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NCT00050349_exc
NCT00050349
[ { "id": "NCT00050349_exc_text", "type": "exclusion", "text": [ "Patients with symptomatic CNS metastases or leptomeningeal involvement \nPatients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression. \nPatients with bone metastases as the only site(s) of measurable disease \nPatients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease) \nPatients who have been previously treated with radioactive directed therapies \nPatients who have been previously treated with epothilone \nPatients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 \nPatients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports \nPatients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ \nPatients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae \nPatients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits \nHIV+ patients \nPregnant or lactating females. \n \n" ], "offsets": [ [ 0, 1564 ] ] } ]
[ { "id": "NCT00050349_exc_T1", "text": [ "CNS metastases" ], "type": "Condition", "offsets": [ [ 26, 40 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T2", "text": [ "leptomeningeal involvement" ], "type": "Condition", "offsets": [ [ 44, 70 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T5", "text": [ "treated" ], "type": "Procedure", "offsets": [ [ 144, 151 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T6", "text": [ "been stable for" ], "type": "Qualifier", "offsets": [ [ 164, 179 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T7", "text": [ "at least six months prior to study start" ], "type": "Temporal", "offsets": [ [ 180, 220 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T4", "text": [ "brain metastases" ], "type": "Condition", "offsets": [ [ 92, 108 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T8", "text": [ "history of" ], "type": "Observation", "offsets": [ [ 238, 248 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T9", "text": [ "brain metastases" ], "type": "Condition", "offsets": [ [ 249, 265 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T10", "text": [ "head CT with contrast" ], "type": "Procedure", "offsets": [ [ 278, 299 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T11", "text": [ "history of brain metastases" ], "type": "Scope", "offsets": [ [ 238, 265 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T12", "text": [ "bone metastases" ], "type": "Condition", "offsets": [ [ 359, 374 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T13", "text": [ "hepatic artery chemoembolization" ], "type": "Procedure", "offsets": [ [ 432, 464 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T14", "text": [ "within the last 6 months" ], "type": "Temporal", "offsets": [ [ 465, 489 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T15", "text": [ "one month" ], "type": "Temporal", "offsets": [ [ 491, 500 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T16", "text": [ "other sites of measurable disease" ], "type": "Observation", "offsets": [ [ 514, 547 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T17", "text": [ "within the last 6 months (one month if there are other sites of measurable disease" ], "type": "Scope", "offsets": [ [ 465, 547 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T18", "text": [ "radioactive directed therapies" ], "type": "Procedure", "offsets": [ [ 597, 627 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T19", "text": [ "epothilone" ], "type": "Drug", "offsets": [ [ 676, 686 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T20", "text": [ "peripheral neuropathy" ], "type": "Condition", "offsets": [ [ 706, 727 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T21", "text": [ "unresolved diarrhea" ], "type": "Condition", "offsets": [ [ 731, 750 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T22", "text": [ "Grade" ], "type": "Measurement", "offsets": [ [ 764, 769 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T23", "text": [ "greater than", "1" ], "type": "Value", "offsets": [ [ 751, 763 ], [ 770, 771 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T24", "text": [ "severe cardiac insufficiency" ], "type": "Condition", "offsets": [ [ 787, 815 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T25", "text": [ "Coumadin" ], "type": "Drug", "offsets": [ [ 832, 840 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T26", "text": [ "warfarin-containing agents" ], "type": "Drug", "offsets": [ [ 850, 876 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T27", "text": [ "low dose" ], "type": "Qualifier", "offsets": [ [ 899, 907 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T28", "text": [ "warfarin" ], "type": "Drug", "offsets": [ [ 908, 916 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T29", "text": [ "1 mg or less" ], "type": "Multiplier", "offsets": [ [ 918, 930 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T30", "text": [ "in-dwelling lines" ], "type": "Device", "offsets": [ [ 955, 972 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T31", "text": [ "in-dwelling", "ports" ], "type": "Device", "offsets": [ [ 955, 966 ], [ 976, 981 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T32", "text": [ "severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less)" ], "type": "Scope", "offsets": [ [ 787, 931 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T34", "text": [ "another malignancy" ], "type": "Condition", "offsets": [ [ 1037, 1055 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T35", "text": [ "within 5 years prior to study entry" ], "type": "Temporal", "offsets": [ [ 1056, 1091 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T36", "text": [ "Coumadin or other warfarin-containing agents" ], "type": "Scope", "offsets": [ [ 832, 876 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T37", "text": [ "non-melanoma skin cancer" ], "type": "Condition", "offsets": [ [ 1118, 1142 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T38", "text": [ "curatively treated" ], "type": "Qualifier", "offsets": [ [ 1099, 1117 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T39", "text": [ "prostate cancer" ], "type": "Condition", "offsets": [ [ 1144, 1159 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T40", "text": [ "cervical cancer in situ" ], "type": "Condition", "offsets": [ [ 1164, 1187 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T41", "text": [ "non-melanoma skin cancer, prostate cancer, or cervical cancer in situ" ], "type": "Scope", "offsets": [ [ 1118, 1187 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T42", "text": [ "history of" ], "type": "Observation", "offsets": [ [ 1026, 1036 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T43", "text": [ "uncontrolled infection" ], "type": "Condition", "offsets": [ [ 1240, 1262 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T44", "text": [ "abcesses" ], "type": "Condition", "offsets": [ [ 1273, 1281 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T45", "text": [ "fistulae" ], "type": "Condition", "offsets": [ [ 1285, 1293 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T46", "text": [ "abcesses or fistulae" ], "type": "Scope", "offsets": [ [ 1273, 1293 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T47", "text": [ "active" ], "type": "Qualifier", "offsets": [ [ 1203, 1209 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T48", "text": [ "suspected" ], "type": "Qualifier", "offsets": [ [ 1213, 1222 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T49", "text": [ "acute" ], "type": "Qualifier", "offsets": [ [ 1223, 1228 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T50", "text": [ "chronic" ], "type": "Qualifier", "offsets": [ [ 1232, 1239 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T51", "text": [ "active or suspected acute or chronic" ], "type": "Scope", "offsets": [ [ 1203, 1239 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T52", "text": [ "psychiatric illness" ], "type": "Condition", "offsets": [ [ 1322, 1341 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T53", "text": [ "medical", "illness" ], "type": "Condition", "offsets": [ [ 1311, 1318 ], [ 1334, 1341 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T54", "text": [ "preclude study" ], "type": "Observation", "offsets": [ [ 1353, 1367 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T55", "text": [ "informed consent" ], "type": "Observation", "offsets": [ [ 1371, 1387 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T56", "text": [ "noncompliance to medical regimens" ], "type": "Observation", "offsets": [ [ 1406, 1439 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T57", "text": [ "inability", "to return for all scheduled visits" ], "type": "Observation", "offsets": [ [ 1443, 1452 ], [ 1470, 1504 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T58", "text": [ "unwillingness to return for all scheduled visit" ], "type": "Observation", "offsets": [ [ 1456, 1503 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T59", "text": [ "would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits" ], "type": "Scope", "offsets": [ [ 1347, 1504 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T60", "text": [ "HIV+" ], "type": "Condition", "offsets": [ [ 1506, 1510 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T61", "text": [ "HIV" ], "type": "Measurement", "offsets": [ [ 1506, 1509 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T62", "text": [ "+" ], "type": "Value", "offsets": [ [ 1509, 1510 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T63", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 1521, 1529 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T64", "text": [ "lactating" ], "type": "Condition", "offsets": [ [ 1533, 1542 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T65", "text": [ "symptomatic" ], "type": "Qualifier", "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T3", "text": [ "with the exception of" ], "type": "Negation", "offsets": [ [ 877, 898 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T66", "text": [ "except" ], "type": "Negation", "offsets": [ [ 1092, 1098 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T67", "text": [ "previously" ], "type": "Temporal", "offsets": [ [ 652, 662 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T68", "text": [ "previously" ], "type": "Temporal", "offsets": [ [ 573, 583 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T69", "text": [ "only site(s) of measurable disease" ], "type": "Multiplier", "offsets": [ [ 382, 416 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T70", "text": [ "unless" ], "type": "Negation", "offsets": [ [ 110, 116 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00050349_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00050349_exc_T6", "arg2_id": "NCT00050349_exc_T7", "normalized": [] }, { "id": "NCT00050349_exc_R3", "type": "AND", "arg1_id": "NCT00050349_exc_T8", "arg2_id": "NCT00050349_exc_T9", "normalized": [] }, { "id": "NCT00050349_exc_R4", "type": "AND", "arg1_id": "NCT00050349_exc_T11", "arg2_id": "NCT00050349_exc_T10", "normalized": [] }, { "id": "NCT00050349_exc_R6", "type": "Has_scope", "arg1_id": "NCT00050349_exc_T13", "arg2_id": "NCT00050349_exc_T17", "normalized": [] }, { "id": "NCT00050349_exc_R7", "type": "AND", "arg1_id": "NCT00050349_exc_T21", "arg2_id": "NCT00050349_exc_T22", "normalized": [] }, { "id": "NCT00050349_exc_R8", "type": "Has_value", "arg1_id": "NCT00050349_exc_T22", "arg2_id": "NCT00050349_exc_T23", "normalized": [] }, { "id": "NCT00050349_exc_R9", "type": "AND", "arg1_id": "NCT00050349_exc_T24", "arg2_id": "NCT00050349_exc_T25", "normalized": [] }, { "id": "NCT00050349_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT00050349_exc_T28", "arg2_id": "NCT00050349_exc_T27", "normalized": [] }, { "id": "NCT00050349_exc_R11", "type": "AND", "arg1_id": "NCT00050349_exc_T32", "arg2_id": "NCT00050349_exc_T30", "normalized": [] }, { "id": "NCT00050349_exc_R13", "type": "Has_temporal", "arg1_id": "NCT00050349_exc_T34", "arg2_id": "NCT00050349_exc_T35", "normalized": [] }, { "id": "NCT00050349_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT00050349_exc_T41", "arg2_id": "NCT00050349_exc_T38", "normalized": [] }, { "id": "NCT00050349_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00050349_exc_T34", "arg2_id": "NCT00050349_exc_T42", "normalized": [] }, { "id": "NCT00050349_exc_R17", "type": "Subsumes", "arg1_id": "NCT00050349_exc_T43", "arg2_id": "NCT00050349_exc_T46", "normalized": [] }, { "id": "NCT00050349_exc_R18", "type": "Has_scope", "arg1_id": "NCT00050349_exc_T43", "arg2_id": "NCT00050349_exc_T51", "normalized": [] }, { "id": "NCT00050349_exc_R19", "type": "Has_scope", "arg1_id": "NCT00050349_exc_T53", "arg2_id": "NCT00050349_exc_T59", "normalized": [] }, { "id": "NCT00050349_exc_R2", "type": "AND", "arg1_id": "NCT00050349_exc_T4", "arg2_id": "NCT00050349_exc_T5", "normalized": [] }, { "id": "NCT00050349_exc_R20", "type": "Has_value", "arg1_id": "NCT00050349_exc_T61", "arg2_id": "NCT00050349_exc_T62", "normalized": [] }, { "id": "NCT00050349_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT00050349_exc_T1", "arg2_id": "NCT00050349_exc_T65", "normalized": [] }, { "id": "NCT00050349_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT00050349_exc_T2", "arg2_id": "NCT00050349_exc_T65", "normalized": [] }, { "id": "NCT00050349_exc_R12", "type": "Has_negation", "arg1_id": "NCT00050349_exc_T28", "arg2_id": "NCT00050349_exc_T3", "normalized": [] }, { "id": "NCT00050349_exc_R24", "type": "AND", "arg1_id": "NCT00050349_exc_T36", "arg2_id": "NCT00050349_exc_T28", "normalized": [] }, { "id": "NCT00050349_exc_R15", "type": "Has_negation", "arg1_id": "NCT00050349_exc_T41", "arg2_id": "NCT00050349_exc_T66", "normalized": [] }, { "id": "NCT00050349_exc_R25", "type": "Has_scope", "arg1_id": "NCT00050349_exc_T34", "arg2_id": "NCT00050349_exc_T41", "normalized": [] }, { "id": "NCT00050349_exc_R26", "type": "Has_temporal", "arg1_id": "NCT00050349_exc_T19", "arg2_id": "NCT00050349_exc_T67", "normalized": [] }, { "id": "NCT00050349_exc_R27", "type": "Has_temporal", "arg1_id": "NCT00050349_exc_T18", "arg2_id": "NCT00050349_exc_T68", "normalized": [] }, { "id": "NCT00050349_exc_R28", "type": "AND", "arg1_id": "NCT00050349_exc_T69", "arg2_id": "NCT00050349_exc_T12", "normalized": [] }, { "id": "NCT00050349_exc_R29", "type": "Has_negation", "arg1_id": "NCT00050349_exc_T5", "arg2_id": "NCT00050349_exc_T70", "normalized": [] } ]
NCT00050349_inc
NCT00050349
[ { "id": "NCT00050349_inc_text", "type": "inclusion", "text": [ "Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy \nThe patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present) \nPatients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry \nMust have a life expectancy of greater than three (3) months \nKarnofsky Performance Status > 60 \nFemale patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.) \n" ], "offsets": [ [ 0, 1064 ] ] } ]
[ { "id": "NCT00050349_inc_T1", "text": [ "metastatic carcinoid tumors" ], "type": "Condition", "offsets": [ [ 28, 55 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T2", "text": [ "proven" ], "type": "Value", "offsets": [ [ 21, 27 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T3", "text": [ "biopsy" ], "type": "Procedure", "offsets": [ [ 14, 20 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T4", "text": [ "other neuroendocrine tumors" ], "type": "Condition", "offsets": [ [ 59, 86 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T5", "text": [ "Islet cell" ], "type": "Condition", "offsets": [ [ 88, 98 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T6", "text": [ "Gastrinomas" ], "type": "Condition", "offsets": [ [ 100, 111 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T7", "text": [ "VIPomas" ], "type": "Condition", "offsets": [ [ 116, 123 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T8", "text": [ "Islet cell, Gastrinomas and VIPomas" ], "type": "Scope", "offsets": [ [ 88, 123 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T9", "text": [ "measurable lesion" ], "type": "Condition", "offsets": [ [ 143, 160 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T10", "text": [ "bone" ], "type": "Qualifier", "offsets": [ [ 173, 177 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T11", "text": [ "biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas)" ], "type": "Scope", "offsets": [ [ 14, 124 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T12", "text": [ "irradiated" ], "type": "Procedure", "offsets": [ [ 215, 225 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T13", "text": [ "irradiated" ], "type": "Procedure", "offsets": [ [ 243, 253 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T14", "text": [ "progression" ], "type": "Observation", "offsets": [ [ 271, 282 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T15", "text": [ "radiation therapy" ], "type": "Procedure", "offsets": [ [ 293, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T16", "text": [ "since the radiation therapy" ], "type": "Temporal", "offsets": [ [ 283, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T18", "text": [ "not been" ], "type": "Negation", "offsets": [ [ 195, 203 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T17", "text": [ "not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy" ], "type": "Scope", "offsets": [ [ 195, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T19", "text": [ "major impairment of renal", "function" ], "type": "Condition", "offsets": [ [ 331, 356 ], [ 368, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T20", "text": [ "major impairment of", "hepatic function" ], "type": "Condition", "offsets": [ [ 331, 350 ], [ 360, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T21", "text": [ "no" ], "type": "Negation", "offsets": [ [ 328, 330 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T22", "text": [ "major impairment of renal or hepatic function" ], "type": "Scope", "offsets": [ [ 331, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T23", "text": [ "total bilirubin" ], "type": "Measurement", "offsets": [ [ 429, 444 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T24", "text": [ "<1.5 X ULN" ], "type": "Value", "offsets": [ [ 445, 455 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T25", "text": [ "AST" ], "type": "Measurement", "offsets": [ [ 457, 460 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T26", "text": [ "ALT" ], "type": "Measurement", "offsets": [ [ 462, 465 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T27", "text": [ "<2.5X ULN" ], "type": "Value", "offsets": [ [ 465, 474 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T28", "text": [ "liver metastases" ], "type": "Condition", "offsets": [ [ 488, 504 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T29", "text": [ "<5 X ULN" ], "type": "Value", "offsets": [ [ 476, 484 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T30", "text": [ "AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)" ], "type": "Scope", "offsets": [ [ 457, 517 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T31", "text": [ "total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)" ], "type": "Scope", "offsets": [ [ 429, 517 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T32", "text": [ "Sandostatin Lar" ], "type": "Drug", "offsets": [ [ 531, 546 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T33", "text": [ "long acting somatostatin analogue" ], "type": "Drug", "offsets": [ [ 548, 581 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T34", "text": [ "stable dose" ], "type": "Qualifier", "offsets": [ [ 596, 607 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T35", "text": [ "for 30 days prior to study entry" ], "type": "Temporal", "offsets": [ [ 608, 640 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T36", "text": [ "short acting somatostatin analogues" ], "type": "Drug", "offsets": [ [ 645, 680 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T37", "text": [ "clinically stable dose" ], "type": "Qualifier", "offsets": [ [ 707, 729 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T38", "text": [ "prior to study entry" ], "type": "Temporal", "offsets": [ [ 750, 770 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T39", "text": [ "life expectancy" ], "type": "Observation", "offsets": [ [ 784, 799 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T40", "text": [ "greater than three (3) months" ], "type": "Value", "offsets": [ [ 803, 832 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T41", "text": [ "Karnofsky Performance Status" ], "type": "Measurement", "offsets": [ [ 834, 862 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T42", "text": [ "> 60" ], "type": "Value", "offsets": [ [ 863, 867 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T43", "text": [ "Female" ], "type": "Person", "offsets": [ [ 869, 875 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T44", "text": [ "serum pregnancy test" ], "type": "Measurement", "offsets": [ [ 906, 926 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T45", "text": [ "negative" ], "type": "Value", "offsets": [ [ 897, 905 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T46", "text": [ "at screening" ], "type": "Temporal", "offsets": [ [ 927, 939 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T47", "text": [ "bilateral oophorectomy" ], "type": "Procedure", "offsets": [ [ 974, 996 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T48", "text": [ "hysterectomy" ], "type": "Procedure", "offsets": [ [ 1004, 1016 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T49", "text": [ "postmenopausal" ], "type": "Condition", "offsets": [ [ 1046, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T51", "text": [ "bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal" ], "type": "Scope", "offsets": [ [ 974, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T50", "text": [ "bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal" ], "type": "Scope", "offsets": [ [ 974, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T52", "text": [ "negative serum pregnancy test at screening" ], "type": "Scope", "offsets": [ [ 897, 939 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T53", "text": [ "radiation therapy" ], "type": "Reference_point", "offsets": [ [ 293, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T54", "text": [ "other than" ], "type": "Negation", "offsets": [ [ 162, 172 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00050349_inc_R1", "type": "Has_value", "arg1_id": "NCT00050349_inc_T3", "arg2_id": "NCT00050349_inc_T2", "normalized": [] }, { "id": "NCT00050349_inc_R2", "type": "AND", "arg1_id": "NCT00050349_inc_T1", "arg2_id": "NCT00050349_inc_T3", "normalized": [] }, { "id": "NCT00050349_inc_R3", "type": "Subsumes", "arg1_id": "NCT00050349_inc_T4", "arg2_id": "NCT00050349_inc_T8", "normalized": [] }, { "id": "NCT00050349_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00050349_inc_T14", "arg2_id": "NCT00050349_inc_T16", "normalized": [] }, { "id": "NCT00050349_inc_R5", "type": "Has_negation", "arg1_id": "NCT00050349_inc_T12", "arg2_id": "NCT00050349_inc_T18", "normalized": [] }, { "id": "NCT00050349_inc_R9", "type": "AND", "arg1_id": "NCT00050349_inc_T11", "arg2_id": "NCT00050349_inc_T9", "normalized": [] }, { "id": "NCT00050349_inc_R8", "type": "Has_scope", "arg1_id": "NCT00050349_inc_T9", "arg2_id": "NCT00050349_inc_T17", "normalized": [] }, { "id": "NCT00050349_inc_R10", "type": "Has_negation", "arg1_id": "NCT00050349_inc_T22", "arg2_id": "NCT00050349_inc_T21", "normalized": [] }, { "id": "NCT00050349_inc_R11", "type": "AND", "arg1_id": "NCT00050349_inc_T29", "arg2_id": "NCT00050349_inc_T28", "normalized": [] }, { "id": "NCT00050349_inc_R12", "type": "Has_value", "arg1_id": "NCT00050349_inc_T26", "arg2_id": "NCT00050349_inc_T27", "normalized": [] }, { "id": "NCT00050349_inc_R13", "type": "Has_value", "arg1_id": "NCT00050349_inc_T25", "arg2_id": "NCT00050349_inc_T27", "normalized": [] }, { "id": "NCT00050349_inc_R14", "type": "Has_value", "arg1_id": "NCT00050349_inc_T23", "arg2_id": "NCT00050349_inc_T24", "normalized": [] }, { "id": "NCT00050349_inc_R15", "type": "Subsumes", "arg1_id": "NCT00050349_inc_T22", "arg2_id": "NCT00050349_inc_T31", "normalized": [] }, { "id": "NCT00050349_inc_R16", "type": "Subsumes", "arg1_id": "NCT00050349_inc_T32", "arg2_id": "NCT00050349_inc_T33", "normalized": [] }, { "id": "NCT00050349_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00050349_inc_T37", "arg2_id": "NCT00050349_inc_T38", "normalized": [] }, { "id": "NCT00050349_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT00050349_inc_T32", "arg2_id": "NCT00050349_inc_T34", "normalized": [] }, { "id": "NCT00050349_inc_R19", "type": "Has_temporal", "arg1_id": "NCT00050349_inc_T34", "arg2_id": "NCT00050349_inc_T35", "normalized": [] }, { "id": "NCT00050349_inc_R20", "type": "Has_qualifier", "arg1_id": "NCT00050349_inc_T36", "arg2_id": "NCT00050349_inc_T37", "normalized": [] }, { "id": "NCT00050349_inc_R21", "type": "Has_value", "arg1_id": "NCT00050349_inc_T39", "arg2_id": "NCT00050349_inc_T40", "normalized": [] }, { "id": "NCT00050349_inc_R22", "type": "Has_value", "arg1_id": "NCT00050349_inc_T41", "arg2_id": "NCT00050349_inc_T42", "normalized": [] }, { "id": "NCT00050349_inc_R23", "type": "Has_value", "arg1_id": "NCT00050349_inc_T44", "arg2_id": "NCT00050349_inc_T45", "normalized": [] }, { "id": "NCT00050349_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00050349_inc_T44", "arg2_id": "NCT00050349_inc_T46", "normalized": [] }, { "id": "NCT00050349_inc_R25", "type": "AND", "arg1_id": "NCT00050349_inc_T43", "arg2_id": "NCT00050349_inc_T44", "normalized": [] }, { "id": "NCT00050349_inc_R27", "type": "Has_index", "arg1_id": "NCT00050349_inc_T16", "arg2_id": "NCT00050349_inc_T53", "normalized": [] }, { "id": "NCT00050349_inc_R4", "type": "Has_negation", "arg1_id": "NCT00050349_inc_T10", "arg2_id": "NCT00050349_inc_T54", "normalized": [] }, { "id": "NCT00050349_inc_R28", "type": "Has_qualifier", "arg1_id": "NCT00050349_inc_T9", "arg2_id": "NCT00050349_inc_T10", "normalized": [] } ]
NCT00061308_exc
NCT00061308
[ { "id": "NCT00061308_exc_text", "type": "exclusion", "text": [ "Women of child-bearing potential that do not practice adequate contraception. \nPregnant or lactating. \nReceived more than one primary chemotherapy regimen. \nConcomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years. \nActive uncontrolled infection requiring antibiotics. \nConcurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study. \nReceived radiation to more than 10% of bone. \nPrior treatment with topotecan or gemcitabine. \nHypersensitivity to camptothecin or nucleoside analogues. \nUse of an investigational agent within 30 days. \n \n" ], "offsets": [ [ 0, 779 ] ] } ]
[ { "id": "NCT00061308_exc_T1", "text": [ "Women" ], "type": "Person", "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T2", "text": [ "child-bearing potential" ], "type": "Condition", "offsets": [ [ 9, 32 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T3", "text": [ "do not" ], "type": "Negation", "offsets": [ [ 38, 44 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T4", "text": [ "adequate contraception" ], "type": "Procedure", "offsets": [ [ 54, 76 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T5", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 79, 87 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T6", "text": [ "lactating" ], "type": "Condition", "offsets": [ [ 91, 100 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T7", "text": [ "primary chemotherapy regimen" ], "type": "Drug", "offsets": [ [ 126, 154 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T8", "text": [ "more than one" ], "type": "Multiplier", "offsets": [ [ 112, 125 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T9", "text": [ "malignancies" ], "type": "Condition", "offsets": [ [ 181, 193 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T10", "text": [ "previous" ], "type": "Qualifier", "offsets": [ [ 172, 180 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T11", "text": [ "Concomitant" ], "type": "Qualifier", "offsets": [ [ 157, 168 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T12", "text": [ "Concomitant or previous" ], "type": "Scope", "offsets": [ [ 157, 180 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T13", "text": [ "basal cell", "skin cancer" ], "type": "Condition", "offsets": [ [ 235, 245 ], [ 263, 274 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T14", "text": [ "squamous cell skin cancer" ], "type": "Condition", "offsets": [ [ 249, 274 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T15", "text": [ "in situ cervical cancer" ], "type": "Condition", "offsets": [ [ 276, 299 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T16", "text": [ "incidental carcinoid" ], "type": "Condition", "offsets": [ [ 301, 321 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T17", "text": [ "other cancer" ], "type": "Condition", "offsets": [ [ 326, 338 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T18", "text": [ "the exception of" ], "type": "Negation", "offsets": [ [ 199, 215 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T19", "text": [ "adequately treated" ], "type": "Qualifier", "offsets": [ [ 216, 234 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T20", "text": [ "basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer" ], "type": "Scope", "offsets": [ [ 235, 338 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T21", "text": [ "for 5 years" ], "type": "Temporal", "offsets": [ [ 384, 395 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T22", "text": [ "has been disease free" ], "type": "Qualifier", "offsets": [ [ 362, 383 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T23", "text": [ "infection" ], "type": "Condition", "offsets": [ [ 418, 427 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T24", "text": [ "Active uncontrolled" ], "type": "Qualifier", "offsets": [ [ 398, 417 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T25", "text": [ "antibiotics" ], "type": "Drug", "offsets": [ [ 438, 449 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T27", "text": [ "radiation" ], "type": "Procedure", "offsets": [ [ 575, 584 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T28", "text": [ "more than 10%" ], "type": "Value", "offsets": [ [ 588, 601 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T29", "text": [ "bone" ], "type": "Qualifier", "offsets": [ [ 605, 609 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T30", "text": [ "topotecan" ], "type": "Drug", "offsets": [ [ 633, 642 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T31", "text": [ "gemcitabine" ], "type": "Drug", "offsets": [ [ 646, 657 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T32", "text": [ "treatment" ], "type": "Observation", "offsets": [ [ 618, 627 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T33", "text": [ "topotecan or gemcitabine" ], "type": "Scope", "offsets": [ [ 633, 657 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T34", "text": [ "Hypersensitivity" ], "type": "Condition", "offsets": [ [ 660, 676 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T35", "text": [ "camptothecin" ], "type": "Drug", "offsets": [ [ 680, 692 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T36", "text": [ "nucleoside analogues" ], "type": "Drug", "offsets": [ [ 696, 716 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T37", "text": [ "camptothecin or nucleoside analogues" ], "type": "Scope", "offsets": [ [ 680, 716 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T38", "text": [ "investigational agent" ], "type": "Drug", "offsets": [ [ 729, 750 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T39", "text": [ "within 30 days" ], "type": "Temporal", "offsets": [ [ 751, 765 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T40", "text": [ "Prior" ], "type": "Temporal", "offsets": [ [ 612, 617 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T26", "text": [ "Concurrent" ], "type": "Temporal", "offsets": [ [ 452, 462 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T41", "text": [ "severe" ], "type": "Qualifier", "offsets": [ [ 463, 469 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T42", "text": [ "medical problems" ], "type": "Condition", "offsets": [ [ 470, 486 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T43", "text": [ "limit full compliance with the study" ], "type": "Qualifier", "offsets": [ [ 527, 563 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T44", "text": [ "unrelated to the malignancy" ], "type": "Qualifier", "offsets": [ [ 487, 514 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T45", "text": [ "malignancy" ], "type": "Condition", "offsets": [ [ 504, 514 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00061308_exc_R1", "type": "Has_negation", "arg1_id": "NCT00061308_exc_T4", "arg2_id": "NCT00061308_exc_T3", "normalized": [] }, { "id": "NCT00061308_exc_R2", "type": "AND", "arg1_id": "NCT00061308_exc_T2", "arg2_id": "NCT00061308_exc_T4", "normalized": [] }, { "id": "NCT00061308_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT00061308_exc_T7", "arg2_id": "NCT00061308_exc_T8", "normalized": [] }, { "id": "NCT00061308_exc_R4", "type": "Has_scope", "arg1_id": "NCT00061308_exc_T9", "arg2_id": "NCT00061308_exc_T12", "normalized": [] }, { "id": "NCT00061308_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T20", "arg2_id": "NCT00061308_exc_T19", "normalized": [] }, { "id": "NCT00061308_exc_R6", "type": "Has_negation", "arg1_id": "NCT00061308_exc_T20", "arg2_id": "NCT00061308_exc_T18", "normalized": [] }, { "id": "NCT00061308_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00061308_exc_T22", "arg2_id": "NCT00061308_exc_T21", "normalized": [] }, { "id": "NCT00061308_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T20", "arg2_id": "NCT00061308_exc_T22", "normalized": [] }, { "id": "NCT00061308_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T23", "arg2_id": "NCT00061308_exc_T24", "normalized": [] }, { "id": "NCT00061308_exc_R10", "type": "AND", "arg1_id": "NCT00061308_exc_T23", "arg2_id": "NCT00061308_exc_T25", "normalized": [] }, { "id": "NCT00061308_exc_R11", "type": "AND", "arg1_id": "NCT00061308_exc_T29", "arg2_id": "NCT00061308_exc_T27", "normalized": [] }, { "id": "NCT00061308_exc_R12", "type": "Has_value", "arg1_id": "NCT00061308_exc_T29", "arg2_id": "NCT00061308_exc_T28", "normalized": [] }, { "id": "NCT00061308_exc_R13", "type": "Has_scope", "arg1_id": "NCT00061308_exc_T32", "arg2_id": "NCT00061308_exc_T33", "normalized": [] }, { "id": "NCT00061308_exc_R14", "type": "Has_scope", "arg1_id": "NCT00061308_exc_T34", "arg2_id": "NCT00061308_exc_T37", "normalized": [] }, { "id": "NCT00061308_exc_R15", "type": "Has_temporal", "arg1_id": "NCT00061308_exc_T38", "arg2_id": "NCT00061308_exc_T39", "normalized": [] }, { "id": "NCT00061308_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00061308_exc_T32", "arg2_id": "NCT00061308_exc_T40", "normalized": [] }, { "id": "NCT00061308_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T42", "arg2_id": "NCT00061308_exc_T41", "normalized": [] }, { "id": "NCT00061308_exc_R18", "type": "Has_temporal", "arg1_id": "NCT00061308_exc_T42", "arg2_id": "NCT00061308_exc_T26", "normalized": [] }, { "id": "NCT00061308_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T42", "arg2_id": "NCT00061308_exc_T43", "normalized": [] }, { "id": "NCT00061308_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT00061308_exc_T42", "arg2_id": "NCT00061308_exc_T44", "normalized": [] } ]
NCT00061308_inc
NCT00061308
[ { "id": "NCT00061308_inc_text", "type": "inclusion", "text": [ "Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease. \nAt least 4 weeks since last surgery or radiation therapy. \nMust have had a treatment-free interval of greater than 6 months following response to platinum. \nECOG performance status of 0,1, or 2. \n" ], "offsets": [ [ 0, 290 ] ] } ]
[ { "id": "NCT00061308_inc_T1", "text": [ "platinum-based chemotherapy regimen" ], "type": "Drug", "offsets": [ [ 19, 54 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T2", "text": [ "primary disease" ], "type": "Condition", "offsets": [ [ 76, 91 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T3", "text": [ "prior" ], "type": "Temporal", "offsets": [ [ 13, 18 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T4", "text": [ "At least 4 weeks since last surgery or radiation therapy" ], "type": "Temporal", "offsets": [ [ 94, 150 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T5", "text": [ "last surgery" ], "type": "Reference_point", "offsets": [ [ 117, 129 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T6", "text": [ "radiation therapy" ], "type": "Reference_point", "offsets": [ [ 133, 150 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T7", "text": [ "a treatment-free interval" ], "type": "Condition", "offsets": [ [ 167, 192 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T8", "text": [ "greater than 6 months following response to platinum" ], "type": "Temporal", "offsets": [ [ 196, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T9", "text": [ "response to platinum" ], "type": "Reference_point", "offsets": [ [ 228, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T10", "text": [ "platinum" ], "type": "Drug", "offsets": [ [ 240, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T11", "text": [ "ECOG performance status" ], "type": "Measurement", "offsets": [ [ 251, 274 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T12", "text": [ "0" ], "type": "Value", "offsets": [ [ 278, 279 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T13", "text": [ "0,1" ], "type": "Value", "offsets": [ [ 278, 281 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T14", "text": [ "." ], "type": "Value", "offsets": [ [ 287, 288 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T15", "text": [ "0,1, or 2" ], "type": "Scope", "offsets": [ [ 278, 287 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00061308_inc_R1", "type": "AND", "arg1_id": "NCT00061308_inc_T2", "arg2_id": "NCT00061308_inc_T1", "normalized": [] }, { "id": "NCT00061308_inc_R2", "type": "Has_temporal", "arg1_id": "NCT00061308_inc_T1", "arg2_id": "NCT00061308_inc_T3", "normalized": [] }, { "id": "NCT00061308_inc_R3", "type": "Has_index", "arg1_id": "NCT00061308_inc_T4", "arg2_id": "NCT00061308_inc_T5", "normalized": [] }, { "id": "NCT00061308_inc_R4", "type": "Has_index", "arg1_id": "NCT00061308_inc_T4", "arg2_id": "NCT00061308_inc_T6", "normalized": [] }, { "id": "NCT00061308_inc_R5", "type": "Has_index", "arg1_id": "NCT00061308_inc_T8", "arg2_id": "NCT00061308_inc_T9", "normalized": [] }, { "id": "NCT00061308_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00061308_inc_T7", "arg2_id": "NCT00061308_inc_T8", "normalized": [] }, { "id": "NCT00061308_inc_R8", "type": "Has_scope", "arg1_id": "NCT00061308_inc_T11", "arg2_id": "NCT00061308_inc_T15", "normalized": [] } ]
NCT00094861_exc
NCT00094861
[ { "id": "NCT00094861_exc_text", "type": "exclusion", "text": [ "Metastatic disease (M1)/stage 4 NSCLC \nPleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized. \nPlan to remove the tumor surgically before completing the protocol chemo/radiotherapy course \nShielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding) \nPrior chemotherapy, radiotherapy, or surgery for NSCLC \nPrior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Patients with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before patient is randomized. \nPresence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc) \nHistory of pancreatitis \nFour weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment \nPrevious treatment on this study or with a fibroblast growth factor \nKnown to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) \nPregnant or breastfeeding women \nKnown sensitivity to E. coli derived products \nCompromised ability of the patient to give written informed consent and/or to comply with study procedures \nRefusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable \nUnwilling or unable to complete the patient reported outcome (PRO) questionnaires \nPsychological, social, familial, or geographical reasons that would prevent regular follow-up \n \n" ], "offsets": [ [ 0, 2375 ] ] } ]
[ { "id": "NCT00094861_exc_T1", "text": [ "Metastatic disease", "NSCLC" ], "type": "Condition", "offsets": [ [ 0, 18 ], [ 32, 37 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T2", "text": [ "(M1)/stage 4" ], "type": "Condition", "offsets": [ [ 19, 31 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T3", "text": [ "Pleural", "effusion" ], "type": "Condition", "offsets": [ [ 39, 46 ], [ 62, 70 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T4", "text": [ "pericardial effusion" ], "type": "Condition", "offsets": [ [ 50, 70 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T5", "text": [ "greater than 100 ml in volume" ], "type": "Value", "offsets": [ [ 71, 100 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T6", "text": [ "positron emission tomography" ], "type": "Measurement", "offsets": [ [ 139, 167 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T7", "text": [ "computed tomography", "scan" ], "type": "Measurement", "offsets": [ [ 175, 194 ], [ 200, 204 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T8", "text": [ "PET" ], "type": "Measurement", "offsets": [ [ 169, 172 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T9", "text": [ "CT" ], "type": "Measurement", "offsets": [ [ 196, 198 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T10", "text": [ "ultrasound" ], "type": "Measurement", "offsets": [ [ 208, 218 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T11", "text": [ "positron emission tomography [PET], computed tomography [CT] scan or ultrasound" ], "type": "Scope", "offsets": [ [ 139, 218 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T13", "text": [ "before completing the protocol chemo/radiotherapy course" ], "type": "Temporal", "offsets": [ [ 782, 838 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T14", "text": [ "Plan to remove the tumor surgically" ], "type": "Observation", "offsets": [ [ 746, 781 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T15", "text": [ "esophagus" ], "type": "Qualifier", "offsets": [ [ 869, 878 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T16", "text": [ "any part of" ], "type": "Multiplier", "offsets": [ [ 853, 864 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T17", "text": [ "radiotherapy" ], "type": "Procedure", "offsets": [ [ 886, 898 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T18", "text": [ "Shielding" ], "type": "Procedure", "offsets": [ [ 840, 849 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T19", "text": [ "posterior spinal cord shielding" ], "type": "Procedure", "offsets": [ [ 910, 941 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T20", "text": [ "chemotherapy" ], "type": "Drug", "offsets": [ [ 950, 962 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T21", "text": [ "radiotherapy" ], "type": "Procedure", "offsets": [ [ 964, 976 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T22", "text": [ "surgery" ], "type": "Procedure", "offsets": [ [ 981, 988 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T23", "text": [ "NSCLC" ], "type": "Condition", "offsets": [ [ 993, 998 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T24", "text": [ "Prior" ], "type": "Temporal", "offsets": [ [ 944, 949 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T25", "text": [ "chemotherapy, radiotherapy, or surgery" ], "type": "Scope", "offsets": [ [ 950, 988 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T26", "text": [ "malignancy" ], "type": "Condition", "offsets": [ [ 1015, 1025 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T27", "text": [ "invasive" ], "type": "Qualifier", "offsets": [ [ 1006, 1014 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T29", "text": [ "during the past 3 years" ], "type": "Temporal", "offsets": [ [ 1026, 1049 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T28", "text": [ "other than" ], "type": "Negation", "offsets": [ [ 1050, 1060 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T30", "text": [ "non-melanomatous skin cancer" ], "type": "Condition", "offsets": [ [ 1061, 1089 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T31", "text": [ "are not" ], "type": "Negation", "offsets": [ [ 1232, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T32", "text": [ "surgically-cured malignancies" ], "type": "Condition", "offsets": [ [ 1117, 1146 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T34", "text": [ "dysphagia" ], "type": "Condition", "offsets": [ [ 1347, 1356 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T35", "text": [ "conditions predisposing to dysphagia" ], "type": "Condition", "offsets": [ [ 1360, 1396 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T36", "text": [ "gastroesophageal reflux disease" ], "type": "Condition", "offsets": [ [ 1415, 1446 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T37", "text": [ "uncontrolled" ], "type": "Qualifier", "offsets": [ [ 1402, 1414 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T38", "text": [ "GERD" ], "type": "Condition", "offsets": [ [ 1448, 1452 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T39", "text": [ "dyspepsia" ], "type": "Condition", "offsets": [ [ 1455, 1464 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T40", "text": [ "uncontrolled gastroesophageal reflux disease [GERD], dyspepsia" ], "type": "Scope", "offsets": [ [ 1402, 1464 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T41", "text": [ "dysphagia or conditions predisposing to dysphagia" ], "type": "Scope", "offsets": [ [ 1347, 1396 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T42", "text": [ "pancreatitis" ], "type": "Condition", "offsets": [ [ 1483, 1495 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T43", "text": [ "History of" ], "type": "Observation", "offsets": [ [ 1472, 1482 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T44", "text": [ "Four weeks or less since completion of treatment" ], "type": "Temporal", "offsets": [ [ 1497, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T45", "text": [ "completion of treatment" ], "type": "Reference_point", "offsets": [ [ 1522, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T46", "text": [ "treatment" ], "type": "Procedure", "offsets": [ [ 1536, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T47", "text": [ "investigational product" ], "type": "Drug", "offsets": [ [ 1555, 1578 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T48", "text": [ "investigational", "device" ], "type": "Device", "offsets": [ [ 1555, 1570 ], [ 1579, 1585 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T49", "text": [ "unresolved" ], "type": "Qualifier", "offsets": [ [ 1631, 1641 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T50", "text": [ "toxicity" ], "type": "Condition", "offsets": [ [ 1642, 1650 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T52", "text": [ "previous" ], "type": "Temporal", "offsets": [ [ 1656, 1664 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T53", "text": [ "treatment" ], "type": "Procedure", "offsets": [ [ 1665, 1674 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T54", "text": [ "investigational product/device" ], "type": "Scope", "offsets": [ [ 1555, 1585 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T55", "text": [ "history of" ], "type": "Observation", "offsets": [ [ 1336, 1346 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T56", "text": [ "Prior" ], "type": "Temporal", "offsets": [ [ 1000, 1005 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T57", "text": [ "Previous" ], "type": "Temporal", "offsets": [ [ 1676, 1684 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T58", "text": [ "treatment" ], "type": "Procedure", "offsets": [ [ 1685, 1694 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T59", "text": [ "fibroblast growth factor" ], "type": "Drug", "offsets": [ [ 1719, 1743 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T60", "text": [ "sero-positive" ], "type": "Value", "offsets": [ [ 1757, 1770 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T61", "text": [ "human immunodeficiency virus (HIV)" ], "type": "Measurement", "offsets": [ [ 1775, 1809 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T62", "text": [ "sero-positive for human immunodeficiency virus (HIV)" ], "type": "Condition", "offsets": [ [ 1757, 1809 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T63", "text": [ "sero-positive for", "hepatitis C virus (HCV)" ], "type": "Condition", "offsets": [ [ 1757, 1774 ], [ 1811, 1834 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T64", "text": [ "sero-positive for", "hepatitis B virus (HBV)" ], "type": "Condition", "offsets": [ [ 1757, 1774 ], [ 1839, 1862 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T65", "text": [ "hepatitis C virus (HCV)" ], "type": "Measurement", "offsets": [ [ 1811, 1834 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T66", "text": [ "hepatitis B virus (HBV)" ], "type": "Measurement", "offsets": [ [ 1839, 1862 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T67", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 1864, 1872 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T68", "text": [ "breastfeeding" ], "type": "Condition", "offsets": [ [ 1876, 1889 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T69", "text": [ "women" ], "type": "Person", "offsets": [ [ 1890, 1895 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T70", "text": [ "sensitivity" ], "type": "Condition", "offsets": [ [ 1903, 1914 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T71", "text": [ "E. coli derived" ], "type": "Qualifier", "offsets": [ [ 1918, 1933 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T72", "text": [ "products" ], "type": "Drug", "offsets": [ [ 1934, 1942 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T73", "text": [ "Compromised ability" ], "type": "Condition", "offsets": [ [ 1944, 1963 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T76", "text": [ "give written informed consent and/or to comply with study procedures" ], "type": "Scope", "offsets": [ [ 1982, 2050 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T78", "text": [ "Refusal to" ], "type": "Observation", "offsets": [ [ 2052, 2062 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00094861_exc_R1", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T1", "arg2_id": "NCT00094861_exc_T2", "normalized": [] }, { "id": "NCT00094861_exc_R2", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T6", "arg2_id": "NCT00094861_exc_T8", "normalized": [] }, { "id": "NCT00094861_exc_R3", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T7", "arg2_id": "NCT00094861_exc_T9", "normalized": [] }, { "id": "NCT00094861_exc_R4", "type": "Has_scope", "arg1_id": "NCT00094861_exc_T4", "arg2_id": "NCT00094861_exc_T11", "normalized": [] }, { "id": "NCT00094861_exc_R5", "type": "Has_value", "arg1_id": "NCT00094861_exc_T11", "arg2_id": "NCT00094861_exc_T5", "normalized": [] }, { "id": "NCT00094861_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T14", "arg2_id": "NCT00094861_exc_T13", "normalized": [] }, { "id": "NCT00094861_exc_R7", "type": "Has_multiplier", "arg1_id": "NCT00094861_exc_T15", "arg2_id": "NCT00094861_exc_T16", "normalized": [] }, { "id": "NCT00094861_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00094861_exc_T18", "arg2_id": "NCT00094861_exc_T15", "normalized": [] }, { "id": "NCT00094861_exc_R9", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T18", "arg2_id": "NCT00094861_exc_T19", "normalized": [] }, { "id": "NCT00094861_exc_R10", "type": "Has_scope", "arg1_id": "NCT00094861_exc_T23", "arg2_id": "NCT00094861_exc_T25", "normalized": [] }, { "id": "NCT00094861_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T25", "arg2_id": "NCT00094861_exc_T24", "normalized": [] }, { "id": "NCT00094861_exc_R12", "type": "Has_negation", "arg1_id": "NCT00094861_exc_T30", "arg2_id": "NCT00094861_exc_T28", "normalized": [] }, { "id": "NCT00094861_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00094861_exc_T26", "arg2_id": "NCT00094861_exc_T27", "normalized": [] }, { "id": "NCT00094861_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T26", "arg2_id": "NCT00094861_exc_T29", "normalized": [] }, { "id": "NCT00094861_exc_R15", "type": "Has_negation", "arg1_id": "NCT00094861_exc_T32", "arg2_id": "NCT00094861_exc_T31", "normalized": [] }, { "id": "NCT00094861_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT00094861_exc_T36", "arg2_id": "NCT00094861_exc_T37", "normalized": [] }, { "id": "NCT00094861_exc_R17", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T36", "arg2_id": "NCT00094861_exc_T38", "normalized": [] }, { "id": "NCT00094861_exc_R18", "type": "Subsumes", "arg1_id": "NCT00094861_exc_T41", "arg2_id": "NCT00094861_exc_T40", "normalized": [] }, { "id": "NCT00094861_exc_R19", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T42", "arg2_id": "NCT00094861_exc_T43", "normalized": [] }, { "id": "NCT00094861_exc_R20", "type": "AND", "arg1_id": "NCT00094861_exc_T45", "arg2_id": "NCT00094861_exc_T46", "normalized": [] }, { "id": "NCT00094861_exc_R21", "type": "Has_index", "arg1_id": "NCT00094861_exc_T44", "arg2_id": "NCT00094861_exc_T45", "normalized": [] }, { "id": "NCT00094861_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT00094861_exc_T50", "arg2_id": "NCT00094861_exc_T49", "normalized": [] }, { "id": "NCT00094861_exc_R23", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T53", "arg2_id": "NCT00094861_exc_T52", "normalized": [] }, { "id": "NCT00094861_exc_R24", "type": "AND", "arg1_id": "NCT00094861_exc_T50", "arg2_id": "NCT00094861_exc_T53", "normalized": [] }, { "id": "NCT00094861_exc_R25", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T54", "arg2_id": "NCT00094861_exc_T44", "normalized": [] }, { "id": "NCT00094861_exc_R27", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T41", "arg2_id": "NCT00094861_exc_T55", "normalized": [] }, { "id": "NCT00094861_exc_R28", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T26", "arg2_id": "NCT00094861_exc_T56", "normalized": [] }, { "id": "NCT00094861_exc_R29", "type": "Has_temporal", "arg1_id": "NCT00094861_exc_T58", "arg2_id": "NCT00094861_exc_T57", "normalized": [] }, { "id": "NCT00094861_exc_R30", "type": "AND", "arg1_id": "NCT00094861_exc_T58", "arg2_id": "NCT00094861_exc_T59", "normalized": [] }, { "id": "NCT00094861_exc_R31", "type": "Has_value", "arg1_id": "NCT00094861_exc_T61", "arg2_id": "NCT00094861_exc_T60", "normalized": [] }, { "id": "NCT00094861_exc_R33", "type": "Has_value", "arg1_id": "NCT00094861_exc_T65", "arg2_id": "NCT00094861_exc_T60", "normalized": [] }, { "id": "NCT00094861_exc_R34", "type": "Has_value", "arg1_id": "NCT00094861_exc_T66", "arg2_id": "NCT00094861_exc_T60", "normalized": [] }, { "id": "NCT00094861_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT00094861_exc_T72", "arg2_id": "NCT00094861_exc_T71", "normalized": [] }, { "id": "NCT00094861_exc_R38", "type": "AND", "arg1_id": "NCT00094861_exc_T70", "arg2_id": "NCT00094861_exc_T72", "normalized": [] }, { "id": "NCT00094861_exc_R39", "type": "Has_scope", "arg1_id": "NCT00094861_exc_T73", "arg2_id": "NCT00094861_exc_T76", "normalized": [] } ]
NCT00094861_inc
NCT00094861
[ { "id": "NCT00094861_inc_text", "type": "inclusion", "text": [ "Patients with a histologically or cytologically proven diagnosis of NSCLC \nUnresectable (locally advanced) stage IIIa or IIIb disease \nInitial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus \nLife expectancy greater than or equal to 6 months \nEstimated weight loss less than or equal to 10% in the 3 months before study randomization \nMeasurable disease \n18 years of age or older \nEastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 \nHemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization \nAbsolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization \nPlatelet count greater than or equal to 100 x 10^9/L \nSerum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN) \nSerum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min) \nFemales of childbearing potential: negative serum or urine pregnancy test \nPatient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product. \nPatients with reproductive capability must agree to practice adequate contraception methods. \n" ], "offsets": [ [ 0, 1486 ] ] } ]
[ { "id": "NCT00094861_inc_T1", "text": [ "NSCLC" ], "type": "Condition", "offsets": [ [ 68, 73 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T2", "text": [ "cytologically proven" ], "type": "Qualifier", "offsets": [ [ 34, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T3", "text": [ "histologically", "proven" ], "type": "Qualifier", "offsets": [ [ 16, 30 ], [ 48, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T4", "text": [ "histologically or cytologically proven" ], "type": "Scope", "offsets": [ [ 16, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T5", "text": [ "stage", "IIIb disease" ], "type": "Condition", "offsets": [ [ 107, 112 ], [ 121, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T6", "text": [ "stage IIIa", "disease" ], "type": "Condition", "offsets": [ [ 107, 117 ], [ 126, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T7", "text": [ "Unresectable" ], "type": "Qualifier", "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T8", "text": [ "locally advanced" ], "type": "Qualifier", "offsets": [ [ 89, 105 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T9", "text": [ "stage IIIa or IIIb disease" ], "type": "Scope", "offsets": [ [ 107, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T10", "text": [ "esophagus" ], "type": "Qualifier", "offsets": [ [ 224, 233 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T11", "text": [ "greater than", "30" ], "type": "Multiplier", "offsets": [ [ 188, 200 ], [ 213, 215 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T12", "text": [ "equal to 30%" ], "type": "Multiplier", "offsets": [ [ 204, 216 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T13", "text": [ "greater than or equal to 30%" ], "type": "Scope", "offsets": [ [ 188, 216 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T14", "text": [ "radiotherapy" ], "type": "Measurement", "offsets": [ [ 143, 155 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T15", "text": [ "Initial" ], "type": "Qualifier", "offsets": [ [ 135, 142 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T16", "text": [ "Life expectancy" ], "type": "Observation", "offsets": [ [ 235, 250 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T17", "text": [ "equal to 6 months" ], "type": "Value", "offsets": [ [ 267, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T18", "text": [ "greater than", "6 months" ], "type": "Value", "offsets": [ [ 251, 263 ], [ 276, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T19", "text": [ "greater than or equal to 6 months" ], "type": "Scope", "offsets": [ [ 251, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T20", "text": [ "Measurable disease" ], "type": "Condition", "offsets": [ [ 378, 396 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T21", "text": [ "3 months before study randomization" ], "type": "Temporal", "offsets": [ [ 341, 376 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T22", "text": [ "study randomization" ], "type": "Reference_point", "offsets": [ [ 357, 376 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T23", "text": [ "Estimated weight loss" ], "type": "Measurement", "offsets": [ [ 286, 307 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T24", "text": [ "equal to 10%" ], "type": "Value", "offsets": [ [ 321, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T25", "text": [ "less than", "10%" ], "type": "Value", "offsets": [ [ 308, 317 ], [ 330, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T26", "text": [ "less than or equal to 10%" ], "type": "Scope", "offsets": [ [ 308, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T28", "text": [ "Eastern Cooperative Oncology Group", "performance status" ], "type": "Measurement", "offsets": [ [ 424, 458 ], [ 466, 484 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T29", "text": [ "ECOG" ], "type": "Measurement", "offsets": [ [ 460, 464 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T30", "text": [ "0 - 2" ], "type": "Value", "offsets": [ [ 488, 493 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T31", "text": [ "Hemoglobin" ], "type": "Measurement", "offsets": [ [ 495, 505 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T32", "text": [ "hgb" ], "type": "Measurement", "offsets": [ [ 507, 510 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T33", "text": [ "equal to 10 g/dL" ], "type": "Value", "offsets": [ [ 528, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T34", "text": [ "greater than", "10 g/dL" ], "type": "Value", "offsets": [ [ 512, 524 ], [ 537, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T35", "text": [ "greater than or equal to 10 g/dL" ], "type": "Scope", "offsets": [ [ 512, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T36", "text": [ "in the 4 weeks before study randomization" ], "type": "Temporal", "offsets": [ [ 596, 637 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T37", "text": [ "study randomization" ], "type": "Reference_point", "offsets": [ [ 618, 637 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T38", "text": [ "without" ], "type": "Negation", "offsets": [ [ 545, 552 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T39", "text": [ "transfusional support" ], "type": "Observation", "offsets": [ [ 553, 574 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T40", "text": [ "growth factor use" ], "type": "Observation", "offsets": [ [ 578, 595 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T41", "text": [ "transfusional support or growth factor use" ], "type": "Scope", "offsets": [ [ 553, 595 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T42", "text": [ "Absolute neutrophil count" ], "type": "Measurement", "offsets": [ [ 639, 664 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T43", "text": [ "ANC" ], "type": "Measurement", "offsets": [ [ 666, 669 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T44", "text": [ "equal to 1.5 x 10^9/L" ], "type": "Value", "offsets": [ [ 687, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T45", "text": [ "greater than", "1.5 x 10^9/L" ], "type": "Value", "offsets": [ [ 671, 683 ], [ 696, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T46", "text": [ "greater than or equal to 1.5 x 10^9/L" ], "type": "Scope", "offsets": [ [ 671, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T47", "text": [ "without" ], "type": "Negation", "offsets": [ [ 709, 716 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T48", "text": [ "growth factor use" ], "type": "Observation", "offsets": [ [ 717, 734 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T49", "text": [ "in the 2 weeks before study randomization" ], "type": "Temporal", "offsets": [ [ 735, 776 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T50", "text": [ "study randomization" ], "type": "Reference_point", "offsets": [ [ 757, 776 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T51", "text": [ "Platelet count" ], "type": "Measurement", "offsets": [ [ 778, 792 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T52", "text": [ "greater than", "100 x 10^9/L" ], "type": "Value", "offsets": [ [ 793, 805 ], [ 818, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T53", "text": [ "equal to 100 x 10^9/L" ], "type": "Value", "offsets": [ [ 809, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T54", "text": [ "greater than or equal to 100 x 10^9/L" ], "type": "Scope", "offsets": [ [ 793, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T55", "text": [ "Serum bilirubin" ], "type": "Measurement", "offsets": [ [ 832, 847 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T56", "text": [ "equal to 1.5 x institutional upper limit of normal (ULN)" ], "type": "Value", "offsets": [ [ 861, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T57", "text": [ "less than", "1.5 x institutional upper limit of normal (ULN)" ], "type": "Value", "offsets": [ [ 848, 857 ], [ 870, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T58", "text": [ "less than or equal to 1.5 x institutional upper limit of normal (ULN)" ], "type": "Scope", "offsets": [ [ 848, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T59", "text": [ "Serum creatinine" ], "type": "Measurement", "offsets": [ [ 919, 935 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T60", "text": [ "equal to 2.0 mg/dL" ], "type": "Value", "offsets": [ [ 949, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T61", "text": [ "less than" ], "type": "Value", "offsets": [ [ 936, 945 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T62", "text": [ "2.0 mg/dL" ], "type": "Value", "offsets": [ [ 958, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T63", "text": [ "ess than or equal to 2.0 mg/dL" ], "type": "Scope", "offsets": [ [ 937, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T64", "text": [ "serum creatinine" ], "type": "Measurement", "offsets": [ [ 991, 1007 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T65", "text": [ "equal to 1.4", "mg/dL" ], "type": "Value", "offsets": [ [ 1024, 1036 ], [ 1067, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T66", "text": [ "greater than", "1.4", "mg/dL" ], "type": "Value", "offsets": [ [ 1008, 1020 ], [ 1033, 1036 ], [ 1067, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T67", "text": [ "less than", "2.0 mg/dL" ], "type": "Value", "offsets": [ [ 1041, 1050 ], [ 1063, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T68", "text": [ "equal to 2.0 mg/dL" ], "type": "Value", "offsets": [ [ 1054, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T69", "text": [ "greater than or equal to 1.4 and less than or equal to 2.0 mg/dL" ], "type": "Scope", "offsets": [ [ 1008, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T70", "text": [ "24-hour urinary creatinine clearance" ], "type": "Measurement", "offsets": [ [ 1092, 1128 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T71", "text": [ "equal to 50 mL/min" ], "type": "Value", "offsets": [ [ 1145, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T72", "text": [ "greater than", "50 mL/min" ], "type": "Value", "offsets": [ [ 1129, 1141 ], [ 1154, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T73", "text": [ "greater than or equal to 50 mL/min" ], "type": "Scope", "offsets": [ [ 1129, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T74", "text": [ "Serum creatinine less than or equal to 2.0 mg/dL" ], "type": "Scope", "offsets": [ [ 919, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T75", "text": [ "serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min" ], "type": "Scope", "offsets": [ [ 991, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T76", "text": [ "Females" ], "type": "Person", "offsets": [ [ 1166, 1173 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T77", "text": [ "childbearing potential" ], "type": "Condition", "offsets": [ [ 1177, 1199 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T78", "text": [ "urine pregnancy test" ], "type": "Measurement", "offsets": [ [ 1219, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T79", "text": [ "serum", "pregnancy test" ], "type": "Measurement", "offsets": [ [ 1210, 1215 ], [ 1225, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T80", "text": [ "serum or urine pregnancy test" ], "type": "Scope", "offsets": [ [ 1210, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T81", "text": [ "negative" ], "type": "Value", "offsets": [ [ 1201, 1209 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T82", "text": [ "informed consent" ], "type": "Observation", "offsets": [ [ 1267, 1283 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T84", "text": [ "before participating in any study-specific procedure, randomization, or receiving investigational product" ], "type": "Temporal", "offsets": [ [ 1284, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T85", "text": [ "participating in any study-specific procedure, randomization, or receiving investigational product" ], "type": "Reference_point", "offsets": [ [ 1291, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T86", "text": [ "study-specific" ], "type": "Qualifier", "offsets": [ [ 1312, 1326 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T87", "text": [ "procedure" ], "type": "Procedure", "offsets": [ [ 1327, 1336 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T88", "text": [ "randomization" ], "type": "Procedure", "offsets": [ [ 1338, 1351 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T89", "text": [ "investigational product" ], "type": "Drug", "offsets": [ [ 1366, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T90", "text": [ "study-specific procedure, randomization, or receiving investigational product" ], "type": "Scope", "offsets": [ [ 1312, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T83", "text": [ "adequate" ], "type": "Qualifier", "offsets": [ [ 1453, 1461 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T91", "text": [ "contraception methods" ], "type": "Procedure", "offsets": [ [ 1462, 1483 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T92", "text": [ "reproductive capability" ], "type": "Condition", "offsets": [ [ 1406, 1429 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T27", "text": [ "18 years", "or older" ], "type": "Value", "offsets": [ [ 398, 406 ], [ 414, 422 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T93", "text": [ "age" ], "type": "Person", "offsets": [ [ 410, 413 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00094861_inc_R1", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T1", "arg2_id": "NCT00094861_inc_T4", "normalized": [] }, { "id": "NCT00094861_inc_R2", "type": "Subsumes", "arg1_id": "NCT00094861_inc_T7", "arg2_id": "NCT00094861_inc_T8", "normalized": [] }, { "id": "NCT00094861_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00094861_inc_T9", "arg2_id": "NCT00094861_inc_T7", "normalized": [] }, { "id": "NCT00094861_inc_R4", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T10", "arg2_id": "NCT00094861_inc_T13", "normalized": [] }, { "id": "NCT00094861_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00094861_inc_T14", "arg2_id": "NCT00094861_inc_T15", "normalized": [] }, { "id": "NCT00094861_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00094861_inc_T14", "arg2_id": "NCT00094861_inc_T10", "normalized": [] }, { "id": "NCT00094861_inc_R7", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T16", "arg2_id": "NCT00094861_inc_T19", "normalized": [] }, { "id": "NCT00094861_inc_R8", "type": "Has_index", "arg1_id": "NCT00094861_inc_T21", "arg2_id": "NCT00094861_inc_T22", "normalized": [] }, { "id": "NCT00094861_inc_R9", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T23", "arg2_id": "NCT00094861_inc_T26", "normalized": [] }, { "id": "NCT00094861_inc_R10", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T23", "arg2_id": "NCT00094861_inc_T21", "normalized": [] }, { "id": "NCT00094861_inc_R11", "type": "Subsumes", "arg1_id": "NCT00094861_inc_T28", "arg2_id": "NCT00094861_inc_T29", "normalized": [] }, { "id": "NCT00094861_inc_R12", "type": "Has_value", "arg1_id": "NCT00094861_inc_T28", "arg2_id": "NCT00094861_inc_T30", "normalized": [] }, { "id": "NCT00094861_inc_R13", "type": "Subsumes", "arg1_id": "NCT00094861_inc_T31", "arg2_id": "NCT00094861_inc_T32", "normalized": [] }, { "id": "NCT00094861_inc_R14", "type": "Has_index", "arg1_id": "NCT00094861_inc_T36", "arg2_id": "NCT00094861_inc_T37", "normalized": [] }, { "id": "NCT00094861_inc_R15", "type": "Has_negation", "arg1_id": "NCT00094861_inc_T41", "arg2_id": "NCT00094861_inc_T38", "normalized": [] }, { "id": "NCT00094861_inc_R16", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T31", "arg2_id": "NCT00094861_inc_T35", "normalized": [] }, { "id": "NCT00094861_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T31", "arg2_id": "NCT00094861_inc_T36", "normalized": [] }, { "id": "NCT00094861_inc_R18", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T41", "arg2_id": "NCT00094861_inc_T36", "normalized": [] }, { "id": "NCT00094861_inc_R19", "type": "Subsumes", "arg1_id": "NCT00094861_inc_T42", "arg2_id": "NCT00094861_inc_T43", "normalized": [] }, { "id": "NCT00094861_inc_R20", "type": "Has_negation", "arg1_id": "NCT00094861_inc_T48", "arg2_id": "NCT00094861_inc_T47", "normalized": [] }, { "id": "NCT00094861_inc_R21", "type": "Has_index", "arg1_id": "NCT00094861_inc_T49", "arg2_id": "NCT00094861_inc_T50", "normalized": [] }, { "id": "NCT00094861_inc_R22", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T42", "arg2_id": "NCT00094861_inc_T46", "normalized": [] }, { "id": "NCT00094861_inc_R23", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T42", "arg2_id": "NCT00094861_inc_T49", "normalized": [] }, { "id": "NCT00094861_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T48", "arg2_id": "NCT00094861_inc_T49", "normalized": [] }, { "id": "NCT00094861_inc_R25", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T51", "arg2_id": "NCT00094861_inc_T54", "normalized": [] }, { "id": "NCT00094861_inc_R26", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T55", "arg2_id": "NCT00094861_inc_T58", "normalized": [] }, { "id": "NCT00094861_inc_R27", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T59", "arg2_id": "NCT00094861_inc_T63", "normalized": [] }, { "id": "NCT00094861_inc_R28", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T64", "arg2_id": "NCT00094861_inc_T69", "normalized": [] }, { "id": "NCT00094861_inc_R29", "type": "Has_scope", "arg1_id": "NCT00094861_inc_T70", "arg2_id": "NCT00094861_inc_T73", "normalized": [] }, { "id": "NCT00094861_inc_R30", "type": "AND", "arg1_id": "NCT00094861_inc_T76", "arg2_id": "NCT00094861_inc_T77", "normalized": [] }, { "id": "NCT00094861_inc_R31", "type": "Has_value", "arg1_id": "NCT00094861_inc_T80", "arg2_id": "NCT00094861_inc_T81", "normalized": [] }, { "id": "NCT00094861_inc_R33", "type": "Has_temporal", "arg1_id": "NCT00094861_inc_T82", "arg2_id": "NCT00094861_inc_T84", "normalized": [] }, { "id": "NCT00094861_inc_R34", "type": "Has_qualifier", "arg1_id": "NCT00094861_inc_T91", "arg2_id": "NCT00094861_inc_T83", "normalized": [] }, { "id": "NCT00094861_inc_R35", "type": "AND", "arg1_id": "NCT00094861_inc_T92", "arg2_id": "NCT00094861_inc_T91", "normalized": [] }, { "id": "NCT00094861_inc_R36", "type": "Has_value", "arg1_id": "NCT00094861_inc_T93", "arg2_id": "NCT00094861_inc_T27", "normalized": [] } ]
NCT00122070_exc
NCT00122070
[ { "id": "NCT00122070_exc_text", "type": "exclusion", "text": [ "Are pregnant or lactating. \nHave participated in any other studies involving investigational products within 30 days prior to entry into this study. \nAre undergoing an acute withdrawal syndrome from drugs or alcohol. \nHave an Axis I diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or Bipolar I Disorder as diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), and pertinent subsequent for ruling out exclusionary diagnoses. \nHave an unstable medical disorder as determined by physical examination or laboratory testing. The primary investigator will be responsible for making this judgment based on the above. \nHad an unsatisfactory response to a previous adequate trial of quetiapine as judged by a study investigator. \nPatients cannot begin psychotherapy during the study period, but may continue if started prior to the study. \nPatients who are currently receiving quetiapine therapy may not undergo a washout period and then restart quetiapine in the study. \n \n" ], "offsets": [ [ 0, 1037 ] ] } ]
[ { "id": "NCT00122070_exc_T1", "text": [ "pregnant" ], "type": "Condition", "offsets": [ [ 4, 12 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T2", "text": [ "lactating" ], "type": "Condition", "offsets": [ [ 16, 25 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T3", "text": [ "Have participated in any other studies involving investigational products" ], "type": "Observation", "offsets": [ [ 28, 101 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T4", "text": [ "within 30 days prior to entry into this study" ], "type": "Temporal", "offsets": [ [ 102, 147 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T5", "text": [ "entry into this stud" ], "type": "Reference_point", "offsets": [ [ 126, 146 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T6", "text": [ "acute withdrawal syndrome" ], "type": "Condition", "offsets": [ [ 168, 193 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T7", "text": [ "drugs" ], "type": "Drug", "offsets": [ [ 199, 204 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T8", "text": [ "alcohol" ], "type": "Drug", "offsets": [ [ 208, 215 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T9", "text": [ "drugs or alcohol" ], "type": "Scope", "offsets": [ [ 199, 215 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T10", "text": [ "Schizophrenia" ], "type": "Condition", "offsets": [ [ 246, 259 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T11", "text": [ "Schizoaffective Disorder" ], "type": "Condition", "offsets": [ [ 261, 285 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T12", "text": [ "Schizophreniform Disorder" ], "type": "Condition", "offsets": [ [ 287, 312 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T13", "text": [ "Bipolar I Disorder" ], "type": "Condition", "offsets": [ [ 316, 334 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T18", "text": [ "Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)" ], "type": "Procedure", "offsets": [ [ 355, 421 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T19", "text": [ "Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or Bipolar I Disorder" ], "type": "Scope", "offsets": [ [ 246, 334 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00122070_exc_R1", "type": "Has_index", "arg1_id": "NCT00122070_exc_T4", "arg2_id": "NCT00122070_exc_T5", "normalized": [] }, { "id": "NCT00122070_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00122070_exc_T3", "arg2_id": "NCT00122070_exc_T4", "normalized": [] }, { "id": "NCT00122070_exc_R3", "type": "Has_scope", "arg1_id": "NCT00122070_exc_T6", "arg2_id": "NCT00122070_exc_T9", "normalized": [] }, { "id": "NCT00122070_exc_R4", "type": "Has_scope", "arg1_id": "NCT00122070_exc_T18", "arg2_id": "NCT00122070_exc_T19", "normalized": [] } ]
NCT00122070_inc
NCT00122070
[ { "id": "NCT00122070_inc_text", "type": "inclusion", "text": [ "Provide written informed consent before beginning any study related activities \nBe between age 18 and 55 years \nBe able to speak, read and write English and follow simple instructions for completing self-rated scales \nMeet DSM-IV criteria for BPD as assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II). \n" ], "offsets": [ [ 0, 341 ] ] } ]
[ { "id": "NCT00122070_inc_T2", "text": [ "age" ], "type": "Person", "offsets": [ [ 91, 94 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T3", "text": [ "between", "18 and 55 years" ], "type": "Value", "offsets": [ [ 83, 90 ], [ 95, 110 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T5", "text": [ "BPD" ], "type": "Condition", "offsets": [ [ 243, 246 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T6", "text": [ "Meet DSM-IV criteria" ], "type": "Qualifier", "offsets": [ [ 218, 238 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T4", "text": [ "able to speak, read and write English" ], "type": "Observation", "offsets": [ [ 115, 152 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T8", "text": [ "able to", "follow simple instructions" ], "type": "Observation", "offsets": [ [ 115, 122 ], [ 157, 183 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T1", "text": [ "written informed consent" ], "type": "Observation", "offsets": [ [ 8, 32 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T9", "text": [ "before beginning any study related activities" ], "type": "Temporal", "offsets": [ [ 33, 78 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T10", "text": [ "any study related activities" ], "type": "Reference_point", "offsets": [ [ 50, 78 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T7", "text": [ "Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II)" ], "type": "Procedure", "offsets": [ [ 266, 338 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00122070_inc_R1", "type": "Has_value", "arg1_id": "NCT00122070_inc_T2", "arg2_id": "NCT00122070_inc_T3", "normalized": [] }, { "id": "NCT00122070_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00122070_inc_T5", "arg2_id": "NCT00122070_inc_T6", "normalized": [] }, { "id": "NCT00122070_inc_R3", "type": "Has_index", "arg1_id": "NCT00122070_inc_T9", "arg2_id": "NCT00122070_inc_T10", "normalized": [] }, { "id": "NCT00122070_inc_R4", "type": "Has_temporal", "arg1_id": "NCT00122070_inc_T1", "arg2_id": "NCT00122070_inc_T9", "normalized": [] }, { "id": "NCT00122070_inc_R5", "type": "AND", "arg1_id": "NCT00122070_inc_T7", "arg2_id": "NCT00122070_inc_T5", "normalized": [] } ]
NCT00182520_exc
NCT00182520
[ { "id": "NCT00182520_exc_text", "type": "exclusion", "text": [ "Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.\nA previous adequate trial of topiramate\nComorbid major depressive disorder diagnosis which predates OCD diagnosis\nCognitive behavioural therapy or additional psychotherapy in past four months\nAllergy or hypersensitivity to topiramate\nBMI < 20\nHistory of kidney stones\n" ], "offsets": [ [ 0, 446 ] ] } ]
[ { "id": "NCT00182520_exc_T1", "text": [ "DSM-IV" ], "type": "Qualifier", "offsets": [ [ 18, 24 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T2", "text": [ "primary" ], "type": "Qualifier", "offsets": [ [ 10, 17 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T3", "text": [ "diagnosis" ], "type": "Condition", "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T4", "text": [ "DSM-IV criteria" ], "type": "Measurement", "offsets": [ [ 36, 51 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T5", "text": [ "body dysmorphic disorder" ], "type": "Condition", "offsets": [ [ 56, 80 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T6", "text": [ "bipolar affective disorder" ], "type": "Condition", "offsets": [ [ 82, 108 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T7", "text": [ "schizophrenia" ], "type": "Condition", "offsets": [ [ 110, 123 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T8", "text": [ "psychotic disorder," ], "type": "Condition", "offsets": [ [ 125, 144 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T9", "text": [ "substance abuse" ], "type": "Condition", "offsets": [ [ 161, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T10", "text": [ "alcohol", "abuse" ], "type": "Condition", "offsets": [ [ 153, 160 ], [ 171, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T11", "text": [ "body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse" ], "type": "Scope", "offsets": [ [ 56, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T13", "text": [ "major depressive disorder" ], "type": "Condition", "offsets": [ [ 227, 252 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T14", "text": [ "Comorbid" ], "type": "Qualifier", "offsets": [ [ 218, 226 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T15", "text": [ "predates OCD diagnosis" ], "type": "Temporal", "offsets": [ [ 269, 291 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T16", "text": [ "OCD diagnosis" ], "type": "Reference_point", "offsets": [ [ 278, 291 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T17", "text": [ "Cognitive behavioural therapy" ], "type": "Procedure", "offsets": [ [ 292, 321 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T18", "text": [ "psychotherapy" ], "type": "Procedure", "offsets": [ [ 336, 349 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T19", "text": [ "additional" ], "type": "Qualifier", "offsets": [ [ 325, 335 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T20", "text": [ "in past four months" ], "type": "Temporal", "offsets": [ [ 350, 369 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T21", "text": [ "Allergy" ], "type": "Condition", "offsets": [ [ 370, 377 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T22", "text": [ "hypersensitivity" ], "type": "Condition", "offsets": [ [ 381, 397 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T23", "text": [ "topiramate" ], "type": "Drug", "offsets": [ [ 401, 411 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T24", "text": [ "Allergy or hypersensitivity" ], "type": "Scope", "offsets": [ [ 370, 397 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T25", "text": [ "BMI" ], "type": "Measurement", "offsets": [ [ 412, 415 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T26", "text": [ "< 20" ], "type": "Value", "offsets": [ [ 416, 420 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T27", "text": [ "kidney stones" ], "type": "Condition", "offsets": [ [ 432, 445 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T12", "text": [ "topiramate" ], "type": "Drug", "offsets": [ [ 207, 217 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T28", "text": [ "previous" ], "type": "Temporal", "offsets": [ [ 180, 188 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T29", "text": [ "History of" ], "type": "Observation", "offsets": [ [ 421, 431 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00182520_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00182520_exc_T3", "arg2_id": "NCT00182520_exc_T1", "normalized": [] }, { "id": "NCT00182520_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00182520_exc_T3", "arg2_id": "NCT00182520_exc_T2", "normalized": [] }, { "id": "NCT00182520_exc_R3", "type": "Has_scope", "arg1_id": "NCT00182520_exc_T4", "arg2_id": "NCT00182520_exc_T11", "normalized": [] }, { "id": "NCT00182520_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00182520_exc_T13", "arg2_id": "NCT00182520_exc_T14", "normalized": [] }, { "id": "NCT00182520_exc_R6", "type": "Has_index", "arg1_id": "NCT00182520_exc_T15", "arg2_id": "NCT00182520_exc_T16", "normalized": [] }, { "id": "NCT00182520_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00182520_exc_T13", "arg2_id": "NCT00182520_exc_T15", "normalized": [] }, { "id": "NCT00182520_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00182520_exc_T18", "arg2_id": "NCT00182520_exc_T19", "normalized": [] }, { "id": "NCT00182520_exc_R9", "type": "AND", "arg1_id": "NCT00182520_exc_T24", "arg2_id": "NCT00182520_exc_T23", "normalized": [] }, { "id": "NCT00182520_exc_R10", "type": "Has_value", "arg1_id": "NCT00182520_exc_T25", "arg2_id": "NCT00182520_exc_T26", "normalized": [] }, { "id": "NCT00182520_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00182520_exc_T12", "arg2_id": "NCT00182520_exc_T28", "normalized": [] }, { "id": "NCT00182520_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00182520_exc_T27", "arg2_id": "NCT00182520_exc_T29", "normalized": [] } ]
NCT00182520_inc
NCT00182520
[ { "id": "NCT00182520_inc_text", "type": "inclusion", "text": [ "Outpatient with primary DSM- IV OCD\nCompletion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of < 35%)\nStable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.\n" ], "offsets": [ [ 0, 505 ] ] } ]
[ { "id": "NCT00182520_inc_T1", "text": [ "OCD" ], "type": "Condition", "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T2", "text": [ "primary" ], "type": "Qualifier", "offsets": [ [ 16, 23 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T3", "text": [ "DSM- IV" ], "type": "Qualifier", "offsets": [ [ 24, 31 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T4", "text": [ "medications" ], "type": "Drug", "offsets": [ [ 409, 420 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T5", "text": [ "concurrent" ], "type": "Qualifier", "offsets": [ [ 398, 408 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T6", "text": [ "Stable" ], "type": "Qualifier", "offsets": [ [ 373, 379 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T7", "text": [ "8 wks or longer" ], "type": "Temporal", "offsets": [ [ 381, 396 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T8", "text": [ "benzodiazepines" ], "type": "Drug", "offsets": [ [ 431, 446 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T9", "text": [ "sedative hypnotics" ], "type": "Drug", "offsets": [ [ 448, 466 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T10", "text": [ "antipsychotics" ], "type": "Drug", "offsets": [ [ 468, 482 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T11", "text": [ "antidepressants" ], "type": "Drug", "offsets": [ [ 488, 503 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T12", "text": [ "benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants" ], "type": "Scope", "offsets": [ [ 431, 503 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T13", "text": [ "14-week" ], "type": "Multiplier", "offsets": [ [ 52, 59 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T14", "text": [ "fluoxetine" ], "type": "Drug", "offsets": [ [ 105, 115 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T15", "text": [ "80 mg/day" ], "type": "Multiplier", "offsets": [ [ 116, 125 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T16", "text": [ "paroxetine" ], "type": "Drug", "offsets": [ [ 127, 137 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T17", "text": [ "60 mg/day" ], "type": "Multiplier", "offsets": [ [ 138, 147 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T18", "text": [ "fluvoxamine" ], "type": "Drug", "offsets": [ [ 149, 160 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T19", "text": [ "300 mg/day" ], "type": "Multiplier", "offsets": [ [ 161, 171 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T20", "text": [ "clomipramine" ], "type": "Drug", "offsets": [ [ 173, 185 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T21", "text": [ "250 mg/day" ], "type": "Multiplier", "offsets": [ [ 186, 196 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T22", "text": [ "sertraline" ], "type": "Drug", "offsets": [ [ 198, 208 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T23", "text": [ "200 mg/day" ], "type": "Multiplier", "offsets": [ [ 209, 219 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T24", "text": [ "citalopram" ], "type": "Drug", "offsets": [ [ 221, 231 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T25", "text": [ "60 mg/day" ], "type": "Multiplier", "offsets": [ [ 232, 241 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T26", "text": [ "escitalopram" ], "type": "Drug", "offsets": [ [ 243, 255 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T27", "text": [ "30 mg/day" ], "type": "Multiplier", "offsets": [ [ 256, 265 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T28", "text": [ "responses to" ], "type": "Condition", "offsets": [ [ 301, 313 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T29", "text": [ "CGI-I" ], "type": "Measurement", "offsets": [ [ 329, 334 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T30", "text": [ "3" ], "type": "Value", "offsets": [ [ 338, 339 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T31", "text": [ "4" ], "type": "Value", "offsets": [ [ 343, 344 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T32", "text": [ "3 or 4" ], "type": "Scope", "offsets": [ [ 338, 344 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T33", "text": [ "Y-BOCS" ], "type": "Measurement", "offsets": [ [ 346, 352 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T34", "text": [ "reduction of < 35%" ], "type": "Value", "offsets": [ [ 353, 371 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T35", "text": [ "CGI-I of 3 or 4, Y-BOCS reduction of < 35%" ], "type": "Scope", "offsets": [ [ 329, 371 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T36", "text": [ "one the following" ], "type": "Multiplier", "offsets": [ [ 80, 97 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T37", "text": [ "fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day" ], "type": "Scope", "offsets": [ [ 105, 265 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T38", "text": [ "SRI treatment" ], "type": "Procedure", "offsets": [ [ 314, 327 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T39", "text": [ "responses to SRI treatment" ], "type": "Scope", "offsets": [ [ 301, 327 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T40", "text": [ "Outpatient" ], "type": "Visit", "offsets": [ [ 0, 10 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00182520_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT00182520_inc_T1", "arg2_id": "NCT00182520_inc_T3", "normalized": [] }, { "id": "NCT00182520_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00182520_inc_T1", "arg2_id": "NCT00182520_inc_T2", "normalized": [] }, { "id": "NCT00182520_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00182520_inc_T4", "arg2_id": "NCT00182520_inc_T5", "normalized": [] }, { "id": "NCT00182520_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00182520_inc_T4", "arg2_id": "NCT00182520_inc_T6", "normalized": [] }, { "id": "NCT00182520_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00182520_inc_T4", "arg2_id": "NCT00182520_inc_T7", "normalized": [] }, { "id": "NCT00182520_inc_R6", "type": "Subsumes", "arg1_id": "NCT00182520_inc_T4", "arg2_id": "NCT00182520_inc_T12", "normalized": [] }, { "id": "NCT00182520_inc_R7", "type": "Has_scope", "arg1_id": "NCT00182520_inc_T29", "arg2_id": "NCT00182520_inc_T32", "normalized": [] }, { "id": "NCT00182520_inc_R8", "type": "Has_value", "arg1_id": "NCT00182520_inc_T33", "arg2_id": "NCT00182520_inc_T34", "normalized": [] }, { "id": "NCT00182520_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T14", "arg2_id": "NCT00182520_inc_T15", "normalized": [] }, { "id": "NCT00182520_inc_R11", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T16", "arg2_id": "NCT00182520_inc_T17", "normalized": [] }, { "id": "NCT00182520_inc_R12", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T18", "arg2_id": "NCT00182520_inc_T19", "normalized": [] }, { "id": "NCT00182520_inc_R13", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T20", "arg2_id": "NCT00182520_inc_T21", "normalized": [] }, { "id": "NCT00182520_inc_R14", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T22", "arg2_id": "NCT00182520_inc_T23", "normalized": [] }, { "id": "NCT00182520_inc_R15", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T24", "arg2_id": "NCT00182520_inc_T25", "normalized": [] }, { "id": "NCT00182520_inc_R16", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T26", "arg2_id": "NCT00182520_inc_T27", "normalized": [] }, { "id": "NCT00182520_inc_R17", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T37", "arg2_id": "NCT00182520_inc_T36", "normalized": [] }, { "id": "NCT00182520_inc_R18", "type": "Has_multiplier", "arg1_id": "NCT00182520_inc_T37", "arg2_id": "NCT00182520_inc_T13", "normalized": [] }, { "id": "NCT00182520_inc_R19", "type": "AND", "arg1_id": "NCT00182520_inc_T28", "arg2_id": "NCT00182520_inc_T38", "normalized": [] }, { "id": "NCT00182520_inc_R9", "type": "Subsumes", "arg1_id": "NCT00182520_inc_T39", "arg2_id": "NCT00182520_inc_T35", "normalized": [] }, { "id": "NCT00182520_inc_R20", "type": "AND", "arg1_id": "NCT00182520_inc_T1", "arg2_id": "NCT00182520_inc_T40", "normalized": [] } ]
NCT00183885_exc
NCT00183885
[ { "id": "NCT00183885_exc_text", "type": "exclusion", "text": [ "Patients who have received prior chemotherapy for unresectable disease \nPatients with any active or uncontrolled infection, including known HIV infection. (Patients with active hepatitis B will be placed on lamivudine. Patients with active hepatitis C will be eligible if liver tests qualify (5.1.9) \nPatients with psychiatric disorders that would interfere with consent or follow-up. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. \nPatients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study. \n \n" ], "offsets": [ [ 0, 711 ] ] } ]
[ { "id": "NCT00183885_exc_T1", "text": [ "chemotherapy" ], "type": "Procedure", "offsets": [ [ 33, 45 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T2", "text": [ "unresectable disease" ], "type": "Condition", "offsets": [ [ 50, 70 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T3", "text": [ "uncontrolled" ], "type": "Qualifier", "offsets": [ [ 100, 112 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T4", "text": [ "active" ], "type": "Qualifier", "offsets": [ [ 90, 96 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T5", "text": [ "infection" ], "type": "Condition", "offsets": [ [ 113, 122 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T6", "text": [ "active or uncontrolled" ], "type": "Scope", "offsets": [ [ 90, 112 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T7", "text": [ "HIV infection" ], "type": "Procedure", "offsets": [ [ 140, 153 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T8", "text": [ "hepatitis B" ], "type": "Condition", "offsets": [ [ 177, 188 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T9", "text": [ "active" ], "type": "Qualifier", "offsets": [ [ 170, 176 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T10", "text": [ "active hepatitis B" ], "type": "Scope", "offsets": [ [ 170, 188 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T11", "text": [ "lamivudine" ], "type": "Drug", "offsets": [ [ 207, 217 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T12", "text": [ "hepatitis C" ], "type": "Condition", "offsets": [ [ 240, 251 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T13", "text": [ "active" ], "type": "Qualifier", "offsets": [ [ 233, 239 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T14", "text": [ "active hepatitis C" ], "type": "Scope", "offsets": [ [ 233, 251 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T15", "text": [ "liver tests" ], "type": "Measurement", "offsets": [ [ 272, 283 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T16", "text": [ "qualify" ], "type": "Value", "offsets": [ [ 284, 291 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T17", "text": [ "psychiatric disorders" ], "type": "Condition", "offsets": [ [ 315, 336 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T18", "text": [ "interfere with consent" ], "type": "Qualifier", "offsets": [ [ 348, 370 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T19", "text": [ "interfere with", "follow-up" ], "type": "Qualifier", "offsets": [ [ 348, 362 ], [ 374, 383 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T20", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 385, 393 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T21", "text": [ "lactating" ], "type": "Condition", "offsets": [ [ 397, 406 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T22", "text": [ "women" ], "type": "Person", "offsets": [ [ 407, 412 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T23", "text": [ "reproductive potential" ], "type": "Condition", "offsets": [ [ 431, 453 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T24", "text": [ "effective contraceptive method" ], "type": "Procedure", "offsets": [ [ 508, 538 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T25", "text": [ "severe" ], "type": "Qualifier", "offsets": [ [ 565, 571 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T26", "text": [ "concurrent disease" ], "type": "Condition", "offsets": [ [ 572, 590 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T28", "text": [ "entry into this study" ], "type": "Observation", "offsets": [ [ 676, 697 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T29", "text": [ "inappropriate for" ], "type": "Mood", "offsets": [ [ 658, 675 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00183885_exc_R1", "type": "AND", "arg1_id": "NCT00183885_exc_T1", "arg2_id": "NCT00183885_exc_T2", "normalized": [] }, { "id": "NCT00183885_exc_R2", "type": "Has_scope", "arg1_id": "NCT00183885_exc_T5", "arg2_id": "NCT00183885_exc_T6", "normalized": [] }, { "id": "NCT00183885_exc_R3", "type": "Subsumes", "arg1_id": "NCT00183885_exc_T5", "arg2_id": "NCT00183885_exc_T7", "normalized": [] }, { "id": "NCT00183885_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00183885_exc_T8", "arg2_id": "NCT00183885_exc_T9", "normalized": [] }, { "id": "NCT00183885_exc_R5", "type": "AND", "arg1_id": "NCT00183885_exc_T10", "arg2_id": "NCT00183885_exc_T11", "normalized": [] }, { "id": "NCT00183885_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00183885_exc_T12", "arg2_id": "NCT00183885_exc_T13", "normalized": [] }, { "id": "NCT00183885_exc_R7", "type": "Has_value", "arg1_id": "NCT00183885_exc_T15", "arg2_id": "NCT00183885_exc_T16", "normalized": [] }, { "id": "NCT00183885_exc_R8", "type": "AND", "arg1_id": "NCT00183885_exc_T14", "arg2_id": "NCT00183885_exc_T15", "normalized": [] }, { "id": "NCT00183885_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT00183885_exc_T17", "arg2_id": "NCT00183885_exc_T19", "normalized": [] }, { "id": "NCT00183885_exc_R10", "type": "AND", "arg1_id": "NCT00183885_exc_T23", "arg2_id": "NCT00183885_exc_T24", "normalized": [] }, { "id": "NCT00183885_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00183885_exc_T26", "arg2_id": "NCT00183885_exc_T25", "normalized": [] }, { "id": "NCT00183885_exc_R12", "type": "Has_mood", "arg1_id": "NCT00183885_exc_T28", "arg2_id": "NCT00183885_exc_T29", "normalized": [] } ]
NCT00183885_inc
NCT00183885
[ { "id": "NCT00183885_inc_text", "type": "inclusion", "text": [ "Unresectable, histologically confirmed hepatocellular carcinoma with evident disease limited to liver. \nTissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed. The requirement for biopsy may be waived if alpha-fetoprotein is greater than 500 ng/mL and in the investigators opinion not explained by a concurrent hepatic inflammatory process. \nPatients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy. \nPatients must have measurable disease. If prior radiation therapy was administered, measurable disease must be outside the radiation field. \nPatients must have a Zubrod performance status of 0-2. \nPatients must have a predicted life expectancy of at least 12 weeks. \nPatients must have a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3. The granulocyte requirement may be waived if in the investigator's opinion the lower count reflects hypersplenism with adequate bone marrow reserves. \nPatients must have adequate renal function as documented by a calculated creatinine clearance ≥ 60. \nPatients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2x the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor. Patients may not have ascites or the ascites must be responsive to diuretics. \n" ], "offsets": [ [ 0, 1630 ] ] } ]
[ { "id": "NCT00183885_inc_T1", "text": [ "Unresectable" ], "type": "Qualifier", "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T2", "text": [ "hepatocellular carcinoma" ], "type": "Condition", "offsets": [ [ 39, 63 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T3", "text": [ "histologically" ], "type": "Measurement", "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T4", "text": [ "confirmed" ], "type": "Value", "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T5", "text": [ "disease limited to liver" ], "type": "Qualifier", "offsets": [ [ 77, 101 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T6", "text": [ "biopsy" ], "type": "Procedure", "offsets": [ [ 291, 297 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T7", "text": [ "alpha-fetoprotein" ], "type": "Measurement", "offsets": [ [ 315, 332 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T8", "text": [ "greater than 500 ng/mL" ], "type": "Value", "offsets": [ [ 336, 358 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T9", "text": [ "measurable disease" ], "type": "Qualifier", "offsets": [ [ 589, 607 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T10", "text": [ "radiation therapy" ], "type": "Procedure", "offsets": [ [ 618, 635 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T11", "text": [ "measurable disease" ], "type": "Qualifier", "offsets": [ [ 654, 672 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T12", "text": [ "outside the radiation field" ], "type": "Qualifier", "offsets": [ [ 681, 708 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T13", "text": [ "Zubrod performance status" ], "type": "Measurement", "offsets": [ [ 732, 757 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T14", "text": [ "0-2" ], "type": "Value", "offsets": [ [ 761, 764 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T15", "text": [ "predicted life expectancy" ], "type": "Measurement", "offsets": [ [ 788, 813 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T16", "text": [ "at least 12 weeks" ], "type": "Value", "offsets": [ [ 817, 834 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T17", "text": [ "granulocyte count" ], "type": "Measurement", "offsets": [ [ 872, 889 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T18", "text": [ "pre-treatment" ], "type": "Temporal", "offsets": [ [ 858, 871 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T19", "text": [ "segmented neutrophils + bands" ], "type": "Measurement", "offsets": [ [ 897, 926 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T20", "text": [ "greater than or equal to 1,500/mm3" ], "type": "Value", "offsets": [ [ 931, 965 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T21", "text": [ "hemoglobin level" ], "type": "Measurement", "offsets": [ [ 969, 985 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T22", "text": [ "greater than or equal to 9 gm/dl" ], "type": "Value", "offsets": [ [ 989, 1021 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T23", "text": [ "platelet count" ], "type": "Measurement", "offsets": [ [ 1027, 1041 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T24", "text": [ "greater than or equal to 50,000/mm3" ], "type": "Value", "offsets": [ [ 1042, 1077 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T25", "text": [ "granulocyte count (i.e., segmented neutrophils + bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3" ], "type": "Scope", "offsets": [ [ 872, 1077 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T26", "text": [ "renal function" ], "type": "Measurement", "offsets": [ [ 1258, 1272 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T27", "text": [ "adequate" ], "type": "Value", "offsets": [ [ 1249, 1257 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T28", "text": [ "calculated creatinine clearance" ], "type": "Measurement", "offsets": [ [ 1292, 1323 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T29", "text": [ "≥ 60" ], "type": "Value", "offsets": [ [ 1324, 1328 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T30", "text": [ "hepatic function" ], "type": "Measurement", "offsets": [ [ 1359, 1375 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T31", "text": [ "adequate" ], "type": "Value", "offsets": [ [ 1350, 1358 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T32", "text": [ "serum bilirubin" ], "type": "Measurement", "offsets": [ [ 1395, 1410 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T33", "text": [ "less than or equal to 2x the institutional upper limit of normal" ], "type": "Value", "offsets": [ [ 1411, 1475 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T34", "text": [ "ascites" ], "type": "Condition", "offsets": [ [ 1573, 1580 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T35", "text": [ "may not have" ], "type": "Negation", "offsets": [ [ 1560, 1572 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T36", "text": [ "ascites" ], "type": "Condition", "offsets": [ [ 1588, 1595 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T37", "text": [ "responsive to diuretics" ], "type": "Qualifier", "offsets": [ [ 1604, 1627 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T38", "text": [ "blood sample drawn" ], "type": "Procedure", "offsets": [ [ 489, 507 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T39", "text": [ "20 cc" ], "type": "Qualifier", "offsets": [ [ 483, 488 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T41", "text": [ "routine labs" ], "type": "Procedure", "offsets": [ [ 523, 535 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T42", "text": [ "with each cycle of chemotherapy" ], "type": "Multiplier", "offsets": [ [ 536, 567 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T43", "text": [ "20 cc blood sample drawn in addition to routine labs" ], "type": "Scope", "offsets": [ [ 483, 535 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00183885_inc_R1", "type": "Has_value", "arg1_id": "NCT00183885_inc_T3", "arg2_id": "NCT00183885_inc_T4", "normalized": [] }, { "id": "NCT00183885_inc_R2", "type": "AND", "arg1_id": "NCT00183885_inc_T2", "arg2_id": "NCT00183885_inc_T3", "normalized": [] }, { "id": "NCT00183885_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T2", "arg2_id": "NCT00183885_inc_T1", "normalized": [] }, { "id": "NCT00183885_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T2", "arg2_id": "NCT00183885_inc_T5", "normalized": [] }, { "id": "NCT00183885_inc_R5", "type": "Has_value", "arg1_id": "NCT00183885_inc_T7", "arg2_id": "NCT00183885_inc_T8", "normalized": [] }, { "id": "NCT00183885_inc_R6", "type": "Subsumes", "arg1_id": "NCT00183885_inc_T6", "arg2_id": "NCT00183885_inc_T7", "normalized": [] }, { "id": "NCT00183885_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T11", "arg2_id": "NCT00183885_inc_T12", "normalized": [] }, { "id": "NCT00183885_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T10", "arg2_id": "NCT00183885_inc_T11", "normalized": [] }, { "id": "NCT00183885_inc_R9", "type": "Has_value", "arg1_id": "NCT00183885_inc_T13", "arg2_id": "NCT00183885_inc_T14", "normalized": [] }, { "id": "NCT00183885_inc_R10", "type": "Has_value", "arg1_id": "NCT00183885_inc_T15", "arg2_id": "NCT00183885_inc_T16", "normalized": [] }, { "id": "NCT00183885_inc_R12", "type": "Subsumes", "arg1_id": "NCT00183885_inc_T17", "arg2_id": "NCT00183885_inc_T19", "normalized": [] }, { "id": "NCT00183885_inc_R13", "type": "Has_value", "arg1_id": "NCT00183885_inc_T23", "arg2_id": "NCT00183885_inc_T24", "normalized": [] }, { "id": "NCT00183885_inc_R14", "type": "Has_value", "arg1_id": "NCT00183885_inc_T21", "arg2_id": "NCT00183885_inc_T22", "normalized": [] }, { "id": "NCT00183885_inc_R15", "type": "Has_value", "arg1_id": "NCT00183885_inc_T17", "arg2_id": "NCT00183885_inc_T20", "normalized": [] }, { "id": "NCT00183885_inc_R11", "type": "Has_temporal", "arg1_id": "NCT00183885_inc_T25", "arg2_id": "NCT00183885_inc_T18", "normalized": [] }, { "id": "NCT00183885_inc_R16", "type": "Has_value", "arg1_id": "NCT00183885_inc_T26", "arg2_id": "NCT00183885_inc_T27", "normalized": [] }, { "id": "NCT00183885_inc_R17", "type": "Has_value", "arg1_id": "NCT00183885_inc_T28", "arg2_id": "NCT00183885_inc_T29", "normalized": [] }, { "id": "NCT00183885_inc_R18", "type": "AND", "arg1_id": "NCT00183885_inc_T26", "arg2_id": "NCT00183885_inc_T28", "normalized": [] }, { "id": "NCT00183885_inc_R19", "type": "Has_value", "arg1_id": "NCT00183885_inc_T30", "arg2_id": "NCT00183885_inc_T31", "normalized": [] }, { "id": "NCT00183885_inc_R20", "type": "Has_value", "arg1_id": "NCT00183885_inc_T32", "arg2_id": "NCT00183885_inc_T33", "normalized": [] }, { "id": "NCT00183885_inc_R21", "type": "AND", "arg1_id": "NCT00183885_inc_T30", "arg2_id": "NCT00183885_inc_T32", "normalized": [] }, { "id": "NCT00183885_inc_R22", "type": "Has_negation", "arg1_id": "NCT00183885_inc_T34", "arg2_id": "NCT00183885_inc_T35", "normalized": [] }, { "id": "NCT00183885_inc_R23", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T36", "arg2_id": "NCT00183885_inc_T37", "normalized": [] }, { "id": "NCT00183885_inc_R24", "type": "Has_qualifier", "arg1_id": "NCT00183885_inc_T38", "arg2_id": "NCT00183885_inc_T39", "normalized": [] }, { "id": "NCT00183885_inc_R25", "type": "Has_multiplier", "arg1_id": "NCT00183885_inc_T43", "arg2_id": "NCT00183885_inc_T42", "normalized": [] } ]
NCT00198913_exc
NCT00198913
[ { "id": "NCT00198913_exc_text", "type": "exclusion", "text": [ "type 1 diabetic or non-diabetic \n \n" ], "offsets": [ [ 0, 44 ] ] } ]
[ { "id": "NCT00198913_exc_T1", "text": [ "type 1 diabetic" ], "type": "Condition", "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT00198913_exc_T2", "text": [ "non-diabetic" ], "type": "Condition", "offsets": [ [ 19, 31 ] ], "normalized": [] } ]
[]
[]
[]
NCT00198913_inc
NCT00198913
[ { "id": "NCT00198913_inc_text", "type": "inclusion", "text": [ "type 2 diabetic, age 18 and over, informed consent, \n" ], "offsets": [ [ 0, 53 ] ] } ]
[ { "id": "NCT00198913_inc_T1", "text": [ "type 2 diabetic" ], "type": "Condition", "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT00198913_inc_T2", "text": [ "age" ], "type": "Person", "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT00198913_inc_T3", "text": [ "18 and over" ], "type": "Value", "offsets": [ [ 21, 32 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00198913_inc_R1", "type": "Has_value", "arg1_id": "NCT00198913_inc_T2", "arg2_id": "NCT00198913_inc_T3", "normalized": [] } ]
NCT00235170_exc
NCT00235170
[ { "id": "NCT00235170_exc_text", "type": "exclusion", "text": [ "1. Congestive heart failure; \n2. CABG or Percutaneous Coronary Intervention (PCI) procedure; \n3. Planned need for major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid end-arterectomy, abdominal aortic aneurysm surgery etc.); \n4. Congenital heart disease; \n5. Transmural myocardial infarction within the previous seven days and CK has not returned to normal; \n6. Chest pain lasting longer than 30 minutes within 12 hours pre-procedure, if CK enzymes positive (≥ 2x the normal upper limit). \n7. History of any cerebrovascular accident; \n8. Left main stenosis of 50% or more; \n9. Intention to treat more than 1 totally occluded major epicardial vessel; \n10. Single vessel (single territory) disease. \n \n" ], "offsets": [ [ 0, 751 ] ] } ]
[ { "id": "NCT00235170_exc_T1", "text": [ "Congestive heart failure" ], "type": "Condition", "offsets": [ [ 3, 27 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T2", "text": [ "CABG" ], "type": "Procedure", "offsets": [ [ 33, 37 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T3", "text": [ "Percutaneous Coronary Intervention (PCI)" ], "type": "Procedure", "offsets": [ [ 41, 81 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T4", "text": [ "major surgery" ], "type": "Procedure", "offsets": [ [ 114, 127 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T5", "text": [ "valve surgery" ], "type": "Procedure", "offsets": [ [ 134, 147 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T8", "text": [ "carotid end-arterectomy" ], "type": "Procedure", "offsets": [ [ 201, 224 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T9", "text": [ "abdominal aortic aneurysm surgery" ], "type": "Procedure", "offsets": [ [ 226, 259 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T6", "text": [ "resection of", "left ventricular aneurysm" ], "type": "Procedure", "offsets": [ [ 151, 163 ], [ 174, 199 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T7", "text": [ "resection of aortic", "aneurysm" ], "type": "Procedure", "offsets": [ [ 151, 170 ], [ 191, 199 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T10", "text": [ "Congenital heart disease" ], "type": "Procedure", "offsets": [ [ 271, 295 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T11", "text": [ "Transmural myocardial infarction" ], "type": "Procedure", "offsets": [ [ 301, 333 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T12", "text": [ "within the previous seven days" ], "type": "Temporal", "offsets": [ [ 334, 364 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T13", "text": [ "CK" ], "type": "Measurement", "offsets": [ [ 369, 371 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T14", "text": [ "has not returned" ], "type": "Negation", "offsets": [ [ 372, 388 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T15", "text": [ "normal" ], "type": "Value", "offsets": [ [ 392, 398 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T16", "text": [ "Chest pain" ], "type": "Condition", "offsets": [ [ 404, 414 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T17", "text": [ "lasting longer than 30 minutes" ], "type": "Qualifier", "offsets": [ [ 415, 445 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T18", "text": [ "within 12 hours pre-procedure" ], "type": "Temporal", "offsets": [ [ 446, 475 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T19", "text": [ "CK enzymes" ], "type": "Measurement", "offsets": [ [ 480, 490 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T20", "text": [ "positive" ], "type": "Value", "offsets": [ [ 491, 499 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T21", "text": [ "≥ 2x the normal upper limit" ], "type": "Value", "offsets": [ [ 501, 528 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T22", "text": [ "CK enzymes positive (≥ 2x the normal upper limit)" ], "type": "Scope", "offsets": [ [ 480, 529 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T23", "text": [ "any cerebrovascular accident" ], "type": "Condition", "offsets": [ [ 546, 574 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T24", "text": [ "History of" ], "type": "Observation", "offsets": [ [ 535, 545 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T25", "text": [ "Left main stenosis" ], "type": "Condition", "offsets": [ [ 580, 598 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T26", "text": [ "50% or more" ], "type": "Value", "offsets": [ [ 602, 613 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T27", "text": [ "Single vessel", "disease" ], "type": "Condition", "offsets": [ [ 697, 710 ], [ 730, 737 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T28", "text": [ "single territory", "disease" ], "type": "Condition", "offsets": [ [ 712, 728 ], [ 730, 737 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T29", "text": [ "Intention to" ], "type": "Mood", "offsets": [ [ 619, 631 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T30", "text": [ "more than 1" ], "type": "Multiplier", "offsets": [ [ 638, 649 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T31", "text": [ "totally occluded major epicardial vessel" ], "type": "Qualifier", "offsets": [ [ 650, 690 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T32", "text": [ "treat" ], "type": "Procedure", "offsets": [ [ 632, 637 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00235170_exc_R1", "type": "Has_negation", "arg1_id": "NCT00235170_exc_T15", "arg2_id": "NCT00235170_exc_T14", "normalized": [] }, { "id": "NCT00235170_exc_R2", "type": "Has_value", "arg1_id": "NCT00235170_exc_T13", "arg2_id": "NCT00235170_exc_T15", "normalized": [] }, { "id": "NCT00235170_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00235170_exc_T11", "arg2_id": "NCT00235170_exc_T12", "normalized": [] }, { "id": "NCT00235170_exc_R4", "type": "AND", "arg1_id": "NCT00235170_exc_T11", "arg2_id": "NCT00235170_exc_T13", "normalized": [] }, { "id": "NCT00235170_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00235170_exc_T16", "arg2_id": "NCT00235170_exc_T17", "normalized": [] }, { "id": "NCT00235170_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00235170_exc_T16", "arg2_id": "NCT00235170_exc_T18", "normalized": [] }, { "id": "NCT00235170_exc_R7", "type": "Subsumes", "arg1_id": "NCT00235170_exc_T20", "arg2_id": "NCT00235170_exc_T21", "normalized": [] }, { "id": "NCT00235170_exc_R8", "type": "Has_value", "arg1_id": "NCT00235170_exc_T19", "arg2_id": "NCT00235170_exc_T20", "normalized": [] }, { "id": "NCT00235170_exc_R9", "type": "AND", "arg1_id": "NCT00235170_exc_T22", "arg2_id": "NCT00235170_exc_T16", "normalized": [] }, { "id": "NCT00235170_exc_R10", "type": "AND", "arg1_id": "NCT00235170_exc_T24", "arg2_id": "NCT00235170_exc_T23", "normalized": [] }, { "id": "NCT00235170_exc_R11", "type": "Has_value", "arg1_id": "NCT00235170_exc_T25", "arg2_id": "NCT00235170_exc_T26", "normalized": [] }, { "id": "NCT00235170_exc_R12", "type": "Subsumes", "arg1_id": "NCT00235170_exc_T27", "arg2_id": "NCT00235170_exc_T28", "normalized": [] }, { "id": "NCT00235170_exc_R13", "type": "Has_multiplier", "arg1_id": "NCT00235170_exc_T31", "arg2_id": "NCT00235170_exc_T30", "normalized": [] }, { "id": "NCT00235170_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT00235170_exc_T32", "arg2_id": "NCT00235170_exc_T31", "normalized": [] }, { "id": "NCT00235170_exc_R14", "type": "Has_mood", "arg1_id": "NCT00235170_exc_T32", "arg2_id": "NCT00235170_exc_T29", "normalized": [] } ]
NCT00235170_inc
NCT00235170
[ { "id": "NCT00235170_inc_text", "type": "inclusion", "text": [ "1. Patients with stable (Canadian Cardiovascular Society 1, 2, 3 or 4) or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC) angina pectoris and ischemia, or patients with atypical chest pain or even those who are asymptomatic provided they have documented myocardial ischaemia (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography, Holter tape); \n2. Patients who are eligible for coronary revascularization (angioplasty or CABG); \n3. At least 2 lesions (located in different vessels and in different territories) potentially amenable to stent implantation; \n4. de novo native vessels; \n5. Multivessel disease with at least one significant stenosis in LAD and with treatment of the lesion in another major epicardial coronary artery. A two-vessel disease or a three-vessel disease may be viewed as a combination of a side branch and a main epicardial vessel provided they supply different territories; left anterior descending, left circumflex and right coronary artery); \n6. Total occluded vessels. One total occluded major epicardial vessel or side branch can be included and targeted as long as one other major vessel has a significant stenosis amenable for SA, provided the age of occlusion is less than one month e.g. recent instability, infarction with ECG changes in the area subtended by the occluded vessel. Patients with total occluded vessels of unknown duration or existing longer than one month and a reference over 1.50 mm should not be included, not even as a third or fourth vessel to be dilated; \n7. Significant stenosis has been defined as a stenosis of more than 50% in luminal diameter (in at least one view, on visual interpretation or preferably by QCA); \n8. Left ventricular ejection fraction should be at least 30%. \n" ], "offsets": [ [ 0, 1774 ] ] } ]
[ { "id": "NCT00235170_inc_T1", "text": [ "Canadian Cardiovascular Society" ], "type": "Measurement", "offsets": [ [ 25, 56 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T2", "text": [ "1, 2, 3 or 4" ], "type": "Value", "offsets": [ [ 57, 69 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T3", "text": [ "stable" ], "type": "Qualifier", "offsets": [ [ 17, 23 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T4", "text": [ "unstable" ], "type": "Qualifier", "offsets": [ [ 74, 82 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T5", "text": [ "Braunwald class" ], "type": "Measurement", "offsets": [ [ 84, 99 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T6", "text": [ "IB" ], "type": "Value", "offsets": [ [ 100, 102 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T7", "text": [ "angina pectoris" ], "type": "Condition", "offsets": [ [ 130, 145 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T8", "text": [ "ischemia" ], "type": "Condition", "offsets": [ [ 150, 158 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T9", "text": [ "atypical chest pain" ], "type": "Condition", "offsets": [ [ 177, 196 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T10", "text": [ "stable (Canadian Cardiovascular Society 1, 2, 3 or 4) or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC) angina pectoris and ischemia" ], "type": "Scope", "offsets": [ [ 17, 158 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T11", "text": [ "asymptomatic" ], "type": "Condition", "offsets": [ [ 219, 231 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T12", "text": [ "myocardial ischaemia" ], "type": "Condition", "offsets": [ [ 262, 282 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T13", "text": [ "documented" ], "type": "Observation", "offsets": [ [ 251, 261 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T14", "text": [ "treadmill exercise test" ], "type": "Procedure", "offsets": [ [ 289, 312 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T15", "text": [ "radionuclide scintigraphy" ], "type": "Procedure", "offsets": [ [ 314, 339 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T16", "text": [ "stress echocardiography" ], "type": "Procedure", "offsets": [ [ 341, 364 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T17", "text": [ "Holter tape" ], "type": "Procedure", "offsets": [ [ 366, 377 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T18", "text": [ "treadmill exercise test, radionuclide scintigraphy, stress echocardiography, Holter tape" ], "type": "Scope", "offsets": [ [ 289, 377 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T19", "text": [ "coronary revascularization" ], "type": "Procedure", "offsets": [ [ 414, 440 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T20", "text": [ "eligible for" ], "type": "Mood", "offsets": [ [ 401, 413 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T21", "text": [ "angioplasty" ], "type": "Procedure", "offsets": [ [ 442, 453 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T22", "text": [ "CABG" ], "type": "Procedure", "offsets": [ [ 457, 461 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T23", "text": [ "angioplasty or CABG" ], "type": "Scope", "offsets": [ [ 442, 461 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T24", "text": [ "At least 2" ], "type": "Value", "offsets": [ [ 468, 478 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T25", "text": [ "lesions" ], "type": "Condition", "offsets": [ [ 479, 486 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T26", "text": [ "located in different vessels" ], "type": "Qualifier", "offsets": [ [ 488, 516 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T27", "text": [ "located in", "different territories" ], "type": "Qualifier", "offsets": [ [ 488, 498 ], [ 524, 545 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T28", "text": [ "located in different vessels and in different territories" ], "type": "Scope", "offsets": [ [ 488, 545 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T29", "text": [ "stent implantation" ], "type": "Procedure", "offsets": [ [ 571, 589 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T30", "text": [ "potentially amenable" ], "type": "Observation", "offsets": [ [ 547, 567 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T31", "text": [ "Multivessel disease" ], "type": "Condition", "offsets": [ [ 623, 642 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T32", "text": [ "at least one" ], "type": "Value", "offsets": [ [ 648, 660 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T33", "text": [ "significant stenosis in LAD" ], "type": "Condition", "offsets": [ [ 661, 688 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T34", "text": [ "treatment of the lesion" ], "type": "Procedure", "offsets": [ [ 698, 721 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T35", "text": [ "in another major epicardial coronary artery" ], "type": "Qualifier", "offsets": [ [ 722, 765 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T36", "text": [ "total occluded vessels" ], "type": "Condition", "offsets": [ [ 1364, 1386 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T37", "text": [ "unknown duration" ], "type": "Temporal", "offsets": [ [ 1390, 1406 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T38", "text": [ "longer than one month" ], "type": "Temporal", "offsets": [ [ 1419, 1440 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T39", "text": [ "over 1.50 mm" ], "type": "Value", "offsets": [ [ 1457, 1469 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T40", "text": [ "reference" ], "type": "Measurement", "offsets": [ [ 1447, 1456 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T41", "text": [ "longer than one month and a reference over 1.50 mm" ], "type": "Scope", "offsets": [ [ 1419, 1469 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T42", "text": [ "stenosis" ], "type": "Measurement", "offsets": [ [ 1593, 1601 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T43", "text": [ "more than 50% in luminal diameter" ], "type": "Value", "offsets": [ [ 1605, 1638 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T44", "text": [ "Significant stenosis" ], "type": "Condition", "offsets": [ [ 1550, 1570 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T45", "text": [ "Left ventricular ejection fraction" ], "type": "Measurement", "offsets": [ [ 1714, 1748 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T46", "text": [ "at least 30%" ], "type": "Value", "offsets": [ [ 1759, 1771 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T47", "text": [ "IC" ], "type": "Value", "offsets": [ [ 104, 106 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T48", "text": [ "IIB" ], "type": "Value", "offsets": [ [ 108, 111 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T49", "text": [ "IIC" ], "type": "Value", "offsets": [ [ 113, 116 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T50", "text": [ "IIIB" ], "type": "Value", "offsets": [ [ 118, 122 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T51", "text": [ "IIIC" ], "type": "Value", "offsets": [ [ 124, 128 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T52", "text": [ "IB, IC, IIB, IIC, IIIB, IIIC" ], "type": "Scope", "offsets": [ [ 100, 128 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T53", "text": [ "de novo" ], "type": "Qualifier", "offsets": [ [ 595, 602 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T54", "text": [ "native vessels" ], "type": "Condition", "offsets": [ [ 603, 617 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T56", "text": [ "Total occluded vessels" ], "type": "Condition", "offsets": [ [ 1009, 1031 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T57", "text": [ "One" ], "type": "Multiplier", "offsets": [ [ 1033, 1036 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T58", "text": [ "total occluded major epicardial vessel" ], "type": "Condition", "offsets": [ [ 1037, 1075 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T59", "text": [ "total occluded", "side branch" ], "type": "Condition", "offsets": [ [ 1037, 1051 ], [ 1079, 1090 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T60", "text": [ "total occluded major epicardial vessel or side branch" ], "type": "Scope", "offsets": [ [ 1037, 1090 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00235170_inc_R1", "type": "Has_value", "arg1_id": "NCT00235170_inc_T1", "arg2_id": "NCT00235170_inc_T2", "normalized": [] }, { "id": "NCT00235170_inc_R2", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T3", "arg2_id": "NCT00235170_inc_T1", "normalized": [] }, { "id": "NCT00235170_inc_R4", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T4", "arg2_id": "NCT00235170_inc_T5", "normalized": [] }, { "id": "NCT00235170_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00235170_inc_T7", "arg2_id": "NCT00235170_inc_T3", "normalized": [] }, { "id": "NCT00235170_inc_R6", "type": "AND", "arg1_id": "NCT00235170_inc_T13", "arg2_id": "NCT00235170_inc_T12", "normalized": [] }, { "id": "NCT00235170_inc_R8", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T13", "arg2_id": "NCT00235170_inc_T18", "normalized": [] }, { "id": "NCT00235170_inc_R9", "type": "Has_mood", "arg1_id": "NCT00235170_inc_T19", "arg2_id": "NCT00235170_inc_T20", "normalized": [] }, { "id": "NCT00235170_inc_R10", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T19", "arg2_id": "NCT00235170_inc_T23", "normalized": [] }, { "id": "NCT00235170_inc_R11", "type": "Has_value", "arg1_id": "NCT00235170_inc_T25", "arg2_id": "NCT00235170_inc_T24", "normalized": [] }, { "id": "NCT00235170_inc_R12", "type": "Has_scope", "arg1_id": "NCT00235170_inc_T25", "arg2_id": "NCT00235170_inc_T28", "normalized": [] }, { "id": "NCT00235170_inc_R13", "type": "AND", "arg1_id": "NCT00235170_inc_T30", "arg2_id": "NCT00235170_inc_T29", "normalized": [] }, { "id": "NCT00235170_inc_R15", "type": "AND", "arg1_id": "NCT00235170_inc_T32", "arg2_id": "NCT00235170_inc_T33", "normalized": [] }, { "id": "NCT00235170_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT00235170_inc_T34", "arg2_id": "NCT00235170_inc_T35", "normalized": [] }, { "id": "NCT00235170_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00235170_inc_T36", "arg2_id": "NCT00235170_inc_T37", "normalized": [] }, { "id": "NCT00235170_inc_R18", "type": "Has_value", "arg1_id": "NCT00235170_inc_T42", "arg2_id": "NCT00235170_inc_T43", "normalized": [] }, { "id": "NCT00235170_inc_R19", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T44", "arg2_id": "NCT00235170_inc_T42", "normalized": [] }, { "id": "NCT00235170_inc_R20", "type": "Has_value", "arg1_id": "NCT00235170_inc_T45", "arg2_id": "NCT00235170_inc_T46", "normalized": [] }, { "id": "NCT00235170_inc_R3", "type": "Has_scope", "arg1_id": "NCT00235170_inc_T5", "arg2_id": "NCT00235170_inc_T52", "normalized": [] }, { "id": "NCT00235170_inc_R21", "type": "Has_qualifier", "arg1_id": "NCT00235170_inc_T54", "arg2_id": "NCT00235170_inc_T53", "normalized": [] }, { "id": "NCT00235170_inc_R22", "type": "Has_multiplier", "arg1_id": "NCT00235170_inc_T60", "arg2_id": "NCT00235170_inc_T57", "normalized": [] }, { "id": "NCT00235170_inc_R23", "type": "Subsumes", "arg1_id": "NCT00235170_inc_T56", "arg2_id": "NCT00235170_inc_T60", "normalized": [] } ]
NCT00236340_exc
NCT00236340
[ { "id": "NCT00236340_exc_text", "type": "exclusion", "text": [ "Multiple pregnancy (more than 3 fetuses) \nMaternal history of placental abruptio \nFetus with IUGR \nPregnancy complicated with pre-eclampsia \nUnability to give informed consent \n \n" ], "offsets": [ [ 0, 188 ] ] } ]
[ { "id": "NCT00236340_exc_T1", "text": [ "Multiple pregnancy" ], "type": "Condition", "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T2", "text": [ "more than 3" ], "type": "Value", "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T3", "text": [ "fetuses" ], "type": "Measurement", "offsets": [ [ 32, 39 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T4", "text": [ "placental abruptio" ], "type": "Condition", "offsets": [ [ 62, 80 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T5", "text": [ "Maternal history of" ], "type": "Observation", "offsets": [ [ 42, 61 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T7", "text": [ "IUGR" ], "type": "Condition", "offsets": [ [ 93, 97 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T6", "text": [ "Fetus" ], "type": "Condition", "offsets": [ [ 82, 87 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T8", "text": [ "Pregnancy" ], "type": "Condition", "offsets": [ [ 99, 108 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T9", "text": [ "pre-eclampsia" ], "type": "Condition", "offsets": [ [ 126, 139 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T10", "text": [ "give informed consent" ], "type": "Observation", "offsets": [ [ 154, 175 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T11", "text": [ "Unability to" ], "type": "Negation", "offsets": [ [ 141, 153 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T12", "text": [ "more than 3 fetuses" ], "type": "Scope", "offsets": [ [ 20, 39 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00236340_exc_R2", "type": "Has_value", "arg1_id": "NCT00236340_exc_T3", "arg2_id": "NCT00236340_exc_T2", "normalized": [] }, { "id": "NCT00236340_exc_R3", "type": "AND", "arg1_id": "NCT00236340_exc_T5", "arg2_id": "NCT00236340_exc_T4", "normalized": [] }, { "id": "NCT00236340_exc_R4", "type": "AND", "arg1_id": "NCT00236340_exc_T6", "arg2_id": "NCT00236340_exc_T7", "normalized": [] }, { "id": "NCT00236340_exc_R5", "type": "Has_negation", "arg1_id": "NCT00236340_exc_T10", "arg2_id": "NCT00236340_exc_T11", "normalized": [] }, { "id": "NCT00236340_exc_R1", "type": "Subsumes", "arg1_id": "NCT00236340_exc_T1", "arg2_id": "NCT00236340_exc_T12", "normalized": [] } ]
NCT00236340_inc
NCT00236340
[ { "id": "NCT00236340_inc_text", "type": "inclusion", "text": [ "Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI>25cm) \nSingle or twin pregnancies \n" ], "offsets": [ [ 0, 122 ] ] } ]
[ { "id": "NCT00236340_inc_T1", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T2", "text": [ "women" ], "type": "Person", "offsets": [ [ 9, 14 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T3", "text": [ "abdomen discumfort" ], "type": "Condition", "offsets": [ [ 20, 38 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T4", "text": [ "ultrasound" ], "type": "Procedure", "offsets": [ [ 43, 53 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T5", "text": [ "polyhydramnios" ], "type": "Condition", "offsets": [ [ 67, 81 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T6", "text": [ "AFI" ], "type": "Measurement", "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T7", "text": [ ">25cm" ], "type": "Value", "offsets": [ [ 86, 91 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T8", "text": [ "diagnosis" ], "type": "Value", "offsets": [ [ 54, 63 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T9", "text": [ "pregnancies" ], "type": "Condition", "offsets": [ [ 109, 120 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T10", "text": [ "Single" ], "type": "Value", "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T11", "text": [ "twin" ], "type": "Value", "offsets": [ [ 104, 108 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T12", "text": [ "Single or twin" ], "type": "Scope", "offsets": [ [ 94, 108 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00236340_inc_R1", "type": "Has_value", "arg1_id": "NCT00236340_inc_T6", "arg2_id": "NCT00236340_inc_T7", "normalized": [] }, { "id": "NCT00236340_inc_R3", "type": "Has_value", "arg1_id": "NCT00236340_inc_T4", "arg2_id": "NCT00236340_inc_T8", "normalized": [] }, { "id": "NCT00236340_inc_R2", "type": "AND", "arg1_id": "NCT00236340_inc_T5", "arg2_id": "NCT00236340_inc_T4", "normalized": [] }, { "id": "NCT00236340_inc_R4", "type": "Subsumes", "arg1_id": "NCT00236340_inc_T4", "arg2_id": "NCT00236340_inc_T6", "normalized": [] }, { "id": "NCT00236340_inc_R5", "type": "AND", "arg1_id": "NCT00236340_inc_T12", "arg2_id": "NCT00236340_inc_T9", "normalized": [] } ]
NCT00250640_exc
NCT00250640
[ { "id": "NCT00250640_exc_text", "type": "exclusion", "text": [ "Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert) \n \n" ], "offsets": [ [ 0, 237 ] ] } ]
[ { "id": "NCT00250640_exc_T1", "text": [ "pregnancy" ], "type": "Condition", "offsets": [ [ 66, 75 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T2", "text": [ "contraindications" ], "type": "Condition", "offsets": [ [ 86, 103 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T3", "text": [ "Ventavis treatment" ], "type": "Procedure", "offsets": [ [ 108, 126 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T4", "text": [ "Ventavis Summary of Product Characteristics and patient package insert" ], "type": "Qualifier", "offsets": [ [ 153, 223 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00250640_exc_R1", "type": "AND", "arg1_id": "NCT00250640_exc_T2", "arg2_id": "NCT00250640_exc_T3", "normalized": [] }, { "id": "NCT00250640_exc_R2", "type": "Subsumes", "arg1_id": "NCT00250640_exc_T2", "arg2_id": "NCT00250640_exc_T4", "normalized": [] } ]
NCT00250640_inc
NCT00250640
[ { "id": "NCT00250640_inc_text", "type": "inclusion", "text": [ "The treating physician has chosen Ventavis as a suitable long-term treatment for the patient \nPatient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association) \nNo prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma) \n" ], "offsets": [ [ 0, 503 ] ] } ]
[ { "id": "NCT00250640_inc_T1", "text": [ "Ventavis" ], "type": "Drug", "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T2", "text": [ "primary pulmonary hypertension" ], "type": "Condition", "offsets": [ [ 107, 137 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T3", "text": [ "Idiopathic Pulmonary Arterial Hypertension" ], "type": "Condition", "offsets": [ [ 144, 186 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T4", "text": [ "Familial Pulmonary Arterial Hypertension" ], "type": "Condition", "offsets": [ [ 190, 230 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T5", "text": [ "Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension" ], "type": "Scope", "offsets": [ [ 144, 230 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T6", "text": [ "NYHA functional class" ], "type": "Measurement", "offsets": [ [ 250, 271 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T7", "text": [ "III" ], "type": "Value", "offsets": [ [ 272, 275 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T8", "text": [ "treatment with Ventavis" ], "type": "Procedure", "offsets": [ [ 322, 345 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T9", "text": [ "primary pulmonary hypertension" ], "type": "Condition", "offsets": [ [ 377, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T10", "text": [ "treatments" ], "type": "Procedure", "offsets": [ [ 362, 372 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T11", "text": [ "for primary pulmonary hypertension" ], "type": "Qualifier", "offsets": [ [ 373, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T12", "text": [ "within 6 weeks of date of study inclusion" ], "type": "Temporal", "offsets": [ [ 408, 449 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T13", "text": [ "No" ], "type": "Negation", "offsets": [ [ 313, 315 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T14", "text": [ "treatment with Ventavis or other active treatments for primary pulmonary hypertension" ], "type": "Scope", "offsets": [ [ 322, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T15", "text": [ "long-term" ], "type": "Multiplier", "offsets": [ [ 57, 66 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00250640_inc_R1", "type": "Subsumes", "arg1_id": "NCT00250640_inc_T2", "arg2_id": "NCT00250640_inc_T5", "normalized": [] }, { "id": "NCT00250640_inc_R2", "type": "Has_value", "arg1_id": "NCT00250640_inc_T6", "arg2_id": "NCT00250640_inc_T7", "normalized": [] }, { "id": "NCT00250640_inc_R3", "type": "AND", "arg1_id": "NCT00250640_inc_T2", "arg2_id": "NCT00250640_inc_T6", "normalized": [] }, { "id": "NCT00250640_inc_R4", "type": "AND", "arg1_id": "NCT00250640_inc_T11", "arg2_id": "NCT00250640_inc_T9", "normalized": [] }, { "id": "NCT00250640_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00250640_inc_T10", "arg2_id": "NCT00250640_inc_T11", "normalized": [] }, { "id": "NCT00250640_inc_R6", "type": "Has_negation", "arg1_id": "NCT00250640_inc_T14", "arg2_id": "NCT00250640_inc_T13", "normalized": [] }, { "id": "NCT00250640_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00250640_inc_T14", "arg2_id": "NCT00250640_inc_T12", "normalized": [] }, { "id": "NCT00250640_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT00250640_inc_T1", "arg2_id": "NCT00250640_inc_T15", "normalized": [] } ]
NCT00279552_exc
NCT00279552
[ { "id": "NCT00279552_exc_text", "type": "exclusion", "text": [ "Patients who were pregnant, nursing or not able to give written informed consent were excluded. \n \n" ], "offsets": [ [ 0, 108 ] ] } ]
[ { "id": "NCT00279552_exc_T1", "text": [ "pregnant" ], "type": "Condition", "offsets": [ [ 18, 26 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T2", "text": [ "nursing" ], "type": "Condition", "offsets": [ [ 28, 35 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T3", "text": [ "able to give written informed consent" ], "type": "Observation", "offsets": [ [ 43, 80 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T4", "text": [ "not" ], "type": "Negation", "offsets": [ [ 39, 42 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00279552_exc_R1", "type": "Has_negation", "arg1_id": "NCT00279552_exc_T3", "arg2_id": "NCT00279552_exc_T4", "normalized": [] } ]
NCT00279552_inc
NCT00279552
[ { "id": "NCT00279552_inc_text", "type": "inclusion", "text": [ "Patients suspected to have vitamin B12 deficiency defined as a plasma vitamin B12 below the reference interval (<200 pmol/L). \n" ], "offsets": [ [ 0, 127 ] ] } ]
[ { "id": "NCT00279552_inc_T1", "text": [ "vitamin B12 deficiency" ], "type": "Condition", "offsets": [ [ 27, 49 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T2", "text": [ "suspected" ], "type": "Mood", "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T3", "text": [ "plasma vitamin B12" ], "type": "Measurement", "offsets": [ [ 63, 81 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T4", "text": [ "below the reference interval" ], "type": "Value", "offsets": [ [ 82, 110 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T5", "text": [ "<200 pmol/L" ], "type": "Value", "offsets": [ [ 112, 123 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00279552_inc_R1", "type": "Has_mood", "arg1_id": "NCT00279552_inc_T1", "arg2_id": "NCT00279552_inc_T2", "normalized": [] }, { "id": "NCT00279552_inc_R2", "type": "Subsumes", "arg1_id": "NCT00279552_inc_T4", "arg2_id": "NCT00279552_inc_T5", "normalized": [] }, { "id": "NCT00279552_inc_R3", "type": "Has_value", "arg1_id": "NCT00279552_inc_T3", "arg2_id": "NCT00279552_inc_T4", "normalized": [] }, { "id": "NCT00279552_inc_R4", "type": "Subsumes", "arg1_id": "NCT00279552_inc_T1", "arg2_id": "NCT00279552_inc_T3", "normalized": [] } ]
NCT00305097_exc
NCT00305097
[ { "id": "NCT00305097_exc_text", "type": "exclusion", "text": [ "Any condition/illness that may affect the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer, according to a detailed medical history. \nAbnormal hepatic function (liver function test > twice the normal range), abnormal renal function (creatinine > 1.1 mg/dl), fasting plasma glucose in the diabetic range (>/= 126 mg/dl), or blood pressure > 140/90 mmHg. \nPresent alcoholism or drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives. \n \n" ], "offsets": [ [ 0, 774 ] ] } ]
[ { "id": "NCT00305097_exc_T1", "text": [ "pregnancy" ], "type": "Condition", "offsets": [ [ 113, 122 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T2", "text": [ "breastfeeding" ], "type": "Observation", "offsets": [ [ 126, 139 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T3", "text": [ "diabetes mellitus" ], "type": "Condition", "offsets": [ [ 141, 158 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T4", "text": [ "heart disease" ], "type": "Condition", "offsets": [ [ 160, 173 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T5", "text": [ "stroke" ], "type": "Condition", "offsets": [ [ 175, 181 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T6", "text": [ "hypertension" ], "type": "Condition", "offsets": [ [ 183, 195 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T7", "text": [ "malabsorption syndromes" ], "type": "Condition", "offsets": [ [ 197, 220 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T8", "text": [ "GERD" ], "type": "Condition", "offsets": [ [ 222, 226 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T9", "text": [ "history of" ], "type": "Observation", "offsets": [ [ 230, 240 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T10", "text": [ "ulcer" ], "type": "Condition", "offsets": [ [ 241, 246 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T11", "text": [ "illness that may affect the study outcomes" ], "type": "Condition", "offsets": [ [ 14, 56 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T12", "text": [ "illness that", "would make participation potentially harmful" ], "type": "Condition", "offsets": [ [ 14, 26 ], [ 60, 104 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T13", "text": [ "pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer" ], "type": "Scope", "offsets": [ [ 113, 246 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T14", "text": [ "illness that may affect the study outcomes or would make participation potentially harmful" ], "type": "Scope", "offsets": [ [ 14, 104 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T15", "text": [ "hepatic function" ], "type": "Measurement", "offsets": [ [ 299, 315 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T16", "text": [ "Abnormal" ], "type": "Value", "offsets": [ [ 290, 298 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T17", "text": [ "liver function test" ], "type": "Measurement", "offsets": [ [ 317, 336 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T18", "text": [ "> twice the normal range" ], "type": "Value", "offsets": [ [ 337, 361 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T19", "text": [ "renal function" ], "type": "Measurement", "offsets": [ [ 373, 387 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T20", "text": [ "abnormal" ], "type": "Value", "offsets": [ [ 364, 372 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T21", "text": [ "creatinine" ], "type": "Measurement", "offsets": [ [ 389, 399 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T22", "text": [ "> 1.1 mg/dl" ], "type": "Value", "offsets": [ [ 400, 411 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T23", "text": [ "fasting plasma glucose" ], "type": "Measurement", "offsets": [ [ 414, 436 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T24", "text": [ "in the diabetic range" ], "type": "Value", "offsets": [ [ 437, 458 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T25", "text": [ ">/= 126 mg/dl" ], "type": "Value", "offsets": [ [ 460, 473 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T26", "text": [ "blood pressure" ], "type": "Measurement", "offsets": [ [ 479, 493 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T27", "text": [ "> 140/90 mmHg" ], "type": "Value", "offsets": [ [ 494, 507 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T28", "text": [ "alcoholism" ], "type": "Condition", "offsets": [ [ 518, 528 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T29", "text": [ "drug abuse" ], "type": "Condition", "offsets": [ [ 532, 542 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T30", "text": [ "medications that could interfere with the treatment" ], "type": "Drug", "offsets": [ [ 553, 604 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T31", "text": [ "bronchodilators" ], "type": "Drug", "offsets": [ [ 615, 630 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T32", "text": [ "quinolone antibiotics" ], "type": "Drug", "offsets": [ [ 632, 653 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T33", "text": [ "monoamine oxidase inhibitors" ], "type": "Drug", "offsets": [ [ 655, 683 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T34", "text": [ "anxiolytics" ], "type": "Drug", "offsets": [ [ 685, 696 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T35", "text": [ "ranitidine" ], "type": "Drug", "offsets": [ [ 698, 708 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T36", "text": [ "corticosteroids" ], "type": "Drug", "offsets": [ [ 710, 725 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T37", "text": [ "growth hormone" ], "type": "Drug", "offsets": [ [ 727, 741 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T38", "text": [ "antihypertensives" ], "type": "Drug", "offsets": [ [ 743, 760 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T39", "text": [ "bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives" ], "type": "Scope", "offsets": [ [ 615, 760 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T40", "text": [ "medical history" ], "type": "Observation", "offsets": [ [ 272, 287 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00305097_exc_R1", "type": "AND", "arg1_id": "NCT00305097_exc_T9", "arg2_id": "NCT00305097_exc_T10", "normalized": [] }, { "id": "NCT00305097_exc_R2", "type": "Subsumes", "arg1_id": "NCT00305097_exc_T14", "arg2_id": "NCT00305097_exc_T13", "normalized": [] }, { "id": "NCT00305097_exc_R3", "type": "Has_value", "arg1_id": "NCT00305097_exc_T15", "arg2_id": "NCT00305097_exc_T16", "normalized": [] }, { "id": "NCT00305097_exc_R4", "type": "Has_value", "arg1_id": "NCT00305097_exc_T17", "arg2_id": "NCT00305097_exc_T18", "normalized": [] }, { "id": "NCT00305097_exc_R5", "type": "Has_value", "arg1_id": "NCT00305097_exc_T19", "arg2_id": "NCT00305097_exc_T20", "normalized": [] }, { "id": "NCT00305097_exc_R6", "type": "Has_value", "arg1_id": "NCT00305097_exc_T21", "arg2_id": "NCT00305097_exc_T22", "normalized": [] }, { "id": "NCT00305097_exc_R8", "type": "Has_value", "arg1_id": "NCT00305097_exc_T23", "arg2_id": "NCT00305097_exc_T24", "normalized": [] }, { "id": "NCT00305097_exc_R7", "type": "Subsumes", "arg1_id": "NCT00305097_exc_T20", "arg2_id": "NCT00305097_exc_T21", "normalized": [] }, { "id": "NCT00305097_exc_R9", "type": "Subsumes", "arg1_id": "NCT00305097_exc_T24", "arg2_id": "NCT00305097_exc_T25", "normalized": [] }, { "id": "NCT00305097_exc_R10", "type": "Has_value", "arg1_id": "NCT00305097_exc_T26", "arg2_id": "NCT00305097_exc_T27", "normalized": [] }, { "id": "NCT00305097_exc_R11", "type": "Subsumes", "arg1_id": "NCT00305097_exc_T30", "arg2_id": "NCT00305097_exc_T39", "normalized": [] }, { "id": "NCT00305097_exc_R12", "type": "Has_temporal", "arg1_id": "NCT00305097_exc_T13", "arg2_id": "NCT00305097_exc_T40", "normalized": [] } ]
NCT00305097_inc
NCT00305097
[ { "id": "NCT00305097_inc_text", "type": "inclusion", "text": [ "Aged at least 18 years with an ability and willingness to give written informed consent. \nBody mass index 25-35 kg/m2 \nUsers of at least 2 cups of caffeinated coffee per day who are willing to be randomized to any of the interventions. \nNon-smoking \n" ], "offsets": [ [ 0, 250 ] ] } ]
[ { "id": "NCT00305097_inc_T1", "text": [ "Aged" ], "type": "Person", "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T2", "text": [ "at least 18 years" ], "type": "Value", "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T3", "text": [ "ability", "to give written informed consent" ], "type": "Observation", "offsets": [ [ 31, 38 ], [ 55, 87 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T4", "text": [ "willingness", "to give written informed consent" ], "type": "Observation", "offsets": [ [ 43, 54 ], [ 55, 87 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T5", "text": [ "Body mass index" ], "type": "Measurement", "offsets": [ [ 90, 105 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T6", "text": [ "25-35 kg/m2" ], "type": "Value", "offsets": [ [ 106, 117 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T7", "text": [ "at least 2 cups", "per day" ], "type": "Multiplier", "offsets": [ [ 128, 143 ], [ 166, 173 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T8", "text": [ "caffeinated coffee" ], "type": "Drug", "offsets": [ [ 147, 165 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T9", "text": [ "willing to be randomized" ], "type": "Observation", "offsets": [ [ 182, 206 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T10", "text": [ "Non-smoking" ], "type": "Condition", "offsets": [ [ 237, 248 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00305097_inc_R1", "type": "Has_value", "arg1_id": "NCT00305097_inc_T1", "arg2_id": "NCT00305097_inc_T2", "normalized": [] }, { "id": "NCT00305097_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT00305097_inc_T8", "arg2_id": "NCT00305097_inc_T7", "normalized": [] } ]
NCT00312429_exc
NCT00312429
[ { "id": "NCT00312429_exc_text", "type": "exclusion", "text": [ "Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry \nDiagnosed with a medical or psychiatric illness that may interfere with study participation \nPregnant \n \n" ], "offsets": [ [ 0, 185 ] ] } ]
[ { "id": "NCT00312429_exc_T1", "text": [ "Interleukin-2 (IL-2) therapy" ], "type": "Procedure", "offsets": [ [ 11, 39 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T2", "text": [ "within 8 weeks of study entry" ], "type": "Temporal", "offsets": [ [ 40, 69 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T3", "text": [ "illness that may interfere with study participation", "medical" ], "type": "Condition", "offsets": [ [ 111, 162 ], [ 88, 95 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T4", "text": [ "psychiatric illness that may interfere with study participation" ], "type": "Condition", "offsets": [ [ 99, 162 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T5", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 164, 172 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00312429_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00312429_exc_T1", "arg2_id": "NCT00312429_exc_T2", "normalized": [] } ]
NCT00312429_inc
NCT00312429
[ { "id": "NCT00312429_inc_text", "type": "inclusion", "text": [ "Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study \nEstimated life expectancy of at least 6 weeks following study entry \nCancer and Leukemia Group B (CALGB) performance status less than or equal to 2 \nWhite blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center \nMultiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity [DLCO] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy) \nSufficient number of umbilical cord blood units available for transplantation \nIf female, willing to use contraception throughout the study \n" ], "offsets": [ [ 0, 1029 ] ] } ]
[ { "id": "NCT00312429_inc_T1", "text": [ "high risk blood disease" ], "type": "Condition", "offsets": [ [ 79, 102 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T2", "text": [ "cancer" ], "type": "Condition", "offsets": [ [ 106, 112 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T3", "text": [ "Estimated life expectancy" ], "type": "Measurement", "offsets": [ [ 140, 165 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T4", "text": [ "at least 6 weeks following study entry" ], "type": "Value", "offsets": [ [ 169, 207 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T5", "text": [ "Cancer and Leukemia Group B (CALGB) performance status" ], "type": "Measurement", "offsets": [ [ 209, 263 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T8", "text": [ "less than or equal to 2" ], "type": "Value", "offsets": [ [ 264, 287 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T9", "text": [ "White blood cell count" ], "type": "Measurement", "offsets": [ [ 289, 311 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T10", "text": [ "platelet" ], "type": "Measurement", "offsets": [ [ 313, 321 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T11", "text": [ "hematocrit" ], "type": "Measurement", "offsets": [ [ 323, 333 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T12", "text": [ "tuberculosis" ], "type": "Measurement", "offsets": [ [ 335, 347 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T13", "text": [ "aspartate aminotransferase (AST)" ], "type": "Measurement", "offsets": [ [ 349, 381 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T6", "text": [ "alanine aminotransferase (ALT)" ], "type": "Measurement", "offsets": [ [ 383, 413 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T7", "text": [ "alkaline phosphatase" ], "type": "Measurement", "offsets": [ [ 415, 435 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T14", "text": [ "creatinine" ], "type": "Measurement", "offsets": [ [ 437, 447 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T15", "text": [ "HIV test results" ], "type": "Measurement", "offsets": [ [ 453, 469 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T16", "text": [ "reviewed by transplant center" ], "type": "Qualifier", "offsets": [ [ 470, 499 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T17", "text": [ "White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results" ], "type": "Scope", "offsets": [ [ 289, 469 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T18", "text": [ "Multiple gated acquisition (MUGA)" ], "type": "Procedure", "offsets": [ [ 501, 534 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T19", "text": [ "echocardiogram" ], "type": "Procedure", "offsets": [ [ 536, 550 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T20", "text": [ "cardiac MRI" ], "type": "Procedure", "offsets": [ [ 552, 563 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T21", "text": [ "pulmonary function tests (PFT)" ], "type": "Procedure", "offsets": [ [ 572, 602 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T22", "text": [ "reviewed by transplant center" ], "type": "Qualifier", "offsets": [ [ 617, 646 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T23", "text": [ "Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT)" ], "type": "Scope", "offsets": [ [ 501, 602 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T24", "text": [ "female" ], "type": "Person", "offsets": [ [ 970, 976 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T25", "text": [ "contraception" ], "type": "Procedure", "offsets": [ [ 993, 1006 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T26", "text": [ "throughout the study" ], "type": "Temporal", "offsets": [ [ 1007, 1027 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T27", "text": [ "umbilical cord blood units available" ], "type": "Measurement", "offsets": [ [ 909, 945 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T28", "text": [ "Sufficient number" ], "type": "Value", "offsets": [ [ 888, 905 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T29", "text": [ "for transplantation" ], "type": "Qualifier", "offsets": [ [ 946, 965 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T30", "text": [ "transplantation" ], "type": "Procedure", "offsets": [ [ 950, 965 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00312429_inc_R1", "type": "Has_value", "arg1_id": "NCT00312429_inc_T3", "arg2_id": "NCT00312429_inc_T4", "normalized": [] }, { "id": "NCT00312429_inc_R2", "type": "Has_value", "arg1_id": "NCT00312429_inc_T5", "arg2_id": "NCT00312429_inc_T8", "normalized": [] }, { "id": "NCT00312429_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00312429_inc_T17", "arg2_id": "NCT00312429_inc_T16", "normalized": [] }, { "id": "NCT00312429_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00312429_inc_T23", "arg2_id": "NCT00312429_inc_T22", "normalized": [] }, { "id": "NCT00312429_inc_R5", "type": "AND", "arg1_id": "NCT00312429_inc_T24", "arg2_id": "NCT00312429_inc_T25", "normalized": [] }, { "id": "NCT00312429_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00312429_inc_T25", "arg2_id": "NCT00312429_inc_T26", "normalized": [] }, { "id": "NCT00312429_inc_R7", "type": "Has_value", "arg1_id": "NCT00312429_inc_T27", "arg2_id": "NCT00312429_inc_T28", "normalized": [] }, { "id": "NCT00312429_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT00312429_inc_T27", "arg2_id": "NCT00312429_inc_T29", "normalized": [] } ]
NCT00317148_exc
NCT00317148
[ { "id": "NCT00317148_exc_text", "type": "exclusion", "text": [ "Body mass index (BMI) of 35 kg/m2 or more. \nSignificant metabolic and endocrine diseases. \nDiagnosis of cancer. \nUse of steroids or drugs that interfere with the metabolism of estrogen. \nUse of any systemic estrogen, progestin, or DHEA in the eight weeks prior to randomization. \nUse of alternative therapies or natural products to treat postmenopausal symptoms in the four weeks prior to randomization. \nPalpable fibroids or uterine prolapse: Grade 2 or 3. \nCigarette smoking \n \n" ], "offsets": [ [ 0, 489 ] ] } ]
[ { "id": "NCT00317148_exc_T1", "text": [ "Body mass index (BMI)" ], "type": "Measurement", "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T2", "text": [ "35 kg/m2 or more" ], "type": "Value", "offsets": [ [ 25, 41 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T3", "text": [ "metabolic", "diseases" ], "type": "Condition", "offsets": [ [ 56, 65 ], [ 80, 88 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T4", "text": [ "endocrine diseases" ], "type": "Condition", "offsets": [ [ 70, 88 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T5", "text": [ "cancer" ], "type": "Condition", "offsets": [ [ 104, 110 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T6", "text": [ "steroids" ], "type": "Drug", "offsets": [ [ 120, 128 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T7", "text": [ "drugs that interfere with the metabolism of estrogen" ], "type": "Drug", "offsets": [ [ 132, 184 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T8", "text": [ "systemic estrogen" ], "type": "Drug", "offsets": [ [ 198, 215 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T9", "text": [ "systemic", "progestin" ], "type": "Drug", "offsets": [ [ 198, 206 ], [ 217, 226 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T10", "text": [ "DHEA" ], "type": "Drug", "offsets": [ [ 231, 235 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T11", "text": [ "in the eight weeks prior to randomization" ], "type": "Temporal", "offsets": [ [ 236, 277 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T12", "text": [ "systemic estrogen, progestin, or DHEA" ], "type": "Scope", "offsets": [ [ 198, 235 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T13", "text": [ "alternative therapies" ], "type": "Procedure", "offsets": [ [ 287, 308 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T14", "text": [ "natural products" ], "type": "Drug", "offsets": [ [ 312, 328 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T15", "text": [ "postmenopausal symptoms" ], "type": "Condition", "offsets": [ [ 338, 361 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T16", "text": [ "in the four weeks prior to randomization" ], "type": "Temporal", "offsets": [ [ 362, 402 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T17", "text": [ "alternative therapies or natural products" ], "type": "Scope", "offsets": [ [ 287, 328 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T18", "text": [ "Palpable fibroids" ], "type": "Condition", "offsets": [ [ 405, 422 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T19", "text": [ "uterine prolapse" ], "type": "Condition", "offsets": [ [ 426, 442 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T20", "text": [ "Grade" ], "type": "Measurement", "offsets": [ [ 444, 449 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T21", "text": [ "2 or 3" ], "type": "Value", "offsets": [ [ 450, 456 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T22", "text": [ "Palpable fibroids or uterine prolapse" ], "type": "Scope", "offsets": [ [ 405, 442 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T23", "text": [ "Cigarette smoking" ], "type": "Condition", "offsets": [ [ 459, 476 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00317148_exc_R1", "type": "Has_value", "arg1_id": "NCT00317148_exc_T1", "arg2_id": "NCT00317148_exc_T2", "normalized": [] }, { "id": "NCT00317148_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00317148_exc_T12", "arg2_id": "NCT00317148_exc_T11", "normalized": [] }, { "id": "NCT00317148_exc_R3", "type": "AND", "arg1_id": "NCT00317148_exc_T17", "arg2_id": "NCT00317148_exc_T15", "normalized": [] }, { "id": "NCT00317148_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00317148_exc_T17", "arg2_id": "NCT00317148_exc_T16", "normalized": [] }, { "id": "NCT00317148_exc_R5", "type": "Has_value", "arg1_id": "NCT00317148_exc_T20", "arg2_id": "NCT00317148_exc_T21", "normalized": [] }, { "id": "NCT00317148_exc_R6", "type": "AND", "arg1_id": "NCT00317148_exc_T22", "arg2_id": "NCT00317148_exc_T20", "normalized": [] } ]
NCT00317148_inc
NCT00317148
[ { "id": "NCT00317148_inc_text", "type": "inclusion", "text": [ "Healthy postmenopausal women with 50 or more moderate to severe hot flushes. \nWomen between 40 to 70 years of age. \n" ], "offsets": [ [ 0, 116 ] ] } ]
[ { "id": "NCT00317148_inc_T1", "text": [ "postmenopausal" ], "type": "Condition", "offsets": [ [ 8, 22 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T2", "text": [ "Healthy" ], "type": "Condition", "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T3", "text": [ "women" ], "type": "Person", "offsets": [ [ 23, 28 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T4", "text": [ "50 or more" ], "type": "Value", "offsets": [ [ 34, 44 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T5", "text": [ "moderate to severe hot flushes" ], "type": "Condition", "offsets": [ [ 45, 75 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T6", "text": [ "Women" ], "type": "Person", "offsets": [ [ 78, 83 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T7", "text": [ "between 40 to 70 years" ], "type": "Value", "offsets": [ [ 84, 106 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T8", "text": [ "age" ], "type": "Person", "offsets": [ [ 110, 113 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00317148_inc_R1", "type": "AND", "arg1_id": "NCT00317148_inc_T4", "arg2_id": "NCT00317148_inc_T5", "normalized": [] }, { "id": "NCT00317148_inc_R2", "type": "Has_value", "arg1_id": "NCT00317148_inc_T8", "arg2_id": "NCT00317148_inc_T7", "normalized": [] } ]
NCT00319748_exc
NCT00319748
[ { "id": "NCT00319748_exc_text", "type": "exclusion", "text": [ "Had/have the following prior/concurrent therapy: \nSystemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed) \nInvestigational drugs/agents within 14 days of first dose of 852A \nImmunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose) \nDrugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions \nRadiotherapy within 3 weeks of the first dose of 852A \nHematopoietic cell transplantation within 4 weeks of first dose of 852A \nEvidence of active infection within 3 days of first dose of 852A \nActive fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable) \nCardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication \nHistory of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk \nUncontrolled intercurrent or chronic illness \nActive autoimmune disease requiring immunosuppressive therapy within 30 days \nActive coagulation disorder not controlled with medication \nPregnant or lactating \nConcurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated \nAny history of brain metastases or any other active central nervous system (CNS) disease \n \n" ], "offsets": [ [ 0, 1603 ] ] } ]
[ { "id": "NCT00319748_exc_T1", "text": [ "Systemic corticosteroids" ], "type": "Drug", "offsets": [ [ 50, 74 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T2", "text": [ "within 7 days of first dose" ], "type": "Temporal", "offsets": [ [ 96, 123 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T3", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 127, 131 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T4", "text": [ "topical", "steroids" ], "type": "Drug", "offsets": [ [ 133, 140 ], [ 152, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T5", "text": [ "inhaled steroids" ], "type": "Drug", "offsets": [ [ 144, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T6", "text": [ "topical or inhaled steroids are allowed" ], "type": "Scope", "offsets": [ [ 133, 172 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T7", "text": [ "Investigational drugs/agents" ], "type": "Drug", "offsets": [ [ 175, 203 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T8", "text": [ "within 14 days of first dose" ], "type": "Temporal", "offsets": [ [ 204, 232 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T9", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 236, 240 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T10", "text": [ "Immunosuppressive therapy" ], "type": "Procedure", "offsets": [ [ 242, 267 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T11", "text": [ "cytotoxic agents" ], "type": "Drug", "offsets": [ [ 279, 295 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T12", "text": [ "within 14 days of first dose" ], "type": "Temporal", "offsets": [ [ 296, 324 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T13", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 328, 332 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T14", "text": [ "nitrosoureas" ], "type": "Drug", "offsets": [ [ 334, 346 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T15", "text": [ "within 30 days of first dose" ], "type": "Temporal", "offsets": [ [ 347, 375 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T16", "text": [ "Drugs known to induce QT interval prolongation" ], "type": "Drug", "offsets": [ [ 378, 424 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T17", "text": [ "Drugs known to", "induce Torsades de pointes" ], "type": "Drug", "offsets": [ [ 378, 392 ], [ 432, 458 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T19", "text": [ "Drugs known to induce QT interval prolongation and/or induce Torsades de pointes" ], "type": "Scope", "offsets": [ [ 378, 458 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T20", "text": [ "Radiotherapy" ], "type": "Procedure", "offsets": [ [ 533, 545 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T21", "text": [ "within 3 weeks of the first dose" ], "type": "Temporal", "offsets": [ [ 546, 578 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T22", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 582, 586 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T23", "text": [ "Hematopoietic cell transplantation" ], "type": "Procedure", "offsets": [ [ 588, 622 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T24", "text": [ "within 4 weeks of first dose" ], "type": "Temporal", "offsets": [ [ 623, 651 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T25", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 655, 659 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T26", "text": [ "active infection" ], "type": "Condition", "offsets": [ [ 673, 689 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T27", "text": [ "Evidence" ], "type": "Observation", "offsets": [ [ 661, 669 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T28", "text": [ "within 3 days of first dose" ], "type": "Temporal", "offsets": [ [ 690, 717 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T29", "text": [ "852A" ], "type": "Drug", "offsets": [ [ 721, 725 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T30", "text": [ "fungal infection" ], "type": "Condition", "offsets": [ [ 734, 750 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T31", "text": [ "pulmonary infiltrates" ], "type": "Condition", "offsets": [ [ 754, 775 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T32", "text": [ "prior treated disease" ], "type": "Condition", "offsets": [ [ 777, 798 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T33", "text": [ "stable" ], "type": "Qualifier", "offsets": [ [ 799, 805 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T34", "text": [ "for 2 weeks" ], "type": "Temporal", "offsets": [ [ 806, 817 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T35", "text": [ "fungal infection or pulmonary infiltrates" ], "type": "Scope", "offsets": [ [ 734, 775 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T36", "text": [ "Cardiac ischemia" ], "type": "Condition", "offsets": [ [ 833, 849 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T37", "text": [ "cardiac arrhythmias" ], "type": "Condition", "offsets": [ [ 851, 870 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T38", "text": [ "congestive heart failure" ], "type": "Condition", "offsets": [ [ 874, 898 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T39", "text": [ "uncontrolled by medication" ], "type": "Qualifier", "offsets": [ [ 899, 925 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T40", "text": [ "History" ], "type": "Observation", "offsets": [ [ 927, 934 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T41", "text": [ "clinical evidence" ], "type": "Observation", "offsets": [ [ 942, 959 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T42", "text": [ "could confound the results of the study or put the subject at undue risk", "a condition which" ], "type": "Condition", "offsets": [ [ 1019, 1091 ], [ 964, 981 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T43", "text": [ "History of, or clinical evidence of" ], "type": "Scope", "offsets": [ [ 927, 962 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T44", "text": [ "intercurrent", "illness" ], "type": "Condition", "offsets": [ [ 1106, 1118 ], [ 1130, 1137 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T45", "text": [ "chronic illness" ], "type": "Condition", "offsets": [ [ 1122, 1137 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T46", "text": [ "Uncontrolled" ], "type": "Qualifier", "offsets": [ [ 1093, 1105 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T47", "text": [ "autoimmune disease" ], "type": "Condition", "offsets": [ [ 1146, 1164 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T48", "text": [ "requiring" ], "type": "Qualifier", "offsets": [ [ 1165, 1174 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T49", "text": [ "immunosuppressive therapy" ], "type": "Procedure", "offsets": [ [ 1175, 1200 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T50", "text": [ "within 30 days" ], "type": "Temporal", "offsets": [ [ 1201, 1215 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T51", "text": [ "coagulation disorder" ], "type": "Condition", "offsets": [ [ 1224, 1244 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T52", "text": [ "Active" ], "type": "Temporal", "offsets": [ [ 1139, 1145 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T53", "text": [ "Active" ], "type": "Temporal", "offsets": [ [ 1217, 1223 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T54", "text": [ "controlled with medication" ], "type": "Qualifier", "offsets": [ [ 1249, 1275 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T55", "text": [ "not" ], "type": "Negation", "offsets": [ [ 1245, 1248 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T56", "text": [ "Pregnant" ], "type": "Condition", "offsets": [ [ 1277, 1285 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T57", "text": [ "lactating" ], "type": "Condition", "offsets": [ [ 1289, 1298 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T58", "text": [ "malignancy" ], "type": "Condition", "offsets": [ [ 1311, 1321 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T59", "text": [ "Concurrent" ], "type": "Temporal", "offsets": [ [ 1300, 1310 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T60", "text": [ "at least 5 years" ], "type": "Value", "offsets": [ [ 1340, 1356 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T61", "text": [ "disease free" ], "type": "Qualifier", "offsets": [ [ 1357, 1369 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T62", "text": [ "in remission" ], "type": "Qualifier", "offsets": [ [ 1326, 1338 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T63", "text": [ "localized (in-situ) disease" ], "type": "Condition", "offsets": [ [ 1382, 1409 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T64", "text": [ "basal carcinomas" ], "type": "Condition", "offsets": [ [ 1411, 1427 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T65", "text": [ "cutaneous squamous cell carcinomas" ], "type": "Condition", "offsets": [ [ 1432, 1466 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T66", "text": [ "adequately treated" ], "type": "Qualifier", "offsets": [ [ 1482, 1500 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T67", "text": [ "localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas" ], "type": "Scope", "offsets": [ [ 1382, 1466 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T68", "text": [ "brain metastases" ], "type": "Condition", "offsets": [ [ 1517, 1533 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T69", "text": [ "history of" ], "type": "Observation", "offsets": [ [ 1506, 1516 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T70", "text": [ "any other", "central nervous system (CNS) disease" ], "type": "Condition", "offsets": [ [ 1537, 1546 ], [ 1554, 1590 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T71", "text": [ "active" ], "type": "Temporal", "offsets": [ [ 1547, 1553 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T72", "text": [ "brain metastases or any other active central nervous system (CNS) disease" ], "type": "Scope", "offsets": [ [ 1517, 1590 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T73", "text": [ "is allowable" ], "type": "Negation", "offsets": [ [ 818, 830 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T74", "text": [ "prior treated disease stable for 2 weeks is allowable" ], "type": "Scope", "offsets": [ [ 777, 830 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T75", "text": [ "except for" ], "type": "Negation", "offsets": [ [ 1371, 1381 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T76", "text": [ "localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated" ], "type": "Scope", "offsets": [ [ 1382, 1500 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T77", "text": [ "are allowed" ], "type": "Negation", "offsets": [ [ 161, 172 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T78", "text": [ "topical or inhaled steroids" ], "type": "Scope", "offsets": [ [ 133, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T83", "text": [ "injectable" ], "type": "Qualifier", "offsets": [ [ 84, 94 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T84", "text": [ "oral" ], "type": "Qualifier", "offsets": [ [ 76, 80 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T85", "text": [ "oral or injectable" ], "type": "Scope", "offsets": [ [ 76, 94 ] ], "normalized": [] } ]
[]
[]
[ { "id": "NCT00319748_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T1", "arg2_id": "NCT00319748_exc_T2", "normalized": [] }, { "id": "NCT00319748_exc_R2", "type": "AND", "arg1_id": "NCT00319748_exc_T2", "arg2_id": "NCT00319748_exc_T3", "normalized": [] }, { "id": "NCT00319748_exc_R4", "type": "AND", "arg1_id": "NCT00319748_exc_T8", "arg2_id": "NCT00319748_exc_T9", "normalized": [] }, { "id": "NCT00319748_exc_R5", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T7", "arg2_id": "NCT00319748_exc_T8", "normalized": [] }, { "id": "NCT00319748_exc_R6", "type": "Subsumes", "arg1_id": "NCT00319748_exc_T10", "arg2_id": "NCT00319748_exc_T11", "normalized": [] }, { "id": "NCT00319748_exc_R7", "type": "AND", "arg1_id": "NCT00319748_exc_T12", "arg2_id": "NCT00319748_exc_T13", "normalized": [] }, { "id": "NCT00319748_exc_R8", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T10", "arg2_id": "NCT00319748_exc_T12", "normalized": [] }, { "id": "NCT00319748_exc_R9", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T14", "arg2_id": "NCT00319748_exc_T15", "normalized": [] }, { "id": "NCT00319748_exc_R11", "type": "AND", "arg1_id": "NCT00319748_exc_T21", "arg2_id": "NCT00319748_exc_T22", "normalized": [] }, { "id": "NCT00319748_exc_R12", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T20", "arg2_id": "NCT00319748_exc_T21", "normalized": [] }, { "id": "NCT00319748_exc_R13", "type": "AND", "arg1_id": "NCT00319748_exc_T24", "arg2_id": "NCT00319748_exc_T25", "normalized": [] }, { "id": "NCT00319748_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T23", "arg2_id": "NCT00319748_exc_T24", "normalized": [] }, { "id": "NCT00319748_exc_R15", "type": "AND", "arg1_id": "NCT00319748_exc_T27", "arg2_id": "NCT00319748_exc_T26", "normalized": [] }, { "id": "NCT00319748_exc_R16", "type": "AND", "arg1_id": "NCT00319748_exc_T28", "arg2_id": "NCT00319748_exc_T29", "normalized": [] }, { "id": "NCT00319748_exc_R17", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T27", "arg2_id": "NCT00319748_exc_T28", "normalized": [] }, { "id": "NCT00319748_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T32", "arg2_id": "NCT00319748_exc_T33", "normalized": [] }, { "id": "NCT00319748_exc_R19", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T33", "arg2_id": "NCT00319748_exc_T34", "normalized": [] }, { "id": "NCT00319748_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T38", "arg2_id": "NCT00319748_exc_T39", "normalized": [] }, { "id": "NCT00319748_exc_R22", "type": "AND", "arg1_id": "NCT00319748_exc_T43", "arg2_id": "NCT00319748_exc_T42", "normalized": [] }, { "id": "NCT00319748_exc_R23", "type": "AND", "arg1_id": "NCT00319748_exc_T48", "arg2_id": "NCT00319748_exc_T49", "normalized": [] }, { "id": "NCT00319748_exc_R24", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T48", "arg2_id": "NCT00319748_exc_T50", "normalized": [] }, { "id": "NCT00319748_exc_R25", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T47", "arg2_id": "NCT00319748_exc_T52", "normalized": [] }, { "id": "NCT00319748_exc_R26", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T51", "arg2_id": "NCT00319748_exc_T53", "normalized": [] }, { "id": "NCT00319748_exc_R27", "type": "Has_negation", "arg1_id": "NCT00319748_exc_T54", "arg2_id": "NCT00319748_exc_T55", "normalized": [] }, { "id": "NCT00319748_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T51", "arg2_id": "NCT00319748_exc_T54", "normalized": [] }, { "id": "NCT00319748_exc_R29", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T58", "arg2_id": "NCT00319748_exc_T59", "normalized": [] }, { "id": "NCT00319748_exc_R30", "type": "Has_value", "arg1_id": "NCT00319748_exc_T61", "arg2_id": "NCT00319748_exc_T60", "normalized": [] }, { "id": "NCT00319748_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T62", "arg2_id": "NCT00319748_exc_T61", "normalized": [] }, { "id": "NCT00319748_exc_R32", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T58", "arg2_id": "NCT00319748_exc_T62", "normalized": [] }, { "id": "NCT00319748_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT00319748_exc_T67", "arg2_id": "NCT00319748_exc_T66", "normalized": [] }, { "id": "NCT00319748_exc_R35", "type": "Has_temporal", "arg1_id": "NCT00319748_exc_T70", "arg2_id": "NCT00319748_exc_T71", "normalized": [] }, { "id": "NCT00319748_exc_R36", "type": "Has_scope", "arg1_id": "NCT00319748_exc_T69", "arg2_id": "NCT00319748_exc_T72", "normalized": [] }, { "id": "NCT00319748_exc_R20", "type": "Has_negation", "arg1_id": "NCT00319748_exc_T32", "arg2_id": "NCT00319748_exc_T73", "normalized": [] }, { "id": "NCT00319748_exc_R37", "type": "Has_scope", "arg1_id": "NCT00319748_exc_T35", "arg2_id": "NCT00319748_exc_T74", "normalized": [] }, { "id": "NCT00319748_exc_R34", "type": "Has_negation", "arg1_id": "NCT00319748_exc_T76", "arg2_id": "NCT00319748_exc_T75", "normalized": [] }, { "id": "NCT00319748_exc_R38", "type": "Has_scope", "arg1_id": "NCT00319748_exc_T58", "arg2_id": "NCT00319748_exc_T76", "normalized": [] }, { "id": "NCT00319748_exc_R3", "type": "Has_negation", "arg1_id": "NCT00319748_exc_T78", "arg2_id": "NCT00319748_exc_T77", "normalized": [] }, { "id": "NCT00319748_exc_R39", "type": "Has_scope", "arg1_id": "NCT00319748_exc_T1", "arg2_id": "NCT00319748_exc_T6", "normalized": [] }, { "id": "NCT00319748_exc_R40", "type": "Has_scope", "arg1_id": "NCT00319748_exc_T1", "arg2_id": "NCT00319748_exc_T85", "normalized": [] } ]

Dataset Card for CHIA

A large annotated corpus of patient eligibility criteria extracted from 1,000 interventional, Phase IV clinical trials registered in ClinicalTrials.gov. This dataset includes 12,409 annotated eligibility criteria, represented by 41,487 distinctive entities of 15 entity types and 25,017 relationships of 12 relationship types.

Citation Information

@article{kury2020chia,
  title        = {Chia, a large annotated corpus of clinical trial eligibility criteria},
  author       = {
    Kury, Fabr{'\i}cio and Butler, Alex and Yuan, Chi and Fu, Li-heng and
    Sun, Yingcheng and Liu, Hao and Sim, Ida and Carini, Simona and Weng,
    Chunhua
  },
  year         = 2020,
  journal      = {Scientific data},
  publisher    = {Nature Publishing Group},
  volume       = 7,
  number       = 1,
  pages        = {1--11}
}
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