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[ { "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", "type": "Condition", "text": [ "CNS metastases" ], "offsets": [ [ 26, 40 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T2", "type": "Condition", "text": [ "leptomeningeal involvement" ], "offsets": [ [ 44, 70 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T5", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 144, 151 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T6", "type": "Qualifier", "text": [ "been stable for" ], "offsets": [ [ 164, 179 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T7", "type": "Temporal", "text": [ "at least six months prior to study start" ], "offsets": [ [ 180, 220 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T4", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 92, 108 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T8", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 238, 248 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T9", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 249, 265 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T10", "type": "Procedure", "text": [ "head CT with contrast" ], "offsets": [ [ 278, 299 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T11", "type": "Scope", "text": [ "history of brain metastases" ], "offsets": [ [ 238, 265 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T12", "type": "Condition", "text": [ "bone metastases" ], "offsets": [ [ 359, 374 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T13", "type": "Procedure", "text": [ "hepatic artery chemoembolization" ], "offsets": [ [ 432, 464 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T14", "type": "Temporal", "text": [ "within the last 6 months" ], "offsets": [ [ 465, 489 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T15", "type": "Temporal", "text": [ "one month" ], "offsets": [ [ 491, 500 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T16", "type": "Observation", "text": [ "other sites of measurable disease" ], "offsets": [ [ 514, 547 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T17", "type": "Scope", "text": [ "within the last 6 months (one month if there are other sites of measurable disease" ], "offsets": [ [ 465, 547 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T18", "type": "Procedure", "text": [ "radioactive directed therapies" ], "offsets": [ [ 597, 627 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T19", "type": "Drug", "text": [ "epothilone" ], "offsets": [ [ 676, 686 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T20", "type": "Condition", "text": [ "peripheral neuropathy" ], "offsets": [ [ 706, 727 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T21", "type": "Condition", "text": [ "unresolved diarrhea" ], "offsets": [ [ 731, 750 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T22", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 764, 769 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T23", "type": "Value", "text": [ "greater than", "1" ], "offsets": [ [ 751, 763 ], [ 770, 771 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T24", "type": "Condition", "text": [ "severe cardiac insufficiency" ], "offsets": [ [ 787, 815 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T25", "type": "Drug", "text": [ "Coumadin" ], "offsets": [ [ 832, 840 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T26", "type": "Drug", "text": [ "warfarin-containing agents" ], "offsets": [ [ 850, 876 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T27", "type": "Qualifier", "text": [ "low dose" ], "offsets": [ [ 899, 907 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T28", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 908, 916 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T29", "type": "Multiplier", "text": [ "1 mg or less" ], "offsets": [ [ 918, 930 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T30", "type": "Device", "text": [ "in-dwelling lines" ], "offsets": [ [ 955, 972 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T31", "type": "Device", "text": [ "in-dwelling", "ports" ], "offsets": [ [ 955, 966 ], [ 976, 981 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T32", "type": "Scope", "text": [ "severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less)" ], "offsets": [ [ 787, 931 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T34", "type": "Condition", "text": [ "another malignancy" ], "offsets": [ [ 1037, 1055 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T35", "type": "Temporal", "text": [ "within 5 years prior to study entry" ], "offsets": [ [ 1056, 1091 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T36", "type": "Scope", "text": [ "Coumadin or other warfarin-containing agents" ], "offsets": [ [ 832, 876 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T37", "type": "Condition", "text": [ "non-melanoma skin cancer" ], "offsets": [ [ 1118, 1142 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T38", "type": "Qualifier", "text": [ "curatively treated" ], "offsets": [ [ 1099, 1117 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T39", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 1144, 1159 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T40", "type": "Condition", "text": [ "cervical cancer in situ" ], "offsets": [ [ 1164, 1187 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T41", "type": "Scope", "text": [ "non-melanoma skin cancer, prostate cancer, or cervical cancer in situ" ], "offsets": [ [ 1118, 1187 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T42", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1026, 1036 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T43", "type": "Condition", "text": [ "uncontrolled infection" ], "offsets": [ [ 1240, 1262 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T44", "type": "Condition", "text": [ "abcesses" ], "offsets": [ [ 1273, 1281 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T45", "type": "Condition", "text": [ "fistulae" ], "offsets": [ [ 1285, 1293 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T46", "type": "Scope", "text": [ "abcesses or fistulae" ], "offsets": [ [ 1273, 1293 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T47", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 1203, 1209 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T48", "type": "Qualifier", "text": [ "suspected" ], "offsets": [ [ 1213, 1222 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T49", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 1223, 1228 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T50", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 1232, 1239 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T51", "type": "Scope", "text": [ "active or suspected acute or chronic" ], "offsets": [ [ 1203, 1239 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T52", "type": "Condition", "text": [ "psychiatric illness" ], "offsets": [ [ 1322, 1341 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T53", "type": "Condition", "text": [ "medical", "illness" ], "offsets": [ [ 1311, 1318 ], [ 1334, 1341 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T54", "type": "Observation", "text": [ "preclude study" ], "offsets": [ [ 1353, 1367 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T55", "type": "Observation", "text": [ "informed consent" ], "offsets": [ [ 1371, 1387 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T56", "type": "Observation", "text": [ "noncompliance to medical regimens" ], "offsets": [ [ 1406, 1439 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T57", "type": "Observation", "text": [ "inability", "to return for all scheduled visits" ], "offsets": [ [ 1443, 1452 ], [ 1470, 1504 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T58", "type": "Observation", "text": [ "unwillingness to return for all scheduled visit" ], "offsets": [ [ 1456, 1503 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T59", "type": "Scope", "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" ], "offsets": [ [ 1347, 1504 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T60", "type": "Condition", "text": [ "HIV+" ], "offsets": [ [ 1506, 1510 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T61", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 1506, 1509 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T62", "type": "Value", "text": [ "+" ], "offsets": [ [ 1509, 1510 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T63", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1521, 1529 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T64", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1533, 1542 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T65", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T3", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 877, 898 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T66", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1092, 1098 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T67", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 652, 662 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T68", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 573, 583 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T69", "type": "Multiplier", "text": [ "only site(s) of measurable disease" ], "offsets": [ [ 382, 416 ] ], "normalized": [] }, { "id": "NCT00050349_exc_T70", "type": "Negation", "text": [ "unless" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "metastatic carcinoid tumors" ], "offsets": [ [ 28, 55 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T2", "type": "Value", "text": [ "proven" ], "offsets": [ [ 21, 27 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T3", "type": "Procedure", "text": [ "biopsy" ], "offsets": [ [ 14, 20 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T4", "type": "Condition", "text": [ "other neuroendocrine tumors" ], "offsets": [ [ 59, 86 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T5", "type": "Condition", "text": [ "Islet cell" ], "offsets": [ [ 88, 98 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T6", "type": "Condition", "text": [ "Gastrinomas" ], "offsets": [ [ 100, 111 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T7", "type": "Condition", "text": [ "VIPomas" ], "offsets": [ [ 116, 123 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T8", "type": "Scope", "text": [ "Islet cell, Gastrinomas and VIPomas" ], "offsets": [ [ 88, 123 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T9", "type": "Condition", "text": [ "measurable lesion" ], "offsets": [ [ 143, 160 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T10", "type": "Qualifier", "text": [ "bone" ], "offsets": [ [ 173, 177 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T11", "type": "Scope", "text": [ "biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas)" ], "offsets": [ [ 14, 124 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T12", "type": "Procedure", "text": [ "irradiated" ], "offsets": [ [ 215, 225 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T13", "type": "Procedure", "text": [ "irradiated" ], "offsets": [ [ 243, 253 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T14", "type": "Observation", "text": [ "progression" ], "offsets": [ [ 271, 282 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T15", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 293, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T16", "type": "Temporal", "text": [ "since the radiation therapy" ], "offsets": [ [ 283, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T18", "type": "Negation", "text": [ "not been" ], "offsets": [ [ 195, 203 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T17", "type": "Scope", "text": [ "not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy" ], "offsets": [ [ 195, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T19", "type": "Condition", "text": [ "major impairment of renal", "function" ], "offsets": [ [ 331, 356 ], [ 368, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T20", "type": "Condition", "text": [ "major impairment of", "hepatic function" ], "offsets": [ [ 331, 350 ], [ 360, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T21", "type": "Negation", "text": [ "no" ], "offsets": [ [ 328, 330 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T22", "type": "Scope", "text": [ "major impairment of renal or hepatic function" ], "offsets": [ [ 331, 376 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T23", "type": "Measurement", "text": [ "total bilirubin" ], "offsets": [ [ 429, 444 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T24", "type": "Value", "text": [ "<1.5 X ULN" ], "offsets": [ [ 445, 455 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T25", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 457, 460 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T26", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 462, 465 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T27", "type": "Value", "text": [ "<2.5X ULN" ], "offsets": [ [ 465, 474 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T28", "type": "Condition", "text": [ "liver metastases" ], "offsets": [ [ 488, 504 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T29", "type": "Value", "text": [ "<5 X ULN" ], "offsets": [ [ 476, 484 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T30", "type": "Scope", "text": [ "AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)" ], "offsets": [ [ 457, 517 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T31", "type": "Scope", "text": [ "total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)" ], "offsets": [ [ 429, 517 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T32", "type": "Drug", "text": [ "Sandostatin Lar" ], "offsets": [ [ 531, 546 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T33", "type": "Drug", "text": [ "long acting somatostatin analogue" ], "offsets": [ [ 548, 581 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T34", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 596, 607 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T35", "type": "Temporal", "text": [ "for 30 days prior to study entry" ], "offsets": [ [ 608, 640 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T36", "type": "Drug", "text": [ "short acting somatostatin analogues" ], "offsets": [ [ 645, 680 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T37", "type": "Qualifier", "text": [ "clinically stable dose" ], "offsets": [ [ 707, 729 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T38", "type": "Temporal", "text": [ "prior to study entry" ], "offsets": [ [ 750, 770 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T39", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 784, 799 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T40", "type": "Value", "text": [ "greater than three (3) months" ], "offsets": [ [ 803, 832 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T41", "type": "Measurement", "text": [ "Karnofsky Performance Status" ], "offsets": [ [ 834, 862 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T42", "type": "Value", "text": [ "> 60" ], "offsets": [ [ 863, 867 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T43", "type": "Person", "text": [ "Female" ], "offsets": [ [ 869, 875 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T44", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 906, 926 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T45", "type": "Value", "text": [ "negative" ], "offsets": [ [ 897, 905 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T46", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 927, 939 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T47", "type": "Procedure", "text": [ "bilateral oophorectomy" ], "offsets": [ [ 974, 996 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T48", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 1004, 1016 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T49", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 1046, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T51", "type": "Scope", "text": [ "bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal" ], "offsets": [ [ 974, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T50", "type": "Scope", "text": [ "bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal" ], "offsets": [ [ 974, 1060 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T52", "type": "Scope", "text": [ "negative serum pregnancy test at screening" ], "offsets": [ [ 897, 939 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T53", "type": "Reference_point", "text": [ "radiation therapy" ], "offsets": [ [ 293, 310 ] ], "normalized": [] }, { "id": "NCT00050349_inc_T54", "type": "Negation", "text": [ "other than" ], "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": [] } ]

[ { "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", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T2", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 9, 32 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T3", "type": "Negation", "text": [ "do not" ], "offsets": [ [ 38, 44 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T4", "type": "Procedure", "text": [ "adequate contraception" ], "offsets": [ [ 54, 76 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T5", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 79, 87 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T6", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 91, 100 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T7", "type": "Drug", "text": [ "primary chemotherapy regimen" ], "offsets": [ [ 126, 154 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T8", "type": "Multiplier", "text": [ "more than one" ], "offsets": [ [ 112, 125 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T9", "type": "Condition", "text": [ "malignancies" ], "offsets": [ [ 181, 193 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T10", "type": "Qualifier", "text": [ "previous" ], "offsets": [ [ 172, 180 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T11", "type": "Qualifier", "text": [ "Concomitant" ], "offsets": [ [ 157, 168 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T12", "type": "Scope", "text": [ "Concomitant or previous" ], "offsets": [ [ 157, 180 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T13", "type": "Condition", "text": [ "basal cell", "skin cancer" ], "offsets": [ [ 235, 245 ], [ 263, 274 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T14", "type": "Condition", "text": [ "squamous cell skin cancer" ], "offsets": [ [ 249, 274 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T15", "type": "Condition", "text": [ "in situ cervical cancer" ], "offsets": [ [ 276, 299 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T16", "type": "Condition", "text": [ "incidental carcinoid" ], "offsets": [ [ 301, 321 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T17", "type": "Condition", "text": [ "other cancer" ], "offsets": [ [ 326, 338 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T18", "type": "Negation", "text": [ "the exception of" ], "offsets": [ [ 199, 215 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T19", "type": "Qualifier", "text": [ "adequately treated" ], "offsets": [ [ 216, 234 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T20", "type": "Scope", "text": [ "basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer" ], "offsets": [ [ 235, 338 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T21", "type": "Temporal", "text": [ "for 5 years" ], "offsets": [ [ 384, 395 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T22", "type": "Qualifier", "text": [ "has been disease free" ], "offsets": [ [ 362, 383 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T23", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 418, 427 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T24", "type": "Qualifier", "text": [ "Active uncontrolled" ], "offsets": [ [ 398, 417 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T25", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 438, 449 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T27", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 575, 584 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T28", "type": "Value", "text": [ "more than 10%" ], "offsets": [ [ 588, 601 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T29", "type": "Qualifier", "text": [ "bone" ], "offsets": [ [ 605, 609 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T30", "type": "Drug", "text": [ "topotecan" ], "offsets": [ [ 633, 642 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T31", "type": "Drug", "text": [ "gemcitabine" ], "offsets": [ [ 646, 657 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T32", "type": "Observation", "text": [ "treatment" ], "offsets": [ [ 618, 627 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T33", "type": "Scope", "text": [ "topotecan or gemcitabine" ], "offsets": [ [ 633, 657 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T34", "type": "Condition", "text": [ "Hypersensitivity" ], "offsets": [ [ 660, 676 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T35", "type": "Drug", "text": [ "camptothecin" ], "offsets": [ [ 680, 692 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T36", "type": "Drug", "text": [ "nucleoside analogues" ], "offsets": [ [ 696, 716 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T37", "type": "Scope", "text": [ "camptothecin or nucleoside analogues" ], "offsets": [ [ 680, 716 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T38", "type": "Drug", "text": [ "investigational agent" ], "offsets": [ [ 729, 750 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T39", "type": "Temporal", "text": [ "within 30 days" ], "offsets": [ [ 751, 765 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T40", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 612, 617 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T26", "type": "Temporal", "text": [ "Concurrent" ], "offsets": [ [ 452, 462 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T41", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 463, 469 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T42", "type": "Condition", "text": [ "medical problems" ], "offsets": [ [ 470, 486 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T43", "type": "Qualifier", "text": [ "limit full compliance with the study" ], "offsets": [ [ 527, 563 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T44", "type": "Qualifier", "text": [ "unrelated to the malignancy" ], "offsets": [ [ 487, 514 ] ], "normalized": [] }, { "id": "NCT00061308_exc_T45", "type": "Condition", "text": [ "malignancy" ], "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": [] } ]

[ { "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", "type": "Drug", "text": [ "platinum-based chemotherapy regimen" ], "offsets": [ [ 19, 54 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T2", "type": "Condition", "text": [ "primary disease" ], "offsets": [ [ 76, 91 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T3", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 13, 18 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T4", "type": "Temporal", "text": [ "At least 4 weeks since last surgery or radiation therapy" ], "offsets": [ [ 94, 150 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T5", "type": "Reference_point", "text": [ "last surgery" ], "offsets": [ [ 117, 129 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T6", "type": "Reference_point", "text": [ "radiation therapy" ], "offsets": [ [ 133, 150 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T7", "type": "Condition", "text": [ "a treatment-free interval" ], "offsets": [ [ 167, 192 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T8", "type": "Temporal", "text": [ "greater than 6 months following response to platinum" ], "offsets": [ [ 196, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T9", "type": "Reference_point", "text": [ "response to platinum" ], "offsets": [ [ 228, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T10", "type": "Drug", "text": [ "platinum" ], "offsets": [ [ 240, 248 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T11", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 251, 274 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T12", "type": "Value", "text": [ "0" ], "offsets": [ [ 278, 279 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T13", "type": "Value", "text": [ "0,1" ], "offsets": [ [ 278, 281 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T14", "type": "Value", "text": [ "." ], "offsets": [ [ 287, 288 ] ], "normalized": [] }, { "id": "NCT00061308_inc_T15", "type": "Scope", "text": [ "0,1, or 2" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "Metastatic disease", "NSCLC" ], "offsets": [ [ 0, 18 ], [ 32, 37 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T2", "type": "Condition", "text": [ "(M1)/stage 4" ], "offsets": [ [ 19, 31 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T3", "type": "Condition", "text": [ "Pleural", "effusion" ], "offsets": [ [ 39, 46 ], [ 62, 70 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T4", "type": "Condition", "text": [ "pericardial effusion" ], "offsets": [ [ 50, 70 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T5", "type": "Value", "text": [ "greater than 100 ml in volume" ], "offsets": [ [ 71, 100 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T6", "type": "Measurement", "text": [ "positron emission tomography" ], "offsets": [ [ 139, 167 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T7", "type": "Measurement", "text": [ "computed tomography", "scan" ], "offsets": [ [ 175, 194 ], [ 200, 204 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T8", "type": "Measurement", "text": [ "PET" ], "offsets": [ [ 169, 172 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T9", "type": "Measurement", "text": [ "CT" ], "offsets": [ [ 196, 198 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T10", "type": "Measurement", "text": [ "ultrasound" ], "offsets": [ [ 208, 218 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T11", "type": "Scope", "text": [ "positron emission tomography [PET], computed tomography [CT] scan or ultrasound" ], "offsets": [ [ 139, 218 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T13", "type": "Temporal", "text": [ "before completing the protocol chemo/radiotherapy course" ], "offsets": [ [ 782, 838 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T14", "type": "Observation", "text": [ "Plan to remove the tumor surgically" ], "offsets": [ [ 746, 781 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T15", "type": "Qualifier", "text": [ "esophagus" ], "offsets": [ [ 869, 878 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T16", "type": "Multiplier", "text": [ "any part of" ], "offsets": [ [ 853, 864 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T17", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 886, 898 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T18", "type": "Procedure", "text": [ "Shielding" ], "offsets": [ [ 840, 849 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T19", "type": "Procedure", "text": [ "posterior spinal cord shielding" ], "offsets": [ [ 910, 941 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T20", "type": "Drug", "text": [ "chemotherapy" ], "offsets": [ [ 950, 962 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T21", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 964, 976 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T22", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 981, 988 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T23", "type": "Condition", "text": [ "NSCLC" ], "offsets": [ [ 993, 998 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T24", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 944, 949 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T25", "type": "Scope", "text": [ "chemotherapy, radiotherapy, or surgery" ], "offsets": [ [ 950, 988 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T26", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1015, 1025 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T27", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 1006, 1014 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T29", "type": "Temporal", "text": [ "during the past 3 years" ], "offsets": [ [ 1026, 1049 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T28", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1050, 1060 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T30", "type": "Condition", "text": [ "non-melanomatous skin cancer" ], "offsets": [ [ 1061, 1089 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T31", "type": "Negation", "text": [ "are not" ], "offsets": [ [ 1232, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T32", "type": "Condition", "text": [ "surgically-cured malignancies" ], "offsets": [ [ 1117, 1146 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T34", "type": "Condition", "text": [ "dysphagia" ], "offsets": [ [ 1347, 1356 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T35", "type": "Condition", "text": [ "conditions predisposing to dysphagia" ], "offsets": [ [ 1360, 1396 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T36", "type": "Condition", "text": [ "gastroesophageal reflux disease" ], "offsets": [ [ 1415, 1446 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T37", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1402, 1414 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T38", "type": "Condition", "text": [ "GERD" ], "offsets": [ [ 1448, 1452 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T39", "type": "Condition", "text": [ "dyspepsia" ], "offsets": [ [ 1455, 1464 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T40", "type": "Scope", "text": [ "uncontrolled gastroesophageal reflux disease [GERD], dyspepsia" ], "offsets": [ [ 1402, 1464 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T41", "type": "Scope", "text": [ "dysphagia or conditions predisposing to dysphagia" ], "offsets": [ [ 1347, 1396 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T42", "type": "Condition", "text": [ "pancreatitis" ], "offsets": [ [ 1483, 1495 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T43", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 1472, 1482 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T44", "type": "Temporal", "text": [ "Four weeks or less since completion of treatment" ], "offsets": [ [ 1497, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T45", "type": "Reference_point", "text": [ "completion of treatment" ], "offsets": [ [ 1522, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T46", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1536, 1545 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T47", "type": "Drug", "text": [ "investigational product" ], "offsets": [ [ 1555, 1578 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T48", "type": "Device", "text": [ "investigational", "device" ], "offsets": [ [ 1555, 1570 ], [ 1579, 1585 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T49", "type": "Qualifier", "text": [ "unresolved" ], "offsets": [ [ 1631, 1641 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T50", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 1642, 1650 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T52", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1656, 1664 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T53", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1665, 1674 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T54", "type": "Scope", "text": [ "investigational product/device" ], "offsets": [ [ 1555, 1585 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T55", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1336, 1346 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T56", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 1000, 1005 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T57", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 1676, 1684 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T58", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1685, 1694 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T59", "type": "Drug", "text": [ "fibroblast growth factor" ], "offsets": [ [ 1719, 1743 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T60", "type": "Value", "text": [ "sero-positive" ], "offsets": [ [ 1757, 1770 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T61", "type": "Measurement", "text": [ "human immunodeficiency virus (HIV)" ], "offsets": [ [ 1775, 1809 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T62", "type": "Condition", "text": [ "sero-positive for human immunodeficiency virus (HIV)" ], "offsets": [ [ 1757, 1809 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T63", "type": "Condition", "text": [ "sero-positive for", "hepatitis C virus (HCV)" ], "offsets": [ [ 1757, 1774 ], [ 1811, 1834 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T64", "type": "Condition", "text": [ "sero-positive for", "hepatitis B virus (HBV)" ], "offsets": [ [ 1757, 1774 ], [ 1839, 1862 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T65", "type": "Measurement", "text": [ "hepatitis C virus (HCV)" ], "offsets": [ [ 1811, 1834 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T66", "type": "Measurement", "text": [ "hepatitis B virus (HBV)" ], "offsets": [ [ 1839, 1862 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T67", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1864, 1872 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T68", "type": "Condition", "text": [ "breastfeeding" ], "offsets": [ [ 1876, 1889 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T69", "type": "Person", "text": [ "women" ], "offsets": [ [ 1890, 1895 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T70", "type": "Condition", "text": [ "sensitivity" ], "offsets": [ [ 1903, 1914 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T71", "type": "Qualifier", "text": [ "E. coli derived" ], "offsets": [ [ 1918, 1933 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T72", "type": "Drug", "text": [ "products" ], "offsets": [ [ 1934, 1942 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T73", "type": "Condition", "text": [ "Compromised ability" ], "offsets": [ [ 1944, 1963 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T76", "type": "Scope", "text": [ "give written informed consent and/or to comply with study procedures" ], "offsets": [ [ 1982, 2050 ] ], "normalized": [] }, { "id": "NCT00094861_exc_T78", "type": "Observation", "text": [ "Refusal to" ], "offsets": [ [ 2052, 2062 ] ], "normalized": [] } ]

[]

[]

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[ { "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", "type": "Condition", "text": [ "NSCLC" ], "offsets": [ [ 68, 73 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T2", "type": "Qualifier", "text": [ "cytologically proven" ], "offsets": [ [ 34, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T3", "type": "Qualifier", "text": [ "histologically", "proven" ], "offsets": [ [ 16, 30 ], [ 48, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T4", "type": "Scope", "text": [ "histologically or cytologically proven" ], "offsets": [ [ 16, 54 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T5", "type": "Condition", "text": [ "stage", "IIIb disease" ], "offsets": [ [ 107, 112 ], [ 121, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T6", "type": "Condition", "text": [ "stage IIIa", "disease" ], "offsets": [ [ 107, 117 ], [ 126, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T7", "type": "Qualifier", "text": [ "Unresectable" ], "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T8", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 89, 105 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T9", "type": "Scope", "text": [ "stage IIIa or IIIb disease" ], "offsets": [ [ 107, 133 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T10", "type": "Qualifier", "text": [ "esophagus" ], "offsets": [ [ 224, 233 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T11", "type": "Multiplier", "text": [ "greater than", "30" ], "offsets": [ [ 188, 200 ], [ 213, 215 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T12", "type": "Multiplier", "text": [ "equal to 30%" ], "offsets": [ [ 204, 216 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T13", "type": "Scope", "text": [ "greater than or equal to 30%" ], "offsets": [ [ 188, 216 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T14", "type": "Measurement", "text": [ "radiotherapy" ], "offsets": [ [ 143, 155 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T15", "type": "Qualifier", "text": [ "Initial" ], "offsets": [ [ 135, 142 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T16", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 235, 250 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T17", "type": "Value", "text": [ "equal to 6 months" ], "offsets": [ [ 267, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T18", "type": "Value", "text": [ "greater than", "6 months" ], "offsets": [ [ 251, 263 ], [ 276, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T19", "type": "Scope", "text": [ "greater than or equal to 6 months" ], "offsets": [ [ 251, 284 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T20", "type": "Condition", "text": [ "Measurable disease" ], "offsets": [ [ 378, 396 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T21", "type": "Temporal", "text": [ "3 months before study randomization" ], "offsets": [ [ 341, 376 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T22", "type": "Reference_point", "text": [ "study randomization" ], "offsets": [ [ 357, 376 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T23", "type": "Measurement", "text": [ "Estimated weight loss" ], "offsets": [ [ 286, 307 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T24", "type": "Value", "text": [ "equal to 10%" ], "offsets": [ [ 321, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T25", "type": "Value", "text": [ "less than", "10%" ], "offsets": [ [ 308, 317 ], [ 330, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T26", "type": "Scope", "text": [ "less than or equal to 10%" ], "offsets": [ [ 308, 333 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T28", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group", "performance status" ], "offsets": [ [ 424, 458 ], [ 466, 484 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T29", "type": "Measurement", "text": [ "ECOG" ], "offsets": [ [ 460, 464 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T30", "type": "Value", "text": [ "0 - 2" ], "offsets": [ [ 488, 493 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T31", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 495, 505 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T32", "type": "Measurement", "text": [ "hgb" ], "offsets": [ [ 507, 510 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T33", "type": "Value", "text": [ "equal to 10 g/dL" ], "offsets": [ [ 528, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T34", "type": "Value", "text": [ "greater than", "10 g/dL" ], "offsets": [ [ 512, 524 ], [ 537, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T35", "type": "Scope", "text": [ "greater than or equal to 10 g/dL" ], "offsets": [ [ 512, 544 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T36", "type": "Temporal", "text": [ "in the 4 weeks before study randomization" ], "offsets": [ [ 596, 637 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T37", "type": "Reference_point", "text": [ "study randomization" ], "offsets": [ [ 618, 637 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T38", "type": "Negation", "text": [ "without" ], "offsets": [ [ 545, 552 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T39", "type": "Observation", "text": [ "transfusional support" ], "offsets": [ [ 553, 574 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T40", "type": "Observation", "text": [ "growth factor use" ], "offsets": [ [ 578, 595 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T41", "type": "Scope", "text": [ "transfusional support or growth factor use" ], "offsets": [ [ 553, 595 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T42", "type": "Measurement", "text": [ "Absolute neutrophil count" ], "offsets": [ [ 639, 664 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T43", "type": "Measurement", "text": [ "ANC" ], "offsets": [ [ 666, 669 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T44", "type": "Value", "text": [ "equal to 1.5 x 10^9/L" ], "offsets": [ [ 687, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T45", "type": "Value", "text": [ "greater than", "1.5 x 10^9/L" ], "offsets": [ [ 671, 683 ], [ 696, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T46", "type": "Scope", "text": [ "greater than or equal to 1.5 x 10^9/L" ], "offsets": [ [ 671, 708 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T47", "type": "Negation", "text": [ "without" ], "offsets": [ [ 709, 716 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T48", "type": "Observation", "text": [ "growth factor use" ], "offsets": [ [ 717, 734 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T49", "type": "Temporal", "text": [ "in the 2 weeks before study randomization" ], "offsets": [ [ 735, 776 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T50", "type": "Reference_point", "text": [ "study randomization" ], "offsets": [ [ 757, 776 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T51", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 778, 792 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T52", "type": "Value", "text": [ "greater than", "100 x 10^9/L" ], "offsets": [ [ 793, 805 ], [ 818, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T53", "type": "Value", "text": [ "equal to 100 x 10^9/L" ], "offsets": [ [ 809, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T54", "type": "Scope", "text": [ "greater than or equal to 100 x 10^9/L" ], "offsets": [ [ 793, 830 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T55", "type": "Measurement", "text": [ "Serum bilirubin" ], "offsets": [ [ 832, 847 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T56", "type": "Value", "text": [ "equal to 1.5 x institutional upper limit of normal (ULN)" ], "offsets": [ [ 861, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T57", "type": "Value", "text": [ "less than", "1.5 x institutional upper limit of normal (ULN)" ], "offsets": [ [ 848, 857 ], [ 870, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T58", "type": "Scope", "text": [ "less than or equal to 1.5 x institutional upper limit of normal (ULN)" ], "offsets": [ [ 848, 917 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T59", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 919, 935 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T60", "type": "Value", "text": [ "equal to 2.0 mg/dL" ], "offsets": [ [ 949, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T61", "type": "Value", "text": [ "less than" ], "offsets": [ [ 936, 945 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T62", "type": "Value", "text": [ "2.0 mg/dL" ], "offsets": [ [ 958, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T63", "type": "Scope", "text": [ "ess than or equal to 2.0 mg/dL" ], "offsets": [ [ 937, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T64", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 991, 1007 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T65", "type": "Value", "text": [ "equal to 1.4", "mg/dL" ], "offsets": [ [ 1024, 1036 ], [ 1067, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T66", "type": "Value", "text": [ "greater than", "1.4", "mg/dL" ], "offsets": [ [ 1008, 1020 ], [ 1033, 1036 ], [ 1067, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T67", "type": "Value", "text": [ "less than", "2.0 mg/dL" ], "offsets": [ [ 1041, 1050 ], [ 1063, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T68", "type": "Value", "text": [ "equal to 2.0 mg/dL" ], "offsets": [ [ 1054, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T69", "type": "Scope", "text": [ "greater than or equal to 1.4 and less than or equal to 2.0 mg/dL" ], "offsets": [ [ 1008, 1072 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T70", "type": "Measurement", "text": [ "24-hour urinary creatinine clearance" ], "offsets": [ [ 1092, 1128 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T71", "type": "Value", "text": [ "equal to 50 mL/min" ], "offsets": [ [ 1145, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T72", "type": "Value", "text": [ "greater than", "50 mL/min" ], "offsets": [ [ 1129, 1141 ], [ 1154, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T73", "type": "Scope", "text": [ "greater than or equal to 50 mL/min" ], "offsets": [ [ 1129, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T74", "type": "Scope", "text": [ "Serum creatinine less than or equal to 2.0 mg/dL" ], "offsets": [ [ 919, 967 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T75", "type": "Scope", "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" ], "offsets": [ [ 991, 1163 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T76", "type": "Person", "text": [ "Females" ], "offsets": [ [ 1166, 1173 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T77", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1177, 1199 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T78", "type": "Measurement", "text": [ "urine pregnancy test" ], "offsets": [ [ 1219, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T79", "type": "Measurement", "text": [ "serum", "pregnancy test" ], "offsets": [ [ 1210, 1215 ], [ 1225, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T80", "type": "Scope", "text": [ "serum or urine pregnancy test" ], "offsets": [ [ 1210, 1239 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T81", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1201, 1209 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T82", "type": "Observation", "text": [ "informed consent" ], "offsets": [ [ 1267, 1283 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T84", "type": "Temporal", "text": [ "before participating in any study-specific procedure, randomization, or receiving investigational product" ], "offsets": [ [ 1284, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T85", "type": "Reference_point", "text": [ "participating in any study-specific procedure, randomization, or receiving investigational product" ], "offsets": [ [ 1291, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T86", "type": "Qualifier", "text": [ "study-specific" ], "offsets": [ [ 1312, 1326 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T87", "type": "Procedure", "text": [ "procedure" ], "offsets": [ [ 1327, 1336 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T88", "type": "Procedure", "text": [ "randomization" ], "offsets": [ [ 1338, 1351 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T89", "type": "Drug", "text": [ "investigational product" ], "offsets": [ [ 1366, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T90", "type": "Scope", "text": [ "study-specific procedure, randomization, or receiving investigational product" ], "offsets": [ [ 1312, 1389 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T83", "type": "Qualifier", "text": [ "adequate" ], "offsets": [ [ 1453, 1461 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T91", "type": "Procedure", "text": [ "contraception methods" ], "offsets": [ [ 1462, 1483 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T92", "type": "Condition", "text": [ "reproductive capability" ], "offsets": [ [ 1406, 1429 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T27", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 398, 406 ], [ 414, 422 ] ], "normalized": [] }, { "id": "NCT00094861_inc_T93", "type": "Person", "text": [ "age" ], "offsets": [ [ 410, 413 ] ], "normalized": [] } ]

[]

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[ { "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": [] } ]

[ { "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", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 4, 12 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T2", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 16, 25 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T3", "type": "Observation", "text": [ "Have participated in any other studies involving investigational products" ], "offsets": [ [ 28, 101 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T4", "type": "Temporal", "text": [ "within 30 days prior to entry into this study" ], "offsets": [ [ 102, 147 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T5", "type": "Reference_point", "text": [ "entry into this stud" ], "offsets": [ [ 126, 146 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T6", "type": "Condition", "text": [ "acute withdrawal syndrome" ], "offsets": [ [ 168, 193 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T7", "type": "Drug", "text": [ "drugs" ], "offsets": [ [ 199, 204 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T8", "type": "Drug", "text": [ "alcohol" ], "offsets": [ [ 208, 215 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T9", "type": "Scope", "text": [ "drugs or alcohol" ], "offsets": [ [ 199, 215 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T10", "type": "Condition", "text": [ "Schizophrenia" ], "offsets": [ [ 246, 259 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T11", "type": "Condition", "text": [ "Schizoaffective Disorder" ], "offsets": [ [ 261, 285 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T12", "type": "Condition", "text": [ "Schizophreniform Disorder" ], "offsets": [ [ 287, 312 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T13", "type": "Condition", "text": [ "Bipolar I Disorder" ], "offsets": [ [ 316, 334 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T18", "type": "Procedure", "text": [ "Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)" ], "offsets": [ [ 355, 421 ] ], "normalized": [] }, { "id": "NCT00122070_exc_T19", "type": "Scope", "text": [ "Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or Bipolar I Disorder" ], "offsets": [ [ 246, 334 ] ], "normalized": [] } ]

[]

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[ { "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": [] } ]

[ { "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", "type": "Person", "text": [ "age" ], "offsets": [ [ 91, 94 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T3", "type": "Value", "text": [ "between", "18 and 55 years" ], "offsets": [ [ 83, 90 ], [ 95, 110 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T5", "type": "Condition", "text": [ "BPD" ], "offsets": [ [ 243, 246 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T6", "type": "Qualifier", "text": [ "Meet DSM-IV criteria" ], "offsets": [ [ 218, 238 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T4", "type": "Observation", "text": [ "able to speak, read and write English" ], "offsets": [ [ 115, 152 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T8", "type": "Observation", "text": [ "able to", "follow simple instructions" ], "offsets": [ [ 115, 122 ], [ 157, 183 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T1", "type": "Observation", "text": [ "written informed consent" ], "offsets": [ [ 8, 32 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T9", "type": "Temporal", "text": [ "before beginning any study related activities" ], "offsets": [ [ 33, 78 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T10", "type": "Reference_point", "text": [ "any study related activities" ], "offsets": [ [ 50, 78 ] ], "normalized": [] }, { "id": "NCT00122070_inc_T7", "type": "Procedure", "text": [ "Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II)" ], "offsets": [ [ 266, 338 ] ], "normalized": [] } ]

[]

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[ { "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": [] } ]

[ { "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", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 18, 24 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T2", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 10, 17 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T3", "type": "Condition", "text": [ "diagnosis" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T4", "type": "Measurement", "text": [ "DSM-IV criteria" ], "offsets": [ [ 36, 51 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T5", "type": "Condition", "text": [ "body dysmorphic disorder" ], "offsets": [ [ 56, 80 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T6", "type": "Condition", "text": [ "bipolar affective disorder" ], "offsets": [ [ 82, 108 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T7", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 110, 123 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T8", "type": "Condition", "text": [ "psychotic disorder," ], "offsets": [ [ 125, 144 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T9", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 161, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T10", "type": "Condition", "text": [ "alcohol", "abuse" ], "offsets": [ [ 153, 160 ], [ 171, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T11", "type": "Scope", "text": [ "body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse" ], "offsets": [ [ 56, 176 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T13", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 227, 252 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T14", "type": "Qualifier", "text": [ "Comorbid" ], "offsets": [ [ 218, 226 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T15", "type": "Temporal", "text": [ "predates OCD diagnosis" ], "offsets": [ [ 269, 291 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T16", "type": "Reference_point", "text": [ "OCD diagnosis" ], "offsets": [ [ 278, 291 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T17", "type": "Procedure", "text": [ "Cognitive behavioural therapy" ], "offsets": [ [ 292, 321 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T18", "type": "Procedure", "text": [ "psychotherapy" ], "offsets": [ [ 336, 349 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T19", "type": "Qualifier", "text": [ "additional" ], "offsets": [ [ 325, 335 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T20", "type": "Temporal", "text": [ "in past four months" ], "offsets": [ [ 350, 369 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T21", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 370, 377 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T22", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 381, 397 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T23", "type": "Drug", "text": [ "topiramate" ], "offsets": [ [ 401, 411 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T24", "type": "Scope", "text": [ "Allergy or hypersensitivity" ], "offsets": [ [ 370, 397 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T25", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 412, 415 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T26", "type": "Value", "text": [ "< 20" ], "offsets": [ [ 416, 420 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T27", "type": "Condition", "text": [ "kidney stones" ], "offsets": [ [ 432, 445 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T12", "type": "Drug", "text": [ "topiramate" ], "offsets": [ [ 207, 217 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T28", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 180, 188 ] ], "normalized": [] }, { "id": "NCT00182520_exc_T29", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 421, 431 ] ], "normalized": [] } ]

[]

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[ { "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": [] } ]

[ { "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", "type": "Condition", "text": [ "OCD" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T2", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 16, 23 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T3", "type": "Qualifier", "text": [ "DSM- IV" ], "offsets": [ [ 24, 31 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T4", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 409, 420 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T5", "type": "Qualifier", "text": [ "concurrent" ], "offsets": [ [ 398, 408 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T6", "type": "Qualifier", "text": [ "Stable" ], "offsets": [ [ 373, 379 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T7", "type": "Temporal", "text": [ "8 wks or longer" ], "offsets": [ [ 381, 396 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T8", "type": "Drug", "text": [ "benzodiazepines" ], "offsets": [ [ 431, 446 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T9", "type": "Drug", "text": [ "sedative hypnotics" ], "offsets": [ [ 448, 466 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T10", "type": "Drug", "text": [ "antipsychotics" ], "offsets": [ [ 468, 482 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T11", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 488, 503 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T12", "type": "Scope", "text": [ "benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants" ], "offsets": [ [ 431, 503 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T13", "type": "Multiplier", "text": [ "14-week" ], "offsets": [ [ 52, 59 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T14", "type": "Drug", "text": [ "fluoxetine" ], "offsets": [ [ 105, 115 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T15", "type": "Multiplier", "text": [ "80 mg/day" ], "offsets": [ [ 116, 125 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T16", "type": "Drug", "text": [ "paroxetine" ], "offsets": [ [ 127, 137 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T17", "type": "Multiplier", "text": [ "60 mg/day" ], "offsets": [ [ 138, 147 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T18", "type": "Drug", "text": [ "fluvoxamine" ], "offsets": [ [ 149, 160 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T19", "type": "Multiplier", "text": [ "300 mg/day" ], "offsets": [ [ 161, 171 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T20", "type": "Drug", "text": [ "clomipramine" ], "offsets": [ [ 173, 185 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T21", "type": "Multiplier", "text": [ "250 mg/day" ], "offsets": [ [ 186, 196 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T22", "type": "Drug", "text": [ "sertraline" ], "offsets": [ [ 198, 208 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T23", "type": "Multiplier", "text": [ "200 mg/day" ], "offsets": [ [ 209, 219 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T24", "type": "Drug", "text": [ "citalopram" ], "offsets": [ [ 221, 231 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T25", "type": "Multiplier", "text": [ "60 mg/day" ], "offsets": [ [ 232, 241 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T26", "type": "Drug", "text": [ "escitalopram" ], "offsets": [ [ 243, 255 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T27", "type": "Multiplier", "text": [ "30 mg/day" ], "offsets": [ [ 256, 265 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T28", "type": "Condition", "text": [ "responses to" ], "offsets": [ [ 301, 313 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T29", "type": "Measurement", "text": [ "CGI-I" ], "offsets": [ [ 329, 334 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T30", "type": "Value", "text": [ "3" ], "offsets": [ [ 338, 339 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T31", "type": "Value", "text": [ "4" ], "offsets": [ [ 343, 344 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T32", "type": "Scope", "text": [ "3 or 4" ], "offsets": [ [ 338, 344 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T33", "type": "Measurement", "text": [ "Y-BOCS" ], "offsets": [ [ 346, 352 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T34", "type": "Value", "text": [ "reduction of < 35%" ], "offsets": [ [ 353, 371 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T35", "type": "Scope", "text": [ "CGI-I of 3 or 4, Y-BOCS reduction of < 35%" ], "offsets": [ [ 329, 371 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T36", "type": "Multiplier", "text": [ "one the following" ], "offsets": [ [ 80, 97 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T37", "type": "Scope", "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" ], "offsets": [ [ 105, 265 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T38", "type": "Procedure", "text": [ "SRI treatment" ], "offsets": [ [ 314, 327 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T39", "type": "Scope", "text": [ "responses to SRI treatment" ], "offsets": [ [ 301, 327 ] ], "normalized": [] }, { "id": "NCT00182520_inc_T40", "type": "Visit", "text": [ "Outpatient" ], "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": [] } ]

[ { "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", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 33, 45 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T2", "type": "Condition", "text": [ "unresectable disease" ], "offsets": [ [ 50, 70 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T3", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 100, 112 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T4", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 90, 96 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T5", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 113, 122 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T6", "type": "Scope", "text": [ "active or uncontrolled" ], "offsets": [ [ 90, 112 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T7", "type": "Procedure", "text": [ "HIV infection" ], "offsets": [ [ 140, 153 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T8", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 177, 188 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T9", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 170, 176 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T10", "type": "Scope", "text": [ "active hepatitis B" ], "offsets": [ [ 170, 188 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T11", "type": "Drug", "text": [ "lamivudine" ], "offsets": [ [ 207, 217 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T12", "type": "Condition", "text": [ "hepatitis C" ], "offsets": [ [ 240, 251 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T13", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 233, 239 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T14", "type": "Scope", "text": [ "active hepatitis C" ], "offsets": [ [ 233, 251 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T15", "type": "Measurement", "text": [ "liver tests" ], "offsets": [ [ 272, 283 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T16", "type": "Value", "text": [ "qualify" ], "offsets": [ [ 284, 291 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T17", "type": "Condition", "text": [ "psychiatric disorders" ], "offsets": [ [ 315, 336 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T18", "type": "Qualifier", "text": [ "interfere with consent" ], "offsets": [ [ 348, 370 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T19", "type": "Qualifier", "text": [ "interfere with", "follow-up" ], "offsets": [ [ 348, 362 ], [ 374, 383 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T20", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 385, 393 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T21", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 397, 406 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T22", "type": "Person", "text": [ "women" ], "offsets": [ [ 407, 412 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T23", "type": "Condition", "text": [ "reproductive potential" ], "offsets": [ [ 431, 453 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T24", "type": "Procedure", "text": [ "effective contraceptive method" ], "offsets": [ [ 508, 538 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T25", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 565, 571 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T26", "type": "Condition", "text": [ "concurrent disease" ], "offsets": [ [ 572, 590 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T28", "type": "Observation", "text": [ "entry into this study" ], "offsets": [ [ 676, 697 ] ], "normalized": [] }, { "id": "NCT00183885_exc_T29", "type": "Mood", "text": [ "inappropriate for" ], "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": [] } ]

[ { "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", "type": "Qualifier", "text": [ "Unresectable" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T2", "type": "Condition", "text": [ "hepatocellular carcinoma" ], "offsets": [ [ 39, 63 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T3", "type": "Measurement", "text": [ "histologically" ], "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T4", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T5", "type": "Qualifier", "text": [ "disease limited to liver" ], "offsets": [ [ 77, 101 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T6", "type": "Procedure", "text": [ "biopsy" ], "offsets": [ [ 291, 297 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T7", "type": "Measurement", "text": [ "alpha-fetoprotein" ], "offsets": [ [ 315, 332 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T8", "type": "Value", "text": [ "greater than 500 ng/mL" ], "offsets": [ [ 336, 358 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T9", "type": "Qualifier", "text": [ "measurable disease" ], "offsets": [ [ 589, 607 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T10", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 618, 635 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T11", "type": "Qualifier", "text": [ "measurable disease" ], "offsets": [ [ 654, 672 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T12", "type": "Qualifier", "text": [ "outside the radiation field" ], "offsets": [ [ 681, 708 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T13", "type": "Measurement", "text": [ "Zubrod performance status" ], "offsets": [ [ 732, 757 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T14", "type": "Value", "text": [ "0-2" ], "offsets": [ [ 761, 764 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T15", "type": "Measurement", "text": [ "predicted life expectancy" ], "offsets": [ [ 788, 813 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T16", "type": "Value", "text": [ "at least 12 weeks" ], "offsets": [ [ 817, 834 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T17", "type": "Measurement", "text": [ "granulocyte count" ], "offsets": [ [ 872, 889 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T18", "type": "Temporal", "text": [ "pre-treatment" ], "offsets": [ [ 858, 871 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T19", "type": "Measurement", "text": [ "segmented neutrophils + bands" ], "offsets": [ [ 897, 926 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T20", "type": "Value", "text": [ "greater than or equal to 1,500/mm3" ], "offsets": [ [ 931, 965 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T21", "type": "Measurement", "text": [ "hemoglobin level" ], "offsets": [ [ 969, 985 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T22", "type": "Value", "text": [ "greater than or equal to 9 gm/dl" ], "offsets": [ [ 989, 1021 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T23", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 1027, 1041 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T24", "type": "Value", "text": [ "greater than or equal to 50,000/mm3" ], "offsets": [ [ 1042, 1077 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T25", "type": "Scope", "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" ], "offsets": [ [ 872, 1077 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T26", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 1258, 1272 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T27", "type": "Value", "text": [ "adequate" ], "offsets": [ [ 1249, 1257 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T28", "type": "Measurement", "text": [ "calculated creatinine clearance" ], "offsets": [ [ 1292, 1323 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T29", "type": "Value", "text": [ "≥ 60" ], "offsets": [ [ 1324, 1328 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T30", "type": "Measurement", "text": [ "hepatic function" ], "offsets": [ [ 1359, 1375 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T31", "type": "Value", "text": [ "adequate" ], "offsets": [ [ 1350, 1358 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T32", "type": "Measurement", "text": [ "serum bilirubin" ], "offsets": [ [ 1395, 1410 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T33", "type": "Value", "text": [ "less than or equal to 2x the institutional upper limit of normal" ], "offsets": [ [ 1411, 1475 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T34", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 1573, 1580 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T35", "type": "Negation", "text": [ "may not have" ], "offsets": [ [ 1560, 1572 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T36", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 1588, 1595 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T37", "type": "Qualifier", "text": [ "responsive to diuretics" ], "offsets": [ [ 1604, 1627 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T38", "type": "Procedure", "text": [ "blood sample drawn" ], "offsets": [ [ 489, 507 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T39", "type": "Qualifier", "text": [ "20 cc" ], "offsets": [ [ 483, 488 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T41", "type": "Procedure", "text": [ "routine labs" ], "offsets": [ [ 523, 535 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T42", "type": "Multiplier", "text": [ "with each cycle of chemotherapy" ], "offsets": [ [ 536, 567 ] ], "normalized": [] }, { "id": "NCT00183885_inc_T43", "type": "Scope", "text": [ "20 cc blood sample drawn in addition to routine labs" ], "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": [] } ]

[ { "id": "NCT00198913_exc_text", "type": "exclusion", "text": [ "type 1 diabetic or non-diabetic \n \n" ], "offsets": [ [ 0, 44 ] ] } ]

[ { "id": "NCT00198913_exc_T1", "type": "Condition", "text": [ "type 1 diabetic" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT00198913_exc_T2", "type": "Condition", "text": [ "non-diabetic" ], "offsets": [ [ 19, 31 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT00198913_inc_text", "type": "inclusion", "text": [ "type 2 diabetic, age 18 and over, informed consent, \n" ], "offsets": [ [ 0, 53 ] ] } ]

[ { "id": "NCT00198913_inc_T1", "type": "Condition", "text": [ "type 2 diabetic" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT00198913_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT00198913_inc_T3", "type": "Value", "text": [ "18 and over" ], "offsets": [ [ 21, 32 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00198913_inc_R1", "type": "Has_value", "arg1_id": "NCT00198913_inc_T2", "arg2_id": "NCT00198913_inc_T3", "normalized": [] } ]

[ { "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", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 3, 27 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T2", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 33, 37 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T3", "type": "Procedure", "text": [ "Percutaneous Coronary Intervention (PCI)" ], "offsets": [ [ 41, 81 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T4", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 114, 127 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T5", "type": "Procedure", "text": [ "valve surgery" ], "offsets": [ [ 134, 147 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T8", "type": "Procedure", "text": [ "carotid end-arterectomy" ], "offsets": [ [ 201, 224 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T9", "type": "Procedure", "text": [ "abdominal aortic aneurysm surgery" ], "offsets": [ [ 226, 259 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T6", "type": "Procedure", "text": [ "resection of", "left ventricular aneurysm" ], "offsets": [ [ 151, 163 ], [ 174, 199 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T7", "type": "Procedure", "text": [ "resection of aortic", "aneurysm" ], "offsets": [ [ 151, 170 ], [ 191, 199 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T10", "type": "Procedure", "text": [ "Congenital heart disease" ], "offsets": [ [ 271, 295 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T11", "type": "Procedure", "text": [ "Transmural myocardial infarction" ], "offsets": [ [ 301, 333 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T12", "type": "Temporal", "text": [ "within the previous seven days" ], "offsets": [ [ 334, 364 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T13", "type": "Measurement", "text": [ "CK" ], "offsets": [ [ 369, 371 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T14", "type": "Negation", "text": [ "has not returned" ], "offsets": [ [ 372, 388 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T15", "type": "Value", "text": [ "normal" ], "offsets": [ [ 392, 398 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T16", "type": "Condition", "text": [ "Chest pain" ], "offsets": [ [ 404, 414 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T17", "type": "Qualifier", "text": [ "lasting longer than 30 minutes" ], "offsets": [ [ 415, 445 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T18", "type": "Temporal", "text": [ "within 12 hours pre-procedure" ], "offsets": [ [ 446, 475 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T19", "type": "Measurement", "text": [ "CK enzymes" ], "offsets": [ [ 480, 490 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T20", "type": "Value", "text": [ "positive" ], "offsets": [ [ 491, 499 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T21", "type": "Value", "text": [ "≥ 2x the normal upper limit" ], "offsets": [ [ 501, 528 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T22", "type": "Scope", "text": [ "CK enzymes positive (≥ 2x the normal upper limit)" ], "offsets": [ [ 480, 529 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T23", "type": "Condition", "text": [ "any cerebrovascular accident" ], "offsets": [ [ 546, 574 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T24", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 535, 545 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T25", "type": "Condition", "text": [ "Left main stenosis" ], "offsets": [ [ 580, 598 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T26", "type": "Value", "text": [ "50% or more" ], "offsets": [ [ 602, 613 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T27", "type": "Condition", "text": [ "Single vessel", "disease" ], "offsets": [ [ 697, 710 ], [ 730, 737 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T28", "type": "Condition", "text": [ "single territory", "disease" ], "offsets": [ [ 712, 728 ], [ 730, 737 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T29", "type": "Mood", "text": [ "Intention to" ], "offsets": [ [ 619, 631 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T30", "type": "Multiplier", "text": [ "more than 1" ], "offsets": [ [ 638, 649 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T31", "type": "Qualifier", "text": [ "totally occluded major epicardial vessel" ], "offsets": [ [ 650, 690 ] ], "normalized": [] }, { "id": "NCT00235170_exc_T32", "type": "Procedure", "text": [ "treat" ], "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": [] } ]

[ { "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", "type": "Measurement", "text": [ "Canadian Cardiovascular Society" ], "offsets": [ [ 25, 56 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T2", "type": "Value", "text": [ "1, 2, 3 or 4" ], "offsets": [ [ 57, 69 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T3", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 17, 23 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T4", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 74, 82 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T5", "type": "Measurement", "text": [ "Braunwald class" ], "offsets": [ [ 84, 99 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T6", "type": "Value", "text": [ "IB" ], "offsets": [ [ 100, 102 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T7", "type": "Condition", "text": [ "angina pectoris" ], "offsets": [ [ 130, 145 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T8", "type": "Condition", "text": [ "ischemia" ], "offsets": [ [ 150, 158 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T9", "type": "Condition", "text": [ "atypical chest pain" ], "offsets": [ [ 177, 196 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T10", "type": "Scope", "text": [ "stable (Canadian Cardiovascular Society 1, 2, 3 or 4) or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC) angina pectoris and ischemia" ], "offsets": [ [ 17, 158 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T11", "type": "Condition", "text": [ "asymptomatic" ], "offsets": [ [ 219, 231 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T12", "type": "Condition", "text": [ "myocardial ischaemia" ], "offsets": [ [ 262, 282 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T13", "type": "Observation", "text": [ "documented" ], "offsets": [ [ 251, 261 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T14", "type": "Procedure", "text": [ "treadmill exercise test" ], "offsets": [ [ 289, 312 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T15", "type": "Procedure", "text": [ "radionuclide scintigraphy" ], "offsets": [ [ 314, 339 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T16", "type": "Procedure", "text": [ "stress echocardiography" ], "offsets": [ [ 341, 364 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T17", "type": "Procedure", "text": [ "Holter tape" ], "offsets": [ [ 366, 377 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T18", "type": "Scope", "text": [ "treadmill exercise test, radionuclide scintigraphy, stress echocardiography, Holter tape" ], "offsets": [ [ 289, 377 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T19", "type": "Procedure", "text": [ "coronary revascularization" ], "offsets": [ [ 414, 440 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T20", "type": "Mood", "text": [ "eligible for" ], "offsets": [ [ 401, 413 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T21", "type": "Procedure", "text": [ "angioplasty" ], "offsets": [ [ 442, 453 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T22", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 457, 461 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T23", "type": "Scope", "text": [ "angioplasty or CABG" ], "offsets": [ [ 442, 461 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T24", "type": "Value", "text": [ "At least 2" ], "offsets": [ [ 468, 478 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T25", "type": "Condition", "text": [ "lesions" ], "offsets": [ [ 479, 486 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T26", "type": "Qualifier", "text": [ "located in different vessels" ], "offsets": [ [ 488, 516 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T27", "type": "Qualifier", "text": [ "located in", "different territories" ], "offsets": [ [ 488, 498 ], [ 524, 545 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T28", "type": "Scope", "text": [ "located in different vessels and in different territories" ], "offsets": [ [ 488, 545 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T29", "type": "Procedure", "text": [ "stent implantation" ], "offsets": [ [ 571, 589 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T30", "type": "Observation", "text": [ "potentially amenable" ], "offsets": [ [ 547, 567 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T31", "type": "Condition", "text": [ "Multivessel disease" ], "offsets": [ [ 623, 642 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T32", "type": "Value", "text": [ "at least one" ], "offsets": [ [ 648, 660 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T33", "type": "Condition", "text": [ "significant stenosis in LAD" ], "offsets": [ [ 661, 688 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T34", "type": "Procedure", "text": [ "treatment of the lesion" ], "offsets": [ [ 698, 721 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T35", "type": "Qualifier", "text": [ "in another major epicardial coronary artery" ], "offsets": [ [ 722, 765 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T36", "type": "Condition", "text": [ "total occluded vessels" ], "offsets": [ [ 1364, 1386 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T37", "type": "Temporal", "text": [ "unknown duration" ], "offsets": [ [ 1390, 1406 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T38", "type": "Temporal", "text": [ "longer than one month" ], "offsets": [ [ 1419, 1440 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T39", "type": "Value", "text": [ "over 1.50 mm" ], "offsets": [ [ 1457, 1469 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T40", "type": "Measurement", "text": [ "reference" ], "offsets": [ [ 1447, 1456 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T41", "type": "Scope", "text": [ "longer than one month and a reference over 1.50 mm" ], "offsets": [ [ 1419, 1469 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T42", "type": "Measurement", "text": [ "stenosis" ], "offsets": [ [ 1593, 1601 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T43", "type": "Value", "text": [ "more than 50% in luminal diameter" ], "offsets": [ [ 1605, 1638 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T44", "type": "Condition", "text": [ "Significant stenosis" ], "offsets": [ [ 1550, 1570 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T45", "type": "Measurement", "text": [ "Left ventricular ejection fraction" ], "offsets": [ [ 1714, 1748 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T46", "type": "Value", "text": [ "at least 30%" ], "offsets": [ [ 1759, 1771 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T47", "type": "Value", "text": [ "IC" ], "offsets": [ [ 104, 106 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T48", "type": "Value", "text": [ "IIB" ], "offsets": [ [ 108, 111 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T49", "type": "Value", "text": [ "IIC" ], "offsets": [ [ 113, 116 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T50", "type": "Value", "text": [ "IIIB" ], "offsets": [ [ 118, 122 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T51", "type": "Value", "text": [ "IIIC" ], "offsets": [ [ 124, 128 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T52", "type": "Scope", "text": [ "IB, IC, IIB, IIC, IIIB, IIIC" ], "offsets": [ [ 100, 128 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T53", "type": "Qualifier", "text": [ "de novo" ], "offsets": [ [ 595, 602 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T54", "type": "Condition", "text": [ "native vessels" ], "offsets": [ [ 603, 617 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T56", "type": "Condition", "text": [ "Total occluded vessels" ], "offsets": [ [ 1009, 1031 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T57", "type": "Multiplier", "text": [ "One" ], "offsets": [ [ 1033, 1036 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T58", "type": "Condition", "text": [ "total occluded major epicardial vessel" ], "offsets": [ [ 1037, 1075 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T59", "type": "Condition", "text": [ "total occluded", "side branch" ], "offsets": [ [ 1037, 1051 ], [ 1079, 1090 ] ], "normalized": [] }, { "id": "NCT00235170_inc_T60", "type": "Scope", "text": [ "total occluded major epicardial vessel or side branch" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "Multiple pregnancy" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T2", "type": "Value", "text": [ "more than 3" ], "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T3", "type": "Measurement", "text": [ "fetuses" ], "offsets": [ [ 32, 39 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T4", "type": "Condition", "text": [ "placental abruptio" ], "offsets": [ [ 62, 80 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T5", "type": "Observation", "text": [ "Maternal history of" ], "offsets": [ [ 42, 61 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T7", "type": "Condition", "text": [ "IUGR" ], "offsets": [ [ 93, 97 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T6", "type": "Condition", "text": [ "Fetus" ], "offsets": [ [ 82, 87 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T8", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 99, 108 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T9", "type": "Condition", "text": [ "pre-eclampsia" ], "offsets": [ [ 126, 139 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T10", "type": "Observation", "text": [ "give informed consent" ], "offsets": [ [ 154, 175 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T11", "type": "Negation", "text": [ "Unability to" ], "offsets": [ [ 141, 153 ] ], "normalized": [] }, { "id": "NCT00236340_exc_T12", "type": "Scope", "text": [ "more than 3 fetuses" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 9, 14 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T3", "type": "Condition", "text": [ "abdomen discumfort" ], "offsets": [ [ 20, 38 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T4", "type": "Procedure", "text": [ "ultrasound" ], "offsets": [ [ 43, 53 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T5", "type": "Condition", "text": [ "polyhydramnios" ], "offsets": [ [ 67, 81 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T6", "type": "Measurement", "text": [ "AFI" ], "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T7", "type": "Value", "text": [ ">25cm" ], "offsets": [ [ 86, 91 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T8", "type": "Value", "text": [ "diagnosis" ], "offsets": [ [ 54, 63 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T9", "type": "Condition", "text": [ "pregnancies" ], "offsets": [ [ 109, 120 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T10", "type": "Value", "text": [ "Single" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T11", "type": "Value", "text": [ "twin" ], "offsets": [ [ 104, 108 ] ], "normalized": [] }, { "id": "NCT00236340_inc_T12", "type": "Scope", "text": [ "Single or twin" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 66, 75 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T2", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 86, 103 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T3", "type": "Procedure", "text": [ "Ventavis treatment" ], "offsets": [ [ 108, 126 ] ], "normalized": [] }, { "id": "NCT00250640_exc_T4", "type": "Qualifier", "text": [ "Ventavis Summary of Product Characteristics and patient package insert" ], "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": [] } ]

[ { "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", "type": "Drug", "text": [ "Ventavis" ], "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T2", "type": "Condition", "text": [ "primary pulmonary hypertension" ], "offsets": [ [ 107, 137 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T3", "type": "Condition", "text": [ "Idiopathic Pulmonary Arterial Hypertension" ], "offsets": [ [ 144, 186 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T4", "type": "Condition", "text": [ "Familial Pulmonary Arterial Hypertension" ], "offsets": [ [ 190, 230 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T5", "type": "Scope", "text": [ "Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension" ], "offsets": [ [ 144, 230 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T6", "type": "Measurement", "text": [ "NYHA functional class" ], "offsets": [ [ 250, 271 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T7", "type": "Value", "text": [ "III" ], "offsets": [ [ 272, 275 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T8", "type": "Procedure", "text": [ "treatment with Ventavis" ], "offsets": [ [ 322, 345 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T9", "type": "Condition", "text": [ "primary pulmonary hypertension" ], "offsets": [ [ 377, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T10", "type": "Procedure", "text": [ "treatments" ], "offsets": [ [ 362, 372 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T11", "type": "Qualifier", "text": [ "for primary pulmonary hypertension" ], "offsets": [ [ 373, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T12", "type": "Temporal", "text": [ "within 6 weeks of date of study inclusion" ], "offsets": [ [ 408, 449 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T13", "type": "Negation", "text": [ "No" ], "offsets": [ [ 313, 315 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T14", "type": "Scope", "text": [ "treatment with Ventavis or other active treatments for primary pulmonary hypertension" ], "offsets": [ [ 322, 407 ] ], "normalized": [] }, { "id": "NCT00250640_inc_T15", "type": "Multiplier", "text": [ "long-term" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 18, 26 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T2", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 28, 35 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T3", "type": "Observation", "text": [ "able to give written informed consent" ], "offsets": [ [ 43, 80 ] ], "normalized": [] }, { "id": "NCT00279552_exc_T4", "type": "Negation", "text": [ "not" ], "offsets": [ [ 39, 42 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00279552_exc_R1", "type": "Has_negation", "arg1_id": "NCT00279552_exc_T3", "arg2_id": "NCT00279552_exc_T4", "normalized": [] } ]

[ { "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", "type": "Condition", "text": [ "vitamin B12 deficiency" ], "offsets": [ [ 27, 49 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T2", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T3", "type": "Measurement", "text": [ "plasma vitamin B12" ], "offsets": [ [ 63, 81 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T4", "type": "Value", "text": [ "below the reference interval" ], "offsets": [ [ 82, 110 ] ], "normalized": [] }, { "id": "NCT00279552_inc_T5", "type": "Value", "text": [ "<200 pmol/L" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 113, 122 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T2", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 126, 139 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T3", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 141, 158 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T4", "type": "Condition", "text": [ "heart disease" ], "offsets": [ [ 160, 173 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T5", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 175, 181 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T6", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 183, 195 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T7", "type": "Condition", "text": [ "malabsorption syndromes" ], "offsets": [ [ 197, 220 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T8", "type": "Condition", "text": [ "GERD" ], "offsets": [ [ 222, 226 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T9", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 230, 240 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T10", "type": "Condition", "text": [ "ulcer" ], "offsets": [ [ 241, 246 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T11", "type": "Condition", "text": [ "illness that may affect the study outcomes" ], "offsets": [ [ 14, 56 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T12", "type": "Condition", "text": [ "illness that", "would make participation potentially harmful" ], "offsets": [ [ 14, 26 ], [ 60, 104 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T13", "type": "Scope", "text": [ "pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer" ], "offsets": [ [ 113, 246 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T14", "type": "Scope", "text": [ "illness that may affect the study outcomes or would make participation potentially harmful" ], "offsets": [ [ 14, 104 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T15", "type": "Measurement", "text": [ "hepatic function" ], "offsets": [ [ 299, 315 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T16", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 290, 298 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T17", "type": "Measurement", "text": [ "liver function test" ], "offsets": [ [ 317, 336 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T18", "type": "Value", "text": [ "> twice the normal range" ], "offsets": [ [ 337, 361 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T19", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 373, 387 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T20", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 364, 372 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T21", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 389, 399 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T22", "type": "Value", "text": [ "> 1.1 mg/dl" ], "offsets": [ [ 400, 411 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T23", "type": "Measurement", "text": [ "fasting plasma glucose" ], "offsets": [ [ 414, 436 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T24", "type": "Value", "text": [ "in the diabetic range" ], "offsets": [ [ 437, 458 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T25", "type": "Value", "text": [ ">/= 126 mg/dl" ], "offsets": [ [ 460, 473 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T26", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 479, 493 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T27", "type": "Value", "text": [ "> 140/90 mmHg" ], "offsets": [ [ 494, 507 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T28", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 518, 528 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T29", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 532, 542 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T30", "type": "Drug", "text": [ "medications that could interfere with the treatment" ], "offsets": [ [ 553, 604 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T31", "type": "Drug", "text": [ "bronchodilators" ], "offsets": [ [ 615, 630 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T32", "type": "Drug", "text": [ "quinolone antibiotics" ], "offsets": [ [ 632, 653 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T33", "type": "Drug", "text": [ "monoamine oxidase inhibitors" ], "offsets": [ [ 655, 683 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T34", "type": "Drug", "text": [ "anxiolytics" ], "offsets": [ [ 685, 696 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T35", "type": "Drug", "text": [ "ranitidine" ], "offsets": [ [ 698, 708 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T36", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 710, 725 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T37", "type": "Drug", "text": [ "growth hormone" ], "offsets": [ [ 727, 741 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T38", "type": "Drug", "text": [ "antihypertensives" ], "offsets": [ [ 743, 760 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T39", "type": "Scope", "text": [ "bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives" ], "offsets": [ [ 615, 760 ] ], "normalized": [] }, { "id": "NCT00305097_exc_T40", "type": "Observation", "text": [ "medical history" ], "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": [] } ]

[ { "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", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T2", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 5, 22 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T3", "type": "Observation", "text": [ "ability", "to give written informed consent" ], "offsets": [ [ 31, 38 ], [ 55, 87 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T4", "type": "Observation", "text": [ "willingness", "to give written informed consent" ], "offsets": [ [ 43, 54 ], [ 55, 87 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T5", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 90, 105 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T6", "type": "Value", "text": [ "25-35 kg/m2" ], "offsets": [ [ 106, 117 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T7", "type": "Multiplier", "text": [ "at least 2 cups", "per day" ], "offsets": [ [ 128, 143 ], [ 166, 173 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T8", "type": "Drug", "text": [ "caffeinated coffee" ], "offsets": [ [ 147, 165 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T9", "type": "Observation", "text": [ "willing to be randomized" ], "offsets": [ [ 182, 206 ] ], "normalized": [] }, { "id": "NCT00305097_inc_T10", "type": "Condition", "text": [ "Non-smoking" ], "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": [] } ]

[ { "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", "type": "Procedure", "text": [ "Interleukin-2 (IL-2) therapy" ], "offsets": [ [ 11, 39 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T2", "type": "Temporal", "text": [ "within 8 weeks of study entry" ], "offsets": [ [ 40, 69 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T3", "type": "Condition", "text": [ "illness that may interfere with study participation", "medical" ], "offsets": [ [ 111, 162 ], [ 88, 95 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T4", "type": "Condition", "text": [ "psychiatric illness that may interfere with study participation" ], "offsets": [ [ 99, 162 ] ], "normalized": [] }, { "id": "NCT00312429_exc_T5", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 164, 172 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00312429_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00312429_exc_T1", "arg2_id": "NCT00312429_exc_T2", "normalized": [] } ]

[ { "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", "type": "Condition", "text": [ "high risk blood disease" ], "offsets": [ [ 79, 102 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T2", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 106, 112 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T3", "type": "Measurement", "text": [ "Estimated life expectancy" ], "offsets": [ [ 140, 165 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T4", "type": "Value", "text": [ "at least 6 weeks following study entry" ], "offsets": [ [ 169, 207 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T5", "type": "Measurement", "text": [ "Cancer and Leukemia Group B (CALGB) performance status" ], "offsets": [ [ 209, 263 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T8", "type": "Value", "text": [ "less than or equal to 2" ], "offsets": [ [ 264, 287 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T9", "type": "Measurement", "text": [ "White blood cell count" ], "offsets": [ [ 289, 311 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T10", "type": "Measurement", "text": [ "platelet" ], "offsets": [ [ 313, 321 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T11", "type": "Measurement", "text": [ "hematocrit" ], "offsets": [ [ 323, 333 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T12", "type": "Measurement", "text": [ "tuberculosis" ], "offsets": [ [ 335, 347 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T13", "type": "Measurement", "text": [ "aspartate aminotransferase (AST)" ], "offsets": [ [ 349, 381 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T6", "type": "Measurement", "text": [ "alanine aminotransferase (ALT)" ], "offsets": [ [ 383, 413 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T7", "type": "Measurement", "text": [ "alkaline phosphatase" ], "offsets": [ [ 415, 435 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T14", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 437, 447 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T15", "type": "Measurement", "text": [ "HIV test results" ], "offsets": [ [ 453, 469 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T16", "type": "Qualifier", "text": [ "reviewed by transplant center" ], "offsets": [ [ 470, 499 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T17", "type": "Scope", "text": [ "White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results" ], "offsets": [ [ 289, 469 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T18", "type": "Procedure", "text": [ "Multiple gated acquisition (MUGA)" ], "offsets": [ [ 501, 534 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T19", "type": "Procedure", "text": [ "echocardiogram" ], "offsets": [ [ 536, 550 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T20", "type": "Procedure", "text": [ "cardiac MRI" ], "offsets": [ [ 552, 563 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T21", "type": "Procedure", "text": [ "pulmonary function tests (PFT)" ], "offsets": [ [ 572, 602 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T22", "type": "Qualifier", "text": [ "reviewed by transplant center" ], "offsets": [ [ 617, 646 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T23", "type": "Scope", "text": [ "Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT)" ], "offsets": [ [ 501, 602 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T24", "type": "Person", "text": [ "female" ], "offsets": [ [ 970, 976 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T25", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 993, 1006 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T26", "type": "Temporal", "text": [ "throughout the study" ], "offsets": [ [ 1007, 1027 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T27", "type": "Measurement", "text": [ "umbilical cord blood units available" ], "offsets": [ [ 909, 945 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T28", "type": "Value", "text": [ "Sufficient number" ], "offsets": [ [ 888, 905 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T29", "type": "Qualifier", "text": [ "for transplantation" ], "offsets": [ [ 946, 965 ] ], "normalized": [] }, { "id": "NCT00312429_inc_T30", "type": "Procedure", "text": [ "transplantation" ], "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": [] } ]

[ { "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", "type": "Measurement", "text": [ "Body mass index (BMI)" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T2", "type": "Value", "text": [ "35 kg/m2 or more" ], "offsets": [ [ 25, 41 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T3", "type": "Condition", "text": [ "metabolic", "diseases" ], "offsets": [ [ 56, 65 ], [ 80, 88 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T4", "type": "Condition", "text": [ "endocrine diseases" ], "offsets": [ [ 70, 88 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T5", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 104, 110 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T6", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 120, 128 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T7", "type": "Drug", "text": [ "drugs that interfere with the metabolism of estrogen" ], "offsets": [ [ 132, 184 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T8", "type": "Drug", "text": [ "systemic estrogen" ], "offsets": [ [ 198, 215 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T9", "type": "Drug", "text": [ "systemic", "progestin" ], "offsets": [ [ 198, 206 ], [ 217, 226 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T10", "type": "Drug", "text": [ "DHEA" ], "offsets": [ [ 231, 235 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T11", "type": "Temporal", "text": [ "in the eight weeks prior to randomization" ], "offsets": [ [ 236, 277 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T12", "type": "Scope", "text": [ "systemic estrogen, progestin, or DHEA" ], "offsets": [ [ 198, 235 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T13", "type": "Procedure", "text": [ "alternative therapies" ], "offsets": [ [ 287, 308 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T14", "type": "Drug", "text": [ "natural products" ], "offsets": [ [ 312, 328 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T15", "type": "Condition", "text": [ "postmenopausal symptoms" ], "offsets": [ [ 338, 361 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T16", "type": "Temporal", "text": [ "in the four weeks prior to randomization" ], "offsets": [ [ 362, 402 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T17", "type": "Scope", "text": [ "alternative therapies or natural products" ], "offsets": [ [ 287, 328 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T18", "type": "Condition", "text": [ "Palpable fibroids" ], "offsets": [ [ 405, 422 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T19", "type": "Condition", "text": [ "uterine prolapse" ], "offsets": [ [ 426, 442 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T20", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 444, 449 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T21", "type": "Value", "text": [ "2 or 3" ], "offsets": [ [ 450, 456 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T22", "type": "Scope", "text": [ "Palpable fibroids or uterine prolapse" ], "offsets": [ [ 405, 442 ] ], "normalized": [] }, { "id": "NCT00317148_exc_T23", "type": "Condition", "text": [ "Cigarette smoking" ], "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": [] } ]

[ { "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", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 8, 22 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T2", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T3", "type": "Person", "text": [ "women" ], "offsets": [ [ 23, 28 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T4", "type": "Value", "text": [ "50 or more" ], "offsets": [ [ 34, 44 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T5", "type": "Condition", "text": [ "moderate to severe hot flushes" ], "offsets": [ [ 45, 75 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T6", "type": "Person", "text": [ "Women" ], "offsets": [ [ 78, 83 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T7", "type": "Value", "text": [ "between 40 to 70 years" ], "offsets": [ [ 84, 106 ] ], "normalized": [] }, { "id": "NCT00317148_inc_T8", "type": "Person", "text": [ "age" ], "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": [] } ]

[ { "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", "type": "Drug", "text": [ "Systemic corticosteroids" ], "offsets": [ [ 50, 74 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T2", "type": "Temporal", "text": [ "within 7 days of first dose" ], "offsets": [ [ 96, 123 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T3", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 127, 131 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T4", "type": "Drug", "text": [ "topical", "steroids" ], "offsets": [ [ 133, 140 ], [ 152, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T5", "type": "Drug", "text": [ "inhaled steroids" ], "offsets": [ [ 144, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T6", "type": "Scope", "text": [ "topical or inhaled steroids are allowed" ], "offsets": [ [ 133, 172 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T7", "type": "Drug", "text": [ "Investigational drugs/agents" ], "offsets": [ [ 175, 203 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T8", "type": "Temporal", "text": [ "within 14 days of first dose" ], "offsets": [ [ 204, 232 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T9", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 236, 240 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T10", "type": "Procedure", "text": [ "Immunosuppressive therapy" ], "offsets": [ [ 242, 267 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T11", "type": "Drug", "text": [ "cytotoxic agents" ], "offsets": [ [ 279, 295 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T12", "type": "Temporal", "text": [ "within 14 days of first dose" ], "offsets": [ [ 296, 324 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T13", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 328, 332 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T14", "type": "Drug", "text": [ "nitrosoureas" ], "offsets": [ [ 334, 346 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T15", "type": "Temporal", "text": [ "within 30 days of first dose" ], "offsets": [ [ 347, 375 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T16", "type": "Drug", "text": [ "Drugs known to induce QT interval prolongation" ], "offsets": [ [ 378, 424 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T17", "type": "Drug", "text": [ "Drugs known to", "induce Torsades de pointes" ], "offsets": [ [ 378, 392 ], [ 432, 458 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T19", "type": "Scope", "text": [ "Drugs known to induce QT interval prolongation and/or induce Torsades de pointes" ], "offsets": [ [ 378, 458 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T20", "type": "Procedure", "text": [ "Radiotherapy" ], "offsets": [ [ 533, 545 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T21", "type": "Temporal", "text": [ "within 3 weeks of the first dose" ], "offsets": [ [ 546, 578 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T22", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 582, 586 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T23", "type": "Procedure", "text": [ "Hematopoietic cell transplantation" ], "offsets": [ [ 588, 622 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T24", "type": "Temporal", "text": [ "within 4 weeks of first dose" ], "offsets": [ [ 623, 651 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T25", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 655, 659 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T26", "type": "Condition", "text": [ "active infection" ], "offsets": [ [ 673, 689 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T27", "type": "Observation", "text": [ "Evidence" ], "offsets": [ [ 661, 669 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T28", "type": "Temporal", "text": [ "within 3 days of first dose" ], "offsets": [ [ 690, 717 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T29", "type": "Drug", "text": [ "852A" ], "offsets": [ [ 721, 725 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T30", "type": "Condition", "text": [ "fungal infection" ], "offsets": [ [ 734, 750 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T31", "type": "Condition", "text": [ "pulmonary infiltrates" ], "offsets": [ [ 754, 775 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T32", "type": "Condition", "text": [ "prior treated disease" ], "offsets": [ [ 777, 798 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T33", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 799, 805 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T34", "type": "Temporal", "text": [ "for 2 weeks" ], "offsets": [ [ 806, 817 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T35", "type": "Scope", "text": [ "fungal infection or pulmonary infiltrates" ], "offsets": [ [ 734, 775 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T36", "type": "Condition", "text": [ "Cardiac ischemia" ], "offsets": [ [ 833, 849 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T37", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 851, 870 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T38", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 874, 898 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T39", "type": "Qualifier", "text": [ "uncontrolled by medication" ], "offsets": [ [ 899, 925 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T40", "type": "Observation", "text": [ "History" ], "offsets": [ [ 927, 934 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T41", "type": "Observation", "text": [ "clinical evidence" ], "offsets": [ [ 942, 959 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T42", "type": "Condition", "text": [ "could confound the results of the study or put the subject at undue risk", "a condition which" ], "offsets": [ [ 1019, 1091 ], [ 964, 981 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T43", "type": "Scope", "text": [ "History of, or clinical evidence of" ], "offsets": [ [ 927, 962 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T44", "type": "Condition", "text": [ "intercurrent", "illness" ], "offsets": [ [ 1106, 1118 ], [ 1130, 1137 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T45", "type": "Condition", "text": [ "chronic illness" ], "offsets": [ [ 1122, 1137 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T46", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1093, 1105 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T47", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 1146, 1164 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T48", "type": "Qualifier", "text": [ "requiring" ], "offsets": [ [ 1165, 1174 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T49", "type": "Procedure", "text": [ "immunosuppressive therapy" ], "offsets": [ [ 1175, 1200 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T50", "type": "Temporal", "text": [ "within 30 days" ], "offsets": [ [ 1201, 1215 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T51", "type": "Condition", "text": [ "coagulation disorder" ], "offsets": [ [ 1224, 1244 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T52", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 1139, 1145 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T53", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 1217, 1223 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T54", "type": "Qualifier", "text": [ "controlled with medication" ], "offsets": [ [ 1249, 1275 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T55", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1245, 1248 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T56", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1277, 1285 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T57", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1289, 1298 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T58", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1311, 1321 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T59", "type": "Temporal", "text": [ "Concurrent" ], "offsets": [ [ 1300, 1310 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T60", "type": "Value", "text": [ "at least 5 years" ], "offsets": [ [ 1340, 1356 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T61", "type": "Qualifier", "text": [ "disease free" ], "offsets": [ [ 1357, 1369 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T62", "type": "Qualifier", "text": [ "in remission" ], "offsets": [ [ 1326, 1338 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T63", "type": "Condition", "text": [ "localized (in-situ) disease" ], "offsets": [ [ 1382, 1409 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T64", "type": "Condition", "text": [ "basal carcinomas" ], "offsets": [ [ 1411, 1427 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T65", "type": "Condition", "text": [ "cutaneous squamous cell carcinomas" ], "offsets": [ [ 1432, 1466 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T66", "type": "Qualifier", "text": [ "adequately treated" ], "offsets": [ [ 1482, 1500 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T67", "type": "Scope", "text": [ "localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas" ], "offsets": [ [ 1382, 1466 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T68", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 1517, 1533 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T69", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 1506, 1516 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T70", "type": "Condition", "text": [ "any other", "central nervous system (CNS) disease" ], "offsets": [ [ 1537, 1546 ], [ 1554, 1590 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T71", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 1547, 1553 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T72", "type": "Scope", "text": [ "brain metastases or any other active central nervous system (CNS) disease" ], "offsets": [ [ 1517, 1590 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T73", "type": "Negation", "text": [ "is allowable" ], "offsets": [ [ 818, 830 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T74", "type": "Scope", "text": [ "prior treated disease stable for 2 weeks is allowable" ], "offsets": [ [ 777, 830 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T75", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 1371, 1381 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T76", "type": "Scope", "text": [ "localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated" ], "offsets": [ [ 1382, 1500 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T77", "type": "Negation", "text": [ "are allowed" ], "offsets": [ [ 161, 172 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T78", "type": "Scope", "text": [ "topical or inhaled steroids" ], "offsets": [ [ 133, 160 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T83", "type": "Qualifier", "text": [ "injectable" ], "offsets": [ [ 84, 94 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T84", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 76, 80 ] ], "normalized": [] }, { "id": "NCT00319748_exc_T85", "type": "Scope", "text": [ "oral or injectable" ], "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": [] } ]

[ { "id": "NCT00319748_inc_text", "type": "inclusion", "text": [ "Adequate performance status: \nBreast - Karnofsky score > 50; \nOvarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2 \nIf female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. \nNormal organ function within 14 days of study entry \nDiagnosis of one of the following malignancies: \nMetastatic breast cancer (BR) \nMetastatic ovarian cancer (OV) \nMetastatic endometrial cancer (EM) \nMetastatic cervical cancer (CX) \nMeasurable metastatic disease (>1cm) in at least one site other than bone-only \nProgression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease \nProgression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen. \nMeasurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) \nPrimary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma). \nSubjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens. \nMeasurable metastatic disease \nHistologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens \nMeasurable metastatic disease \nHistologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens. \n" ], "offsets": [ [ 0, 2066 ] ] } ]

[ { "id": "NCT00319748_inc_T1", "type": "Measurement", "text": [ "Breast - Karnofsky score" ], "offsets": [ [ 30, 54 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T2", "type": "Value", "text": [ "> 50" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T3", "type": "Measurement", "text": [ "Gynecologic Oncology Group (GOG) performance score" ], "offsets": [ [ 97, 147 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T4", "type": "Value", "text": [ "≤2" ], "offsets": [ [ 148, 150 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T5", "type": "Person", "text": [ "female" ], "offsets": [ [ 155, 161 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T6", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 169, 191 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T7", "type": "Scope", "text": [ "female and of childbearing potential" ], "offsets": [ [ 155, 191 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T8", "type": "Observation", "text": [ "willing to" ], "offsets": [ [ 197, 207 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T9", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 221, 234 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T10", "type": "Drug", "text": [ "hormonal" ], "offsets": [ [ 236, 244 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T11", "type": "Procedure", "text": [ "barrier method" ], "offsets": [ [ 246, 260 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T12", "type": "Procedure", "text": [ "abstinence" ], "offsets": [ [ 262, 272 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T13", "type": "Scope", "text": [ "hormonal, barrier method, abstinence" ], "offsets": [ [ 236, 272 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T14", "type": "Temporal", "text": [ "for the duration of study participation" ], "offsets": [ [ 299, 338 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T15", "type": "Temporal", "text": [ "prior to study entry" ], "offsets": [ [ 274, 294 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T16", "type": "Condition", "text": [ "Normal organ function" ], "offsets": [ [ 341, 362 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T17", "type": "Temporal", "text": [ "within 14 days of study entry" ], "offsets": [ [ 363, 392 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T18", "type": "Condition", "text": [ "Metastatic breast cancer" ], "offsets": [ [ 443, 467 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T19", "type": "Condition", "text": [ "Metastatic ovarian cancer" ], "offsets": [ [ 474, 499 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T20", "type": "Condition", "text": [ "Metastatic endometrial cancer" ], "offsets": [ [ 506, 535 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T21", "type": "Condition", "text": [ "Metastatic cervical cancer" ], "offsets": [ [ 542, 568 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T22", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 586, 604 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T23", "type": "Qualifier", "text": [ "Measurable" ], "offsets": [ [ 575, 585 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T24", "type": "Value", "text": [ ">1cm" ], "offsets": [ [ 606, 610 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T25", "type": "Value", "text": [ "at least one" ], "offsets": [ [ 615, 627 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T26", "type": "Qualifier", "text": [ "site other than bone-only" ], "offsets": [ [ 628, 653 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T27", "type": "Observation", "text": [ "failure to respond" ], "offsets": [ [ 673, 691 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T28", "type": "Observation", "text": [ "Progression on" ], "offsets": [ [ 655, 669 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T30", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 708, 716 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T31", "type": "Procedure", "text": [ "chemotherapy regimen" ], "offsets": [ [ 717, 737 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T32", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 742, 760 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T33", "type": "Scope", "text": [ "Progression on or failure to respond" ], "offsets": [ [ 655, 691 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T29", "type": "Observation", "text": [ "Progression on" ], "offsets": [ [ 762, 776 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T34", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 777, 782 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T35", "type": "Procedure", "text": [ "therapy with a hormonal agent" ], "offsets": [ [ 783, 812 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T36", "type": "Condition", "text": [ "estrogen receptor", "positive" ], "offsets": [ [ 816, 833 ], [ 859, 867 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T37", "type": "Condition", "text": [ "progesterone receptor positive" ], "offsets": [ [ 837, 867 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T38", "type": "Scope", "text": [ "estrogen receptor or progesterone receptor positive" ], "offsets": [ [ 816, 867 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T39", "type": "Condition", "text": [ "HER2-neu positive" ], "offsets": [ [ 896, 913 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T40", "type": "Procedure", "text": [ "therapy with", "trastuzumab" ], "offsets": [ [ 783, 795 ], [ 881, 892 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T41", "type": "Scope", "text": [ "prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive" ], "offsets": [ [ 777, 913 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T42", "type": "Observation", "text": [ "progressed through" ], "offsets": [ [ 930, 948 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T43", "type": "Procedure", "text": [ "hormone", "therapy" ], "offsets": [ [ 949, 956 ], [ 972, 979 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T44", "type": "Procedure", "text": [ "trastuzumab therapy" ], "offsets": [ [ 960, 979 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T45", "type": "Scope", "text": [ "progressed through hormone or trastuzumab therapy" ], "offsets": [ [ 930, 979 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T46", "type": "Procedure", "text": [ "chemotherapy regimen" ], "offsets": [ [ 1009, 1029 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T47", "type": "Measurement", "text": [ "Response Evaluation Criteria in Solid Tumors (RECIST)" ], "offsets": [ [ 1076, 1129 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T48", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 1043, 1061 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T49", "type": "Condition", "text": [ "epithelial ovarian cancer" ], "offsets": [ [ 1195, 1220 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T50", "type": "Procedure", "text": [ "histologically" ], "offsets": [ [ 1170, 1184 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T51", "type": "Qualifier", "text": [ "Primary tumor" ], "offsets": [ [ 1131, 1144 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T52", "type": "Condition", "text": [ "fallopian tube cancer" ], "offsets": [ [ 1222, 1243 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T53", "type": "Condition", "text": [ "primary peritoneal cancer" ], "offsets": [ [ 1248, 1273 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T54", "type": "Qualifier", "text": [ "borderline" ], "offsets": [ [ 1279, 1289 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T55", "type": "Condition", "text": [ "epithelial carcinoma" ], "offsets": [ [ 1317, 1337 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T57", "type": "Scope", "text": [ "not borderline or low malignant potential epithelial carcinoma" ], "offsets": [ [ 1275, 1337 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T56", "type": "Scope", "text": [ "epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer" ], "offsets": [ [ 1195, 1273 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T58", "type": "Multiplier", "text": [ "at least two" ], "offsets": [ [ 1367, 1379 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T59", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1380, 1388 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T60", "type": "Procedure", "text": [ "chemotherapy regimens" ], "offsets": [ [ 1389, 1410 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T61", "type": "Observation", "text": [ "failed" ], "offsets": [ [ 1360, 1366 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T62", "type": "Drug", "text": [ "Paclitaxel" ], "offsets": [ [ 1412, 1422 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T63", "type": "Drug", "text": [ "cisplatin" ], "offsets": [ [ 1478, 1487 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T64", "type": "Drug", "text": [ "carboplatin" ], "offsets": [ [ 1491, 1502 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T65", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 1567, 1585 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T66", "type": "Qualifier", "text": [ "Measurable" ], "offsets": [ [ 1556, 1566 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T67", "type": "Measurement", "text": [ "Histologically" ], "offsets": [ [ 1587, 1601 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T68", "type": "Value", "text": [ "proven" ], "offsets": [ [ 1602, 1608 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T71", "type": "Scope", "text": [ "recurrent or persistent endometrial cancer" ], "offsets": [ [ 1609, 1651 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T72", "type": "Qualifier", "text": [ "amenable to curative treatment" ], "offsets": [ [ 1664, 1694 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T73", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1660, 1663 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T74", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1700, 1707 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T75", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 1715, 1732 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T76", "type": "Scope", "text": [ "surgery and/or radiation therapy" ], "offsets": [ [ 1700, 1732 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T77", "type": "Value", "text": [ "2" ], "offsets": [ [ 1748, 1749 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T78", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1750, 1758 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T79", "type": "Procedure", "text": [ "treatment regimens" ], "offsets": [ [ 1759, 1777 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T80", "type": "Observation", "text": [ "failed" ], "offsets": [ [ 1741, 1747 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T81", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 1790, 1808 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T82", "type": "Qualifier", "text": [ "Measurable" ], "offsets": [ [ 1779, 1789 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T83", "type": "Measurement", "text": [ "Histologically" ], "offsets": [ [ 1810, 1824 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T84", "type": "Value", "text": [ "proven" ], "offsets": [ [ 1825, 1831 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T85", "type": "Condition", "text": [ "squamous cell carcinoma" ], "offsets": [ [ 1856, 1879 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T86", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 1845, 1855 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T87", "type": "Qualifier", "text": [ "recurrent" ], "offsets": [ [ 1832, 1841 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T88", "type": "Scope", "text": [ "recurrent or persistent" ], "offsets": [ [ 1832, 1855 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T89", "type": "Condition", "text": [ "adenosquamous carcinoma" ], "offsets": [ [ 1881, 1904 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T90", "type": "Condition", "text": [ "adenocarcinoma of the cervix" ], "offsets": [ [ 1909, 1937 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T91", "type": "Qualifier", "text": [ "amenable to curative treatment" ], "offsets": [ [ 1950, 1980 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T92", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1946, 1949 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T93", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 1986, 1993 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T94", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 2001, 2018 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T95", "type": "Value", "text": [ "2" ], "offsets": [ [ 2034, 2035 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T96", "type": "Procedure", "text": [ "treatment regimens" ], "offsets": [ [ 2045, 2063 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T97", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 2036, 2044 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T69", "type": "Condition", "text": [ "endometrial cancer" ], "offsets": [ [ 1633, 1651 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T70", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 1622, 1632 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T98", "type": "Qualifier", "text": [ "recurrent" ], "offsets": [ [ 1609, 1618 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T99", "type": "Scope", "text": [ "recurrent or persistent" ], "offsets": [ [ 1609, 1632 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T100", "type": "Scope", "text": [ "squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix" ], "offsets": [ [ 1856, 1937 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T101", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1275, 1278 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T102", "type": "Qualifier", "text": [ "low malignant potential" ], "offsets": [ [ 1293, 1316 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T103", "type": "Scope", "text": [ "borderline or low malignant potential" ], "offsets": [ [ 1279, 1316 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T104", "type": "Scope", "text": [ "Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens" ], "offsets": [ [ 1412, 1553 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T105", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 283, 294 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T106", "type": "Reference_point", "text": [ "study participation" ], "offsets": [ [ 319, 338 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T107", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 381, 392 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T108", "type": "Qualifier", "text": [ "Ovarian" ], "offsets": [ [ 62, 69 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T109", "type": "Qualifier", "text": [ "endometrial" ], "offsets": [ [ 71, 82 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T110", "type": "Qualifier", "text": [ "cervical" ], "offsets": [ [ 86, 94 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T111", "type": "Scope", "text": [ "Ovarian, endometrial or cervical" ], "offsets": [ [ 62, 94 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T112", "type": "Measurement", "text": [ "performance status" ], "offsets": [ [ 9, 27 ] ], "normalized": [] }, { "id": "NCT00319748_inc_T113", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 0, 8 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00319748_inc_R1", "type": "Has_value", "arg1_id": "NCT00319748_inc_T1", "arg2_id": "NCT00319748_inc_T2", "normalized": [] }, { "id": "NCT00319748_inc_R2", "type": "Has_value", "arg1_id": "NCT00319748_inc_T3", "arg2_id": "NCT00319748_inc_T4", "normalized": [] }, { "id": "NCT00319748_inc_R3", "type": "Subsumes", "arg1_id": "NCT00319748_inc_T9", "arg2_id": "NCT00319748_inc_T13", "normalized": [] }, { "id": "NCT00319748_inc_R4", "type": "AND", "arg1_id": "NCT00319748_inc_T8", "arg2_id": "NCT00319748_inc_T9", "normalized": [] }, { "id": "NCT00319748_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T9", "arg2_id": "NCT00319748_inc_T15", "normalized": [] }, { "id": "NCT00319748_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T16", "arg2_id": "NCT00319748_inc_T17", "normalized": [] }, { "id": "NCT00319748_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T22", "arg2_id": "NCT00319748_inc_T23", "normalized": [] }, { "id": "NCT00319748_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T25", "arg2_id": "NCT00319748_inc_T26", "normalized": [] }, { "id": "NCT00319748_inc_R10", "type": "AND", "arg1_id": "NCT00319748_inc_T25", "arg2_id": "NCT00319748_inc_T22", "normalized": [] }, { "id": "NCT00319748_inc_R11", "type": "AND", "arg1_id": "NCT00319748_inc_T31", "arg2_id": "NCT00319748_inc_T32", "normalized": [] }, { "id": "NCT00319748_inc_R13", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T31", "arg2_id": "NCT00319748_inc_T30", "normalized": [] }, { "id": "NCT00319748_inc_R12", "type": "AND", "arg1_id": "NCT00319748_inc_T33", "arg2_id": "NCT00319748_inc_T31", "normalized": [] }, { "id": "NCT00319748_inc_R16", "type": "AND", "arg1_id": "NCT00319748_inc_T38", "arg2_id": "NCT00319748_inc_T35", "normalized": [] }, { "id": "NCT00319748_inc_R17", "type": "AND", "arg1_id": "NCT00319748_inc_T39", "arg2_id": "NCT00319748_inc_T40", "normalized": [] }, { "id": "NCT00319748_inc_R14", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T35", "arg2_id": "NCT00319748_inc_T34", "normalized": [] }, { "id": "NCT00319748_inc_R15", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T40", "arg2_id": "NCT00319748_inc_T34", "normalized": [] }, { "id": "NCT00319748_inc_R22", "type": "AND", "arg1_id": "NCT00319748_inc_T45", "arg2_id": "NCT00319748_inc_T46", "normalized": [] }, { "id": "NCT00319748_inc_R23", "type": "AND", "arg1_id": "NCT00319748_inc_T48", "arg2_id": "NCT00319748_inc_T47", "normalized": [] }, { "id": "NCT00319748_inc_R24", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T50", "arg2_id": "NCT00319748_inc_T51", "normalized": [] }, { "id": "NCT00319748_inc_R26", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T50", "arg2_id": "NCT00319748_inc_T56", "normalized": [] }, { "id": "NCT00319748_inc_R27", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T60", "arg2_id": "NCT00319748_inc_T59", "normalized": [] }, { "id": "NCT00319748_inc_R28", "type": "AND", "arg1_id": "NCT00319748_inc_T58", "arg2_id": "NCT00319748_inc_T60", "normalized": [] }, { "id": "NCT00319748_inc_R30", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T65", "arg2_id": "NCT00319748_inc_T66", "normalized": [] }, { "id": "NCT00319748_inc_R31", "type": "Has_value", "arg1_id": "NCT00319748_inc_T67", "arg2_id": "NCT00319748_inc_T68", "normalized": [] }, { "id": "NCT00319748_inc_R32", "type": "AND", "arg1_id": "NCT00319748_inc_T71", "arg2_id": "NCT00319748_inc_T67", "normalized": [] }, { "id": "NCT00319748_inc_R33", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T71", "arg2_id": "NCT00319748_inc_T72", "normalized": [] }, { "id": "NCT00319748_inc_R34", "type": "Has_negation", "arg1_id": "NCT00319748_inc_T72", "arg2_id": "NCT00319748_inc_T73", "normalized": [] }, { "id": "NCT00319748_inc_R35", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T72", "arg2_id": "NCT00319748_inc_T76", "normalized": [] }, { "id": "NCT00319748_inc_R36", "type": "AND", "arg1_id": "NCT00319748_inc_T77", "arg2_id": "NCT00319748_inc_T79", "normalized": [] }, { "id": "NCT00319748_inc_R37", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T79", "arg2_id": "NCT00319748_inc_T78", "normalized": [] }, { "id": "NCT00319748_inc_R39", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T79", "arg2_id": "NCT00319748_inc_T71", "normalized": [] }, { "id": "NCT00319748_inc_R40", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T81", "arg2_id": "NCT00319748_inc_T82", "normalized": [] }, { "id": "NCT00319748_inc_R41", "type": "Has_value", "arg1_id": "NCT00319748_inc_T83", "arg2_id": "NCT00319748_inc_T84", "normalized": [] }, { "id": "NCT00319748_inc_R44", "type": "Has_negation", "arg1_id": "NCT00319748_inc_T91", "arg2_id": "NCT00319748_inc_T92", "normalized": [] }, { "id": "NCT00319748_inc_R45", "type": "AND", "arg1_id": "NCT00319748_inc_T95", "arg2_id": "NCT00319748_inc_T96", "normalized": [] }, { "id": "NCT00319748_inc_R46", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T96", "arg2_id": "NCT00319748_inc_T97", "normalized": [] }, { "id": "NCT00319748_inc_R47", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T69", "arg2_id": "NCT00319748_inc_T99", "normalized": [] }, { "id": "NCT00319748_inc_R42", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T100", "arg2_id": "NCT00319748_inc_T88", "normalized": [] }, { "id": "NCT00319748_inc_R43", "type": "AND", "arg1_id": "NCT00319748_inc_T100", "arg2_id": "NCT00319748_inc_T83", "normalized": [] }, { "id": "NCT00319748_inc_R48", "type": "Has_qualifier", "arg1_id": "NCT00319748_inc_T100", "arg2_id": "NCT00319748_inc_T91", "normalized": [] }, { "id": "NCT00319748_inc_R49", "type": "AND", "arg1_id": "NCT00319748_inc_T91", "arg2_id": "NCT00319748_inc_T93", "normalized": [] }, { "id": "NCT00319748_inc_R50", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T96", "arg2_id": "NCT00319748_inc_T100", "normalized": [] }, { "id": "NCT00319748_inc_R25", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T55", "arg2_id": "NCT00319748_inc_T103", "normalized": [] }, { "id": "NCT00319748_inc_R51", "type": "Has_negation", "arg1_id": "NCT00319748_inc_T55", "arg2_id": "NCT00319748_inc_T101", "normalized": [] }, { "id": "NCT00319748_inc_R52", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T56", "arg2_id": "NCT00319748_inc_T57", "normalized": [] }, { "id": "NCT00319748_inc_R53", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T60", "arg2_id": "NCT00319748_inc_T104", "normalized": [] }, { "id": "NCT00319748_inc_R54", "type": "Has_temporal", "arg1_id": "NCT00319748_inc_T9", "arg2_id": "NCT00319748_inc_T14", "normalized": [] }, { "id": "NCT00319748_inc_R55", "type": "Has_index", "arg1_id": "NCT00319748_inc_T15", "arg2_id": "NCT00319748_inc_T105", "normalized": [] }, { "id": "NCT00319748_inc_R56", "type": "Has_index", "arg1_id": "NCT00319748_inc_T14", "arg2_id": "NCT00319748_inc_T106", "normalized": [] }, { "id": "NCT00319748_inc_R57", "type": "Has_index", "arg1_id": "NCT00319748_inc_T17", "arg2_id": "NCT00319748_inc_T107", "normalized": [] }, { "id": "NCT00319748_inc_R58", "type": "Has_scope", "arg1_id": "NCT00319748_inc_T3", "arg2_id": "NCT00319748_inc_T111", "normalized": [] }, { "id": "NCT00319748_inc_R59", "type": "Has_value", "arg1_id": "NCT00319748_inc_T112", "arg2_id": "NCT00319748_inc_T113", "normalized": [] } ]

[ { "id": "NCT00324363_exc_text", "type": "exclusion", "text": [ "Have participated in this study previously, or any other study using exenatide or GLP-1 analogs. \nHave participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening. \nHave characteristics contraindicating metformin or sulfonylurea use. \nHave been treated with exogenous insulin for more than 1 week within the 3 months prior to screening. \nHave used drugs for weight loss within 1 month of screening. \n \n" ], "offsets": [ [ 0, 457 ] ] } ]

[ { "id": "NCT00324363_exc_T1", "type": "Drug", "text": [ "GLP-1 analogs" ], "offsets": [ [ 82, 95 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T2", "type": "Observation", "text": [ "this study" ], "offsets": [ [ 21, 31 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T4", "type": "Observation", "text": [ "any other study" ], "offsets": [ [ 47, 62 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T3", "type": "Drug", "text": [ "exenatide" ], "offsets": [ [ 69, 78 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T6", "type": "Scope", "text": [ "this study previously, or any other study" ], "offsets": [ [ 21, 62 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T7", "type": "Observation", "text": [ "interventional", "study" ], "offsets": [ [ 122, 136 ], [ 175, 180 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T8", "type": "Observation", "text": [ "medical", "study" ], "offsets": [ [ 138, 145 ], [ 175, 180 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T9", "type": "Observation", "text": [ "surgical", "study" ], "offsets": [ [ 147, 155 ], [ 175, 180 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T10", "type": "Observation", "text": [ "pharmaceutical study" ], "offsets": [ [ 160, 180 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T11", "type": "Temporal", "text": [ "within 30 days of screening" ], "offsets": [ [ 181, 208 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T12", "type": "Scope", "text": [ "interventional, medical, surgical, or pharmaceutical study" ], "offsets": [ [ 122, 180 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T14", "type": "Drug", "text": [ "metformin" ], "offsets": [ [ 249, 258 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T15", "type": "Drug", "text": [ "sulfonylurea" ], "offsets": [ [ 262, 274 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T16", "type": "Condition", "text": [ "characteristics contraindicating" ], "offsets": [ [ 216, 248 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T17", "type": "Scope", "text": [ "metformin or sulfonylurea" ], "offsets": [ [ 249, 274 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T18", "type": "Drug", "text": [ "exogenous insulin" ], "offsets": [ [ 304, 321 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T19", "type": "Multiplier", "text": [ "for more than 1 week" ], "offsets": [ [ 322, 342 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T20", "type": "Temporal", "text": [ "within the 3 months prior to screening" ], "offsets": [ [ 343, 381 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T22", "type": "Drug", "text": [ "drugs for weight loss" ], "offsets": [ [ 394, 415 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T23", "type": "Temporal", "text": [ "within 1 month of screening" ], "offsets": [ [ 416, 443 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T5", "type": "Scope", "text": [ "exenatide or GLP-1 analogs" ], "offsets": [ [ 69, 95 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T13", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 199, 208 ] ], "normalized": [] }, { "id": "NCT00324363_exc_T21", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 372, 381 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00324363_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00324363_exc_T12", "arg2_id": "NCT00324363_exc_T11", "normalized": [] }, { "id": "NCT00324363_exc_R6", "type": "Has_scope", "arg1_id": "NCT00324363_exc_T16", "arg2_id": "NCT00324363_exc_T17", "normalized": [] }, { "id": "NCT00324363_exc_R7", "type": "Has_multiplier", "arg1_id": "NCT00324363_exc_T18", "arg2_id": "NCT00324363_exc_T19", "normalized": [] }, { "id": "NCT00324363_exc_R8", "type": "Has_temporal", "arg1_id": "NCT00324363_exc_T18", "arg2_id": "NCT00324363_exc_T20", "normalized": [] }, { "id": "NCT00324363_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00324363_exc_T22", "arg2_id": "NCT00324363_exc_T23", "normalized": [] }, { "id": "NCT00324363_exc_R1", "type": "Has_scope", "arg1_id": "NCT00324363_exc_T6", "arg2_id": "NCT00324363_exc_T5", "normalized": [] }, { "id": "NCT00324363_exc_R2", "type": "Has_index", "arg1_id": "NCT00324363_exc_T11", "arg2_id": "NCT00324363_exc_T13", "normalized": [] }, { "id": "NCT00324363_exc_R3", "type": "Has_index", "arg1_id": "NCT00324363_exc_T20", "arg2_id": "NCT00324363_exc_T21", "normalized": [] } ]

[ { "id": "NCT00324363_inc_text", "type": "inclusion", "text": [ "Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy. \nHbA1c between 7.1% and 11.0%, inclusive. \nBody Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2. \n" ], "offsets": [ [ 0, 323 ] ] } ]

[ { "id": "NCT00324363_inc_T1", "type": "Qualifier", "text": [ "stable dose" ], "offsets": [ [ 15, 26 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T2", "type": "Temporal", "text": [ "at least 3 months prior to screening" ], "offsets": [ [ 55, 91 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T3", "type": "Drug", "text": [ "immediate-release metformin" ], "offsets": [ [ 109, 136 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T4", "type": "Value", "text": [ ">=1000 mg/day" ], "offsets": [ [ 95, 108 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T5", "type": "Drug", "text": [ "metformin" ], "offsets": [ [ 141, 150 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T6", "type": "Value", "text": [ ">=1000 mg/day" ], "offsets": [ [ 151, 164 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T7", "type": "Drug", "text": [ "sulfonylurea" ], "offsets": [ [ 169, 181 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T8", "type": "Drug", "text": [ "sulfonylurea" ], "offsets": [ [ 186, 198 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T9", "type": "Drug", "text": [ "metformin" ], "offsets": [ [ 199, 208 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T10", "type": "Procedure", "text": [ "combination therapy" ], "offsets": [ [ 209, 228 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T11", "type": "Scope", "text": [ "metformin >=1000 mg/day and sulfonylurea" ], "offsets": [ [ 141, 181 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T12", "type": "Scope", "text": [ ">=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy" ], "offsets": [ [ 95, 228 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T13", "type": "Measurement", "text": [ "HbA1c" ], "offsets": [ [ 231, 236 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T14", "type": "Value", "text": [ "between 7.1% and 11.0%, inclusive" ], "offsets": [ [ 237, 270 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T15", "type": "Measurement", "text": [ "Body Mass Index (BMI)" ], "offsets": [ [ 273, 294 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T16", "type": "Value", "text": [ ">21 kg/m^2 and <35 kg/m^2" ], "offsets": [ [ 295, 320 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T17", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 82, 91 ] ], "normalized": [] }, { "id": "NCT00324363_inc_T18", "type": "Multiplier", "text": [ "one of the following" ], "offsets": [ [ 30, 50 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00324363_inc_R1", "type": "Has_temporal", "arg1_id": "NCT00324363_inc_T1", "arg2_id": "NCT00324363_inc_T2", "normalized": [] }, { "id": "NCT00324363_inc_R2", "type": "AND", "arg1_id": "NCT00324363_inc_T6", "arg2_id": "NCT00324363_inc_T5", "normalized": [] }, { "id": "NCT00324363_inc_R3", "type": "AND", "arg1_id": "NCT00324363_inc_T10", "arg2_id": "NCT00324363_inc_T9", "normalized": [] }, { "id": "NCT00324363_inc_R4", "type": "AND", "arg1_id": "NCT00324363_inc_T10", "arg2_id": "NCT00324363_inc_T8", "normalized": [] }, { "id": "NCT00324363_inc_R5", "type": "AND", "arg1_id": "NCT00324363_inc_T4", "arg2_id": "NCT00324363_inc_T3", "normalized": [] }, { "id": "NCT00324363_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00324363_inc_T12", "arg2_id": "NCT00324363_inc_T1", "normalized": [] }, { "id": "NCT00324363_inc_R7", "type": "Has_value", "arg1_id": "NCT00324363_inc_T15", "arg2_id": "NCT00324363_inc_T16", "normalized": [] }, { "id": "NCT00324363_inc_R8", "type": "Has_value", "arg1_id": "NCT00324363_inc_T13", "arg2_id": "NCT00324363_inc_T14", "normalized": [] }, { "id": "NCT00324363_inc_R9", "type": "Has_index", "arg1_id": "NCT00324363_inc_T2", "arg2_id": "NCT00324363_inc_T17", "normalized": [] }, { "id": "NCT00324363_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT00324363_inc_T12", "arg2_id": "NCT00324363_inc_T18", "normalized": [] } ]

[ { "id": "NCT00343668_exc_text", "type": "exclusion", "text": [ "Other tumor type than adenocarcinoma \nCentral nervous system (CNS) metastases or prior radiation for CNS metastases \nGastric outlet obstruction or intestinal obstruction \nEvidence of gastrointestinal bleeding \nThe patient has bony lesions as the sole evaluable disease. \nPast or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri \nPregnant or lactating women, women of childbearing potential not employing adequate contraception \nOther serious illness or medical conditions \nUnstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry \nHistory of significant neurologic or psychiatric disorders including dementia or seizures \nActive uncontrolled infection \nOther serious underlying medical conditions which could impair the ability of the patient to participate in the study \nConcomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy \nconcomitant drug medication; The following drugs cause drug interaction with S-1. \ni. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1 \n \n" ], "offsets": [ [ 0, 1386 ] ] } ]

[ { "id": "NCT00343668_exc_T1", "type": "Condition", "text": [ "adenocarcinoma" ], "offsets": [ [ 22, 36 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T2", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 6, 11 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T3", "type": "Condition", "text": [ "Central nervous system (CNS) metastases" ], "offsets": [ [ 38, 77 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T4", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 87, 96 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T5", "type": "Condition", "text": [ "CNS metastases" ], "offsets": [ [ 101, 115 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T6", "type": "Condition", "text": [ "Gastric outlet obstruction" ], "offsets": [ [ 117, 143 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T7", "type": "Condition", "text": [ "intestinal obstruction" ], "offsets": [ [ 147, 169 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T8", "type": "Condition", "text": [ "gastrointestinal bleeding" ], "offsets": [ [ 183, 208 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T9", "type": "Observation", "text": [ "Evidence of" ], "offsets": [ [ 171, 182 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T10", "type": "Condition", "text": [ "bony lesions" ], "offsets": [ [ 226, 238 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T11", "type": "Value", "text": [ "the sole" ], "offsets": [ [ 242, 250 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T12", "type": "Qualifier", "text": [ "evaluable disease" ], "offsets": [ [ 251, 268 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T13", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 290, 300 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T14", "type": "Condition", "text": [ "neoplasm" ], "offsets": [ [ 301, 309 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T15", "type": "Condition", "text": [ "stomach cancer" ], "offsets": [ [ 321, 335 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T16", "type": "Condition", "text": [ "non-melanoma skin cancer" ], "offsets": [ [ 367, 391 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T17", "type": "Condition", "text": [ "in situ carcinoma of the cervix uteri" ], "offsets": [ [ 395, 432 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T18", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 359, 366 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T19", "type": "Qualifier", "text": [ "curatively" ], "offsets": [ [ 348, 358 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T20", "type": "Scope", "text": [ "non-melanoma skin cancer or in situ carcinoma of the cervix uteri" ], "offsets": [ [ 367, 432 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T21", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 434, 442 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T22", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 446, 455 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T23", "type": "Person", "text": [ "women" ], "offsets": [ [ 456, 461 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T24", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 472, 494 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T25", "type": "Person", "text": [ "women" ], "offsets": [ [ 463, 468 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T26", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 518, 531 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T27", "type": "Negation", "text": [ "not employing" ], "offsets": [ [ 495, 508 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T28", "type": "Condition", "text": [ "serious illness" ], "offsets": [ [ 539, 554 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T29", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 558, 576 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T30", "type": "Condition", "text": [ "Unstable cardiac disease" ], "offsets": [ [ 578, 602 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T31", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 611, 620 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T32", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 622, 643 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T33", "type": "Temporal", "text": [ "within 6 months prior to study entry" ], "offsets": [ [ 644, 680 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T34", "type": "Condition", "text": [ "neurologic", "disorders" ], "offsets": [ [ 705, 715 ], [ 731, 740 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T35", "type": "Condition", "text": [ "psychiatric disorders" ], "offsets": [ [ 719, 740 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T36", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 751, 759 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T37", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 763, 771 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T38", "type": "Scope", "text": [ "dementia or seizures" ], "offsets": [ [ 751, 771 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T39", "type": "Scope", "text": [ "neurologic or psychiatric disorders" ], "offsets": [ [ 705, 740 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T40", "type": "Observation", "text": [ "History" ], "offsets": [ [ 682, 689 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T41", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 793, 802 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T42", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 780, 792 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T43", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 773, 779 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T44", "type": "Condition", "text": [ "serious", "medical conditions" ], "offsets": [ [ 810, 817 ], [ 829, 847 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T45", "type": "Observation", "text": [ "ability of the patient to participate" ], "offsets": [ [ 871, 908 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T46", "type": "Drug", "text": [ "experimental drug" ], "offsets": [ [ 963, 980 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T47", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 923, 934 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T48", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 1017, 1029 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T49", "type": "Procedure", "text": [ "hormonal therapy" ], "offsets": [ [ 1031, 1047 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T50", "type": "Procedure", "text": [ "immunotherapy" ], "offsets": [ [ 1052, 1065 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T51", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 1005, 1016 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T52", "type": "Scope", "text": [ "chemotherapy, hormonal therapy, or immunotherapy" ], "offsets": [ [ 1017, 1065 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T53", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 1084, 1094 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T54", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 1079, 1083 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T55", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 1067, 1078 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T56", "type": "Scope", "text": [ "drug medication" ], "offsets": [ [ 1079, 1094 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T57", "type": "Drug", "text": [ "Warfarin" ], "offsets": [ [ 1153, 1161 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T58", "type": "Drug", "text": [ "phenprocoumon" ], "offsets": [ [ 1163, 1176 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T59", "type": "Measurement", "text": [ "bleeding tendency" ], "offsets": [ [ 1187, 1204 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T60", "type": "Measurement", "text": [ "blood concentration of phenytoin" ], "offsets": [ [ 1218, 1250 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T61", "type": "Value", "text": [ "Increase" ], "offsets": [ [ 1209, 1217 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T62", "type": "Drug", "text": [ "sorivudine" ], "offsets": [ [ 1256, 1266 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T63", "type": "Drug", "text": [ "allopurinol" ], "offsets": [ [ 1335, 1346 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T64", "type": "Value", "text": [ "increase" ], "offsets": [ [ 1178, 1186 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T65", "type": "Drug", "text": [ "fluoropyrimidine" ], "offsets": [ [ 1314, 1330 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T66", "type": "Scope", "text": [ "childbearing potential not employing adequate contraception" ], "offsets": [ [ 472, 531 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T70", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 310, 320 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T71", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 337, 347 ] ], "normalized": [] }, { "id": "NCT00343668_exc_T72", "type": "Negation", "text": [ "Other" ], "offsets": [ [ 0, 5 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00343668_exc_R2", "type": "AND", "arg1_id": "NCT00343668_exc_T4", "arg2_id": "NCT00343668_exc_T5", "normalized": [] }, { "id": "NCT00343668_exc_R3", "type": "AND", "arg1_id": "NCT00343668_exc_T9", "arg2_id": "NCT00343668_exc_T8", "normalized": [] }, { "id": "NCT00343668_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00343668_exc_T11", "arg2_id": "NCT00343668_exc_T12", "normalized": [] }, { "id": "NCT00343668_exc_R5", "type": "Has_value", "arg1_id": "NCT00343668_exc_T10", "arg2_id": "NCT00343668_exc_T11", "normalized": [] }, { "id": "NCT00343668_exc_R7", "type": "AND", "arg1_id": "NCT00343668_exc_T13", "arg2_id": "NCT00343668_exc_T14", "normalized": [] }, { "id": "NCT00343668_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00343668_exc_T18", "arg2_id": "NCT00343668_exc_T19", "normalized": [] }, { "id": "NCT00343668_exc_R9", "type": "Has_scope", "arg1_id": "NCT00343668_exc_T18", "arg2_id": "NCT00343668_exc_T20", "normalized": [] }, { "id": "NCT00343668_exc_R10", "type": "Has_negation", "arg1_id": "NCT00343668_exc_T26", "arg2_id": "NCT00343668_exc_T27", "normalized": [] }, { "id": "NCT00343668_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00343668_exc_T32", "arg2_id": "NCT00343668_exc_T33", "normalized": [] }, { "id": "NCT00343668_exc_R12", "type": "Subsumes", "arg1_id": "NCT00343668_exc_T39", "arg2_id": "NCT00343668_exc_T38", "normalized": [] }, { "id": "NCT00343668_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00343668_exc_T41", "arg2_id": "NCT00343668_exc_T42", "normalized": [] }, { "id": "NCT00343668_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00343668_exc_T41", "arg2_id": "NCT00343668_exc_T43", "normalized": [] }, { "id": "NCT00343668_exc_R15", "type": "AND", "arg1_id": "NCT00343668_exc_T45", "arg2_id": "NCT00343668_exc_T44", "normalized": [] }, { "id": "NCT00343668_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00343668_exc_T46", "arg2_id": "NCT00343668_exc_T47", "normalized": [] }, { "id": "NCT00343668_exc_R17", "type": "Has_temporal", "arg1_id": "NCT00343668_exc_T52", "arg2_id": "NCT00343668_exc_T51", "normalized": [] }, { "id": "NCT00343668_exc_R18", "type": "Has_temporal", "arg1_id": "NCT00343668_exc_T56", "arg2_id": "NCT00343668_exc_T55", "normalized": [] }, { "id": "NCT00343668_exc_R19", "type": "Has_value", "arg1_id": "NCT00343668_exc_T60", "arg2_id": "NCT00343668_exc_T61", "normalized": [] }, { "id": "NCT00343668_exc_R20", "type": "Has_value", "arg1_id": "NCT00343668_exc_T59", "arg2_id": "NCT00343668_exc_T64", "normalized": [] }, { "id": "NCT00343668_exc_R6", "type": "Has_negation", "arg1_id": "NCT00343668_exc_T15", "arg2_id": "NCT00343668_exc_T70", "normalized": [] }, { "id": "NCT00343668_exc_R21", "type": "AND", "arg1_id": "NCT00343668_exc_T14", "arg2_id": "NCT00343668_exc_T15", "normalized": [] }, { "id": "NCT00343668_exc_R22", "type": "AND", "arg1_id": "NCT00343668_exc_T14", "arg2_id": "NCT00343668_exc_T18", "normalized": [] }, { "id": "NCT00343668_exc_R1", "type": "Has_negation", "arg1_id": "NCT00343668_exc_T1", "arg2_id": "NCT00343668_exc_T72", "normalized": [] }, { "id": "NCT00343668_exc_R23", "type": "AND", "arg1_id": "NCT00343668_exc_T2", "arg2_id": "NCT00343668_exc_T1", "normalized": [] }, { "id": "NCT00343668_exc_R24", "type": "Has_negation", "arg1_id": "NCT00343668_exc_T18", "arg2_id": "NCT00343668_exc_T71", "normalized": [] } ]

[ { "id": "NCT00343668_inc_text", "type": "inclusion", "text": [ "Pathologically proven unresectable adenocarcinoma of stomach \nWith uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan) \nAge 18 to 70 years old \nEstimated life expectancy of more than 3 months \nECOG performance status of 2 or lower \nAdequate bone marrow function(absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL) \nAdequate kidney function (serum creatinine < 1.5 mg/dL) \nAdequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL) \nNo prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded) \nNo prior radiation therapy for at least 4 weeks before enrollment in the study \n" ], "offsets": [ [ 0, 977 ] ] } ]

[ { "id": "NCT00343668_inc_T1", "type": "Condition", "text": [ "adenocarcinoma of stomach" ], "offsets": [ [ 35, 60 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T2", "type": "Qualifier", "text": [ "unresectable" ], "offsets": [ [ 22, 34 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T3", "type": "Measurement", "text": [ "Pathologically" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T4", "type": "Value", "text": [ "proven" ], "offsets": [ [ 15, 21 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T5", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 96, 103 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T6", "type": "Qualifier", "text": [ "uni-dimensionally measurable" ], "offsets": [ [ 67, 95 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T7", "type": "Measurement", "text": [ "longest diameter" ], "offsets": [ [ 114, 130 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T8", "type": "Procedure", "text": [ "conventional CT scan" ], "offsets": [ [ 139, 159 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T9", "type": "Value", "text": [ "at least", "2 cm" ], "offsets": [ [ 105, 113 ], [ 131, 135 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T10", "type": "Procedure", "text": [ "x-ray" ], "offsets": [ [ 161, 166 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T11", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 170, 190 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T13", "type": "Procedure", "text": [ "spiral CT scan" ], "offsets": [ [ 202, 216 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T14", "type": "Measurement", "text": [ "longest diameter" ], "offsets": [ [ 114, 130 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T15", "type": "Value", "text": [ "at least", "1cm" ], "offsets": [ [ 105, 113 ], [ 195, 198 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T12", "type": "Scope", "text": [ "at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan" ], "offsets": [ [ 105, 216 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T16", "type": "Person", "text": [ "Age" ], "offsets": [ [ 219, 222 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T17", "type": "Value", "text": [ "18 to 70 years old" ], "offsets": [ [ 223, 241 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T18", "type": "Measurement", "text": [ "Estimated life expectancy" ], "offsets": [ [ 243, 268 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T19", "type": "Value", "text": [ "more than 3 months" ], "offsets": [ [ 272, 290 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T20", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 292, 315 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T21", "type": "Value", "text": [ "2 or lower" ], "offsets": [ [ 319, 329 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T22", "type": "Measurement", "text": [ "bone marrow function" ], "offsets": [ [ 340, 360 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T23", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 331, 339 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T24", "type": "Measurement", "text": [ "absolute neutrophil count [ANC]" ], "offsets": [ [ 361, 392 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T25", "type": "Value", "text": [ "≥1,500/µL" ], "offsets": [ [ 393, 402 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T26", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 404, 414 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T27", "type": "Value", "text": [ "≥9.0 g/dL" ], "offsets": [ [ 415, 424 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T28", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 429, 438 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T29", "type": "Value", "text": [ "≥100,000/µL" ], "offsets": [ [ 439, 450 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T30", "type": "Scope", "text": [ "absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL" ], "offsets": [ [ 361, 450 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T31", "type": "Measurement", "text": [ "kidney function" ], "offsets": [ [ 462, 477 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T32", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 453, 461 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T33", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 479, 495 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T34", "type": "Value", "text": [ "< 1.5 mg/dL" ], "offsets": [ [ 496, 507 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T35", "type": "Measurement", "text": [ "liver function" ], "offsets": [ [ 519, 533 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T36", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 510, 518 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T37", "type": "Measurement", "text": [ "serum total bilirubin" ], "offsets": [ [ 535, 556 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T38", "type": "Value", "text": [ "< 2 times the upper normal limit (UNL)" ], "offsets": [ [ 557, 595 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T39", "type": "Measurement", "text": [ "serum transaminases levels" ], "offsets": [ [ 597, 623 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T40", "type": "Value", "text": [ "<3 times", "UNL" ], "offsets": [ [ 624, 632 ], [ 679, 682 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T41", "type": "Condition", "text": [ "liver metastasis" ], "offsets": [ [ 661, 677 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T42", "type": "Value", "text": [ "<5 times", "UNL" ], "offsets": [ [ 634, 642 ], [ 679, 682 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T43", "type": "Scope", "text": [ "<3 times [<5 times for patients with liver metastasis] UNL" ], "offsets": [ [ 624, 682 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T44", "type": "Scope", "text": [ "serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL" ], "offsets": [ [ 535, 682 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T45", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 694, 706 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T46", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 688, 693 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T47", "type": "Negation", "text": [ "No" ], "offsets": [ [ 685, 687 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T48", "type": "Procedure", "text": [ "adjuvant chemotherapy" ], "offsets": [ [ 717, 738 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T49", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 711, 716 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T50", "type": "Temporal", "text": [ "at least 6 months before enrollment" ], "offsets": [ [ 748, 783 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T51", "type": "Procedure", "text": [ "adjuvant chemotherapy" ], "offsets": [ [ 809, 830 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T52", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 803, 808 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T53", "type": "Drug", "text": [ "capecitabine" ], "offsets": [ [ 836, 848 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T54", "type": "Drug", "text": [ "S-1" ], "offsets": [ [ 852, 855 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T55", "type": "Drug", "text": [ "camptothecin analogues" ], "offsets": [ [ 859, 881 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T56", "type": "Negation", "text": [ "excluded" ], "offsets": [ [ 886, 894 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T57", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 906, 923 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T58", "type": "Temporal", "text": [ "at least 4 weeks before enrollment" ], "offsets": [ [ 928, 962 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T59", "type": "Negation", "text": [ "No" ], "offsets": [ [ 897, 899 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T60", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 900, 905 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T61", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 773, 783 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T62", "type": "Negation", "text": [ "was allowed" ], "offsets": [ [ 784, 795 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T63", "type": "Scope", "text": [ "prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed" ], "offsets": [ [ 711, 795 ] ], "normalized": [] }, { "id": "NCT00343668_inc_T64", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 952, 962 ] ], "normalized": [] } ]

[]

[]

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"AND", "arg1_id": "NCT00343668_inc_T13", "arg2_id": "NCT00343668_inc_T14", "normalized": [] }, { "id": "NCT00343668_inc_R9", "type": "Subsumes", "arg1_id": "NCT00343668_inc_T6", "arg2_id": "NCT00343668_inc_T12", "normalized": [] }, { "id": "NCT00343668_inc_R10", "type": "Has_value", "arg1_id": "NCT00343668_inc_T16", "arg2_id": "NCT00343668_inc_T17", "normalized": [] }, { "id": "NCT00343668_inc_R11", "type": "Has_value", "arg1_id": "NCT00343668_inc_T18", "arg2_id": "NCT00343668_inc_T19", "normalized": [] }, { "id": "NCT00343668_inc_R12", "type": "Has_value", "arg1_id": "NCT00343668_inc_T20", "arg2_id": "NCT00343668_inc_T21", "normalized": [] }, { "id": "NCT00343668_inc_R13", "type": "Has_value", "arg1_id": "NCT00343668_inc_T22", "arg2_id": "NCT00343668_inc_T23", "normalized": [] }, { "id": "NCT00343668_inc_R14", "type": "Has_value", "arg1_id": "NCT00343668_inc_T24", "arg2_id": "NCT00343668_inc_T25", "normalized": [] }, { "id": "NCT00343668_inc_R15", "type": "Has_value", "arg1_id": "NCT00343668_inc_T26", "arg2_id": "NCT00343668_inc_T27", "normalized": [] }, { "id": "NCT00343668_inc_R16", "type": "Has_value", "arg1_id": "NCT00343668_inc_T28", "arg2_id": "NCT00343668_inc_T29", "normalized": [] }, { "id": "NCT00343668_inc_R17", "type": "Subsumes", "arg1_id": "NCT00343668_inc_T23", "arg2_id": "NCT00343668_inc_T30", "normalized": [] }, { "id": "NCT00343668_inc_R18", "type": "Has_value", "arg1_id": "NCT00343668_inc_T31", "arg2_id": "NCT00343668_inc_T32", "normalized": [] }, { "id": "NCT00343668_inc_R19", "type": "Has_value", "arg1_id": "NCT00343668_inc_T33", "arg2_id": "NCT00343668_inc_T34", "normalized": [] }, { "id": "NCT00343668_inc_R20", "type": "Subsumes", "arg1_id": "NCT00343668_inc_T32", "arg2_id": "NCT00343668_inc_T33", "normalized": [] }, { "id": "NCT00343668_inc_R21", "type": "Has_value", "arg1_id": "NCT00343668_inc_T35", "arg2_id": "NCT00343668_inc_T36", "normalized": [] }, { "id": "NCT00343668_inc_R22", "type": "Has_value", "arg1_id": "NCT00343668_inc_T37", "arg2_id": "NCT00343668_inc_T38", "normalized": [] }, { "id": "NCT00343668_inc_R24", "type": "Has_scope", "arg1_id": "NCT00343668_inc_T39", "arg2_id": "NCT00343668_inc_T43", "normalized": [] }, { "id": "NCT00343668_inc_R25", "type": "AND", "arg1_id": "NCT00343668_inc_T37", "arg2_id": "NCT00343668_inc_T39", "normalized": [] }, { "id": "NCT00343668_inc_R26", "type": "Subsumes", "arg1_id": "NCT00343668_inc_T36", "arg2_id": "NCT00343668_inc_T44", "normalized": [] }, { "id": "NCT00343668_inc_R27", "type": "Has_negation", "arg1_id": "NCT00343668_inc_T45", "arg2_id": "NCT00343668_inc_T47", "normalized": [] }, { "id": "NCT00343668_inc_R28", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T45", "arg2_id": "NCT00343668_inc_T46", "normalized": [] }, { "id": "NCT00343668_inc_R29", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T48", "arg2_id": "NCT00343668_inc_T49", "normalized": [] }, { "id": "NCT00343668_inc_R30", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T48", "arg2_id": "NCT00343668_inc_T50", "normalized": [] }, { "id": "NCT00343668_inc_R32", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T51", "arg2_id": "NCT00343668_inc_T52", "normalized": [] }, { "id": "NCT00343668_inc_R33", "type": "AND", "arg1_id": "NCT00343668_inc_T51", "arg2_id": "NCT00343668_inc_T53", "normalized": [] }, { "id": "NCT00343668_inc_R34", "type": "Has_negation", "arg1_id": "NCT00343668_inc_T51", "arg2_id": "NCT00343668_inc_T56", "normalized": [] }, { "id": "NCT00343668_inc_R35", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T57", "arg2_id": "NCT00343668_inc_T58", "normalized": [] }, { "id": "NCT00343668_inc_R36", "type": "Has_temporal", "arg1_id": "NCT00343668_inc_T57", "arg2_id": "NCT00343668_inc_T60", "normalized": [] }, { "id": "NCT00343668_inc_R37", "type": "Has_negation", "arg1_id": "NCT00343668_inc_T57", "arg2_id": "NCT00343668_inc_T59", "normalized": [] }, { "id": "NCT00343668_inc_R31", "type": "Has_index", "arg1_id": "NCT00343668_inc_T50", "arg2_id": "NCT00343668_inc_T61", "normalized": [] }, { "id": "NCT00343668_inc_R38", "type": "Has_negation", "arg1_id": "NCT00343668_inc_T48", "arg2_id": "NCT00343668_inc_T62", "normalized": [] }, { "id": "NCT00343668_inc_R39", "type": "Has_scope", "arg1_id": "NCT00343668_inc_T45", "arg2_id": "NCT00343668_inc_T63", "normalized": [] }, { "id": "NCT00343668_inc_R40", "type": "Has_index", "arg1_id": "NCT00343668_inc_T58", "arg2_id": "NCT00343668_inc_T64", "normalized": [] }, { "id": "NCT00343668_inc_R23", "type": "Has_value", "arg1_id": "NCT00343668_inc_T41", "arg2_id": "NCT00343668_inc_T42", "normalized": [] } ]

[ { "id": "NCT00344318_exc_text", "type": "exclusion", "text": [ "Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period \nChronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. \nPlanned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. \nPrevious vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations \nHistory of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases. \nHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccines. \nHistory of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease. \nAcute disease at the time of enrolment \nAny confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical \nA family history of congenital or hereditary immunodeficiency. \nMajor congenital defects or serious chronic illness. \nAdministration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study. \n \n" ], "offsets": [ [ 0, 1662 ] ] } ]

[ { "id": "NCT00344318_exc_T1", "type": "Drug", "text": [ "product", "any investigational", "other than the study vaccine(s)" ], "offsets": [ [ 45, 52 ], [ 7, 26 ], [ 71, 102 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T2", "type": "Drug", "text": [ "non-registered product", "any", "other than the study vaccine(s)" ], "offsets": [ [ 30, 52 ], [ 7, 10 ], [ 71, 102 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T3", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 54, 58 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T4", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 62, 69 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T5", "type": "Scope", "text": [ "drug or vaccine" ], "offsets": [ [ 54, 69 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T6", "type": "Scope", "text": [ "any investigational or non-registered product", "other than the study vaccine(s)" ], "offsets": [ [ 7, 52 ], [ 71, 102 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T7", "type": "Temporal", "text": [ "within 30 days" ], "offsets": [ [ 103, 117 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T8", "type": "Observation", "text": [ "planned use" ], "offsets": [ [ 164, 175 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T9", "type": "Temporal", "text": [ "during the study period" ], "offsets": [ [ 176, 199 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T10", "type": "Drug", "text": [ "immunosuppressants" ], "offsets": [ [ 258, 276 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T11", "type": "Drug", "text": [ "other immune-modifying drugs" ], "offsets": [ [ 280, 308 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T12", "type": "Temporal", "text": [ "within six months" ], "offsets": [ [ 309, 326 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T13", "type": "Temporal", "text": [ "Chronic" ], "offsets": [ [ 201, 208 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T14", "type": "Temporal", "text": [ "more than 14 days" ], "offsets": [ [ 236, 253 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T15", "type": "Scope", "text": [ "immunosuppressants or other immune-modifying drugs" ], "offsets": [ [ 258, 308 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T16", "type": "Observation", "text": [ "Planned" ], "offsets": [ [ 361, 368 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T17", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 405, 412 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T18", "type": "Qualifier", "text": [ "not foreseen by the study protocol" ], "offsets": [ [ 413, 447 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T19", "type": "Temporal", "text": [ "period starting one month before each dose of vaccine(s)" ], "offsets": [ [ 459, 515 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T20", "type": "Temporal", "text": [ "1 month after dose 3" ], "offsets": [ [ 561, 581 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T21", "type": "Temporal", "text": [ "ending 7 days after dose 1 and dose 2" ], "offsets": [ [ 520, 557 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T22", "type": "Drug", "text": [ "dose 1" ], "offsets": [ [ 540, 546 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T23", "type": "Drug", "text": [ "dose 2" ], "offsets": [ [ 551, 557 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T24", "type": "Drug", "text": [ "dose 3" ], "offsets": [ [ 575, 581 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T25", "type": "Scope", "text": [ "dose 1 and dose 2" ], "offsets": [ [ 540, 557 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T26", "type": "Scope", "text": [ "period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3" ], "offsets": [ [ 459, 581 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T27", "type": "Drug", "text": [ "vaccination" ], "offsets": [ [ 593, 604 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T28", "type": "Condition", "text": [ "diphtheria" ], "offsets": [ [ 613, 623 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T29", "type": "Condition", "text": [ "tetanus" ], "offsets": [ [ 625, 632 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T30", "type": "Condition", "text": [ "pertussis" ], "offsets": [ [ 634, 643 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T31", "type": "Condition", "text": [ "polio" ], "offsets": [ [ 645, 650 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T32", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 652, 663 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T33", "type": "Condition", "text": [ "Haemophilus influenzae type b" ], "offsets": [ [ 665, 694 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T34", "type": "Condition", "text": [ "S. pneumoniae" ], "offsets": [ [ 703, 716 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T35", "type": "Temporal", "text": [ "within the first two weeks of life" ], "offsets": [ [ 782, 816 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T36", "type": "Qualifier", "text": [ "first dose can be given" ], "offsets": [ [ 758, 781 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T37", "type": "Scope", "text": [ "diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae" ], "offsets": [ [ 613, 716 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T38", "type": "Scope", "text": [ "vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae" ], "offsets": [ [ 593, 716 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T39", "type": "Drug", "text": [ "vaccines" ], "offsets": [ [ 739, 747 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T40", "type": "Observation", "text": [ "History" ], "offsets": [ [ 860, 867 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T41", "type": "Condition", "text": [ "diphtheria" ], "offsets": [ [ 887, 897 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T42", "type": "Condition", "text": [ "tetanus" ], "offsets": [ [ 899, 906 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T43", "type": "Condition", "text": [ "pertussis" ], "offsets": [ [ 908, 917 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T44", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 919, 930 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T45", "type": "Condition", "text": [ "polio" ], "offsets": [ [ 932, 937 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T46", "type": "Condition", "text": [ "Haemophilus influenzae type b" ], "offsets": [ [ 943, 972 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T47", "type": "Scope", "text": [ "diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b" ], "offsets": [ [ 887, 972 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T48", "type": "Condition", "text": [ "allergic disease" ], "offsets": [ [ 995, 1011 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T49", "type": "Observation", "text": [ "History" ], "offsets": [ [ 984, 991 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T50", "type": "Condition", "text": [ "reactions", "allergic" ], "offsets": [ [ 1015, 1024 ], [ 995, 1003 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T51", "type": "Scope", "text": [ "allergic disease or reactions" ], "offsets": [ [ 995, 1024 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T52", "type": "Qualifier", "text": [ "exacerbated" ], "offsets": [ [ 1038, 1049 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T53", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 1096, 1104 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T54", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1085, 1092 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T55", "type": "Condition", "text": [ "febrile convulsion" ], "offsets": [ [ 1185, 1203 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T56", "type": "Qualifier", "text": [ "uncomplicated" ], "offsets": [ [ 1171, 1184 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T57", "type": "Multiplier", "text": [ "single" ], "offsets": [ [ 1163, 1169 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T59", "type": "Condition", "text": [ "neurological disease" ], "offsets": [ [ 1220, 1240 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T60", "type": "Condition", "text": [ "Acute disease" ], "offsets": [ [ 1243, 1256 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T61", "type": "Temporal", "text": [ "at the time of enrolment" ], "offsets": [ [ 1257, 1281 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T62", "type": "Condition", "text": [ "immunosuppressive", "condition" ], "offsets": [ [ 1310, 1327 ], [ 1347, 1356 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T63", "type": "Condition", "text": [ "immunodeficient condition" ], "offsets": [ [ 1331, 1356 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T64", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 1398, 1412 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T65", "type": "Condition", "text": [ "congenital", "immunodeficiency" ], "offsets": [ [ 1416, 1426 ], [ 1441, 1457 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T66", "type": "Condition", "text": [ "hereditary immunodeficiency" ], "offsets": [ [ 1430, 1457 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T67", "type": "Scope", "text": [ "congenital or hereditary immunodeficiency" ], "offsets": [ [ 1416, 1457 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T68", "type": "Condition", "text": [ "Major congenital defects" ], "offsets": [ [ 1460, 1484 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T69", "type": "Condition", "text": [ "serious chronic illness" ], "offsets": [ [ 1488, 1511 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T70", "type": "Drug", "text": [ "immunoglobulins" ], "offsets": [ [ 1532, 1547 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T71", "type": "Drug", "text": [ "any blood products" ], "offsets": [ [ 1555, 1573 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T72", "type": "Temporal", "text": [ "since birth" ], "offsets": [ [ 1574, 1585 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T73", "type": "Scope", "text": [ "immunoglobulins and/or any blood products" ], "offsets": [ [ 1532, 1573 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T74", "type": "Observation", "text": [ "planned" ], "offsets": [ [ 1589, 1596 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T75", "type": "Temporal", "text": [ "during the active phase of the study" ], "offsets": [ [ 1612, 1648 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T76", "type": "Scope", "text": [ "since birth or planned administration during the active phase of the study" ], "offsets": [ [ 1574, 1648 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T77", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 717, 738 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T78", "type": "Reference_point", "text": [ "the first two weeks of life" ], "offsets": [ [ 789, 816 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T58", "type": "Negation", "text": [ "does not apply" ], "offsets": [ [ 1121, 1135 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T79", "type": "Scope", "text": [ "seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease" ], "offsets": [ [ 1096, 1240 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T80", "type": "Reference_point", "text": [ "enrolment" ], "offsets": [ [ 1272, 1281 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T81", "type": "Reference_point", "text": [ "active phase of the study" ], "offsets": [ [ 1623, 1648 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T82", "type": "Reference_point", "text": [ "birth" ], "offsets": [ [ 1580, 1585 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T83", "type": "Reference_point", "text": [ "each dose of vaccine(s)" ], "offsets": [ [ 492, 515 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T84", "type": "Reference_point", "text": [ "dose 1 and dose 2" ], "offsets": [ [ 540, 557 ] ], "normalized": [] }, { "id": "NCT00344318_exc_T85", "type": "Reference_point", "text": [ "dose 3" ], "offsets": [ [ 575, 581 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT00344318_inc_text", "type": "inclusion", "text": [ "Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination. \nSubjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol \nWritten informed consent obtained from the parent or guardian of the subject. \nFree of obvious health problems as established by medical history and clinical examination before entering into the study. \nBorn after a gestation period between 36 and 42 weeks. \n" ], "offsets": [ [ 0, 503 ] ] } ]

[ { "id": "NCT00344318_inc_T1", "type": "Value", "text": [ "between", "6-12 weeks" ], "offsets": [ [ 15, 22 ], [ 39, 49 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T2", "type": "Value", "text": [ "between", "42 to 90 days" ], "offsets": [ [ 15, 22 ], [ 51, 64 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T3", "type": "Person", "text": [ "of age" ], "offsets": [ [ 66, 72 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T4", "type": "Temporal", "text": [ "at the time of the first vaccination" ], "offsets": [ [ 73, 109 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T5", "type": "Condition", "text": [ "health problems" ], "offsets": [ [ 339, 354 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T6", "type": "Qualifier", "text": [ "obvious" ], "offsets": [ [ 331, 338 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T7", "type": "Negation", "text": [ "Free" ], "offsets": [ [ 323, 327 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T8", "type": "Value", "text": [ "between 36 and 42 weeks" ], "offsets": [ [ 477, 500 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T9", "type": "Measurement", "text": [ "gestation period" ], "offsets": [ [ 460, 476 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T10", "type": "Condition", "text": [ "Born" ], "offsets": [ [ 447, 451 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T12", "type": "Observation", "text": [ "Written informed consent" ], "offsets": [ [ 244, 268 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T13", "type": "Qualifier", "text": [ "parent" ], "offsets": [ [ 287, 293 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T14", "type": "Qualifier", "text": [ "guardian" ], "offsets": [ [ 297, 305 ] ], "normalized": [] }, { "id": "NCT00344318_inc_T15", "type": "Scope", "text": [ "parent or guardian" ], "offsets": [ [ 287, 305 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00344318_inc_R1", "type": "Subsumes", "arg1_id": "NCT00344318_inc_T1", "arg2_id": "NCT00344318_inc_T2", "normalized": [] }, { "id": "NCT00344318_inc_R2", "type": "Has_value", "arg1_id": "NCT00344318_inc_T3", "arg2_id": "NCT00344318_inc_T1", "normalized": [] }, { "id": "NCT00344318_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00344318_inc_T3", "arg2_id": "NCT00344318_inc_T4", "normalized": [] }, { "id": "NCT00344318_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00344318_inc_T5", "arg2_id": "NCT00344318_inc_T6", "normalized": [] }, { "id": "NCT00344318_inc_R5", "type": "Has_negation", "arg1_id": "NCT00344318_inc_T5", "arg2_id": "NCT00344318_inc_T7", "normalized": [] }, { "id": "NCT00344318_inc_R6", "type": "Has_value", "arg1_id": "NCT00344318_inc_T9", "arg2_id": "NCT00344318_inc_T8", "normalized": [] }, { "id": "NCT00344318_inc_R7", "type": "AND", "arg1_id": "NCT00344318_inc_T10", "arg2_id": "NCT00344318_inc_T9", "normalized": [] }, { "id": "NCT00344318_inc_R8", "type": "Has_scope", "arg1_id": "NCT00344318_inc_T12", "arg2_id": "NCT00344318_inc_T15", "normalized": [] } ]

[ { "id": "NCT00351611_exc_text", "type": "exclusion", "text": [ "Pre-existing eye diseases (glaucoma).\nInsufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.\n" ], "offsets": [ [ 0, 165 ] ] } ]

[ { "id": "NCT00351611_exc_T1", "type": "Condition", "text": [ "eye diseases" ], "offsets": [ [ 13, 25 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T2", "type": "Qualifier", "text": [ "Pre-existing" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T3", "type": "Condition", "text": [ "glaucoma" ], "offsets": [ [ 27, 35 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T4", "type": "Drug", "text": [ "pregabalin" ], "offsets": [ [ 63, 73 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T5", "type": "Condition", "text": [ "partial seizure" ], "offsets": [ [ 94, 109 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T6", "type": "Drug", "text": [ "pregabalin" ], "offsets": [ [ 143, 153 ] ], "normalized": [] }, { "id": "NCT00351611_exc_T7", "type": "Observation", "text": [ "Insufficient response" ], "offsets": [ [ 38, 59 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00351611_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00351611_exc_T1", "arg2_id": "NCT00351611_exc_T2", "normalized": [] }, { "id": "NCT00351611_exc_R2", "type": "Subsumes", "arg1_id": "NCT00351611_exc_T1", "arg2_id": "NCT00351611_exc_T3", "normalized": [] }, { "id": "NCT00351611_exc_R3", "type": "AND", "arg1_id": "NCT00351611_exc_T7", "arg2_id": "NCT00351611_exc_T4", "normalized": [] }, { "id": "NCT00351611_exc_R4", "type": "AND", "arg1_id": "NCT00351611_exc_T4", "arg2_id": "NCT00351611_exc_T5", "normalized": [] } ]

[ { "id": "NCT00351611_inc_text", "type": "inclusion", "text": [ "Epilepsy partial seizure subjects.\nCurrently taking 1 to 3 antiepileptic drugs.\n" ], "offsets": [ [ 0, 80 ] ] } ]

[ { "id": "NCT00351611_inc_T1", "type": "Condition", "text": [ "Epilepsy" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00351611_inc_T2", "type": "Condition", "text": [ "partial seizure" ], "offsets": [ [ 9, 24 ] ], "normalized": [] }, { "id": "NCT00351611_inc_T3", "type": "Drug", "text": [ "antiepileptic drugs" ], "offsets": [ [ 59, 78 ] ], "normalized": [] }, { "id": "NCT00351611_inc_T4", "type": "Multiplier", "text": [ "1 to 3" ], "offsets": [ [ 52, 58 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00351611_inc_R1", "type": "AND", "arg1_id": "NCT00351611_inc_T1", "arg2_id": "NCT00351611_inc_T2", "normalized": [] }, { "id": "NCT00351611_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT00351611_inc_T3", "arg2_id": "NCT00351611_inc_T4", "normalized": [] } ]

[ { "id": "NCT00356148_exc_text", "type": "exclusion", "text": [ "Ductal carcinoma in situ (DCIS; stage 0 cancer), \nAdvanced or distant metastatic stage, \nReceiving any neoadjuvant therapy, \nHistory of receiving any antibiotics within prior 3 months, \nHistory of immunodeficiency, \nHaving a remote infection, \nHistory of reaction to study antibiotics, \nDenial of signing the consent form. \n \n" ], "offsets": [ [ 0, 335 ] ] } ]

[ { "id": "NCT00356148_exc_T1", "type": "Condition", "text": [ "Ductal carcinoma in situ" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T2", "type": "Condition", "text": [ "DCIS" ], "offsets": [ [ 26, 30 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T3", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 32, 37 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T4", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 40, 46 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T5", "type": "Value", "text": [ "0" ], "offsets": [ [ 38, 39 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T6", "type": "Scope", "text": [ "DCIS; stage 0 cancer" ], "offsets": [ [ 26, 46 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T7", "type": "Value", "text": [ "distant metastatic" ], "offsets": [ [ 62, 80 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T8", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 81, 86 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T9", "type": "Value", "text": [ "Advanced", "metastatic" ], "offsets": [ [ 50, 58 ], [ 70, 80 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T10", "type": "Scope", "text": [ "Advanced or distant metastatic" ], "offsets": [ [ 50, 80 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T11", "type": "Procedure", "text": [ "neoadjuvant therapy" ], "offsets": [ [ 103, 122 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T12", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 150, 161 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T13", "type": "Temporal", "text": [ "within prior 3 months" ], "offsets": [ [ 162, 183 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T14", "type": "Observation", "text": [ "History" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T16", "type": "Condition", "text": [ "immunodeficiency" ], "offsets": [ [ 197, 213 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T17", "type": "Observation", "text": [ "History" ], "offsets": [ [ 186, 193 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T18", "type": "Condition", "text": [ "remote infection" ], "offsets": [ [ 225, 241 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T15", "type": "Condition", "text": [ "reaction" ], "offsets": [ [ 255, 263 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T19", "type": "Observation", "text": [ "History" ], "offsets": [ [ 244, 251 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T20", "type": "Drug", "text": [ "study antibiotics" ], "offsets": [ [ 267, 284 ] ], "normalized": [] }, { "id": "NCT00356148_exc_T21", "type": "Negation", "text": [ "Denial of" ], "offsets": [ [ 287, 296 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00356148_exc_R1", "type": "AND", "arg1_id": "NCT00356148_exc_T4", "arg2_id": "NCT00356148_exc_T3", "normalized": [] }, { "id": "NCT00356148_exc_R2", "type": "Has_value", "arg1_id": "NCT00356148_exc_T3", "arg2_id": "NCT00356148_exc_T5", "normalized": [] }, { "id": "NCT00356148_exc_R3", "type": "Subsumes", "arg1_id": "NCT00356148_exc_T1", "arg2_id": "NCT00356148_exc_T6", "normalized": [] }, { "id": "NCT00356148_exc_R4", "type": "Has_scope", "arg1_id": "NCT00356148_exc_T8", "arg2_id": "NCT00356148_exc_T10", "normalized": [] }, { "id": "NCT00356148_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00356148_exc_T12", "arg2_id": "NCT00356148_exc_T13", "normalized": [] }, { "id": "NCT00356148_exc_R7", "type": "AND", "arg1_id": "NCT00356148_exc_T14", "arg2_id": "NCT00356148_exc_T12", "normalized": [] }, { "id": "NCT00356148_exc_R8", "type": "AND", "arg1_id": "NCT00356148_exc_T17", "arg2_id": "NCT00356148_exc_T16", "normalized": [] }, { "id": "NCT00356148_exc_R5", "type": "AND", "arg1_id": "NCT00356148_exc_T19", "arg2_id": "NCT00356148_exc_T15", "normalized": [] }, { "id": "NCT00356148_exc_R9", "type": "AND", "arg1_id": "NCT00356148_exc_T15", "arg2_id": "NCT00356148_exc_T20", "normalized": [] } ]

[ { "id": "NCT00356148_inc_text", "type": "inclusion", "text": [ "Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II. \n" ], "offsets": [ [ 0, 125 ] ] } ]

[ { "id": "NCT00356148_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T2", "type": "Person", "text": [ "any age" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T3", "type": "Value", "text": [ "early" ], "offsets": [ [ 22, 27 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T4", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 28, 33 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T5", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 34, 47 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T6", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 49, 54 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T7", "type": "Value", "text": [ "I-II" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T9", "type": "Scope", "text": [ "stage I-II" ], "offsets": [ [ 49, 59 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T10", "type": "Measurement", "text": [ "American Society of Anesthesiologists (ASA) score" ], "offsets": [ [ 65, 114 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T11", "type": "Value", "text": [ "I-II" ], "offsets": [ [ 118, 122 ] ], "normalized": [] }, { "id": "NCT00356148_inc_T8", "type": "Scope", "text": [ "early stage" ], "offsets": [ [ 22, 33 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00356148_inc_R3", "type": "Has_value", "arg1_id": "NCT00356148_inc_T4", "arg2_id": "NCT00356148_inc_T3", "normalized": [] }, { "id": "NCT00356148_inc_R4", "type": "Has_value", "arg1_id": "NCT00356148_inc_T6", "arg2_id": "NCT00356148_inc_T7", "normalized": [] }, { "id": "NCT00356148_inc_R5", "type": "Has_value", "arg1_id": "NCT00356148_inc_T10", "arg2_id": "NCT00356148_inc_T11", "normalized": [] }, { "id": "NCT00356148_inc_R1", "type": "Subsumes", "arg1_id": "NCT00356148_inc_T8", "arg2_id": "NCT00356148_inc_T9", "normalized": [] }, { "id": "NCT00356148_inc_R2", "type": "Has_scope", "arg1_id": "NCT00356148_inc_T5", "arg2_id": "NCT00356148_inc_T8", "normalized": [] }, { "id": "NCT00356148_inc_R6", "type": "AND", "arg1_id": "NCT00356148_inc_T5", "arg2_id": "NCT00356148_inc_T10", "normalized": [] } ]

[ { "id": "NCT00379366_exc_text", "type": "exclusion", "text": [ "contra-indications of radiotherapy \nangioplasty with stenting \n \n" ], "offsets": [ [ 0, 74 ] ] } ]

[ { "id": "NCT00379366_exc_T1", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 22, 34 ] ], "normalized": [] }, { "id": "NCT00379366_exc_T2", "type": "Condition", "text": [ "contra-indications" ], "offsets": [ [ 0, 18 ] ], "normalized": [] }, { "id": "NCT00379366_exc_T3", "type": "Procedure", "text": [ "angioplasty with stenting" ], "offsets": [ [ 36, 61 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00379366_exc_R1", "type": "AND", "arg1_id": "NCT00379366_exc_T2", "arg2_id": "NCT00379366_exc_T1", "normalized": [] } ]

[ { "id": "NCT00379366_inc_text", "type": "inclusion", "text": [ "over 18 years \nsuccessful angioplasty (residual stenosis < 30%) on a significant stenosis (maximal systolic speed 3 times > from basal maximal systolic speed, stenosis > 70% on angiography) on the venous-prosthesis anastomosis or on the venous segment 5 cm after the anastomosis of a prosthetic haemodialysis vascular access (at least 1 month old) \nsocial security affiliation \nsigned informed consent \n" ], "offsets": [ [ 0, 403 ] ] } ]

[ { "id": "NCT00379366_inc_T1", "type": "Value", "text": [ "over 18 years" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T2", "type": "Person", "text": [ "over 18 years" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T3", "type": "Procedure", "text": [ "on the venous-prosthesis anastomosis", "angioplasty" ], "offsets": [ [ 190, 226 ], [ 26, 37 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T4", "type": "Qualifier", "text": [ "successful" ], "offsets": [ [ 15, 25 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T5", "type": "Measurement", "text": [ "residual stenosis" ], "offsets": [ [ 39, 56 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T6", "type": "Value", "text": [ "< 30%" ], "offsets": [ [ 57, 62 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T7", "type": "Condition", "text": [ "stenosis" ], "offsets": [ [ 81, 89 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T8", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 69, 80 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T9", "type": "Measurement", "text": [ "maximal systolic speed" ], "offsets": [ [ 91, 113 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T10", "type": "Value", "text": [ "3 times > from basal" ], "offsets": [ [ 114, 134 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T11", "type": "Measurement", "text": [ "stenosis" ], "offsets": [ [ 159, 167 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T12", "type": "Value", "text": [ "> 70%" ], "offsets": [ [ 168, 173 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T13", "type": "Procedure", "text": [ "angiography" ], "offsets": [ [ 177, 188 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T14", "type": "Scope", "text": [ "maximal systolic speed 3 times > from basal maximal systolic speed, stenosis > 70% on angiography" ], "offsets": [ [ 91, 188 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T15", "type": "Procedure", "text": [ "on the venous segment 5 cm after the anastomosis", "angioplasty" ], "offsets": [ [ 230, 278 ], [ 26, 37 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T16", "type": "Observation", "text": [ "social security affiliation" ], "offsets": [ [ 349, 376 ] ], "normalized": [] }, { "id": "NCT00379366_inc_T17", "type": "Observation", "text": [ "signed informed consent" ], "offsets": [ [ 378, 401 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00379366_inc_R1", "type": "Has_value", "arg1_id": "NCT00379366_inc_T2", "arg2_id": "NCT00379366_inc_T1", "normalized": [] }, { "id": "NCT00379366_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00379366_inc_T3", "arg2_id": "NCT00379366_inc_T4", "normalized": [] }, { "id": "NCT00379366_inc_R3", "type": "Has_value", "arg1_id": "NCT00379366_inc_T5", "arg2_id": "NCT00379366_inc_T6", "normalized": [] }, { "id": "NCT00379366_inc_R4", "type": "Subsumes", "arg1_id": "NCT00379366_inc_T4", "arg2_id": "NCT00379366_inc_T5", "normalized": [] }, { "id": "NCT00379366_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00379366_inc_T7", "arg2_id": "NCT00379366_inc_T8", "normalized": [] }, { "id": "NCT00379366_inc_R6", "type": "AND", "arg1_id": "NCT00379366_inc_T3", "arg2_id": "NCT00379366_inc_T7", "normalized": [] }, { "id": "NCT00379366_inc_R7", "type": "Has_value", "arg1_id": "NCT00379366_inc_T9", "arg2_id": "NCT00379366_inc_T10", "normalized": [] }, { "id": "NCT00379366_inc_R8", "type": "Has_value", "arg1_id": "NCT00379366_inc_T11", "arg2_id": "NCT00379366_inc_T12", "normalized": [] }, { "id": "NCT00379366_inc_R9", "type": "AND", "arg1_id": "NCT00379366_inc_T13", "arg2_id": "NCT00379366_inc_T11", "normalized": [] }, { "id": "NCT00379366_inc_R10", "type": "AND", "arg1_id": "NCT00379366_inc_T13", "arg2_id": "NCT00379366_inc_T9", "normalized": [] }, { "id": "NCT00379366_inc_R11", "type": "Subsumes", "arg1_id": "NCT00379366_inc_T4", "arg2_id": "NCT00379366_inc_T14", "normalized": [] } ]

[ { "id": "NCT00391690_exc_text", "type": "exclusion", "text": [ "Prior treatment with a bisphosphonate \nAbnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. \nCorrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L). \nPatients with clinically symptomatic brain metastases \nHistory of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism \nSevere physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG \nKnown hypersensitivity to zoledronic acid or other bisphosphonates \nUse of other investigational drugs 30 days prior to the date of randomization \nKnown history or present abuse of alcohol or drugs \nSubjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study \nCurrent active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. \nRecent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) \nOther protocol defined inclusion/exclusion criteria may apply. \n \n" ], "offsets": [ [ 0, 1455 ] ] } ]

[ { "id": "NCT00391690_exc_T1", "type": "Drug", "text": [ "bisphosphonate" ], "offsets": [ [ 23, 37 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T2", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T3", "type": "Measurement", "text": [ "renal function" ], "offsets": [ [ 48, 62 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T4", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 39, 47 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T5", "type": "Measurement", "text": [ "calculated creatinine clearance" ], "offsets": [ [ 81, 112 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T6", "type": "Value", "text": [ "< 30 ml/minute" ], "offsets": [ [ 113, 127 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T7", "type": "Measurement", "text": [ "Corrected", "serum calcium concentration" ], "offsets": [ [ 130, 139 ], [ 169, 196 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T8", "type": "Value", "text": [ "< 8.0 mg/dl" ], "offsets": [ [ 197, 208 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T9", "type": "Value", "text": [ "2.00 mmol/L" ], "offsets": [ [ 210, 221 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T10", "type": "Value", "text": [ "≥ 12.0 mg/dl" ], "offsets": [ [ 226, 238 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T11", "type": "Value", "text": [ "3.00 mmol/L" ], "offsets": [ [ 240, 251 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T12", "type": "Scope", "text": [ "< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L" ], "offsets": [ [ 197, 251 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T13", "type": "Observation", "text": [ "clinically symptomatic" ], "offsets": [ [ 269, 291 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T14", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 292, 308 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T15", "type": "Observation", "text": [ "History" ], "offsets": [ [ 310, 317 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T16", "type": "Condition", "text": [ "diseases with influence on bone metabolism" ], "offsets": [ [ 321, 363 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T17", "type": "Condition", "text": [ "Paget's disease" ], "offsets": [ [ 372, 387 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T18", "type": "Condition", "text": [ "primary hyperparathyroidism" ], "offsets": [ [ 392, 419 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T19", "type": "Scope", "text": [ "diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism" ], "offsets": [ [ 321, 419 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T20", "type": "Condition", "text": [ "physical", "diseases" ], "offsets": [ [ 428, 436 ], [ 466, 474 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T21", "type": "Condition", "text": [ "psychological", "diseases" ], "offsets": [ [ 440, 453 ], [ 466, 474 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T22", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 637, 644 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T23", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 614, 636 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T24", "type": "Condition", "text": [ "cardiac failure" ], "offsets": [ [ 646, 661 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T25", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 663, 667 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T26", "type": "Value", "text": [ "III or IV" ], "offsets": [ [ 668, 677 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T27", "type": "Qualifier", "text": [ "clinically relevant" ], "offsets": [ [ 679, 698 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T28", "type": "Observation", "text": [ "pathologic findings" ], "offsets": [ [ 699, 718 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T29", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 722, 725 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T30", "type": "Scope", "text": [ "clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG" ], "offsets": [ [ 614, 725 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T31", "type": "Scope", "text": [ "physical or psychological concomitant diseases" ], "offsets": [ [ 428, 474 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T32", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 733, 749 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T33", "type": "Drug", "text": [ "zoledronic acid" ], "offsets": [ [ 753, 768 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T34", "type": "Drug", "text": [ "other bisphosphonates" ], "offsets": [ [ 772, 793 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T35", "type": "Scope", "text": [ "zoledronic acid or other bisphosphonates" ], "offsets": [ [ 753, 793 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T36", "type": "Drug", "text": [ "other investigational drugs" ], "offsets": [ [ 802, 829 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T37", "type": "Temporal", "text": [ "30 days prior to the date of randomization" ], "offsets": [ [ 830, 872 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T38", "type": "Observation", "text": [ "history" ], "offsets": [ [ 880, 887 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T39", "type": "Temporal", "text": [ "present" ], "offsets": [ [ 891, 898 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T40", "type": "Scope", "text": [ "history or present" ], "offsets": [ [ 880, 898 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T41", "type": "Condition", "text": [ "abuse of alcohol" ], "offsets": [ [ 899, 915 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T42", "type": "Condition", "text": [ "abuse of", "drugs" ], "offsets": [ [ 899, 907 ], [ 919, 924 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T43", "type": "Scope", "text": [ "abuse of alcohol or drugs" ], "offsets": [ [ 899, 924 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T44", "type": "Condition", "text": [ "dental problems" ], "offsets": [ [ 1041, 1056 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T45", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 1026, 1033 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T46", "type": "Condition", "text": [ "infection of the teeth" ], "offsets": [ [ 1067, 1089 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T47", "type": "Condition", "text": [ "infection of the", "jawbone" ], "offsets": [ [ 1067, 1083 ], [ 1093, 1100 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T48", "type": "Scope", "text": [ "infection of the teeth or jawbone" ], "offsets": [ [ 1067, 1100 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T49", "type": "Condition", "text": [ "infection of the", "maxilla" ], "offsets": [ [ 1067, 1083 ], [ 1102, 1109 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T50", "type": "Condition", "text": [ "infection of the", "mandibular" ], "offsets": [ [ 1067, 1083 ], [ 1113, 1123 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T51", "type": "Scope", "text": [ "infection of the", "maxilla or mandibular" ], "offsets": [ [ 1067, 1083 ], [ 1102, 1123 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T52", "type": "Condition", "text": [ "dental", "trauma" ], "offsets": [ [ 1126, 1132 ], [ 1144, 1150 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T53", "type": "Condition", "text": [ "fixture trauma" ], "offsets": [ [ 1136, 1150 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T54", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1157, 1164 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T55", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 1168, 1173 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T56", "type": "Condition", "text": [ "osteonecrosis of the jaw (ONJ)" ], "offsets": [ [ 1187, 1217 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T57", "type": "Condition", "text": [ "exposed bone in the mouth" ], "offsets": [ [ 1222, 1247 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T58", "type": "Condition", "text": [ "slow healing after dental procedures" ], "offsets": [ [ 1255, 1291 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T59", "type": "Scope", "text": [ "osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures" ], "offsets": [ [ 1187, 1291 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T60", "type": "Scope", "text": [ "current or prior" ], "offsets": [ [ 1157, 1173 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T61", "type": "Scope", "text": [ "infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures" ], "offsets": [ [ 1067, 1291 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T62", "type": "Temporal", "text": [ "within 6 weeks" ], "offsets": [ [ 1302, 1316 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T63", "type": "Temporal", "text": [ "Recent" ], "offsets": [ [ 1294, 1300 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T64", "type": "Observation", "text": [ "planned" ], "offsets": [ [ 1321, 1328 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T65", "type": "Procedure", "text": [ "dental", "surgery" ], "offsets": [ [ 1329, 1335 ], [ 1343, 1350 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T66", "type": "Procedure", "text": [ "jaw surgery" ], "offsets": [ [ 1339, 1350 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T67", "type": "Procedure", "text": [ "extraction" ], "offsets": [ [ 1357, 1367 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T68", "type": "Procedure", "text": [ "implants" ], "offsets": [ [ 1369, 1377 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T69", "type": "Scope", "text": [ "extraction, implants" ], "offsets": [ [ 1357, 1377 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T70", "type": "Scope", "text": [ "dental or jaw surgery" ], "offsets": [ [ 1329, 1350 ] ], "normalized": [] }, { "id": "NCT00391690_exc_T71", "type": "Scope", "text": [ "Recent (within 6 weeks) or planned" ], "offsets": [ [ 1294, 1328 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00391690_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00391690_exc_T1", "arg2_id": "NCT00391690_exc_T2", "normalized": [] }, { "id": "NCT00391690_exc_R2", "type": "Has_value", "arg1_id": "NCT00391690_exc_T3", "arg2_id": "NCT00391690_exc_T4", "normalized": [] }, { "id": "NCT00391690_exc_R3", "type": "Has_value", "arg1_id": "NCT00391690_exc_T5", "arg2_id": "NCT00391690_exc_T6", "normalized": [] }, { "id": "NCT00391690_exc_R4", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T4", "arg2_id": "NCT00391690_exc_T5", "normalized": [] }, { "id": "NCT00391690_exc_R5", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T7", "arg2_id": "NCT00391690_exc_T12", "normalized": [] }, { "id": "NCT00391690_exc_R7", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T15", "arg2_id": "NCT00391690_exc_T19", "normalized": [] }, { "id": "NCT00391690_exc_R8", "type": "Has_value", "arg1_id": "NCT00391690_exc_T25", "arg2_id": "NCT00391690_exc_T26", "normalized": [] }, { "id": "NCT00391690_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT00391690_exc_T29", "arg2_id": "NCT00391690_exc_T27", "normalized": [] }, { "id": "NCT00391690_exc_R11", "type": "AND", "arg1_id": "NCT00391690_exc_T24", "arg2_id": "NCT00391690_exc_T25", "normalized": [] }, { "id": "NCT00391690_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00391690_exc_T22", "arg2_id": "NCT00391690_exc_T23", "normalized": [] }, { "id": "NCT00391690_exc_R13", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T31", "arg2_id": "NCT00391690_exc_T30", "normalized": [] }, { "id": "NCT00391690_exc_R14", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T32", "arg2_id": "NCT00391690_exc_T35", "normalized": [] }, { "id": "NCT00391690_exc_R15", "type": "Has_temporal", "arg1_id": "NCT00391690_exc_T36", "arg2_id": "NCT00391690_exc_T37", "normalized": [] }, { "id": "NCT00391690_exc_R16", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T40", "arg2_id": "NCT00391690_exc_T43", "normalized": [] }, { "id": "NCT00391690_exc_R17", "type": "Has_temporal", "arg1_id": "NCT00391690_exc_T44", "arg2_id": "NCT00391690_exc_T45", "normalized": [] }, { "id": "NCT00391690_exc_R18", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T48", "arg2_id": "NCT00391690_exc_T51", "normalized": [] }, { "id": "NCT00391690_exc_R19", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T60", "arg2_id": "NCT00391690_exc_T59", "normalized": [] }, { "id": "NCT00391690_exc_R20", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T44", "arg2_id": "NCT00391690_exc_T61", "normalized": [] }, { "id": "NCT00391690_exc_R21", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T63", "arg2_id": "NCT00391690_exc_T62", "normalized": [] }, { "id": "NCT00391690_exc_R22", "type": "Subsumes", "arg1_id": "NCT00391690_exc_T70", "arg2_id": "NCT00391690_exc_T69", "normalized": [] }, { "id": "NCT00391690_exc_R23", "type": "Has_scope", "arg1_id": "NCT00391690_exc_T70", "arg2_id": "NCT00391690_exc_T71", "normalized": [] } ]

[ { "id": "NCT00391690_inc_text", "type": "inclusion", "text": [ "Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases \nProstate cancer patients with a rise in PSA under hormone therapy. \nPSA criteria: \nPatients who have undergone prostatectomy: any rise in PSA or \nPatients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement. \nPrevious chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry. \nEastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day) \nAdequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value \nAge: ≥ 18 years \nPatient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study. \n" ], "offsets": [ [ 0, 1182 ] ] } ]

[ { "id": "NCT00391690_inc_T1", "type": "Measurement", "text": [ "histologically" ], "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T2", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T3", "type": "Condition", "text": [ "prostate cancer" ], "offsets": [ [ 52, 67 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T4", "type": "Condition", "text": [ "bone metastases" ], "offsets": [ [ 95, 110 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T5", "type": "Condition", "text": [ "Prostate cancer" ], "offsets": [ [ 112, 127 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T6", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 152, 155 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T7", "type": "Value", "text": [ "rise" ], "offsets": [ [ 144, 148 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T8", "type": "Procedure", "text": [ "hormone therapy" ], "offsets": [ [ 162, 177 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T9", "type": "Procedure", "text": [ "prostatectomy" ], "offsets": [ [ 223, 236 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T10", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 250, 253 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T11", "type": "Value", "text": [ "rise" ], "offsets": [ [ 242, 246 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T12", "type": "Procedure", "text": [ "prostatectomy" ], "offsets": [ [ 275, 288 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T13", "type": "Negation", "text": [ "without" ], "offsets": [ [ 267, 274 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T14", "type": "Measurement", "text": [ "PSA levels" ], "offsets": [ [ 313, 323 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T15", "type": "Value", "text": [ "rises" ], "offsets": [ [ 304, 309 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T16", "type": "Value", "text": [ "2" ], "offsets": [ [ 290, 291 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T17", "type": "Temporal", "text": [ "consecutive" ], "offsets": [ [ 292, 303 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T18", "type": "Temporal", "text": [ "separated by one month" ], "offsets": [ [ 364, 386 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T19", "type": "Temporal", "text": [ "one month after the reference value" ], "offsets": [ [ 421, 456 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T20", "type": "Value", "text": [ "above the reference value" ], "offsets": [ [ 469, 494 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T21", "type": "Value", "text": [ "first" ], "offsets": [ [ 392, 397 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T22", "type": "Procedure", "text": [ "measurement" ], "offsets": [ [ 398, 409 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T23", "type": "Value", "text": [ "second" ], "offsets": [ [ 500, 506 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T24", "type": "Procedure", "text": [ "measurement" ], "offsets": [ [ 520, 531 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T25", "type": "Temporal", "text": [ "one month after the first measurement" ], "offsets": [ [ 538, 575 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T26", "type": "Value", "text": [ "greater than the first measurement" ], "offsets": [ [ 584, 618 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T27", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 630, 642 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T28", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 646, 658 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T29", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 621, 629 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T30", "type": "Temporal", "text": [ "≥ 8 weeks prior to study entry" ], "offsets": [ [ 684, 714 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T31", "type": "Scope", "text": [ "chemotherapy or radiotherapy" ], "offsets": [ [ 630, 658 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T32", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group (ECOG) score" ], "offsets": [ [ 717, 764 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T33", "type": "Value", "text": [ "0, 1 or 2" ], "offsets": [ [ 768, 777 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T34", "type": "Measurement", "text": [ "spend", "time in bed during the day" ], "offsets": [ [ 793, 798 ], [ 816, 842 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T35", "type": "Value", "text": [ "less than 50%" ], "offsets": [ [ 799, 812 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T36", "type": "Scope", "text": [ "Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2" ], "offsets": [ [ 717, 777 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T37", "type": "Scope", "text": [ "spend less than 50% of time in bed during the day" ], "offsets": [ [ 793, 842 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T38", "type": "Measurement", "text": [ "liver function" ], "offsets": [ [ 854, 868 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T39", "type": "Value", "text": [ "Adequate" ], "offsets": [ [ 845, 853 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T40", "type": "Measurement", "text": [ "serum total bilirubin concentration" ], "offsets": [ [ 871, 906 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T41", "type": "Value", "text": [ "less than 1.5 x upper limit of normal value" ], "offsets": [ [ 907, 950 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T42", "type": "Person", "text": [ "Age" ], "offsets": [ [ 952, 955 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T43", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 957, 967 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T44", "type": "Condition", "text": [ "psychiatric", "disorders" ], "offsets": [ [ 1066, 1077 ], [ 1091, 1100 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T45", "type": "Condition", "text": [ "addictive disorders" ], "offsets": [ [ 1081, 1100 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T46", "type": "Observation", "text": [ "giving", "informed consent" ], "offsets": [ [ 1125, 1131 ], [ 1138, 1154 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T47", "type": "Negation", "text": [ "prevent" ], "offsets": [ [ 1107, 1114 ] ], "normalized": [] }, { "id": "NCT00391690_inc_T48", "type": "Scope", "text": [ "psychiatric or addictive disorders" ], "offsets": [ [ 1066, 1100 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00391690_inc_R1", "type": "Has_value", "arg1_id": "NCT00391690_inc_T1", "arg2_id": "NCT00391690_inc_T2", "normalized": [] }, { "id": "NCT00391690_inc_R2", "type": "AND", "arg1_id": "NCT00391690_inc_T3", "arg2_id": "NCT00391690_inc_T1", "normalized": [] }, { "id": "NCT00391690_inc_R3", "type": "Has_value", "arg1_id": "NCT00391690_inc_T6", "arg2_id": "NCT00391690_inc_T7", "normalized": [] }, { "id": "NCT00391690_inc_R4", "type": "AND", "arg1_id": "NCT00391690_inc_T8", "arg2_id": "NCT00391690_inc_T5", "normalized": [] }, { "id": "NCT00391690_inc_R5", "type": "Has_value", "arg1_id": "NCT00391690_inc_T10", "arg2_id": "NCT00391690_inc_T11", "normalized": [] }, { "id": "NCT00391690_inc_R6", "type": "AND", "arg1_id": "NCT00391690_inc_T9", "arg2_id": "NCT00391690_inc_T10", "normalized": [] }, { "id": "NCT00391690_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T16", "arg2_id": "NCT00391690_inc_T17", "normalized": [] }, { "id": "NCT00391690_inc_R8", "type": "Has_value", "arg1_id": "NCT00391690_inc_T16", "arg2_id": "NCT00391690_inc_T15", "normalized": [] }, { "id": "NCT00391690_inc_R9", "type": "Has_value", "arg1_id": "NCT00391690_inc_T14", "arg2_id": "NCT00391690_inc_T15", "normalized": [] }, { "id": "NCT00391690_inc_R10", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T16", "arg2_id": "NCT00391690_inc_T18", "normalized": [] }, { "id": "NCT00391690_inc_R11", "type": "AND", "arg1_id": "NCT00391690_inc_T21", "arg2_id": "NCT00391690_inc_T22", "normalized": [] }, { "id": "NCT00391690_inc_R12", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T22", "arg2_id": "NCT00391690_inc_T19", "normalized": [] }, { "id": "NCT00391690_inc_R13", "type": "Has_value", "arg1_id": "NCT00391690_inc_T22", "arg2_id": "NCT00391690_inc_T20", "normalized": [] }, { "id": "NCT00391690_inc_R14", "type": "AND", "arg1_id": "NCT00391690_inc_T23", "arg2_id": "NCT00391690_inc_T24", "normalized": [] }, { "id": "NCT00391690_inc_R15", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T24", "arg2_id": "NCT00391690_inc_T25", "normalized": [] }, { "id": "NCT00391690_inc_R16", "type": "Has_value", "arg1_id": "NCT00391690_inc_T24", "arg2_id": "NCT00391690_inc_T26", "normalized": [] }, { "id": "NCT00391690_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T31", "arg2_id": "NCT00391690_inc_T29", "normalized": [] }, { "id": "NCT00391690_inc_R18", "type": "Has_temporal", "arg1_id": "NCT00391690_inc_T31", "arg2_id": "NCT00391690_inc_T30", "normalized": [] }, { "id": "NCT00391690_inc_R19", "type": "Has_value", "arg1_id": "NCT00391690_inc_T32", "arg2_id": "NCT00391690_inc_T33", "normalized": [] }, { "id": "NCT00391690_inc_R20", "type": "Has_value", "arg1_id": "NCT00391690_inc_T34", "arg2_id": "NCT00391690_inc_T35", "normalized": [] }, { "id": "NCT00391690_inc_R21", "type": "Subsumes", "arg1_id": "NCT00391690_inc_T36", "arg2_id": "NCT00391690_inc_T37", "normalized": [] }, { "id": "NCT00391690_inc_R22", "type": "Has_value", "arg1_id": "NCT00391690_inc_T40", "arg2_id": "NCT00391690_inc_T41", "normalized": [] }, { "id": "NCT00391690_inc_R23", "type": "Has_value", "arg1_id": "NCT00391690_inc_T38", "arg2_id": "NCT00391690_inc_T39", "normalized": [] }, { "id": "NCT00391690_inc_R24", "type": "Subsumes", "arg1_id": "NCT00391690_inc_T39", "arg2_id": "NCT00391690_inc_T40", "normalized": [] }, { "id": "NCT00391690_inc_R25", "type": "Has_value", "arg1_id": "NCT00391690_inc_T42", "arg2_id": "NCT00391690_inc_T43", "normalized": [] }, { "id": "NCT00391690_inc_R26", "type": "Has_negation", "arg1_id": "NCT00391690_inc_T46", "arg2_id": "NCT00391690_inc_T47", "normalized": [] } ]

[ { "id": "NCT00396734_exc_text", "type": "exclusion", "text": [ "use more than 2g a day; 5 times a week to everyday \nSubjects who are diagnosed as suffering from psychotic illness according to DSM-IV (Axis 1)22, or with a history of CNS disease, a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of consciousness,pregnant women. \n \n" ], "offsets": [ [ 0, 351 ] ] } ]

[ { "id": "NCT00396734_exc_T1", "type": "Multiplier", "text": [ "more than 2g a day" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T2", "type": "Multiplier", "text": [ "5 times a week to everyday" ], "offsets": [ [ 24, 50 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T3", "type": "Condition", "text": [ "psychotic illness" ], "offsets": [ [ 97, 114 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T4", "type": "Measurement", "text": [ "DSM-IV" ], "offsets": [ [ 128, 134 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T5", "type": "Qualifier", "text": [ "Axis 1" ], "offsets": [ [ 136, 142 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 157, 164 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T7", "type": "Condition", "text": [ "CNS disease" ], "offsets": [ [ 168, 179 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T8", "type": "Observation", "text": [ "history" ], "offsets": [ [ 183, 190 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T9", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 194, 203 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T10", "type": "Qualifier", "text": [ "affect CNS" ], "offsets": [ [ 215, 225 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T11", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 227, 230 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T12", "type": "Condition", "text": [ "syphilis" ], "offsets": [ [ 232, 240 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T13", "type": "Condition", "text": [ "cytomegalovirus" ], "offsets": [ [ 242, 257 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T14", "type": "Condition", "text": [ "herpes" ], "offsets": [ [ 259, 265 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T15", "type": "Scope", "text": [ "HIV, syphilis, cytomegalovirus, herpes" ], "offsets": [ [ 227, 265 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T16", "type": "Observation", "text": [ "history" ], "offsets": [ [ 273, 280 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T17", "type": "Condition", "text": [ "head injury" ], "offsets": [ [ 284, 295 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T18", "type": "Condition", "text": [ "loss of consciousness" ], "offsets": [ [ 301, 322 ] ], "normalized": [] }, { "id": "NCT00396734_exc_T19", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 323, 331 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00396734_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT00396734_exc_T1", "arg2_id": "NCT00396734_exc_T2", "normalized": [] }, { "id": "NCT00396734_exc_R3", "type": "Subsumes", "arg1_id": "NCT00396734_exc_T3", "arg2_id": "NCT00396734_exc_T4", "normalized": [] }, { "id": "NCT00396734_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00396734_exc_T4", "arg2_id": "NCT00396734_exc_T5", "normalized": [] }, { "id": "NCT00396734_exc_R4", "type": "AND", "arg1_id": "NCT00396734_exc_T6", "arg2_id": "NCT00396734_exc_T7", "normalized": [] }, { "id": "NCT00396734_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00396734_exc_T9", "arg2_id": "NCT00396734_exc_T10", "normalized": [] }, { "id": "NCT00396734_exc_R6", "type": "Subsumes", "arg1_id": "NCT00396734_exc_T9", "arg2_id": "NCT00396734_exc_T15", "normalized": [] }, { "id": "NCT00396734_exc_R7", "type": "AND", "arg1_id": "NCT00396734_exc_T16", "arg2_id": "NCT00396734_exc_T17", "normalized": [] }, { "id": "NCT00396734_exc_R8", "type": "AND", "arg1_id": "NCT00396734_exc_T17", "arg2_id": "NCT00396734_exc_T18", "normalized": [] }, { "id": "NCT00396734_exc_R9", "type": "AND", "arg1_id": "NCT00396734_exc_T8", "arg2_id": "NCT00396734_exc_T9", "normalized": [] } ]

[ { "id": "NCT00396734_inc_text", "type": "inclusion", "text": [ "Methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3 times a week \n" ], "offsets": [ [ 0, 97 ] ] } ]

[ { "id": "NCT00396734_inc_T1", "type": "Drug", "text": [ "Methadone" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT00396734_inc_T2", "type": "Condition", "text": [ "cocaine-dependent" ], "offsets": [ [ 21, 38 ] ], "normalized": [] }, { "id": "NCT00396734_inc_T3", "type": "Multiplier", "text": [ "1g to 2g a day" ], "offsets": [ [ 60, 74 ] ], "normalized": [] }, { "id": "NCT00396734_inc_T4", "type": "Multiplier", "text": [ "1 to 3 times a week" ], "offsets": [ [ 76, 95 ] ], "normalized": [] }, { "id": "NCT00396734_inc_T5", "type": "Qualifier", "text": [ "Methadone-maintained" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT00396734_inc_T6", "type": "Scope", "text": [ "1g to 2g a day; 1 to 3 times a week" ], "offsets": [ [ 60, 95 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00396734_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00396734_inc_T2", "arg2_id": "NCT00396734_inc_T5", "normalized": [] }, { "id": "NCT00396734_inc_R1", "type": "Has_scope", "arg1_id": "NCT00396734_inc_T1", "arg2_id": "NCT00396734_inc_T6", "normalized": [] } ]

[ { "id": "NCT00397215_exc_text", "type": "exclusion", "text": [ "Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season. \nAdministration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. \nPlanned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine. \nChronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. \nAny confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). \nHistory of chronic alcohol consumption and/or drug abuse. \nHistory of hypersensitivity to vaccines. \nHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy). \nAcute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. \nAcute disease at the time of enrolment. \nSerious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. \nAdministration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study. \nUse of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period. \nAny condition which, in the opinion of the investigator, prevents the subject from participation in the study. \n \n" ], "offsets": [ [ 0, 1940 ] ] } ]

[ { "id": "NCT00397215_exc_T1", "type": "Drug", "text": [ "MF59-containing vaccines" ], "offsets": [ [ 31, 55 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T2", "type": "Drug", "text": [ "Fluad" ], "offsets": [ [ 62, 67 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T3", "type": "Drug", "text": [ "Addigrip" ], "offsets": [ [ 72, 80 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T4", "type": "Drug", "text": [ "virosome-based influenza vaccines" ], "offsets": [ [ 85, 118 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T5", "type": "Drug", "text": [ "Inflexal V" ], "offsets": [ [ 127, 137 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T6", "type": "Drug", "text": [ "InfectoVac Flu" ], "offsets": [ [ 140, 154 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T7", "type": "Drug", "text": [ "Invivac" ], "offsets": [ [ 159, 166 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T8", "type": "Temporal", "text": [ "during the 2006-2007 influenza season" ], "offsets": [ [ 168, 205 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T9", "type": "Scope", "text": [ "Inflexal V™, InfectoVac Flu™ or Invivac™" ], "offsets": [ [ 127, 167 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T10", "type": "Scope", "text": [ "Fluad™ or Addigrip™" ], "offsets": [ [ 62, 81 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T11", "type": "Scope", "text": [ "MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™" ], "offsets": [ [ 31, 167 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T12", "type": "Temporal", "text": [ "within 2 weeks", "prior to enrolment in this study" ], "offsets": [ [ 244, 258 ], [ 317, 349 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T13", "type": "Temporal", "text": [ "within", "4 weeks", "prior to enrolment in this study" ], "offsets": [ [ 244, 250 ], [ 289, 296 ], [ 317, 349 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T14", "type": "Drug", "text": [ "inactivated vaccines" ], "offsets": [ [ 264, 284 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T15", "type": "Drug", "text": [ "live vaccines" ], "offsets": [ [ 302, 315 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T16", "type": "Drug", "text": [ "licensed vaccines" ], "offsets": [ [ 226, 243 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T17", "type": "Scope", "text": [ "within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study" ], "offsets": [ [ 244, 349 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T18", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 380, 387 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T19", "type": "Qualifier", "text": [ "foreseen by the study protocol" ], "offsets": [ [ 392, 422 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T20", "type": "Negation", "text": [ "not" ], "offsets": [ [ 388, 391 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T21", "type": "Temporal", "text": [ "up to 30 days" ], "offsets": [ [ 423, 436 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T22", "type": "Drug", "text": [ "vaccination" ], "offsets": [ [ 454, 465 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T23", "type": "Value", "text": [ "second" ], "offsets": [ [ 447, 453 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T24", "type": "Drug", "text": [ "H5N1 vaccine" ], "offsets": [ [ 471, 483 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T25", "type": "Temporal", "text": [ "more than 14 days" ], "offsets": [ [ 521, 538 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T26", "type": "Qualifier", "text": [ "Chronic" ], "offsets": [ [ 486, 493 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T27", "type": "Drug", "text": [ "immunosuppressants" ], "offsets": [ [ 543, 561 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T28", "type": "Drug", "text": [ "other immune-modifying drugs" ], "offsets": [ [ 565, 593 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T29", "type": "Temporal", "text": [ "within six months prior" ], "offsets": [ [ 594, 617 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T30", "type": "Scope", "text": [ "immunosuppressants or other immune-modifying drugs" ], "offsets": [ [ 543, 593 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T31", "type": "Condition", "text": [ "immunosuppressive", "condition" ], "offsets": [ [ 696, 713 ], [ 733, 742 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T32", "type": "Condition", "text": [ "immunodeficient condition" ], "offsets": [ [ 717, 742 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T33", "type": "Qualifier", "text": [ "confirmed" ], "offsets": [ [ 673, 682 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T34", "type": "Qualifier", "text": [ "suspected" ], "offsets": [ [ 686, 695 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T35", "type": "Scope", "text": [ "confirmed or suspected" ], "offsets": [ [ 673, 695 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T36", "type": "Scope", "text": [ "immunosuppressive or immunodeficient condition" ], "offsets": [ [ 696, 742 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T37", "type": "Condition", "text": [ "chronic alcohol consumption" ], "offsets": [ [ 840, 867 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T38", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 875, 885 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T39", "type": "Observation", "text": [ "History" ], "offsets": [ [ 829, 836 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T40", "type": "Scope", "text": [ "chronic alcohol consumption and/or drug abuse" ], "offsets": [ [ 840, 885 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T41", "type": "Condition", "text": [ "hypersensitivity to vaccines" ], "offsets": [ [ 899, 927 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T42", "type": "Observation", "text": [ "History" ], "offsets": [ [ 888, 895 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T43", "type": "Condition", "text": [ "allergic disease" ], "offsets": [ [ 941, 957 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T44", "type": "Condition", "text": [ "allergic", "reactions" ], "offsets": [ [ 941, 949 ], [ 961, 970 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T45", "type": "Observation", "text": [ "History" ], "offsets": [ [ 930, 937 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T46", "type": "Scope", "text": [ "egg and thiomersal allergy" ], "offsets": [ [ 1039, 1065 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T47", "type": "Condition", "text": [ "egg", "allergy" ], "offsets": [ [ 1039, 1042 ], [ 1058, 1065 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T48", "type": "Condition", "text": [ "thiomersal allergy" ], "offsets": [ [ 1047, 1065 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T49", "type": "Scope", "text": [ "allergic disease or reactions" ], "offsets": [ [ 941, 970 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T51", "type": "Condition", "text": [ "cardiovascular", "functional abnormality" ], "offsets": [ [ 1109, 1123 ], [ 1142, 1164 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T52", "type": "Condition", "text": [ "hepatic", "functional abnormality" ], "offsets": [ [ 1125, 1132 ], [ 1142, 1164 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T53", "type": "Condition", "text": [ "renal functional abnormality" ], "offsets": [ [ 1136, 1164 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T50", "type": "Condition", "text": [ "pulmonary", "functional abnormality" ], "offsets": [ [ 1098, 1107 ], [ 1142, 1164 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T54", "type": "Condition", "text": [ "Acute disease" ], "offsets": [ [ 1236, 1249 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T55", "type": "Temporal", "text": [ "at the time of enrolment" ], "offsets": [ [ 1250, 1274 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T56", "type": "Condition", "text": [ "chronic pulmonary", "disorder" ], "offsets": [ [ 1337, 1354 ], [ 1418, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T57", "type": "Condition", "text": [ "chronic", "cardiovascular", "disorder" ], "offsets": [ [ 1337, 1344 ], [ 1356, 1370 ], [ 1418, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T58", "type": "Condition", "text": [ "chronic", "renal", "disorder" ], "offsets": [ [ 1337, 1344 ], [ 1372, 1377 ], [ 1418, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T59", "type": "Condition", "text": [ "chronic", "neurological", "disorder" ], "offsets": [ [ 1337, 1344 ], [ 1379, 1391 ], [ 1418, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T60", "type": "Condition", "text": [ "chronic", "psychiatric", "disorder" ], "offsets": [ [ 1337, 1344 ], [ 1393, 1404 ], [ 1418, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T61", "type": "Condition", "text": [ "chronic", "metabolic disorder" ], "offsets": [ [ 1337, 1344 ], [ 1408, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T62", "type": "Drug", "text": [ "immunoglobulins" ], "offsets": [ [ 1506, 1521 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T63", "type": "Drug", "text": [ "any blood products" ], "offsets": [ [ 1529, 1547 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T64", "type": "Temporal", "text": [ "within the three months preceding the first vaccination" ], "offsets": [ [ 1548, 1603 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T65", "type": "Scope", "text": [ "immunoglobulins and/or any blood products" ], "offsets": [ [ 1506, 1547 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T66", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 1821, 1830 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T67", "type": "Qualifier", "text": [ "which", "prevents the subject from participation in the study" ], "offsets": [ [ 1831, 1836 ], [ 1874, 1926 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T70", "type": "Qualifier", "text": [ "investigational" ], "offsets": [ [ 1637, 1652 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T71", "type": "Qualifier", "text": [ "non-registered" ], "offsets": [ [ 1656, 1670 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T72", "type": "Drug", "text": [ "product" ], "offsets": [ [ 1671, 1678 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T73", "type": "Scope", "text": [ "investigational or non-registered" ], "offsets": [ [ 1637, 1670 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T74", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 1680, 1684 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T75", "type": "Drug", "text": [ "vaccine" ], "offsets": [ [ 1688, 1695 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T76", "type": "Scope", "text": [ "drug or vaccine" ], "offsets": [ [ 1680, 1695 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T77", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1697, 1707 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T78", "type": "Drug", "text": [ "study vaccine(s)" ], "offsets": [ [ 1712, 1728 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T79", "type": "Qualifier", "text": [ "other than the study vaccine(s)" ], "offsets": [ [ 1697, 1728 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T80", "type": "Temporal", "text": [ "within 30 days prior to the first vaccination" ], "offsets": [ [ 1729, 1774 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T81", "type": "Reference_point", "text": [ "the first vaccination" ], "offsets": [ [ 1753, 1774 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T82", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 1763, 1774 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T83", "type": "Temporal", "text": [ "first" ], "offsets": [ [ 1757, 1762 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T84", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 1779, 1786 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T85", "type": "Temporal", "text": [ "during the study period" ], "offsets": [ [ 1791, 1814 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T86", "type": "Procedure", "text": [ "use" ], "offsets": [ [ 1787, 1790 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T87", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 1277, 1284 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T88", "type": "Condition", "text": [ "chronic disease" ], "offsets": [ [ 1285, 1300 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T89", "type": "Scope", "text": [ "chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder" ], "offsets": [ [ 1337, 1426 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T90", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 1607, 1623 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T91", "type": "Reference_point", "text": [ "the first vaccination" ], "offsets": [ [ 1582, 1603 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T92", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 1592, 1603 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T93", "type": "Temporal", "text": [ "first" ], "offsets": [ [ 1586, 1591 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T94", "type": "Scope", "text": [ "within the three months preceding the first vaccination or during the study" ], "offsets": [ [ 1548, 1623 ] ], "normalized": [] }, { "id": "NCT00397215_exc_T95", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 1614, 1623 ] ], "normalized": [] } ]

[]

[]

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"NCT00397215_exc_R8", "type": "AND", "arg1_id": "NCT00397215_exc_T23", "arg2_id": "NCT00397215_exc_T22", "normalized": [] }, { "id": "NCT00397215_exc_R9", "type": "AND", "arg1_id": "NCT00397215_exc_T22", "arg2_id": "NCT00397215_exc_T24", "normalized": [] }, { "id": "NCT00397215_exc_R10", "type": "Has_value", "arg1_id": "NCT00397215_exc_T21", "arg2_id": "NCT00397215_exc_T23", "normalized": [] }, { "id": "NCT00397215_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T18", "arg2_id": "NCT00397215_exc_T21", "normalized": [] }, { "id": "NCT00397215_exc_R13", "type": "Subsumes", "arg1_id": "NCT00397215_exc_T26", "arg2_id": "NCT00397215_exc_T25", "normalized": [] }, { "id": "NCT00397215_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00397215_exc_T30", "arg2_id": "NCT00397215_exc_T26", "normalized": [] }, { "id": "NCT00397215_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T30", "arg2_id": "NCT00397215_exc_T29", "normalized": [] }, { "id": "NCT00397215_exc_R15", "type": "Has_scope", "arg1_id": "NCT00397215_exc_T36", "arg2_id": "NCT00397215_exc_T35", "normalized": [] }, { "id": "NCT00397215_exc_R16", "type": "Has_scope", "arg1_id": "NCT00397215_exc_T39", "arg2_id": "NCT00397215_exc_T40", "normalized": [] }, { "id": "NCT00397215_exc_R17", "type": "AND", "arg1_id": "NCT00397215_exc_T42", "arg2_id": "NCT00397215_exc_T41", "normalized": [] }, { "id": "NCT00397215_exc_R18", "type": "Subsumes", "arg1_id": "NCT00397215_exc_T49", "arg2_id": "NCT00397215_exc_T46", "normalized": [] }, { "id": "NCT00397215_exc_R19", "type": "Has_scope", "arg1_id": "NCT00397215_exc_T45", "arg2_id": "NCT00397215_exc_T49", "normalized": [] }, { "id": "NCT00397215_exc_R20", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T54", "arg2_id": "NCT00397215_exc_T55", "normalized": [] }, { "id": "NCT00397215_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT00397215_exc_T66", "arg2_id": "NCT00397215_exc_T67", "normalized": [] }, { "id": "NCT00397215_exc_R24", "type": "Has_scope", "arg1_id": "NCT00397215_exc_T72", "arg2_id": "NCT00397215_exc_T73", "normalized": [] }, { "id": "NCT00397215_exc_R25", "type": "Subsumes", "arg1_id": "NCT00397215_exc_T72", "arg2_id": "NCT00397215_exc_T76", "normalized": [] }, { "id": "NCT00397215_exc_R26", "type": "Has_negation", "arg1_id": "NCT00397215_exc_T78", "arg2_id": "NCT00397215_exc_T77", "normalized": [] }, { "id": "NCT00397215_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT00397215_exc_T72", "arg2_id": "NCT00397215_exc_T79", "normalized": [] }, { "id": "NCT00397215_exc_R29", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T72", "arg2_id": "NCT00397215_exc_T80", "normalized": [] }, { "id": "NCT00397215_exc_R30", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T82", "arg2_id": "NCT00397215_exc_T83", "normalized": [] }, { "id": "NCT00397215_exc_R32", "type": "Has_index", "arg1_id": "NCT00397215_exc_T80", "arg2_id": "NCT00397215_exc_T81", "normalized": [] }, { "id": "NCT00397215_exc_R33", "type": "Has_mood", "arg1_id": "NCT00397215_exc_T86", "arg2_id": "NCT00397215_exc_T84", "normalized": [] }, { "id": "NCT00397215_exc_R34", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T86", "arg2_id": "NCT00397215_exc_T85", "normalized": [] }, { "id": "NCT00397215_exc_R35", "type": "AND", "arg1_id": "NCT00397215_exc_T72", "arg2_id": "NCT00397215_exc_T86", "normalized": [] }, { "id": "NCT00397215_exc_R36", "type": "Has_qualifier", "arg1_id": "NCT00397215_exc_T88", "arg2_id": "NCT00397215_exc_T87", "normalized": [] }, { "id": "NCT00397215_exc_R37", "type": "Subsumes", "arg1_id": "NCT00397215_exc_T88", "arg2_id": "NCT00397215_exc_T89", "normalized": [] }, { "id": "NCT00397215_exc_R38", "type": "Has_temporal", "arg1_id": "NCT00397215_exc_T92", "arg2_id": "NCT00397215_exc_T93", "normalized": [] }, { "id": "NCT00397215_exc_R40", "type": "Has_index", "arg1_id": "NCT00397215_exc_T64", "arg2_id": "NCT00397215_exc_T91", "normalized": [] }, { "id": "NCT00397215_exc_R21", "type": "Has_scope", "arg1_id": "NCT00397215_exc_T65", "arg2_id": "NCT00397215_exc_T94", "normalized": [] }, { "id": "NCT00397215_exc_R41", "type": "Has_index", "arg1_id": "NCT00397215_exc_T90", "arg2_id": "NCT00397215_exc_T95", "normalized": [] } ]

[ { "id": "NCT00397215_inc_text", "type": "inclusion", "text": [ "Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. \nA male or female aged 61 years or above at the time of the first vaccination. \nWritten informed consent obtained from the subject. \nHealthy subjects or subjects with well controlled underlying disease. \n" ], "offsets": [ [ 0, 344 ] ] } ]

[ { "id": "NCT00397215_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 158, 162 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T2", "type": "Value", "text": [ "61 years or above" ], "offsets": [ [ 163, 180 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T3", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 273, 280 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T4", "type": "Condition", "text": [ "underlying disease" ], "offsets": [ [ 323, 341 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T5", "type": "Qualifier", "text": [ "well controlled" ], "offsets": [ [ 307, 322 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T6", "type": "Person", "text": [ "female" ], "offsets": [ [ 151, 157 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T7", "type": "Person", "text": [ "male" ], "offsets": [ [ 143, 147 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T8", "type": "Observation", "text": [ "Written informed consent" ], "offsets": [ [ 220, 244 ] ], "normalized": [] }, { "id": "NCT00397215_inc_T9", "type": "Observation", "text": [ "can and will comply with the requirements of the protocol" ], "offsets": [ [ 49, 106 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00397215_inc_R1", "type": "Has_value", "arg1_id": "NCT00397215_inc_T1", "arg2_id": "NCT00397215_inc_T2", "normalized": [] }, { "id": "NCT00397215_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00397215_inc_T4", "arg2_id": "NCT00397215_inc_T5", "normalized": [] } ]

[ { "id": "NCT00401245_exc_text", "type": "exclusion", "text": [ "History of a seizure disorder other than a single childhood febrile seizure. \nHistory or presence of clinically important hepatic or renal disease or other medical disease. \nPresence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy. \n \n" ], "offsets": [ [ 0, 332 ] ] } ]

[ { "id": "NCT00401245_exc_T1", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 13, 29 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T2", "type": "Condition", "text": [ "childhood febrile seizure" ], "offsets": [ [ 50, 75 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T3", "type": "Multiplier", "text": [ "single" ], "offsets": [ [ 43, 49 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T4", "type": "Observation", "text": [ "History" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T5", "type": "Observation", "text": [ "History" ], "offsets": [ [ 78, 85 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T6", "type": "Condition", "text": [ "clinically important", "hepatic", "disease" ], "offsets": [ [ 101, 121 ], [ 122, 129 ], [ 139, 146 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T7", "type": "Condition", "text": [ "clinically important", "renal disease" ], "offsets": [ [ 101, 121 ], [ 133, 146 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T8", "type": "Condition", "text": [ "clinically important", "other medical disease" ], "offsets": [ [ 101, 121 ], [ 150, 171 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T9", "type": "Observation", "text": [ "history" ], "offsets": [ [ 193, 200 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T10", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 204, 229 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T11", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 231, 247 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T12", "type": "Condition", "text": [ "psychotic disorder" ], "offsets": [ [ 249, 267 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T13", "type": "Condition", "text": [ "generalized anxiety disorder" ], "offsets": [ [ 272, 300 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T14", "type": "Qualifier", "text": [ "requiring therapy" ], "offsets": [ [ 301, 318 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T15", "type": "Scope", "text": [ "major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder" ], "offsets": [ [ 204, 300 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T16", "type": "Scope", "text": [ "clinically important hepatic or renal disease or other medical disease" ], "offsets": [ [ 101, 171 ] ], "normalized": [] }, { "id": "NCT00401245_exc_T17", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 30, 40 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00401245_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT00401245_exc_T2", "arg2_id": "NCT00401245_exc_T3", "normalized": [] }, { "id": "NCT00401245_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00401245_exc_T1", "arg2_id": "NCT00401245_exc_T4", "normalized": [] }, { "id": "NCT00401245_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00401245_exc_T15", "arg2_id": "NCT00401245_exc_T9", "normalized": [] }, { "id": "NCT00401245_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00401245_exc_T15", "arg2_id": "NCT00401245_exc_T14", "normalized": [] }, { "id": "NCT00401245_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00401245_exc_T16", "arg2_id": "NCT00401245_exc_T5", "normalized": [] }, { "id": "NCT00401245_exc_R2", "type": "Has_negation", "arg1_id": "NCT00401245_exc_T2", "arg2_id": "NCT00401245_exc_T17", "normalized": [] }, { "id": "NCT00401245_exc_R7", "type": "AND", "arg1_id": "NCT00401245_exc_T1", "arg2_id": "NCT00401245_exc_T2", "normalized": [] } ]

[ { "id": "NCT00401245_inc_text", "type": "inclusion", "text": [ "Generally healthy, postmenopausal woman who seeks treatment for hot flushes. \nMeets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL. \n" ], "offsets": [ [ 0, 431 ] ] } ]

[ { "id": "NCT00401245_inc_T1", "type": "Condition", "text": [ "healthy" ], "offsets": [ [ 10, 17 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T2", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 19, 33 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T3", "type": "Person", "text": [ "woman" ], "offsets": [ [ 34, 39 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T4", "type": "Condition", "text": [ "hot flushes" ], "offsets": [ [ 64, 75 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T5", "type": "Temporal", "text": [ "At least 12 months" ], "offsets": [ [ 104, 122 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T6", "type": "Condition", "text": [ "spontaneous amenorrhea" ], "offsets": [ [ 126, 148 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T7", "type": "Temporal", "text": [ "At least 6 months" ], "offsets": [ [ 150, 167 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T8", "type": "Condition", "text": [ "spontaneous amenorrhea" ], "offsets": [ [ 171, 193 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T9", "type": "Measurement", "text": [ "serum follicle-stimulating hormone (FSH) levels" ], "offsets": [ [ 199, 246 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T10", "type": "Value", "text": [ "> 40 mIU/mL" ], "offsets": [ [ 247, 258 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T11", "type": "Temporal", "text": [ "At least 6 weeks postsurgical" ], "offsets": [ [ 260, 289 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T12", "type": "Procedure", "text": [ "bilateral oophorectomy" ], "offsets": [ [ 290, 312 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T13", "type": "Procedure", "text": [ "bilateral oophorectomy", "without hysterectomy" ], "offsets": [ [ 290, 312 ], [ 322, 342 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T14", "type": "Procedure", "text": [ "bilateral oophorectomy", "with", "hysterectomy" ], "offsets": [ [ 290, 312 ], [ 314, 318 ], [ 330, 342 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T15", "type": "Scope", "text": [ "with or without hysterectomy" ], "offsets": [ [ 314, 342 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T16", "type": "Scope", "text": [ "bilateral oophorectomy (with or without hysterectomy)" ], "offsets": [ [ 290, 343 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T17", "type": "Condition", "text": [ "Hysterectomized" ], "offsets": [ [ 345, 360 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T18", "type": "Procedure", "text": [ "bilateral oophorectomy" ], "offsets": [ [ 369, 391 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T19", "type": "Negation", "text": [ "without" ], "offsets": [ [ 361, 368 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T20", "type": "Measurement", "text": [ "serum FSH levels" ], "offsets": [ [ 401, 417 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T21", "type": "Value", "text": [ ">40 mIU/mL" ], "offsets": [ [ 418, 428 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T22", "type": "Scope", "text": [ "At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL" ], "offsets": [ [ 150, 258 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T23", "type": "Scope", "text": [ "At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy)" ], "offsets": [ [ 260, 343 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T24", "type": "Scope", "text": [ "Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL" ], "offsets": [ [ 345, 428 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T26", "type": "Scope", "text": [ "At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL" ], "offsets": [ [ 150, 258 ] ], "normalized": [] }, { "id": "NCT00401245_inc_T27", "type": "Multiplier", "text": [ "Meets 1 of the following" ], "offsets": [ [ 78, 102 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00401245_inc_R1", "type": "Has_temporal", "arg1_id": "NCT00401245_inc_T6", "arg2_id": "NCT00401245_inc_T5", "normalized": [] }, { "id": "NCT00401245_inc_R2", "type": "Has_temporal", "arg1_id": "NCT00401245_inc_T8", "arg2_id": "NCT00401245_inc_T7", "normalized": [] }, { "id": "NCT00401245_inc_R3", "type": "Has_value", "arg1_id": "NCT00401245_inc_T9", "arg2_id": "NCT00401245_inc_T10", "normalized": [] }, { "id": "NCT00401245_inc_R4", "type": "Subsumes", "arg1_id": "NCT00401245_inc_T12", "arg2_id": "NCT00401245_inc_T15", "normalized": [] }, { "id": "NCT00401245_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00401245_inc_T16", "arg2_id": "NCT00401245_inc_T11", "normalized": [] }, { "id": "NCT00401245_inc_R6", "type": "Has_negation", "arg1_id": "NCT00401245_inc_T18", "arg2_id": "NCT00401245_inc_T19", "normalized": [] }, { "id": "NCT00401245_inc_R7", "type": "Has_value", "arg1_id": "NCT00401245_inc_T20", "arg2_id": "NCT00401245_inc_T21", "normalized": [] } ]

[ { "id": "NCT00404495_exc_text", "type": "exclusion", "text": [ "Diagnosis of brainstem glioma \nConcurrent administration of any other anti-tumor therapy \nPre-existing uncontrolled diarrhea \n \n" ], "offsets": [ [ 0, 137 ] ] } ]

[ { "id": "NCT00404495_exc_T1", "type": "Condition", "text": [ "brainstem glioma" ], "offsets": [ [ 13, 29 ] ], "normalized": [] }, { "id": "NCT00404495_exc_T2", "type": "Procedure", "text": [ "anti-tumor therapy" ], "offsets": [ [ 70, 88 ] ], "normalized": [] }, { "id": "NCT00404495_exc_T3", "type": "Condition", "text": [ "uncontrolled diarrhea" ], "offsets": [ [ 103, 124 ] ], "normalized": [] }, { "id": "NCT00404495_exc_T4", "type": "Temporal", "text": [ "Concurrent" ], "offsets": [ [ 31, 41 ] ], "normalized": [] }, { "id": "NCT00404495_exc_T5", "type": "Qualifier", "text": [ "any other" ], "offsets": [ [ 60, 69 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00404495_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00404495_exc_T2", "arg2_id": "NCT00404495_exc_T4", "normalized": [] }, { "id": "NCT00404495_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00404495_exc_T2", "arg2_id": "NCT00404495_exc_T5", "normalized": [] } ]

[ { "id": "NCT00404495_inc_text", "type": "inclusion", "text": [ "Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease. \nCohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4) \nLife expectancy ≥ 3 months \n" ], "offsets": [ [ 0, 277 ] ] } ]

[ { "id": "NCT00404495_inc_T1", "type": "Condition", "text": [ "refractory medulloblastoma" ], "offsets": [ [ 23, 49 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T2", "type": "Condition", "text": [ "Recurrent", "medulloblastoma" ], "offsets": [ [ 10, 19 ], [ 34, 49 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T3", "type": "Procedure", "text": [ "standard treatment" ], "offsets": [ [ 67, 85 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T4", "type": "Qualifier", "text": [ "failed" ], "offsets": [ [ 102, 108 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T5", "type": "Scope", "text": [ "Recurrent or refractory medulloblastoma" ], "offsets": [ [ 10, 49 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T6", "type": "Condition", "text": [ "high-grade glioma" ], "offsets": [ [ 183, 200 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T7", "type": "Measurement", "text": [ "World Health Organization [WHO] grade" ], "offsets": [ [ 202, 239 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T8", "type": "Value", "text": [ "3 or 4" ], "offsets": [ [ 240, 246 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T9", "type": "Measurement", "text": [ "Life expectancy" ], "offsets": [ [ 249, 264 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T10", "type": "Value", "text": [ "≥ 3 months" ], "offsets": [ [ 265, 275 ] ], "normalized": [] }, { "id": "NCT00404495_inc_T11", "type": "Mood", "text": [ "not required" ], "offsets": [ [ 120, 132 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00404495_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT00404495_inc_T3", "arg2_id": "NCT00404495_inc_T4", "normalized": [] }, { "id": "NCT00404495_inc_R2", "type": "AND", "arg1_id": "NCT00404495_inc_T5", "arg2_id": "NCT00404495_inc_T3", "normalized": [] }, { "id": "NCT00404495_inc_R3", "type": "Has_value", "arg1_id": "NCT00404495_inc_T7", "arg2_id": "NCT00404495_inc_T8", "normalized": [] }, { "id": "NCT00404495_inc_R4", "type": "AND", "arg1_id": "NCT00404495_inc_T6", "arg2_id": "NCT00404495_inc_T7", "normalized": [] }, { "id": "NCT00404495_inc_R5", "type": "Has_value", "arg1_id": "NCT00404495_inc_T9", "arg2_id": "NCT00404495_inc_T10", "normalized": [] } ]

[ { "id": "NCT00425789_exc_text", "type": "exclusion", "text": [ "Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia \n \n" ], "offsets": [ [ 0, 116 ] ] } ]

[ { "id": "NCT00425789_exc_T1", "type": "Condition", "text": [ "middle ear disease" ], "offsets": [ [ 45, 63 ] ], "normalized": [] }, { "id": "NCT00425789_exc_T2", "type": "Condition", "text": [ "chronic lung disease" ], "offsets": [ [ 65, 85 ] ], "normalized": [] }, { "id": "NCT00425789_exc_T3", "type": "Condition", "text": [ "claustrophobia" ], "offsets": [ [ 89, 103 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00425789_inc_text", "type": "inclusion", "text": [ "The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist (dr. Landau). \nThe treatment group will receive 5 consecutive daily hyperbaric treatments, 1 hours long each, at 2 ATF, starting from day 7 to peel. Prior to treatment, each patient will be signed on informed consent and will have complete physical examination. \nThe control group will be matched by the following parameters: age, skin color and type, and indication for peeling, and will be picked up by the dermatologist. \n" ], "offsets": [ [ 0, 542 ] ] } ]

[ { "id": "NCT00425789_inc_T1", "type": "Condition", "text": [ "deep peel" ], "offsets": [ [ 31, 40 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 41, 46 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T3", "type": "Condition", "text": [ "exoderm" ], "offsets": [ [ 48, 55 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T4", "type": "Value", "text": [ "older than 18 years" ], "offsets": [ [ 58, 77 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T5", "type": "Person", "text": [ "old" ], "offsets": [ [ 78, 81 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T7", "type": "Observation", "text": [ "control group" ], "offsets": [ [ 384, 397 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T8", "type": "Person", "text": [ "age" ], "offsets": [ [ 443, 446 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T9", "type": "Person", "text": [ "skin color" ], "offsets": [ [ 448, 458 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T10", "type": "Person", "text": [ "type" ], "offsets": [ [ 463, 467 ] ], "normalized": [] }, { "id": "NCT00425789_inc_T11", "type": "Scope", "text": [ "age, skin color and type" ], "offsets": [ [ 443, 467 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00425789_inc_R1", "type": "Subsumes", "arg1_id": "NCT00425789_inc_T1", "arg2_id": "NCT00425789_inc_T3", "normalized": [] }, { "id": "NCT00425789_inc_R2", "type": "Has_value", "arg1_id": "NCT00425789_inc_T5", "arg2_id": "NCT00425789_inc_T4", "normalized": [] } ]

[ { "id": "NCT00426751_exc_text", "type": "exclusion", "text": [ "Subjects not able to give informed consent \nLeft Bundle Branch Block \nThrombolytic therapy within 24 hours before randomization \nOral anticoagulation with International Normalized Ratio (INR) > 2 \nKnown platelets < 100.000/µl or known hemorrhagic diathesis \nStroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect \nEvidence of an active gastrointestinal or urogenital bleeding \nMajor surgery within 6 weeks \nHistory of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media) \nKnown severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation \nSevere concomitant disease with life expectation < 1 year \nSubject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study. \nSubjects who will be inaccessible due to geographic or social factors during treatment or follow-up \nIn France, a subject is neither affiliated with nor a beneficiary of a social security category. \n \n" ], "offsets": [ [ 0, 1322 ] ] } ]

[ { "id": "NCT00426751_exc_T1", "type": "Condition", "text": [ "Left Bundle Branch Block" ], "offsets": [ [ 44, 68 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T2", "type": "Procedure", "text": [ "Thrombolytic therapy" ], "offsets": [ [ 70, 90 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T3", "type": "Temporal", "text": [ "within 24 hours before randomization" ], "offsets": [ [ 91, 127 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T4", "type": "Procedure", "text": [ "Oral anticoagulation" ], "offsets": [ [ 129, 149 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T5", "type": "Measurement", "text": [ "International Normalized Ratio (INR)" ], "offsets": [ [ 155, 191 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T6", "type": "Value", "text": [ "> 2" ], "offsets": [ [ 192, 195 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T7", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 203, 212 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T8", "type": "Value", "text": [ "< 100.000/µl" ], "offsets": [ [ 213, 225 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T9", "type": "Condition", "text": [ "hemorrhagic diathesis" ], "offsets": [ [ 235, 256 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T10", "type": "Condition", "text": [ "Transient Ischemic Attack (TIA)" ], "offsets": [ [ 268, 299 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T11", "type": "Condition", "text": [ "Stroke" ], "offsets": [ [ 258, 264 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T12", "type": "Scope", "text": [ "Stroke or Transient Ischemic Attack (TIA)" ], "offsets": [ [ 258, 299 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T13", "type": "Temporal", "text": [ "within the past 6 months" ], "offsets": [ [ 300, 324 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T14", "type": "Condition", "text": [ "residual neurological defect" ], "offsets": [ [ 342, 370 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T15", "type": "Condition", "text": [ "gastrointestinal", "bleeding" ], "offsets": [ [ 394, 410 ], [ 425, 433 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T16", "type": "Condition", "text": [ "urogenital bleeding" ], "offsets": [ [ 414, 433 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T17", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 387, 393 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T18", "type": "Scope", "text": [ "gastrointestinal or urogenital bleeding" ], "offsets": [ [ 394, 433 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T19", "type": "Temporal", "text": [ "within 6 weeks" ], "offsets": [ [ 449, 463 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T20", "type": "Procedure", "text": [ "Major surgery" ], "offsets": [ [ 435, 448 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T21", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 476, 493 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T22", "type": "Observation", "text": [ "History" ], "offsets": [ [ 465, 472 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T23", "type": "Drug", "text": [ "abciximab" ], "offsets": [ [ 497, 506 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T24", "type": "Drug", "text": [ "eptifibatide" ], "offsets": [ [ 510, 522 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T25", "type": "Drug", "text": [ "component used in the study" ], "offsets": [ [ 530, 557 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T26", "type": "Drug", "text": [ "contrast media" ], "offsets": [ [ 569, 583 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T27", "type": "Scope", "text": [ "abciximab or eptifibatide or any component used in the study (including contrast media)" ], "offsets": [ [ 497, 584 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T28", "type": "Measurement", "text": [ "creatinine clearance" ], "offsets": [ [ 606, 626 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T29", "type": "Value", "text": [ "<30ml/min" ], "offsets": [ [ 627, 636 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T30", "type": "Condition", "text": [ "hepatic insufficiency" ], "offsets": [ [ 641, 662 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T31", "type": "Measurement", "text": [ "Alanine transaminase (ALT)" ], "offsets": [ [ 674, 700 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T32", "type": "Measurement", "text": [ "aspartate transaminase (AST)" ], "offsets": [ [ 701, 729 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T33", "type": "Value", "text": [ "elevations" ], "offsets": [ [ 730, 740 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T34", "type": "Value", "text": [ "3xUpper limit normal (ULN)" ], "offsets": [ [ 743, 769 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T35", "type": "Condition", "text": [ "renal", "insufficiency" ], "offsets": [ [ 599, 604 ], [ 649, 662 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T36", "type": "Scope", "text": [ "creatinine clearance <30ml/min" ], "offsets": [ [ 606, 636 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T37", "type": "Scope", "text": [ "Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN)" ], "offsets": [ [ 674, 769 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T38", "type": "Condition", "text": [ "Severe", "disease" ], "offsets": [ [ 860, 866 ], [ 879, 886 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T39", "type": "Measurement", "text": [ "life expectation" ], "offsets": [ [ 892, 908 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T40", "type": "Value", "text": [ "< 1 year" ], "offsets": [ [ 909, 917 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T41", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 592, 598 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T42", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 867, 878 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T43", "type": "Observation", "text": [ "participated in any study" ], "offsets": [ [ 931, 956 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T44", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 966, 986 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T45", "type": "Device", "text": [ "device" ], "offsets": [ [ 990, 996 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T46", "type": "Scope", "text": [ "investigational drug or device" ], "offsets": [ [ 966, 996 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T47", "type": "Temporal", "text": [ "of the investigational drug", "within 30 days" ], "offsets": [ [ 1035, 1062 ], [ 997, 1011 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T48", "type": "Temporal", "text": [ "within 5 half-lives of the investigational drug" ], "offsets": [ [ 1015, 1062 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T49", "type": "Reference_point", "text": [ "of the investigational drug" ], "offsets": [ [ 1035, 1062 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T50", "type": "Scope", "text": [ "within 30 days or within 5 half-lives of the investigational drug" ], "offsets": [ [ 997, 1062 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T51", "type": "Observation", "text": [ "inaccessible" ], "offsets": [ [ 1133, 1145 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T52", "type": "Temporal", "text": [ "during treatment or follow-up" ], "offsets": [ [ 1182, 1211 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T53", "type": "Reference_point", "text": [ "treatment" ], "offsets": [ [ 1189, 1198 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T54", "type": "Reference_point", "text": [ "follow-up" ], "offsets": [ [ 1202, 1211 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T56", "type": "Negation", "text": [ "not" ], "offsets": [ [ 9, 12 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T58", "type": "Mood", "text": [ "able to" ], "offsets": [ [ 13, 20 ] ], "normalized": [] }, { "id": "NCT00426751_exc_T59", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 114, 127 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00426751_exc_R1", "type": "Has_value", "arg1_id": "NCT00426751_exc_T5", "arg2_id": "NCT00426751_exc_T6", "normalized": [] }, { "id": "NCT00426751_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T12", "arg2_id": "NCT00426751_exc_T13", "normalized": [] }, { "id": "NCT00426751_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T18", "arg2_id": "NCT00426751_exc_T17", "normalized": [] }, { "id": "NCT00426751_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T20", "arg2_id": "NCT00426751_exc_T19", "normalized": [] }, { "id": "NCT00426751_exc_R5", "type": "Subsumes", "arg1_id": "NCT00426751_exc_T25", "arg2_id": "NCT00426751_exc_T26", "normalized": [] }, { "id": "NCT00426751_exc_R6", "type": "AND", "arg1_id": "NCT00426751_exc_T22", "arg2_id": "NCT00426751_exc_T21", "normalized": [] }, { "id": "NCT00426751_exc_R7", "type": "Has_scope", "arg1_id": "NCT00426751_exc_T21", "arg2_id": "NCT00426751_exc_T27", "normalized": [] }, { "id": "NCT00426751_exc_R8", "type": "Has_value", "arg1_id": "NCT00426751_exc_T28", "arg2_id": "NCT00426751_exc_T29", "normalized": [] }, { "id": "NCT00426751_exc_R9", "type": "Subsumes", "arg1_id": "NCT00426751_exc_T33", "arg2_id": "NCT00426751_exc_T34", "normalized": [] }, { "id": "NCT00426751_exc_R10", "type": "Has_value", "arg1_id": "NCT00426751_exc_T31", "arg2_id": "NCT00426751_exc_T33", "normalized": [] }, { "id": "NCT00426751_exc_R11", "type": "Has_value", "arg1_id": "NCT00426751_exc_T32", "arg2_id": "NCT00426751_exc_T33", "normalized": [] }, { "id": "NCT00426751_exc_R12", "type": "Subsumes", "arg1_id": "NCT00426751_exc_T35", "arg2_id": "NCT00426751_exc_T36", "normalized": [] }, { "id": "NCT00426751_exc_R13", "type": "AND", "arg1_id": "NCT00426751_exc_T38", "arg2_id": "NCT00426751_exc_T39", "normalized": [] }, { "id": "NCT00426751_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT00426751_exc_T35", "arg2_id": "NCT00426751_exc_T41", "normalized": [] }, { "id": "NCT00426751_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT00426751_exc_T30", "arg2_id": "NCT00426751_exc_T41", "normalized": [] }, { "id": "NCT00426751_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T38", "arg2_id": "NCT00426751_exc_T42", "normalized": [] }, { "id": "NCT00426751_exc_R17", "type": "Has_scope", "arg1_id": "NCT00426751_exc_T43", "arg2_id": "NCT00426751_exc_T46", "normalized": [] }, { "id": "NCT00426751_exc_R18", "type": "Has_scope", "arg1_id": "NCT00426751_exc_T43", "arg2_id": "NCT00426751_exc_T50", "normalized": [] }, { "id": "NCT00426751_exc_R19", "type": "Has_index", "arg1_id": "NCT00426751_exc_T50", "arg2_id": "NCT00426751_exc_T49", "normalized": [] }, { "id": "NCT00426751_exc_R20", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T2", "arg2_id": "NCT00426751_exc_T3", "normalized": [] }, { "id": "NCT00426751_exc_R21", "type": "Has_temporal", "arg1_id": "NCT00426751_exc_T51", "arg2_id": "NCT00426751_exc_T52", "normalized": [] }, { "id": "NCT00426751_exc_R24", "type": "Has_index", "arg1_id": "NCT00426751_exc_T3", "arg2_id": "NCT00426751_exc_T59", "normalized": [] } ]

[ { "id": "NCT00426751_inc_text", "type": "inclusion", "text": [ "Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible) \nAcute myocardial infarction < 12 h defined as: \n1. Angina or equivalent symptoms > 20 min and \n2. ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I. \nPlanned primary percutaneous coronary intervention \nThe subject has given written informed, dated consent to participate in the study \n" ], "offsets": [ [ 0, 692 ] ] } ]

[ { "id": "NCT00426751_inc_T1", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T2", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T3", "type": "Temporal", "text": [ "12 months" ], "offsets": [ [ 34, 43 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T4", "type": "Condition", "text": [ "menstrual period" ], "offsets": [ [ 52, 68 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T5", "type": "Negation", "text": [ "without" ], "offsets": [ [ 44, 51 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T6", "type": "Scope", "text": [ "12 months without menstrual period" ], "offsets": [ [ 34, 68 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T7", "type": "Condition", "text": [ "surgically sterile" ], "offsets": [ [ 74, 92 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T8", "type": "Person", "text": [ "women" ], "offsets": [ [ 99, 104 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T9", "type": "Condition", "text": [ "child bearing potential" ], "offsets": [ [ 108, 131 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T10", "type": "Scope", "text": [ "women of child bearing potential" ], "offsets": [ [ 99, 131 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T11", "type": "Negation", "text": [ "not" ], "offsets": [ [ 136, 139 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T12", "type": "Condition", "text": [ "pregnancy test" ], "offsets": [ [ 199, 213 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T13", "type": "Qualifier", "text": [ "doubt" ], "offsets": [ [ 191, 196 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T14", "type": "Condition", "text": [ "Acute myocardial infarction" ], "offsets": [ [ 320, 347 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T15", "type": "Temporal", "text": [ "< 12 h" ], "offsets": [ [ 348, 354 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T16", "type": "Condition", "text": [ "Angina" ], "offsets": [ [ 371, 377 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T17", "type": "Condition", "text": [ "Angina", "symptoms" ], "offsets": [ [ 371, 377 ], [ 392, 400 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T18", "type": "Temporal", "text": [ "> 20 min" ], "offsets": [ [ 401, 409 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T19", "type": "Scope", "text": [ "Angina or equivalent symptoms" ], "offsets": [ [ 371, 400 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T20", "type": "Condition", "text": [ "ST elevation" ], "offsets": [ [ 418, 430 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T21", "type": "Measurement", "text": [ "precordial lead" ], "offsets": [ [ 465, 480 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T22", "type": "Measurement", "text": [ "limb lead" ], "offsets": [ [ 489, 498 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T23", "type": "Value", "text": [ "1 mm" ], "offsets": [ [ 484, 488 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T24", "type": "Value", "text": [ "2 mm" ], "offsets": [ [ 460, 464 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T25", "type": "Scope", "text": [ "2 mm precordial lead, = 1 mm limb lead" ], "offsets": [ [ 460, 498 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T26", "type": "Measurement", "text": [ "contiguous ECG leads" ], "offsets": [ [ 436, 456 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T27", "type": "Value", "text": [ "2" ], "offsets": [ [ 434, 435 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T28", "type": "Scope", "text": [ "2 contiguous ECG leads" ], "offsets": [ [ 434, 456 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T29", "type": "Observation", "text": [ "Planned" ], "offsets": [ [ 557, 564 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T30", "type": "Procedure", "text": [ "primary percutaneous coronary intervention" ], "offsets": [ [ 565, 607 ] ], "normalized": [] }, { "id": "NCT00426751_inc_T31", "type": "Observation", "text": [ "given written informed", "consent" ], "offsets": [ [ 625, 647 ], [ 655, 662 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00426751_inc_R1", "type": "AND", "arg1_id": "NCT00426751_inc_T2", "arg2_id": "NCT00426751_inc_T1", "normalized": [] }, { "id": "NCT00426751_inc_R2", "type": "Has_negation", "arg1_id": "NCT00426751_inc_T4", "arg2_id": "NCT00426751_inc_T5", "normalized": [] }, { "id": "NCT00426751_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00426751_inc_T4", "arg2_id": "NCT00426751_inc_T3", "normalized": [] }, { "id": "NCT00426751_inc_R4", "type": "Subsumes", "arg1_id": "NCT00426751_inc_T1", "arg2_id": "NCT00426751_inc_T6", "normalized": [] }, { "id": "NCT00426751_inc_R5", "type": "Has_negation", "arg1_id": "NCT00426751_inc_T10", "arg2_id": "NCT00426751_inc_T11", "normalized": [] }, { "id": "NCT00426751_inc_R6", "type": "AND", "arg1_id": "NCT00426751_inc_T13", "arg2_id": "NCT00426751_inc_T12", "normalized": [] }, { "id": "NCT00426751_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00426751_inc_T19", "arg2_id": "NCT00426751_inc_T18", "normalized": [] }, { "id": "NCT00426751_inc_R8", "type": "Has_value", "arg1_id": "NCT00426751_inc_T21", "arg2_id": "NCT00426751_inc_T24", "normalized": [] }, { "id": "NCT00426751_inc_R9", "type": "Has_value", "arg1_id": "NCT00426751_inc_T22", "arg2_id": "NCT00426751_inc_T23", "normalized": [] }, { "id": "NCT00426751_inc_R11", "type": "Has_value", "arg1_id": "NCT00426751_inc_T26", "arg2_id": "NCT00426751_inc_T27", "normalized": [] }, { "id": "NCT00426751_inc_R12", "type": "Subsumes", "arg1_id": "NCT00426751_inc_T28", "arg2_id": "NCT00426751_inc_T25", "normalized": [] }, { "id": "NCT00426751_inc_R10", "type": "Has_scope", "arg1_id": "NCT00426751_inc_T20", "arg2_id": "NCT00426751_inc_T28", "normalized": [] }, { "id": "NCT00426751_inc_R13", "type": "AND", "arg1_id": "NCT00426751_inc_T29", "arg2_id": "NCT00426751_inc_T30", "normalized": [] }, { "id": "NCT00426751_inc_R14", "type": "Has_temporal", "arg1_id": "NCT00426751_inc_T14", "arg2_id": "NCT00426751_inc_T15", "normalized": [] } ]

[ { "id": "NCT00440245_exc_text", "type": "exclusion", "text": [ "asthma and COPD\n" ], "offsets": [ [ 0, 16 ] ] } ]

[ { "id": "NCT00440245_exc_T1", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT00440245_exc_T2", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 11, 15 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT00440245_inc_text", "type": "inclusion", "text": [ "asthma or COPD\n" ], "offsets": [ [ 0, 15 ] ] } ]

[ { "id": "NCT00440245_inc_T1", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT00440245_inc_T2", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 10, 14 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT00445029_exc_text", "type": "exclusion", "text": [ "Pregnant or lactating women. \nEvolutive skin disease on the testing zone (lower back). \nPatients with a clinically significant disease (chronic, recurrent or active). \nSystemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid treatment the week before the patch testing. \nLocal or systemic drug use which interacts with the outcome measures. \nExposure to sun or UV radiations, 15 days before the patch testing. \nPatients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision. \nPatients subject to a protection measure. \nPatients in a critical medical situation. \nPatients with a personal situation judged by the investigator as unlikely to be compatible with optimal participation in the study, or which could constitute a risk for the patient. \nLinguistic barrier or psychological profile preventing the patient from signing the consent form. \nPatient still in an exclusion period following the participation in another clinical trial. \nPatients having earned more than 4500€ in indemnities for participation in clinical trials during the previous 12 months, including this study. \n \n" ], "offsets": [ [ 0, 1190 ] ] } ]

[ { "id": "NCT00445029_exc_T1", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T2", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 12, 21 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T3", "type": "Person", "text": [ "women" ], "offsets": [ [ 22, 27 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T4", "type": "Condition", "text": [ "Evolutive skin disease" ], "offsets": [ [ 30, 52 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T5", "type": "Qualifier", "text": [ "testing zone" ], "offsets": [ [ 60, 72 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T6", "type": "Qualifier", "text": [ "lower back" ], "offsets": [ [ 74, 84 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T7", "type": "Procedure", "text": [ "Systemic corticotherapy" ], "offsets": [ [ 168, 191 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T8", "type": "Procedure", "text": [ "immunosuppressive treatment" ], "offsets": [ [ 195, 222 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T9", "type": "Temporal", "text": [ "during the previous month" ], "offsets": [ [ 223, 248 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T10", "type": "Scope", "text": [ "Systemic corticotherapy or immunosuppressive treatment" ], "offsets": [ [ 168, 222 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T11", "type": "Procedure", "text": [ "local corticoid treatment" ], "offsets": [ [ 253, 278 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T12", "type": "Temporal", "text": [ "the week before" ], "offsets": [ [ 279, 294 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T13", "type": "Condition", "text": [ "Exposure to sun" ], "offsets": [ [ 386, 401 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T14", "type": "Condition", "text": [ "Exposure to", "UV radiations" ], "offsets": [ [ 386, 397 ], [ 405, 418 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T15", "type": "Temporal", "text": [ "15 days before the patch testing" ], "offsets": [ [ 420, 452 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T16", "type": "Scope", "text": [ "Exposure to sun or UV radiations" ], "offsets": [ [ 386, 418 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T17", "type": "Condition", "text": [ "deprived of their civic rights" ], "offsets": [ [ 464, 494 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T18", "type": "Condition", "text": [ "in custody" ], "offsets": [ [ 496, 506 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T19", "type": "Condition", "text": [ "subject to a tutorial" ], "offsets": [ [ 511, 532 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T20", "type": "Condition", "text": [ "subject to a", "judiciary", "decision" ], "offsets": [ [ 511, 523 ], [ 534, 543 ], [ 562, 570 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T21", "type": "Condition", "text": [ "subject to", "administrative decision" ], "offsets": [ [ 511, 521 ], [ 547, 570 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T22", "type": "Condition", "text": [ "critical medical situation" ], "offsets": [ [ 630, 656 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T23", "type": "Condition", "text": [ "subject to a protection measure" ], "offsets": [ [ 582, 613 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T24", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 104, 126 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T25", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 127, 134 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T26", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 136, 143 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T27", "type": "Qualifier", "text": [ "recurrent" ], "offsets": [ [ 145, 154 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T28", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 158, 164 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T29", "type": "Scope", "text": [ "chronic, recurrent or active" ], "offsets": [ [ 136, 164 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T30", "type": "Qualifier", "text": [ "Local" ], "offsets": [ [ 315, 320 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T31", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 324, 332 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T32", "type": "Drug", "text": [ "drug" ], "offsets": [ [ 333, 337 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T33", "type": "Qualifier", "text": [ "interacts with the outcome measures" ], "offsets": [ [ 348, 383 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T34", "type": "Scope", "text": [ "Local or systemic" ], "offsets": [ [ 315, 332 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T35", "type": "Reference_point", "text": [ "the patch testing" ], "offsets": [ [ 435, 452 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T36", "type": "Observation", "text": [ "personal situation" ], "offsets": [ [ 675, 693 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T39", "type": "Scope", "text": [ "judged by the investigator as unlikely to be compatible with optimal participation in the study, or which could constitute a risk for the patient" ], "offsets": [ [ 694, 839 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T40", "type": "Observation", "text": [ "Linguistic barrier" ], "offsets": [ [ 842, 860 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T41", "type": "Condition", "text": [ "psychological profile" ], "offsets": [ [ 864, 885 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T42", "type": "Negation", "text": [ "preventing" ], "offsets": [ [ 886, 896 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T44", "type": "Scope", "text": [ "Linguistic barrier or psychological profile" ], "offsets": [ [ 842, 885 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T46", "type": "Temporal", "text": [ "still in an exclusion period following" ], "offsets": [ [ 949, 987 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T48", "type": "Temporal", "text": [ "during the previous 12 months" ], "offsets": [ [ 1125, 1154 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T49", "type": "Reference_point", "text": [ "the previous 12 months" ], "offsets": [ [ 1132, 1154 ] ], "normalized": [] }, { "id": "NCT00445029_exc_T50", "type": "Observation", "text": [ "earned more than 4500€ in indemnities" ], "offsets": [ [ 1050, 1087 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00445029_exc_R1", "type": "Subsumes", "arg1_id": "NCT00445029_exc_T5", "arg2_id": "NCT00445029_exc_T6", "normalized": [] }, { "id": "NCT00445029_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00445029_exc_T4", "arg2_id": "NCT00445029_exc_T5", "normalized": [] }, { "id": "NCT00445029_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00445029_exc_T10", "arg2_id": "NCT00445029_exc_T9", "normalized": [] }, { "id": "NCT00445029_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00445029_exc_T16", "arg2_id": "NCT00445029_exc_T15", "normalized": [] }, { "id": "NCT00445029_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00445029_exc_T25", "arg2_id": "NCT00445029_exc_T24", "normalized": [] }, { "id": "NCT00445029_exc_R6", "type": "Subsumes", "arg1_id": "NCT00445029_exc_T24", "arg2_id": "NCT00445029_exc_T29", "normalized": [] }, { "id": "NCT00445029_exc_R7", "type": "Has_scope", "arg1_id": "NCT00445029_exc_T32", "arg2_id": "NCT00445029_exc_T34", "normalized": [] }, { "id": "NCT00445029_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00445029_exc_T32", "arg2_id": "NCT00445029_exc_T33", "normalized": [] }, { "id": "NCT00445029_exc_R9", "type": "Has_index", "arg1_id": "NCT00445029_exc_T15", "arg2_id": "NCT00445029_exc_T35", "normalized": [] }, { "id": "NCT00445029_exc_R10", "type": "Has_scope", "arg1_id": "NCT00445029_exc_T36", "arg2_id": "NCT00445029_exc_T39", "normalized": [] }, { "id": "NCT00445029_exc_R14", "type": "Has_index", "arg1_id": "NCT00445029_exc_T48", "arg2_id": "NCT00445029_exc_T49", "normalized": [] } ]

[ { "id": "NCT00445029_inc_text", "type": "inclusion", "text": [ "For both groups: \nPatients aged from 18 to 65 years old. \nBoth genders eligible for study. \nFemale participants must use a contraceptive method. \nFeasibility of patch testing. \nParticipants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol. \nPatients must be registered in a social security system or with a health insurance coverage \n First group: allergic patients \nPatients with allergic contact dermatitis to para-phenylenediamine (PPD) based on a history of PPD contact dermatitis and positive PPD patch tests. \n Second group : healthy volunteers \nNo history of PPD allergic contact dermatitis, with a negative PPD patch test. \n" ], "offsets": [ [ 0, 687 ] ] } ]

[ { "id": "NCT00445029_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 27, 31 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T2", "type": "Value", "text": [ "from 18 to 65 years old" ], "offsets": [ [ 32, 55 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T3", "type": "Person", "text": [ "Female" ], "offsets": [ [ 92, 98 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T4", "type": "Procedure", "text": [ "contraceptive method" ], "offsets": [ [ 123, 143 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T5", "type": "Condition", "text": [ "allergic contact dermatitis" ], "offsets": [ [ 435, 462 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T6", "type": "Drug", "text": [ "para-phenylenediamine (PPD)" ], "offsets": [ [ 466, 493 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T7", "type": "Condition", "text": [ "contact dermatitis" ], "offsets": [ [ 520, 538 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T8", "type": "Drug", "text": [ "PPD" ], "offsets": [ [ 516, 519 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T9", "type": "Measurement", "text": [ "PPD patch tests" ], "offsets": [ [ 552, 567 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T10", "type": "Value", "text": [ "positive" ], "offsets": [ [ 543, 551 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T11", "type": "Scope", "text": [ "PPD contact dermatitis and positive PPD patch tests" ], "offsets": [ [ 516, 567 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T12", "type": "Condition", "text": [ "allergic contact dermatitis" ], "offsets": [ [ 625, 652 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T13", "type": "Drug", "text": [ "PPD" ], "offsets": [ [ 621, 624 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T14", "type": "Negation", "text": [ "No" ], "offsets": [ [ 607, 609 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T15", "type": "Measurement", "text": [ "PPD patch test" ], "offsets": [ [ 670, 684 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T16", "type": "Value", "text": [ "negative" ], "offsets": [ [ 661, 669 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T17", "type": "Scope", "text": [ "negative PPD patch test" ], "offsets": [ [ 661, 684 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T18", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 402, 410 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T19", "type": "Observation", "text": [ "healthy" ], "offsets": [ [ 587, 594 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T20", "type": "Mood", "text": [ "Feasibility of" ], "offsets": [ [ 146, 160 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T22", "type": "Person", "text": [ "Both genders" ], "offsets": [ [ 58, 70 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T23", "type": "Mood", "text": [ "be able to" ], "offsets": [ [ 195, 205 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T26", "type": "Scope", "text": [ "understand and sign the Informed Consent, and comply with all aspects of the protocol" ], "offsets": [ [ 206, 291 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T27", "type": "Observation", "text": [ "registered in a social security system" ], "offsets": [ [ 311, 349 ] ], "normalized": [] }, { "id": "NCT00445029_inc_T28", "type": "Observation", "text": [ "health insurance coverage" ], "offsets": [ [ 360, 385 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00445029_inc_R1", "type": "Has_value", "arg1_id": "NCT00445029_inc_T1", "arg2_id": "NCT00445029_inc_T2", "normalized": [] }, { "id": "NCT00445029_inc_R2", "type": "AND", "arg1_id": "NCT00445029_inc_T3", "arg2_id": "NCT00445029_inc_T4", "normalized": [] }, { "id": "NCT00445029_inc_R3", "type": "AND", "arg1_id": "NCT00445029_inc_T5", "arg2_id": "NCT00445029_inc_T6", "normalized": [] }, { "id": "NCT00445029_inc_R4", "type": "AND", "arg1_id": "NCT00445029_inc_T7", "arg2_id": "NCT00445029_inc_T8", "normalized": [] }, { "id": "NCT00445029_inc_R5", "type": "Has_value", "arg1_id": "NCT00445029_inc_T9", "arg2_id": "NCT00445029_inc_T10", "normalized": [] }, { "id": "NCT00445029_inc_R6", "type": "Subsumes", "arg1_id": "NCT00445029_inc_T5", "arg2_id": "NCT00445029_inc_T11", "normalized": [] }, { "id": "NCT00445029_inc_R7", "type": "AND", "arg1_id": "NCT00445029_inc_T12", "arg2_id": "NCT00445029_inc_T13", "normalized": [] }, { "id": "NCT00445029_inc_R8", "type": "Has_negation", "arg1_id": "NCT00445029_inc_T12", "arg2_id": "NCT00445029_inc_T14", "normalized": [] }, { "id": "NCT00445029_inc_R9", "type": "Has_value", "arg1_id": "NCT00445029_inc_T15", "arg2_id": "NCT00445029_inc_T16", "normalized": [] }, { "id": "NCT00445029_inc_R10", "type": "Subsumes", "arg1_id": "NCT00445029_inc_T17", "arg2_id": "NCT00445029_inc_T12", "normalized": [] }, { "id": "NCT00445029_inc_R12", "type": "Has_mood", "arg1_id": "NCT00445029_inc_T26", "arg2_id": "NCT00445029_inc_T23", "normalized": [] } ]

[ { "id": "NCT00455663_exc_text", "type": "exclusion", "text": [ "History of significant head trauma, seizure disorder, or mental retardation \nHistory of alcohol or drug abuse or dependence within 1 month prior to study entry \nHistory of violence within 6 months prior to study entry \n \n" ], "offsets": [ [ 0, 230 ] ] } ]

[ { "id": "NCT00455663_exc_T1", "type": "Condition", "text": [ "head trauma" ], "offsets": [ [ 23, 34 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T2", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 36, 52 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T3", "type": "Condition", "text": [ "mental retardation" ], "offsets": [ [ 57, 75 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T4", "type": "Observation", "text": [ "History" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T5", "type": "Scope", "text": [ "head trauma, seizure disorder, or mental retardation" ], "offsets": [ [ 23, 75 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T6", "type": "Observation", "text": [ "History" ], "offsets": [ [ 77, 84 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T7", "type": "Condition", "text": [ "abuse", "alcohol" ], "offsets": [ [ 104, 109 ], [ 88, 95 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T8", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 99, 109 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T9", "type": "Condition", "text": [ "dependence", "alcohol" ], "offsets": [ [ 113, 123 ], [ 88, 95 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T10", "type": "Condition", "text": [ "dependence", "drug" ], "offsets": [ [ 113, 123 ], [ 99, 103 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T11", "type": "Temporal", "text": [ "within 1 month prior" ], "offsets": [ [ 124, 144 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T12", "type": "Scope", "text": [ "alcohol or drug abuse or dependence" ], "offsets": [ [ 88, 123 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T13", "type": "Temporal", "text": [ "within 6 months prior" ], "offsets": [ [ 181, 202 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T14", "type": "Observation", "text": [ "violence" ], "offsets": [ [ 172, 180 ] ], "normalized": [] }, { "id": "NCT00455663_exc_T15", "type": "Observation", "text": [ "History" ], "offsets": [ [ 161, 168 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00455663_exc_R1", "type": "Has_scope", "arg1_id": "NCT00455663_exc_T4", "arg2_id": "NCT00455663_exc_T5", "normalized": [] }, { "id": "NCT00455663_exc_R2", "type": "Has_scope", "arg1_id": "NCT00455663_exc_T6", "arg2_id": "NCT00455663_exc_T12", "normalized": [] }, { "id": "NCT00455663_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00455663_exc_T12", "arg2_id": "NCT00455663_exc_T11", "normalized": [] }, { "id": "NCT00455663_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00455663_exc_T14", "arg2_id": "NCT00455663_exc_T13", "normalized": [] } ]

[ { "id": "NCT00455663_inc_text", "type": "inclusion", "text": [ "Diagnosis of schizophrenia or schizoaffective disorder \nIf entering the study as an inpatient, hospitalization was recent \nCurrently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended \nAssumes primary responsibility for taking medication \nCurrently living in a stable environment \n" ], "offsets": [ [ 0, 337 ] ] } ]

[ { "id": "NCT00455663_inc_T1", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 13, 26 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T2", "type": "Condition", "text": [ "schizoaffective disorder" ], "offsets": [ [ 30, 54 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T3", "type": "Drug", "text": [ "atypical antipsychotic" ], "offsets": [ [ 161, 183 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T4", "type": "Observation", "text": [ "living in a stable environment" ], "offsets": [ [ 305, 335 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T5", "type": "Visit", "text": [ "inpatient" ], "offsets": [ [ 84, 93 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T6", "type": "Visit", "text": [ "hospitalization" ], "offsets": [ [ 95, 110 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T7", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 115, 121 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T8", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 123, 132 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T9", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 143, 152 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T10", "type": "Procedure", "text": [ "continuation on the medication" ], "offsets": [ [ 188, 218 ] ], "normalized": [] }, { "id": "NCT00455663_inc_T11", "type": "Mood", "text": [ "recommended" ], "offsets": [ [ 228, 239 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00455663_inc_R1", "type": "Has_temporal", "arg1_id": "NCT00455663_inc_T6", "arg2_id": "NCT00455663_inc_T7", "normalized": [] }, { "id": "NCT00455663_inc_R2", "type": "AND", "arg1_id": "NCT00455663_inc_T5", "arg2_id": "NCT00455663_inc_T6", "normalized": [] }, { "id": "NCT00455663_inc_R3", "type": "AND", "arg1_id": "NCT00455663_inc_T9", "arg2_id": "NCT00455663_inc_T3", "normalized": [] }, { "id": "NCT00455663_inc_R4", "type": "Has_temporal", "arg1_id": "NCT00455663_inc_T9", "arg2_id": "NCT00455663_inc_T8", "normalized": [] }, { "id": "NCT00455663_inc_R5", "type": "Has_mood", "arg1_id": "NCT00455663_inc_T10", "arg2_id": "NCT00455663_inc_T11", "normalized": [] }, { "id": "NCT00455663_inc_R6", "type": "AND", "arg1_id": "NCT00455663_inc_T10", "arg2_id": "NCT00455663_inc_T3", "normalized": [] } ]

[ { "id": "NCT00461136_exc_text", "type": "exclusion", "text": [ "Severe Hypertension Grade 3 WHO classification (Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg) \nAcetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drug (NSAIDs) \nKidney disease not caused by diabetes or hypertension \nSerum potassium < 3.5 or > 5.1 mEq/L \nGFR < 40 ml/min/1.73m2 as measured by the MDRD formula \nSerum albumin < 2.0mg/dL \nHistory of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit1. \nCurrent diagnosis of heart failure (New York Heart Association (NYHA) Class II-IV) \nHistory of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1 \nSecond or third degree heart block without a pacemaker \nConcurrent potentially life threatening arrhythmia or symptomatic arrhythmia \nClinically significant valvular heart disease \nType 1 diabetes mellitus \nUncontrolled Type II diabetes mellitus (Hemaglobin subtype A1C (HbA1C) >11 %) \nHistory of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years \nParticipation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. \nDonation or loss of 400 mL or more of blood within 8 weeks prior to dosing. \nSignificant illness within the two weeks prior to dosing. \nAny surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: \nHistory of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection \n-Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1. \nAny history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt \nCurrent treatment with cholestyramine or cholestipol resins \nHistory of immunocompromise, including a positive HIV test result. \nHistory of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. \nHistory of drug or alcohol abuse within the 12 months prior to dosing. \nPersons directly involved in the execution of this protocol. \nAny condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety \nHistory of noncompliance to medical regimens or unwillingness to comply with the study protocol \nKnown or suspected contraindications to the study medications, including history of allergy to Angiotensin converting enzyme (ACE) inhibitors and/or to thiazide diuretics or other sulfonamide derived drug \nAny surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study \nUse of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol. \nPatients who previously participated in any Aliskiren study. \nPregnant or nursing woman. \nOther protocol-defined inclusion/exclusion criteria may apply \n \n" ], "offsets": [ [ 0, 3596 ] ] } ]

[ { "id": "NCT00461136_exc_T1", "type": "Condition", "text": [ "Severe Hypertension" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T2", "type": "Measurement", "text": [ "Grade", "WHO classification" ], "offsets": [ [ 20, 25 ], [ 28, 46 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T3", "type": "Value", "text": [ "3" ], "offsets": [ [ 26, 27 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T4", "type": "Measurement", "text": [ "Mean Sitting Diastolic Blood Pressure (MSDBP)" ], "offsets": [ [ 48, 93 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T5", "type": "Value", "text": [ "110 mmHg" ], "offsets": [ [ 94, 102 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T6", "type": "Measurement", "text": [ "Mean Sitting Systolic Blood Pressure MSSBP" ], "offsets": [ [ 110, 152 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T7", "type": "Value", "text": [ "180 mmHg" ], "offsets": [ [ 153, 161 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T8", "type": "Scope", "text": [ "Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg" ], "offsets": [ [ 48, 161 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T9", "type": "Procedure", "text": [ "Acetylsalicyclic acid (ASA) treatment" ], "offsets": [ [ 164, 201 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T10", "type": "Value", "text": [ ">1g/day" ], "offsets": [ [ 202, 209 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T11", "type": "Drug", "text": [ "Non steroidal anti-inflammatory drug (NSAIDs)" ], "offsets": [ [ 228, 273 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T12", "type": "Condition", "text": [ "Kidney disease" ], "offsets": [ [ 275, 289 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T13", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 304, 312 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T14", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 316, 328 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T15", "type": "Measurement", "text": [ "Serum potassium" ], "offsets": [ [ 330, 345 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T16", "type": "Value", "text": [ "< 3.5" ], "offsets": [ [ 346, 351 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T17", "type": "Value", "text": [ "> 5.1 mEq/L" ], "offsets": [ [ 355, 366 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T18", "type": "Measurement", "text": [ "GFR" ], "offsets": [ [ 368, 371 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T19", "type": "Value", "text": [ "< 40 ml/min/1.73m2" ], "offsets": [ [ 372, 390 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T20", "type": "Qualifier", "text": [ "MDRD formula" ], "offsets": [ [ 410, 422 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T21", "type": "Measurement", "text": [ "Serum albumin" ], "offsets": [ [ 424, 437 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T22", "type": "Value", "text": [ "< 2.0mg/dL" ], "offsets": [ [ 438, 448 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T23", "type": "Condition", "text": [ "hypertensive encephalopathy" ], "offsets": [ [ 461, 488 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T24", "type": "Condition", "text": [ "cerebrovascular accident" ], "offsets": [ [ 492, 516 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T25", "type": "Observation", "text": [ "History" ], "offsets": [ [ 450, 457 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T26", "type": "Temporal", "text": [ "any time prior" ], "offsets": [ [ 520, 534 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T27", "type": "Scope", "text": [ "hypertensive encephalopathy or cerebrovascular accident" ], "offsets": [ [ 461, 516 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T28", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 568, 581 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T29", "type": "Measurement", "text": [ "New York Heart Association (NYHA) Class" ], "offsets": [ [ 583, 622 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T30", "type": "Value", "text": [ "II-IV" ], "offsets": [ [ 623, 628 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T31", "type": "Scope", "text": [ "New York Heart Association (NYHA) Class II-IV" ], "offsets": [ [ 583, 628 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T32", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 642, 663 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T33", "type": "Condition", "text": [ "unstable angina pectoris" ], "offsets": [ [ 665, 689 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T34", "type": "Condition", "text": [ "coronary bypass surgery" ], "offsets": [ [ 691, 714 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T35", "type": "Condition", "text": [ "percutaneous coronary intervention (PCI)" ], "offsets": [ [ 723, 763 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T36", "type": "Temporal", "text": [ "during the 6 months prior" ], "offsets": [ [ 764, 789 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T37", "type": "Observation", "text": [ "History" ], "offsets": [ [ 631, 638 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T38", "type": "Scope", "text": [ "myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI)" ], "offsets": [ [ 642, 763 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T39", "type": "Condition", "text": [ "third degree heart block" ], "offsets": [ [ 812, 836 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T40", "type": "Condition", "text": [ "Second", "degree heart block" ], "offsets": [ [ 802, 808 ], [ 818, 836 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T41", "type": "Device", "text": [ "pacemaker" ], "offsets": [ [ 847, 856 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T42", "type": "Negation", "text": [ "without" ], "offsets": [ [ 837, 844 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T43", "type": "Scope", "text": [ "Second or third degree heart block" ], "offsets": [ [ 802, 836 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T44", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 898, 908 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T45", "type": "Qualifier", "text": [ "potentially life threatening" ], "offsets": [ [ 869, 897 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T46", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 924, 934 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T47", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 912, 923 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T48", "type": "Condition", "text": [ "valvular heart disease" ], "offsets": [ [ 959, 981 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T49", "type": "Condition", "text": [ "Type 1 diabetes mellitus" ], "offsets": [ [ 983, 1007 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T50", "type": "Condition", "text": [ "Type II diabetes mellitus" ], "offsets": [ [ 1022, 1047 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T51", "type": "Measurement", "text": [ "Hemaglobin subtype A1C (HbA1C)" ], "offsets": [ [ 1049, 1079 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T52", "type": "Value", "text": [ ">11 %" ], "offsets": [ [ 1080, 1085 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T53", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1009, 1021 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T54", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 1099, 1109 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T55", "type": "Condition", "text": [ "leukemia" ], "offsets": [ [ 1120, 1128 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T56", "type": "Condition", "text": [ "lymphoma" ], "offsets": [ [ 1133, 1141 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T57", "type": "Condition", "text": [ "basal cell skin carcinoma" ], "offsets": [ [ 1151, 1176 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T58", "type": "Scope", "text": [ "leukemia and lymphoma" ], "offsets": [ [ 1120, 1141 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T59", "type": "Temporal", "text": [ "within the past five years" ], "offsets": [ [ 1178, 1204 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T60", "type": "Temporal", "text": [ "within 4 weeks prior to dosing" ], "offsets": [ [ 1250, 1280 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T61", "type": "Value", "text": [ "400 mL or more" ], "offsets": [ [ 1345, 1359 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T62", "type": "Temporal", "text": [ "within 8 weeks prior" ], "offsets": [ [ 1369, 1389 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T63", "type": "Procedure", "text": [ "Donation", "of blood" ], "offsets": [ [ 1325, 1333 ], [ 1360, 1368 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T64", "type": "Condition", "text": [ "loss", "of blood" ], "offsets": [ [ 1337, 1341 ], [ 1360, 1368 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T65", "type": "Condition", "text": [ "Significant illness" ], "offsets": [ [ 1402, 1421 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T66", "type": "Temporal", "text": [ "within the two weeks prior" ], "offsets": [ [ 1422, 1448 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T67", "type": "Condition", "text": [ "surgical", "condition" ], "offsets": [ [ 1465, 1473 ], [ 1485, 1494 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T68", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 1477, 1494 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T69", "type": "Scope", "text": [ "surgical or medical condition" ], "offsets": [ [ 1465, 1494 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T70", "type": "Qualifier", "text": [ "alter the absorption, distribution, metabolism, or excretion of study drugs" ], "offsets": [ [ 1521, 1596 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T71", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1651, 1658 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T72", "type": "Condition", "text": [ "major gastrointestinal tract surgery" ], "offsets": [ [ 1662, 1698 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T73", "type": "Procedure", "text": [ "gastrectomy" ], "offsets": [ [ 1707, 1718 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T74", "type": "Procedure", "text": [ "gastroenterostomy" ], "offsets": [ [ 1720, 1737 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T75", "type": "Procedure", "text": [ "bowel resection" ], "offsets": [ [ 1742, 1757 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T76", "type": "Scope", "text": [ "gastrectomy, gastroenterostomy, or bowel resection" ], "offsets": [ [ 1707, 1757 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T77", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 1798, 1824 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T78", "type": "Temporal", "text": [ "during the 12 months prior" ], "offsets": [ [ 1825, 1851 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T79", "type": "Temporal", "text": [ "Currently active" ], "offsets": [ [ 1863, 1879 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T80", "type": "Temporal", "text": [ "Currently active" ], "offsets": [ [ 1760, 1776 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T81", "type": "Temporal", "text": [ "previously active" ], "offsets": [ [ 1780, 1797 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T82", "type": "Condition", "text": [ "gastritis" ], "offsets": [ [ 1880, 1889 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T83", "type": "Condition", "text": [ "duodenal" ], "offsets": [ [ 1891, 1899 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T84", "type": "Condition", "text": [ "gastric ulcers" ], "offsets": [ [ 1903, 1917 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T85", "type": "Condition", "text": [ "gastrointestinal", "bleeding" ], "offsets": [ [ 1922, 1938 ], [ 1946, 1954 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T86", "type": "Condition", "text": [ "rectal bleeding" ], "offsets": [ [ 1939, 1954 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T87", "type": "Temporal", "text": [ "during the 3 months prior" ], "offsets": [ [ 1955, 1980 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T88", "type": "Scope", "text": [ "gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding" ], "offsets": [ [ 1880, 1954 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T89", "type": "Condition", "text": [ "pancreatic injury" ], "offsets": [ [ 2009, 2026 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T90", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1998, 2005 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T91", "type": "Condition", "text": [ "pancreatitis" ], "offsets": [ [ 2028, 2040 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T92", "type": "Measurement", "text": [ "pancreatic function" ], "offsets": [ [ 2065, 2084 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T93", "type": "Value", "text": [ "impaired" ], "offsets": [ [ 2056, 2064 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T94", "type": "Condition", "text": [ "pancreatic", "injury" ], "offsets": [ [ 2065, 2075 ], [ 2085, 2091 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T95", "type": "Measurement", "text": [ "lipase" ], "offsets": [ [ 2117, 2123 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T96", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 2108, 2116 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T97", "type": "Measurement", "text": [ "amylase" ], "offsets": [ [ 2127, 2134 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T98", "type": "Scope", "text": [ "abnormal lipase or amylase" ], "offsets": [ [ 2108, 2134 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T99", "type": "Condition", "text": [ "hepatic disease" ], "offsets": [ [ 2147, 2162 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T100", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2166, 2173 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T101", "type": "Condition", "text": [ "hepatic encephalopathy" ], "offsets": [ [ 2177, 2199 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T102", "type": "Condition", "text": [ "esophageal varices" ], "offsets": [ [ 2214, 2232 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T103", "type": "Condition", "text": [ "portocaval shunt" ], "offsets": [ [ 2250, 2266 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T104", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2239, 2246 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T105", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2203, 2210 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T106", "type": "Scope", "text": [ "pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase" ], "offsets": [ [ 2009, 2134 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T107", "type": "Drug", "text": [ "cholestyramine" ], "offsets": [ [ 2291, 2305 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T108", "type": "Drug", "text": [ "cholestipol resins" ], "offsets": [ [ 2309, 2327 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T109", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 2268, 2275 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T110", "type": "Condition", "text": [ "immunocompromise" ], "offsets": [ [ 2340, 2356 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T111", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2329, 2336 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T112", "type": "Measurement", "text": [ "HIV test" ], "offsets": [ [ 2379, 2387 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T113", "type": "Value", "text": [ "positive" ], "offsets": [ [ 2370, 2378 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T114", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2397, 2404 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T115", "type": "Measurement", "text": [ "Hepatitis B surface antigen (HBsAg)", "test" ], "offsets": [ [ 2419, 2454 ], [ 2470, 2474 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T116", "type": "Measurement", "text": [ "Hepatitis C test" ], "offsets": [ [ 2458, 2474 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T117", "type": "Value", "text": [ "positive" ], "offsets": [ [ 2410, 2418 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T118", "type": "Scope", "text": [ "positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test" ], "offsets": [ [ 2410, 2474 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T119", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2484, 2491 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T120", "type": "Condition", "text": [ "drug", "abuse" ], "offsets": [ [ 2495, 2499 ], [ 2511, 2516 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T121", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 2503, 2516 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T122", "type": "Temporal", "text": [ "within the 12 months prior" ], "offsets": [ [ 2517, 2543 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T123", "type": "Scope", "text": [ "drug or alcohol abuse" ], "offsets": [ [ 2495, 2516 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T124", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 2940, 2947 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T125", "type": "Drug", "text": [ "Angiotensin converting enzyme (ACE) inhibitors" ], "offsets": [ [ 2951, 2997 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T126", "type": "Drug", "text": [ "thiazide diuretics" ], "offsets": [ [ 3008, 3026 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T127", "type": "Drug", "text": [ "sulfonamide derived drug" ], "offsets": [ [ 3036, 3060 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T128", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 2875, 2892 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T129", "type": "Drug", "text": [ "study medications" ], "offsets": [ [ 2900, 2917 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T130", "type": "Drug", "text": [ "Aliskiren" ], "offsets": [ [ 3476, 3485 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T131", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 3494, 3502 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T132", "type": "Condition", "text": [ "nursing" ], "offsets": [ [ 3506, 3513 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T133", "type": "Person", "text": [ "woman" ], "offsets": [ [ 3514, 3519 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T135", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 1274, 1280 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T137", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 2622, 2631 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T140", "type": "Qualifier", "text": [ "that", "would jeopardize the evaluation of efficacy" ], "offsets": [ [ 2632, 2636 ], [ 2704, 2747 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T141", "type": "Qualifier", "text": [ "that", "would jeopardize", "safety" ], "offsets": [ [ 2632, 2636 ], [ 2704, 2720 ], [ 2751, 2757 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T142", "type": "Scope", "text": [ "that", "would jeopardize the evaluation of efficacy", "safety" ], "offsets": [ [ 2632, 2636 ], [ 2704, 2747 ], [ 2751, 2757 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T143", "type": "Scope", "text": [ "in the opinion of the investigator or the Novartis medical monitor" ], "offsets": [ [ 2637, 2703 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T144", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 2759, 2769 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T145", "type": "Observation", "text": [ "noncompliance to medical regimens" ], "offsets": [ [ 2770, 2803 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T146", "type": "Mood", "text": [ "unwillingness to" ], "offsets": [ [ 2807, 2823 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T148", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 2929, 2939 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T149", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 3030, 3035 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T150", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 3078, 3095 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T151", "type": "Condition", "text": [ "surgical", "condition" ], "offsets": [ [ 3066, 3074 ], [ 3086, 3095 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T153", "type": "Scope", "text": [ "surgical or medical condition" ], "offsets": [ [ 3066, 3095 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T154", "type": "Drug", "text": [ "prescription drug" ], "offsets": [ [ 3339, 3356 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T155", "type": "Drug", "text": [ "over-the-counter (OTC) medication" ], "offsets": [ [ 3360, 3393 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T156", "type": "Qualifier", "text": [ "prohibited by the protocol" ], "offsets": [ [ 3403, 3429 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T157", "type": "Scope", "text": [ "prescription drug or over-the-counter (OTC) medication" ], "offsets": [ [ 3339, 3393 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T158", "type": "Qualifier", "text": [ "place the patient at higher risk from his/her participation in the study" ], "offsets": [ [ 3143, 3215 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T159", "type": "Mood", "text": [ "likely to prevent the patient from" ], "offsets": [ [ 3223, 3257 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T161", "type": "Negation", "text": [ "prevent" ], "offsets": [ [ 3233, 3240 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T162", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 3445, 3455 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T164", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 3522, 3527 ] ], "normalized": [] }, { "id": "NCT00461136_exc_T165", "type": "Qualifier", "text": [ "protocol-defined" ], "offsets": [ [ 3528, 3544 ] ], "normalized": [] } ]

[]

[]

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"arg1_id": "NCT00461136_exc_T100", "arg2_id": "NCT00461136_exc_T101", "normalized": [] }, { "id": "NCT00461136_exc_R44", "type": "AND", "arg1_id": "NCT00461136_exc_T105", "arg2_id": "NCT00461136_exc_T102", "normalized": [] }, { "id": "NCT00461136_exc_R45", "type": "AND", "arg1_id": "NCT00461136_exc_T104", "arg2_id": "NCT00461136_exc_T103", "normalized": [] }, { "id": "NCT00461136_exc_R46", "type": "Has_temporal", "arg1_id": "NCT00461136_exc_T107", "arg2_id": "NCT00461136_exc_T109", "normalized": [] }, { "id": "NCT00461136_exc_R47", "type": "Has_temporal", "arg1_id": "NCT00461136_exc_T108", "arg2_id": "NCT00461136_exc_T109", "normalized": [] }, { "id": "NCT00461136_exc_R48", "type": "Has_value", "arg1_id": "NCT00461136_exc_T112", "arg2_id": "NCT00461136_exc_T113", "normalized": [] }, { "id": "NCT00461136_exc_R49", "type": "AND", "arg1_id": "NCT00461136_exc_T111", "arg2_id": "NCT00461136_exc_T110", "normalized": [] }, { "id": "NCT00461136_exc_R51", "type": "Has_value", "arg1_id": "NCT00461136_exc_T116", "arg2_id": "NCT00461136_exc_T117", "normalized": [] }, { "id": "NCT00461136_exc_R52", "type": "Has_value", "arg1_id": "NCT00461136_exc_T115", "arg2_id": "NCT00461136_exc_T117", "normalized": [] }, { "id": "NCT00461136_exc_R50", "type": "Has_scope", "arg1_id": "NCT00461136_exc_T114", "arg2_id": "NCT00461136_exc_T118", "normalized": [] }, { "id": "NCT00461136_exc_R53", "type": "Has_scope", "arg1_id": "NCT00461136_exc_T119", "arg2_id": "NCT00461136_exc_T123", "normalized": [] }, { "id": "NCT00461136_exc_R54", "type": "Has_temporal", "arg1_id": "NCT00461136_exc_T123", "arg2_id": "NCT00461136_exc_T122", "normalized": [] }, { "id": "NCT00461136_exc_R55", "type": "AND", "arg1_id": "NCT00461136_exc_T124", "arg2_id": "NCT00461136_exc_T125", "normalized": [] }, { "id": "NCT00461136_exc_R56", "type": "AND", "arg1_id": "NCT00461136_exc_T128", "arg2_id": "NCT00461136_exc_T129", "normalized": [] }, { "id": "NCT00461136_exc_R57", "type": "Subsumes", "arg1_id": "NCT00461136_exc_T128", "arg2_id": "NCT00461136_exc_T124", "normalized": [] }, { "id": "NCT00461136_exc_R59", "type": "Has_index", "arg1_id": "NCT00461136_exc_T60", "arg2_id": "NCT00461136_exc_T135", "normalized": [] }, { "id": "NCT00461136_exc_R60", "type": "Has_scope", "arg1_id": "NCT00461136_exc_T137", "arg2_id": "NCT00461136_exc_T142", "normalized": [] }, { "id": "NCT00461136_exc_R61", "type": "Has_scope", "arg1_id": "NCT00461136_exc_T142", "arg2_id": "NCT00461136_exc_T143", "normalized": [] }, { "id": "NCT00461136_exc_R62", "type": "Has_temporal", "arg1_id": "NCT00461136_exc_T145", "arg2_id": "NCT00461136_exc_T144", "normalized": [] }, { "id": "NCT00461136_exc_R64", "type": "Has_temporal", "arg1_id": "NCT00461136_exc_T124", "arg2_id": "NCT00461136_exc_T148", "normalized": [] }, { "id": "NCT00461136_exc_R65", "type": "Has_qualifier", "arg1_id": "NCT00461136_exc_T127", "arg2_id": "NCT00461136_exc_T149", "normalized": [] }, { "id": "NCT00461136_exc_R67", "type": "Has_qualifier", "arg1_id": "NCT00461136_exc_T157", "arg2_id": "NCT00461136_exc_T156", "normalized": [] }, { "id": "NCT00461136_exc_R68", "type": "Has_qualifier", "arg1_id": "NCT00461136_exc_T153", "arg2_id": "NCT00461136_exc_T158", "normalized": [] } ]

[ { "id": "NCT00461136_inc_text", "type": "inclusion", "text": [ "Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria). \nIncipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day). \nGlomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months. \nFemale patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening. \nTo be eligible patients must fulfill the following criteria: Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1). \nPatients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 ( Day -1). \nPatients must be willing and medically able to discontinue all Angiotensin-converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study. \nOral body temperature within the range 35.0-37.5 °C \nAble to provide written informed consent prior to study participation. . \nAble to communicate well with the investigator and comply with the requirements of the study. \n" ], "offsets": [ [ 0, 1545 ] ] } ]

[ { "id": "NCT00461136_inc_T1", "type": "Value", "text": [ "30-80 years" ], "offsets": [ [ 33, 44 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T3", "type": "Condition", "text": [ "Type 2 diabetes" ], "offsets": [ [ 72, 87 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T4", "type": "Condition", "text": [ "diabetic nephropathy" ], "offsets": [ [ 131, 151 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T7", "type": "Value", "text": [ "≤ 2000 mg/day" ], "offsets": [ [ 196, 209 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T2", "type": "Person", "text": [ "of age" ], "offsets": [ [ 45, 51 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T5", "type": "Value", "text": [ "≥ 100 mg/day" ], "offsets": [ [ 179, 191 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T6", "type": "Measurement", "text": [ "urinary albumin excretion" ], "offsets": [ [ 153, 178 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T8", "type": "Scope", "text": [ "urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day" ], "offsets": [ [ 153, 209 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T9", "type": "Measurement", "text": [ "Glomerular filtration rate (GFR)" ], "offsets": [ [ 213, 245 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T10", "type": "Value", "text": [ "≥ 40 ml/min" ], "offsets": [ [ 246, 257 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T11", "type": "Qualifier", "text": [ "Modification of Diet in Renal Disease (MDRD) formula" ], "offsets": [ [ 275, 327 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T12", "type": "Temporal", "text": [ "in the last 4 months" ], "offsets": [ [ 329, 349 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T13", "type": "Person", "text": [ "Female" ], "offsets": [ [ 352, 358 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T14", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 376, 390 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T15", "type": "Procedure", "text": [ "bilateral oophorectomy" ], "offsets": [ [ 410, 432 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T16", "type": "Procedure", "text": [ "surgically sterilized" ], "offsets": [ [ 451, 472 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T17", "type": "Procedure", "text": [ "hysterectomized" ], "offsets": [ [ 476, 491 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T18", "type": "Temporal", "text": [ "at least 6 months prior to screening" ], "offsets": [ [ 492, 528 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T19", "type": "Scope", "text": [ "surgically sterilized or hysterectomized" ], "offsets": [ [ 451, 491 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T20", "type": "Scope", "text": [ "postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening" ], "offsets": [ [ 376, 528 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T21", "type": "Procedure", "text": [ "hypertensive therapy" ], "offsets": [ [ 612, 632 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T22", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 645, 659 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T23", "type": "Value", "text": [ "≥ 135/85 mm Hg" ], "offsets": [ [ 660, 674 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T24", "type": "Value", "text": [ "lower than 170/105 mm Hg" ], "offsets": [ [ 679, 703 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T25", "type": "Scope", "text": [ "≥ 135/85 mm Hg but lower than 170/105 mm Hg" ], "offsets": [ [ 660, 703 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T26", "type": "Drug", "text": [ "antihypertensive medications" ], "offsets": [ [ 756, 784 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T27", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 749, 755 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T28", "type": "Temporal", "text": [ "at least 8 weeks prior to baseline" ], "offsets": [ [ 789, 823 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T29", "type": "Qualifier", "text": [ "Newly diagnosed" ], "offsets": [ [ 835, 850 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T30", "type": "Condition", "text": [ "hypertensive patients" ], "offsets": [ [ 851, 872 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T31", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 885, 899 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T32", "type": "Value", "text": [ "≥ 135/85 mm Hg" ], "offsets": [ [ 900, 914 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T33", "type": "Value", "text": [ "lower than 170/105 mm Hg" ], "offsets": [ [ 919, 943 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T34", "type": "Scope", "text": [ "≥ 135/85 mm Hg but lower than 170/105 mm Hg" ], "offsets": [ [ 900, 943 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T35", "type": "Drug", "text": [ "hypoglycemic medications" ], "offsets": [ [ 994, 1018 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T36", "type": "Temporal", "text": [ "at least 8 weeks prior to Visit 2" ], "offsets": [ [ 1023, 1056 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T37", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 987, 993 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T39", "type": "Measurement", "text": [ "Oral body temperature" ], "offsets": [ [ 1323, 1344 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T40", "type": "Value", "text": [ "35.0-37.5 °C" ], "offsets": [ [ 1362, 1374 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T43", "type": "Scope", "text": [ "Newly diagnosed hypertensive patients" ], "offsets": [ [ 835, 872 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T44", "type": "Temporal", "text": [ "at baseline (Day -1)" ], "offsets": [ [ 944, 964 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T45", "type": "Reference_point", "text": [ "baseline (Day -1)" ], "offsets": [ [ 947, 964 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T46", "type": "Reference_point", "text": [ "baseline" ], "offsets": [ [ 815, 823 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T47", "type": "Reference_point", "text": [ "Visit 2" ], "offsets": [ [ 1049, 1056 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T41", "type": "Observation", "text": [ "written informed consent" ], "offsets": [ [ 1392, 1416 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T48", "type": "Temporal", "text": [ "prior to study participation" ], "offsets": [ [ 1417, 1445 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T49", "type": "Reference_point", "text": [ "study participation" ], "offsets": [ [ 1426, 1445 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T42", "type": "Observation", "text": [ "Able to communicate well" ], "offsets": [ [ 1450, 1474 ] ], "normalized": [] }, { "id": "NCT00461136_inc_T50", "type": "Observation", "text": [ "comply with the requirements of the study" ], "offsets": [ [ 1501, 1542 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00461136_inc_R1", "type": "Has_value", "arg1_id": "NCT00461136_inc_T2", "arg2_id": "NCT00461136_inc_T1", "normalized": [] }, { "id": "NCT00461136_inc_R2", "type": "Has_value", "arg1_id": "NCT00461136_inc_T6", "arg2_id": "NCT00461136_inc_T5", "normalized": [] }, { "id": "NCT00461136_inc_R4", "type": "Subsumes", "arg1_id": "NCT00461136_inc_T4", "arg2_id": "NCT00461136_inc_T8", "normalized": [] }, { "id": "NCT00461136_inc_R5", "type": "Has_value", "arg1_id": "NCT00461136_inc_T9", "arg2_id": "NCT00461136_inc_T10", "normalized": [] }, { "id": "NCT00461136_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00461136_inc_T9", "arg2_id": "NCT00461136_inc_T11", "normalized": [] }, { "id": "NCT00461136_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T9", "arg2_id": "NCT00461136_inc_T12", "normalized": [] }, { "id": "NCT00461136_inc_R9", "type": "OR", "arg1_id": "NCT00461136_inc_T16", "arg2_id": "NCT00461136_inc_T17", "normalized": [] }, { "id": "NCT00461136_inc_R10", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T19", "arg2_id": "NCT00461136_inc_T18", "normalized": [] }, { "id": "NCT00461136_inc_R11", "type": "OR", "arg1_id": "NCT00461136_inc_T15", "arg2_id": "NCT00461136_inc_T19", "normalized": [] }, { "id": "NCT00461136_inc_R8", "type": "OR", "arg1_id": "NCT00461136_inc_T14", "arg2_id": "NCT00461136_inc_T15", "normalized": [] }, { "id": "NCT00461136_inc_R12", "type": "Has_scope", "arg1_id": "NCT00461136_inc_T13", "arg2_id": "NCT00461136_inc_T20", "normalized": [] }, { "id": "NCT00461136_inc_R14", "type": "AND", "arg1_id": "NCT00461136_inc_T21", "arg2_id": "NCT00461136_inc_T22", "normalized": [] }, { "id": "NCT00461136_inc_R15", "type": "Has_scope", "arg1_id": "NCT00461136_inc_T22", "arg2_id": "NCT00461136_inc_T25", "normalized": [] }, { "id": "NCT00461136_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT00461136_inc_T26", "arg2_id": "NCT00461136_inc_T27", "normalized": [] }, { "id": "NCT00461136_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T26", "arg2_id": "NCT00461136_inc_T28", "normalized": [] }, { "id": "NCT00461136_inc_R19", "type": "Has_scope", "arg1_id": "NCT00461136_inc_T31", "arg2_id": "NCT00461136_inc_T34", "normalized": [] }, { "id": "NCT00461136_inc_R20", "type": "Has_qualifier", "arg1_id": "NCT00461136_inc_T30", "arg2_id": "NCT00461136_inc_T29", "normalized": [] }, { "id": "NCT00461136_inc_R21", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T35", "arg2_id": "NCT00461136_inc_T36", "normalized": [] }, { "id": "NCT00461136_inc_R22", "type": "Has_qualifier", "arg1_id": "NCT00461136_inc_T35", "arg2_id": "NCT00461136_inc_T37", "normalized": [] }, { "id": "NCT00461136_inc_R23", "type": "Has_value", "arg1_id": "NCT00461136_inc_T39", "arg2_id": "NCT00461136_inc_T40", "normalized": [] }, { "id": "NCT00461136_inc_R3", "type": "Has_value", "arg1_id": "NCT00461136_inc_T6", "arg2_id": "NCT00461136_inc_T7", "normalized": [] }, { "id": "NCT00461136_inc_R13", "type": "AND", "arg1_id": "NCT00461136_inc_T43", "arg2_id": "NCT00461136_inc_T31", "normalized": [] }, { "id": "NCT00461136_inc_R18", "type": "Has_index", "arg1_id": "NCT00461136_inc_T44", "arg2_id": "NCT00461136_inc_T45", "normalized": [] }, { "id": "NCT00461136_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T31", "arg2_id": "NCT00461136_inc_T44", "normalized": [] }, { "id": "NCT00461136_inc_R25", "type": "Has_index", "arg1_id": "NCT00461136_inc_T28", "arg2_id": "NCT00461136_inc_T46", "normalized": [] }, { "id": "NCT00461136_inc_R26", "type": "Has_index", "arg1_id": "NCT00461136_inc_T36", "arg2_id": "NCT00461136_inc_T47", "normalized": [] }, { "id": "NCT00461136_inc_R27", "type": "Has_index", "arg1_id": "NCT00461136_inc_T48", "arg2_id": "NCT00461136_inc_T49", "normalized": [] }, { "id": "NCT00461136_inc_R28", "type": "Has_temporal", "arg1_id": "NCT00461136_inc_T41", "arg2_id": "NCT00461136_inc_T48", "normalized": [] } ]

[ { "id": "NCT00480129_exc_text", "type": "exclusion", "text": [ "Ongoing allergen immunotherapy \nupper respiratory tract infection \nPregnancy \nClinical history of lactose-intolerance or allergies to cow-milk \n \n" ], "offsets": [ [ 0, 155 ] ] } ]

[ { "id": "NCT00480129_exc_T1", "type": "Procedure", "text": [ "allergen immunotherapy" ], "offsets": [ [ 8, 30 ] ], "normalized": [] }, { "id": "NCT00480129_exc_T2", "type": "Condition", "text": [ "upper respiratory tract infection" ], "offsets": [ [ 32, 65 ] ], "normalized": [] }, { "id": "NCT00480129_exc_T3", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 67, 76 ] ], "normalized": [] }, { "id": "NCT00480129_exc_T4", "type": "Condition", "text": [ "lactose-intolerance" ], "offsets": [ [ 98, 117 ] ], "normalized": [] }, { "id": "NCT00480129_exc_T5", "type": "Condition", "text": [ "allergies to cow-milk" ], "offsets": [ [ 121, 142 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00480129_exc_R1", "type": "OR", "arg1_id": "NCT00480129_exc_T4", "arg2_id": "NCT00480129_exc_T5", "normalized": [] } ]

[ { "id": "NCT00480129_inc_text", "type": "inclusion", "text": [ "Clinical diagnosis of allergic rhinitis based on sneeze attacks, runny/blocked/itchy nose in the absence of a common cold during the previous 12 months. \nHistory of positive skin prick test or blood radio-allergosorbent test (RAST) to grass and/or ragweed pollen \n" ], "offsets": [ [ 0, 264 ] ] } ]

[ { "id": "NCT00480129_inc_T1", "type": "Condition", "text": [ "allergic rhinitis" ], "offsets": [ [ 22, 39 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T2", "type": "Condition", "text": [ "sneeze attacks" ], "offsets": [ [ 49, 63 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T3", "type": "Condition", "text": [ "runny", "nose" ], "offsets": [ [ 65, 70 ], [ 85, 89 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T4", "type": "Condition", "text": [ "blocked", "nose" ], "offsets": [ [ 71, 78 ], [ 85, 89 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T5", "type": "Condition", "text": [ "itchy nose" ], "offsets": [ [ 79, 89 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T6", "type": "Condition", "text": [ "common cold" ], "offsets": [ [ 110, 121 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T7", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 97, 104 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T8", "type": "Temporal", "text": [ "during the previous 12 months" ], "offsets": [ [ 122, 151 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T9", "type": "Measurement", "text": [ "skin prick test" ], "offsets": [ [ 174, 189 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T10", "type": "Value", "text": [ "positive" ], "offsets": [ [ 165, 173 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T11", "type": "Measurement", "text": [ "blood radio-allergosorbent test (RAST)" ], "offsets": [ [ 193, 231 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T12", "type": "Qualifier", "text": [ "grass" ], "offsets": [ [ 235, 240 ] ], "normalized": [] }, { "id": "NCT00480129_inc_T13", "type": "Qualifier", "text": [ "ragweed pollen" ], "offsets": [ [ 248, 262 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00480129_inc_R1", "type": "Subsumes", "arg1_id": "NCT00480129_inc_T1", "arg2_id": "NCT00480129_inc_T2", "normalized": [] }, { "id": "NCT00480129_inc_R2", "type": "Has_negation", "arg1_id": "NCT00480129_inc_T6", "arg2_id": "NCT00480129_inc_T7", "normalized": [] }, { "id": "NCT00480129_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00480129_inc_T6", "arg2_id": "NCT00480129_inc_T8", "normalized": [] }, { "id": "NCT00480129_inc_R4", "type": "OR", "arg1_id": "NCT00480129_inc_T1", "arg2_id": "NCT00480129_inc_T3", "normalized": [] }, { "id": "NCT00480129_inc_R5", "type": "OR", "arg1_id": "NCT00480129_inc_T4", "arg2_id": "NCT00480129_inc_T3", "normalized": [] }, { "id": "NCT00480129_inc_R6", "type": "OR", "arg1_id": "NCT00480129_inc_T5", "arg2_id": "NCT00480129_inc_T3", "normalized": [] }, { "id": "NCT00480129_inc_R7", "type": "Has_value", "arg1_id": "NCT00480129_inc_T9", "arg2_id": "NCT00480129_inc_T10", "normalized": [] }, { "id": "NCT00480129_inc_R8", "type": "Has_value", "arg1_id": "NCT00480129_inc_T11", "arg2_id": "NCT00480129_inc_T10", "normalized": [] }, { "id": "NCT00480129_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT00480129_inc_T11", "arg2_id": "NCT00480129_inc_T12", "normalized": [] } ]

[ { "id": "NCT00483106_exc_text", "type": "exclusion", "text": [ "Psychosis\nTourette syndrome\nIntelligence quotient (IQ) < 70\nPervasive developmental disorder (PDD)\n" ], "offsets": [ [ 0, 99 ] ] } ]

[ { "id": "NCT00483106_exc_T1", "type": "Condition", "text": [ "Psychosis" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T2", "type": "Condition", "text": [ "Tourette syndrome" ], "offsets": [ [ 10, 27 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T3", "type": "Measurement", "text": [ "Intelligence quotient" ], "offsets": [ [ 28, 49 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T4", "type": "Measurement", "text": [ "IQ" ], "offsets": [ [ 51, 53 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T5", "type": "Value", "text": [ "< 70" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T6", "type": "Condition", "text": [ "Pervasive developmental disorder" ], "offsets": [ [ 60, 92 ] ], "normalized": [] }, { "id": "NCT00483106_exc_T7", "type": "Condition", "text": [ "PDD" ], "offsets": [ [ 94, 97 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00483106_exc_R1", "type": "Subsumes", "arg1_id": "NCT00483106_exc_T3", "arg2_id": "NCT00483106_exc_T4", "normalized": [] }, { "id": "NCT00483106_exc_R2", "type": "Has_value", "arg1_id": "NCT00483106_exc_T3", "arg2_id": "NCT00483106_exc_T5", "normalized": [] }, { "id": "NCT00483106_exc_R3", "type": "Subsumes", "arg1_id": "NCT00483106_exc_T6", "arg2_id": "NCT00483106_exc_T7", "normalized": [] } ]

[ { "id": "NCT00483106_inc_text", "type": "inclusion", "text": [ "ADHD\n" ], "offsets": [ [ 0, 5 ] ] } ]

[ { "id": "NCT00483106_inc_T1", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 0, 4 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT00500500_exc_text", "type": "exclusion", "text": [ "patient already treated by medicines which could interfere with the study \nlow level of vitamin B12 and folate which are considered as clinically relevant \nclinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness….) \n \n" ], "offsets": [ [ 0, 305 ] ] } ]

[ { "id": "NCT00500500_exc_T2", "type": "Measurement", "text": [ "level of vitamin B12" ], "offsets": [ [ 79, 99 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T3", "type": "Value", "text": [ "low" ], "offsets": [ [ 75, 78 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T4", "type": "Measurement", "text": [ "folate", "level of" ], "offsets": [ [ 104, 110 ], [ 79, 87 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T5", "type": "Condition", "text": [ "pulmonary illness" ], "offsets": [ [ 193, 210 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T6", "type": "Condition", "text": [ "cardiovascular illness" ], "offsets": [ [ 212, 234 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T7", "type": "Condition", "text": [ "evolutive cancer" ], "offsets": [ [ 236, 252 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T8", "type": "Condition", "text": [ "neurological illness" ], "offsets": [ [ 254, 274 ] ], "normalized": [] }, { "id": "NCT00500500_exc_T9", "type": "Condition", "text": [ "blood illness" ], "offsets": [ [ 276, 289 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00500500_exc_R1", "type": "Has_value", "arg1_id": "NCT00500500_exc_T2", "arg2_id": "NCT00500500_exc_T3", "normalized": [] }, { "id": "NCT00500500_exc_R2", "type": "Has_value", "arg1_id": "NCT00500500_exc_T4", "arg2_id": "NCT00500500_exc_T3", "normalized": [] } ]

[ { "id": "NCT00500500_inc_text", "type": "inclusion", "text": [ "female or male of 50 to 85 years old with a care giver \nMini Mental Status (MMS) test between 16 to 26 inclusive \nClinical Dementia Rating (CDR) test inferior or equal to 1 \nNational Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease \nDiagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia \n" ], "offsets": [ [ 0, 465 ] ] } ]

[ { "id": "NCT00500500_inc_T1", "type": "Value", "text": [ "50 to 85 years" ], "offsets": [ [ 18, 32 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T3", "type": "Measurement", "text": [ "Mini Mental Status (MMS) tes" ], "offsets": [ [ 56, 84 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T4", "type": "Value", "text": [ "between 16 to 26 inclusive" ], "offsets": [ [ 86, 112 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T5", "type": "Measurement", "text": [ "Clinical Dementia Rating (CDR) test" ], "offsets": [ [ 114, 149 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T6", "type": "Value", "text": [ "inferior or equal to 1" ], "offsets": [ [ 150, 172 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T7", "type": "Measurement", "text": [ "National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test" ], "offsets": [ [ 174, 323 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T8", "type": "Value", "text": [ "positive" ], "offsets": [ [ 324, 332 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T9", "type": "Measurement", "text": [ "Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test" ], "offsets": [ [ 361, 441 ] ], "normalized": [] }, { "id": "NCT00500500_inc_T10", "type": "Value", "text": [ "positive" ], "offsets": [ [ 442, 450 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00500500_inc_R1", "type": "Has_value", "arg1_id": "NCT00500500_inc_T2", "arg2_id": "NCT00500500_inc_T1", "normalized": [] }, { "id": "NCT00500500_inc_R2", "type": "Has_value", "arg1_id": "NCT00500500_inc_T3", "arg2_id": "NCT00500500_inc_T4", "normalized": [] }, { "id": "NCT00500500_inc_R3", "type": "Has_value", "arg1_id": "NCT00500500_inc_T5", "arg2_id": "NCT00500500_inc_T6", "normalized": [] }, { "id": "NCT00500500_inc_R4", "type": "Has_value", "arg1_id": "NCT00500500_inc_T7", "arg2_id": "NCT00500500_inc_T8", "normalized": [] }, { "id": "NCT00500500_inc_R5", "type": "Has_value", "arg1_id": "NCT00500500_inc_T9", "arg2_id": "NCT00500500_inc_T10", "normalized": [] } ]

[ { "id": "NCT00502567_exc_text", "type": "exclusion", "text": [ "Inadequate bone marrow reserve \nhistory of poorly controlled hypertension \n \n" ], "offsets": [ [ 0, 86 ] ] } ]

[ { "id": "NCT00502567_exc_T1", "type": "Condition", "text": [ "Inadequate bone marrow reserve" ], "offsets": [ [ 0, 30 ] ], "normalized": [] }, { "id": "NCT00502567_exc_T2", "type": "Condition", "text": [ "poorly controlled hypertension" ], "offsets": [ [ 43, 73 ] ], "normalized": [] }, { "id": "NCT00502567_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 32, 39 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00502567_exc_R1", "type": "AND", "arg1_id": "NCT00502567_exc_T3", "arg2_id": "NCT00502567_exc_T2", "normalized": [] } ]

[ { "id": "NCT00502567_inc_text", "type": "inclusion", "text": [ "histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent \nmeasurable lesion by CT or other techniques according to RECIST \n" ], "offsets": [ [ 0, 183 ] ] } ]

[ { "id": "NCT00502567_inc_T1", "type": "Condition", "text": [ "metastatic cancer" ], "offsets": [ [ 25, 42 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T2", "type": "Measurement", "text": [ "histologically" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T3", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 15, 24 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T5", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 78, 95 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T4", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 67, 74 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T6", "type": "Qualifier", "text": [ "not amenable" ], "offsets": [ [ 51, 63 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T7", "type": "Scope", "text": [ "surgery or radiation therapy" ], "offsets": [ [ 67, 95 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T8", "type": "Procedure", "text": [ "CT" ], "offsets": [ [ 139, 141 ] ], "normalized": [] }, { "id": "NCT00502567_inc_T9", "type": "Condition", "text": [ "measurable lesion" ], "offsets": [ [ 118, 135 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00502567_inc_R1", "type": "Has_value", "arg1_id": "NCT00502567_inc_T2", "arg2_id": "NCT00502567_inc_T3", "normalized": [] }, { "id": "NCT00502567_inc_R2", "type": "AND", "arg1_id": "NCT00502567_inc_T1", "arg2_id": "NCT00502567_inc_T2", "normalized": [] }, { "id": "NCT00502567_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00502567_inc_T4", "arg2_id": "NCT00502567_inc_T6", "normalized": [] }, { "id": "NCT00502567_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00502567_inc_T5", "arg2_id": "NCT00502567_inc_T6", "normalized": [] }, { "id": "NCT00502567_inc_R5", "type": "Has_scope", "arg1_id": "NCT00502567_inc_T1", "arg2_id": "NCT00502567_inc_T7", "normalized": [] }, { "id": "NCT00502567_inc_R6", "type": "AND", "arg1_id": "NCT00502567_inc_T9", "arg2_id": "NCT00502567_inc_T8", "normalized": [] } ]

[ { "id": "NCT00527826_exc_text", "type": "exclusion", "text": [ "Known other respiratory disorders or signs for other respiratory disorders (e.g. asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis). \nKnown history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and systemic lupus erythematosus). \nKnown to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ) \nHaving undergone lung surgery (e.g. lung resection including lung volume reduction surgery, lung transplant) or subjects scheduled for surgery. \nConcurrent medication from Visit 1 and for the duration of the study with any of the prohibited medications: monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor). \nSubjects receiving chronic or prophylactic antibiotic therapy. \nSerious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety. \nHave, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. \nHistory of depression. \nHistory or presence of clinically significant drug sensitivity or clinically significant allergic reaction to corticosteroids or salmeterol. \nModerate or severe COPD exacerbation (requiring corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalization) within the 4 weeks prior to Visit 1 \nLower respiratory tract infection within the 4 weeks prior to Visit 1 . \nPregnant or lactating female and female of childbearing potential. \nSubject is a participating investigator, sub-investigator, study coordinator, or other employee of a participating investigator, or is an immediate family member of the before mentioned. Subject is an employee of GlaxoSmithKline (GSK). \nSubject participated in an investigational drug study within 30 days prior to Visit 1 \n \n" ], "offsets": [ [ 0, 1864 ] ] } ]

[ { "id": "NCT00527826_exc_T1", "type": "Condition", "text": [ "respiratory disorders" ], "offsets": [ [ 12, 33 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T2", "type": "Condition", "text": [ "signs for", "respiratory disorders" ], "offsets": [ [ 37, 46 ], [ 53, 74 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T3", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 81, 87 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T4", "type": "Condition", "text": [ "lung cancer" ], "offsets": [ [ 89, 100 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T5", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 102, 113 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T6", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 115, 127 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T7", "type": "Condition", "text": [ "lung fibrosis" ], "offsets": [ [ 129, 142 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T8", "type": "Condition", "text": [ "cystic fibrosis" ], "offsets": [ [ 144, 159 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T9", "type": "Condition", "text": [ "bronchoectasis" ], "offsets": [ [ 161, 175 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T10", "type": "Scope", "text": [ "asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis" ], "offsets": [ [ 81, 175 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T11", "type": "Scope", "text": [ "respiratory disorders or signs for other respiratory disorders" ], "offsets": [ [ 12, 74 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T12", "type": "Condition", "text": [ "inflammatory disease" ], "offsets": [ [ 208, 228 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T13", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 241, 245 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T14", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 252, 272 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T15", "type": "Condition", "text": [ "systemic lupus erythematosus" ], "offsets": [ [ 277, 305 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T16", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 230, 240 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T17", "type": "Condition", "text": [ "alpha-1-antitrypsin deficient" ], "offsets": [ [ 330, 359 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T18", "type": "Procedure", "text": [ "lung surgery" ], "offsets": [ [ 392, 404 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T19", "type": "Procedure", "text": [ "lung resection" ], "offsets": [ [ 411, 425 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T20", "type": "Procedure", "text": [ "lung volume reduction surgery" ], "offsets": [ [ 436, 465 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T21", "type": "Procedure", "text": [ "lung transplant" ], "offsets": [ [ 467, 482 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T22", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 510, 517 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T23", "type": "Observation", "text": [ "scheduled" ], "offsets": [ [ 496, 505 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T24", "type": "Drug", "text": [ "medication from Visit 1" ], "offsets": [ [ 531, 554 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T25", "type": "Drug", "text": [ "monoamine oxidase inhibitors" ], "offsets": [ [ 629, 657 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T26", "type": "Drug", "text": [ "tricyclic antidepressants" ], "offsets": [ [ 662, 687 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T27", "type": "Drug", "text": [ "ritonavir" ], "offsets": [ [ 693, 702 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T28", "type": "Drug", "text": [ "cytochrome P450 3A4 inhibitor" ], "offsets": [ [ 720, 749 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T29", "type": "Scope", "text": [ "monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor)" ], "offsets": [ [ 629, 750 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T30", "type": "Procedure", "text": [ "prophylactic antibiotic therapy" ], "offsets": [ [ 783, 814 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T31", "type": "Procedure", "text": [ "chronic", "antibiotic therapy" ], "offsets": [ [ 772, 779 ], [ 796, 814 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T32", "type": "Condition", "text": [ "uncontrolled disease" ], "offsets": [ [ 826, 846 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T33", "type": "Condition", "text": [ "psychological disorders" ], "offsets": [ [ 866, 889 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T34", "type": "Condition", "text": [ "alcohol", "abuse" ], "offsets": [ [ 1010, 1017 ], [ 1035, 1040 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T35", "type": "Condition", "text": [ "drug", "abuse" ], "offsets": [ [ 1019, 1023 ], [ 1035, 1040 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T36", "type": "Condition", "text": [ "solvent abuse" ], "offsets": [ [ 1027, 1040 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T37", "type": "Condition", "text": [ "drug sensitivity" ], "offsets": [ [ 1113, 1129 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T38", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 1156, 1173 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T39", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 1177, 1192 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T40", "type": "Drug", "text": [ "salmeterol" ], "offsets": [ [ 1196, 1206 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T41", "type": "Scope", "text": [ "corticosteroids or salmeterol" ], "offsets": [ [ 1177, 1206 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T42", "type": "Scope", "text": [ "drug sensitivity or clinically significant allergic reaction" ], "offsets": [ [ 1113, 1173 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T43", "type": "Condition", "text": [ "COPD exacerbation" ], "offsets": [ [ 1228, 1245 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T44", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1221, 1227 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T45", "type": "Qualifier", "text": [ "Moderate" ], "offsets": [ [ 1209, 1217 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T46", "type": "Scope", "text": [ "Moderate or severe" ], "offsets": [ [ 1209, 1227 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T47", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 1257, 1272 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T48", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 1296, 1311 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T49", "type": "Qualifier", "text": [ "increased dosage" ], "offsets": [ [ 1276, 1292 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T50", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 1319, 1330 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T51", "type": "Visit", "text": [ "hospitalization" ], "offsets": [ [ 1334, 1349 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T52", "type": "Scope", "text": [ "corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalization" ], "offsets": [ [ 1257, 1349 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T53", "type": "Temporal", "text": [ "within the 4 weeks prior to Visit 1" ], "offsets": [ [ 1351, 1386 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T54", "type": "Condition", "text": [ "Lower respiratory tract infection" ], "offsets": [ [ 1388, 1421 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T55", "type": "Temporal", "text": [ "within the 4 weeks prior to Visit 1" ], "offsets": [ [ 1422, 1457 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T56", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1461, 1469 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T57", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1473, 1482 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T58", "type": "Person", "text": [ "female" ], "offsets": [ [ 1483, 1489 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T59", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1504, 1526 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T60", "type": "Person", "text": [ "female" ], "offsets": [ [ 1494, 1500 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T61", "type": "Scope", "text": [ "rheumatoid arthritis and systemic lupus erythematosus" ], "offsets": [ [ 252, 305 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T62", "type": "Scope", "text": [ "inflammatory disease, other than COPD" ], "offsets": [ [ 208, 245 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T63", "type": "Scope", "text": [ "lung volume reduction surgery, lung transplant" ], "offsets": [ [ 436, 482 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T64", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 1379, 1386 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T65", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 1450, 1457 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T67", "type": "Observation", "text": [ "participated in an investigational drug study" ], "offsets": [ [ 1774, 1819 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T68", "type": "Temporal", "text": [ "within 30 days prior to Visit 1" ], "offsets": [ [ 1820, 1851 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T69", "type": "Reference_point", "text": [ "Visit 1" ], "offsets": [ [ 1844, 1851 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T70", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 196, 207 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T71", "type": "Qualifier", "text": [ "severely" ], "offsets": [ [ 321, 329 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T72", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 1043, 1053 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T73", "type": "Condition", "text": [ "depression" ], "offsets": [ [ 1054, 1064 ] ], "normalized": [] }, { "id": "NCT00527826_exc_T75", "type": "Scope", "text": [ "alcohol, drug or solvent abuse" ], "offsets": [ [ 1010, 1040 ] ], "normalized": [] } ]

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[ { "id": "NCT00527826_exc_R1", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T11", "arg2_id": "NCT00527826_exc_T10", "normalized": [] }, { "id": "NCT00527826_exc_R2", "type": "Has_negation", "arg1_id": "NCT00527826_exc_T13", "arg2_id": "NCT00527826_exc_T16", "normalized": [] }, { "id": "NCT00527826_exc_R4", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T18", "arg2_id": "NCT00527826_exc_T19", "normalized": [] }, { "id": "NCT00527826_exc_R5", "type": "AND", "arg1_id": "NCT00527826_exc_T23", "arg2_id": "NCT00527826_exc_T22", "normalized": [] }, { "id": "NCT00527826_exc_R6", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T27", "arg2_id": "NCT00527826_exc_T28", "normalized": [] }, { "id": "NCT00527826_exc_R7", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T24", "arg2_id": "NCT00527826_exc_T29", "normalized": [] }, { "id": "NCT00527826_exc_R8", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T32", "arg2_id": "NCT00527826_exc_T33", "normalized": [] }, { "id": "NCT00527826_exc_R9", "type": "Has_scope", "arg1_id": "NCT00527826_exc_T42", "arg2_id": "NCT00527826_exc_T41", "normalized": [] }, { "id": "NCT00527826_exc_R10", "type": "Has_scope", "arg1_id": "NCT00527826_exc_T43", "arg2_id": "NCT00527826_exc_T46", "normalized": [] }, { "id": "NCT00527826_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00527826_exc_T48", "arg2_id": "NCT00527826_exc_T49", "normalized": [] }, { "id": "NCT00527826_exc_R12", "type": "AND", "arg1_id": "NCT00527826_exc_T48", "arg2_id": "NCT00527826_exc_T47", "normalized": [] }, { "id": "NCT00527826_exc_R13", "type": "Has_scope", "arg1_id": "NCT00527826_exc_T43", "arg2_id": "NCT00527826_exc_T52", "normalized": [] }, { "id": "NCT00527826_exc_R14", "type": "AND", "arg1_id": "NCT00527826_exc_T12", "arg2_id": "NCT00527826_exc_T13", "normalized": [] }, { "id": "NCT00527826_exc_R15", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T62", "arg2_id": "NCT00527826_exc_T61", "normalized": [] }, { "id": "NCT00527826_exc_R3", "type": "Subsumes", "arg1_id": "NCT00527826_exc_T19", "arg2_id": "NCT00527826_exc_T63", "normalized": [] }, { "id": "NCT00527826_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00527826_exc_T43", "arg2_id": "NCT00527826_exc_T53", "normalized": [] }, { "id": "NCT00527826_exc_R17", "type": "Has_index", "arg1_id": "NCT00527826_exc_T53", "arg2_id": "NCT00527826_exc_T64", "normalized": [] }, { "id": "NCT00527826_exc_R18", "type": "Has_index", "arg1_id": "NCT00527826_exc_T55", "arg2_id": "NCT00527826_exc_T65", "normalized": [] }, { "id": "NCT00527826_exc_R19", "type": "Has_temporal", "arg1_id": "NCT00527826_exc_T54", "arg2_id": "NCT00527826_exc_T55", "normalized": [] }, { "id": "NCT00527826_exc_R20", "type": "Has_index", "arg1_id": "NCT00527826_exc_T68", "arg2_id": "NCT00527826_exc_T69", "normalized": [] }, { "id": "NCT00527826_exc_R21", "type": "Has_temporal", "arg1_id": "NCT00527826_exc_T67", "arg2_id": "NCT00527826_exc_T68", "normalized": [] }, { "id": "NCT00527826_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT00527826_exc_T62", "arg2_id": "NCT00527826_exc_T70", "normalized": [] }, { "id": "NCT00527826_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT00527826_exc_T17", "arg2_id": "NCT00527826_exc_T71", "normalized": [] }, { "id": "NCT00527826_exc_R24", "type": "Has_temporal", "arg1_id": "NCT00527826_exc_T73", "arg2_id": "NCT00527826_exc_T72", "normalized": [] } ]

[ { "id": "NCT00527826_inc_text", "type": "inclusion", "text": [ "Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria. \nMale or female subjects, aged >=40 years. Females must be of Non Child Bearing Potential. The definition of Non Child Bearing Potential is as following: Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal. \nHave diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator Forced Expiratory Volume, measured at 1 second (FEV1) <50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (IVC) ratio <70%. \nHave experienced at least 2 moderate or severe COPD exacerbations leading to medical consultation (requiring oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding Visit 1. \nHave stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication). \nCurrent or ex-smokers with a smoking history of at least 10 pack years (number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). \nAre currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale. \nA signed and dated written informed consent is obtained prior to participation. \nAble to comply with the requirements of the protocol and be available for study visits over 52 weeks. \n" ], "offsets": [ [ 0, 1988 ] ] } ]

[ { "id": "NCT00527826_inc_T1", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 33, 37 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T2", "type": "Measurement", "text": [ "American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria" ], "offsets": [ [ 51, 127 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T3", "type": "Value", "text": [ ">=40 years" ], "offsets": [ [ 160, 170 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 155, 159 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T5", "type": "Person", "text": [ "Male" ], "offsets": [ [ 130, 134 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T6", "type": "Person", "text": [ "female" ], "offsets": [ [ 138, 144 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T7", "type": "Person", "text": [ "Females" ], "offsets": [ [ 172, 179 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T8", "type": "Condition", "text": [ "Child Bearing Potential" ], "offsets": [ [ 195, 218 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T9", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 191, 194 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T10", "type": "Condition", "text": [ "Child Bearing Potential" ], "offsets": [ [ 242, 265 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T11", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 238, 241 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T12", "type": "Person", "text": [ "Females" ], "offsets": [ [ 283, 290 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T13", "type": "Condition", "text": [ "functioning ovaries" ], "offsets": [ [ 322, 341 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T14", "type": "Condition", "text": [ "tubal ligation" ], "offsets": [ [ 376, 390 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T15", "type": "Condition", "text": [ "hysterectomy" ], "offsets": [ [ 394, 406 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T17", "type": "Condition", "text": [ "post-menopausal" ], "offsets": [ [ 427, 442 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T16", "type": "Person", "text": [ "females" ], "offsets": [ [ 411, 418 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T18", "type": "Scope", "text": [ "Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy" ], "offsets": [ [ 283, 406 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T19", "type": "Scope", "text": [ "females who are post-menopausal" ], "offsets": [ [ 411, 442 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T20", "type": "Scope", "text": [ "Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal" ], "offsets": [ [ 283, 442 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T21", "type": "Scope", "text": [ "Non Child Bearing Potential" ], "offsets": [ [ 238, 265 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T22", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 460, 464 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T23", "type": "Value", "text": [ "stage III or IV" ], "offsets": [ [ 465, 480 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T24", "type": "Measurement", "text": [ "GOLD criteria" ], "offsets": [ [ 494, 507 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T25", "type": "Measurement", "text": [ "Forced Expiratory Volume, measured at 1 second (FEV1)" ], "offsets": [ [ 540, 593 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T26", "type": "Value", "text": [ "<50% of predicted normal" ], "offsets": [ [ 594, 618 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T27", "type": "Temporal", "text": [ "post-bronchodilator" ], "offsets": [ [ 520, 539 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T28", "type": "Temporal", "text": [ "post- bronchodilator" ], "offsets": [ [ 634, 654 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T29", "type": "Measurement", "text": [ "FEV1/Inspiratory Vital Capacity (IVC) ratio" ], "offsets": [ [ 655, 698 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T30", "type": "Value", "text": [ "<70%" ], "offsets": [ [ 699, 703 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T31", "type": "Multiplier", "text": [ "at least 2" ], "offsets": [ [ 723, 733 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T32", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 746, 752 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T33", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 734, 742 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T34", "type": "Condition", "text": [ "COPD exacerbations" ], "offsets": [ [ 753, 771 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T35", "type": "Scope", "text": [ "moderate or severe" ], "offsets": [ [ 734, 752 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T36", "type": "Drug", "text": [ "oral corticosteroids" ], "offsets": [ [ 815, 835 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T37", "type": "Drug", "text": [ "oral corticosteroids" ], "offsets": [ [ 860, 880 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T38", "type": "Qualifier", "text": [ "increasing dosage" ], "offsets": [ [ 839, 856 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T39", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 888, 899 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T40", "type": "Visit", "text": [ "hospitalization" ], "offsets": [ [ 903, 918 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T41", "type": "Temporal", "text": [ "within the 12 months preceding Visit 1" ], "offsets": [ [ 920, 958 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T42", "type": "Scope", "text": [ "oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization" ], "offsets": [ [ 815, 918 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T43", "type": "Drug", "text": [ "COPD medication" ], "offsets": [ [ 973, 988 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T44", "type": "Temporal", "text": [ "within 4 weeks prior to Visit 1" ], "offsets": [ [ 989, 1020 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T45", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 966, 972 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T46", "type": "Condition", "text": [ "smokers" ], "offsets": [ [ 1099, 1106 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T47", "type": "Measurement", "text": [ "smoking history" ], "offsets": [ [ 1114, 1129 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T48", "type": "Value", "text": [ "10 pack years" ], "offsets": [ [ 1142, 1155 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T49", "type": "Scope", "text": [ "number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years" ], "offsets": [ [ 1157, 1321 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T52", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 1085, 1092 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T53", "type": "Negation", "text": [ "ex" ], "offsets": [ [ 1096, 1098 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T54", "type": "Scope", "text": [ "Current or ex" ], "offsets": [ [ 1085, 1098 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T55", "type": "Observation", "text": [ "managed at home" ], "offsets": [ [ 1339, 1354 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T56", "type": "Visit", "text": [ "at home" ], "offsets": [ [ 1347, 1354 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T57", "type": "Procedure", "text": [ "managed" ], "offsets": [ [ 1339, 1346 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T58", "type": "Observation", "text": [ "outpatients" ], "offsets": [ [ 1356, 1367 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T59", "type": "Visit", "text": [ "outpatients" ], "offsets": [ [ 1356, 1367 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T51", "type": "Condition", "text": [ "ambulatory" ], "offsets": [ [ 1374, 1384 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T60", "type": "Observation", "text": [ "able to travel to the clinic" ], "offsets": [ [ 1389, 1417 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T61", "type": "Observation", "text": [ "written informed consent" ], "offsets": [ [ 1823, 1847 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T62", "type": "Temporal", "text": [ "prior to participation" ], "offsets": [ [ 1860, 1882 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T50", "type": "Observation", "text": [ "Able to comply with the requirements of the protocol" ], "offsets": [ [ 1885, 1937 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T63", "type": "Observation", "text": [ "available for study visits" ], "offsets": [ [ 1945, 1971 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T64", "type": "Visit", "text": [ "study visits" ], "offsets": [ [ 1959, 1971 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T65", "type": "Temporal", "text": [ "over 52 weeks" ], "offsets": [ [ 1972, 1985 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T66", "type": "Drug", "text": [ "COPD medication" ], "offsets": [ [ 1461, 1476 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T67", "type": "Drug", "text": [ "vaccines" ], "offsets": [ [ 1492, 1500 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T68", "type": "Drug", "text": [ "inhaled short-acting beta-2-agonists" ], "offsets": [ [ 1502, 1538 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T69", "type": "Drug", "text": [ "short-acting" ], "offsets": [ [ 1550, 1562 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T70", "type": "Drug", "text": [ "long-acting anticholinergics" ], "offsets": [ [ 1566, 1594 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T71", "type": "Drug", "text": [ "tiotropium" ], "offsets": [ [ 1596, 1606 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T72", "type": "Drug", "text": [ "systemic beta-2-agonists" ], "offsets": [ [ 1609, 1633 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T73", "type": "Drug", "text": [ "theophylline" ], "offsets": [ [ 1635, 1647 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T74", "type": "Drug", "text": [ "mucolytics" ], "offsets": [ [ 1649, 1659 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T75", "type": "Drug", "text": [ "antioxidants" ], "offsets": [ [ 1661, 1673 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T76", "type": "Drug", "text": [ "beta-1-agonists" ], "offsets": [ [ 1675, 1690 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T78", "type": "Condition", "text": [ "cardiovascular indication" ], "offsets": [ [ 1696, 1721 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T77", "type": "Condition", "text": [ "non-invasive ventilation" ], "offsets": [ [ 1724, 1748 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T79", "type": "Multiplier", "text": [ "long term" ], "offsets": [ [ 1750, 1759 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T80", "type": "Procedure", "text": [ "oxygen therapy" ], "offsets": [ [ 1760, 1774 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T81", "type": "Drug", "text": [ "oxygen" ], "offsets": [ [ 1760, 1766 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T82", "type": "Condition", "text": [ "Cor Pulmonale" ], "offsets": [ [ 1788, 1801 ] ], "normalized": [] }, { "id": "NCT00527826_inc_T83", "type": "Scope", "text": [ "COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants" ], "offsets": [ [ 1461, 1673 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00543712_exc_text", "type": "exclusion", "text": [ "Systemic therapy or radiotherapy within 4 weeks prior to Day 1 \nPrior therapy with agents targeting the DR5 apoptosis pathway \nMajor surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study \nOther invasive malignancies within 5 years prior to Day 1 \nKnown active brain metastases \nUncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment \nClinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements \nKnown to be positive for hepatitis C or hepatitis B surface antigen \nHistory of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications \nUse of anticoagulation therapy \nParticipation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1 \nPregnancy or breast feeding \nKnown sensitivity to any of the products administered during the study \nAny disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures \n \n" ], "offsets": [ [ 0, 1693 ] ] } ]

[ { "id": "NCT00543712_exc_T1", "type": "Procedure", "text": [ "Systemic therapy" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T2", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 20, 32 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T3", "type": "Temporal", "text": [ "within 4 weeks prior to Day 1" ], "offsets": [ [ 33, 62 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T4", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 57, 62 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T5", "type": "Scope", "text": [ "Systemic therapy or radiotherapy" ], "offsets": [ [ 0, 32 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T6", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 64, 69 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T7", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 70, 77 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T8", "type": "Drug", "text": [ "agents targeting the DR5 apoptosis pathway" ], "offsets": [ [ 83, 125 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T9", "type": "Qualifier", "text": [ "Major" ], "offsets": [ [ 127, 132 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T10", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 133, 151 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T11", "type": "Procedure", "text": [ "open biopsy" ], "offsets": [ [ 153, 164 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T12", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 169, 180 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T13", "type": "Condition", "text": [ "traumatic injury" ], "offsets": [ [ 181, 197 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T14", "type": "Temporal", "text": [ "within 4 weeks prior to Day 1" ], "offsets": [ [ 198, 227 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T15", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 222, 227 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T16", "type": "Scope", "text": [ "Major surgical procedure, open biopsy, or significant traumatic injury" ], "offsets": [ [ 127, 197 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T17", "type": "Mood", "text": [ "anticipation of need" ], "offsets": [ [ 232, 252 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T18", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 257, 262 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T19", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 263, 281 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T20", "type": "Temporal", "text": [ "during the course of the study" ], "offsets": [ [ 282, 312 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T21", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 303, 312 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T22", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 314, 319 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T23", "type": "Condition", "text": [ "invasive malignancies" ], "offsets": [ [ 320, 341 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T24", "type": "Temporal", "text": [ "within 5 years prior to Day 1" ], "offsets": [ [ 342, 371 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T25", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 366, 371 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T26", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 379, 385 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T27", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 386, 402 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T28", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 379, 385 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T29", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 404, 416 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T30", "type": "Condition", "text": [ "intercurrent illness" ], "offsets": [ [ 417, 437 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T31", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 468, 475 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T32", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 479, 485 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T33", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 486, 495 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T34", "type": "Drug", "text": [ "parenteral antibiotics" ], "offsets": [ [ 506, 528 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T35", "type": "Temporal", "text": [ "at enrollment" ], "offsets": [ [ 529, 542 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T36", "type": "Scope", "text": [ "ongoing or active" ], "offsets": [ [ 468, 485 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T37", "type": "Scope", "text": [ "Uncontrolled intercurrent illness" ], "offsets": [ [ 404, 437 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T38", "type": "Scope", "text": [ "ongoing or active infection requiring parenteral antibiotics at enrollment" ], "offsets": [ [ 468, 542 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T39", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 532, 542 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T40", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 544, 566 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T41", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 568, 579 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T42", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 580, 602 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T43", "type": "Measurement", "text": [ "New York Heart Association (NYHA)" ], "offsets": [ [ 604, 637 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T44", "type": "Value", "text": [ "Grade II or greater" ], "offsets": [ [ 638, 657 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T45", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 658, 682 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T46", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 684, 691 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T47", "type": "Condition", "text": [ "cardiac arrhythmia" ], "offsets": [ [ 692, 710 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T48", "type": "Value", "text": [ "Grade II or greater" ], "offsets": [ [ 712, 731 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T49", "type": "Condition", "text": [ "peripheral vascular disease" ], "offsets": [ [ 732, 759 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T50", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 764, 774 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T51", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 775, 780 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T52", "type": "Procedure", "text": [ "heart surgery" ], "offsets": [ [ 781, 794 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T53", "type": "Temporal", "text": [ "within 6 months of Day 1" ], "offsets": [ [ 795, 819 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T54", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 814, 819 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T55", "type": "Scope", "text": [ "peripheral vascular disease, or history of major heart surgery", "limit compliance" ], "offsets": [ [ 732, 794 ], [ 856, 872 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T56", "type": "Observation", "text": [ "limit compliance" ], "offsets": [ [ 856, 872 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T57", "type": "Value", "text": [ "positive" ], "offsets": [ [ 910, 918 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T58", "type": "Measurement", "text": [ "hepatitis C" ], "offsets": [ [ 923, 934 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T59", "type": "Measurement", "text": [ "hepatitis B surface antigen" ], "offsets": [ [ 938, 965 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T60", "type": "Scope", "text": [ "hepatitis C or hepatitis B surface antigen" ], "offsets": [ [ 923, 965 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T61", "type": "Observation", "text": [ "History" ], "offsets": [ [ 967, 974 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T62", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 978, 983 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T63", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 984, 991 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T64", "type": "Condition", "text": [ "metabolic dysfunction" ], "offsets": [ [ 993, 1014 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T65", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 1016, 1036 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T66", "type": "Condition", "text": [ "physical examination finding" ], "offsets": [ [ 1016, 1044 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T67", "type": "Condition", "text": [ "clinical laboratory finding" ], "offsets": [ [ 1049, 1076 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T68", "type": "Procedure", "text": [ "clinical laboratory" ], "offsets": [ [ 1049, 1068 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T69", "type": "Mood", "text": [ "suspicion of" ], "offsets": [ [ 1095, 1107 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T70", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 1110, 1117 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T71", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 1121, 1130 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T72", "type": "Condition", "text": [ "contraindicates" ], "offsets": [ [ 1136, 1151 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T73", "type": "Scope", "text": [ "disease or condition" ], "offsets": [ [ 1110, 1130 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T74", "type": "Scope", "text": [ "suspicion of a disease or condition" ], "offsets": [ [ 1095, 1130 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T75", "type": "Drug", "text": [ "investigational drug" ], "offsets": [ [ 1162, 1182 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T76", "type": "Observation", "text": [ "affect interpretation of the results" ], "offsets": [ [ 1197, 1233 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T77", "type": "Observation", "text": [ "render the patient at high risk" ], "offsets": [ [ 1250, 1281 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T78", "type": "Condition", "text": [ "treatment complications" ], "offsets": [ [ 1286, 1309 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T79", "type": "Scope", "text": [ "contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications" ], "offsets": [ [ 1136, 1309 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T80", "type": "Procedure", "text": [ "anticoagulation therapy" ], "offsets": [ [ 1318, 1341 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T81", "type": "Drug", "text": [ "anticoagulation" ], "offsets": [ [ 1318, 1333 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T82", "type": "Observation", "text": [ "Participation in clinical trials" ], "offsets": [ [ 1343, 1375 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T83", "type": "Observation", "text": [ "undergoing other investigational procedures" ], "offsets": [ [ 1379, 1422 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T84", "type": "Temporal", "text": [ "within 30 days prior to Day 1" ], "offsets": [ [ 1423, 1452 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T85", "type": "Reference_point", "text": [ "prior to Day 1" ], "offsets": [ [ 1438, 1452 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T86", "type": "Scope", "text": [ "Participation in clinical trials or undergoing other investigational procedures" ], "offsets": [ [ 1343, 1422 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T87", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 1454, 1463 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T88", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 1467, 1481 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T89", "type": "Condition", "text": [ "sensitivity" ], "offsets": [ [ 1489, 1500 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T90", "type": "Drug", "text": [ "any of the products administered during the study" ], "offsets": [ [ 1504, 1553 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T91", "type": "Condition", "text": [ "disorder" ], "offsets": [ [ 1559, 1567 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T92", "type": "Negation", "text": [ "compromises the ability of" ], "offsets": [ [ 1573, 1599 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T93", "type": "Measurement", "text": [ "give written informed consent" ], "offsets": [ [ 1615, 1644 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T94", "type": "Procedure", "text": [ "comply with study procedures" ], "offsets": [ [ 1652, 1680 ] ], "normalized": [] }, { "id": "NCT00543712_exc_T95", "type": "Scope", "text": [ "give written informed consent and/or comply with study procedures" ], "offsets": [ [ 1615, 1680 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00543712_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T5", "arg2_id": "NCT00543712_exc_T3", "normalized": [] }, { "id": "NCT00543712_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T13", "arg2_id": "NCT00543712_exc_T12", "normalized": [] }, { "id": "NCT00543712_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T10", "arg2_id": "NCT00543712_exc_T9", "normalized": [] }, { "id": "NCT00543712_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T16", "arg2_id": "NCT00543712_exc_T14", "normalized": [] }, { "id": "NCT00543712_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T19", "arg2_id": "NCT00543712_exc_T18", "normalized": [] }, { "id": "NCT00543712_exc_R6", "type": "Has_mood", "arg1_id": "NCT00543712_exc_T19", "arg2_id": "NCT00543712_exc_T17", "normalized": [] }, { "id": "NCT00543712_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T19", "arg2_id": "NCT00543712_exc_T20", "normalized": [] }, { "id": "NCT00543712_exc_R8", "type": "Has_index", "arg1_id": "NCT00543712_exc_T24", "arg2_id": "NCT00543712_exc_T25", "normalized": [] }, { "id": "NCT00543712_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T23", "arg2_id": "NCT00543712_exc_T22", "normalized": [] }, { "id": "NCT00543712_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T23", "arg2_id": "NCT00543712_exc_T24", "normalized": [] }, { "id": "NCT00543712_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T27", "arg2_id": "NCT00543712_exc_T26", "normalized": [] }, { "id": "NCT00543712_exc_R13", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T34", "arg2_id": "NCT00543712_exc_T35", "normalized": [] }, { "id": "NCT00543712_exc_R14", "type": "Has_scope", "arg1_id": "NCT00543712_exc_T33", "arg2_id": "NCT00543712_exc_T36", "normalized": [] }, { "id": "NCT00543712_exc_R15", "type": "AND", "arg1_id": "NCT00543712_exc_T33", "arg2_id": "NCT00543712_exc_T34", "normalized": [] }, { "id": "NCT00543712_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T30", "arg2_id": "NCT00543712_exc_T29", "normalized": [] }, { "id": "NCT00543712_exc_R17", "type": "Has_index", "arg1_id": "NCT00543712_exc_T35", "arg2_id": "NCT00543712_exc_T39", "normalized": [] }, { "id": "NCT00543712_exc_R18", "type": "Subsumes", "arg1_id": "NCT00543712_exc_T37", "arg2_id": "NCT00543712_exc_T38", "normalized": [] }, { "id": "NCT00543712_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T42", "arg2_id": "NCT00543712_exc_T41", "normalized": [] }, { "id": "NCT00543712_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T42", "arg2_id": "NCT00543712_exc_T40", "normalized": [] }, { "id": "NCT00543712_exc_R19", "type": "Has_value", "arg1_id": "NCT00543712_exc_T43", "arg2_id": "NCT00543712_exc_T44", "normalized": [] }, { "id": "NCT00543712_exc_R22", "type": "AND", "arg1_id": "NCT00543712_exc_T45", "arg2_id": "NCT00543712_exc_T43", "normalized": [] }, { "id": "NCT00543712_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T47", "arg2_id": "NCT00543712_exc_T46", "normalized": [] }, { "id": "NCT00543712_exc_R24", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T52", "arg2_id": "NCT00543712_exc_T51", "normalized": [] }, { "id": "NCT00543712_exc_R25", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T52", "arg2_id": "NCT00543712_exc_T50", "normalized": [] }, { "id": "NCT00543712_exc_R26", "type": "Has_index", "arg1_id": "NCT00543712_exc_T53", "arg2_id": "NCT00543712_exc_T54", "normalized": [] }, { "id": "NCT00543712_exc_R27", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T55", "arg2_id": "NCT00543712_exc_T53", "normalized": [] }, { "id": "NCT00543712_exc_R28", "type": "Has_value", "arg1_id": "NCT00543712_exc_T60", "arg2_id": "NCT00543712_exc_T57", "normalized": [] }, { "id": "NCT00543712_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT00543712_exc_T63", "arg2_id": "NCT00543712_exc_T62", "normalized": [] }, { "id": "NCT00543712_exc_R30", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T63", "arg2_id": "NCT00543712_exc_T61", "normalized": [] }, { "id": "NCT00543712_exc_R34", "type": "AND", "arg1_id": "NCT00543712_exc_T77", "arg2_id": "NCT00543712_exc_T78", "normalized": [] }, { "id": "NCT00543712_exc_R33", "type": "AND", "arg1_id": "NCT00543712_exc_T72", "arg2_id": "NCT00543712_exc_T75", "normalized": [] }, { "id": "NCT00543712_exc_R35", "type": "Subsumes", "arg1_id": "NCT00543712_exc_T74", "arg2_id": "NCT00543712_exc_T79", "normalized": [] }, { "id": "NCT00543712_exc_R36", "type": "Subsumes", "arg1_id": "NCT00543712_exc_T80", "arg2_id": "NCT00543712_exc_T81", "normalized": [] }, { "id": "NCT00543712_exc_R38", "type": "Has_temporal", "arg1_id": "NCT00543712_exc_T86", "arg2_id": "NCT00543712_exc_T84", "normalized": [] }, { "id": "NCT00543712_exc_R39", "type": "Has_negation", "arg1_id": "NCT00543712_exc_T95", "arg2_id": "NCT00543712_exc_T92", "normalized": [] }, { "id": "NCT00543712_exc_R40", "type": "Has_negation", "arg1_id": "NCT00543712_exc_T91", "arg2_id": "NCT00543712_exc_T92", "normalized": [] } ]

[ { "id": "NCT00543712_inc_text", "type": "inclusion", "text": [ "Ability to understand and willingness to sign a written informed consent document \nAge ≥ 18 years \nHistologic diagnosis of chondrosarcoma, verifiable after enrollment \nMeasurable disease \nPreviously treated or incurable disease without options for standard of care therapy \nECOG performance status of 0-2 \nLife expectancy of > 3 months \nFor patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment \n" ], "offsets": [ [ 0, 596 ] ] } ]

[ { "id": "NCT00543712_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 83, 86 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T2", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 87, 97 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T3", "type": "Condition", "text": [ "chondrosarcoma" ], "offsets": [ [ 123, 137 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T4", "type": "Measurement", "text": [ "Histologic" ], "offsets": [ [ 99, 109 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T8", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 274, 297 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T9", "type": "Value", "text": [ "0-2" ], "offsets": [ [ 301, 304 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T10", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 306, 321 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T11", "type": "Value", "text": [ "> 3 months" ], "offsets": [ [ 325, 335 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T12", "type": "Condition", "text": [ "reproductive potential" ], "offsets": [ [ 353, 375 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T13", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 423, 436 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T14", "type": "Drug", "text": [ "contraceptive pill" ], "offsets": [ [ 444, 462 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T15", "type": "Device", "text": [ "intrauterine device [IUD]" ], "offsets": [ [ 464, 489 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T16", "type": "Device", "text": [ "physical barrier" ], "offsets": [ [ 491, 507 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T17", "type": "Scope", "text": [ "contraceptive pill, intrauterine device [IUD], physical barrier" ], "offsets": [ [ 444, 507 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T18", "type": "Temporal", "text": [ "throughout the trial" ], "offsets": [ [ 509, 529 ] ], "normalized": [] }, { "id": "NCT00543712_inc_T19", "type": "Temporal", "text": [ "for 1 year following their final exposure" ], "offsets": [ [ 534, 575 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00543712_inc_R1", "type": "Has_value", "arg1_id": "NCT00543712_inc_T1", "arg2_id": "NCT00543712_inc_T2", "normalized": [] }, { "id": "NCT00543712_inc_R2", "type": "AND", "arg1_id": "NCT00543712_inc_T3", "arg2_id": "NCT00543712_inc_T4", "normalized": [] }, { "id": "NCT00543712_inc_R3", "type": "Has_value", "arg1_id": "NCT00543712_inc_T8", "arg2_id": "NCT00543712_inc_T9", "normalized": [] }, { "id": "NCT00543712_inc_R4", "type": "Has_value", "arg1_id": "NCT00543712_inc_T10", "arg2_id": "NCT00543712_inc_T11", "normalized": [] }, { "id": "NCT00543712_inc_R5", "type": "Subsumes", "arg1_id": "NCT00543712_inc_T13", "arg2_id": "NCT00543712_inc_T17", "normalized": [] }, { "id": "NCT00543712_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00543712_inc_T13", "arg2_id": "NCT00543712_inc_T18", "normalized": [] }, { "id": "NCT00543712_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00543712_inc_T13", "arg2_id": "NCT00543712_inc_T19", "normalized": [] }, { "id": "NCT00543712_inc_R8", "type": "AND", "arg1_id": "NCT00543712_inc_T12", "arg2_id": "NCT00543712_inc_T13", "normalized": [] } ]

[ { "id": "NCT00576173_exc_text", "type": "exclusion", "text": [ "Patients who have taken either morphine with daily dose more than 120mg or Fentanyl with daily dose more than 50ug/hr \nPatients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study \nPatients with significant clinical abnormalities in CNS, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study \nPatients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen \n \n" ], "offsets": [ [ 0, 712 ] ] } ]

[ { "id": "NCT00576173_exc_T1", "type": "Drug", "text": [ "morphine" ], "offsets": [ [ 31, 39 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T2", "type": "Multiplier", "text": [ "daily dose more than 120mg" ], "offsets": [ [ 45, 71 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T3", "type": "Drug", "text": [ "Fentanyl" ], "offsets": [ [ 75, 83 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T4", "type": "Multiplier", "text": [ "daily dose more than 50ug/hr" ], "offsets": [ [ 89, 117 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T5", "type": "Condition", "text": [ "abnormalities in hepatic", "function" ], "offsets": [ [ 145, 169 ], [ 179, 187 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T6", "type": "Condition", "text": [ "abnormalities in", "renal function" ], "offsets": [ [ 145, 161 ], [ 173, 187 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T7", "type": "Condition", "text": [ "abnormalities in CNS" ], "offsets": [ [ 319, 339 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T8", "type": "Condition", "text": [ "abnormalities in", "cardiovascular function" ], "offsets": [ [ 319, 335 ], [ 356, 379 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T9", "type": "Condition", "text": [ "abnormalities in", "respiratory", "function" ], "offsets": [ [ 319, 335 ], [ 341, 352 ], [ 371, 379 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T10", "type": "Drug", "text": [ "antidepressants" ], "offsets": [ [ 479, 494 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T11", "type": "Drug", "text": [ "anti-epileptic drugs" ], "offsets": [ [ 498, 518 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T12", "type": "Drug", "text": [ "sedative hypnotics" ], "offsets": [ [ 520, 538 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T13", "type": "Drug", "text": [ "selective serotonin reuptake inhibitor" ], "offsets": [ [ 540, 578 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T14", "type": "Drug", "text": [ "short-acting analgesics" ], "offsets": [ [ 580, 603 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T15", "type": "Drug", "text": [ "topical medications" ], "offsets": [ [ 605, 624 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T16", "type": "Drug", "text": [ "anesthetics" ], "offsets": [ [ 629, 640 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T17", "type": "Drug", "text": [ "muscle relaxants" ], "offsets": [ [ 648, 664 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T18", "type": "Drug", "text": [ "Tramadol" ], "offsets": [ [ 677, 685 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T19", "type": "Drug", "text": [ "Acetaminophen" ], "offsets": [ [ 686, 699 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T20", "type": "Scope", "text": [ "Tramadol/Acetaminophen" ], "offsets": [ [ 677, 699 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T21", "type": "Scope", "text": [ "antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants" ], "offsets": [ [ 479, 664 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T22", "type": "Temporal", "text": [ "when taking Tramadol/Acetaminophen" ], "offsets": [ [ 665, 699 ] ], "normalized": [] }, { "id": "NCT00576173_exc_T23", "type": "Reference_point", "text": [ "taking Tramadol/Acetaminophen" ], "offsets": [ [ 670, 699 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00576173_exc_R1", "type": "Has_multiplier", "arg1_id": "NCT00576173_exc_T1", "arg2_id": "NCT00576173_exc_T2", "normalized": [] }, { "id": "NCT00576173_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT00576173_exc_T3", "arg2_id": "NCT00576173_exc_T4", "normalized": [] }, { "id": "NCT00576173_exc_R3", "type": "Has_index", "arg1_id": "NCT00576173_exc_T22", "arg2_id": "NCT00576173_exc_T23", "normalized": [] }, { "id": "NCT00576173_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00576173_exc_T21", "arg2_id": "NCT00576173_exc_T22", "normalized": [] } ]

[ { "id": "NCT00576173_inc_text", "type": "inclusion", "text": [ "Patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy \nPatients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study \nPatients must have a VAS (Visual analog scale) >=40mm \n" ], "offsets": [ [ 0, 414 ] ] } ]

[ { "id": "NCT00576173_inc_T1", "type": "Procedure", "text": [ "histologically" ], "offsets": [ [ 16, 30 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T2", "type": "Procedure", "text": [ "radiologically" ], "offsets": [ [ 32, 46 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T3", "type": "Procedure", "text": [ "haematologically" ], "offsets": [ [ 50, 66 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T4", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 67, 76 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T5", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 77, 87 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T6", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 94, 98 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T7", "type": "Scope", "text": [ "histologically, radiologically or haematologically" ], "offsets": [ [ 16, 66 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T8", "type": "Drug", "text": [ "weak opioids" ], "offsets": [ [ 211, 223 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T9", "type": "Drug", "text": [ "strong opioids" ], "offsets": [ [ 227, 241 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T10", "type": "Temporal", "text": [ "at least 72 hours prior to the start the study" ], "offsets": [ [ 246, 292 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T11", "type": "Scope", "text": [ "weak opioids or strong opioids" ], "offsets": [ [ 211, 241 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T12", "type": "Measurement", "text": [ "VAS (Visual analog scale)" ], "offsets": [ [ 380, 405 ] ], "normalized": [] }, { "id": "NCT00576173_inc_T13", "type": "Value", "text": [ ">=40mm" ], "offsets": [ [ 406, 412 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00576173_inc_R1", "type": "AND", "arg1_id": "NCT00576173_inc_T5", "arg2_id": "NCT00576173_inc_T6", "normalized": [] }, { "id": "NCT00576173_inc_R2", "type": "Has_value", "arg1_id": "NCT00576173_inc_T7", "arg2_id": "NCT00576173_inc_T4", "normalized": [] }, { "id": "NCT00576173_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00576173_inc_T11", "arg2_id": "NCT00576173_inc_T10", "normalized": [] }, { "id": "NCT00576173_inc_R4", "type": "Has_value", "arg1_id": "NCT00576173_inc_T12", "arg2_id": "NCT00576173_inc_T13", "normalized": [] } ]

[ { "id": "NCT00586898_exc_text", "type": "exclusion", "text": [ "Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease. \nUncontrolled serious active infection. \nAnticipated survival of less than 3 months. \nActive CNS or epiduraltumor \nInability or unwillingness to comply with the treatment protocol, follow-up, or research tests. \n \n" ], "offsets": [ [ 0, 346 ] ] } ]

[ { "id": "NCT00586898_exc_T1", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 23, 38 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T2", "type": "Measurement", "text": [ "New York Heart Association" ], "offsets": [ [ 40, 66 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T3", "type": "Value", "text": [ "Class III/IV" ], "offsets": [ [ 67, 79 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T4", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 11, 22 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T5", "type": "Condition", "text": [ "debilitating puhnonary disease" ], "offsets": [ [ 91, 121 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T6", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 84, 90 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T7", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 152, 161 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T8", "type": "Qualifier", "text": [ "Uncontrolled serious" ], "offsets": [ [ 124, 144 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T9", "type": "Observation", "text": [ "Anticipated survival" ], "offsets": [ [ 164, 184 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T10", "type": "Value", "text": [ "less than 3 months" ], "offsets": [ [ 188, 206 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T11", "type": "Condition", "text": [ "CNS", "tumor" ], "offsets": [ [ 216, 219 ], [ 231, 236 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T12", "type": "Condition", "text": [ "epiduraltumor" ], "offsets": [ [ 223, 236 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T13", "type": "Condition", "text": [ "Inability" ], "offsets": [ [ 238, 247 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T14", "type": "Observation", "text": [ "unwillingness" ], "offsets": [ [ 251, 264 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T16", "type": "Procedure", "text": [ "follow-up" ], "offsets": [ [ 304, 313 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T18", "type": "Scope", "text": [ "comply with the treatment protocol, follow-up, or research tests" ], "offsets": [ [ 268, 332 ] ], "normalized": [] }, { "id": "NCT00586898_exc_T19", "type": "Scope", "text": [ "Inability or unwillingness" ], "offsets": [ [ 238, 264 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00586898_exc_R1", "type": "Has_value", "arg1_id": "NCT00586898_exc_T2", "arg2_id": "NCT00586898_exc_T3", "normalized": [] }, { "id": "NCT00586898_exc_R2", "type": "Subsumes", "arg1_id": "NCT00586898_exc_T4", "arg2_id": "NCT00586898_exc_T2", "normalized": [] }, { "id": "NCT00586898_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00586898_exc_T1", "arg2_id": "NCT00586898_exc_T4", "normalized": [] }, { "id": "NCT00586898_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00586898_exc_T5", "arg2_id": "NCT00586898_exc_T6", "normalized": [] }, { "id": "NCT00586898_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00586898_exc_T7", "arg2_id": "NCT00586898_exc_T8", "normalized": [] }, { "id": "NCT00586898_exc_R6", "type": "Has_value", "arg1_id": "NCT00586898_exc_T9", "arg2_id": "NCT00586898_exc_T10", "normalized": [] }, { "id": "NCT00586898_exc_R7", "type": "Has_scope", "arg1_id": "NCT00586898_exc_T18", "arg2_id": "NCT00586898_exc_T19", "normalized": [] } ]

[ { "id": "NCT00586898_inc_text", "type": "inclusion", "text": [ "-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease. \nB. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50% \nDiagnosis of prostate adenocarcinoma histologically confirmed at MSKCC. \nPatient must have level of serum testosterone above the lower limit of normal. \nKarnofskcy performance status (KPS) >_70%. \nPatients must have adequate organ function as defined by the following laboratory criteria: \nWBC >_3500/mm3, platelet count >_100,000/mm3. \nBilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal. \nCreatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min. \nPrior hormonal therapy is allowed as: \n1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months. \n2. One cycle of intermittent therapy up to a maximum exposure of 10 months. \nPatients must be at least 18 years of age. \nPatients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment \n" ], "offsets": [ [ 0, 1691 ] ] } ]

[ { "id": "NCT00586898_inc_T3", "type": "Measurement", "text": [ "PSA" ], "offsets": [ [ 82, 85 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T4", "type": "Value", "text": [ "Rising" ], "offsets": [ [ 75, 81 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T5", "type": "Observation", "text": [ "history of" ], "offsets": [ [ 103, 113 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T6", "type": "Condition", "text": [ "localized disease" ], "offsets": [ [ 114, 131 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T7", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 162, 171 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T8", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 175, 182 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T9", "type": "Qualifier", "text": [ "definitive" ], "offsets": [ [ 151, 161 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T10", "type": "Scope", "text": [ "radiation or surgery" ], "offsets": [ [ 162, 182 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T11", "type": "Observation", "text": [ "progression of disease" ], "offsets": [ [ 216, 238 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T12", "type": "Qualifier", "text": [ "biochemically" ], "offsets": [ [ 239, 252 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T13", "type": "Qualifier", "text": [ "radiographically evident" ], "offsets": [ [ 308, 332 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T14", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 333, 340 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T15", "type": "Qualifier", "text": [ "Non-castrate" ], "offsets": [ [ 346, 358 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T16", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 359, 369 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T17", "type": "Observation", "text": [ "radiographic evidence" ], "offsets": [ [ 398, 419 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T18", "type": "Procedure", "text": [ "radiographic" ], "offsets": [ [ 398, 410 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T19", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 423, 441 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T20", "type": "Temporal", "text": [ "at the time of diagnosis" ], "offsets": [ [ 442, 466 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T21", "type": "Temporal", "text": [ "after treatment for localized disease" ], "offsets": [ [ 470, 507 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T22", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 476, 485 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T23", "type": "Condition", "text": [ "localized disease" ], "offsets": [ [ 490, 507 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T24", "type": "Reference_point", "text": [ "treatment for localized disease" ], "offsets": [ [ 476, 507 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T25", "type": "Reference_point", "text": [ "the time of diagnosis" ], "offsets": [ [ 445, 466 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T26", "type": "Scope", "text": [ "at the time of diagnosis or after treatment for localized disease" ], "offsets": [ [ 442, 507 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T27", "type": "Scope", "text": [ "Non-castrate metastatic" ], "offsets": [ [ 346, 369 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T28", "type": "Temporal", "text": [ "newly detected" ], "offsets": [ [ 534, 548 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T29", "type": "Condition", "text": [ "disease", "in bone" ], "offsets": [ [ 549, 556 ], [ 580, 587 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T30", "type": "Condition", "text": [ "progressing disease", "in soft tissue" ], "offsets": [ [ 560, 579 ], [ 591, 605 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T31", "type": "Condition", "text": [ "disease", "in soft tissue" ], "offsets": [ [ 549, 556 ], [ 591, 605 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T32", "type": "Condition", "text": [ "progressing disease in bone" ], "offsets": [ [ 560, 587 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T33", "type": "Observation", "text": [ "Biochemical progression" ], "offsets": [ [ 607, 630 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T34", "type": "Measurement", "text": [ "Minimal % increase in range of values" ], "offsets": [ [ 736, 773 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T35", "type": "Value", "text": [ "50%" ], "offsets": [ [ 775, 778 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T36", "type": "Measurement", "text": [ "Minimal Baseline PSA value" ], "offsets": [ [ 698, 724 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T37", "type": "Value", "text": [ "(ng/ml): 2" ], "offsets": [ [ 725, 735 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T38", "type": "Measurement", "text": [ "minimum no. of determinations" ], "offsets": [ [ 646, 675 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T39", "type": "Value", "text": [ "3" ], "offsets": [ [ 677, 678 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T40", "type": "Measurement", "text": [ "Interval" ], "offsets": [ [ 679, 687 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T41", "type": "Value", "text": [ ">2 weeks" ], "offsets": [ [ 689, 697 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T42", "type": "Scope", "text": [ "minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%" ], "offsets": [ [ 646, 778 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T43", "type": "Scope", "text": [ "disease or progressing disease in bone or in soft tissue" ], "offsets": [ [ 549, 605 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T44", "type": "Condition", "text": [ "prostate adenocarcinoma" ], "offsets": [ [ 793, 816 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T45", "type": "Procedure", "text": [ "histologically" ], "offsets": [ [ 817, 831 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T46", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 832, 841 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T47", "type": "Qualifier", "text": [ "histologically confirmed" ], "offsets": [ [ 817, 841 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T48", "type": "Measurement", "text": [ "level of serum testosterone" ], "offsets": [ [ 871, 898 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T49", "type": "Value", "text": [ "above the lower limit of normal" ], "offsets": [ [ 899, 930 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T50", "type": "Measurement", "text": [ "Karnofskcy performance status (KPS)" ], "offsets": [ [ 933, 968 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T51", "type": "Value", "text": [ ">_70%" ], "offsets": [ [ 969, 974 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T52", "type": "Value", "text": [ "adequate" ], "offsets": [ [ 996, 1004 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T53", "type": "Measurement", "text": [ "organ function" ], "offsets": [ [ 1005, 1019 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T54", "type": "Observation", "text": [ "adequate organ function" ], "offsets": [ [ 996, 1019 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T55", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 1070, 1073 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T56", "type": "Value", "text": [ ">_3500/mm3" ], "offsets": [ [ 1074, 1084 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T57", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 1086, 1100 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T58", "type": "Value", "text": [ ">_100,000/mm3" ], "offsets": [ [ 1101, 1114 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T59", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 1117, 1126 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T60", "type": "Value", "text": [ "<2.0 mg/dl" ], "offsets": [ [ 1127, 1137 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T61", "type": "Measurement", "text": [ "SGOT" ], "offsets": [ [ 1141, 1145 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T62", "type": "Value", "text": [ "<3.0 X the upper limit of normal" ], "offsets": [ [ 1146, 1178 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T63", "type": "Measurement", "text": [ "Creatinine" ], "offsets": [ [ 1181, 1191 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T64", "type": "Value", "text": [ "<_1.6 mg/dl" ], "offsets": [ [ 1192, 1203 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T65", "type": "Measurement", "text": [ "creatinine clearance" ], "offsets": [ [ 1207, 1227 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T66", "type": "Value", "text": [ ">_60 cc/min" ], "offsets": [ [ 1228, 1239 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T67", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 1242, 1247 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T68", "type": "Procedure", "text": [ "hormonal therapy" ], "offsets": [ [ 1248, 1264 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T69", "type": "Mood", "text": [ "is allowed" ], "offsets": [ [ 1265, 1275 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T70", "type": "Procedure", "text": [ "Neoadjuvant treatment" ], "offsets": [ [ 1284, 1305 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T71", "type": "Temporal", "text": [ "prior to radiation therapy or radical prostatectomy" ], "offsets": [ [ 1306, 1357 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T72", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 1315, 1332 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T73", "type": "Procedure", "text": [ "radical prostatectomy" ], "offsets": [ [ 1336, 1357 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T74", "type": "Reference_point", "text": [ "radiation therapy or radical prostatectomy" ], "offsets": [ [ 1315, 1357 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T75", "type": "Measurement", "text": [ "total duration of exposure" ], "offsets": [ [ 1377, 1403 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T76", "type": "Value", "text": [ "does not exceed 10 months" ], "offsets": [ [ 1404, 1429 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T77", "type": "Multiplier", "text": [ "One cycle" ], "offsets": [ [ 1435, 1444 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T78", "type": "Procedure", "text": [ "intermittent therapy" ], "offsets": [ [ 1448, 1468 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T79", "type": "Measurement", "text": [ "maximum exposure" ], "offsets": [ [ 1477, 1493 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T80", "type": "Value", "text": [ "10 months" ], "offsets": [ [ 1497, 1506 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T81", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 1526, 1543 ] ], "normalized": [] }, { "id": "NCT00586898_inc_T82", "type": "Person", "text": [ "age" ], "offsets": [ [ 1547, 1550 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00586898_inc_R1", "type": "Has_value", "arg1_id": "NCT00586898_inc_T3", "arg2_id": "NCT00586898_inc_T4", "normalized": [] }, { "id": "NCT00586898_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00586898_inc_T10", "arg2_id": "NCT00586898_inc_T9", "normalized": [] }, { "id": "NCT00586898_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00586898_inc_T11", "arg2_id": "NCT00586898_inc_T12", "normalized": [] }, { "id": "NCT00586898_inc_R4", "type": "Has_temporal", "arg1_id": "NCT00586898_inc_T6", "arg2_id": "NCT00586898_inc_T5", "normalized": [] }, { "id": "NCT00586898_inc_R5", "type": "Has_scope", "arg1_id": "NCT00586898_inc_T6", "arg2_id": "NCT00586898_inc_T10", "normalized": [] }, { "id": "NCT00586898_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00586898_inc_T14", "arg2_id": "NCT00586898_inc_T13", "normalized": [] }, { "id": "NCT00586898_inc_R8", "type": "AND", "arg1_id": "NCT00586898_inc_T18", "arg2_id": "NCT00586898_inc_T19", "normalized": [] }, { "id": "NCT00586898_inc_R9", "type": "Has_index", "arg1_id": "NCT00586898_inc_T20", "arg2_id": "NCT00586898_inc_T25", "normalized": [] }, { "id": "NCT00586898_inc_R10", "type": "Has_scope", "arg1_id": "NCT00586898_inc_T19", "arg2_id": "NCT00586898_inc_T26", "normalized": [] }, { "id": "NCT00586898_inc_R11", "type": "Has_scope", "arg1_id": "NCT00586898_inc_T19", "arg2_id": "NCT00586898_inc_T27", "normalized": [] }, { "id": "NCT00586898_inc_R12", "type": "Has_value", "arg1_id": "NCT00586898_inc_T34", "arg2_id": "NCT00586898_inc_T35", "normalized": [] }, { "id": "NCT00586898_inc_R13", "type": "Has_value", "arg1_id": "NCT00586898_inc_T36", "arg2_id": "NCT00586898_inc_T37", "normalized": [] }, { "id": "NCT00586898_inc_R14", "type": "Has_value", "arg1_id": "NCT00586898_inc_T38", "arg2_id": "NCT00586898_inc_T39", "normalized": [] }, { "id": "NCT00586898_inc_R15", "type": "Has_value", "arg1_id": "NCT00586898_inc_T40", "arg2_id": "NCT00586898_inc_T41", "normalized": [] }, { "id": "NCT00586898_inc_R16", "type": "Has_scope", "arg1_id": "NCT00586898_inc_T33", "arg2_id": "NCT00586898_inc_T42", "normalized": [] }, { "id": "NCT00586898_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00586898_inc_T43", "arg2_id": "NCT00586898_inc_T28", "normalized": [] }, { "id": "NCT00586898_inc_R20", "type": "Has_value", "arg1_id": "NCT00586898_inc_T45", "arg2_id": "NCT00586898_inc_T46", "normalized": [] }, { "id": "NCT00586898_inc_R22", "type": "Has_qualifier", "arg1_id": "NCT00586898_inc_T44", "arg2_id": "NCT00586898_inc_T47", "normalized": [] }, { "id": "NCT00586898_inc_R23", "type": "Has_value", "arg1_id": "NCT00586898_inc_T48", "arg2_id": "NCT00586898_inc_T49", "normalized": [] }, { "id": "NCT00586898_inc_R24", "type": "Has_value", "arg1_id": "NCT00586898_inc_T50", "arg2_id": "NCT00586898_inc_T51", "normalized": [] }, { "id": "NCT00586898_inc_R25", "type": "Has_value", "arg1_id": "NCT00586898_inc_T53", "arg2_id": "NCT00586898_inc_T52", "normalized": [] }, { "id": "NCT00586898_inc_R27", "type": "Has_value", "arg1_id": "NCT00586898_inc_T57", "arg2_id": "NCT00586898_inc_T58", "normalized": [] }, { "id": "NCT00586898_inc_R28", "type": "Has_value", "arg1_id": "NCT00586898_inc_T55", "arg2_id": "NCT00586898_inc_T56", "normalized": [] }, { "id": "NCT00586898_inc_R29", "type": "Has_value", "arg1_id": "NCT00586898_inc_T61", "arg2_id": "NCT00586898_inc_T62", "normalized": [] }, { "id": "NCT00586898_inc_R30", "type": "Has_value", "arg1_id": "NCT00586898_inc_T59", "arg2_id": "NCT00586898_inc_T60", "normalized": [] }, { "id": "NCT00586898_inc_R31", "type": "Has_value", "arg1_id": "NCT00586898_inc_T65", "arg2_id": "NCT00586898_inc_T66", "normalized": [] }, { "id": "NCT00586898_inc_R32", "type": "Has_value", "arg1_id": "NCT00586898_inc_T63", "arg2_id": "NCT00586898_inc_T64", "normalized": [] }, { "id": "NCT00586898_inc_R33", "type": "Has_temporal", "arg1_id": "NCT00586898_inc_T68", "arg2_id": "NCT00586898_inc_T67", "normalized": [] }, { "id": "NCT00586898_inc_R34", "type": "Has_mood", "arg1_id": "NCT00586898_inc_T68", "arg2_id": "NCT00586898_inc_T69", "normalized": [] }, { "id": "NCT00586898_inc_R35", "type": "Has_index", "arg1_id": "NCT00586898_inc_T71", "arg2_id": "NCT00586898_inc_T74", "normalized": [] }, { "id": "NCT00586898_inc_R36", "type": "Has_temporal", "arg1_id": "NCT00586898_inc_T70", "arg2_id": "NCT00586898_inc_T71", "normalized": [] }, { "id": "NCT00586898_inc_R37", "type": "Has_value", "arg1_id": "NCT00586898_inc_T75", "arg2_id": "NCT00586898_inc_T76", "normalized": [] }, { "id": "NCT00586898_inc_R38", "type": "AND", "arg1_id": "NCT00586898_inc_T70", "arg2_id": "NCT00586898_inc_T75", "normalized": [] }, { "id": "NCT00586898_inc_R39", "type": "Has_multiplier", "arg1_id": "NCT00586898_inc_T78", "arg2_id": "NCT00586898_inc_T77", "normalized": [] }, { "id": "NCT00586898_inc_R40", "type": "Has_value", "arg1_id": "NCT00586898_inc_T79", "arg2_id": "NCT00586898_inc_T80", "normalized": [] }, { "id": "NCT00586898_inc_R41", "type": "AND", "arg1_id": "NCT00586898_inc_T78", "arg2_id": "NCT00586898_inc_T79", "normalized": [] }, { "id": "NCT00586898_inc_R42", "type": "Has_value", "arg1_id": "NCT00586898_inc_T82", "arg2_id": "NCT00586898_inc_T81", "normalized": [] } ]

[ { "id": "NCT00599924_exc_text", "type": "exclusion", "text": [ "Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens \nPrior treatment with more than 2 cycles of carboplating-based chemotherapy regimens \nFor colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting \n \n" ], "offsets": [ [ 0, 344 ] ] } ]

[ { "id": "NCT00599924_exc_T1", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T2", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T3", "type": "Procedure", "text": [ "chemotherapy regimens" ], "offsets": [ [ 78, 99 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T4", "type": "Qualifier", "text": [ "alkylating agent-based" ], "offsets": [ [ 55, 77 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T5", "type": "Value", "text": [ "more than 6 cycles" ], "offsets": [ [ 21, 39 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T6", "type": "Qualifier", "text": [ "carboplating-based" ], "offsets": [ [ 144, 162 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T7", "type": "Value", "text": [ "more than 2 cycles" ], "offsets": [ [ 122, 140 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T8", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 107, 116 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T9", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 101, 106 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T10", "type": "Procedure", "text": [ "chemotherapy regimens" ], "offsets": [ [ 163, 184 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T11", "type": "Condition", "text": [ "colorectal cancer" ], "offsets": [ [ 190, 207 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T12", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 248, 257 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T13", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 242, 247 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T14", "type": "Value", "text": [ "more than 2" ], "offsets": [ [ 263, 274 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T15", "type": "Procedure", "text": [ "systemic chemotherapy regimens" ], "offsets": [ [ 275, 305 ] ], "normalized": [] }, { "id": "NCT00599924_exc_T16", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 313, 323 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00599924_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00599924_exc_T3", "arg2_id": "NCT00599924_exc_T4", "normalized": [] }, { "id": "NCT00599924_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00599924_exc_T10", "arg2_id": "NCT00599924_exc_T6", "normalized": [] }, { "id": "NCT00599924_exc_R3", "type": "AND", "arg1_id": "NCT00599924_exc_T5", "arg2_id": "NCT00599924_exc_T3", "normalized": [] }, { "id": "NCT00599924_exc_R5", "type": "AND", "arg1_id": "NCT00599924_exc_T7", "arg2_id": "NCT00599924_exc_T10", "normalized": [] }, { "id": "NCT00599924_exc_R1", "type": "Subsumes", "arg1_id": "NCT00599924_exc_T10", "arg2_id": "NCT00599924_exc_T8", "normalized": [] }, { "id": "NCT00599924_exc_R6", "type": "Subsumes", "arg1_id": "NCT00599924_exc_T3", "arg2_id": "NCT00599924_exc_T1", "normalized": [] }, { "id": "NCT00599924_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00599924_exc_T3", "arg2_id": "NCT00599924_exc_T2", "normalized": [] }, { "id": "NCT00599924_exc_R8", "type": "Has_temporal", "arg1_id": "NCT00599924_exc_T10", "arg2_id": "NCT00599924_exc_T9", "normalized": [] }, { "id": "NCT00599924_exc_R9", "type": "AND", "arg1_id": "NCT00599924_exc_T14", "arg2_id": "NCT00599924_exc_T15", "normalized": [] }, { "id": "NCT00599924_exc_R10", "type": "Subsumes", "arg1_id": "NCT00599924_exc_T15", "arg2_id": "NCT00599924_exc_T12", "normalized": [] }, { "id": "NCT00599924_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00599924_exc_T15", "arg2_id": "NCT00599924_exc_T13", "normalized": [] }, { "id": "NCT00599924_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00599924_exc_T15", "arg2_id": "NCT00599924_exc_T16", "normalized": [] }, { "id": "NCT00599924_exc_R13", "type": "AND", "arg1_id": "NCT00599924_exc_T11", "arg2_id": "NCT00599924_exc_T15", "normalized": [] } ]

[ { "id": "NCT00599924_inc_text", "type": "inclusion", "text": [ "Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum) \nEastern Cooperative Oncology Group (ECOG) 0 or 1 \n" ], "offsets": [ [ 0, 210 ] ] } ]

[ { "id": "NCT00599924_inc_T1", "type": "Condition", "text": [ "Advanced solid tumor malignancy" ], "offsets": [ [ 0, 31 ] ], "normalized": [] }, { "id": "NCT00599924_inc_T3", "type": "Measurement", "text": [ "Eastern Cooperative Oncology Group (ECOG)" ], "offsets": [ [ 160, 201 ] ], "normalized": [] }, { "id": "NCT00599924_inc_T4", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 202, 208 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00599924_inc_R1", "type": "Has_value", "arg1_id": "NCT00599924_inc_T3", "arg2_id": "NCT00599924_inc_T4", "normalized": [] } ]

[ { "id": "NCT00609531_exc_text", "type": "exclusion", "text": [ "Age less than 10 years or greater than 55 years, at time of consent \nEstimated IQ < 70 \nUncontrolled epilepsy (seizure within 6 months prior to consent) \n4. Presence of medical conditions that might interfere with participation, or where participation would be contraindicated \nHistory of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview \nHistory of claustrophobia \nImplanted or irremovable metal in the body (including certain tattoos and permanent make-up) \nCurrent pregnancy (as verified by testing prior to both initial dose administration of citalopram or placebo and prior to magnetic resonance imaging) due to the risk that may be associated with SSRI treatment and magnetic resonance imaging on fetal health \nMedical contraindications to SSRI therapy as determined by history (including induction of mania or hypomania during SSRI therapy, or known drug allergy) \nConcomitant medication that would interfere with study participation \nPrior history of citalopram treatment failure at appropriate doses and duration \nPrior history of treatment failure to two previous SSRI trials at appropriate doses and duration \nOngoing need for psychoactive medication other than study medication [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep] \n \n" ], "offsets": [ [ 0, 1524 ] ] } ]

[ { "id": "NCT00609531_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T2", "type": "Value", "text": [ "less than 10 years" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T3", "type": "Value", "text": [ "greater than 55 years" ], "offsets": [ [ 26, 47 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T4", "type": "Scope", "text": [ "less than 10 years or greater than 55 years" ], "offsets": [ [ 4, 47 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T5", "type": "Temporal", "text": [ "at time of consent" ], "offsets": [ [ 49, 67 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T6", "type": "Measurement", "text": [ "Estimated IQ" ], "offsets": [ [ 69, 81 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T7", "type": "Value", "text": [ "< 70" ], "offsets": [ [ 82, 86 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T8", "type": "Condition", "text": [ "Uncontrolled epilepsy" ], "offsets": [ [ 88, 109 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T9", "type": "Value", "text": [ "within 6 months prior to consent" ], "offsets": [ [ 119, 151 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T10", "type": "Condition", "text": [ "seizure" ], "offsets": [ [ 111, 118 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T12", "type": "Condition", "text": [ "neurological injury" ], "offsets": [ [ 289, 308 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T13", "type": "Observation", "text": [ "History" ], "offsets": [ [ 278, 285 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T14", "type": "Condition", "text": [ "head trauma" ], "offsets": [ [ 310, 321 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T15", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 341, 357 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T16", "type": "Qualifier", "text": [ "poorly-controlled" ], "offsets": [ [ 323, 340 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T17", "type": "Condition", "text": [ "seizure" ], "offsets": [ [ 359, 366 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T18", "type": "Temporal", "text": [ "within the preceding six months" ], "offsets": [ [ 367, 398 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T19", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 401, 407 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T20", "type": "Condition", "text": [ "neurosurgery" ], "offsets": [ [ 415, 427 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T21", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 409, 414 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T22", "type": "Observation", "text": [ "under the care of a neurologist" ], "offsets": [ [ 432, 463 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T23", "type": "Observation", "text": [ "under the care of a", "neurosurgeon" ], "offsets": [ [ 432, 451 ], [ 467, 479 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T24", "type": "Scope", "text": [ "head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon" ], "offsets": [ [ 310, 479 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T25", "type": "Condition", "text": [ "claustrophobia" ], "offsets": [ [ 519, 533 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T26", "type": "Observation", "text": [ "History" ], "offsets": [ [ 508, 515 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T27", "type": "Device", "text": [ "Implanted", "metal in the body" ], "offsets": [ [ 535, 544 ], [ 560, 577 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T28", "type": "Device", "text": [ "irremovable metal in the body" ], "offsets": [ [ 548, 577 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T29", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 637, 646 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T30", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 629, 636 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T32", "type": "Condition", "text": [ "contraindications to SSRI therapy" ], "offsets": [ [ 894, 927 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T33", "type": "Condition", "text": [ "mania" ], "offsets": [ [ 977, 982 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T34", "type": "Temporal", "text": [ "during SSRI therapy" ], "offsets": [ [ 996, 1015 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T35", "type": "Condition", "text": [ "hypomania" ], "offsets": [ [ 986, 995 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T36", "type": "Scope", "text": [ "mania or hypomania" ], "offsets": [ [ 977, 995 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T37", "type": "Condition", "text": [ "drug allergy" ], "offsets": [ [ 1026, 1038 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T38", "type": "Observation", "text": [ "history" ], "offsets": [ [ 945, 952 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T40", "type": "Drug", "text": [ "citalopram" ], "offsets": [ [ 1128, 1138 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T41", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1117, 1124 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T42", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 1111, 1116 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T43", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1139, 1148 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T44", "type": "Qualifier", "text": [ "failure" ], "offsets": [ [ 1149, 1156 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T47", "type": "Drug", "text": [ "psychoactive medication" ], "offsets": [ [ 1307, 1330 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T48", "type": "Drug", "text": [ "study medication" ], "offsets": [ [ 1342, 1358 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T51", "type": "Temporal", "text": [ "greater than three months" ], "offsets": [ [ 1384, 1409 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T52", "type": "Drug", "text": [ "anticonvulsant medication" ], "offsets": [ [ 1423, 1448 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T53", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 1453, 1469 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T54", "type": "Drug", "text": [ "diphenhydramine" ], "offsets": [ [ 1474, 1489 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T55", "type": "Scope", "text": [ "excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep" ], "offsets": [ [ 1360, 1510 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T56", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1331, 1341 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T49", "type": "Negation", "text": [ "excepting" ], "offsets": [ [ 1360, 1369 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T57", "type": "Observation", "text": [ "consent" ], "offsets": [ [ 60, 67 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T58", "type": "Reference_point", "text": [ "consent" ], "offsets": [ [ 60, 67 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T59", "type": "Procedure", "text": [ "SSRI therapy" ], "offsets": [ [ 915, 927 ] ], "normalized": [] }, { "id": "NCT00609531_exc_T60", "type": "Scope", "text": [ "mania or hypomania during SSRI therapy, or known drug allergy" ], "offsets": [ [ 977, 1038 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00609531_exc_R1", "type": "Has_scope", "arg1_id": "NCT00609531_exc_T1", "arg2_id": "NCT00609531_exc_T4", "normalized": [] }, { "id": "NCT00609531_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T1", "arg2_id": "NCT00609531_exc_T5", "normalized": [] }, { "id": "NCT00609531_exc_R3", "type": "Has_value", "arg1_id": "NCT00609531_exc_T6", "arg2_id": "NCT00609531_exc_T7", "normalized": [] }, { "id": "NCT00609531_exc_R4", "type": "Has_value", "arg1_id": "NCT00609531_exc_T10", "arg2_id": "NCT00609531_exc_T9", "normalized": [] }, { "id": "NCT00609531_exc_R5", "type": "Subsumes", "arg1_id": "NCT00609531_exc_T8", "arg2_id": "NCT00609531_exc_T10", "normalized": [] }, { "id": "NCT00609531_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T12", "arg2_id": "NCT00609531_exc_T13", "normalized": [] }, { "id": "NCT00609531_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T17", "arg2_id": "NCT00609531_exc_T18", "normalized": [] }, { "id": "NCT00609531_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00609531_exc_T15", "arg2_id": "NCT00609531_exc_T16", "normalized": [] }, { "id": "NCT00609531_exc_R9", "type": "AND", "arg1_id": "NCT00609531_exc_T16", "arg2_id": "NCT00609531_exc_T17", "normalized": [] }, { "id": "NCT00609531_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T20", "arg2_id": "NCT00609531_exc_T21", "normalized": [] }, { "id": "NCT00609531_exc_R11", "type": "Subsumes", "arg1_id": "NCT00609531_exc_T12", "arg2_id": "NCT00609531_exc_T24", "normalized": [] }, { "id": "NCT00609531_exc_R12", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T25", "arg2_id": "NCT00609531_exc_T26", "normalized": [] }, { "id": "NCT00609531_exc_R13", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T29", "arg2_id": "NCT00609531_exc_T30", "normalized": [] }, { "id": "NCT00609531_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T36", "arg2_id": "NCT00609531_exc_T34", "normalized": [] }, { "id": "NCT00609531_exc_R15", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T32", "arg2_id": "NCT00609531_exc_T38", "normalized": [] }, { "id": "NCT00609531_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT00609531_exc_T43", "arg2_id": "NCT00609531_exc_T44", "normalized": [] }, { "id": "NCT00609531_exc_R17", "type": "AND", "arg1_id": "NCT00609531_exc_T43", "arg2_id": "NCT00609531_exc_T40", "normalized": [] }, { "id": "NCT00609531_exc_R18", "type": "AND", "arg1_id": "NCT00609531_exc_T41", "arg2_id": "NCT00609531_exc_T43", "normalized": [] }, { "id": "NCT00609531_exc_R19", "type": "Has_temporal", "arg1_id": "NCT00609531_exc_T43", "arg2_id": "NCT00609531_exc_T42", "normalized": [] }, { "id": "NCT00609531_exc_R20", "type": "AND", "arg1_id": "NCT00609531_exc_T52", "arg2_id": "NCT00609531_exc_T53", "normalized": [] }, { "id": "NCT00609531_exc_R24", "type": "Has_negation", "arg1_id": "NCT00609531_exc_T48", "arg2_id": "NCT00609531_exc_T56", "normalized": [] }, { "id": "NCT00609531_exc_R25", "type": "AND", "arg1_id": "NCT00609531_exc_T47", "arg2_id": "NCT00609531_exc_T48", "normalized": [] }, { "id": "NCT00609531_exc_R23", "type": "Has_negation", "arg1_id": "NCT00609531_exc_T52", "arg2_id": "NCT00609531_exc_T49", "normalized": [] }, { "id": "NCT00609531_exc_R26", "type": "AND", "arg1_id": "NCT00609531_exc_T47", "arg2_id": "NCT00609531_exc_T52", "normalized": [] }, { "id": "NCT00609531_exc_R28", "type": "Has_index", "arg1_id": "NCT00609531_exc_T5", "arg2_id": "NCT00609531_exc_T58", "normalized": [] }, { "id": "NCT00609531_exc_R30", "type": "Subsumes", "arg1_id": "NCT00609531_exc_T32", "arg2_id": "NCT00609531_exc_T60", "normalized": [] } ]

[ { "id": "NCT00609531_inc_text", "type": "inclusion", "text": [ "Ambulatory status (outpatient) at time of consent \nAge 10-55 years \nClinical diagnosis of Autism Spectrum Disorder \nIQ greater than or equal to 70 \nScore greater than 8 on Children's Yale-Brown Obsessive Compulsive Scale \nFree of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder] \n" ], "offsets": [ [ 0, 502 ] ] } ]

[ { "id": "NCT00609531_inc_T1", "type": "Visit", "text": [ "Ambulatory status" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T2", "type": "Visit", "text": [ "outpatient" ], "offsets": [ [ 19, 29 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T3", "type": "Temporal", "text": [ "at time of consent" ], "offsets": [ [ 31, 49 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T4", "type": "Value", "text": [ "10-55 years" ], "offsets": [ [ 55, 66 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 51, 54 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T6", "type": "Condition", "text": [ "Autism Spectrum Disorder" ], "offsets": [ [ 90, 114 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T7", "type": "Measurement", "text": [ "IQ" ], "offsets": [ [ 116, 118 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T8", "type": "Value", "text": [ "greater than or equal to 70" ], "offsets": [ [ 119, 146 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T9", "type": "Measurement", "text": [ "Children's Yale-Brown Obsessive Compulsive Scale" ], "offsets": [ [ 172, 220 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T10", "type": "Value", "text": [ "greater than 8" ], "offsets": [ [ 154, 168 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T11", "type": "Drug", "text": [ "psychoactive medication" ], "offsets": [ [ 230, 253 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T12", "type": "Negation", "text": [ "Free of" ], "offsets": [ [ 222, 229 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T13", "type": "Temporal", "text": [ "at least", "one month" ], "offsets": [ [ 258, 266 ], [ 268, 277 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T14", "type": "Temporal", "text": [ "at least", "two weeks" ], "offsets": [ [ 258, 266 ], [ 294, 303 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T15", "type": "Temporal", "text": [ "at least", "five days" ], "offsets": [ [ 258, 266 ], [ 342, 351 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T16", "type": "Drug", "text": [ "fluoxetine" ], "offsets": [ [ 282, 292 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T17", "type": "Drug", "text": [ "SSRIs" ], "offsets": [ [ 314, 319 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T18", "type": "Drug", "text": [ "neuroleptics" ], "offsets": [ [ 324, 336 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T19", "type": "Scope", "text": [ "SSRIs and neuroleptics" ], "offsets": [ [ 314, 336 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T20", "type": "Drug", "text": [ "stimulants" ], "offsets": [ [ 356, 366 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T21", "type": "Temporal", "text": [ "prior to MRI scanning" ], "offsets": [ [ 367, 388 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T22", "type": "Drug", "text": [ "anticonvulsant medication" ], "offsets": [ [ 453, 478 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T23", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 483, 499 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T24", "type": "Temporal", "text": [ "greater than three months" ], "offsets": [ [ 414, 439 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T25", "type": "Qualifier", "text": [ "stable doses" ], "offsets": [ [ 400, 412 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T26", "type": "Scope", "text": [ "at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants" ], "offsets": [ [ 258, 366 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T27", "type": "Negation", "text": [ "excepting" ], "offsets": [ [ 390, 399 ] ], "normalized": [] }, { "id": "NCT00609531_inc_T28", "type": "Qualifier", "text": [ "Clinical diagnosis" ], "offsets": [ [ 68, 86 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00609531_inc_R1", "type": "Subsumes", "arg1_id": "NCT00609531_inc_T1", "arg2_id": "NCT00609531_inc_T2", "normalized": [] }, { "id": "NCT00609531_inc_R2", "type": "Has_temporal", "arg1_id": "NCT00609531_inc_T1", "arg2_id": "NCT00609531_inc_T3", "normalized": [] }, { "id": "NCT00609531_inc_R3", "type": "Has_value", "arg1_id": "NCT00609531_inc_T5", "arg2_id": "NCT00609531_inc_T4", "normalized": [] }, { "id": "NCT00609531_inc_R4", "type": "Has_value", "arg1_id": "NCT00609531_inc_T9", "arg2_id": "NCT00609531_inc_T10", "normalized": [] }, { "id": "NCT00609531_inc_R5", "type": "Has_negation", "arg1_id": "NCT00609531_inc_T11", "arg2_id": "NCT00609531_inc_T12", "normalized": [] }, { "id": "NCT00609531_inc_R7", "type": "AND", "arg1_id": "NCT00609531_inc_T22", "arg2_id": "NCT00609531_inc_T23", "normalized": [] }, { "id": "NCT00609531_inc_R8", "type": "Has_temporal", "arg1_id": "NCT00609531_inc_T20", "arg2_id": "NCT00609531_inc_T15", "normalized": [] }, { "id": "NCT00609531_inc_R9", "type": "Subsumes", "arg1_id": "NCT00609531_inc_T25", "arg2_id": "NCT00609531_inc_T24", "normalized": [] }, { "id": "NCT00609531_inc_R10", "type": "Has_temporal", "arg1_id": "NCT00609531_inc_T26", "arg2_id": "NCT00609531_inc_T21", "normalized": [] }, { "id": "NCT00609531_inc_R11", "type": "Has_scope", "arg1_id": "NCT00609531_inc_T11", "arg2_id": "NCT00609531_inc_T26", "normalized": [] }, { "id": "NCT00609531_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT00609531_inc_T22", "arg2_id": "NCT00609531_inc_T25", "normalized": [] }, { "id": "NCT00609531_inc_R13", "type": "Has_value", "arg1_id": "NCT00609531_inc_T7", "arg2_id": "NCT00609531_inc_T8", "normalized": [] }, { "id": "NCT00609531_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00609531_inc_T16", "arg2_id": "NCT00609531_inc_T13", "normalized": [] }, { "id": "NCT00609531_inc_R14", "type": "Has_temporal", "arg1_id": "NCT00609531_inc_T19", "arg2_id": "NCT00609531_inc_T14", "normalized": [] }, { "id": "NCT00609531_inc_R15", "type": "Has_negation", "arg1_id": "NCT00609531_inc_T22", "arg2_id": "NCT00609531_inc_T27", "normalized": [] }, { "id": "NCT00609531_inc_R16", "type": "AND", "arg1_id": "NCT00609531_inc_T11", "arg2_id": "NCT00609531_inc_T22", "normalized": [] }, { "id": "NCT00609531_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT00609531_inc_T6", "arg2_id": "NCT00609531_inc_T28", "normalized": [] } ]

[ { "id": "NCT00625742_exc_text", "type": "exclusion", "text": [ "1. Have dementia or delirium (as determined by the palliative care specialist) at study entry. \n2. Are pregnant \n3. Have been taking corticosteroids for longer than 48 hours. \n4. Have pulmonary edema, ascites or pitting edema on clinical examination. \n5. Are unable to walk. \n6. Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use. \n7. Have an ALT/AST>3x upper limit of normal. \n8. Patients on methotrexate. \n9. Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]). \n \n" ], "offsets": [ [ 0, 594 ] ] } ]

[ { "id": "NCT00625742_exc_T1", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 8, 16 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T2", "type": "Condition", "text": [ "delirium" ], "offsets": [ [ 20, 28 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T3", "type": "Temporal", "text": [ "at study entry" ], "offsets": [ [ 79, 93 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T4", "type": "Scope", "text": [ "dementia or delirium" ], "offsets": [ [ 8, 28 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T5", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 103, 111 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T6", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 133, 148 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T7", "type": "Temporal", "text": [ "longer than 48 hours" ], "offsets": [ [ 153, 173 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T8", "type": "Condition", "text": [ "pulmonary edema" ], "offsets": [ [ 184, 199 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T9", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 201, 208 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T10", "type": "Condition", "text": [ "pitting edema" ], "offsets": [ [ 212, 225 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T11", "type": "Condition", "text": [ "unable to walk" ], "offsets": [ [ 259, 273 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T12", "type": "Observation", "text": [ "history" ], "offsets": [ [ 286, 293 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T13", "type": "Condition", "text": [ "adverse gastrointestinal events" ], "offsets": [ [ 305, 336 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T14", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 297, 304 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T15", "type": "Condition", "text": [ "bleeding" ], "offsets": [ [ 344, 352 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T16", "type": "Condition", "text": [ "perforation" ], "offsets": [ [ 356, 367 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T17", "type": "Scope", "text": [ "bleeding or perforation" ], "offsets": [ [ 344, 367 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T18", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 382, 394 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T19", "type": "Observation", "text": [ "history" ], "offsets": [ [ 369, 376 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T20", "type": "Drug", "text": [ "anti-coagulant" ], "offsets": [ [ 406, 420 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T21", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 398, 405 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T22", "type": "Measurement", "text": [ "ALT/AST" ], "offsets": [ [ 438, 445 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T23", "type": "Value", "text": [ ">3x upper limit of normal" ], "offsets": [ [ 445, 470 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T24", "type": "Drug", "text": [ "methotrexate" ], "offsets": [ [ 488, 500 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T25", "type": "Drug", "text": [ "melatonin receptor agonists" ], "offsets": [ [ 522, 549 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T26", "type": "Drug", "text": [ "Rozerem" ], "offsets": [ [ 559, 566 ] ], "normalized": [] }, { "id": "NCT00625742_exc_T27", "type": "Drug", "text": [ "ramelteon" ], "offsets": [ [ 569, 578 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00625742_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00625742_exc_T4", "arg2_id": "NCT00625742_exc_T3", "normalized": [] }, { "id": "NCT00625742_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00625742_exc_T13", "arg2_id": "NCT00625742_exc_T14", "normalized": [] }, { "id": "NCT00625742_exc_R5", "type": "Subsumes", "arg1_id": "NCT00625742_exc_T13", "arg2_id": "NCT00625742_exc_T17", "normalized": [] }, { "id": "NCT00625742_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00625742_exc_T13", "arg2_id": "NCT00625742_exc_T12", "normalized": [] }, { "id": "NCT00625742_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00625742_exc_T18", "arg2_id": "NCT00625742_exc_T19", "normalized": [] }, { "id": "NCT00625742_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00625742_exc_T20", "arg2_id": "NCT00625742_exc_T21", "normalized": [] }, { "id": "NCT00625742_exc_R8", "type": "Has_value", "arg1_id": "NCT00625742_exc_T22", "arg2_id": "NCT00625742_exc_T23", "normalized": [] }, { "id": "NCT00625742_exc_R9", "type": "Subsumes", "arg1_id": "NCT00625742_exc_T26", "arg2_id": "NCT00625742_exc_T27", "normalized": [] }, { "id": "NCT00625742_exc_R10", "type": "Subsumes", "arg1_id": "NCT00625742_exc_T25", "arg2_id": "NCT00625742_exc_T26", "normalized": [] }, { "id": "NCT00625742_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00625742_exc_T6", "arg2_id": "NCT00625742_exc_T7", "normalized": [] } ]

[ { "id": "NCT00625742_inc_text", "type": "inclusion", "text": [ "1. Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months. \n2. Are 18 years of age or older \n3. Have a Karnofsky performance score of 60 or higher. \n4. Can maintain oral food intake during the study \n5. Can understand the study procedures and can sign an informed consent form. \n6. Are not currently taking melatonin. \n7. Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy. \n8. Have a calculated creatinine clearance of >/= 60 cc/min. \n" ], "offsets": [ [ 0, 550 ] ] } ]

[ { "id": "NCT00625742_inc_T1", "type": "Visit", "text": [ "Cachexia Clinic" ], "offsets": [ [ 23, 38 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T2", "type": "Condition", "text": [ "involuntary weight loss" ], "offsets": [ [ 44, 67 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T3", "type": "Value", "text": [ ">5% of their premorbid weight" ], "offsets": [ [ 71, 100 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T4", "type": "Temporal", "text": [ "within the previous 6 months" ], "offsets": [ [ 101, 129 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T5", "type": "Person", "text": [ "of age" ], "offsets": [ [ 148, 154 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T6", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 139, 147 ], [ 155, 163 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T7", "type": "Measurement", "text": [ "Karnofsky performance score" ], "offsets": [ [ 175, 202 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T8", "type": "Value", "text": [ "60 or higher" ], "offsets": [ [ 206, 218 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T12", "type": "Drug", "text": [ "melatonin" ], "offsets": [ [ 379, 388 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T13", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 362, 371 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T14", "type": "Negation", "text": [ "not" ], "offsets": [ [ 358, 361 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T15", "type": "Drug", "text": [ "megestrol acetate" ], "offsets": [ [ 405, 422 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T16", "type": "Observation", "text": [ "lose weight" ], "offsets": [ [ 439, 450 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T17", "type": "Temporal", "text": [ "continue" ], "offsets": [ [ 427, 435 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T18", "type": "Temporal", "text": [ "at least 2 weeks" ], "offsets": [ [ 459, 475 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T19", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 479, 486 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T20", "type": "Temporal", "text": [ "Are taking" ], "offsets": [ [ 394, 404 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T21", "type": "Measurement", "text": [ "calculated creatinine clearance" ], "offsets": [ [ 499, 530 ] ], "normalized": [] }, { "id": "NCT00625742_inc_T22", "type": "Value", "text": [ ">/= 60 cc/min" ], "offsets": [ [ 534, 547 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00625742_inc_R1", "type": "Has_value", "arg1_id": "NCT00625742_inc_T2", "arg2_id": "NCT00625742_inc_T3", "normalized": [] }, { "id": "NCT00625742_inc_R2", "type": "Has_temporal", "arg1_id": "NCT00625742_inc_T2", "arg2_id": "NCT00625742_inc_T4", "normalized": [] }, { "id": "NCT00625742_inc_R3", "type": "Has_value", "arg1_id": "NCT00625742_inc_T5", "arg2_id": "NCT00625742_inc_T6", "normalized": [] }, { "id": "NCT00625742_inc_R4", "type": "Has_value", "arg1_id": "NCT00625742_inc_T7", "arg2_id": "NCT00625742_inc_T8", "normalized": [] }, { "id": "NCT00625742_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00625742_inc_T12", "arg2_id": "NCT00625742_inc_T13", "normalized": [] }, { "id": "NCT00625742_inc_R6", "type": "Has_negation", "arg1_id": "NCT00625742_inc_T12", "arg2_id": "NCT00625742_inc_T14", "normalized": [] }, { "id": "NCT00625742_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00625742_inc_T16", "arg2_id": "NCT00625742_inc_T17", "normalized": [] }, { "id": "NCT00625742_inc_R8", "type": "Has_temporal", "arg1_id": "NCT00625742_inc_T19", "arg2_id": "NCT00625742_inc_T18", "normalized": [] }, { "id": "NCT00625742_inc_R9", "type": "AND", "arg1_id": "NCT00625742_inc_T16", "arg2_id": "NCT00625742_inc_T19", "normalized": [] }, { "id": "NCT00625742_inc_R10", "type": "Has_temporal", "arg1_id": "NCT00625742_inc_T15", "arg2_id": "NCT00625742_inc_T20", "normalized": [] }, { "id": "NCT00625742_inc_R11", "type": "Has_value", "arg1_id": "NCT00625742_inc_T21", "arg2_id": "NCT00625742_inc_T22", "normalized": [] } ]

[ { "id": "NCT00639795_exc_text", "type": "exclusion", "text": [ "Age less than 18 \nClinical or laboratory evidence of systemic infection \nCurrent pregnancy as assessed by preoperative urine HCG test \nSerious, uncontrolled, non-malignant illness \nMalignant illness requiring systemic chemotherapy in the last 6 months \nDocumented allergy to oxycodone, morphine sulfate or acetaminophen \nContraindication to peripheral nerve blockade or general anesthesia including: \n1. patient refusal \n2. active infection at site of planned block \n3. documented allergy to any local or general anesthetic medications \n4. significant coagulopathy( prothrombin time >15 seconds, INR>1.5 \n5. pre-existing neuropathy and medical conditions or deformities which would compromise block or anesthetic safety \nPlanned pleurodesis \nCurrent use of high dose inhaled or systemic steroids \nCurrent use of Amiodarone (Cordarone) \nMorbid obesity (BMI=40kg/m2) \nPatients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications. \nPatients unable to consent \nPatients with active infections requiring antibiotics within one month of registration \nParticipation in other clinical trials that may interfere with this study \n \n" ], "offsets": [ [ 0, 1197 ] ] } ]

[ { "id": "NCT00639795_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T2", "type": "Value", "text": [ "less than 18" ], "offsets": [ [ 4, 16 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T4", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 106, 118 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T5", "type": "Measurement", "text": [ "urine HCG test" ], "offsets": [ [ 119, 133 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T6", "type": "Value", "text": [ "pregnancy" ], "offsets": [ [ 81, 90 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T7", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 81, 90 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T8", "type": "Condition", "text": [ "non-malignant illness" ], "offsets": [ [ 158, 179 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T9", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 144, 156 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T10", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 135, 142 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T11", "type": "Condition", "text": [ "Malignant illness" ], "offsets": [ [ 181, 198 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T12", "type": "Procedure", "text": [ "systemic chemotherapy" ], "offsets": [ [ 209, 230 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T13", "type": "Temporal", "text": [ "in the last 6 months" ], "offsets": [ [ 231, 251 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T14", "type": "Drug", "text": [ "oxycodone" ], "offsets": [ [ 275, 284 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T15", "type": "Drug", "text": [ "morphine sulfate" ], "offsets": [ [ 286, 302 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T16", "type": "Drug", "text": [ "acetaminophen" ], "offsets": [ [ 306, 319 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T17", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 264, 271 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T18", "type": "Scope", "text": [ "oxycodone, morphine sulfate or acetaminophen" ], "offsets": [ [ 275, 319 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T19", "type": "Condition", "text": [ "Contraindication to peripheral nerve blockade" ], "offsets": [ [ 321, 366 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T20", "type": "Condition", "text": [ "Contraindication to", "general anesthesia" ], "offsets": [ [ 321, 340 ], [ 370, 388 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T24", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 552, 564 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T25", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 540, 551 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T26", "type": "Measurement", "text": [ "prothrombin time" ], "offsets": [ [ 566, 582 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T27", "type": "Value", "text": [ ">15 seconds" ], "offsets": [ [ 583, 594 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T28", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 596, 599 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T29", "type": "Value", "text": [ ">1.5" ], "offsets": [ [ 599, 603 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T30", "type": "Scope", "text": [ "prothrombin time >15 seconds, INR>1.5" ], "offsets": [ [ 566, 603 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T31", "type": "Condition", "text": [ "neuropathy" ], "offsets": [ [ 621, 631 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T32", "type": "Temporal", "text": [ "pre-existing" ], "offsets": [ [ 608, 620 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T34", "type": "Condition", "text": [ "pleurodesis" ], "offsets": [ [ 729, 740 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T36", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 787, 795 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T37", "type": "Qualifier", "text": [ "inhaled" ], "offsets": [ [ 767, 774 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T38", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 778, 786 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T39", "type": "Scope", "text": [ "inhaled or systemic" ], "offsets": [ [ 767, 786 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T40", "type": "Qualifier", "text": [ "high dose" ], "offsets": [ [ 757, 766 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T41", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 742, 749 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T42", "type": "Drug", "text": [ "Amiodarone" ], "offsets": [ [ 812, 822 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T43", "type": "Drug", "text": [ "Cordarone" ], "offsets": [ [ 824, 833 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T44", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 797, 804 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T45", "type": "Condition", "text": [ "Morbid obesity" ], "offsets": [ [ 836, 850 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T46", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 852, 855 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T47", "type": "Value", "text": [ "40kg/m2" ], "offsets": [ [ 856, 863 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T48", "type": "Condition", "text": [ "mental health issues" ], "offsets": [ [ 903, 923 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T49", "type": "Condition", "text": [ "psychosis" ], "offsets": [ [ 932, 941 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T50", "type": "Drug", "text": [ "antipsychotic medications" ], "offsets": [ [ 967, 992 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T51", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 952, 961 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T52", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 880, 902 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T53", "type": "Scope", "text": [ "clinically significant mental health issues such as psychosis" ], "offsets": [ [ 880, 941 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T55", "type": "Condition", "text": [ "infections" ], "offsets": [ [ 1044, 1054 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T56", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 1037, 1043 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T57", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 1065, 1076 ] ], "normalized": [] }, { "id": "NCT00639795_exc_T58", "type": "Temporal", "text": [ "within one month of registration" ], "offsets": [ [ 1077, 1109 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00639795_exc_R1", "type": "Has_value", "arg1_id": "NCT00639795_exc_T1", "arg2_id": "NCT00639795_exc_T2", "normalized": [] }, { "id": "NCT00639795_exc_R2", "type": "Has_value", "arg1_id": "NCT00639795_exc_T5", "arg2_id": "NCT00639795_exc_T6", "normalized": [] }, { "id": "NCT00639795_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00639795_exc_T8", "arg2_id": "NCT00639795_exc_T9", "normalized": [] }, { "id": "NCT00639795_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00639795_exc_T8", "arg2_id": "NCT00639795_exc_T10", "normalized": [] }, { "id": "NCT00639795_exc_R5", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T12", "arg2_id": "NCT00639795_exc_T13", "normalized": [] }, { "id": "NCT00639795_exc_R6", "type": "AND", "arg1_id": "NCT00639795_exc_T11", "arg2_id": "NCT00639795_exc_T12", "normalized": [] }, { "id": "NCT00639795_exc_R7", "type": "Has_scope", "arg1_id": "NCT00639795_exc_T17", "arg2_id": "NCT00639795_exc_T18", "normalized": [] }, { "id": "NCT00639795_exc_R8", "type": "Has_value", "arg1_id": "NCT00639795_exc_T26", "arg2_id": "NCT00639795_exc_T27", "normalized": [] }, { "id": "NCT00639795_exc_R9", "type": "Has_value", "arg1_id": "NCT00639795_exc_T28", "arg2_id": "NCT00639795_exc_T29", "normalized": [] }, { "id": "NCT00639795_exc_R10", "type": "Subsumes", "arg1_id": "NCT00639795_exc_T25", "arg2_id": "NCT00639795_exc_T30", "normalized": [] }, { "id": "NCT00639795_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00639795_exc_T24", "arg2_id": "NCT00639795_exc_T25", "normalized": [] }, { "id": "NCT00639795_exc_R12", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T31", "arg2_id": "NCT00639795_exc_T32", "normalized": [] }, { "id": "NCT00639795_exc_R13", "type": "Has_scope", "arg1_id": "NCT00639795_exc_T36", "arg2_id": "NCT00639795_exc_T39", "normalized": [] }, { "id": "NCT00639795_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT00639795_exc_T36", "arg2_id": "NCT00639795_exc_T40", "normalized": [] }, { "id": "NCT00639795_exc_R15", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T36", "arg2_id": "NCT00639795_exc_T41", "normalized": [] }, { "id": "NCT00639795_exc_R16", "type": "Subsumes", "arg1_id": "NCT00639795_exc_T42", "arg2_id": "NCT00639795_exc_T43", "normalized": [] }, { "id": "NCT00639795_exc_R17", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T42", "arg2_id": "NCT00639795_exc_T44", "normalized": [] }, { "id": "NCT00639795_exc_R18", "type": "Has_value", "arg1_id": "NCT00639795_exc_T46", "arg2_id": "NCT00639795_exc_T47", "normalized": [] }, { "id": "NCT00639795_exc_R19", "type": "AND", "arg1_id": "NCT00639795_exc_T45", "arg2_id": "NCT00639795_exc_T46", "normalized": [] }, { "id": "NCT00639795_exc_R20", "type": "AND", "arg1_id": "NCT00639795_exc_T51", "arg2_id": "NCT00639795_exc_T50", "normalized": [] }, { "id": "NCT00639795_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT00639795_exc_T48", "arg2_id": "NCT00639795_exc_T52", "normalized": [] }, { "id": "NCT00639795_exc_R22", "type": "Subsumes", "arg1_id": "NCT00639795_exc_T48", "arg2_id": "NCT00639795_exc_T49", "normalized": [] }, { "id": "NCT00639795_exc_R23", "type": "AND", "arg1_id": "NCT00639795_exc_T53", "arg2_id": "NCT00639795_exc_T51", "normalized": [] }, { "id": "NCT00639795_exc_R24", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T55", "arg2_id": "NCT00639795_exc_T56", "normalized": [] }, { "id": "NCT00639795_exc_R25", "type": "AND", "arg1_id": "NCT00639795_exc_T55", "arg2_id": "NCT00639795_exc_T57", "normalized": [] }, { "id": "NCT00639795_exc_R26", "type": "Has_temporal", "arg1_id": "NCT00639795_exc_T55", "arg2_id": "NCT00639795_exc_T58", "normalized": [] } ]

[ { "id": "NCT00639795_inc_text", "type": "inclusion", "text": [ "Age greater than 18 \nPlanned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure \n" ], "offsets": [ [ 0, 117 ] ] } ]

[ { "id": "NCT00639795_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00639795_inc_T2", "type": "Value", "text": [ "greater than 18" ], "offsets": [ [ 4, 19 ] ], "normalized": [] }, { "id": "NCT00639795_inc_T3", "type": "Procedure", "text": [ "thoracoscopy" ], "offsets": [ [ 29, 41 ] ], "normalized": [] }, { "id": "NCT00639795_inc_T4", "type": "Qualifier", "text": [ "low probability(by surgeon estimate) of conversion to open procedure" ], "offsets": [ [ 47, 115 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00639795_inc_R1", "type": "Has_value", "arg1_id": "NCT00639795_inc_T1", "arg2_id": "NCT00639795_inc_T2", "normalized": [] }, { "id": "NCT00639795_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00639795_inc_T3", "arg2_id": "NCT00639795_inc_T4", "normalized": [] } ]

[ { "id": "NCT00650312_exc_text", "type": "exclusion", "text": [ "1. Institutionalized subjects will not be used. 2 Social Habits: \n1. Use of any tobacco products. \n2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. \n3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication. \n4. Any recent, significant change in dietary or exercise habits. \n5. Positive test for any drug included in the urine drug screen. \n3. Medications: \n1. Use of any medication within the 14 days prior to the initial dose of study medication. \n2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. \n3. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication. \n4. Diseases: \na. History of any significant chronic disease and/or hepatitis. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing. \nd. Positive HIV, Hepatitis B, or Hepatitis C test. e. Renal disease or renal dysfunction (as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance). \n5. Abnormal and clinically significant laboratory test results: \n1. Clinically significant deviation from the Guide for Clinically Relevant Abnormalities (see Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). \n2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. \n7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. \n8. Allergy or hypersensitivity to metformin hydrochloride. 9. History of difficulty in swallowing medication, or any gastrointestinal disorder which could affect the drug absorption. \n \n" ], "offsets": [ [ 0, 2058 ] ] } ]

[ { "id": "NCT00650312_exc_T5", "type": "Drug", "text": [ "tobacco products" ], "offsets": [ [ 80, 96 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T17", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 531, 541 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T18", "type": "Temporal", "text": [ "within the 14 days prior" ], "offsets": [ [ 542, 566 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T19", "type": "Reference_point", "text": [ "the initial dose of study medication" ], "offsets": [ [ 570, 606 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T20", "type": "Drug", "text": [ "medication known to alter hepatic enzyme activity" ], "offsets": [ [ 623, 672 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T21", "type": "Temporal", "text": [ "within 28 days prior" ], "offsets": [ [ 673, 693 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T22", "type": "Reference_point", "text": [ "the initial dose of study medication" ], "offsets": [ [ 697, 733 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T24", "type": "Drug", "text": [ "hormonal contraceptives" ], "offsets": [ [ 746, 769 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T25", "type": "Drug", "text": [ "hormonal replacement therapy" ], "offsets": [ [ 774, 802 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T26", "type": "Temporal", "text": [ "within three months prior" ], "offsets": [ [ 803, 828 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T27", "type": "Reference_point", "text": [ "the initial dose of study medication" ], "offsets": [ [ 832, 868 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T31", "type": "Observation", "text": [ "History" ], "offsets": [ [ 888, 895 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T32", "type": "Condition", "text": [ "chronic disease" ], "offsets": [ [ 915, 930 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T33", "type": "Condition", "text": [ "hepatitis" ], "offsets": [ [ 938, 947 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T34", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 903, 914 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T36", "type": "Scope", "text": [ "significant chronic disease and/or hepatitis" ], "offsets": [ [ 903, 947 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T37", "type": "Condition", "text": [ "drug", "abuse" ], "offsets": [ [ 963, 967 ], [ 983, 988 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T38", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 975, 988 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T39", "type": "Observation", "text": [ "History" ], "offsets": [ [ 952, 959 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T41", "type": "Measurement", "text": [ "HIV", "test" ], "offsets": [ [ 1085, 1088 ], [ 1118, 1122 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T42", "type": "Measurement", "text": [ "Hepatitis B", "test" ], "offsets": [ [ 1090, 1101 ], [ 1118, 1122 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T43", "type": "Measurement", "text": [ "Hepatitis C test" ], "offsets": [ [ 1106, 1122 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T44", "type": "Scope", "text": [ "HIV, Hepatitis B, or Hepatitis C test" ], "offsets": [ [ 1085, 1122 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T45", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 1076, 1084 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T50", "type": "Condition", "text": [ "Renal disease" ], "offsets": [ [ 1127, 1140 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T51", "type": "Condition", "text": [ "renal dysfunction" ], "offsets": [ [ 1144, 1161 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T52", "type": "Measurement", "text": [ "serum creatinine levels" ], "offsets": [ [ 1179, 1202 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T53", "type": "Value", "text": [ "greater than or equal to 1.5 mg/dL" ], "offsets": [ [ 1203, 1237 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T54", "type": "Person", "text": [ "males" ], "offsets": [ [ 1243, 1248 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T55", "type": "Person", "text": [ "females" ], "offsets": [ [ 1294, 1301 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T56", "type": "Value", "text": [ "greater than or equal to 1.4 mg/dL" ], "offsets": [ [ 1254, 1288 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T57", "type": "Condition", "text": [ "abnormal creatinine clearance" ], "offsets": [ [ 1306, 1335 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T58", "type": "Scope", "text": [ "greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females)" ], "offsets": [ [ 1203, 1302 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T59", "type": "Scope", "text": [ "serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance" ], "offsets": [ [ 1179, 1335 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T60", "type": "Scope", "text": [ "Renal disease or renal dysfunction" ], "offsets": [ [ 1127, 1161 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T69", "type": "Condition", "text": [ "Abnormal", "ECG tracing" ], "offsets": [ [ 1563, 1571 ], [ 1596, 1607 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T76", "type": "Drug", "text": [ "metformin hydrochloride" ], "offsets": [ [ 1897, 1920 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T77", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1877, 1893 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T78", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 1866, 1873 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T79", "type": "Condition", "text": [ "difficulty in swallowing medication" ], "offsets": [ [ 1936, 1971 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T81", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1925, 1932 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T82", "type": "Condition", "text": [ "gastrointestinal disorder" ], "offsets": [ [ 1980, 2005 ] ], "normalized": [] }, { "id": "NCT00650312_exc_T83", "type": "Qualifier", "text": [ "affect the drug absorption" ], "offsets": [ [ 2018, 2044 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00650312_exc_R1", "type": "Has_index", "arg1_id": "NCT00650312_exc_T18", "arg2_id": "NCT00650312_exc_T19", "normalized": [] }, { "id": "NCT00650312_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T17", "arg2_id": "NCT00650312_exc_T18", "normalized": [] }, { "id": "NCT00650312_exc_R3", "type": "Has_index", "arg1_id": "NCT00650312_exc_T21", "arg2_id": "NCT00650312_exc_T22", "normalized": [] }, { "id": "NCT00650312_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T20", "arg2_id": "NCT00650312_exc_T21", "normalized": [] }, { "id": "NCT00650312_exc_R5", "type": "Has_index", "arg1_id": "NCT00650312_exc_T26", "arg2_id": "NCT00650312_exc_T27", "normalized": [] }, { "id": "NCT00650312_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T25", "arg2_id": "NCT00650312_exc_T26", "normalized": [] }, { "id": "NCT00650312_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T24", "arg2_id": "NCT00650312_exc_T26", "normalized": [] }, { "id": "NCT00650312_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00650312_exc_T32", "arg2_id": "NCT00650312_exc_T34", "normalized": [] }, { "id": "NCT00650312_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT00650312_exc_T33", "arg2_id": "NCT00650312_exc_T34", "normalized": [] }, { "id": "NCT00650312_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T36", "arg2_id": "NCT00650312_exc_T31", "normalized": [] }, { "id": "NCT00650312_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T38", "arg2_id": "NCT00650312_exc_T39", "normalized": [] }, { "id": "NCT00650312_exc_R12", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T37", "arg2_id": "NCT00650312_exc_T39", "normalized": [] }, { "id": "NCT00650312_exc_R13", "type": "Has_value", "arg1_id": "NCT00650312_exc_T44", "arg2_id": "NCT00650312_exc_T45", "normalized": [] }, { "id": "NCT00650312_exc_R14", "type": "Has_value", "arg1_id": "NCT00650312_exc_T55", "arg2_id": "NCT00650312_exc_T56", "normalized": [] }, { "id": "NCT00650312_exc_R15", "type": "Has_value", "arg1_id": "NCT00650312_exc_T54", "arg2_id": "NCT00650312_exc_T53", "normalized": [] }, { "id": "NCT00650312_exc_R16", "type": "Has_scope", "arg1_id": "NCT00650312_exc_T52", "arg2_id": "NCT00650312_exc_T58", "normalized": [] }, { "id": "NCT00650312_exc_R17", "type": "Subsumes", "arg1_id": "NCT00650312_exc_T60", "arg2_id": "NCT00650312_exc_T59", "normalized": [] }, { "id": "NCT00650312_exc_R18", "type": "AND", "arg1_id": "NCT00650312_exc_T77", "arg2_id": "NCT00650312_exc_T76", "normalized": [] }, { "id": "NCT00650312_exc_R19", "type": "AND", "arg1_id": "NCT00650312_exc_T78", "arg2_id": "NCT00650312_exc_T76", "normalized": [] }, { "id": "NCT00650312_exc_R20", "type": "Has_temporal", "arg1_id": "NCT00650312_exc_T79", "arg2_id": "NCT00650312_exc_T81", "normalized": [] }, { "id": "NCT00650312_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT00650312_exc_T82", "arg2_id": "NCT00650312_exc_T83", "normalized": [] } ]

[ { "id": "NCT00650312_inc_text", "type": "inclusion", "text": [ "1. Age: 18 years and older. \n2. Sex: Male and non-pregnant, non-lactating female \n1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study. \n2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following: \n(1) intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or (2) barrier methods containing or used in conjunction with a spermicidal agent, or (3) postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy). \n3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form. \n3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of \"\"Desirable Weights of Adults\"\" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). \n4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication. \n" ], "offsets": [ [ 0, 2099 ] ] } ]

[ { "id": "NCT00650312_inc_T1", "type": "Value", "text": [ "18 years and older" ], "offsets": [ [ 8, 26 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 3, 6 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T3", "type": "Person", "text": [ "Male" ], "offsets": [ [ 37, 41 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T4", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 50, 58 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T5", "type": "Negation", "text": [ "non" ], "offsets": [ [ 46, 49 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T6", "type": "Negation", "text": [ "non" ], "offsets": [ [ 60, 63 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T7", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 64, 73 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T8", "type": "Person", "text": [ "female" ], "offsets": [ [ 74, 80 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T9", "type": "Scope", "text": [ "non-pregnant, non-lactating" ], "offsets": [ [ 46, 73 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T14", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 1417, 1423 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T15", "type": "Value", "text": [ "At least 60 kg" ], "offsets": [ [ 1425, 1439 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T16", "type": "Value", "text": [ "At least", "132 lbs" ], "offsets": [ [ 1425, 1433 ], [ 1441, 1448 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T17", "type": "Person", "text": [ "man" ], "offsets": [ [ 1454, 1457 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T18", "type": "Value", "text": [ "At least", "48 kg" ], "offsets": [ [ 1425, 1433 ], [ 1462, 1467 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T19", "type": "Value", "text": [ "At least", "106 lbs" ], "offsets": [ [ 1425, 1433 ], [ 1469, 1476 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T20", "type": "Person", "text": [ "women" ], "offsets": [ [ 1482, 1487 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T21", "type": "Scope", "text": [ "At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women" ], "offsets": [ [ 1425, 1487 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T22", "type": "Value", "text": [ "within 15% of Ideal Body Weight (IBW)" ], "offsets": [ [ 1492, 1529 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T10", "type": "Person", "text": [ "Women" ], "offsets": [ [ 85, 90 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T11", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 94, 116 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T12", "type": "Value", "text": [ "negative" ], "offsets": [ [ 127, 135 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T13", "type": "Procedure", "text": [ "serum", "pregnancy tests" ], "offsets": [ [ 136, 141 ], [ 153, 168 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T23", "type": "Procedure", "text": [ "Beta HCG" ], "offsets": [ [ 143, 151 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T24", "type": "Temporal", "text": [ "within 14 days prior to the start of the study" ], "offsets": [ [ 179, 225 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T25", "type": "Reference_point", "text": [ "the start of the study" ], "offsets": [ [ 203, 225 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T26", "type": "Temporal", "text": [ "on the evening prior to each dose administration" ], "offsets": [ [ 230, 278 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T27", "type": "Reference_point", "text": [ "each dose administration" ], "offsets": [ [ 254, 278 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T28", "type": "Scope", "text": [ "Women of childbearing potential" ], "offsets": [ [ 85, 116 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T29", "type": "Scope", "text": [ "negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration" ], "offsets": [ [ 127, 278 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T30", "type": "Person", "text": [ "Women" ], "offsets": [ [ 515, 520 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T31", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 524, 546 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T32", "type": "Procedure", "text": [ "abstinence" ], "offsets": [ [ 561, 571 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T33", "type": "Qualifier", "text": [ "acceptable form" ], "offsets": [ [ 587, 602 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T34", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 606, 619 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T35", "type": "Temporal", "text": [ "throughout the duration of the study" ], "offsets": [ [ 620, 656 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T36", "type": "Scope", "text": [ "abstinence or be using an acceptable form of contraception" ], "offsets": [ [ 561, 619 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T37", "type": "Scope", "text": [ "Women of childbearing potential" ], "offsets": [ [ 515, 546 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T38", "type": "Device", "text": [ "intrauterine device" ], "offsets": [ [ 720, 739 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T39", "type": "Temporal", "text": [ "for at least 3 months prior to the start of the study" ], "offsets": [ [ 749, 802 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T40", "type": "Reference_point", "text": [ "the start of the study" ], "offsets": [ [ 780, 802 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T41", "type": "Temporal", "text": [ "in place during the study period" ], "offsets": [ [ 817, 849 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T42", "type": "Reference_point", "text": [ "the study period" ], "offsets": [ [ 833, 849 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T43", "type": "Procedure", "text": [ "barrier methods" ], "offsets": [ [ 858, 873 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T44", "type": "Drug", "text": [ "spermicidal agent" ], "offsets": [ [ 915, 932 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T45", "type": "Scope", "text": [ "barrier methods containing or used in conjunction with a spermicidal agent" ], "offsets": [ [ 858, 932 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T46", "type": "Condition", "text": [ "postmenopausal" ], "offsets": [ [ 941, 955 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T47", "type": "Temporal", "text": [ "at least one year" ], "offsets": [ [ 1011, 1028 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T48", "type": "Condition", "text": [ "surgical sterility" ], "offsets": [ [ 1032, 1050 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T49", "type": "Procedure", "text": [ "tubal ligation" ], "offsets": [ [ 1052, 1066 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T50", "type": "Procedure", "text": [ "oophorectomy" ], "offsets": [ [ 1068, 1080 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T51", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 1084, 1096 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T52", "type": "Scope", "text": [ "tubal ligation, oophorectomy or hysterectomy" ], "offsets": [ [ 1052, 1096 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T53", "type": "Scope", "text": [ "surgical sterility (tubal ligation, oophorectomy or hysterectomy)" ], "offsets": [ [ 1032, 1097 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T54", "type": "Person", "text": [ "women" ], "offsets": [ [ 1202, 1207 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T55", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1211, 1233 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T56", "type": "Procedure", "text": [ "spermicide containing barrier method of contraception" ], "offsets": [ [ 1245, 1298 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T57", "type": "Multiplier", "text": [ "in addition to" ], "offsets": [ [ 1299, 1313 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T58", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1320, 1327 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T59", "type": "Device", "text": [ "contraceptive device" ], "offsets": [ [ 1328, 1348 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T60", "type": "Scope", "text": [ "women of childbearing potential" ], "offsets": [ [ 1202, 1233 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T61", "type": "Scope", "text": [ "spermicide containing barrier method of contraception in addition to their current contraceptive device" ], "offsets": [ [ 1245, 1348 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T62", "type": "Temporal", "text": [ "During the course of the study" ], "offsets": [ [ 1103, 1133 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T63", "type": "Condition", "text": [ "normal" ], "offsets": [ [ 1735, 1741 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T64", "type": "Condition", "text": [ "healthy" ], "offsets": [ [ 1746, 1753 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T65", "type": "Procedure", "text": [ "pre-study medical evaluation" ], "offsets": [ [ 1763, 1791 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T66", "type": "Scope", "text": [ "normal and healthy" ], "offsets": [ [ 1735, 1753 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T67", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 1793, 1813 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T68", "type": "Procedure", "text": [ "laboratory evaluation" ], "offsets": [ [ 1815, 1836 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T69", "type": "Procedure", "text": [ "12-lead ECG" ], "offsets": [ [ 1838, 1849 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T70", "type": "Procedure", "text": [ "hepatitis B", "tests" ], "offsets": [ [ 1851, 1862 ], [ 1879, 1884 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T71", "type": "Procedure", "text": [ "hepatitis C tests" ], "offsets": [ [ 1867, 1884 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T72", "type": "Procedure", "text": [ "HIV test" ], "offsets": [ [ 1886, 1894 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T73", "type": "Procedure", "text": [ "urine drug screen" ], "offsets": [ [ 1900, 1917 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T74", "type": "Qualifier", "text": [ "amphetamine" ], "offsets": [ [ 1928, 1939 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T75", "type": "Qualifier", "text": [ "barbiturates" ], "offsets": [ [ 1941, 1953 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T76", "type": "Qualifier", "text": [ "benzodiazepine" ], "offsets": [ [ 1955, 1969 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T77", "type": "Qualifier", "text": [ "cannabinoid" ], "offsets": [ [ 1971, 1982 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T78", "type": "Qualifier", "text": [ "cocaine" ], "offsets": [ [ 1984, 1991 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T79", "type": "Qualifier", "text": [ "opiates" ], "offsets": [ [ 1993, 2000 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T80", "type": "Qualifier", "text": [ "phencyclidine" ], "offsets": [ [ 2002, 2015 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T81", "type": "Qualifier", "text": [ "methadone" ], "offsets": [ [ 2021, 2030 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T82", "type": "Scope", "text": [ "amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone" ], "offsets": [ [ 1928, 2030 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T83", "type": "Scope", "text": [ "physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone" ], "offsets": [ [ 1793, 2030 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T84", "type": "Temporal", "text": [ "within 14 days of the initial dose of study medication" ], "offsets": [ [ 2042, 2096 ] ], "normalized": [] }, { "id": "NCT00650312_inc_T85", "type": "Reference_point", "text": [ "the initial dose of study medication" ], "offsets": [ [ 2060, 2096 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00650312_inc_R1", "type": "Has_value", "arg1_id": "NCT00650312_inc_T2", "arg2_id": "NCT00650312_inc_T1", "normalized": [] }, { "id": "NCT00650312_inc_R2", "type": "Has_negation", "arg1_id": "NCT00650312_inc_T7", "arg2_id": "NCT00650312_inc_T6", "normalized": [] }, { "id": "NCT00650312_inc_R3", "type": "Has_negation", "arg1_id": "NCT00650312_inc_T4", "arg2_id": "NCT00650312_inc_T5", "normalized": [] }, { "id": "NCT00650312_inc_R4", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T8", "arg2_id": "NCT00650312_inc_T9", "normalized": [] }, { "id": "NCT00650312_inc_R5", "type": "Subsumes", "arg1_id": "NCT00650312_inc_T15", "arg2_id": "NCT00650312_inc_T16", "normalized": [] }, { "id": "NCT00650312_inc_R6", "type": "Subsumes", "arg1_id": "NCT00650312_inc_T18", "arg2_id": "NCT00650312_inc_T19", "normalized": [] }, { "id": "NCT00650312_inc_R7", "type": "Has_value", "arg1_id": "NCT00650312_inc_T17", "arg2_id": "NCT00650312_inc_T15", "normalized": [] }, { "id": "NCT00650312_inc_R8", "type": "Has_value", "arg1_id": "NCT00650312_inc_T20", "arg2_id": "NCT00650312_inc_T18", "normalized": [] }, { "id": "NCT00650312_inc_R9", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T14", "arg2_id": "NCT00650312_inc_T21", "normalized": [] }, { "id": "NCT00650312_inc_R10", "type": "Has_value", "arg1_id": "NCT00650312_inc_T14", "arg2_id": "NCT00650312_inc_T22", "normalized": [] }, { "id": "NCT00650312_inc_R11", "type": "Subsumes", "arg1_id": "NCT00650312_inc_T13", "arg2_id": "NCT00650312_inc_T23", "normalized": [] }, { "id": "NCT00650312_inc_R12", "type": "Has_value", "arg1_id": "NCT00650312_inc_T13", "arg2_id": "NCT00650312_inc_T12", "normalized": [] }, { "id": "NCT00650312_inc_R13", "type": "Has_index", "arg1_id": "NCT00650312_inc_T24", "arg2_id": "NCT00650312_inc_T25", "normalized": [] }, { "id": "NCT00650312_inc_R14", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T13", "arg2_id": "NCT00650312_inc_T24", "normalized": [] }, { "id": "NCT00650312_inc_R15", "type": "Has_index", "arg1_id": "NCT00650312_inc_T26", "arg2_id": "NCT00650312_inc_T27", "normalized": [] }, { "id": "NCT00650312_inc_R16", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T13", "arg2_id": "NCT00650312_inc_T26", "normalized": [] }, { "id": "NCT00650312_inc_R17", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T28", "arg2_id": "NCT00650312_inc_T29", "normalized": [] }, { "id": "NCT00650312_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT00650312_inc_T34", "arg2_id": "NCT00650312_inc_T33", "normalized": [] }, { "id": "NCT00650312_inc_R19", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T36", "arg2_id": "NCT00650312_inc_T35", "normalized": [] }, { "id": "NCT00650312_inc_R20", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T37", "arg2_id": "NCT00650312_inc_T36", "normalized": [] }, { "id": "NCT00650312_inc_R21", "type": "Has_index", "arg1_id": "NCT00650312_inc_T39", "arg2_id": "NCT00650312_inc_T40", "normalized": [] }, { "id": "NCT00650312_inc_R22", "type": "Has_index", "arg1_id": "NCT00650312_inc_T41", "arg2_id": "NCT00650312_inc_T42", "normalized": [] }, { "id": "NCT00650312_inc_R23", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T38", "arg2_id": "NCT00650312_inc_T39", "normalized": [] }, { "id": "NCT00650312_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T38", "arg2_id": "NCT00650312_inc_T41", "normalized": [] }, { "id": "NCT00650312_inc_R25", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T46", "arg2_id": "NCT00650312_inc_T47", "normalized": [] }, { "id": "NCT00650312_inc_R26", "type": "Subsumes", "arg1_id": "NCT00650312_inc_T48", "arg2_id": "NCT00650312_inc_T52", "normalized": [] }, { "id": "NCT00650312_inc_R27", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T59", "arg2_id": "NCT00650312_inc_T58", "normalized": [] }, { "id": "NCT00650312_inc_R28", "type": "Has_multiplier", "arg1_id": "NCT00650312_inc_T56", "arg2_id": "NCT00650312_inc_T57", "normalized": [] }, { "id": "NCT00650312_inc_R29", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T60", "arg2_id": "NCT00650312_inc_T61", "normalized": [] }, { "id": "NCT00650312_inc_R30", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T61", "arg2_id": "NCT00650312_inc_T62", "normalized": [] }, { "id": "NCT00650312_inc_R31", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T65", "arg2_id": "NCT00650312_inc_T66", "normalized": [] }, { "id": "NCT00650312_inc_R32", "type": "Has_scope", "arg1_id": "NCT00650312_inc_T73", "arg2_id": "NCT00650312_inc_T82", "normalized": [] }, { "id": "NCT00650312_inc_R33", "type": "Has_index", "arg1_id": "NCT00650312_inc_T84", "arg2_id": "NCT00650312_inc_T85", "normalized": [] }, { "id": "NCT00650312_inc_R34", "type": "Subsumes", "arg1_id": "NCT00650312_inc_T65", "arg2_id": "NCT00650312_inc_T83", "normalized": [] }, { "id": "NCT00650312_inc_R35", "type": "Has_temporal", "arg1_id": "NCT00650312_inc_T65", "arg2_id": "NCT00650312_inc_T84", "normalized": [] } ]

[ { "id": "NCT00676273_exc_text", "type": "exclusion", "text": [ "Patients: \nWho are pregnant or planning to become pregnant during the study or in the future \nWith a elevated post-void residual (defined as PVR > 100cc) \nWith a bleeding condition or on anti-coagulant therapy \nWith immunosuppression (i.e. HIV, lymphoma) \nWith multiple sclerosis or other progressive neurological disease \nWith evidence of a local or systemic infection, including urinary tract infection \nWith evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of <20 cm H2O \nPrevious sub-urethral sling \nPredominant overactive bladder symptoms \n \n" ], "offsets": [ [ 0, 600 ] ] } ]

[ { "id": "NCT00676273_exc_T3", "type": "Measurement", "text": [ "post-void residual" ], "offsets": [ [ 110, 128 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T4", "type": "Measurement", "text": [ "PVR" ], "offsets": [ [ 141, 144 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T5", "type": "Value", "text": [ "> 100cc" ], "offsets": [ [ 145, 152 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T6", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 101, 109 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T7", "type": "Condition", "text": [ "bleeding condition" ], "offsets": [ [ 162, 180 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T8", "type": "Procedure", "text": [ "anti-coagulant therapy" ], "offsets": [ [ 187, 209 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T9", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 240, 243 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T10", "type": "Condition", "text": [ "lymphoma" ], "offsets": [ [ 245, 253 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T11", "type": "Observation", "text": [ "immunosuppression" ], "offsets": [ [ 216, 233 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T12", "type": "Scope", "text": [ "HIV, lymphoma" ], "offsets": [ [ 240, 253 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T13", "type": "Condition", "text": [ "multiple sclerosis" ], "offsets": [ [ 261, 279 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T14", "type": "Condition", "text": [ "progressive neurological disease" ], "offsets": [ [ 289, 321 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T15", "type": "Condition", "text": [ "systemic infection" ], "offsets": [ [ 351, 369 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T16", "type": "Condition", "text": [ "urinary tract infection" ], "offsets": [ [ 381, 404 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T17", "type": "Condition", "text": [ "local", "infection" ], "offsets": [ [ 342, 347 ], [ 360, 369 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T18", "type": "Scope", "text": [ "local or systemic infection" ], "offsets": [ [ 342, 369 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T19", "type": "Condition", "text": [ "intrinsic sphincter deficiency" ], "offsets": [ [ 423, 453 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T20", "type": "Measurement", "text": [ "maximal urethral closure pressure" ], "offsets": [ [ 470, 503 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T21", "type": "Value", "text": [ "<20 cm H2O" ], "offsets": [ [ 507, 517 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T22", "type": "Procedure", "text": [ "sub-urethral sling" ], "offsets": [ [ 528, 546 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T23", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 519, 527 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T24", "type": "Condition", "text": [ "overactive bladder symptoms" ], "offsets": [ [ 560, 587 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T26", "type": "Qualifier", "text": [ "Predominant" ], "offsets": [ [ 548, 559 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T2", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 19, 27 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T27", "type": "Mood", "text": [ "planning to become" ], "offsets": [ [ 31, 49 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T28", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 50, 58 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T29", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 59, 75 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T30", "type": "Temporal", "text": [ "in the future" ], "offsets": [ [ 79, 92 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T31", "type": "Scope", "text": [ "during the study or in the future" ], "offsets": [ [ 59, 92 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T32", "type": "Scope", "text": [ "pregnant or planning to become pregnant" ], "offsets": [ [ 19, 58 ] ], "normalized": [] }, { "id": "NCT00676273_exc_T25", "type": "Condition", "text": [ "overactive bladder" ], "offsets": [ [ 560, 578 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00676273_exc_R1", "type": "Has_value", "arg1_id": "NCT00676273_exc_T4", "arg2_id": "NCT00676273_exc_T5", "normalized": [] }, { "id": "NCT00676273_exc_R2", "type": "Subsumes", "arg1_id": "NCT00676273_exc_T3", "arg2_id": "NCT00676273_exc_T4", "normalized": [] }, { "id": "NCT00676273_exc_R3", "type": "Has_value", "arg1_id": "NCT00676273_exc_T3", "arg2_id": "NCT00676273_exc_T6", "normalized": [] }, { "id": "NCT00676273_exc_R4", "type": "Subsumes", "arg1_id": "NCT00676273_exc_T11", "arg2_id": "NCT00676273_exc_T12", "normalized": [] }, { "id": "NCT00676273_exc_R5", "type": "Subsumes", "arg1_id": "NCT00676273_exc_T14", "arg2_id": "NCT00676273_exc_T13", "normalized": [] }, { "id": "NCT00676273_exc_R6", "type": "Subsumes", "arg1_id": "NCT00676273_exc_T18", "arg2_id": "NCT00676273_exc_T16", "normalized": [] }, { "id": "NCT00676273_exc_R7", "type": "Has_value", "arg1_id": "NCT00676273_exc_T20", "arg2_id": "NCT00676273_exc_T21", "normalized": [] }, { "id": "NCT00676273_exc_R8", "type": "AND", "arg1_id": "NCT00676273_exc_T19", "arg2_id": "NCT00676273_exc_T20", "normalized": [] }, { "id": "NCT00676273_exc_R9", "type": "Has_temporal", "arg1_id": "NCT00676273_exc_T22", "arg2_id": "NCT00676273_exc_T23", "normalized": [] }, { "id": "NCT00676273_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00676273_exc_T24", "arg2_id": "NCT00676273_exc_T26", "normalized": [] }, { "id": "NCT00676273_exc_R12", "type": "Has_mood", "arg1_id": "NCT00676273_exc_T28", "arg2_id": "NCT00676273_exc_T27", "normalized": [] }, { "id": "NCT00676273_exc_R13", "type": "Has_scope", "arg1_id": "NCT00676273_exc_T32", "arg2_id": "NCT00676273_exc_T31", "normalized": [] } ]

[ { "id": "NCT00676273_inc_text", "type": "inclusion", "text": [ "Are at least 18 years of age \nDemonstrate a positive cough stress test during complex multi-channel urodynamic testing \nDemonstrate impact of stress urinary incontinence on quality of life questionnaire \nAre able to comprehend and sign a written informed consent \nUnderstand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations \nAre psychologically stable and suitable for interventions determined by the investigator \nAre ambulatory and able to use a toilet independently \n" ], "offsets": [ [ 0, 541 ] ] } ]

[ { "id": "NCT00676273_inc_T1", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 4, 21 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 25, 28 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T3", "type": "Measurement", "text": [ "cough stress test" ], "offsets": [ [ 53, 70 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T4", "type": "Value", "text": [ "positive" ], "offsets": [ [ 44, 52 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T5", "type": "Procedure", "text": [ "complex multi-channel urodynamic testing" ], "offsets": [ [ 78, 118 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T6", "type": "Condition", "text": [ "stress urinary incontinence" ], "offsets": [ [ 142, 169 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T7", "type": "Procedure", "text": [ "quality of life questionnaire" ], "offsets": [ [ 173, 202 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T8", "type": "Observation", "text": [ "able to comprehend", "a written informed consent" ], "offsets": [ [ 208, 226 ], [ 236, 262 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T13", "type": "Observation", "text": [ "able to", "sign a written informed consent" ], "offsets": [ [ 208, 215 ], [ 231, 262 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T9", "type": "Observation", "text": [ "willing to comply with the study requirements" ], "offsets": [ [ 283, 328 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T14", "type": "Observation", "text": [ "Understand", "the study requirements" ], "offsets": [ [ 264, 274 ], [ 306, 328 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T10", "type": "Condition", "text": [ "psychologically stable" ], "offsets": [ [ 400, 422 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T11", "type": "Condition", "text": [ "suitable for interventions" ], "offsets": [ [ 427, 453 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T12", "type": "Qualifier", "text": [ "determined by the investigator" ], "offsets": [ [ 454, 484 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T15", "type": "Scope", "text": [ "psychologically stable and suitable for interventions" ], "offsets": [ [ 400, 453 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T16", "type": "Condition", "text": [ "ambulatory" ], "offsets": [ [ 490, 500 ] ], "normalized": [] }, { "id": "NCT00676273_inc_T17", "type": "Condition", "text": [ "able to use a toilet independently" ], "offsets": [ [ 505, 539 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00676273_inc_R1", "type": "Has_value", "arg1_id": "NCT00676273_inc_T2", "arg2_id": "NCT00676273_inc_T1", "normalized": [] }, { "id": "NCT00676273_inc_R2", "type": "Has_value", "arg1_id": "NCT00676273_inc_T3", "arg2_id": "NCT00676273_inc_T4", "normalized": [] }, { "id": "NCT00676273_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00676273_inc_T15", "arg2_id": "NCT00676273_inc_T12", "normalized": [] } ]

[ { "id": "NCT00679341_exc_text", "type": "exclusion", "text": [ "History of any chemotherapy for MBC. \nAn interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis. \nTrastuzumab ≤ 21 days prior to randomization. \nHormone therapy < 7 days prior to randomization. \nCurrent peripheral neuropathy of Grade ≥ 3. \nHistory of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned. \nPrevious radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization. \nBrain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization. \nHistory of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2. \nCurrent unstable angina. \nHistory of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment. \nHistory of myocardial infarction within 6 months prior to randomization. \nLeft ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization. \nHistory of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment. \nCardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization. \nSevere dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy. \nCurrent severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures). \nMajor surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment. \nCurrent pregnancy or lactation. \nHistory of receiving any investigational treatment within approximately 28 days prior to randomization. \nCurrent known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus. \nHistory of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel. \nKnown hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80. \nAssessed by the investigator to be unable or unwilling to comply with the requirements of the protocol. \n \n" ], "offsets": [ [ 0, 2880 ] ] } ]

[ { "id": "NCT00679341_exc_T1", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 15, 27 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T2", "type": "Condition", "text": [ "MBC" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T3", "type": "Observation", "text": [ "History" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T4", "type": "Value", "text": [ "< 6 months" ], "offsets": [ [ 53, 63 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T5", "type": "Procedure", "text": [ "cytotoxic chemotherapy" ], "offsets": [ [ 87, 109 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T6", "type": "Qualifier", "text": [ "neo-adjuvant", "setting" ], "offsets": [ [ 117, 129 ], [ 142, 149 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T7", "type": "Qualifier", "text": [ "adjuvant setting" ], "offsets": [ [ 133, 149 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T8", "type": "Condition", "text": [ "metastatic diagnosis" ], "offsets": [ [ 168, 188 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T9", "type": "Drug", "text": [ "Trastuzumab" ], "offsets": [ [ 191, 202 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T10", "type": "Temporal", "text": [ "≤ 21 days prior to randomization" ], "offsets": [ [ 203, 235 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T11", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 222, 235 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T12", "type": "Procedure", "text": [ "Hormone therapy" ], "offsets": [ [ 238, 253 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T13", "type": "Temporal", "text": [ "< 7 days prior to randomization" ], "offsets": [ [ 254, 285 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T14", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 272, 285 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T15", "type": "Condition", "text": [ "peripheral neuropathy" ], "offsets": [ [ 296, 317 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T16", "type": "Qualifier", "text": [ "Grade ≥ 3" ], "offsets": [ [ 321, 330 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T17", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 321, 326 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T18", "type": "Value", "text": [ "≥ 3" ], "offsets": [ [ 327, 330 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T19", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 288, 295 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T20", "type": "Temporal", "text": [ "within the last 5 years" ], "offsets": [ [ 361, 384 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T21", "type": "Condition", "text": [ "carcinoma in situ of the cervix" ], "offsets": [ [ 419, 450 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T22", "type": "Qualifier", "text": [ "appropriately treated" ], "offsets": [ [ 397, 418 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T23", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 411, 418 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T24", "type": "Condition", "text": [ "non-melanoma skin carcinoma" ], "offsets": [ [ 452, 479 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T25", "type": "Condition", "text": [ "uterine cancer" ], "offsets": [ [ 489, 503 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T26", "type": "Measurement", "text": [ "Stage" ], "offsets": [ [ 481, 486 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T27", "type": "Value", "text": [ "I" ], "offsets": [ [ 487, 488 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T28", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 350, 360 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T29", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 344, 349 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T30", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 386, 396 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T32", "type": "Scope", "text": [ "appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer" ], "offsets": [ [ 397, 503 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T33", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 586, 598 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T34", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 577, 585 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T35", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 665, 678 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T36", "type": "Qualifier", "text": [ "metastatic" ], "offsets": [ [ 654, 664 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T37", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 634, 650 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T38", "type": "Qualifier", "text": [ "unresectable" ], "offsets": [ [ 620, 632 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T39", "type": "Scope", "text": [ "unresectable, locally advanced or metastatic" ], "offsets": [ [ 620, 664 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T40", "type": "Value", "text": [ "more than 25%" ], "offsets": [ [ 697, 710 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T41", "type": "Measurement", "text": [ "marrow-bearing bone", "irradiated" ], "offsets": [ [ 714, 733 ], [ 743, 753 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T43", "type": "Condition", "text": [ "Brain metastases" ], "offsets": [ [ 867, 883 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T44", "type": "Qualifier", "text": [ "untreated" ], "offsets": [ [ 893, 902 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T45", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 904, 915 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T46", "type": "Qualifier", "text": [ "require therapy" ], "offsets": [ [ 920, 935 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T47", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 963, 972 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T48", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 974, 981 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T49", "type": "Procedure", "text": [ "other therapy to control symptoms" ], "offsets": [ [ 986, 1019 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T50", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 1025, 1041 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T51", "type": "Temporal", "text": [ "within 2 months prior to randomization" ], "offsets": [ [ 1042, 1080 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T52", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1067, 1080 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T53", "type": "Scope", "text": [ "radiation, surgery, or other therapy to control symptoms" ], "offsets": [ [ 963, 1019 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T54", "type": "Scope", "text": [ "untreated, symptomatic, or require therapy" ], "offsets": [ [ 893, 935 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T55", "type": "Drug", "text": [ "anthracyclines" ], "offsets": [ [ 1140, 1154 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T56", "type": "Drug", "text": [ "Doxorubicin" ], "offsets": [ [ 1156, 1167 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T57", "type": "Drug", "text": [ "liposomal doxorubicin" ], "offsets": [ [ 1171, 1192 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T58", "type": "Multiplier", "text": [ "> 500 mg/m^2" ], "offsets": [ [ 1193, 1205 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T59", "type": "Drug", "text": [ "epirubicin" ], "offsets": [ [ 1207, 1217 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T60", "type": "Multiplier", "text": [ "> 900 mg/m^2" ], "offsets": [ [ 1218, 1230 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T61", "type": "Drug", "text": [ "mitoxantrone" ], "offsets": [ [ 1232, 1244 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T62", "type": "Multiplier", "text": [ "> 120mg/m^2" ], "offsets": [ [ 1245, 1256 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T63", "type": "Drug", "text": [ "idarubicin" ], "offsets": [ [ 1261, 1271 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T64", "type": "Multiplier", "text": [ "> 90 mg/m^2" ], "offsets": [ [ 1272, 1283 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T65", "type": "Scope", "text": [ "Doxorubicin or liposomal doxorubicin" ], "offsets": [ [ 1156, 1192 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T66", "type": "Scope", "text": [ "Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2" ], "offsets": [ [ 1156, 1283 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T67", "type": "Scope", "text": [ "exposure to the following cumulative doses of anthracyclines" ], "offsets": [ [ 1094, 1154 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T68", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 1294, 1309 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T69", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 1286, 1293 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T70", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 1335, 1359 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T71", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 1323, 1334 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T72", "type": "Condition", "text": [ "ventricular arrhythmia" ], "offsets": [ [ 1364, 1386 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T73", "type": "Qualifier", "text": [ "requiring treatment" ], "offsets": [ [ 1387, 1406 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T74", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1397, 1406 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T75", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 1420, 1441 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T76", "type": "Temporal", "text": [ "within 6 months prior to randomization" ], "offsets": [ [ 1442, 1480 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T77", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1467, 1480 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T78", "type": "Measurement", "text": [ "Left ventricular ejection fraction (LVEF)" ], "offsets": [ [ 1483, 1524 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T79", "type": "Value", "text": [ "below 50%" ], "offsets": [ [ 1525, 1534 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T80", "type": "Temporal", "text": [ "within approximately 28 days prior to randomization" ], "offsets": [ [ 1535, 1586 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T81", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1573, 1586 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T82", "type": "Condition", "text": [ "congestive heart failure (CHF)" ], "offsets": [ [ 1630, 1660 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T83", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 1618, 1629 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T84", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 1610, 1614 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T85", "type": "Value", "text": [ "decreased" ], "offsets": [ [ 1600, 1609 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T86", "type": "Drug", "text": [ "trastuzumab" ], "offsets": [ [ 1684, 1695 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T87", "type": "Qualifier", "text": [ "adjuvant" ], "offsets": [ [ 1675, 1683 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T88", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1666, 1674 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T89", "type": "Scope", "text": [ "symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment" ], "offsets": [ [ 1618, 1705 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T90", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1589, 1596 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T91", "type": "Measurement", "text": [ "Cardiac troponin I" ], "offsets": [ [ 1708, 1726 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T92", "type": "Value", "text": [ "≥ 0.2 ng/mL" ], "offsets": [ [ 1727, 1738 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T93", "type": "Temporal", "text": [ "within 28 days of randomization" ], "offsets": [ [ 1739, 1770 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T94", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1757, 1770 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T95", "type": "Condition", "text": [ "dyspnea" ], "offsets": [ [ 1780, 1787 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T96", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 1773, 1779 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T97", "type": "Condition", "text": [ "advanced malignancy" ], "offsets": [ [ 1824, 1843 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T98", "type": "Procedure", "text": [ "continuous oxygen therapy" ], "offsets": [ [ 1865, 1890 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T99", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1857, 1864 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T100", "type": "Condition", "text": [ "complications" ], "offsets": [ [ 1807, 1820 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T101", "type": "Qualifier", "text": [ "requiring current continuous oxygen therapy" ], "offsets": [ [ 1847, 1890 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T102", "type": "Scope", "text": [ "complications of advanced malignancy or requiring current continuous oxygen therapy" ], "offsets": [ [ 1807, 1890 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T107", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 2285, 2294 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T108", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 2272, 2281 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T109", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 2264, 2271 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T110", "type": "Scope", "text": [ "pregnancy or lactation" ], "offsets": [ [ 2272, 2294 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T113", "type": "Condition", "text": [ "human immunodeficiency virus (HIV)" ], "offsets": [ [ 2431, 2465 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T114", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 2402, 2409 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T115", "type": "Condition", "text": [ "hepatitis B", "virus" ], "offsets": [ [ 2474, 2485 ], [ 2505, 2510 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T116", "type": "Condition", "text": [ "hepatitis C virus" ], "offsets": [ [ 2493, 2510 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T117", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 2524, 2535 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T118", "type": "Condition", "text": [ "infusion reaction" ], "offsets": [ [ 2557, 2574 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T119", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 2547, 2552 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T120", "type": "Value", "text": [ "3-4" ], "offsets": [ [ 2553, 2556 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T121", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 2579, 2595 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T122", "type": "Drug", "text": [ "trastuzumab" ], "offsets": [ [ 2599, 2610 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T123", "type": "Drug", "text": [ "murine proteins" ], "offsets": [ [ 2612, 2627 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T124", "type": "Drug", "text": [ "docetaxel" ], "offsets": [ [ 2632, 2641 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T125", "type": "Scope", "text": [ "trastuzumab, murine proteins, or docetaxel" ], "offsets": [ [ 2599, 2641 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T103", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1901, 1907 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T104", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1909, 1921 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T105", "type": "Condition", "text": [ "systemic disease" ], "offsets": [ [ 1922, 1938 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T106", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1944, 1966 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T129", "type": "Condition", "text": [ "pulmonary", "disease" ], "offsets": [ [ 1983, 1992 ], [ 2007, 2014 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T130", "type": "Condition", "text": [ "metabolic disease" ], "offsets": [ [ 1997, 2014 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T128", "type": "Condition", "text": [ "cardiovascular", "disease" ], "offsets": [ [ 1967, 1981 ], [ 2007, 2014 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T131", "type": "Condition", "text": [ "wound healing disorders" ], "offsets": [ [ 2016, 2039 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T132", "type": "Condition", "text": [ "ulcers" ], "offsets": [ [ 2041, 2047 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T133", "type": "Condition", "text": [ "bone fractures" ], "offsets": [ [ 2052, 2066 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T134", "type": "Scope", "text": [ "cardiovascular, pulmonary, or metabolic disease" ], "offsets": [ [ 1967, 2014 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T135", "type": "Scope", "text": [ "clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures" ], "offsets": [ [ 1944, 2066 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T111", "type": "Procedure", "text": [ "investigational treatment" ], "offsets": [ [ 2322, 2347 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T112", "type": "Temporal", "text": [ "within approximately 28 days prior to randomization" ], "offsets": [ [ 2348, 2399 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T136", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 2386, 2399 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T126", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 2650, 2666 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T137", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 2681, 2692 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T138", "type": "Drug", "text": [ "drugs formulated in polysorbate 80" ], "offsets": [ [ 2727, 2761 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T139", "type": "Scope", "text": [ "study drugs, including the excipients, or any drugs formulated in polysorbate 80" ], "offsets": [ [ 2681, 2761 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T127", "type": "Observation", "text": [ "unwilling to comply with the requirements of the protocol" ], "offsets": [ [ 2809, 2866 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T140", "type": "Observation", "text": [ "unable", "to comply with the requirements of the protocol" ], "offsets": [ [ 2799, 2805 ], [ 2819, 2866 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T141", "type": "Qualifier", "text": [ "Major" ], "offsets": [ [ 2070, 2075 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T142", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 2076, 2094 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T143", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2098, 2109 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T144", "type": "Condition", "text": [ "traumatic injury" ], "offsets": [ [ 2110, 2126 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T145", "type": "Temporal", "text": [ "within approximately 28 days prior to randomization" ], "offsets": [ [ 2127, 2178 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T146", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 2165, 2178 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T147", "type": "Scope", "text": [ "Major surgical procedure or significant traumatic injury" ], "offsets": [ [ 2070, 2126 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T148", "type": "Mood", "text": [ "anticipation of the need" ], "offsets": [ [ 2182, 2206 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T149", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 2211, 2224 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T150", "type": "Temporal", "text": [ "during the course of study treatment" ], "offsets": [ [ 2225, 2261 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T151", "type": "Reference_point", "text": [ "study treatment" ], "offsets": [ [ 2246, 2261 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T152", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2252, 2261 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T153", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 2297, 2307 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T154", "type": "Observation", "text": [ "History of" ], "offsets": [ [ 2513, 2523 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T155", "type": "Scope", "text": [ "Grade 3-4 infusion reaction" ], "offsets": [ [ 2547, 2574 ] ], "normalized": [] }, { "id": "NCT00679341_exc_T156", "type": "Scope", "text": [ "intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel" ], "offsets": [ [ 2524, 2641 ] ], "normalized": [] } ]

[]

[]

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"NCT00679341_exc_R12", "type": "AND", "arg1_id": "NCT00679341_exc_T25", "arg2_id": "NCT00679341_exc_T26", "normalized": [] }, { "id": "NCT00679341_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T28", "arg2_id": "NCT00679341_exc_T29", "normalized": [] }, { "id": "NCT00679341_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T28", "arg2_id": "NCT00679341_exc_T20", "normalized": [] }, { "id": "NCT00679341_exc_R15", "type": "Has_negation", "arg1_id": "NCT00679341_exc_T32", "arg2_id": "NCT00679341_exc_T30", "normalized": [] }, { "id": "NCT00679341_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T33", "arg2_id": "NCT00679341_exc_T34", "normalized": [] }, { "id": "NCT00679341_exc_R17", "type": "Has_scope", "arg1_id": "NCT00679341_exc_T35", "arg2_id": "NCT00679341_exc_T39", "normalized": [] }, { "id": "NCT00679341_exc_R18", "type": "Has_value", "arg1_id": "NCT00679341_exc_T41", "arg2_id": "NCT00679341_exc_T40", "normalized": [] }, { "id": "NCT00679341_exc_R20", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T50", "arg2_id": "NCT00679341_exc_T51", "normalized": [] }, { "id": "NCT00679341_exc_R22", "type": "Has_scope", "arg1_id": "NCT00679341_exc_T43", "arg2_id": "NCT00679341_exc_T54", "normalized": [] }, { "id": "NCT00679341_exc_R23", "type": "Has_multiplier", "arg1_id": "NCT00679341_exc_T63", "arg2_id": "NCT00679341_exc_T64", "normalized": [] }, { "id": "NCT00679341_exc_R24", "type": "Has_multiplier", "arg1_id": "NCT00679341_exc_T61", "arg2_id": "NCT00679341_exc_T62", "normalized": [] }, { "id": "NCT00679341_exc_R25", "type": "Has_multiplier", "arg1_id": "NCT00679341_exc_T59", "arg2_id": "NCT00679341_exc_T60", "normalized": [] }, { "id": "NCT00679341_exc_R26", "type": "Has_multiplier", "arg1_id": "NCT00679341_exc_T65", "arg2_id": "NCT00679341_exc_T58", "normalized": [] }, { "id": "NCT00679341_exc_R27", "type": "Subsumes", "arg1_id": "NCT00679341_exc_T67", "arg2_id": "NCT00679341_exc_T66", "normalized": [] }, { "id": "NCT00679341_exc_R28", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T68", "arg2_id": "NCT00679341_exc_T69", "normalized": [] }, { "id": "NCT00679341_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T70", "arg2_id": "NCT00679341_exc_T71", "normalized": [] }, { "id": "NCT00679341_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T72", "arg2_id": "NCT00679341_exc_T73", "normalized": [] }, { "id": "NCT00679341_exc_R32", "type": "Has_index", "arg1_id": "NCT00679341_exc_T76", "arg2_id": "NCT00679341_exc_T77", "normalized": [] }, { "id": "NCT00679341_exc_R33", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T75", "arg2_id": "NCT00679341_exc_T76", "normalized": [] }, { "id": "NCT00679341_exc_R34", "type": "Has_value", "arg1_id": "NCT00679341_exc_T78", "arg2_id": "NCT00679341_exc_T79", "normalized": [] }, { "id": "NCT00679341_exc_R35", "type": "Has_index", "arg1_id": "NCT00679341_exc_T80", "arg2_id": "NCT00679341_exc_T81", "normalized": [] }, { "id": "NCT00679341_exc_R36", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T78", "arg2_id": "NCT00679341_exc_T80", "normalized": [] }, { "id": "NCT00679341_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T82", "arg2_id": "NCT00679341_exc_T83", "normalized": [] }, { "id": "NCT00679341_exc_R38", "type": "Has_value", "arg1_id": "NCT00679341_exc_T84", "arg2_id": "NCT00679341_exc_T85", "normalized": [] }, { "id": "NCT00679341_exc_R39", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T86", "arg2_id": "NCT00679341_exc_T87", "normalized": [] }, { "id": "NCT00679341_exc_R40", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T86", "arg2_id": "NCT00679341_exc_T88", "normalized": [] }, { "id": "NCT00679341_exc_R41", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T84", "arg2_id": "NCT00679341_exc_T90", "normalized": [] }, { "id": "NCT00679341_exc_R42", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T89", "arg2_id": "NCT00679341_exc_T90", "normalized": [] }, { "id": "NCT00679341_exc_R43", "type": "Has_value", "arg1_id": "NCT00679341_exc_T91", "arg2_id": "NCT00679341_exc_T92", "normalized": [] }, { "id": "NCT00679341_exc_R44", "type": "Has_index", "arg1_id": "NCT00679341_exc_T93", "arg2_id": "NCT00679341_exc_T94", "normalized": [] }, { "id": "NCT00679341_exc_R45", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T91", "arg2_id": "NCT00679341_exc_T93", "normalized": [] }, { "id": "NCT00679341_exc_R46", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T95", "arg2_id": "NCT00679341_exc_T96", "normalized": [] }, { "id": "NCT00679341_exc_R47", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T98", "arg2_id": "NCT00679341_exc_T99", "normalized": [] }, { "id": "NCT00679341_exc_R51", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T110", "arg2_id": "NCT00679341_exc_T109", "normalized": [] }, { "id": "NCT00679341_exc_R52", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T113", "arg2_id": "NCT00679341_exc_T114", "normalized": [] }, { "id": "NCT00679341_exc_R53", "type": "Has_value", "arg1_id": "NCT00679341_exc_T119", "arg2_id": "NCT00679341_exc_T120", "normalized": [] }, { "id": "NCT00679341_exc_R54", "type": "AND", "arg1_id": "NCT00679341_exc_T118", "arg2_id": "NCT00679341_exc_T119", "normalized": [] }, { "id": "NCT00679341_exc_R55", "type": "Has_scope", "arg1_id": "NCT00679341_exc_T121", "arg2_id": "NCT00679341_exc_T125", "normalized": [] }, { "id": "NCT00679341_exc_R56", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T134", "arg2_id": "NCT00679341_exc_T106", "normalized": [] }, { "id": "NCT00679341_exc_R57", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T105", "arg2_id": "NCT00679341_exc_T104", "normalized": [] }, { "id": "NCT00679341_exc_R58", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T105", "arg2_id": "NCT00679341_exc_T103", "normalized": [] }, { "id": "NCT00679341_exc_R59", "type": "AND", "arg1_id": "NCT00679341_exc_T135", "arg2_id": "NCT00679341_exc_T105", "normalized": [] }, { "id": "NCT00679341_exc_R60", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T111", "arg2_id": "NCT00679341_exc_T112", "normalized": [] }, { "id": "NCT00679341_exc_R61", "type": "Has_index", "arg1_id": "NCT00679341_exc_T112", "arg2_id": "NCT00679341_exc_T136", "normalized": [] }, { "id": "NCT00679341_exc_R62", "type": "Has_scope", "arg1_id": "NCT00679341_exc_T126", "arg2_id": "NCT00679341_exc_T139", "normalized": [] }, { "id": "NCT00679341_exc_R63", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T144", "arg2_id": "NCT00679341_exc_T143", "normalized": [] }, { "id": "NCT00679341_exc_R64", "type": "Has_qualifier", "arg1_id": "NCT00679341_exc_T142", "arg2_id": "NCT00679341_exc_T141", "normalized": [] }, { "id": "NCT00679341_exc_R65", "type": "Has_index", "arg1_id": "NCT00679341_exc_T145", "arg2_id": "NCT00679341_exc_T146", "normalized": [] }, { "id": "NCT00679341_exc_R66", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T147", "arg2_id": "NCT00679341_exc_T145", "normalized": [] }, { "id": "NCT00679341_exc_R67", "type": "Has_mood", "arg1_id": "NCT00679341_exc_T149", "arg2_id": "NCT00679341_exc_T148", "normalized": [] }, { "id": "NCT00679341_exc_R68", "type": "Has_index", "arg1_id": "NCT00679341_exc_T150", "arg2_id": "NCT00679341_exc_T151", "normalized": [] }, { "id": "NCT00679341_exc_R70", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T149", "arg2_id": "NCT00679341_exc_T150", "normalized": [] }, { "id": "NCT00679341_exc_R71", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T111", "arg2_id": "NCT00679341_exc_T153", "normalized": [] }, { "id": "NCT00679341_exc_R73", "type": "Subsumes", "arg1_id": "NCT00679341_exc_T117", "arg2_id": "NCT00679341_exc_T155", "normalized": [] }, { "id": "NCT00679341_exc_R72", "type": "Has_temporal", "arg1_id": "NCT00679341_exc_T156", "arg2_id": "NCT00679341_exc_T154", "normalized": [] } ]

[ { "id": "NCT00679341_inc_text", "type": "inclusion", "text": [ "Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy. \nHuman epidermal growth factor receptor 2 (HER2)-positive. \nNo prior chemotherapy for their metastatic breast cancer (MBC). \nMeasurable disease. \nAge ≥ 18 years. \nFor women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study. \n" ], "offsets": [ [ 0, 779 ] ] } ]

[ { "id": "NCT00679341_inc_T1", "type": "Qualifier", "text": [ "cytologically confirmed" ], "offsets": [ [ 18, 41 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T2", "type": "Qualifier", "text": [ "Histologically", "confirmed" ], "offsets": [ [ 0, 14 ], [ 32, 41 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T3", "type": "Condition", "text": [ "adenocarcinoma of the breast" ], "offsets": [ [ 42, 70 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T4", "type": "Condition", "text": [ "metastatic disease" ], "offsets": [ [ 96, 114 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T5", "type": "Condition", "text": [ "disease", "locally advanced" ], "offsets": [ [ 107, 114 ], [ 76, 92 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T6", "type": "Condition", "text": [ "candidate for chemotherapy" ], "offsets": [ [ 122, 148 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T7", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T8", "type": "Scope", "text": [ "Histologically or cytologically confirmed" ], "offsets": [ [ 0, 41 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T9", "type": "Scope", "text": [ "adenocarcinoma of the breast with locally advanced or metastatic disease" ], "offsets": [ [ 42, 114 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T10", "type": "Measurement", "text": [ "Human epidermal growth factor receptor 2 (HER2)" ], "offsets": [ [ 151, 198 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T11", "type": "Value", "text": [ "positive" ], "offsets": [ [ 199, 207 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T12", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 219, 231 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T13", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 213, 218 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T14", "type": "Negation", "text": [ "No" ], "offsets": [ [ 210, 212 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T15", "type": "Person", "text": [ "Age" ], "offsets": [ [ 296, 299 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T16", "type": "Value", "text": [ "≥ 18 years" ], "offsets": [ [ 300, 310 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T17", "type": "Condition", "text": [ "Measurable disease" ], "offsets": [ [ 275, 293 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T18", "type": "Condition", "text": [ "metastatic breast cancer (MBC)" ], "offsets": [ [ 242, 272 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T19", "type": "Person", "text": [ "women" ], "offsets": [ [ 317, 322 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T20", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 326, 348 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T21", "type": "Person", "text": [ "men" ], "offsets": [ [ 353, 356 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T22", "type": "Observation", "text": [ "with partners of childbearing potential" ], "offsets": [ [ 357, 396 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T23", "type": "Scope", "text": [ "women of childbearing potential" ], "offsets": [ [ 317, 348 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T24", "type": "Scope", "text": [ "men with partners of childbearing potential" ], "offsets": [ [ 353, 396 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T25", "type": "Scope", "text": [ "women of childbearing potential and men with partners of childbearing potential" ], "offsets": [ [ 317, 396 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T26", "type": "Qualifier", "text": [ "highly effective" ], "offsets": [ [ 417, 433 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T27", "type": "Qualifier", "text": [ "non-hormonal" ], "offsets": [ [ 435, 447 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T28", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 456, 469 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T29", "type": "Multiplier", "text": [ "2" ], "offsets": [ [ 473, 474 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T30", "type": "Procedure", "text": [ "non-hormonal contraception" ], "offsets": [ [ 494, 520 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T31", "type": "Procedure", "text": [ "Contraception" ], "offsets": [ [ 552, 565 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T32", "type": "Temporal", "text": [ "continue for the duration of study treatment" ], "offsets": [ [ 575, 619 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T33", "type": "Reference_point", "text": [ "study treatment" ], "offsets": [ [ 604, 619 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T34", "type": "Temporal", "text": [ "for at least 6 months after the last dose of study treatment" ], "offsets": [ [ 624, 684 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T35", "type": "Reference_point", "text": [ "the last dose of study treatment" ], "offsets": [ [ 652, 684 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T36", "type": "Person", "text": [ "Male" ], "offsets": [ [ 686, 690 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T37", "type": "Observation", "text": [ "partners are pregnant" ], "offsets": [ [ 706, 727 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T38", "type": "Device", "text": [ "condoms" ], "offsets": [ [ 739, 746 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T39", "type": "Temporal", "text": [ "for the duration of the study" ], "offsets": [ [ 747, 776 ] ], "normalized": [] }, { "id": "NCT00679341_inc_T40", "type": "Scope", "text": [ "Male patients whose partners are pregnant" ], "offsets": [ [ 686, 727 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00679341_inc_R2", "type": "AND", "arg1_id": "NCT00679341_inc_T3", "arg2_id": "NCT00679341_inc_T5", "normalized": [] }, { "id": "NCT00679341_inc_R3", "type": "AND", "arg1_id": "NCT00679341_inc_T3", "arg2_id": "NCT00679341_inc_T4", "normalized": [] }, { "id": "NCT00679341_inc_R4", "type": "Has_scope", "arg1_id": "NCT00679341_inc_T9", "arg2_id": "NCT00679341_inc_T8", "normalized": [] }, { "id": "NCT00679341_inc_R5", "type": "AND", "arg1_id": "NCT00679341_inc_T9", "arg2_id": "NCT00679341_inc_T6", "normalized": [] }, { "id": "NCT00679341_inc_R6", "type": "Has_value", "arg1_id": "NCT00679341_inc_T10", "arg2_id": "NCT00679341_inc_T11", "normalized": [] }, { "id": "NCT00679341_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00679341_inc_T12", "arg2_id": "NCT00679341_inc_T13", "normalized": [] }, { "id": "NCT00679341_inc_R8", "type": "Has_negation", "arg1_id": "NCT00679341_inc_T12", "arg2_id": "NCT00679341_inc_T14", "normalized": [] }, { "id": "NCT00679341_inc_R9", "type": "Has_value", "arg1_id": "NCT00679341_inc_T15", "arg2_id": "NCT00679341_inc_T16", "normalized": [] }, { "id": "NCT00679341_inc_R10", "type": "AND", "arg1_id": "NCT00679341_inc_T12", "arg2_id": "NCT00679341_inc_T18", "normalized": [] }, { "id": "NCT00679341_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT00679341_inc_T28", "arg2_id": "NCT00679341_inc_T27", "normalized": [] }, { "id": "NCT00679341_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT00679341_inc_T28", "arg2_id": "NCT00679341_inc_T26", "normalized": [] }, { "id": "NCT00679341_inc_R13", "type": "Has_multiplier", "arg1_id": "NCT00679341_inc_T30", "arg2_id": "NCT00679341_inc_T29", "normalized": [] }, { "id": "NCT00679341_inc_R14", "type": "Has_index", "arg1_id": "NCT00679341_inc_T32", "arg2_id": "NCT00679341_inc_T33", "normalized": [] }, { "id": "NCT00679341_inc_R15", "type": "Has_index", "arg1_id": "NCT00679341_inc_T34", "arg2_id": "NCT00679341_inc_T35", "normalized": [] }, { "id": "NCT00679341_inc_R16", "type": "Has_temporal", "arg1_id": "NCT00679341_inc_T31", "arg2_id": "NCT00679341_inc_T32", "normalized": [] }, { "id": "NCT00679341_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00679341_inc_T31", "arg2_id": "NCT00679341_inc_T34", "normalized": [] }, { "id": "NCT00679341_inc_R18", "type": "Has_temporal", "arg1_id": "NCT00679341_inc_T38", "arg2_id": "NCT00679341_inc_T39", "normalized": [] }, { "id": "NCT00679341_inc_R19", "type": "AND", "arg1_id": "NCT00679341_inc_T40", "arg2_id": "NCT00679341_inc_T38", "normalized": [] } ]

[ { "id": "NCT00718952_exc_text", "type": "exclusion", "text": [ "The other types of pulmonary hypertension. \nSubjects who refuse to subscribe written informed consents or can't cooperate with the trial well. \nSubjects with serious acute or chronic disease involved liver, kidney, and brain or have to use potent CYP3A4-inhibitor or nitrate to treat the underlying diseases. \nSubjects who are currently treated with sildenafil for PAH or taking sildenafil or tadalafil. \nOther contraindications in package insert. \n \n" ], "offsets": [ [ 0, 460 ] ] } ]

[ { "id": "NCT00718952_exc_T1", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 19, 41 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T3", "type": "Condition", "text": [ "chronic disease involved liver" ], "offsets": [ [ 175, 205 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T4", "type": "Temporal", "text": [ "acute" ], "offsets": [ [ 166, 171 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T5", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 158, 165 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T6", "type": "Condition", "text": [ "chronic disease involved", "kidney" ], "offsets": [ [ 175, 199 ], [ 207, 213 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T7", "type": "Condition", "text": [ "chronic disease involved", "brain" ], "offsets": [ [ 175, 199 ], [ 219, 224 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T8", "type": "Scope", "text": [ "chronic disease involved liver, kidney, and brain" ], "offsets": [ [ 175, 224 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T9", "type": "Drug", "text": [ "CYP3A4-inhibitor" ], "offsets": [ [ 247, 263 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T10", "type": "Drug", "text": [ "nitrate" ], "offsets": [ [ 267, 274 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T11", "type": "Qualifier", "text": [ "potent" ], "offsets": [ [ 240, 246 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T12", "type": "Drug", "text": [ "sildenafil" ], "offsets": [ [ 350, 360 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T13", "type": "Condition", "text": [ "PAH" ], "offsets": [ [ 365, 368 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T14", "type": "Drug", "text": [ "sildenafil" ], "offsets": [ [ 379, 389 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T15", "type": "Drug", "text": [ "tadalafil" ], "offsets": [ [ 393, 402 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T16", "type": "Observation", "text": [ "contraindications in package insert" ], "offsets": [ [ 411, 446 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T2", "type": "Observation", "text": [ "refuse to subscribe written informed consents" ], "offsets": [ [ 57, 102 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T17", "type": "Observation", "text": [ "can't cooperate with the trial" ], "offsets": [ [ 106, 136 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T18", "type": "Condition", "text": [ "underlying diseases" ], "offsets": [ [ 288, 307 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T19", "type": "Scope", "text": [ "CYP3A4-inhibitor or nitrate" ], "offsets": [ [ 247, 274 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T20", "type": "Qualifier", "text": [ "other types" ], "offsets": [ [ 4, 15 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T21", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 327, 336 ] ], "normalized": [] }, { "id": "NCT00718952_exc_T22", "type": "Scope", "text": [ "sildenafil for PAH or taking sildenafil or tadalafil" ], "offsets": [ [ 350, 402 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00718952_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00718952_exc_T8", "arg2_id": "NCT00718952_exc_T4", "normalized": [] }, { "id": "NCT00718952_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00718952_exc_T8", "arg2_id": "NCT00718952_exc_T5", "normalized": [] }, { "id": "NCT00718952_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00718952_exc_T19", "arg2_id": "NCT00718952_exc_T11", "normalized": [] }, { "id": "NCT00718952_exc_R4", "type": "AND", "arg1_id": "NCT00718952_exc_T19", "arg2_id": "NCT00718952_exc_T18", "normalized": [] }, { "id": "NCT00718952_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00718952_exc_T1", "arg2_id": "NCT00718952_exc_T20", "normalized": [] }, { "id": "NCT00718952_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00718952_exc_T22", "arg2_id": "NCT00718952_exc_T21", "normalized": [] } ]

[ { "id": "NCT00718952_inc_text", "type": "inclusion", "text": [ "Subjects aged 12-65. \nConfirmed idiopathic pulmonary hypertension, connective tissue disease associated pulmonary hypertension, congenital heart disease(with Eisenmenger syndrome) associated pulmonary hypertension. \nBaseline 6-minutes walking distance 150m-550m. \nWHO pulmonary hypertension function II-III with non-responder to calcium channel blockers. \nDocumented written informed consent. \n" ], "offsets": [ [ 0, 394 ] ] } ]

[ { "id": "NCT00718952_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T2", "type": "Value", "text": [ "12-65" ], "offsets": [ [ 14, 19 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T3", "type": "Condition", "text": [ "idiopathic pulmonary hypertension" ], "offsets": [ [ 32, 65 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T4", "type": "Qualifier", "text": [ "connective tissue disease associated" ], "offsets": [ [ 67, 103 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T5", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 104, 126 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T6", "type": "Qualifier", "text": [ "congenital heart disease" ], "offsets": [ [ 128, 152 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T7", "type": "Condition", "text": [ "Eisenmenger syndrome" ], "offsets": [ [ 158, 178 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T10", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 191, 213 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T8", "type": "Measurement", "text": [ "6-minutes walking distance" ], "offsets": [ [ 225, 251 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T9", "type": "Value", "text": [ "150m-550m" ], "offsets": [ [ 252, 261 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T11", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 216, 224 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T12", "type": "Measurement", "text": [ "WHO pulmonary hypertension function" ], "offsets": [ [ 264, 299 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T13", "type": "Value", "text": [ "II-III" ], "offsets": [ [ 300, 306 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T14", "type": "Condition", "text": [ "non-responder to calcium channel blockers" ], "offsets": [ [ 312, 353 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T15", "type": "Drug", "text": [ "calcium channel blockers" ], "offsets": [ [ 329, 353 ] ], "normalized": [] }, { "id": "NCT00718952_inc_T16", "type": "Observation", "text": [ "written informed consent" ], "offsets": [ [ 367, 391 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00718952_inc_R1", "type": "Has_value", "arg1_id": "NCT00718952_inc_T1", "arg2_id": "NCT00718952_inc_T2", "normalized": [] }, { "id": "NCT00718952_inc_R2", "type": "AND", "arg1_id": "NCT00718952_inc_T6", "arg2_id": "NCT00718952_inc_T7", "normalized": [] }, { "id": "NCT00718952_inc_R4", "type": "Has_value", "arg1_id": "NCT00718952_inc_T8", "arg2_id": "NCT00718952_inc_T9", "normalized": [] }, { "id": "NCT00718952_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00718952_inc_T8", "arg2_id": "NCT00718952_inc_T11", "normalized": [] }, { "id": "NCT00718952_inc_R6", "type": "Has_value", "arg1_id": "NCT00718952_inc_T12", "arg2_id": "NCT00718952_inc_T13", "normalized": [] }, { "id": "NCT00718952_inc_R8", "type": "AND", "arg1_id": "NCT00718952_inc_T12", "arg2_id": "NCT00718952_inc_T14", "normalized": [] }, { "id": "NCT00718952_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT00718952_inc_T5", "arg2_id": "NCT00718952_inc_T4", "normalized": [] } ]

[ { "id": "NCT00720031_exc_text", "type": "exclusion", "text": [ "Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia. \nInfectious pathologies evoluting and requiring antibiotherapy. \nPatients HIV+. \nTransplanted patients or patients suffering from severe auto-immune disease. \nPsychiatric troubles that do not allow the protocol follow-up. \nPregnant or breast-feeding women. \nNo contraception. \n \n" ], "offsets": [ [ 0, 412 ] ] } ]

[ { "id": "NCT00720031_exc_T1", "type": "Condition", "text": [ "Cardio-vascular pathologies" ], "offsets": [ [ 0, 27 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T2", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 43, 55 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T3", "type": "Qualifier", "text": [ "evoluting" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T4", "type": "Scope", "text": [ "evoluting and uncontrolled" ], "offsets": [ [ 29, 55 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T5", "type": "Condition", "text": [ "HTA" ], "offsets": [ [ 65, 68 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T6", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 58, 64 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T7", "type": "Condition", "text": [ "cardiac deficiency" ], "offsets": [ [ 71, 89 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T8", "type": "Condition", "text": [ "angor" ], "offsets": [ [ 98, 103 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T9", "type": "Condition", "text": [ "arrhythmia" ], "offsets": [ [ 112, 122 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T10", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 105, 111 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T11", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 91, 97 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T12", "type": "Condition", "text": [ "Infectious pathologies" ], "offsets": [ [ 125, 147 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T13", "type": "Qualifier", "text": [ "evoluting" ], "offsets": [ [ 148, 157 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T14", "type": "Qualifier", "text": [ "requiring antibiotherapy" ], "offsets": [ [ 162, 186 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T15", "type": "Drug", "text": [ "antibiotherapy" ], "offsets": [ [ 172, 186 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T16", "type": "Scope", "text": [ "evoluting and requiring antibiotherapy" ], "offsets": [ [ 148, 186 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T17", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 198, 201 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T18", "type": "Value", "text": [ "+" ], "offsets": [ [ 201, 202 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T19", "type": "Condition", "text": [ "HIV+" ], "offsets": [ [ 198, 202 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T20", "type": "Procedure", "text": [ "Transplanted" ], "offsets": [ [ 205, 217 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T21", "type": "Condition", "text": [ "severe auto-immune disease" ], "offsets": [ [ 254, 280 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T22", "type": "Condition", "text": [ "Psychiatric troubles" ], "offsets": [ [ 283, 303 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T24", "type": "Qualifier", "text": [ "do not allow the protocol follow-up" ], "offsets": [ [ 309, 344 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T25", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 347, 355 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T26", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 359, 373 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T27", "type": "Person", "text": [ "women" ], "offsets": [ [ 374, 379 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T28", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 385, 398 ] ], "normalized": [] }, { "id": "NCT00720031_exc_T29", "type": "Negation", "text": [ "No" ], "offsets": [ [ 382, 384 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00720031_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00720031_exc_T9", "arg2_id": "NCT00720031_exc_T10", "normalized": [] }, { "id": "NCT00720031_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00720031_exc_T8", "arg2_id": "NCT00720031_exc_T11", "normalized": [] }, { "id": "NCT00720031_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00720031_exc_T5", "arg2_id": "NCT00720031_exc_T6", "normalized": [] }, { "id": "NCT00720031_exc_R5", "type": "Has_scope", "arg1_id": "NCT00720031_exc_T12", "arg2_id": "NCT00720031_exc_T16", "normalized": [] }, { "id": "NCT00720031_exc_R6", "type": "Has_value", "arg1_id": "NCT00720031_exc_T17", "arg2_id": "NCT00720031_exc_T18", "normalized": [] }, { "id": "NCT00720031_exc_R7", "type": "Subsumes", "arg1_id": "NCT00720031_exc_T19", "arg2_id": "NCT00720031_exc_T17", "normalized": [] }, { "id": "NCT00720031_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00720031_exc_T22", "arg2_id": "NCT00720031_exc_T24", "normalized": [] }, { "id": "NCT00720031_exc_R9", "type": "Has_negation", "arg1_id": "NCT00720031_exc_T28", "arg2_id": "NCT00720031_exc_T29", "normalized": [] } ]

[ { "id": "NCT00720031_inc_text", "type": "inclusion", "text": [ "HLA-A2 melanoma patients with : \neither loco-regional or lymph node metastasis \ntransit nodules not surgically resectable \nmeasurable cutaneous or visceral metastasis \nPatients' tumor express Melan-A/MART-1 antigen. \nNo chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion. \nNo other melanoma treatment during the protocol. \nLife expectancy should be greater than 6 months. \nGeneral state with Karnowsky greater than 80, ECOG = 0, 1 or 2. \nPatient should be negative for HIV and B and C hepatitis. \nBiological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal. \nSigned informed consent \n" ], "offsets": [ [ 0, 846 ] ] } ]

[ { "id": "NCT00720031_inc_T1", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 7, 15 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T2", "type": "Qualifier", "text": [ "HLA-A2" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T3", "type": "Condition", "text": [ "loco-regional", "metastasis" ], "offsets": [ [ 40, 53 ], [ 68, 78 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T4", "type": "Condition", "text": [ "lymph node metastasis" ], "offsets": [ [ 57, 78 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T5", "type": "Condition", "text": [ "transit nodules" ], "offsets": [ [ 80, 95 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T6", "type": "Qualifier", "text": [ "surgically resectable" ], "offsets": [ [ 100, 121 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T7", "type": "Negation", "text": [ "not" ], "offsets": [ [ 96, 99 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T8", "type": "Procedure", "text": [ "surgically" ], "offsets": [ [ 100, 110 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T9", "type": "Condition", "text": [ "visceral metastasis" ], "offsets": [ [ 147, 166 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T10", "type": "Condition", "text": [ "cutaneous", "metastasis" ], "offsets": [ [ 134, 143 ], [ 156, 166 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T11", "type": "Qualifier", "text": [ "measurable" ], "offsets": [ [ 123, 133 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T12", "type": "Scope", "text": [ "cutaneous or visceral metastasis" ], "offsets": [ [ 134, 166 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T13", "type": "Observation", "text": [ "MART-1 antigen" ], "offsets": [ [ 200, 214 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T14", "type": "Observation", "text": [ "Melan-A", "antigen" ], "offsets": [ [ 192, 199 ], [ 207, 214 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T15", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 220, 232 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T16", "type": "Negation", "text": [ "No" ], "offsets": [ [ 217, 219 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T17", "type": "Drug", "text": [ "Deticene" ], "offsets": [ [ 255, 263 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T18", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 244, 254 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T19", "type": "Temporal", "text": [ "before the first T cell clones infusion" ], "offsets": [ [ 269, 308 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T20", "type": "Reference_point", "text": [ "the first T cell clones infusion" ], "offsets": [ [ 276, 308 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T21", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 313, 325 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T22", "type": "Procedure", "text": [ "immunotherapy" ], "offsets": [ [ 329, 342 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T23", "type": "Temporal", "text": [ "in the last 4 weeks before infusion" ], "offsets": [ [ 343, 378 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T24", "type": "Reference_point", "text": [ "infusion" ], "offsets": [ [ 370, 378 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T25", "type": "Condition", "text": [ "melanoma" ], "offsets": [ [ 390, 398 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T26", "type": "Temporal", "text": [ "during the protocol" ], "offsets": [ [ 409, 428 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T27", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 399, 408 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T28", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 431, 446 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T29", "type": "Value", "text": [ "greater than 6 months" ], "offsets": [ [ 457, 478 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T30", "type": "Measurement", "text": [ "Karnowsky" ], "offsets": [ [ 500, 509 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T31", "type": "Value", "text": [ "greater than 80" ], "offsets": [ [ 510, 525 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T32", "type": "Measurement", "text": [ "ECOG" ], "offsets": [ [ 527, 531 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T33", "type": "Value", "text": [ "0, 1 or 2" ], "offsets": [ [ 534, 543 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T34", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 577, 580 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T35", "type": "Value", "text": [ "negative" ], "offsets": [ [ 564, 572 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T36", "type": "Measurement", "text": [ "C hepatitis" ], "offsets": [ [ 591, 602 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T37", "type": "Measurement", "text": [ "B", "hepatitis" ], "offsets": [ [ 585, 586 ], [ 593, 602 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T38", "type": "Scope", "text": [ "HIV and B and C hepatitis" ], "offsets": [ [ 577, 602 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T39", "type": "Measurement", "text": [ "leucocytes" ], "offsets": [ [ 658, 668 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T40", "type": "Value", "text": [ "³ 2000 elements per mm3" ], "offsets": [ [ 669, 692 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T41", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 694, 704 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T42", "type": "Value", "text": [ "³ 10.5g/dl" ], "offsets": [ [ 705, 715 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T43", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 717, 726 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T44", "type": "Value", "text": [ "³ 100 000 per mm3" ], "offsets": [ [ 727, 744 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T45", "type": "Measurement", "text": [ "phosphatases alcalines transaminases" ], "offsets": [ [ 746, 782 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T46", "type": "Value", "text": [ "£ 1 time 1/2 compared to the normal" ], "offsets": [ [ 783, 818 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T47", "type": "Observation", "text": [ "Signed informed consent" ], "offsets": [ [ 821, 844 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T48", "type": "Scope", "text": [ "chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy" ], "offsets": [ [ 220, 342 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T49", "type": "Temporal", "text": [ "at the beginning of the study" ], "offsets": [ [ 627, 656 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T50", "type": "Reference_point", "text": [ "the beginning of the study" ], "offsets": [ [ 630, 656 ] ], "normalized": [] }, { "id": "NCT00720031_inc_T51", "type": "Scope", "text": [ "leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal" ], "offsets": [ [ 658, 818 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00720031_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT00720031_inc_T1", "arg2_id": "NCT00720031_inc_T2", "normalized": [] }, { "id": "NCT00720031_inc_R2", "type": "Has_negation", "arg1_id": "NCT00720031_inc_T6", "arg2_id": "NCT00720031_inc_T7", "normalized": [] }, { "id": "NCT00720031_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT00720031_inc_T5", "arg2_id": "NCT00720031_inc_T6", "normalized": [] }, { "id": "NCT00720031_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00720031_inc_T12", "arg2_id": "NCT00720031_inc_T11", "normalized": [] }, { "id": "NCT00720031_inc_R7", "type": "Has_negation", "arg1_id": "NCT00720031_inc_T17", "arg2_id": "NCT00720031_inc_T18", "normalized": [] }, { "id": "NCT00720031_inc_R8", "type": "Has_index", "arg1_id": "NCT00720031_inc_T19", "arg2_id": "NCT00720031_inc_T20", "normalized": [] }, { "id": "NCT00720031_inc_R9", "type": "Has_temporal", "arg1_id": "NCT00720031_inc_T17", "arg2_id": "NCT00720031_inc_T19", "normalized": [] }, { "id": "NCT00720031_inc_R10", "type": "AND", "arg1_id": "NCT00720031_inc_T15", "arg2_id": "NCT00720031_inc_T17", "normalized": [] }, { "id": "NCT00720031_inc_R11", "type": "Has_index", "arg1_id": "NCT00720031_inc_T23", "arg2_id": "NCT00720031_inc_T24", "normalized": [] }, { "id": "NCT00720031_inc_R13", "type": "Has_temporal", "arg1_id": "NCT00720031_inc_T27", "arg2_id": "NCT00720031_inc_T26", "normalized": [] }, { "id": "NCT00720031_inc_R14", "type": "Has_value", "arg1_id": "NCT00720031_inc_T28", "arg2_id": "NCT00720031_inc_T29", "normalized": [] }, { "id": "NCT00720031_inc_R15", "type": "Has_value", "arg1_id": "NCT00720031_inc_T30", "arg2_id": "NCT00720031_inc_T31", "normalized": [] }, { "id": "NCT00720031_inc_R16", "type": "Has_value", "arg1_id": "NCT00720031_inc_T32", "arg2_id": "NCT00720031_inc_T33", "normalized": [] }, { "id": "NCT00720031_inc_R17", "type": "Has_value", "arg1_id": "NCT00720031_inc_T38", "arg2_id": "NCT00720031_inc_T35", "normalized": [] }, { "id": "NCT00720031_inc_R18", "type": "Has_value", "arg1_id": "NCT00720031_inc_T39", "arg2_id": "NCT00720031_inc_T40", "normalized": [] }, { "id": "NCT00720031_inc_R19", "type": "Has_value", "arg1_id": "NCT00720031_inc_T43", "arg2_id": "NCT00720031_inc_T44", "normalized": [] }, { "id": "NCT00720031_inc_R20", "type": "Has_value", "arg1_id": "NCT00720031_inc_T45", "arg2_id": "NCT00720031_inc_T46", "normalized": [] }, { "id": "NCT00720031_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00720031_inc_T48", "arg2_id": "NCT00720031_inc_T23", "normalized": [] }, { "id": "NCT00720031_inc_R21", "type": "Has_negation", "arg1_id": "NCT00720031_inc_T48", "arg2_id": "NCT00720031_inc_T16", "normalized": [] }, { "id": "NCT00720031_inc_R22", "type": "Has_index", "arg1_id": "NCT00720031_inc_T49", "arg2_id": "NCT00720031_inc_T50", "normalized": [] }, { "id": "NCT00720031_inc_R23", "type": "Has_temporal", "arg1_id": "NCT00720031_inc_T51", "arg2_id": "NCT00720031_inc_T49", "normalized": [] } ]

[ { "id": "NCT00728156_exc_text", "type": "exclusion", "text": [ "Contraindication to Clopidogrel \nSmoking (current smokers and patients who quit smoking less than six months) \nMalignancy(diagnosed or under investigation) \nHaematological disorders (Anaemia, malignancy, bleeding disorders) \nWomen of child-bearing potential \nUse of corticosteroids/other antithrombotic agents(warfarin) \nChronic liver disease (Cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests) \nUnable to consent. \nUse of other investigational study drugs within 1 year prior to study entry \nPrevious participation in this study \n \n" ], "offsets": [ [ 0, 588 ] ] } ]

[ { "id": "NCT00728156_exc_T1", "type": "Drug", "text": [ "Clopidogrel" ], "offsets": [ [ 20, 31 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T2", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 0, 16 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T3", "type": "Condition", "text": [ "Smoking" ], "offsets": [ [ 33, 40 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T4", "type": "Condition", "text": [ "smokers" ], "offsets": [ [ 50, 57 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T5", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 42, 49 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T6", "type": "Condition", "text": [ "quit smoking" ], "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T7", "type": "Temporal", "text": [ "less than six months" ], "offsets": [ [ 88, 108 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T8", "type": "Condition", "text": [ "Malignancy" ], "offsets": [ [ 111, 121 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T9", "type": "Mood", "text": [ "diagnosed" ], "offsets": [ [ 122, 131 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T10", "type": "Mood", "text": [ "under investigation" ], "offsets": [ [ 135, 154 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T11", "type": "Scope", "text": [ "diagnosed or under investigation" ], "offsets": [ [ 122, 154 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T12", "type": "Condition", "text": [ "Haematological disorders" ], "offsets": [ [ 157, 181 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T13", "type": "Condition", "text": [ "Anaemia" ], "offsets": [ [ 183, 190 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T14", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 192, 202 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T15", "type": "Condition", "text": [ "bleeding disorders" ], "offsets": [ [ 204, 222 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T16", "type": "Scope", "text": [ "Anaemia, malignancy, bleeding disorders" ], "offsets": [ [ 183, 222 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T17", "type": "Person", "text": [ "Women" ], "offsets": [ [ 225, 230 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T18", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 234, 257 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T19", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 266, 281 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T20", "type": "Drug", "text": [ "antithrombotic agents" ], "offsets": [ [ 288, 309 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T21", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 310, 318 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T22", "type": "Condition", "text": [ "Chronic liver disease" ], "offsets": [ [ 321, 342 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T23", "type": "Condition", "text": [ "Cirrhosis" ], "offsets": [ [ 344, 353 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T24", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 355, 365 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T25", "type": "Value", "text": [ "more than twice the upper limit" ], "offsets": [ [ 384, 415 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T26", "type": "Measurement", "text": [ "liver function tests" ], "offsets": [ [ 419, 439 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T27", "type": "Scope", "text": [ "Cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests" ], "offsets": [ [ 344, 439 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T28", "type": "Observation", "text": [ "Unable to consent." ], "offsets": [ [ 442, 460 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T29", "type": "Drug", "text": [ "investigational study drugs" ], "offsets": [ [ 475, 502 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T31", "type": "Temporal", "text": [ "within 1 year prior to study entry" ], "offsets": [ [ 503, 537 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T30", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 539, 547 ] ], "normalized": [] }, { "id": "NCT00728156_exc_T32", "type": "Observation", "text": [ "participation in this study" ], "offsets": [ [ 548, 575 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00728156_exc_R1", "type": "AND", "arg1_id": "NCT00728156_exc_T2", "arg2_id": "NCT00728156_exc_T1", "normalized": [] }, { "id": "NCT00728156_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00728156_exc_T4", "arg2_id": "NCT00728156_exc_T5", "normalized": [] }, { "id": "NCT00728156_exc_R3", "type": "AND", "arg1_id": "NCT00728156_exc_T11", "arg2_id": "NCT00728156_exc_T8", "normalized": [] }, { "id": "NCT00728156_exc_R4", "type": "Subsumes", "arg1_id": "NCT00728156_exc_T12", "arg2_id": "NCT00728156_exc_T16", "normalized": [] }, { "id": "NCT00728156_exc_R5", "type": "AND", "arg1_id": "NCT00728156_exc_T18", "arg2_id": "NCT00728156_exc_T17", "normalized": [] }, { "id": "NCT00728156_exc_R6", "type": "Subsumes", "arg1_id": "NCT00728156_exc_T20", "arg2_id": "NCT00728156_exc_T21", "normalized": [] }, { "id": "NCT00728156_exc_R7", "type": "Has_value", "arg1_id": "NCT00728156_exc_T26", "arg2_id": "NCT00728156_exc_T25", "normalized": [] }, { "id": "NCT00728156_exc_R8", "type": "Subsumes", "arg1_id": "NCT00728156_exc_T22", "arg2_id": "NCT00728156_exc_T27", "normalized": [] }, { "id": "NCT00728156_exc_R9", "type": "Has_temporal", "arg1_id": "NCT00728156_exc_T29", "arg2_id": "NCT00728156_exc_T31", "normalized": [] }, { "id": "NCT00728156_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00728156_exc_T32", "arg2_id": "NCT00728156_exc_T30", "normalized": [] } ]

[ { "id": "NCT00728156_inc_text", "type": "inclusion", "text": [ "Patients with T2DM and CAS as defined below: \nClinical definitions \nT2DM: Diagnosed according to the WHO criteria [53]. \nCAD:Presence of any one of the following: Angina plus positive exercise tolerance test, enzyme and/or Q wave positive myocardial infarction, angiographic evidence ( >50% stenosis of one vessel), percutaneous or surgical coronary revascularisation. \nAged between 18 and 75 \nProvided written consent for participation in the trial prior to any study-specific procedures or requirements. \n" ], "offsets": [ [ 0, 507 ] ] } ]

[ { "id": "NCT00728156_inc_T1", "type": "Condition", "text": [ "T2DM" ], "offsets": [ [ 14, 18 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T2", "type": "Condition", "text": [ "CAS" ], "offsets": [ [ 23, 26 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T6", "type": "Condition", "text": [ "T2DM" ], "offsets": [ [ 68, 72 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T7", "type": "Qualifier", "text": [ "WHO criteria" ], "offsets": [ [ 101, 113 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T8", "type": "Condition", "text": [ "CAD" ], "offsets": [ [ 121, 124 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T9", "type": "Condition", "text": [ "Angina" ], "offsets": [ [ 163, 169 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T10", "type": "Measurement", "text": [ "exercise tolerance test" ], "offsets": [ [ 184, 207 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T11", "type": "Value", "text": [ "positive" ], "offsets": [ [ 175, 183 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T12", "type": "Qualifier", "text": [ "Q wave positive" ], "offsets": [ [ 223, 238 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T13", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 239, 260 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T14", "type": "Qualifier", "text": [ "enzyme", "positive" ], "offsets": [ [ 209, 215 ], [ 230, 238 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T15", "type": "Scope", "text": [ "enzyme and/or Q wave positive" ], "offsets": [ [ 209, 238 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T16", "type": "Condition", "text": [ "angiographic evidence" ], "offsets": [ [ 262, 283 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T17", "type": "Value", "text": [ ">50%" ], "offsets": [ [ 286, 290 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T18", "type": "Measurement", "text": [ "stenosis of one vessel" ], "offsets": [ [ 291, 313 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T19", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 370, 374 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T20", "type": "Value", "text": [ "between 18 and 75" ], "offsets": [ [ 375, 392 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T21", "type": "Observation", "text": [ "written consent for participation in the trial" ], "offsets": [ [ 403, 449 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T22", "type": "Temporal", "text": [ "prior to any study-specific procedures or requirements" ], "offsets": [ [ 450, 504 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T23", "type": "Reference_point", "text": [ "any study-specific procedures or requirements" ], "offsets": [ [ 459, 504 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T24", "type": "Scope", "text": [ ">50% stenosis of one vessel" ], "offsets": [ [ 286, 313 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T25", "type": "Scope", "text": [ "Angina plus positive exercise tolerance test" ], "offsets": [ [ 163, 207 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T26", "type": "Qualifier", "text": [ "surgical" ], "offsets": [ [ 332, 340 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T27", "type": "Qualifier", "text": [ "percutaneous" ], "offsets": [ [ 316, 328 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T28", "type": "Procedure", "text": [ "coronary revascularisation" ], "offsets": [ [ 341, 367 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T29", "type": "Scope", "text": [ "percutaneous or surgical" ], "offsets": [ [ 316, 340 ] ], "normalized": [] }, { "id": "NCT00728156_inc_T30", "type": "Scope", "text": [ "Angina plus positive exercise tolerance test, enzyme and/or Q wave positive myocardial infarction, angiographic evidence ( >50% stenosis of one vessel), percutaneous or surgical coronary revascularisation" ], "offsets": [ [ 163, 367 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00728156_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT00728156_inc_T6", "arg2_id": "NCT00728156_inc_T7", "normalized": [] }, { "id": "NCT00728156_inc_R2", "type": "Has_value", "arg1_id": "NCT00728156_inc_T10", "arg2_id": "NCT00728156_inc_T11", "normalized": [] }, { "id": "NCT00728156_inc_R3", "type": "Has_scope", "arg1_id": "NCT00728156_inc_T13", "arg2_id": "NCT00728156_inc_T15", "normalized": [] }, { "id": "NCT00728156_inc_R4", "type": "Has_value", "arg1_id": "NCT00728156_inc_T18", "arg2_id": "NCT00728156_inc_T17", "normalized": [] }, { "id": "NCT00728156_inc_R5", "type": "Has_value", "arg1_id": "NCT00728156_inc_T19", "arg2_id": "NCT00728156_inc_T20", "normalized": [] }, { "id": "NCT00728156_inc_R6", "type": "Has_index", "arg1_id": "NCT00728156_inc_T22", "arg2_id": "NCT00728156_inc_T23", "normalized": [] }, { "id": "NCT00728156_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00728156_inc_T21", "arg2_id": "NCT00728156_inc_T22", "normalized": [] }, { "id": "NCT00728156_inc_R8", "type": "Subsumes", "arg1_id": "NCT00728156_inc_T16", "arg2_id": "NCT00728156_inc_T24", "normalized": [] }, { "id": "NCT00728156_inc_R9", "type": "Has_scope", "arg1_id": "NCT00728156_inc_T28", "arg2_id": "NCT00728156_inc_T29", "normalized": [] }, { "id": "NCT00728156_inc_R10", "type": "Subsumes", "arg1_id": "NCT00728156_inc_T8", "arg2_id": "NCT00728156_inc_T30", "normalized": [] } ]