T18", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 321, 330 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T19", "type": "Condition", "text": [ "chronic pain condition" ], "offsets": [ [ 267, 289 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T20", "type": "Multiplier", "text": [ "chronic use" ], "offsets": [ [ 290, 301 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T21", "type": "Drug", "text": [ "pain medication" ], "offsets": [ [ 305, 320 ] ], "normalized": [] }, { "id": "NCT02105090_exc_T22", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 331, 340 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02105090_exc_R1", "type": "Has_scope", "arg1_id": "NCT02105090_exc_T4", "arg2_id": "NCT02105090_exc_T3", "normalized": [] }, { "id": "NCT02105090_exc_R2", "type": "AND", "arg1_id": "NCT02105090_exc_T5", "arg2_id": "NCT02105090_exc_T6", "normalized": [] }, { "id": "NCT02105090_exc_R3", "type": "Has_scope", "arg1_id": "NCT02105090_exc_T7", "arg2_id": "NCT02105090_exc_T10", "normalized": [] }, { "id": "NCT02105090_exc_R4", "type": "AND", "arg1_id": "NCT02105090_exc_T11", "arg2_id": "NCT02105090_exc_T7", "normalized": [] }, { "id": "NCT02105090_exc_R5", "type": "Has_value", "arg1_id": "NCT02105090_exc_T13", "arg2_id": "NCT02105090_exc_T14", "normalized": [] }, { "id": "NCT02105090_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02105090_exc_T13", "arg2_id": "NCT02105090_exc_T15", "normalized": [] }, { "id": "NCT02105090_exc_R7", "type": "Has_multiplier", "arg1_id": "NCT02105090_exc_T21", "arg2_id": "NCT02105090_exc_T20", "normalized": [] } ]

[ { "id": "NCT02105090_inc_text", "type": "inclusion", "text": [ "elective procedure\nweight over 40 kg\nAmerican Society of Anesthesiology class I-III\nfirst upper GI endoscopy procedure\nfinnish or/and swedish speaking\n" ], "offsets": [ [ 0, 151 ] ] } ]

[ { "id": "NCT02105090_inc_T1", "type": "Procedure", "text": [ "elective procedure" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T2", "type": "Measurement", "text": [ "weight" ], "offsets": [ [ 19, 25 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T3", "type": "Value", "text": [ "over 40 kg" ], "offsets": [ [ 26, 36 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T4", "type": "Measurement", "text": [ "American Society of Anesthesiology class" ], "offsets": [ [ 37, 77 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T5", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 78, 83 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T6", "type": "Multiplier", "text": [ "first" ], "offsets": [ [ 84, 89 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T7", "type": "Qualifier", "text": [ "upper GI" ], "offsets": [ [ 90, 98 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T8", "type": "Procedure", "text": [ "endoscopy procedure" ], "offsets": [ [ 99, 118 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T9", "type": "Observation", "text": [ "ish or/", "king" ], "offsets": [ [ 123, 130 ], [ 146, 150 ] ], "normalized": [] }, { "id": "NCT02105090_inc_T10", "type": "Observation", "text": [ "swedish speaking" ], "offsets": [ [ 134, 150 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02105090_inc_R1", "type": "Has_value", "arg1_id": "NCT02105090_inc_T2", "arg2_id": "NCT02105090_inc_T3", "normalized": [] }, { "id": "NCT02105090_inc_R2", "type": "Has_value", "arg1_id": "NCT02105090_inc_T4", "arg2_id": "NCT02105090_inc_T5", "normalized": [] }, { "id": "NCT02105090_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02105090_inc_T8", "arg2_id": "NCT02105090_inc_T7", "normalized": [] }, { "id": "NCT02105090_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT02105090_inc_T8", "arg2_id": "NCT02105090_inc_T6", "normalized": [] } ]

[ { "id": "NCT02106598_exc_text", "type": "exclusion", "text": [ "Known pregnancy or breast-feeding. \nMedical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease. \n \n" ], "offsets": [ [ 0, 524 ] ] } ]

[ { "id": "NCT02106598_exc_T1", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T2", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 19, 33 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T3", "type": "Condition", "text": [ "Medical illness unrelated to the tumor" ], "offsets": [ [ 36, 74 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T8", "type": "Condition", "text": [ "uncontrolled infection" ], "offsets": [ [ 221, 243 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T10", "type": "Condition", "text": [ "chronic renal insufficiency" ], "offsets": [ [ 245, 272 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T11", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 274, 295 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T12", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 296, 320 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T13", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 322, 337 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T14", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 339, 358 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T15", "type": "Condition", "text": [ "chronic atrial fibrillation" ], "offsets": [ [ 370, 397 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T16", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 359, 369 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T18", "type": "Condition", "text": [ "persistent hepatitis" ], "offsets": [ [ 420, 440 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T17", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 445, 471 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T19", "type": "Value", "text": [ "Classification III or IV" ], "offsets": [ [ 472, 496 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T20", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 497, 510 ] ], "normalized": [] }, { "id": "NCT02106598_exc_T22", "type": "Condition", "text": [ "chronic active", "hepatitis" ], "offsets": [ [ 402, 416 ], [ 431, 440 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02106598_exc_R1", "type": "Has_negation", "arg1_id": "NCT02106598_exc_T15", "arg2_id": "NCT02106598_exc_T16", "normalized": [] }, { "id": "NCT02106598_exc_R2", "type": "AND", "arg1_id": "NCT02106598_exc_T14", "arg2_id": "NCT02106598_exc_T15", "normalized": [] }, { "id": "NCT02106598_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02106598_exc_T11", "arg2_id": "NCT02106598_exc_T12", "normalized": [] }, { "id": "NCT02106598_exc_R4", "type": "Has_value", "arg1_id": "NCT02106598_exc_T17", "arg2_id": "NCT02106598_exc_T19", "normalized": [] }, { "id": "NCT02106598_exc_R5", "type": "AND", "arg1_id": "NCT02106598_exc_T20", "arg2_id": "NCT02106598_exc_T17", "normalized": [] } ]

[ { "id": "NCT02106598_inc_text", "type": "inclusion", "text": [ "18 years of age or older \nHistologically confirmed diagnosis of melanoma, breast cancer or gynecologic cancer at MSKCC \nHave one of the following disease histories: \nNewly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma or breast cancer patients in whom SLN mapping is indicated \nResidual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas \nPrior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region. \nNewly diagnosed patients with previous excisional biopsy. OR \nNewly-diagnosed gynecologic cancer patients in whom SLN mapping and surgical excision is indicated OR \nNormal baseline cardiac function based upon pre-operative evaluation \nAt the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl. \nAt the discretion of the operating surgeon, Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's). \nFor melanoma patients, If patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician. \nAll patients of childbearing and child-creating age must be using an acceptable form of birth control \nWomen who are pre-menopausal must have a negative serum pregnancy test \n" ], "offsets": [ [ 0, 1383 ] ] } ]

[ { "id": "NCT02106598_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 12, 15 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T2", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 0, 8 ], [ 16, 24 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T3", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 64, 72 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T4", "type": "Procedure", "text": [ "Histologically" ], "offsets": [ [ 26, 40 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T5", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 41, 50 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T6", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 74, 87 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T7", "type": "Condition", "text": [ "gynecologic cancer" ], "offsets": [ [ 91, 109 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T8", "type": "Visit", "text": [ "MSKCC" ], "offsets": [ [ 113, 118 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T10", "type": "Condition", "text": [ "malignant melanoma" ], "offsets": [ [ 225, 243 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T11", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 247, 260 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T12", "type": "Qualifier", "text": [ "local" ], "offsets": [ [ 196, 201 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T13", "type": "Qualifier", "text": [ "regional" ], "offsets": [ [ 203, 211 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T14", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 213, 223 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T15", "type": "Scope", "text": [ "local, regional, metastatic" ], "offsets": [ [ 196, 223 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T16", "type": "Temporal", "text": [ "Newly-diagnosed" ], "offsets": [ [ 166, 181 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T17", "type": "Multiplier", "text": [ "recurrent" ], "offsets": [ [ 185, 194 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T18", "type": "Scope", "text": [ "malignant melanoma or breast cancer" ], "offsets": [ [ 225, 260 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T19", "type": "Scope", "text": [ "Newly-diagnosed or recurrent" ], "offsets": [ [ 166, 194 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T20", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 352, 357 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T21", "type": "Procedure", "text": [ "radiographically" ], "offsets": [ [ 327, 343 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T22", "type": "Qualifier", "text": [ "Residual" ], "offsets": [ [ 304, 312 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T23", "type": "Value", "text": [ "evident" ], "offsets": [ [ 344, 351 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T24", "type": "Procedure", "text": [ "clinically" ], "offsets": [ [ 313, 323 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T25", "type": "Scope", "text": [ "Residual clinically or radiographically evident" ], "offsets": [ [ 304, 351 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T26", "type": "Condition", "text": [ "primary cutaneous" ], "offsets": [ [ 369, 386 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T27", "type": "Condition", "text": [ "mucosal melanomas" ], "offsets": [ [ 391, 408 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T28", "type": "Scope", "text": [ "primary cutaneous and mucosal melanomas" ], "offsets": [ [ 369, 408 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T29", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 416, 433 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T30", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 435, 447 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T31", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 452, 459 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T32", "type": "Procedure", "text": [ "flap reconstruction" ], "offsets": [ [ 482, 501 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T33", "type": "Condition", "text": [ "requiring flap reconstruction" ], "offsets": [ [ 472, 501 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T34", "type": "Qualifier", "text": [ "head and neck region" ], "offsets": [ [ 509, 529 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T35", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 410, 415 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T36", "type": "Procedure", "text": [ "excisional biopsy" ], "offsets": [ [ 571, 588 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T37", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 562, 570 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T38", "type": "Condition", "text": [ "gynecologic cancer" ], "offsets": [ [ 610, 628 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T39", "type": "Procedure", "text": [ "SLN mapping" ], "offsets": [ [ 646, 657 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T40", "type": "Procedure", "text": [ "surgical excision" ], "offsets": [ [ 662, 679 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T41", "type": "Condition", "text": [ "surgical excision is indicated" ], "offsets": [ [ 662, 692 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T42", "type": "Condition", "text": [ "SLN mapping", "is indicated" ], "offsets": [ [ 646, 657 ], [ 680, 692 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T43", "type": "Measurement", "text": [ "cardiac function" ], "offsets": [ [ 713, 729 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T44", "type": "Value", "text": [ "Normal" ], "offsets": [ [ 697, 703 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T45", "type": "Measurement", "text": [ "baseline" ], "offsets": [ [ 704, 712 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T46", "type": "Procedure", "text": [ "pre-operative evaluation" ], "offsets": [ [ 741, 765 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T47", "type": "Temporal", "text": [ "pre-operative" ], "offsets": [ [ 741, 754 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T49", "type": "Measurement", "text": [ "ANC" ], "offsets": [ [ 811, 814 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T50", "type": "Value", "text": [ ">1000/mcl" ], "offsets": [ [ 814, 823 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T51", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 828, 837 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T52", "type": "Value", "text": [ ">100,000/mcl" ], "offsets": [ [ 837, 849 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T54", "type": "Measurement", "text": [ "Bilirubin level" ], "offsets": [ [ 896, 911 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T55", "type": "Value", "text": [ "< 2.0 mg/dl" ], "offsets": [ [ 915, 926 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T56", "type": "Condition", "text": [ "Gilbert's disease" ], "offsets": [ [ 958, 975 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T57", "type": "Negation", "text": [ "in the absence of" ], "offsets": [ [ 927, 944 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T58", "type": "Observation", "text": [ "history" ], "offsets": [ [ 947, 954 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T59", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 1021, 1029 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T60", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1070, 1080 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T61", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 1092, 1100 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T62", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1081, 1091 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T63", "type": "Condition", "text": [ "skin cancers" ], "offsets": [ [ 1112, 1124 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T64", "type": "Temporal", "text": [ "in the past five years" ], "offsets": [ [ 1125, 1147 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T67", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1059, 1066 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T69", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1311, 1316 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T70", "type": "Condition", "text": [ "pre-menopausal" ], "offsets": [ [ 1325, 1339 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T71", "type": "Scope", "text": [ "Women who are pre-menopausal" ], "offsets": [ [ 1311, 1339 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T72", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 1361, 1381 ] ], "normalized": [] }, { "id": "NCT02106598_inc_T73", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1352, 1360 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02106598_inc_R1", "type": "Has_value", "arg1_id": "NCT02106598_inc_T4", "arg2_id": "NCT02106598_inc_T5", "normalized": [] }, { "id": "NCT02106598_inc_R2", "type": "AND", "arg1_id": "NCT02106598_inc_T3", "arg2_id": "NCT02106598_inc_T4", "normalized": [] }, { "id": "NCT02106598_inc_R3", "type": "AND", "arg1_id": "NCT02106598_inc_T6", "arg2_id": "NCT02106598_inc_T4", "normalized": [] }, { "id": "NCT02106598_inc_R4", "type": "AND", "arg1_id": "NCT02106598_inc_T7", "arg2_id": "NCT02106598_inc_T4", "normalized": [] }, { "id": "NCT02106598_inc_R5", "type": "Has_scope", "arg1_id": "NCT02106598_inc_T18", "arg2_id": "NCT02106598_inc_T19", "normalized": [] }, { "id": "NCT02106598_inc_R6", "type": "Has_scope", "arg1_id": "NCT02106598_inc_T18", "arg2_id": "NCT02106598_inc_T15", "normalized": [] }, { "id": "NCT02106598_inc_R7", "type": "Has_value", "arg1_id": "NCT02106598_inc_T21", "arg2_id": "NCT02106598_inc_T23", "normalized": [] }, { "id": "NCT02106598_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT02106598_inc_T24", "arg2_id": "NCT02106598_inc_T22", "normalized": [] }, { "id": "NCT02106598_inc_R9", "type": "Has_scope", "arg1_id": "NCT02106598_inc_T20", "arg2_id": "NCT02106598_inc_T25", "normalized": [] }, { "id": "NCT02106598_inc_R10", "type": "Subsumes", "arg1_id": "NCT02106598_inc_T25", "arg2_id": "NCT02106598_inc_T28", "normalized": [] }, { "id": "NCT02106598_inc_R11", "type": "AND", "arg1_id": "NCT02106598_inc_T33", "arg2_id": "NCT02106598_inc_T32", "normalized": [] }, { "id": "NCT02106598_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT02106598_inc_T32", "arg2_id": "NCT02106598_inc_T34", "normalized": [] }, { "id": "NCT02106598_inc_R13", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T36", "arg2_id": "NCT02106598_inc_T37", "normalized": [] }, { "id": "NCT02106598_inc_R14", "type": "AND", "arg1_id": "NCT02106598_inc_T42", "arg2_id": "NCT02106598_inc_T39", "normalized": [] }, { "id": "NCT02106598_inc_R15", "type": "AND", "arg1_id": "NCT02106598_inc_T41", "arg2_id": "NCT02106598_inc_T40", "normalized": [] }, { "id": "NCT02106598_inc_R16", "type": "Has_value", "arg1_id": "NCT02106598_inc_T43", "arg2_id": "NCT02106598_inc_T44", "normalized": [] }, { "id": "NCT02106598_inc_R17", "type": "AND", "arg1_id": "NCT02106598_inc_T43", "arg2_id": "NCT02106598_inc_T45", "normalized": [] }, { "id": "NCT02106598_inc_R18", "type": "AND", "arg1_id": "NCT02106598_inc_T43", "arg2_id": "NCT02106598_inc_T46", "normalized": [] }, { "id": "NCT02106598_inc_R19", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T46", "arg2_id": "NCT02106598_inc_T47", "normalized": [] }, { "id": "NCT02106598_inc_R20", "type": "Has_value", "arg1_id": "NCT02106598_inc_T49", "arg2_id": "NCT02106598_inc_T50", "normalized": [] }, { "id": "NCT02106598_inc_R21", "type": "Has_value", "arg1_id": "NCT02106598_inc_T51", "arg2_id": "NCT02106598_inc_T52", "normalized": [] }, { "id": "NCT02106598_inc_R22", "type": "Has_value", "arg1_id": "NCT02106598_inc_T54", "arg2_id": "NCT02106598_inc_T55", "normalized": [] }, { "id": "NCT02106598_inc_R23", "type": "Has_negation", "arg1_id": "NCT02106598_inc_T56", "arg2_id": "NCT02106598_inc_T57", "normalized": [] }, { "id": "NCT02106598_inc_R24", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T56", "arg2_id": "NCT02106598_inc_T58", "normalized": [] }, { "id": "NCT02106598_inc_R25", "type": "Has_negation", "arg1_id": "NCT02106598_inc_T61", "arg2_id": "NCT02106598_inc_T62", "normalized": [] }, { "id": "NCT02106598_inc_R26", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T63", "arg2_id": "NCT02106598_inc_T64", "normalized": [] }, { "id": "NCT02106598_inc_R27", "type": "AND", "arg1_id": "NCT02106598_inc_T60", "arg2_id": "NCT02106598_inc_T61", "normalized": [] }, { "id": "NCT02106598_inc_R28", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T60", "arg2_id": "NCT02106598_inc_T67", "normalized": [] }, { "id": "NCT02106598_inc_R29", "type": "Has_temporal", "arg1_id": "NCT02106598_inc_T63", "arg2_id": "NCT02106598_inc_T67", "normalized": [] }, { "id": "NCT02106598_inc_R30", "type": "Has_value", "arg1_id": "NCT02106598_inc_T72", "arg2_id": "NCT02106598_inc_T73", "normalized": [] }, { "id": "NCT02106598_inc_R31", "type": "AND", "arg1_id": "NCT02106598_inc_T71", "arg2_id": "NCT02106598_inc_T72", "normalized": [] } ]

[ { "id": "NCT02106624_exc_text", "type": "exclusion", "text": [ "irreversible status of primary disease\nany history of malnutrition before enrollment\nhistory of steroid cortisol administration\nsevere liver dysfunction (Child-Pugh Score C)\npregnancy\nrefuse to enrollment\nre-admission to ICU and has been enrolled during former admission to ICU\n" ], "offsets": [ [ 0, 278 ] ] } ]

[ { "id": "NCT02106624_exc_T1", "type": "Qualifier", "text": [ "irreversible status" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T2", "type": "Condition", "text": [ "primary disease" ], "offsets": [ [ 23, 38 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T3", "type": "Condition", "text": [ "malnutrition" ], "offsets": [ [ 54, 66 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T4", "type": "Temporal", "text": [ "before enrollment" ], "offsets": [ [ 67, 84 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T5", "type": "Drug", "text": [ "steroid cortisol" ], "offsets": [ [ 96, 112 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T6", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 128, 134 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T7", "type": "Condition", "text": [ "liver dysfunction" ], "offsets": [ [ 135, 152 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T8", "type": "Measurement", "text": [ "Child-Pugh Score" ], "offsets": [ [ 154, 170 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T9", "type": "Value", "text": [ "C" ], "offsets": [ [ 171, 172 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T10", "type": "Scope", "text": [ "Child-Pugh Score C" ], "offsets": [ [ 154, 172 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T11", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 174, 183 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T13", "type": "Procedure", "text": [ "re-admission" ], "offsets": [ [ 205, 217 ] ], "normalized": [] }, { "id": "NCT02106624_exc_T14", "type": "Visit", "text": [ "ICU" ], "offsets": [ [ 221, 224 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02106624_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02106624_exc_T2", "arg2_id": "NCT02106624_exc_T1", "normalized": [] }, { "id": "NCT02106624_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02106624_exc_T3", "arg2_id": "NCT02106624_exc_T4", "normalized": [] }, { "id": "NCT02106624_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT02106624_exc_T7", "arg2_id": "NCT02106624_exc_T6", "normalized": [] }, { "id": "NCT02106624_exc_R4", "type": "Has_value", "arg1_id": "NCT02106624_exc_T8", "arg2_id": "NCT02106624_exc_T9", "normalized": [] }, { "id": "NCT02106624_exc_R5", "type": "Subsumes", "arg1_id": "NCT02106624_exc_T6", "arg2_id": "NCT02106624_exc_T10", "normalized": [] }, { "id": "NCT02106624_exc_R6", "type": "AND", "arg1_id": "NCT02106624_exc_T13", "arg2_id": "NCT02106624_exc_T14", "normalized": [] } ]

[ { "id": "NCT02106624_inc_text", "type": "inclusion", "text": [ "need mechanical ventilation for more than 2 days\nmean blood pressure more than 60mmHg\npredicted ICU stay more than 7 days\ntolerance of parenteral or enteral nutrition\n" ], "offsets": [ [ 0, 167 ] ] } ]

[ { "id": "NCT02106624_inc_T1", "type": "Procedure", "text": [ "mechanical ventilation" ], "offsets": [ [ 5, 27 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T2", "type": "Mood", "text": [ "need" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T3", "type": "Multiplier", "text": [ "for more than 2 days" ], "offsets": [ [ 28, 48 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T4", "type": "Measurement", "text": [ "mean blood pressure" ], "offsets": [ [ 49, 68 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T5", "type": "Value", "text": [ "more than 60mmHg" ], "offsets": [ [ 69, 85 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T6", "type": "Observation", "text": [ "predicted ICU stay" ], "offsets": [ [ 86, 104 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T7", "type": "Value", "text": [ "more than 7 days" ], "offsets": [ [ 105, 121 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T8", "type": "Visit", "text": [ "ICU" ], "offsets": [ [ 96, 99 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T9", "type": "Condition", "text": [ "tolerance" ], "offsets": [ [ 122, 131 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T10", "type": "Procedure", "text": [ "enteral or", "rition" ], "offsets": [ [ 138, 148 ], [ 160, 166 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T11", "type": "Procedure", "text": [ "enteral nutrition" ], "offsets": [ [ 149, 166 ] ], "normalized": [] }, { "id": "NCT02106624_inc_T12", "type": "Scope", "text": [ "parenteral or enteral nutrition" ], "offsets": [ [ 135, 166 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02106624_inc_R1", "type": "Has_mood", "arg1_id": "NCT02106624_inc_T1", "arg2_id": "NCT02106624_inc_T2", "normalized": [] }, { "id": "NCT02106624_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02106624_inc_T1", "arg2_id": "NCT02106624_inc_T3", "normalized": [] }, { "id": "NCT02106624_inc_R3", "type": "Has_value", "arg1_id": "NCT02106624_inc_T4", "arg2_id": "NCT02106624_inc_T5", "normalized": [] }, { "id": "NCT02106624_inc_R4", "type": "Has_value", "arg1_id": "NCT02106624_inc_T6", "arg2_id": "NCT02106624_inc_T7", "normalized": [] }, { "id": "NCT02106624_inc_R6", "type": "Has_scope", "arg1_id": "NCT02106624_inc_T9", "arg2_id": "NCT02106624_inc_T12", "normalized": [] } ]

[ { "id": "NCT02109081_exc_text", "type": "exclusion", "text": [ "1) preoperative diagnosis of delirium or dementia; 2) MMSE score of = 20 out of 30 on preoperative testing (more than mild cognitive impairment) or delirium on preoperative CAM testing; 3) language barriers that would preclude testing; 4) preoperative steroid use within 3 days of surgery; or 5) anticipation of postoperative intubation.\n" ], "offsets": [ [ 0, 338 ] ] } ]

[ { "id": "NCT02109081_exc_T6", "type": "Condition", "text": [ "delirium" ], "offsets": [ [ 29, 37 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T7", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 41, 49 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T8", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 3, 15 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T9", "type": "Scope", "text": [ "delirium or dementia" ], "offsets": [ [ 29, 49 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T10", "type": "Measurement", "text": [ "MMSE score" ], "offsets": [ [ 54, 64 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T11", "type": "Value", "text": [ "= 20 out of 30" ], "offsets": [ [ 68, 82 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T12", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 86, 98 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T13", "type": "Qualifier", "text": [ "more than mild" ], "offsets": [ [ 108, 122 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T14", "type": "Condition", "text": [ "cognitive impairment" ], "offsets": [ [ 123, 143 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T15", "type": "Scope", "text": [ "MMSE score of = 20 out of 30" ], "offsets": [ [ 54, 82 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T16", "type": "Scope", "text": [ "more than mild cognitive impairment" ], "offsets": [ [ 108, 143 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T17", "type": "Condition", "text": [ "delirium" ], "offsets": [ [ 148, 156 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T18", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 160, 172 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T19", "type": "Procedure", "text": [ "CAM testing" ], "offsets": [ [ 173, 184 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T20", "type": "Observation", "text": [ "language barriers" ], "offsets": [ [ 189, 206 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T21", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 239, 251 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T22", "type": "Drug", "text": [ "steroid" ], "offsets": [ [ 252, 259 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T23", "type": "Temporal", "text": [ "within 3 days of surgery" ], "offsets": [ [ 264, 288 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T24", "type": "Reference_point", "text": [ "surgery" ], "offsets": [ [ 281, 288 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T25", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 281, 288 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T26", "type": "Temporal", "text": [ "postoperative" ], "offsets": [ [ 312, 325 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T27", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 326, 336 ] ], "normalized": [] }, { "id": "NCT02109081_exc_T28", "type": "Mood", "text": [ "anticipation" ], "offsets": [ [ 296, 308 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02109081_exc_R1", "type": "Has_temporal", "arg1_id": "NCT02109081_exc_T9", "arg2_id": "NCT02109081_exc_T8", "normalized": [] }, { "id": "NCT02109081_exc_R3", "type": "Has_value", "arg1_id": "NCT02109081_exc_T10", "arg2_id": "NCT02109081_exc_T11", "normalized": [] }, { "id": "NCT02109081_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02109081_exc_T14", "arg2_id": "NCT02109081_exc_T13", "normalized": [] }, { "id": "NCT02109081_exc_R2", "type": "Subsumes", "arg1_id": "NCT02109081_exc_T15", "arg2_id": "NCT02109081_exc_T16", "normalized": [] }, { "id": "NCT02109081_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02109081_exc_T15", "arg2_id": "NCT02109081_exc_T12", "normalized": [] }, { "id": "NCT02109081_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02109081_exc_T19", "arg2_id": "NCT02109081_exc_T18", "normalized": [] }, { "id": "NCT02109081_exc_R7", "type": "AND", "arg1_id": "NCT02109081_exc_T19", "arg2_id": "NCT02109081_exc_T17", "normalized": [] }, { "id": "NCT02109081_exc_R9", "type": "Has_index", "arg1_id": "NCT02109081_exc_T23", "arg2_id": "NCT02109081_exc_T24", "normalized": [] }, { "id": "NCT02109081_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02109081_exc_T22", "arg2_id": "NCT02109081_exc_T21", "normalized": [] }, { "id": "NCT02109081_exc_R11", "type": "Subsumes", "arg1_id": "NCT02109081_exc_T21", "arg2_id": "NCT02109081_exc_T23", "normalized": [] }, { "id": "NCT02109081_exc_R12", "type": "Has_mood", "arg1_id": "NCT02109081_exc_T27", "arg2_id": "NCT02109081_exc_T28", "normalized": [] }, { "id": "NCT02109081_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02109081_exc_T27", "arg2_id": "NCT02109081_exc_T26", "normalized": [] } ]

[ { "id": "NCT02109081_inc_text", "type": "inclusion", "text": [ "patients = 70 years of age, undergoing a noncardiac surgical procedure under general anesthesia, with an anticipated duration of postoperative admission of at least 2 days.\n" ], "offsets": [ [ 0, 173 ] ] } ]

[ { "id": "NCT02109081_inc_T1", "type": "Person", "text": [ "age" ], "offsets": [ [ 23, 26 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T2", "type": "Value", "text": [ "= 70 years" ], "offsets": [ [ 9, 19 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T3", "type": "Procedure", "text": [ "noncardiac surgical procedure" ], "offsets": [ [ 41, 70 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T4", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 77, 95 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T5", "type": "Mood", "text": [ "anticipated" ], "offsets": [ [ 105, 116 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T6", "type": "Measurement", "text": [ "duration of postoperative admission" ], "offsets": [ [ 117, 152 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T7", "type": "Value", "text": [ "at least 2 days" ], "offsets": [ [ 156, 171 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T8", "type": "Procedure", "text": [ "admission" ], "offsets": [ [ 143, 152 ] ], "normalized": [] }, { "id": "NCT02109081_inc_T9", "type": "Temporal", "text": [ "postoperative" ], "offsets": [ [ 129, 142 ] ], "normalized": [] } ]

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[ { "id": "NCT02109081_inc_R1", "type": "Has_value", "arg1_id": "NCT02109081_inc_T1", "arg2_id": "NCT02109081_inc_T2", "normalized": [] }, { "id": "NCT02109081_inc_R2", "type": "AND", "arg1_id": "NCT02109081_inc_T3", "arg2_id": "NCT02109081_inc_T4", "normalized": [] }, { "id": "NCT02109081_inc_R3", "type": "Has_value", "arg1_id": "NCT02109081_inc_T6", "arg2_id": "NCT02109081_inc_T7", "normalized": [] }, { "id": "NCT02109081_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02109081_inc_T8", "arg2_id": "NCT02109081_inc_T9", "normalized": [] }, { "id": "NCT02109081_inc_R6", "type": "Has_mood", "arg1_id": "NCT02109081_inc_T6", "arg2_id": "NCT02109081_inc_T5", "normalized": [] } ]

[ { "id": "NCT02112734_exc_text", "type": "exclusion", "text": [ "Infants who have already received postnatal vitamin D supplementation\nprematurity (<37 weeks)/low birthweight <2500 g\npoor health due to a current or past significant disease state or congenital abnormality.\n" ], "offsets": [ [ 0, 208 ] ] } ]

[ { "id": "NCT02112734_exc_T1", "type": "Person", "text": [ "Infants" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T2", "type": "Procedure", "text": [ "postnatal vitamin D supplementation" ], "offsets": [ [ 34, 69 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T3", "type": "Drug", "text": [ "vitamin D" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T4", "type": "Condition", "text": [ "prematurity" ], "offsets": [ [ 70, 81 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T5", "type": "Condition", "text": [ "low birthweight" ], "offsets": [ [ 94, 109 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T6", "type": "Measurement", "text": [ "birthweight" ], "offsets": [ [ 98, 109 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T7", "type": "Value", "text": [ "<2500 g" ], "offsets": [ [ 110, 117 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T8", "type": "Condition", "text": [ "poor health" ], "offsets": [ [ 118, 129 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T9", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 139, 146 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T10", "type": "Temporal", "text": [ "past" ], "offsets": [ [ 150, 154 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T11", "type": "Condition", "text": [ "significant disease state" ], "offsets": [ [ 155, 180 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T12", "type": "Condition", "text": [ "congenital abnormality" ], "offsets": [ [ 184, 206 ] ], "normalized": [] }, { "id": "NCT02112734_exc_T13", "type": "Scope", "text": [ "current or past" ], "offsets": [ [ 139, 154 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02112734_exc_R2", "type": "Has_value", "arg1_id": "NCT02112734_exc_T6", "arg2_id": "NCT02112734_exc_T7", "normalized": [] }, { "id": "NCT02112734_exc_R4", "type": "Has_scope", "arg1_id": "NCT02112734_exc_T11", "arg2_id": "NCT02112734_exc_T13", "normalized": [] } ]

[ { "id": "NCT02112734_inc_text", "type": "inclusion", "text": [ "Healthy, term, breastfeeding infants who will be predominately breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend to breastfeed until your infant is at least 6 months of age.'\n" ], "offsets": [ [ 0, 229 ] ] } ]

[ { "id": "NCT02112734_inc_T1", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02112734_inc_T2", "type": "Condition", "text": [ "term" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT02112734_inc_T3", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 15, 28 ] ], "normalized": [] }, { "id": "NCT02112734_inc_T4", "type": "Person", "text": [ "infants" ], "offsets": [ [ 29, 36 ] ], "normalized": [] }, { "id": "NCT02112734_inc_T5", "type": "Observation", "text": [ "predominately breastfed" ], "offsets": [ [ 49, 72 ] ], "normalized": [] }, { "id": "NCT02112734_inc_T6", "type": "Multiplier", "text": [ "for at least 6-months" ], "offsets": [ [ 73, 94 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02112734_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT02112734_inc_T5", "arg2_id": "NCT02112734_inc_T6", "normalized": [] } ]

[ { "id": "NCT02117986_exc_text", "type": "exclusion", "text": [ "pregnant or breastfeeding patients\npatient with a history of hypersensitivity to colistin\n" ], "offsets": [ [ 0, 90 ] ] } ]

[ { "id": "NCT02117986_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02117986_exc_T2", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 12, 25 ] ], "normalized": [] }, { "id": "NCT02117986_exc_T3", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 50, 60 ] ], "normalized": [] }, { "id": "NCT02117986_exc_T4", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 61, 77 ] ], "normalized": [] }, { "id": "NCT02117986_exc_T5", "type": "Drug", "text": [ "colistin" ], "offsets": [ [ 81, 89 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02117986_exc_R1", "type": "AND", "arg1_id": "NCT02117986_exc_T4", "arg2_id": "NCT02117986_exc_T5", "normalized": [] }, { "id": "NCT02117986_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02117986_exc_T4", "arg2_id": "NCT02117986_exc_T3", "normalized": [] } ]

[ { "id": "NCT02117986_inc_text", "type": "inclusion", "text": [ "patient hospitalized in critical care units\npatient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin\nsource of infection: blood, respiratory, intra abdominal or urinary\n" ], "offsets": [ [ 0, 205 ] ] } ]

[ { "id": "NCT02117986_inc_T1", "type": "Procedure", "text": [ "hospitalized" ], "offsets": [ [ 8, 20 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T2", "type": "Visit", "text": [ "critical care units" ], "offsets": [ [ 24, 43 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T3", "type": "Qualifier", "text": [ "multi drug resistant" ], "offsets": [ [ 64, 84 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T4", "type": "Condition", "text": [ "Gram negative bacteria" ], "offsets": [ [ 85, 107 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T5", "type": "Observation", "text": [ "susceptibly" ], "offsets": [ [ 108, 119 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T6", "type": "Multiplier", "text": [ "only" ], "offsets": [ [ 120, 124 ] ], "normalized": [] }, { "id": "NCT02117986_inc_T7", "type": "Drug", "text": [ "colistin" ], "offsets": [ [ 128, 136 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02117986_inc_R1", "type": "AND", "arg1_id": "NCT02117986_inc_T1", "arg2_id": "NCT02117986_inc_T2", "normalized": [] }, { "id": "NCT02117986_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT02117986_inc_T7", "arg2_id": "NCT02117986_inc_T6", "normalized": [] }, { "id": "NCT02117986_inc_R3", "type": "AND", "arg1_id": "NCT02117986_inc_T5", "arg2_id": "NCT02117986_inc_T7", "normalized": [] }, { "id": "NCT02117986_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02117986_inc_T4", "arg2_id": "NCT02117986_inc_T3", "normalized": [] } ]

[ { "id": "NCT02118467_exc_text", "type": "exclusion", "text": [ "Cardiopulmonary arrest\nPregnancy\nSevere right heart failure\n" ], "offsets": [ [ 0, 60 ] ] } ]

[ { "id": "NCT02118467_exc_T1", "type": "Condition", "text": [ "Cardiopulmonary arrest" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT02118467_exc_T2", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 23, 32 ] ], "normalized": [] }, { "id": "NCT02118467_exc_T3", "type": "Condition", "text": [ "right heart failure" ], "offsets": [ [ 40, 59 ] ], "normalized": [] }, { "id": "NCT02118467_exc_T4", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 33, 39 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02118467_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02118467_exc_T3", "arg2_id": "NCT02118467_exc_T4", "normalized": [] } ]

[ { "id": "NCT02118467_inc_text", "type": "inclusion", "text": [ "Age greater than or equal to 18 years old\nRequirement for vasoactive drugs via a central venous catheter for the treatment of shock. Shock will be defined as mean arterial pressure less than 70 mmHg or systolic blood pressure less than 100 mmHg despite administration of at least 1000 mL of crystalloid or 500 mL of colloid, unless there is an elevation in the central venous pressure to > 12 mmHg or in the pulmonary artery occlusion pressure to > 14 mmHg coupled with signs of tissue hypoperfusion (e.g. altered mental state, mottled skin, urine output < 0.5 mL/kg body weight for one hour, or a serum lactate level of > 2 mmol per liter).\n" ], "offsets": [ [ 0, 642 ] ] } ]

[ { "id": "NCT02118467_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T2", "type": "Value", "text": [ "greater than or equal to 18 years old" ], "offsets": [ [ 4, 41 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T3", "type": "Drug", "text": [ "vasoactive drugs" ], "offsets": [ [ 58, 74 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T4", "type": "Device", "text": [ "central venous catheter" ], "offsets": [ [ 81, 104 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T5", "type": "Condition", "text": [ "shock" ], "offsets": [ [ 126, 131 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T6", "type": "Measurement", "text": [ "mean arterial pressure" ], "offsets": [ [ 158, 180 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T7", "type": "Value", "text": [ "less than 70 mmHg" ], "offsets": [ [ 181, 198 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T8", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 202, 225 ] ], "normalized": [] }, { "id": "NCT02118467_inc_T9", "type": "Value", "text": [ "less than 100 mmHg" ], "offsets": [ [ 226, 244 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02118467_inc_R1", "type": "Has_value", "arg1_id": "NCT02118467_inc_T1", "arg2_id": "NCT02118467_inc_T2", "normalized": [] }, { "id": "NCT02118467_inc_R2", "type": "AND", "arg1_id": "NCT02118467_inc_T3", "arg2_id": "NCT02118467_inc_T5", "normalized": [] }, { "id": "NCT02118467_inc_R3", "type": "AND", "arg1_id": "NCT02118467_inc_T3", "arg2_id": "NCT02118467_inc_T4", "normalized": [] } ]

[ { "id": "NCT02121145_exc_text", "type": "exclusion", "text": [ "Primary groups: Vaccination against typhoid fever within 5 years before dosing.\nHistory of clinical typhoid fever, clinical paratyphoid A or B fever.\nImmunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study\nCurrent intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration\nChronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational vaccine; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed\nAcute or chronic clinically significant gastrointestinal disease\n" ], "offsets": [ [ 0, 741 ] ] } ]

[ { "id": "NCT02121145_exc_T1", "type": "Observation", "text": [ "Primary groups" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T2", "type": "Procedure", "text": [ "Vaccination against typhoid fever" ], "offsets": [ [ 16, 49 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T3", "type": "Condition", "text": [ "typhoid fever" ], "offsets": [ [ 36, 49 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T4", "type": "Temporal", "text": [ "within 5 years before dosing" ], "offsets": [ [ 50, 78 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T5", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 72, 78 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T6", "type": "Observation", "text": [ "History" ], "offsets": [ [ 80, 87 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T7", "type": "Condition", "text": [ "clinical typhoid fever" ], "offsets": [ [ 91, 113 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T8", "type": "Condition", "text": [ "linical paratyphoid A", "ever." ], "offsets": [ [ 116, 137 ], [ 144, 149 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T9", "type": "Condition", "text": [ "linical paratyphoid", " fever" ], "offsets": [ [ 116, 135 ], [ 142, 148 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T10", "type": "Scope", "text": [ "clinical typhoid fever, clinical paratyphoid A or B fever" ], "offsets": [ [ 91, 148 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T12", "type": "Procedure", "text": [ "munization with a", "ccine (" ], "offsets": [ [ 152, 169 ], [ 180, 187 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T13", "type": "Qualifier", "text": [ "any other" ], "offsets": [ [ 168, 177 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T11", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 187, 191 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T14", "type": "Qualifier", "text": [ "parenteral" ], "offsets": [ [ 195, 205 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T15", "type": "Scope", "text": [ "oral or parenteral" ], "offsets": [ [ 187, 205 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T16", "type": "Temporal", "text": [ "within 4 weeks prior to study start" ], "offsets": [ [ 207, 242 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T17", "type": "Reference_point", "text": [ "study start" ], "offsets": [ [ 231, 242 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T18", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 246, 253 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T19", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 254, 265 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T20", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 266, 282 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T21", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 273, 282 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T22", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 301, 312 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T23", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 283, 290 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T24", "type": "Multiplier", "text": [ "end of" ], "offsets": [ [ 316, 322 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T25", "type": "Procedure", "text": [ "antibiotic therapy" ], "offsets": [ [ 323, 341 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T26", "type": "Temporal", "text": [ "<8 days before first IMP administration" ], "offsets": [ [ 342, 381 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T27", "type": "Reference_point", "text": [ "first IMP administration" ], "offsets": [ [ 357, 381 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T28", "type": "Multiplier", "text": [ "nic (lo", "nistration of" ], "offsets": [ [ 386, 393 ], [ 416, 429 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T29", "type": "Multiplier", "text": [ "longer than 14 days" ], "offsets": [ [ 391, 410 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T30", "type": "Drug", "text": [ "immunosuppressants" ], "offsets": [ [ 430, 448 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T31", "type": "Drug", "text": [ "immune-modifying drugs" ], "offsets": [ [ 458, 480 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T32", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 452, 457 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T33", "type": "Scope", "text": [ "immunosuppressants or other immune-modifying drugs" ], "offsets": [ [ 430, 480 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T34", "type": "Temporal", "text": [ "within 6 months before the first dose of investigational vaccine" ], "offsets": [ [ 481, 545 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T35", "type": "Reference_point", "text": [ "the first dose of investigational vaccine" ], "offsets": [ [ 504, 545 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T36", "type": "Drug", "text": [ "investigational vaccine" ], "offsets": [ [ 522, 545 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T37", "type": "Drug", "text": [ "oral corticosteroids" ], "offsets": [ [ 547, 567 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T38", "type": "Multiplier", "text": [ "dosages" ], "offsets": [ [ 571, 578 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T39", "type": "Value", "text": [ "=0.5 mg/kg/d" ], "offsets": [ [ 582, 594 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T40", "type": "Negation", "text": [ "excluded" ], "offsets": [ [ 626, 634 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T41", "type": "Qualifier", "text": [ "prednisolone or equivalent" ], "offsets": [ [ 595, 621 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T43", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 693, 715 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T44", "type": "Condition", "text": [ "gastrointestinal disease" ], "offsets": [ [ 716, 740 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T45", "type": "Qualifier", "text": [ "Acute" ], "offsets": [ [ 676, 681 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T46", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 685, 692 ] ], "normalized": [] }, { "id": "NCT02121145_exc_T47", "type": "Scope", "text": [ "Acute or chronic" ], "offsets": [ [ 676, 692 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02121145_exc_R2", "type": "Has_index", "arg1_id": "NCT02121145_exc_T4", "arg2_id": "NCT02121145_exc_T5", "normalized": [] }, { "id": "NCT02121145_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T2", "arg2_id": "NCT02121145_exc_T4", "normalized": [] }, { "id": "NCT02121145_exc_R4", "type": "AND", "arg1_id": "NCT02121145_exc_T1", "arg2_id": "NCT02121145_exc_T2", "normalized": [] }, { "id": "NCT02121145_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T10", "arg2_id": "NCT02121145_exc_T6", "normalized": [] }, { "id": "NCT02121145_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT02121145_exc_T12", "arg2_id": "NCT02121145_exc_T13", "normalized": [] }, { "id": "NCT02121145_exc_R7", "type": "Has_scope", "arg1_id": "NCT02121145_exc_T12", "arg2_id": "NCT02121145_exc_T15", "normalized": [] }, { "id": "NCT02121145_exc_R8", "type": "Has_index", "arg1_id": "NCT02121145_exc_T16", "arg2_id": "NCT02121145_exc_T17", "normalized": [] }, { "id": "NCT02121145_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T12", "arg2_id": "NCT02121145_exc_T16", "normalized": [] }, { "id": "NCT02121145_exc_R10", "type": "Has_mood", "arg1_id": "NCT02121145_exc_T19", "arg2_id": "NCT02121145_exc_T18", "normalized": [] }, { "id": "NCT02121145_exc_R11", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T19", "arg2_id": "NCT02121145_exc_T20", "normalized": [] }, { "id": "NCT02121145_exc_R12", "type": "Has_index", "arg1_id": "NCT02121145_exc_T20", "arg2_id": "NCT02121145_exc_T21", "normalized": [] }, { "id": "NCT02121145_exc_R13", "type": "Has_index", "arg1_id": "NCT02121145_exc_T26", "arg2_id": "NCT02121145_exc_T27", "normalized": [] }, { "id": "NCT02121145_exc_R14", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T25", "arg2_id": "NCT02121145_exc_T26", "normalized": [] }, { "id": "NCT02121145_exc_R15", "type": "Has_multiplier", "arg1_id": "NCT02121145_exc_T25", "arg2_id": "NCT02121145_exc_T24", "normalized": [] }, { "id": "NCT02121145_exc_R16", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T22", "arg2_id": "NCT02121145_exc_T23", "normalized": [] }, { "id": "NCT02121145_exc_R17", "type": "Subsumes", "arg1_id": "NCT02121145_exc_T28", "arg2_id": "NCT02121145_exc_T29", "normalized": [] }, { "id": "NCT02121145_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT02121145_exc_T31", "arg2_id": "NCT02121145_exc_T32", "normalized": [] }, { "id": "NCT02121145_exc_R19", "type": "Has_multiplier", "arg1_id": "NCT02121145_exc_T33", "arg2_id": "NCT02121145_exc_T28", "normalized": [] }, { "id": "NCT02121145_exc_R21", "type": "Has_index", "arg1_id": "NCT02121145_exc_T34", "arg2_id": "NCT02121145_exc_T35", "normalized": [] }, { "id": "NCT02121145_exc_R22", "type": "Has_value", "arg1_id": "NCT02121145_exc_T38", "arg2_id": "NCT02121145_exc_T39", "normalized": [] }, { "id": "NCT02121145_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT02121145_exc_T39", "arg2_id": "NCT02121145_exc_T41", "normalized": [] }, { "id": "NCT02121145_exc_R24", "type": "Has_multiplier", "arg1_id": "NCT02121145_exc_T37", "arg2_id": "NCT02121145_exc_T38", "normalized": [] }, { "id": "NCT02121145_exc_R25", "type": "Has_negation", "arg1_id": "NCT02121145_exc_T37", "arg2_id": "NCT02121145_exc_T40", "normalized": [] }, { "id": "NCT02121145_exc_R26", "type": "Has_temporal", "arg1_id": "NCT02121145_exc_T33", "arg2_id": "NCT02121145_exc_T34", "normalized": [] }, { "id": "NCT02121145_exc_R27", "type": "AND", "arg1_id": "NCT02121145_exc_T33", "arg2_id": "NCT02121145_exc_T37", "normalized": [] }, { "id": "NCT02121145_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT02121145_exc_T44", "arg2_id": "NCT02121145_exc_T43", "normalized": [] }, { "id": "NCT02121145_exc_R29", "type": "Has_scope", "arg1_id": "NCT02121145_exc_T44", "arg2_id": "NCT02121145_exc_T47", "normalized": [] } ]

[ { "id": "NCT02121145_inc_text", "type": "inclusion", "text": [ "Male or female subjects aged =18 to =65 years\nGeneral good health as established by medical history and physical examination\nWritten informed consent\nFemales of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.\nAvailable for all visits scheduled in this study.\n" ], "offsets": [ [ 0, 355 ] ] } ]

[ { "id": "NCT02121145_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 24, 28 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T4", "type": "Value", "text": [ "=18 to =65 years" ], "offsets": [ [ 29, 45 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T5", "type": "Condition", "text": [ "General good health" ], "offsets": [ [ 46, 65 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T6", "type": "Qualifier", "text": [ "established by medical history" ], "offsets": [ [ 69, 99 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T7", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 104, 124 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T8", "type": "Observation", "text": [ "Written informed consent" ], "offsets": [ [ 125, 149 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T9", "type": "Person", "text": [ "Females" ], "offsets": [ [ 150, 157 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T10", "type": "Observation", "text": [ "childbearing potential" ], "offsets": [ [ 161, 183 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T11", "type": "Mood", "text": [ "agree to use" ], "offsets": [ [ 189, 201 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T12", "type": "Qualifier", "text": [ "efficacious" ], "offsets": [ [ 205, 216 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T13", "type": "Qualifier", "text": [ "monal or", "hod of" ], "offsets": [ [ 220, 228 ], [ 240, 246 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T14", "type": "Qualifier", "text": [ "barrier method" ], "offsets": [ [ 229, 243 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T15", "type": "Procedure", "text": [ "birth control" ], "offsets": [ [ 247, 260 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T16", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 261, 277 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T17", "type": "Scope", "text": [ "hormonal or barrier method" ], "offsets": [ [ 217, 243 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T18", "type": "Observation", "text": [ "Abstinence" ], "offsets": [ [ 279, 289 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T19", "type": "Scope", "text": [ "Females of childbearing potential" ], "offsets": [ [ 150, 183 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T20", "type": "Scope", "text": [ "agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence" ], "offsets": [ [ 189, 289 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T21", "type": "Observation", "text": [ "Available for all visits" ], "offsets": [ [ 305, 329 ] ], "normalized": [] }, { "id": "NCT02121145_inc_T22", "type": "Qualifier", "text": [ "scheduled in this study" ], "offsets": [ [ 330, 353 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02121145_inc_R1", "type": "Has_value", "arg1_id": "NCT02121145_inc_T3", "arg2_id": "NCT02121145_inc_T4", "normalized": [] }, { "id": "NCT02121145_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02121145_inc_T5", "arg2_id": "NCT02121145_inc_T6", "normalized": [] }, { "id": "NCT02121145_inc_R3", "type": "AND", "arg1_id": "NCT02121145_inc_T5", "arg2_id": "NCT02121145_inc_T7", "normalized": [] }, { "id": "NCT02121145_inc_R4", "type": "Has_scope", "arg1_id": "NCT02121145_inc_T15", "arg2_id": "NCT02121145_inc_T17", "normalized": [] }, { "id": "NCT02121145_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02121145_inc_T15", "arg2_id": "NCT02121145_inc_T12", "normalized": [] }, { "id": "NCT02121145_inc_R6", "type": "Has_temporal", "arg1_id": "NCT02121145_inc_T15", "arg2_id": "NCT02121145_inc_T16", "normalized": [] }, { "id": "NCT02121145_inc_R7", "type": "Has_mood", "arg1_id": "NCT02121145_inc_T15", "arg2_id": "NCT02121145_inc_T11", "normalized": [] }, { "id": "NCT02121145_inc_R8", "type": "Has_scope", "arg1_id": "NCT02121145_inc_T19", "arg2_id": "NCT02121145_inc_T20", "normalized": [] }, { "id": "NCT02121145_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT02121145_inc_T21", "arg2_id": "NCT02121145_inc_T22", "normalized": [] } ]

[ { "id": "NCT02137369_exc_text", "type": "exclusion", "text": [ "Lifetime history of Bipolar Disorder, Dementia, Autism Spectrum Disorder, Schizophrenia, or any other Psychotic Disorder.\nPsychotic symptoms occurring at any time during the current major depressive episode.\nCurrent (past 12 months) diagnosis of Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa.\nAlcohol or Drug Dependence within 12 months or Abuse within 3 months (excluding nicotine and caffeine) of baseline visit, as assessed by history and urine drug screen.\nClinical evidence of a severe Personality Disorder, as assessed by the study psychiatrist, which would impede participation or completion of the trial.\nKnown neurological disorders or documented serious head injury.\nSerious and unstable medical illnesses including cardiovascular disease and cancer.\nActive medical conditions with known mood changes (endocrine, autoimmune disorders).\nCurrent diabetes mellitus.\nFor women, pregnancy, lactation, or unwillingness to comply with birth control requirements.\nUse of any of the following treatments or any other alternative therapy within 2 weeks of the pre-treatment PET scan that may have beneficial effects on mood, including St John's Wort, S-adenosyl methionine (SAMe), n-3 fatty acids, or light therapy.\nUse of antidepressant medication within 1 month of the pre-treatment PET scan (within 5 weeks for fluoxetine and protryptyline).\nFailure to achieve a much improved status (i.e. equivalent to >50% symptom reduction) with any lifetime treatment course of CBT (defined as a minimum of 4 sessions of a specified manual-driven therapy by a CBT-trained therapist) or escitalopram (defined as a minimum of 6 weeks of at least 10 mg/day).\nClinically significant active suicidal ideation or self-injurious behavior necessitating immediate treatment, as determined by the investigator.\nReceived electroconvulsive therapy in the past 6 months or during the current depressive episode.\nCurrently responding to medication treatment, without clinical reasons to change.\nCurrent treatment with weekly individual or group psychotherapy of any type targeted at depressive symptoms.\nQTc >500 milliseconds on EKG at screening.\nContraindications for MRI, including, but not limited to pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, intra-uterine devices for birth control.\nMaintenance or prophylactic therapy for stable medical conditions.\nHypnotic medication prescribed or approved by the study physician, (up to a three doses per week) for insomnia, as long if not the night before a PET/MRI or clinic ratings visit. Antipsychotic medications, whether prescribed for sleep or other indications, are prohibited.\n" ], "offsets": [ [ 0, 2724 ] ] } ]

[ { "id": "NCT02137369_exc_T1", "type": "Condition", "text": [ "Bipolar Disorder" ], "offsets": [ [ 20, 36 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T2", "type": "Condition", "text": [ "Dementia" ], "offsets": [ [ 38, 46 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T3", "type": "Condition", "text": [ "Autism Spectrum Disorder" ], "offsets": [ [ 48, 72 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T4", "type": "Condition", "text": [ "Schizophrenia" ], "offsets": [ [ 74, 87 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T5", "type": "Condition", "text": [ "Psychotic Disorder" ], "offsets": [ [ 102, 120 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T6", "type": "Condition", "text": [ "Psychotic symptoms" ], "offsets": [ [ 122, 140 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T7", "type": "Condition", "text": [ "major depressive episode" ], "offsets": [ [ 182, 206 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T8", "type": "Condition", "text": [ "Panic disorder" ], "offsets": [ [ 246, 260 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T9", "type": "Condition", "text": [ "Obsessive Compulsive Disorder" ], "offsets": [ [ 262, 291 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T10", "type": "Condition", "text": [ "Posttraumatic Stress Disorder" ], "offsets": [ [ 293, 322 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T11", "type": "Condition", "text": [ "Anorexia Nervosa" ], "offsets": [ [ 324, 340 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T12", "type": "Condition", "text": [ "Bulimia Nervosa" ], "offsets": [ [ 345, 360 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T13", "type": "Condition", "text": [ "Drug Dependence" ], "offsets": [ [ 373, 388 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T14", "type": "Condition", "text": [ "ohol or", "endence wi" ], "offsets": [ [ 365, 372 ], [ 381, 391 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T15", "type": "Temporal", "text": [ "past 12 months" ], "offsets": [ [ 217, 231 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T16", "type": "Scope", "text": [ "Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa" ], "offsets": [ [ 246, 360 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T17", "type": "Temporal", "text": [ "within 12 months" ], "offsets": [ [ 389, 405 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T18", "type": "Condition", "text": [ "ohol or", "se wi" ], "offsets": [ [ 365, 372 ], [ 412, 417 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T19", "type": "Condition", "text": [ "g De", "se wi" ], "offsets": [ [ 376, 380 ], [ 412, 417 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T20", "type": "Temporal", "text": [ "within 3 months" ], "offsets": [ [ 415, 430 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T21", "type": "Drug", "text": [ "nicotine" ], "offsets": [ [ 442, 450 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T22", "type": "Drug", "text": [ "caffeine" ], "offsets": [ [ 455, 463 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T23", "type": "Measurement", "text": [ "urine drug screen" ], "offsets": [ [ 511, 528 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T24", "type": "Scope", "text": [ "nicotine and caffeine" ], "offsets": [ [ 442, 463 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T25", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 553, 559 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T26", "type": "Condition", "text": [ "Personality Disorder" ], "offsets": [ [ 560, 580 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T27", "type": "Condition", "text": [ "head injury" ], "offsets": [ [ 733, 744 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T28", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 725, 732 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T29", "type": "Condition", "text": [ "neurological disorders" ], "offsets": [ [ 688, 710 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T30", "type": "Condition", "text": [ "medical illnesses" ], "offsets": [ [ 767, 784 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T31", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 746, 753 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T32", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 758, 766 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T33", "type": "Scope", "text": [ "Serious and unstable" ], "offsets": [ [ 746, 766 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T34", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 795, 817 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T35", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 822, 828 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T36", "type": "Scope", "text": [ "cardiovascular disease and cancer" ], "offsets": [ [ 795, 828 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T38", "type": "Condition", "text": [ "ne, autoi", "rs).\nCurr" ], "offsets": [ [ 888, 897 ], [ 910, 919 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T39", "type": "Condition", "text": [ "autoimmune disorders" ], "offsets": [ [ 892, 912 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T40", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 923, 940 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T42", "type": "Procedure", "text": [ "treatments" ], "offsets": [ [ 1063, 1073 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T43", "type": "Procedure", "text": [ "alternative therapy" ], "offsets": [ [ 1087, 1106 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T44", "type": "Temporal", "text": [ "within 2 weeks of the pre-treatment PET scan" ], "offsets": [ [ 1107, 1151 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T45", "type": "Reference_point", "text": [ "pre-treatment PET scan" ], "offsets": [ [ 1129, 1151 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T46", "type": "Scope", "text": [ "treatments or any other alternative therapy" ], "offsets": [ [ 1063, 1106 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T47", "type": "Condition", "text": [ "mood" ], "offsets": [ [ 1188, 1192 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T48", "type": "Drug", "text": [ "St John's Wort" ], "offsets": [ [ 1204, 1218 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T49", "type": "Drug", "text": [ "S-adenosyl methionine" ], "offsets": [ [ 1220, 1241 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T50", "type": "Drug", "text": [ "SAMe" ], "offsets": [ [ 1243, 1247 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T51", "type": "Drug", "text": [ "n-3 fatty acids" ], "offsets": [ [ 1250, 1265 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T52", "type": "Procedure", "text": [ "light therapy" ], "offsets": [ [ 1270, 1283 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T53", "type": "Scope", "text": [ "St John's Wort, S-adenosyl methionine (SAMe), n-3 fatty acids, or light therapy" ], "offsets": [ [ 1204, 1283 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T54", "type": "Drug", "text": [ "antidepressant medication" ], "offsets": [ [ 1292, 1317 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T55", "type": "Temporal", "text": [ "within 1 month of the pre-treatment PET scan" ], "offsets": [ [ 1318, 1362 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T56", "type": "Reference_point", "text": [ "pre-treatment PET scan" ], "offsets": [ [ 1340, 1362 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T57", "type": "Temporal", "text": [ "within 5 weeks for fluoxetine and protryptyline" ], "offsets": [ [ 1364, 1411 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T58", "type": "Reference_point", "text": [ "fluoxetine and protryptyline" ], "offsets": [ [ 1383, 1411 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T60", "type": "Condition", "text": [ "suicidal ideation" ], "offsets": [ [ 1746, 1763 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T61", "type": "Condition", "text": [ "self-injurious behavior" ], "offsets": [ [ 1767, 1790 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T62", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1815, 1824 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T63", "type": "Qualifier", "text": [ "immediate" ], "offsets": [ [ 1805, 1814 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T64", "type": "Scope", "text": [ "active suicidal ideation or self-injurious behavior" ], "offsets": [ [ 1739, 1790 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T66", "type": "Procedure", "text": [ "psychotherapy" ], "offsets": [ [ 2091, 2104 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T67", "type": "Qualifier", "text": [ "group" ], "offsets": [ [ 2085, 2090 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T68", "type": "Qualifier", "text": [ "individual" ], "offsets": [ [ 2071, 2081 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T69", "type": "Scope", "text": [ "individual or group" ], "offsets": [ [ 2071, 2090 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T70", "type": "Multiplier", "text": [ "weekly" ], "offsets": [ [ 2064, 2070 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T71", "type": "Condition", "text": [ "depressive symptoms" ], "offsets": [ [ 2129, 2148 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T72", "type": "Measurement", "text": [ "QTc" ], "offsets": [ [ 2150, 2153 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T73", "type": "Value", "text": [ ">500 milliseconds" ], "offsets": [ [ 2154, 2171 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T74", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 2179, 2191 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T75", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 2182, 2191 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T76", "type": "Procedure", "text": [ "EKG" ], "offsets": [ [ 2175, 2178 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T77", "type": "Condition", "text": [ "Contraindications" ], "offsets": [ [ 2193, 2210 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T78", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 2215, 2218 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T79", "type": "Negation", "text": [ "not" ], "offsets": [ [ 2235, 2238 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T80", "type": "Device", "text": [ "pacemaker" ], "offsets": [ [ 2250, 2259 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T81", "type": "Device", "text": [ "aneurysm clips" ], "offsets": [ [ 2261, 2275 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T82", "type": "Device", "text": [ "neurostimulators" ], "offsets": [ [ 2277, 2293 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T83", "type": "Device", "text": [ "cochlear implants" ], "offsets": [ [ 2295, 2312 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T84", "type": "Device", "text": [ "metal" ], "offsets": [ [ 2314, 2319 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T85", "type": "Qualifier", "text": [ "eyes" ], "offsets": [ [ 2323, 2327 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T86", "type": "Device", "text": [ "steel worker" ], "offsets": [ [ 2329, 2341 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T87", "type": "Device", "text": [ "intra-uterine devices" ], "offsets": [ [ 2343, 2364 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T88", "type": "Scope", "text": [ "pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, intra-uterine devices" ], "offsets": [ [ 2250, 2364 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T90", "type": "Drug", "text": [ "Hypnotic medication" ], "offsets": [ [ 2451, 2470 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T91", "type": "Condition", "text": [ "insomnia" ], "offsets": [ [ 2553, 2561 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T92", "type": "Temporal", "text": [ "the night before a PET/MRI or clinic ratings visit." ], "offsets": [ [ 2578, 2629 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T93", "type": "Reference_point", "text": [ "PET/MRI" ], "offsets": [ [ 2597, 2604 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T94", "type": "Reference_point", "text": [ "clinic ratings visit." ], "offsets": [ [ 2608, 2629 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T95", "type": "Scope", "text": [ "PET/MRI or clinic ratings visit." ], "offsets": [ [ 2597, 2629 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T96", "type": "Negation", "text": [ "not" ], "offsets": [ [ 2574, 2577 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T97", "type": "Drug", "text": [ "Antipsychotic medications" ], "offsets": [ [ 2630, 2655 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T98", "type": "Temporal", "text": [ "at any time during the current major depressive episode" ], "offsets": [ [ 151, 206 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T99", "type": "Reference_point", "text": [ "the current major depressive episode" ], "offsets": [ [ 170, 206 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T100", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 174, 181 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T101", "type": "Procedure", "text": [ "electroconvulsive therapy" ], "offsets": [ [ 1870, 1895 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T102", "type": "Temporal", "text": [ "in the past 6 months" ], "offsets": [ [ 1896, 1916 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T103", "type": "Temporal", "text": [ "during the current depressive episode" ], "offsets": [ [ 1920, 1957 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T104", "type": "Reference_point", "text": [ "the current depressive episode" ], "offsets": [ [ 1927, 1957 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T105", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1931, 1938 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T106", "type": "Condition", "text": [ "depressive episode" ], "offsets": [ [ 1939, 1957 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T107", "type": "Procedure", "text": [ "PET scan" ], "offsets": [ [ 1354, 1362 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T108", "type": "Drug", "text": [ "fluoxetine" ], "offsets": [ [ 1383, 1393 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T109", "type": "Drug", "text": [ "protryptyline" ], "offsets": [ [ 1398, 1411 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T110", "type": "Temporal", "text": [ "pre-treatment" ], "offsets": [ [ 1340, 1353 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T111", "type": "Scope", "text": [ "in the past 6 months or during the current depressive episode" ], "offsets": [ [ 1896, 1957 ] ], "normalized": [] }, { "id": "NCT02137369_exc_T112", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 1739, 1745 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02137369_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T16", "arg2_id": "NCT02137369_exc_T15", "normalized": [] }, { "id": "NCT02137369_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T13", "arg2_id": "NCT02137369_exc_T17", "normalized": [] }, { "id": "NCT02137369_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T14", "arg2_id": "NCT02137369_exc_T17", "normalized": [] }, { "id": "NCT02137369_exc_R5", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T19", "arg2_id": "NCT02137369_exc_T20", "normalized": [] }, { "id": "NCT02137369_exc_R6", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T18", "arg2_id": "NCT02137369_exc_T20", "normalized": [] }, { "id": "NCT02137369_exc_R7", "type": "Subsumes", "arg1_id": "NCT02137369_exc_T19", "arg2_id": "NCT02137369_exc_T24", "normalized": [] }, { "id": "NCT02137369_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT02137369_exc_T26", "arg2_id": "NCT02137369_exc_T25", "normalized": [] }, { "id": "NCT02137369_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02137369_exc_T27", "arg2_id": "NCT02137369_exc_T28", "normalized": [] }, { "id": "NCT02137369_exc_R10", "type": "Has_scope", "arg1_id": "NCT02137369_exc_T30", "arg2_id": "NCT02137369_exc_T33", "normalized": [] }, { "id": "NCT02137369_exc_R11", "type": "Has_scope", "arg1_id": "NCT02137369_exc_T30", "arg2_id": "NCT02137369_exc_T36", "normalized": [] }, { "id": "NCT02137369_exc_R12", "type": "Has_index", "arg1_id": "NCT02137369_exc_T44", "arg2_id": "NCT02137369_exc_T45", "normalized": [] }, { "id": "NCT02137369_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T46", "arg2_id": "NCT02137369_exc_T44", "normalized": [] }, { "id": "NCT02137369_exc_R14", "type": "AND", "arg1_id": "NCT02137369_exc_T46", "arg2_id": "NCT02137369_exc_T47", "normalized": [] }, { "id": "NCT02137369_exc_R15", "type": "Subsumes", "arg1_id": "NCT02137369_exc_T49", "arg2_id": "NCT02137369_exc_T50", "normalized": [] }, { "id": "NCT02137369_exc_R16", "type": "Subsumes", "arg1_id": "NCT02137369_exc_T46", "arg2_id": "NCT02137369_exc_T53", "normalized": [] }, { "id": "NCT02137369_exc_R17", "type": "Has_index", "arg1_id": "NCT02137369_exc_T55", "arg2_id": "NCT02137369_exc_T56", "normalized": [] }, { "id": "NCT02137369_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T54", "arg2_id": "NCT02137369_exc_T55", "normalized": [] }, { "id": "NCT02137369_exc_R19", "type": "Has_index", "arg1_id": "NCT02137369_exc_T57", "arg2_id": "NCT02137369_exc_T58", "normalized": [] }, { "id": "NCT02137369_exc_R20", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T54", "arg2_id": "NCT02137369_exc_T57", "normalized": [] }, { "id": "NCT02137369_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT02137369_exc_T62", "arg2_id": "NCT02137369_exc_T63", "normalized": [] }, { "id": "NCT02137369_exc_R22", "type": "AND", "arg1_id": "NCT02137369_exc_T64", "arg2_id": "NCT02137369_exc_T62", "normalized": [] }, { "id": "NCT02137369_exc_R23", "type": "Has_scope", "arg1_id": "NCT02137369_exc_T66", "arg2_id": "NCT02137369_exc_T69", "normalized": [] }, { "id": "NCT02137369_exc_R24", "type": "Has_multiplier", "arg1_id": "NCT02137369_exc_T66", "arg2_id": "NCT02137369_exc_T70", "normalized": [] }, { "id": "NCT02137369_exc_R25", "type": "AND", "arg1_id": "NCT02137369_exc_T66", "arg2_id": "NCT02137369_exc_T71", "normalized": [] }, { "id": "NCT02137369_exc_R26", "type": "Has_value", "arg1_id": "NCT02137369_exc_T72", "arg2_id": "NCT02137369_exc_T73", "normalized": [] }, { "id": "NCT02137369_exc_R27", "type": "Has_index", "arg1_id": "NCT02137369_exc_T74", "arg2_id": "NCT02137369_exc_T75", "normalized": [] }, { "id": "NCT02137369_exc_R28", "type": "AND", "arg1_id": "NCT02137369_exc_T76", "arg2_id": "NCT02137369_exc_T72", "normalized": [] }, { "id": "NCT02137369_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT02137369_exc_T84", "arg2_id": "NCT02137369_exc_T85", "normalized": [] }, { "id": "NCT02137369_exc_R30", "type": "Has_negation", "arg1_id": "NCT02137369_exc_T88", "arg2_id": "NCT02137369_exc_T79", "normalized": [] }, { "id": "NCT02137369_exc_R31", "type": "AND", "arg1_id": "NCT02137369_exc_T77", "arg2_id": "NCT02137369_exc_T78", "normalized": [] }, { "id": "NCT02137369_exc_R32", "type": "AND", "arg1_id": "NCT02137369_exc_T90", "arg2_id": "NCT02137369_exc_T91", "normalized": [] }, { "id": "NCT02137369_exc_R33", "type": "Has_scope", "arg1_id": "NCT02137369_exc_T92", "arg2_id": "NCT02137369_exc_T95", "normalized": [] }, { "id": "NCT02137369_exc_R34", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T90", "arg2_id": "NCT02137369_exc_T92", "normalized": [] }, { "id": "NCT02137369_exc_R35", "type": "Has_negation", "arg1_id": "NCT02137369_exc_T90", "arg2_id": "NCT02137369_exc_T96", "normalized": [] }, { "id": "NCT02137369_exc_R1", "type": "AND", "arg1_id": "NCT02137369_exc_T99", "arg2_id": "NCT02137369_exc_T7", "normalized": [] }, { "id": "NCT02137369_exc_R36", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T7", "arg2_id": "NCT02137369_exc_T100", "normalized": [] }, { "id": "NCT02137369_exc_R37", "type": "Has_index", "arg1_id": "NCT02137369_exc_T98", "arg2_id": "NCT02137369_exc_T99", "normalized": [] }, { "id": "NCT02137369_exc_R38", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T6", "arg2_id": "NCT02137369_exc_T98", "normalized": [] }, { "id": "NCT02137369_exc_R39", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T106", "arg2_id": "NCT02137369_exc_T105", "normalized": [] }, { "id": "NCT02137369_exc_R43", "type": "Has_temporal", "arg1_id": "NCT02137369_exc_T107", "arg2_id": "NCT02137369_exc_T110", "normalized": [] }, { "id": "NCT02137369_exc_R44", "type": "Has_scope", "arg1_id": "NCT02137369_exc_T101", "arg2_id": "NCT02137369_exc_T111", "normalized": [] }, { "id": "NCT02137369_exc_R45", "type": "Has_qualifier", "arg1_id": "NCT02137369_exc_T60", "arg2_id": "NCT02137369_exc_T112", "normalized": [] } ]

[ { "id": "NCT02137369_inc_text", "type": "inclusion", "text": [ "Men or women aged 18-60 years.\nPrimary psychiatric diagnosis of Major Depressive Disorder, without psychotic features, confirmed via SCID-IV structured diagnostic interview.\nScreening Hamilton Depression Rating Scale (HAMD) = 18; and Baseline HAMD = 15.\nIf the patient is a woman of child-bearing potential, she must agree to use an acceptable form of birth control for duration of study participation.\nAble to understand and provide informed consent for participation.\n" ], "offsets": [ [ 0, 470 ] ] } ]

[ { "id": "NCT02137369_inc_T1", "type": "Person", "text": [ "Men" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 7, 12 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T3", "type": "Person", "text": [ "aged" ], "offsets": [ [ 13, 17 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T4", "type": "Value", "text": [ "18-60 years" ], "offsets": [ [ 18, 29 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T5", "type": "Qualifier", "text": [ "Primary" ], "offsets": [ [ 31, 38 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T6", "type": "Condition", "text": [ "Major Depressive Disorder" ], "offsets": [ [ 64, 89 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T7", "type": "Negation", "text": [ "without" ], "offsets": [ [ 91, 98 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T8", "type": "Condition", "text": [ "Men or women aged 18-60 years.", "rimary psychiatric diagnosis of Major Depressive Disorder, without psychotic features," ], "offsets": [ [ 0, 30 ], [ 32, 118 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T9", "type": "Condition", "text": [ "psychotic features" ], "offsets": [ [ 99, 117 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T10", "type": "Measurement", "text": [ "Screening Hamilton Depression Rating Scale" ], "offsets": [ [ 174, 216 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T11", "type": "Measurement", "text": [ "HAMD" ], "offsets": [ [ 218, 222 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T12", "type": "Value", "text": [ "= 18" ], "offsets": [ [ 224, 228 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T13", "type": "Measurement", "text": [ "HAMD" ], "offsets": [ [ 243, 247 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T14", "type": "Qualifier", "text": [ "Baseline" ], "offsets": [ [ 234, 242 ] ], "normalized": [] }, { "id": "NCT02137369_inc_T15", "type": "Value", "text": [ "= 15" ], "offsets": [ [ 248, 252 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02137369_inc_R1", "type": "Has_value", "arg1_id": "NCT02137369_inc_T3", "arg2_id": "NCT02137369_inc_T4", "normalized": [] }, { "id": "NCT02137369_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02137369_inc_T6", "arg2_id": "NCT02137369_inc_T5", "normalized": [] }, { "id": "NCT02137369_inc_R3", "type": "Has_negation", "arg1_id": "NCT02137369_inc_T9", "arg2_id": "NCT02137369_inc_T7", "normalized": [] }, { "id": "NCT02137369_inc_R4", "type": "AND", "arg1_id": "NCT02137369_inc_T6", "arg2_id": "NCT02137369_inc_T9", "normalized": [] }, { "id": "NCT02137369_inc_R5", "type": "Subsumes", "arg1_id": "NCT02137369_inc_T10", "arg2_id": "NCT02137369_inc_T11", "normalized": [] }, { "id": "NCT02137369_inc_R6", "type": "Has_value", "arg1_id": "NCT02137369_inc_T13", "arg2_id": "NCT02137369_inc_T15", "normalized": [] }, { "id": "NCT02137369_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT02137369_inc_T13", "arg2_id": "NCT02137369_inc_T14", "normalized": [] }, { "id": "NCT02137369_inc_R8", "type": "Has_value", "arg1_id": "NCT02137369_inc_T10", "arg2_id": "NCT02137369_inc_T12", "normalized": [] } ]

[ { "id": "NCT02137538_exc_text", "type": "exclusion", "text": [ "Bone age reading more than 14.0 years\nFollicle stimulating hormone > 20 IU/L\n" ], "offsets": [ [ 0, 77 ] ] } ]

[ { "id": "NCT02137538_exc_T1", "type": "Measurement", "text": [ "Bone age" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02137538_exc_T2", "type": "Value", "text": [ "more than 14.0 years" ], "offsets": [ [ 17, 37 ] ], "normalized": [] }, { "id": "NCT02137538_exc_T3", "type": "Measurement", "text": [ "Follicle stimulating hormone" ], "offsets": [ [ 38, 66 ] ], "normalized": [] }, { "id": "NCT02137538_exc_T4", "type": "Value", "text": [ "> 20 IU/L" ], "offsets": [ [ 67, 76 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02137538_exc_R1", "type": "Has_value", "arg1_id": "NCT02137538_exc_T1", "arg2_id": "NCT02137538_exc_T2", "normalized": [] }, { "id": "NCT02137538_exc_R2", "type": "Has_value", "arg1_id": "NCT02137538_exc_T3", "arg2_id": "NCT02137538_exc_T4", "normalized": [] } ]

[ { "id": "NCT02137538_inc_text", "type": "inclusion", "text": [ "Current height less than 5th percentile AND/OR\nPredicted adult height (based on bone age) more than 10 cm below target height (mid parental height)\nEvidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl\n" ], "offsets": [ [ 0, 253 ] ] } ]

[ { "id": "NCT02137538_inc_T1", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T2", "type": "Measurement", "text": [ "height" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T3", "type": "Value", "text": [ "less than 5th percentile" ], "offsets": [ [ 15, 39 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T5", "type": "Measurement", "text": [ "Predicted adult height" ], "offsets": [ [ 47, 69 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T6", "type": "Qualifier", "text": [ "bone age" ], "offsets": [ [ 80, 88 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T7", "type": "Value", "text": [ "more than 10 cm below target height" ], "offsets": [ [ 90, 125 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T8", "type": "Qualifier", "text": [ "mid parental height" ], "offsets": [ [ 127, 146 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T9", "type": "Observation", "text": [ "Evidence of puberty" ], "offsets": [ [ 148, 167 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T10", "type": "Measurement", "text": [ "serum luteinizing hormone" ], "offsets": [ [ 188, 213 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T11", "type": "Condition", "text": [ "physical signs" ], "offsets": [ [ 169, 183 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T12", "type": "Value", "text": [ "> 0.3 IU/L" ], "offsets": [ [ 214, 224 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T13", "type": "Measurement", "text": [ "testosterone" ], "offsets": [ [ 229, 241 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T14", "type": "Value", "text": [ "> 15 ng/dl" ], "offsets": [ [ 242, 252 ] ], "normalized": [] }, { "id": "NCT02137538_inc_T15", "type": "Scope", "text": [ "physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl" ], "offsets": [ [ 169, 252 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02137538_inc_R1", "type": "Has_value", "arg1_id": "NCT02137538_inc_T2", "arg2_id": "NCT02137538_inc_T3", "normalized": [] }, { "id": "NCT02137538_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02137538_inc_T2", "arg2_id": "NCT02137538_inc_T1", "normalized": [] }, { "id": "NCT02137538_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02137538_inc_T5", "arg2_id": "NCT02137538_inc_T6", "normalized": [] }, { "id": "NCT02137538_inc_R4", "type": "Has_value", "arg1_id": "NCT02137538_inc_T5", "arg2_id": "NCT02137538_inc_T7", "normalized": [] }, { "id": "NCT02137538_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT02137538_inc_T7", "arg2_id": "NCT02137538_inc_T8", "normalized": [] }, { "id": "NCT02137538_inc_R6", "type": "Has_value", "arg1_id": "NCT02137538_inc_T13", "arg2_id": "NCT02137538_inc_T14", "normalized": [] }, { "id": "NCT02137538_inc_R7", "type": "Has_value", "arg1_id": "NCT02137538_inc_T10", "arg2_id": "NCT02137538_inc_T12", "normalized": [] }, { "id": "NCT02137538_inc_R8", "type": "Has_scope", "arg1_id": "NCT02137538_inc_T9", "arg2_id": "NCT02137538_inc_T15", "normalized": [] } ]

[ { "id": "NCT02141061_exc_text", "type": "exclusion", "text": [ "1. Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy \n2. Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study \n3. Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat). \n4. Received an investigational drug in the 30 days prior to the screening for this study \n5. Women with a history of PCOS \n6. Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study. \n7. Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 10 months. \n8. Has an IUD in place \n9. Women currently using narcotics \n10. Women currently taking spironolactone \n11. Infectious disease screen is positive for HIV or Hepatitis A, B or C. \n12. Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study \n \n" ], "offsets": [ [ 0, 1336 ] ] } ]

[ { "id": "NCT02141061_exc_T13", "type": "Condition", "text": [ "post-menopausal" ], "offsets": [ [ 16, 31 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T14", "type": "Person", "text": [ "woman" ], "offsets": [ [ 32, 37 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T15", "type": "Temporal", "text": [ "six (6) months or more" ], "offsets": [ [ 58, 80 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T16", "type": "Temporal", "text": [ "immediately prior to screening visit" ], "offsets": [ [ 82, 118 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T17", "type": "Condition", "text": [ "menstrual period" ], "offsets": [ [ 130, 146 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T18", "type": "Negation", "text": [ "without" ], "offsets": [ [ 120, 127 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T19", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 157, 169 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T20", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 151, 156 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T21", "type": "Procedure", "text": [ "oophorectomy" ], "offsets": [ [ 177, 189 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T22", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 205, 213 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T23", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 217, 226 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T26", "type": "Person", "text": [ "Women" ], "offsets": [ [ 297, 302 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T27", "type": "Measurement", "text": [ "liver enzymes" ], "offsets": [ [ 324, 337 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T28", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 341, 354 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T29", "type": "Value", "text": [ "high" ], "offsets": [ [ 319, 323 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T30", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 357, 360 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T31", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 364, 367 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T32", "type": "Value", "text": [ "exceeding 2.0 x ULN" ], "offsets": [ [ 368, 387 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T33", "type": "Scope", "text": [ "ALT or AST" ], "offsets": [ [ 357, 367 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T34", "type": "Measurement", "text": [ "total bilirubin" ], "offsets": [ [ 392, 407 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T35", "type": "Value", "text": [ "exceeding 1.5 x ULN" ], "offsets": [ [ 408, 427 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T36", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 428, 440 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T37", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 431, 440 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T38", "type": "Temporal", "text": [ "in the 30 days prior to the screening" ], "offsets": [ [ 504, 541 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T39", "type": "Reference_point", "text": [ "the screening" ], "offsets": [ [ 528, 541 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T40", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 483, 503 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T41", "type": "Person", "text": [ "Women" ], "offsets": [ [ 561, 566 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T42", "type": "Condition", "text": [ "PCOS" ], "offsets": [ [ 585, 589 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T43", "type": "Observation", "text": [ "history" ], "offsets": [ [ 574, 581 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T44", "type": "Drug", "text": [ "testosterone" ], "offsets": [ [ 616, 628 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T45", "type": "Drug", "text": [ "progestin" ], "offsets": [ [ 630, 639 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T46", "type": "Drug", "text": [ "androgen" ], "offsets": [ [ 641, 649 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T47", "type": "Drug", "text": [ "estrogen" ], "offsets": [ [ 651, 659 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T48", "type": "Drug", "text": [ "anabolic steroids" ], "offsets": [ [ 661, 678 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T49", "type": "Drug", "text": [ "DHEA" ], "offsets": [ [ 680, 684 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T50", "type": "Temporal", "text": [ "for at least 2 weeks prior to screening" ], "offsets": [ [ 706, 745 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T51", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 750, 766 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T52", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 736, 745 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T53", "type": "Drug", "text": [ "hormonal products" ], "offsets": [ [ 688, 705 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T55", "type": "Scope", "text": [ "testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products" ], "offsets": [ [ 616, 705 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T56", "type": "Drug", "text": [ "oral contraceptives" ], "offsets": [ [ 779, 798 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T57", "type": "Temporal", "text": [ "in the preceding 2 weeks" ], "offsets": [ [ 799, 823 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T58", "type": "Drug", "text": [ "Depo-Provera®" ], "offsets": [ [ 832, 845 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T59", "type": "Temporal", "text": [ "in the preceding 10 months" ], "offsets": [ [ 846, 872 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T60", "type": "Device", "text": [ "IUD" ], "offsets": [ [ 885, 888 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T61", "type": "Person", "text": [ "Women" ], "offsets": [ [ 902, 907 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T62", "type": "Drug", "text": [ "narcotics" ], "offsets": [ [ 924, 933 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T63", "type": "Person", "text": [ "Women" ], "offsets": [ [ 939, 944 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T64", "type": "Drug", "text": [ "spironolactone" ], "offsets": [ [ 962, 976 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T65", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 1024, 1027 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T66", "type": "Condition", "text": [ "Hepatitis A" ], "offsets": [ [ 1031, 1042 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T67", "type": "Condition", "text": [ "Hepatitis", "B" ], "offsets": [ [ 1031, 1040 ], [ 1044, 1045 ] ], "normalized": [] }, { "id": "NCT02141061_exc_T68", "type": "Condition", "text": [ "Hepatitis", "C" ], "offsets": [ [ 1031, 1040 ], [ 1049, 1050 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02141061_exc_R1", "type": "Has_negation", "arg1_id": "NCT02141061_exc_T17", "arg2_id": "NCT02141061_exc_T18", "normalized": [] }, { "id": "NCT02141061_exc_R2", "type": "AND", "arg1_id": "NCT02141061_exc_T15", "arg2_id": "NCT02141061_exc_T17", "normalized": [] }, { "id": "NCT02141061_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T15", "arg2_id": "NCT02141061_exc_T16", "normalized": [] }, { "id": "NCT02141061_exc_R4", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T19", "arg2_id": "NCT02141061_exc_T20", "normalized": [] }, { "id": "NCT02141061_exc_R5", "type": "Has_value", "arg1_id": "NCT02141061_exc_T27", "arg2_id": "NCT02141061_exc_T29", "normalized": [] }, { "id": "NCT02141061_exc_R6", "type": "Has_value", "arg1_id": "NCT02141061_exc_T33", "arg2_id": "NCT02141061_exc_T32", "normalized": [] }, { "id": "NCT02141061_exc_R7", "type": "Has_value", "arg1_id": "NCT02141061_exc_T34", "arg2_id": "NCT02141061_exc_T35", "normalized": [] }, { "id": "NCT02141061_exc_R8", "type": "Has_index", "arg1_id": "NCT02141061_exc_T36", "arg2_id": "NCT02141061_exc_T37", "normalized": [] }, { "id": "NCT02141061_exc_R9", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T34", "arg2_id": "NCT02141061_exc_T36", "normalized": [] }, { "id": "NCT02141061_exc_R10", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T33", "arg2_id": "NCT02141061_exc_T36", "normalized": [] }, { "id": "NCT02141061_exc_R11", "type": "Has_index", "arg1_id": "NCT02141061_exc_T38", "arg2_id": "NCT02141061_exc_T39", "normalized": [] }, { "id": "NCT02141061_exc_R12", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T40", "arg2_id": "NCT02141061_exc_T38", "normalized": [] }, { "id": "NCT02141061_exc_R13", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T42", "arg2_id": "NCT02141061_exc_T43", "normalized": [] }, { "id": "NCT02141061_exc_R14", "type": "Has_index", "arg1_id": "NCT02141061_exc_T50", "arg2_id": "NCT02141061_exc_T52", "normalized": [] }, { "id": "NCT02141061_exc_R15", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T55", "arg2_id": "NCT02141061_exc_T50", "normalized": [] }, { "id": "NCT02141061_exc_R16", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T55", "arg2_id": "NCT02141061_exc_T51", "normalized": [] }, { "id": "NCT02141061_exc_R17", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T56", "arg2_id": "NCT02141061_exc_T57", "normalized": [] }, { "id": "NCT02141061_exc_R18", "type": "Has_temporal", "arg1_id": "NCT02141061_exc_T58", "arg2_id": "NCT02141061_exc_T59", "normalized": [] } ]

[ { "id": "NCT02141061_inc_text", "type": "inclusion", "text": [ "1. Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures; \n2. Healthy, premenopausal female age 18-47; \n3. History of menstrual events that occur in regular cycles \n4. Agreement not to attempt to become pregnant \n5. Agrees to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide; \n6. Has a negative pregnancy test at the Screening visit. An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history \n7. Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator; \n8. Subject is willing to remain in the clinic overnight for PK assessment on Days 0 and 8 \n9. Ability to complete the study procedures in compliance with the protocol. \n" ], "offsets": [ [ 0, 1101 ] ] } ]

[ { "id": "NCT02141061_inc_T11", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 187, 194 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T12", "type": "Condition", "text": [ "premenopausal" ], "offsets": [ [ 196, 209 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T13", "type": "Person", "text": [ "female" ], "offsets": [ [ 210, 216 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T14", "type": "Person", "text": [ "age" ], "offsets": [ [ 217, 220 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T15", "type": "Value", "text": [ "18-47" ], "offsets": [ [ 221, 226 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T16", "type": "Condition", "text": [ "menstrual events that occur in regular cycles" ], "offsets": [ [ 243, 288 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T17", "type": "Observation", "text": [ "History" ], "offsets": [ [ 232, 239 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T24", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 649, 663 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T25", "type": "Value", "text": [ "negative" ], "offsets": [ [ 640, 648 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T26", "type": "Temporal", "text": [ "at the Screening visit" ], "offsets": [ [ 664, 686 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T27", "type": "Reference_point", "text": [ "Screening visit" ], "offsets": [ [ 671, 686 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T30", "type": "Condition", "text": [ "Normal laboratory values" ], "offsets": [ [ 821, 845 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T31", "type": "Value", "text": [ "Normal" ], "offsets": [ [ 821, 827 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T32", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 828, 838 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T33", "type": "Measurement", "text": [ "laboratory" ], "offsets": [ [ 828, 838 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T34", "type": "Qualifier", "text": [ "clinically insignificant" ], "offsets": [ [ 849, 873 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T36", "type": "Condition", "text": [ "findings" ], "offsets": [ [ 874, 882 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T37", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 883, 895 ] ], "normalized": [] }, { "id": "NCT02141061_inc_T38", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 886, 895 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02141061_inc_R1", "type": "Has_value", "arg1_id": "NCT02141061_inc_T14", "arg2_id": "NCT02141061_inc_T15", "normalized": [] }, { "id": "NCT02141061_inc_R2", "type": "Has_index", "arg1_id": "NCT02141061_inc_T26", "arg2_id": "NCT02141061_inc_T27", "normalized": [] }, { "id": "NCT02141061_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02141061_inc_T24", "arg2_id": "NCT02141061_inc_T26", "normalized": [] }, { "id": "NCT02141061_inc_R4", "type": "Has_value", "arg1_id": "NCT02141061_inc_T24", "arg2_id": "NCT02141061_inc_T25", "normalized": [] }, { "id": "NCT02141061_inc_R5", "type": "Has_value", "arg1_id": "NCT02141061_inc_T33", "arg2_id": "NCT02141061_inc_T31", "normalized": [] }, { "id": "NCT02141061_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02141061_inc_T36", "arg2_id": "NCT02141061_inc_T34", "normalized": [] } ]

[ { "id": "NCT02145026_exc_text", "type": "exclusion", "text": [ "Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment\nPoorly controlled hypertension as assessed by the investigator\nHistory of Acute Myeloid Leukemia (AML) or high risk for AML\nAdministration of another investigational drug within 1 month before screening or planned during the study period\nPreviously documented evidence of Pure Red Cell Aplasia (PRCA)\n" ], "offsets": [ [ 0, 428 ] ] } ]

[ { "id": "NCT02145026_exc_T1", "type": "Condition", "text": [ "Contraindications" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T2", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 31, 47 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T3", "type": "Procedure", "text": [ "epoetin beta treatment" ], "offsets": [ [ 104, 126 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T4", "type": "Scope", "text": [ "Contraindications and/or known hypersensitivity" ], "offsets": [ [ 0, 47 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T5", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 145, 157 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T6", "type": "Qualifier", "text": [ "Poorly controlled" ], "offsets": [ [ 127, 144 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T7", "type": "Condition", "text": [ "Acute Myeloid Leukemia" ], "offsets": [ [ 201, 223 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T8", "type": "Condition", "text": [ "AML" ], "offsets": [ [ 225, 228 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T9", "type": "Observation", "text": [ "risk for AML" ], "offsets": [ [ 238, 250 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T10", "type": "Qualifier", "text": [ "high" ], "offsets": [ [ 233, 237 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T12", "type": "Condition", "text": [ "Pure Red Cell Aplasia" ], "offsets": [ [ 399, 420 ] ], "normalized": [] }, { "id": "NCT02145026_exc_T13", "type": "Condition", "text": [ "PRCA" ], "offsets": [ [ 422, 426 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02145026_exc_R1", "type": "AND", "arg1_id": "NCT02145026_exc_T4", "arg2_id": "NCT02145026_exc_T3", "normalized": [] }, { "id": "NCT02145026_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02145026_exc_T5", "arg2_id": "NCT02145026_exc_T6", "normalized": [] }, { "id": "NCT02145026_exc_R3", "type": "Subsumes", "arg1_id": "NCT02145026_exc_T7", "arg2_id": "NCT02145026_exc_T8", "normalized": [] }, { "id": "NCT02145026_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT02145026_exc_T9", "arg2_id": "NCT02145026_exc_T10", "normalized": [] }, { "id": "NCT02145026_exc_R5", "type": "Subsumes", "arg1_id": "NCT02145026_exc_T12", "arg2_id": "NCT02145026_exc_T13", "normalized": [] } ]

[ { "id": "NCT02145026_inc_text", "type": "inclusion", "text": [ "Adult participants with low or intermediate-1 risk MDS\nNo previous treatment with hematopoietic growth factors within 3 months prior to screening\nSymptomatic anemia (hemoglobin <10 g/dL) as determined by investigator\nSerum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment\nRequire no red blood cell transfusion or dependent on <4 units within 8 weeks prior to screening\nClinically stable for at least 1 month prior to entry into the study\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception\n" ], "offsets": [ [ 0, 702 ] ] } ]

[ { "id": "NCT02145026_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T2", "type": "Measurement", "text": [ "MDS" ], "offsets": [ [ 51, 54 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T3", "type": "Value", "text": [ "intermediate-1 risk" ], "offsets": [ [ 31, 50 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T4", "type": "Value", "text": [ "low", "risk" ], "offsets": [ [ 24, 27 ], [ 46, 50 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T5", "type": "Scope", "text": [ "low or intermediate-1 risk" ], "offsets": [ [ 24, 50 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T6", "type": "Drug", "text": [ "hematopoietic growth factors" ], "offsets": [ [ 82, 110 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T7", "type": "Temporal", "text": [ "within 3 months prior to screening" ], "offsets": [ [ 111, 145 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T8", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 136, 145 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T9", "type": "Condition", "text": [ "anemia" ], "offsets": [ [ 158, 164 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T10", "type": "Qualifier", "text": [ "Symptomatic" ], "offsets": [ [ 146, 157 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T11", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 166, 176 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T12", "type": "Value", "text": [ "<10 g/dL" ], "offsets": [ [ 177, 185 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T13", "type": "Measurement", "text": [ "Serum erythropoietin" ], "offsets": [ [ 217, 237 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T14", "type": "Value", "text": [ "<500 milliunits/milliliter" ], "offsets": [ [ 238, 264 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T15", "type": "Temporal", "text": [ "within 14 days prior to the first dose of study treatment" ], "offsets": [ [ 273, 330 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T16", "type": "Procedure", "text": [ "red blood cell transfusion" ], "offsets": [ [ 342, 368 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T17", "type": "Negation", "text": [ "no" ], "offsets": [ [ 339, 341 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T18", "type": "Multiplier", "text": [ "<4 units" ], "offsets": [ [ 385, 393 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T19", "type": "Temporal", "text": [ "within 8 weeks prior to screening" ], "offsets": [ [ 394, 427 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T20", "type": "Condition", "text": [ "stable" ], "offsets": [ [ 439, 445 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T21", "type": "Temporal", "text": [ "for at least 1 month prior to entry into the study" ], "offsets": [ [ 446, 496 ] ], "normalized": [] }, { "id": "NCT02145026_inc_T22", "type": "Reference_point", "text": [ "entry into the study" ], "offsets": [ [ 476, 496 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02145026_inc_R1", "type": "Has_scope", "arg1_id": "NCT02145026_inc_T2", "arg2_id": "NCT02145026_inc_T5", "normalized": [] }, { "id": "NCT02145026_inc_R2", "type": "Has_index", "arg1_id": "NCT02145026_inc_T7", "arg2_id": "NCT02145026_inc_T8", "normalized": [] }, { "id": "NCT02145026_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02145026_inc_T6", "arg2_id": "NCT02145026_inc_T7", "normalized": [] }, { "id": "NCT02145026_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT02145026_inc_T9", "arg2_id": "NCT02145026_inc_T10", "normalized": [] }, { "id": "NCT02145026_inc_R5", "type": "Has_value", "arg1_id": "NCT02145026_inc_T11", "arg2_id": "NCT02145026_inc_T12", "normalized": [] }, { "id": "NCT02145026_inc_R6", "type": "AND", "arg1_id": "NCT02145026_inc_T9", "arg2_id": "NCT02145026_inc_T11", "normalized": [] }, { "id": "NCT02145026_inc_R7", "type": "Has_value", "arg1_id": "NCT02145026_inc_T13", "arg2_id": "NCT02145026_inc_T14", "normalized": [] }, { "id": "NCT02145026_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02145026_inc_T13", "arg2_id": "NCT02145026_inc_T15", "normalized": [] }, { "id": "NCT02145026_inc_R9", "type": "Has_multiplier", "arg1_id": "NCT02145026_inc_T16", "arg2_id": "NCT02145026_inc_T18", "normalized": [] }, { "id": "NCT02145026_inc_R10", "type": "Has_negation", "arg1_id": "NCT02145026_inc_T16", "arg2_id": "NCT02145026_inc_T17", "normalized": [] }, { "id": "NCT02145026_inc_R11", "type": "Has_temporal", "arg1_id": "NCT02145026_inc_T16", "arg2_id": "NCT02145026_inc_T19", "normalized": [] }, { "id": "NCT02145026_inc_R12", "type": "Has_temporal", "arg1_id": "NCT02145026_inc_T20", "arg2_id": "NCT02145026_inc_T21", "normalized": [] }, { "id": "NCT02145026_inc_R13", "type": "Has_index", "arg1_id": "NCT02145026_inc_T21", "arg2_id": "NCT02145026_inc_T22", "normalized": [] } ]

[ { "id": "NCT02150590_exc_text", "type": "exclusion", "text": [ "unstable condition, COPD exacerbation\nmild (GOLD 1) or very severe COPD (GOLD 4)\nrequirement for oxygen therapy at low altitude residence\nhypoventilation\npulmonary hypertension\nmore than mild or unstable cardiovascular disease\nuse of drugs that affect respiratory center drive\ninternal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.\nprevious intolerance to moderate altitude (<2600m).\nexposure to altitudes >1500m for >2 days within the last 4 weeks before the study.\npregnant or nursing patients\n" ], "offsets": [ [ 0, 621 ] ] } ]

[ { "id": "NCT02150590_exc_T1", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T2", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T3", "type": "Condition", "text": [ "COPD exacerbation" ], "offsets": [ [ 20, 37 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T4", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 67, 71 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T5", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 38, 42 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T6", "type": "Measurement", "text": [ "GOLD" ], "offsets": [ [ 44, 48 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T7", "type": "Value", "text": [ "1)" ], "offsets": [ [ 49, 51 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T8", "type": "Measurement", "text": [ "GOLD" ], "offsets": [ [ 73, 77 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T9", "type": "Value", "text": [ "4" ], "offsets": [ [ 78, 79 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T10", "type": "Qualifier", "text": [ "very severe" ], "offsets": [ [ 55, 66 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T11", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 67, 71 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T12", "type": "Procedure", "text": [ "oxygen therapy" ], "offsets": [ [ 97, 111 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T13", "type": "Condition", "text": [ "hypoventilation" ], "offsets": [ [ 138, 153 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T14", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 154, 176 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T15", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 204, 226 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T16", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 195, 203 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T17", "type": "Qualifier", "text": [ "more than mild" ], "offsets": [ [ 177, 191 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T18", "type": "Scope", "text": [ "more than mild or unstable" ], "offsets": [ [ 177, 203 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T20", "type": "Condition", "text": [ "psychiatric disease" ], "offsets": [ [ 301, 320 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T21", "type": "Condition", "text": [ "gic or psy", " that " ], "offsets": [ [ 294, 304 ], [ 320, 326 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T22", "type": "Condition", "text": [ "l, neuro", " that " ], "offsets": [ [ 284, 292 ], [ 320, 326 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T23", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 385, 392 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T24", "type": "Qualifier", "text": [ "heavy" ], "offsets": [ [ 379, 384 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T25", "type": "Multiplier", "text": [ ">20 cigarettes per day" ], "offsets": [ [ 394, 416 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T26", "type": "Negation", "text": [ "inability" ], "offsets": [ [ 419, 428 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T27", "type": "Procedure", "text": [ "6 min walk test" ], "offsets": [ [ 440, 455 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T28", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 466, 477 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T29", "type": "Observation", "text": [ "altitude" ], "offsets": [ [ 490, 498 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T30", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 481, 489 ] ], "normalized": [] }, { "id": "NCT02150590_exc_T31", "type": "Value", "text": [ "<2600m" ], "offsets": [ [ 500, 506 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02150590_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT02150590_exc_T2", "arg2_id": "NCT02150590_exc_T1", "normalized": [] }, { "id": "NCT02150590_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02150590_exc_T11", "arg2_id": "NCT02150590_exc_T5", "normalized": [] }, { "id": "NCT02150590_exc_R3", "type": "Has_value", "arg1_id": "NCT02150590_exc_T6", "arg2_id": "NCT02150590_exc_T7", "normalized": [] }, { "id": "NCT02150590_exc_R4", "type": "AND", "arg1_id": "NCT02150590_exc_T11", "arg2_id": "NCT02150590_exc_T6", "normalized": [] }, { "id": "NCT02150590_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02150590_exc_T4", "arg2_id": "NCT02150590_exc_T10", "normalized": [] }, { "id": "NCT02150590_exc_R6", "type": "AND", "arg1_id": "NCT02150590_exc_T4", "arg2_id": "NCT02150590_exc_T8", "normalized": [] }, { "id": "NCT02150590_exc_R7", "type": "Has_value", "arg1_id": "NCT02150590_exc_T8", "arg2_id": "NCT02150590_exc_T9", "normalized": [] }, { "id": "NCT02150590_exc_R8", "type": "Has_scope", "arg1_id": "NCT02150590_exc_T15", "arg2_id": "NCT02150590_exc_T18", "normalized": [] }, { "id": "NCT02150590_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT02150590_exc_T23", "arg2_id": "NCT02150590_exc_T24", "normalized": [] }, { "id": "NCT02150590_exc_R10", "type": "Has_multiplier", "arg1_id": "NCT02150590_exc_T23", "arg2_id": "NCT02150590_exc_T25", "normalized": [] }, { "id": "NCT02150590_exc_R11", "type": "Has_negation", "arg1_id": "NCT02150590_exc_T27", "arg2_id": "NCT02150590_exc_T26", "normalized": [] }, { "id": "NCT02150590_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT02150590_exc_T29", "arg2_id": "NCT02150590_exc_T30", "normalized": [] }, { "id": "NCT02150590_exc_R13", "type": "Has_value", "arg1_id": "NCT02150590_exc_T29", "arg2_id": "NCT02150590_exc_T31", "normalized": [] } ]

[ { "id": "NCT02150590_inc_text", "type": "inclusion", "text": [ "chronic obstructive pulmonary disease (COPD), GOLD grade 2-3\nresidents at low altitude (<800 m)\n" ], "offsets": [ [ 0, 96 ] ] } ]

[ { "id": "NCT02150590_inc_T1", "type": "Condition", "text": [ "chronic obstructive pulmonary disease" ], "offsets": [ [ 0, 37 ] ], "normalized": [] }, { "id": "NCT02150590_inc_T2", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 39, 43 ] ], "normalized": [] }, { "id": "NCT02150590_inc_T3", "type": "Measurement", "text": [ "GOLD grade" ], "offsets": [ [ 46, 56 ] ], "normalized": [] }, { "id": "NCT02150590_inc_T4", "type": "Value", "text": [ "2-3" ], "offsets": [ [ 57, 60 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02150590_inc_R1", "type": "Has_value", "arg1_id": "NCT02150590_inc_T3", "arg2_id": "NCT02150590_inc_T4", "normalized": [] }, { "id": "NCT02150590_inc_R2", "type": "Subsumes", "arg1_id": "NCT02150590_inc_T1", "arg2_id": "NCT02150590_inc_T2", "normalized": [] }, { "id": "NCT02150590_inc_R3", "type": "AND", "arg1_id": "NCT02150590_inc_T1", "arg2_id": "NCT02150590_inc_T3", "normalized": [] } ]

[ { "id": "NCT02152696_exc_text", "type": "exclusion", "text": [ "Hemodynamically unstable in need of acute treatment \nMost recent hCG > 5000 mIU/mL \nPatient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion) \nDiagnosis of gestational trophoblastic disease \nSubject unwilling or unable to comply with study procedures \nKnown hypersensitivity to MTX \nPresence of clinical contraindications for treatment with MTX \nPrior medical or surgical management of this gestation \nSubject unwilling to accept a blood transfusion \n \n" ], "offsets": [ [ 0, 518 ] ] } ]

[ { "id": "NCT02152696_exc_T1", "type": "Condition", "text": [ "Hemodynamically unstable" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T2", "type": "Measurement", "text": [ "hCG" ], "offsets": [ [ 65, 68 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T3", "type": "Temporal", "text": [ "Most recent" ], "offsets": [ [ 53, 64 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T4", "type": "Value", "text": [ "> 5000 mIU/mL" ], "offsets": [ [ 69, 82 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T6", "type": "Condition", "text": [ "gestational trophoblastic disease" ], "offsets": [ [ 212, 245 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T8", "type": "Condition", "text": [ "hypersensitivity to MTX" ], "offsets": [ [ 314, 337 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T9", "type": "Drug", "text": [ "MTX" ], "offsets": [ [ 334, 337 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T11", "type": "Procedure", "text": [ "medical", "management" ], "offsets": [ [ 408, 415 ], [ 428, 438 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T12", "type": "Procedure", "text": [ "surgical management" ], "offsets": [ [ 419, 438 ] ], "normalized": [] }, { "id": "NCT02152696_exc_T13", "type": "Condition", "text": [ "gestation" ], "offsets": [ [ 447, 456 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02152696_exc_R1", "type": "Has_value", "arg1_id": "NCT02152696_exc_T2", "arg2_id": "NCT02152696_exc_T4", "normalized": [] }, { "id": "NCT02152696_exc_R2", "type": "Has_temporal", "arg1_id": "NCT02152696_exc_T2", "arg2_id": "NCT02152696_exc_T3", "normalized": [] }, { "id": "NCT02152696_exc_R3", "type": "AND", "arg1_id": "NCT02152696_exc_T11", "arg2_id": "NCT02152696_exc_T13", "normalized": [] }, { "id": "NCT02152696_exc_R4", "type": "AND", "arg1_id": "NCT02152696_exc_T12", "arg2_id": "NCT02152696_exc_T13", "normalized": [] } ]

[ { "id": "NCT02152696_inc_text", "type": "inclusion", "text": [ "Female with a persisting pregnancy of unknown location: \nA pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization. \nPersistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value. \nPatient is hemodynamically stable, hemoglobin >10 mg/dL \nGreater than or 18 years of age \n" ], "offsets": [ [ 0, 718 ] ] } ]

[ { "id": "NCT02152696_inc_T1", "type": "Person", "text": [ "Female" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T2", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T3", "type": "Qualifier", "text": [ "unknown location" ], "offsets": [ [ 38, 54 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T4", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 59, 68 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T5", "type": "Qualifier", "text": [ "unknown location" ], "offsets": [ [ 72, 88 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T6", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 105, 114 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T7", "type": "Person", "text": [ "woman" ], "offsets": [ [ 120, 125 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T8", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 142, 156 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T9", "type": "Value", "text": [ "positive" ], "offsets": [ [ 133, 141 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T13", "type": "Procedure", "text": [ "Ultrasound" ], "offsets": [ [ 403, 413 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T15", "type": "Temporal", "text": [ "within 7 days prior to randomization" ], "offsets": [ [ 432, 468 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T16", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 455, 468 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T17", "type": "Condition", "text": [ "Persistence of hCG" ], "offsets": [ [ 471, 489 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T18", "type": "Measurement", "text": [ "hCG" ], "offsets": [ [ 522, 525 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T19", "type": "Multiplier", "text": [ "at least 2" ], "offsets": [ [ 504, 514 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T20", "type": "Temporal", "text": [ "over 2-14 days" ], "offsets": [ [ 534, 548 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T21", "type": "Value", "text": [ "< 15% rise per day" ], "offsets": [ [ 559, 577 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T22", "type": "Value", "text": [ "< 50% fall between the first and last value." ], "offsets": [ [ 582, 626 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T23", "type": "Condition", "text": [ "hemodynamically stable" ], "offsets": [ [ 639, 661 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T24", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 663, 673 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T25", "type": "Value", "text": [ ">10 mg/dL" ], "offsets": [ [ 674, 683 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T26", "type": "Value", "text": [ "Greater than or 18 years" ], "offsets": [ [ 685, 709 ] ], "normalized": [] }, { "id": "NCT02152696_inc_T27", "type": "Person", "text": [ "age" ], "offsets": [ [ 713, 716 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02152696_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT02152696_inc_T2", "arg2_id": "NCT02152696_inc_T3", "normalized": [] }, { "id": "NCT02152696_inc_R2", "type": "Has_value", "arg1_id": "NCT02152696_inc_T8", "arg2_id": "NCT02152696_inc_T9", "normalized": [] }, { "id": "NCT02152696_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT02152696_inc_T4", "arg2_id": "NCT02152696_inc_T5", "normalized": [] }, { "id": "NCT02152696_inc_R4", "type": "Has_index", "arg1_id": "NCT02152696_inc_T15", "arg2_id": "NCT02152696_inc_T16", "normalized": [] }, { "id": "NCT02152696_inc_R5", "type": "Has_temporal", "arg1_id": "NCT02152696_inc_T13", "arg2_id": "NCT02152696_inc_T15", "normalized": [] }, { "id": "NCT02152696_inc_R6", "type": "Has_value", "arg1_id": "NCT02152696_inc_T18", "arg2_id": "NCT02152696_inc_T21", "normalized": [] }, { "id": "NCT02152696_inc_R7", "type": "Has_temporal", "arg1_id": "NCT02152696_inc_T18", "arg2_id": "NCT02152696_inc_T20", "normalized": [] }, { "id": "NCT02152696_inc_R8", "type": "Has_value", "arg1_id": "NCT02152696_inc_T24", "arg2_id": "NCT02152696_inc_T25", "normalized": [] }, { "id": "NCT02152696_inc_R9", "type": "Has_value", "arg1_id": "NCT02152696_inc_T27", "arg2_id": "NCT02152696_inc_T26", "normalized": [] } ]

[ { "id": "NCT02156999_exc_text", "type": "exclusion", "text": [ "Kidney, parathyroid, congenital bone metabolic disease\n" ], "offsets": [ [ 0, 55 ] ] } ]

[ { "id": "NCT02156999_exc_T1", "type": "Qualifier", "text": [ "Kidney" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T2", "type": "Qualifier", "text": [ "parathyroid" ], "offsets": [ [ 8, 19 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T3", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 21, 31 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T4", "type": "Qualifier", "text": [ "bone" ], "offsets": [ [ 32, 36 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T5", "type": "Qualifier", "text": [ "metabolic" ], "offsets": [ [ 37, 46 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T6", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 47, 54 ] ], "normalized": [] }, { "id": "NCT02156999_exc_T7", "type": "Scope", "text": [ "Kidney, parathyroid, congenital bone metabolic" ], "offsets": [ [ 0, 46 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02156999_exc_R1", "type": "Has_scope", "arg1_id": "NCT02156999_exc_T6", "arg2_id": "NCT02156999_exc_T7", "normalized": [] } ]

[ { "id": "NCT02156999_inc_text", "type": "inclusion", "text": [ "Osteoporosis\n" ], "offsets": [ [ 0, 13 ] ] } ]

[ { "id": "NCT02156999_inc_T1", "type": "Condition", "text": [ "Osteoporosis" ], "offsets": [ [ 0, 12 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT02162433_exc_text", "type": "exclusion", "text": [ "Known allergy or hypersensitivity reaction to dexmedetomidine\nOrgan dysfunction (renal/hepatic failure or leukemia)\nCardiac disease (congenital or acquired)\nAirway or thoracic malformation\nCerebral palsy\nHypotonia\nNeed for premedication\nCurrent/recent upper respiratory infection (within four weeks prior to the surgery)\nAsthma\nAllergy or intolerance to clonidine\nNon-English speaking parents/patients.\n" ], "offsets": [ [ 0, 403 ] ] } ]

[ { "id": "NCT02162433_exc_T1", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 6, 13 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T2", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 17, 33 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T3", "type": "Drug", "text": [ "dexmedetomidine" ], "offsets": [ [ 46, 61 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T4", "type": "Scope", "text": [ "allergy or hypersensitivity" ], "offsets": [ [ 6, 33 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T5", "type": "Condition", "text": [ "Organ dysfunction" ], "offsets": [ [ 62, 79 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T6", "type": "Condition", "text": [ "hepatic failure" ], "offsets": [ [ 87, 102 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T7", "type": "Condition", "text": [ "leukemia" ], "offsets": [ [ 106, 114 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T8", "type": "Condition", "text": [ "enal/", "ailure" ], "offsets": [ [ 82, 87 ], [ 96, 102 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T9", "type": "Scope", "text": [ "renal/hepatic failure or leukemia" ], "offsets": [ [ 81, 114 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T10", "type": "Condition", "text": [ "Cardiac disease" ], "offsets": [ [ 116, 131 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T11", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 133, 143 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T12", "type": "Qualifier", "text": [ "acquired" ], "offsets": [ [ 147, 155 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T13", "type": "Scope", "text": [ "congenital or acquired" ], "offsets": [ [ 133, 155 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T14", "type": "Condition", "text": [ "thoracic malformation" ], "offsets": [ [ 167, 188 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T15", "type": "Condition", "text": [ "way or", "formation\nCe" ], "offsets": [ [ 160, 166 ], [ 179, 191 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T16", "type": "Condition", "text": [ "Cerebral palsy" ], "offsets": [ [ 189, 203 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T17", "type": "Condition", "text": [ "Hypotonia" ], "offsets": [ [ 204, 213 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T18", "type": "Drug", "text": [ "premedication" ], "offsets": [ [ 223, 236 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T19", "type": "Mood", "text": [ "Need for" ], "offsets": [ [ 214, 222 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T20", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 237, 244 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T21", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 245, 251 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T22", "type": "Condition", "text": [ "upper respiratory infection" ], "offsets": [ [ 252, 279 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T23", "type": "Temporal", "text": [ "within four weeks prior to the surgery" ], "offsets": [ [ 281, 319 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T24", "type": "Reference_point", "text": [ "the surgery" ], "offsets": [ [ 308, 319 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T25", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 312, 319 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T26", "type": "Scope", "text": [ "Current/recent" ], "offsets": [ [ 237, 251 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T27", "type": "Condition", "text": [ "Asthma" ], "offsets": [ [ 321, 327 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T28", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 328, 335 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T29", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 339, 350 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T30", "type": "Drug", "text": [ "clonidine" ], "offsets": [ [ 354, 363 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T31", "type": "Observation", "text": [ "Non-English speaking parents" ], "offsets": [ [ 364, 392 ] ], "normalized": [] }, { "id": "NCT02162433_exc_T32", "type": "Observation", "text": [ "h speaking parents/p", "" ], "offsets": [ [ 374, 394 ], [ 403, 403 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02162433_exc_R1", "type": "AND", "arg1_id": "NCT02162433_exc_T4", "arg2_id": "NCT02162433_exc_T3", "normalized": [] }, { "id": "NCT02162433_exc_R2", "type": "Subsumes", "arg1_id": "NCT02162433_exc_T5", "arg2_id": "NCT02162433_exc_T9", "normalized": [] }, { "id": "NCT02162433_exc_R3", "type": "Subsumes", "arg1_id": "NCT02162433_exc_T10", "arg2_id": "NCT02162433_exc_T13", "normalized": [] }, { "id": "NCT02162433_exc_R4", "type": "Has_mood", "arg1_id": "NCT02162433_exc_T18", "arg2_id": "NCT02162433_exc_T19", "normalized": [] }, { "id": "NCT02162433_exc_R6", "type": "Has_index", "arg1_id": "NCT02162433_exc_T23", "arg2_id": "NCT02162433_exc_T24", "normalized": [] }, { "id": "NCT02162433_exc_R7", "type": "Has_scope", "arg1_id": "NCT02162433_exc_T22", "arg2_id": "NCT02162433_exc_T26", "normalized": [] }, { "id": "NCT02162433_exc_R8", "type": "Subsumes", "arg1_id": "NCT02162433_exc_T26", "arg2_id": "NCT02162433_exc_T23", "normalized": [] } ]

[ { "id": "NCT02162433_inc_text", "type": "inclusion", "text": [ "Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty\nASA 1 & 2\n" ], "offsets": [ [ 0, 124 ] ] } ]

[ { "id": "NCT02162433_inc_T1", "type": "Value", "text": [ "between 3 to 16 years" ], "offsets": [ [ 9, 30 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 34, 37 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T3", "type": "Procedure", "text": [ "adenotonsillectomy" ], "offsets": [ [ 49, 67 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T4", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 38, 48 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T5", "type": "Procedure", "text": [ "myringotomy" ], "offsets": [ [ 85, 96 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T6", "type": "Procedure", "text": [ "myringoplasty" ], "offsets": [ [ 100, 113 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T7", "type": "Scope", "text": [ "myringotomy or myringoplast" ], "offsets": [ [ 85, 112 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T8", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 114, 117 ] ], "normalized": [] }, { "id": "NCT02162433_inc_T9", "type": "Value", "text": [ "1 & 2" ], "offsets": [ [ 118, 123 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02162433_inc_R1", "type": "Has_value", "arg1_id": "NCT02162433_inc_T2", "arg2_id": "NCT02162433_inc_T1", "normalized": [] }, { "id": "NCT02162433_inc_R2", "type": "Has_temporal", "arg1_id": "NCT02162433_inc_T3", "arg2_id": "NCT02162433_inc_T4", "normalized": [] }, { "id": "NCT02162433_inc_R3", "type": "Has_scope", "arg1_id": "NCT02162433_inc_T3", "arg2_id": "NCT02162433_inc_T7", "normalized": [] }, { "id": "NCT02162433_inc_R4", "type": "Has_value", "arg1_id": "NCT02162433_inc_T8", "arg2_id": "NCT02162433_inc_T9", "normalized": [] } ]

[ { "id": "NCT02164734_exc_text", "type": "exclusion", "text": [ "Weight < 800 g;\nAirway anomalies;\nPulmonary air leaks;\nCraniofacial or cardiothoracic malformations\n" ], "offsets": [ [ 0, 100 ] ] } ]

[ { "id": "NCT02164734_exc_T1", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT02164734_exc_T2", "type": "Value", "text": [ "< 800 g" ], "offsets": [ [ 7, 14 ] ], "normalized": [] }, { "id": "NCT02164734_exc_T3", "type": "Condition", "text": [ "Airway anomalies" ], "offsets": [ [ 16, 32 ] ], "normalized": [] }, { "id": "NCT02164734_exc_T4", "type": "Condition", "text": [ "Pulmonary air leaks" ], "offsets": [ [ 34, 53 ] ], "normalized": [] }, { "id": "NCT02164734_exc_T5", "type": "Condition", "text": [ "cardiothoracic malformations" ], "offsets": [ [ 71, 99 ] ], "normalized": [] }, { "id": "NCT02164734_exc_T6", "type": "Condition", "text": [ "niofacial or", "formations" ], "offsets": [ [ 58, 70 ], [ 89, 99 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02164734_exc_R1", "type": "Has_value", "arg1_id": "NCT02164734_exc_T1", "arg2_id": "NCT02164734_exc_T2", "normalized": [] } ]

[ { "id": "NCT02164734_inc_text", "type": "inclusion", "text": [ "Mild-to-moderate RDS;\nPostnatal age 2 to 48 hours;\nGestational age 27 0/7 to 36 6/7 weeks;\nTreated with nasal CPAP modalities = 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 90-95%;\nInformed consent\n" ], "offsets": [ [ 0, 231 ] ] } ]

[ { "id": "NCT02164734_inc_T1", "type": "Value", "text": [ "Mild-to-moderate" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T2", "type": "Measurement", "text": [ "RDS" ], "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T3", "type": "Measurement", "text": [ "Postnatal age" ], "offsets": [ [ 22, 35 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T4", "type": "Value", "text": [ "2 to 48 hours" ], "offsets": [ [ 36, 49 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T5", "type": "Measurement", "text": [ "Gestational age" ], "offsets": [ [ 51, 66 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T6", "type": "Value", "text": [ "27 0/7 to 36 6/7 weeks" ], "offsets": [ [ 67, 89 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T7", "type": "Measurement", "text": [ "nasal CPAP" ], "offsets": [ [ 104, 114 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T8", "type": "Value", "text": [ "= 5 cm H2O" ], "offsets": [ [ 126, 136 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T9", "type": "Measurement", "text": [ "FiO2" ], "offsets": [ [ 141, 145 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T10", "type": "Value", "text": [ "between 0.30 and 0.60" ], "offsets": [ [ 146, 167 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T11", "type": "Temporal", "text": [ "for at least 2 hours" ], "offsets": [ [ 168, 188 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T12", "type": "Measurement", "text": [ "SpO2" ], "offsets": [ [ 201, 205 ] ], "normalized": [] }, { "id": "NCT02164734_inc_T13", "type": "Value", "text": [ "90-95%" ], "offsets": [ [ 206, 212 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT02164734_inc_R1", "type": "Has_value", "arg1_id": "NCT02164734_inc_T2", "arg2_id": "NCT02164734_inc_T1", "normalized": [] }, { "id": "NCT02164734_inc_R2", "type": "Has_value", "arg1_id": "NCT02164734_inc_T3", "arg2_id": "NCT02164734_inc_T4", "normalized": [] }, { "id": "NCT02164734_inc_R3", "type": "Has_value", "arg1_id": "NCT02164734_inc_T5", "arg2_id": "NCT02164734_inc_T6", "normalized": [] }, { "id": "NCT02164734_inc_R4", "type": "Has_value", "arg1_id": "NCT02164734_inc_T12", "arg2_id": "NCT02164734_inc_T13", "normalized": [] }, { "id": "NCT02164734_inc_R5", "type": "Has_value", "arg1_id": "NCT02164734_inc_T7", "arg2_id": "NCT02164734_inc_T8", "normalized": [] }, { "id": "NCT02164734_inc_R6", "type": "AND", "arg1_id": "NCT02164734_inc_T7", "arg2_id": "NCT02164734_inc_T9", "normalized": [] }, { "id": "NCT02164734_inc_R7", "type": "Has_value", "arg1_id": "NCT02164734_inc_T9", "arg2_id": "NCT02164734_inc_T10", "normalized": [] }, { "id": "NCT02164734_inc_R8", "type": "Has_temporal", "arg1_id": "NCT02164734_inc_T7", "arg2_id": "NCT02164734_inc_T11", "normalized": [] }, { "id": "NCT02164734_inc_R9", "type": "AND", "arg1_id": "NCT02164734_inc_T7", "arg2_id": "NCT02164734_inc_T12", "normalized": [] } ]

[ { "id": "NCT02167022_exc_text", "type": "exclusion", "text": [ "1. Diagnosis: Diagnosis of CP secondary to neuronal migration. \n2. Co-morbidities: Medical conditions that may prevent the administration of rehabilitation therapies at the intensity required by the study, or that may compromise the study ability to maintain blindness, or that have a co-morbidity not typically associated with CP (i.e. cancer, cystic fibrosis). \n3. Co-interventions: Anticipated pharmacological intervention or procedure or participation in other studies that may interfere with this study. \n \n" ], "offsets": [ [ 0, 521 ] ] } ]

[ { "id": "NCT02167022_exc_T4", "type": "Condition", "text": [ "CP secondary to neuronal migration" ], "offsets": [ [ 27, 61 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT02167022_inc_text", "type": "inclusion", "text": [ "1. Age: 12 to 36 months of age (The diagnosis of CP is often uncertain under the age of 12 months. The cutoff at 36 months is to have a population of young children when the brain is most \"plastic\" and most susceptible to reorganization). \n2. Diagnosis: Diagnosis of spastic CP confirmed by a pediatric neurologist or pediatric rehabilitation specialist. \n3. Etiology: The insult to the central nervous system that caused the motor dysfunction must have occurred during gestation or within one year after birth independent of gestational age. \n4. Disease severity level: Gross Motor Function Classification System (GMFCS) levels I, II and III. \n" ], "offsets": [ [ 0, 645 ] ] } ]

[ { "id": "NCT02167022_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 3, 6 ] ], "normalized": [] }, { "id": "NCT02167022_inc_T6", "type": "Value", "text": [ "12 to 36 months of age" ], "offsets": [ [ 8, 30 ] ], "normalized": [] }, { "id": "NCT02167022_inc_T8", "type": "Condition", "text": [ "spastic CP" ], "offsets": [ [ 267, 277 ] ], "normalized": [] }, { "id": "NCT02167022_inc_T10", "type": "Temporal", "text": [ "one year after birth" ], "offsets": [ [ 490, 510 ] ], "normalized": [] }, { "id": "NCT02167022_inc_T11", "type": "Measurement", "text": [ "Gross Motor Function Classification System (GMFCS)" ], "offsets": [ [ 571, 621 ] ], "normalized": [] }, { "id": "NCT02167022_inc_T12", "type": "Value", "text": [ "levels I, II and III" ], "offsets": [ [ 622, 642 ] ], "normalized": [] } ]

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[ { "id": "NCT02167022_inc_R1", "type": "Has_value", "arg1_id": "NCT02167022_inc_T11", "arg2_id": "NCT02167022_inc_T12", "normalized": [] } ]

[ { "id": "NCT02175186_exc_text", "type": "exclusion", "text": [ "Pregnant or breast feeding\nHistory of Stomach or esophagus surgery\nPeptic ulcer or reflux esophagitis\nZollinger-Ellison syndrome or primary esophageal motility disorders\nMalignant tumor\nBleeding tendency or coagulopathy\nContraindication of ALBIS\nLong term use of aspirin or P2Y12 receptor antagonist within 1month\nPatients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed)\nTerminal patient\n" ], "offsets": [ [ 0, 567 ] ] } ]

[ { "id": "NCT02175186_exc_T2", "type": "Procedure", "text": [ "esophagus surgery" ], "offsets": [ [ 49, 66 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T3", "type": "Procedure", "text": [ "tomach", "urgery" ], "offsets": [ [ 39, 45 ], [ 60, 66 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T4", "type": "Condition", "text": [ "reflux esophagitis" ], "offsets": [ [ 83, 101 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T5", "type": "Condition", "text": [ "Peptic ulcer" ], "offsets": [ [ 67, 79 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T6", "type": "Condition", "text": [ "Zollinger-Ellison syndrome" ], "offsets": [ [ 102, 128 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T7", "type": "Condition", "text": [ "primary esophageal motility disorders" ], "offsets": [ [ 132, 169 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T8", "type": "Condition", "text": [ "Malignant tumor" ], "offsets": [ [ 170, 185 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T9", "type": "Condition", "text": [ "Bleeding tendency" ], "offsets": [ [ 186, 203 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T10", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 207, 219 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T11", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 220, 236 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T12", "type": "Drug", "text": [ "ALBIS" ], "offsets": [ [ 240, 245 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T13", "type": "Qualifier", "text": [ "Long term" ], "offsets": [ [ 246, 255 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T14", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 263, 270 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T15", "type": "Drug", "text": [ "P2Y12 receptor antagonist" ], "offsets": [ [ 274, 299 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T16", "type": "Temporal", "text": [ "within 1month" ], "offsets": [ [ 300, 313 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T17", "type": "Scope", "text": [ "aspirin or P2Y12 receptor antagonist" ], "offsets": [ [ 263, 299 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T18", "type": "Drug", "text": [ "PPI" ], "offsets": [ [ 349, 352 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T19", "type": "Drug", "text": [ "APA" ], "offsets": [ [ 354, 357 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T20", "type": "Drug", "text": [ "H2blocker" ], "offsets": [ [ 358, 367 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T21", "type": "Drug", "text": [ "Muscarine receptor antagonist" ], "offsets": [ [ 369, 398 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T22", "type": "Drug", "text": [ "anti-gastic agent" ], "offsets": [ [ 400, 417 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T23", "type": "Drug", "text": [ "antacid" ], "offsets": [ [ 419, 426 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T24", "type": "Drug", "text": [ "anticaogulant" ], "offsets": [ [ 428, 441 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T25", "type": "Drug", "text": [ "Bisphosphonate agents" ], "offsets": [ [ 443, 464 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T26", "type": "Drug", "text": [ "Cytotoxic drug" ], "offsets": [ [ 466, 480 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T27", "type": "Drug", "text": [ "NSAID" ], "offsets": [ [ 482, 487 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T28", "type": "Drug", "text": [ "adrenal cortex hormone agents" ], "offsets": [ [ 489, 518 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T29", "type": "Procedure", "text": [ "topical treatment" ], "offsets": [ [ 520, 537 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T30", "type": "Negation", "text": [ "allowed" ], "offsets": [ [ 541, 548 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T31", "type": "Person", "text": [ "patient" ], "offsets": [ [ 559, 566 ] ], "normalized": [] }, { "id": "NCT02175186_exc_T32", "type": "Qualifier", "text": [ "Terminal" ], "offsets": [ [ 550, 558 ] ], "normalized": [] } ]

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[ { "id": "NCT02175186_exc_R1", "type": "AND", "arg1_id": "NCT02175186_exc_T11", "arg2_id": "NCT02175186_exc_T12", "normalized": [] }, { "id": "NCT02175186_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT02175186_exc_T17", "arg2_id": "NCT02175186_exc_T13", "normalized": [] }, { "id": "NCT02175186_exc_R3", "type": "Has_temporal", "arg1_id": "NCT02175186_exc_T17", "arg2_id": "NCT02175186_exc_T16", "normalized": [] }, { "id": "NCT02175186_exc_R4", "type": "Has_negation", "arg1_id": "NCT02175186_exc_T29", "arg2_id": "NCT02175186_exc_T30", "normalized": [] }, { "id": "NCT02175186_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT02175186_exc_T31", "arg2_id": "NCT02175186_exc_T32", "normalized": [] } ]

[ { "id": "NCT02175186_inc_text", "type": "inclusion", "text": [ "Age between 20 and 80 years\nPatients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks\nModified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy\nmild gastrointestinal symptom\nCreatinen in blood = 3mg/dl\nBUN = 50mg/dl\nBirilubin = 3mg/dl\nAST and ALT = 80U/L\n" ], "offsets": [ [ 0, 343 ] ] } ]

[ { "id": "NCT02175186_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T2", "type": "Value", "text": [ "between 20 and 80 years" ], "offsets": [ [ 4, 27 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T3", "type": "Procedure", "text": [ "percutaneous coronary intervention" ], "offsets": [ [ 48, 82 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T4", "type": "Procedure", "text": [ "dual antiplatelet therapy" ], "offsets": [ [ 100, 125 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T5", "type": "Qualifier", "text": [ "continuously" ], "offsets": [ [ 126, 138 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T6", "type": "Temporal", "text": [ "at least 12weeks" ], "offsets": [ [ 139, 155 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T7", "type": "Measurement", "text": [ "Modified Lanza Score grade" ], "offsets": [ [ 156, 182 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T8", "type": "Value", "text": [ "0-1" ], "offsets": [ [ 183, 186 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T9", "type": "Procedure", "text": [ "upper gastrointestinal endoscopy" ], "offsets": [ [ 199, 231 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T10", "type": "Condition", "text": [ "gastrointestinal symptom" ], "offsets": [ [ 237, 261 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T11", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 232, 236 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T12", "type": "Measurement", "text": [ "Creatinen" ], "offsets": [ [ 262, 271 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T13", "type": "Value", "text": [ "= 3mg/dl" ], "offsets": [ [ 281, 289 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T14", "type": "Measurement", "text": [ "BUN" ], "offsets": [ [ 290, 293 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T15", "type": "Value", "text": [ "= 50mg/dl" ], "offsets": [ [ 294, 303 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T16", "type": "Measurement", "text": [ "Birilubin" ], "offsets": [ [ 304, 313 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T17", "type": "Value", "text": [ "= 3mg/dl" ], "offsets": [ [ 314, 322 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T18", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 323, 326 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T19", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 331, 334 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T20", "type": "Scope", "text": [ "AST and ALT" ], "offsets": [ [ 323, 334 ] ], "normalized": [] }, { "id": "NCT02175186_inc_T21", "type": "Value", "text": [ "= 80U/L" ], "offsets": [ [ 335, 342 ] ], "normalized": [] } ]

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[ { "id": "NCT02175186_inc_R1", "type": "Has_value", "arg1_id": "NCT02175186_inc_T1", "arg2_id": "NCT02175186_inc_T2", "normalized": [] }, { "id": "NCT02175186_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT02175186_inc_T4", "arg2_id": "NCT02175186_inc_T5", "normalized": [] }, { "id": "NCT02175186_inc_R3", "type": "Has_temporal", "arg1_id": "NCT02175186_inc_T4", "arg2_id": "NCT02175186_inc_T6", "normalized": [] }, { "id": "NCT02175186_inc_R4", "type": "Has_value", "arg1_id": "NCT02175186_inc_T7", "arg2_id": "NCT02175186_inc_T8", "normalized": [] }, { "id": "NCT02175186_inc_R5", "type": "AND", "arg1_id": "NCT02175186_inc_T9", "arg2_id": "NCT02175186_inc_T7", "normalized": [] }, { "id": "NCT02175186_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT02175186_inc_T10", "arg2_id": "NCT02175186_inc_T11", "normalized": [] }, { "id": "NCT02175186_inc_R7", "type": "Has_value", "arg1_id": "NCT02175186_inc_T12", "arg2_id": "NCT02175186_inc_T13", "normalized": [] }, { "id": "NCT02175186_inc_R8", "type": "Has_value", "arg1_id": "NCT02175186_inc_T14", "arg2_id": "NCT02175186_inc_T15", "normalized": [] }, { "id": "NCT02175186_inc_R9", "type": "Has_value", "arg1_id": "NCT02175186_inc_T16", "arg2_id": "NCT02175186_inc_T17", "normalized": [] }, { "id": "NCT02175186_inc_R10", "type": "Has_value", "arg1_id": "NCT02175186_inc_T20", "arg2_id": "NCT02175186_inc_T21", "normalized": [] } ]