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[ { "id": "NCT03350659_exc_text", "type": "exclusion", "text": [ "Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month\nHeart failure or Chronic renal failure\nSevere supine hypertension (Systolic Blood Pressure >180 or Diastolic Blood Pressure>110mmHg)\nPregnant women, breast-feeding\nUnable to perform questionnaire\n" ], "offsets": [ [ 0, 306 ] ] } ]

[ { "id": "NCT03350659_exc_T1", "type": "Qualifier", "text": [ "Drug-induced" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T2", "type": "Condition", "text": [ "hypotension" ], "offsets": [ [ 13, 24 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T4", "type": "Condition", "text": [ "Heart failure" ], "offsets": [ [ 110, 123 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T5", "type": "Condition", "text": [ "Chronic renal failure" ], "offsets": [ [ 127, 148 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T6", "type": "Condition", "text": [ "supine hypertension" ], "offsets": [ [ 156, 175 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T7", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 149, 155 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T8", "type": "Measurement", "text": [ "Systolic Blood Pressure" ], "offsets": [ [ 177, 200 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T9", "type": "Measurement", "text": [ "Diastolic Blood Pressure" ], "offsets": [ [ 209, 233 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T10", "type": "Value", "text": [ ">180" ], "offsets": [ [ 201, 205 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T11", "type": "Value", "text": [ ">110mmHg" ], "offsets": [ [ 233, 241 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T12", "type": "Scope", "text": [ "Systolic Blood Pressure >180 or Diastolic Blood Pressure>110mmHg" ], "offsets": [ [ 177, 241 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T13", "type": "Scope", "text": [ "Severe supine hypertension" ], "offsets": [ [ 149, 175 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T14", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 243, 251 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T15", "type": "Person", "text": [ "women" ], "offsets": [ [ 252, 257 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T16", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 259, 273 ] ], "normalized": [] }, { "id": "NCT03350659_exc_T17", "type": "Observation", "text": [ "Unable to perform questionnaire" ], "offsets": [ [ 274, 305 ] ], "normalized": [] } ]

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[ { "id": "NCT03350659_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03350659_exc_T2", "arg2_id": "NCT03350659_exc_T1", "normalized": [] }, { "id": "NCT03350659_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03350659_exc_T6", "arg2_id": "NCT03350659_exc_T7", "normalized": [] }, { "id": "NCT03350659_exc_R3", "type": "Has_value", "arg1_id": "NCT03350659_exc_T9", "arg2_id": "NCT03350659_exc_T11", "normalized": [] }, { "id": "NCT03350659_exc_R4", "type": "Has_value", "arg1_id": "NCT03350659_exc_T8", "arg2_id": "NCT03350659_exc_T10", "normalized": [] }, { "id": "NCT03350659_exc_R5", "type": "Subsumes", "arg1_id": "NCT03350659_exc_T13", "arg2_id": "NCT03350659_exc_T12", "normalized": [] } ]

[ { "id": "NCT03350659_inc_text", "type": "inclusion", "text": [ "Age >=19 patients who complained of dizziness\nOrthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10\n" ], "offsets": [ [ 0, 167 ] ] } ]

[ { "id": "NCT03350659_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T2", "type": "Value", "text": [ ">=19" ], "offsets": [ [ 4, 8 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T3", "type": "Condition", "text": [ "dizziness" ], "offsets": [ [ 36, 45 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T4", "type": "Condition", "text": [ "Orthostatic hypotension" ], "offsets": [ [ 46, 69 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T5", "type": "Qualifier", "text": [ "after 3-minute standing" ], "offsets": [ [ 70, 93 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T6", "type": "Measurement", "text": [ "systolic blood pressure drop" ], "offsets": [ [ 95, 123 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T7", "type": "Measurement", "text": [ "diastolic blood pressure drop" ], "offsets": [ [ 132, 161 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T8", "type": "Value", "text": [ ">=10" ], "offsets": [ [ 162, 166 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T9", "type": "Value", "text": [ ">=20" ], "offsets": [ [ 124, 128 ] ], "normalized": [] }, { "id": "NCT03350659_inc_T10", "type": "Scope", "text": [ "systolic blood pressure drop >=20 or diastolic blood pressure drop >=10" ], "offsets": [ [ 95, 166 ] ], "normalized": [] } ]

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[ { "id": "NCT03350659_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03350659_inc_T4", "arg2_id": "NCT03350659_inc_T5", "normalized": [] }, { "id": "NCT03350659_inc_R2", "type": "Has_value", "arg1_id": "NCT03350659_inc_T6", "arg2_id": "NCT03350659_inc_T9", "normalized": [] }, { "id": "NCT03350659_inc_R3", "type": "Has_value", "arg1_id": "NCT03350659_inc_T7", "arg2_id": "NCT03350659_inc_T8", "normalized": [] }, { "id": "NCT03350659_inc_R4", "type": "Subsumes", "arg1_id": "NCT03350659_inc_T4", "arg2_id": "NCT03350659_inc_T10", "normalized": [] }, { "id": "NCT03350659_inc_R5", "type": "Has_value", "arg1_id": "NCT03350659_inc_T1", "arg2_id": "NCT03350659_inc_T2", "normalized": [] } ]

[ { "id": "NCT03350815_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

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[ { "id": "NCT03350815_inc_text", "type": "inclusion", "text": [ "Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent\nMale or non-pregnant, non-lactating female patients at least 18 years of age\nDiagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS\nActive AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) = 4 (0-10) at baseline\nSpinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline\nTotal back pain as measured by visual analog scale (VAS) = 40 mm (0-100 mm) at baseline\nPatients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications\nStable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit\nPatients who have been on a tumor necrosis factor alpha (TNFa) inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of an anti-TNFa agent\nTotal ankylosis of the spine\nUse of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.\nHistory of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\nChest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.\nPrevious exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFa\nPatients who have taken more than one anti-TNFa agent\nAny intramuscular or intravenous corticosteroid injection within 2 weeks before baseline\nAny therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline\nPrevious treatment with any cell-depleting therapies\nPatients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)\n" ], "offsets": [ [ 0, 2487 ] ] } ]

[ { "id": "NCT03350815_inc_T3", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 236, 244 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T4", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 248, 254 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T5", "type": "Condition", "text": [ "Ankylosing Spondylitis (AS)" ], "offsets": [ [ 255, 282 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T6", "type": "Scope", "text": [ "moderate to severe" ], "offsets": [ [ 236, 254 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T7", "type": "Condition", "text": [ "radiologic evidence" ], "offsets": [ [ 305, 324 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T8", "type": "Procedure", "text": [ "radiologic" ], "offsets": [ [ 305, 315 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T9", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 288, 293 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T10", "type": "Measurement", "text": [ "Modified New York criteria for AS" ], "offsets": [ [ 340, 373 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T11", "type": "Value", "text": [ "fulfilling" ], "offsets": [ [ 325, 335 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T12", "type": "Condition", "text": [ "AS" ], "offsets": [ [ 381, 383 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T13", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 374, 380 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T14", "type": "Measurement", "text": [ "total Bath Ankylosing Spondylitis Disease Activity index (BASDAI)" ], "offsets": [ [ 396, 461 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T15", "type": "Value", "text": [ "= 4" ], "offsets": [ [ 462, 465 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T16", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 473, 484 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T17", "type": "Condition", "text": [ "Spinal pain" ], "offsets": [ [ 485, 496 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T18", "type": "Measurement", "text": [ "BASDAI question #2" ], "offsets": [ [ 512, 530 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T19", "type": "Value", "text": [ "= 4 cm" ], "offsets": [ [ 531, 537 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T20", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 548, 559 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T21", "type": "Measurement", "text": [ "visual analog scale (VAS)" ], "offsets": [ [ 591, 616 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T22", "type": "Value", "text": [ "= 40 mm" ], "offsets": [ [ 617, 624 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T23", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 636, 647 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T24", "type": "Condition", "text": [ "Total back pain" ], "offsets": [ [ 560, 575 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T25", "type": "Drug", "text": [ "non-steroidal anti-inflammatory drugs (NSAIDs)" ], "offsets": [ [ 677, 723 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T26", "type": "Multiplier", "text": [ "maximum tolerated dose" ], "offsets": [ [ 731, 753 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T27", "type": "Temporal", "text": [ "for at least 4 weeks prior to their Baseline Visit" ], "offsets": [ [ 754, 804 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T28", "type": "Reference_point", "text": [ "their Baseline Visit" ], "offsets": [ [ 784, 804 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T29", "type": "Condition", "text": [ "inadequate response" ], "offsets": [ [ 814, 833 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T30", "type": "Temporal", "text": [ "for less than 4 weeks" ], "offsets": [ [ 837, 858 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T31", "type": "Condition", "text": [ "withdrawn for intolerance" ], "offsets": [ [ 862, 887 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T32", "type": "Condition", "text": [ "awn for intol", "ty or co" ], "offsets": [ [ 868, 881 ], [ 895, 903 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T33", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 901, 918 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T34", "type": "Scope", "text": [ "withdrawn for intolerance, toxicity or contraindications" ], "offsets": [ [ 862, 918 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T35", "type": "Drug", "text": [ "ors for at", "ygenase-1 (COX-1) or Cyc" ], "offsets": [ [ 1011, 1021 ], [ 958, 982 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T36", "type": "Drug", "text": [ "Cyclooxygenase-2 (COX-2) inhibitors" ], "offsets": [ [ 979, 1014 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T37", "type": "Drug", "text": [ "NSAIDs" ], "offsets": [ [ 934, 940 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T38", "type": "Temporal", "text": [ "for at least 2 weeks before their Baseline Visit" ], "offsets": [ [ 1015, 1063 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T39", "type": "Reference_point", "text": [ "their Baseline Visit" ], "offsets": [ [ 1043, 1063 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T40", "type": "Scope", "text": [ "NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors" ], "offsets": [ [ 934, 1014 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T41", "type": "Drug", "text": [ "tumor necrosis factor alpha (TNFa) inhibitor" ], "offsets": [ [ 1092, 1136 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T42", "type": "Multiplier", "text": [ "not more than one" ], "offsets": [ [ 1138, 1155 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T43", "type": "Condition", "text": [ "inadequate response" ], "offsets": [ [ 1182, 1201 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T44", "type": "Multiplier", "text": [ "approved dose" ], "offsets": [ [ 1247, 1260 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T45", "type": "Temporal", "text": [ "for at least 3 months prior to baseline" ], "offsets": [ [ 1261, 1300 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T46", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1225, 1234 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T47", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1217, 1224 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T48", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1205, 1213 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T49", "type": "Scope", "text": [ "previous or current" ], "offsets": [ [ 1205, 1224 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T50", "type": "Condition", "text": [ "intolerant" ], "offsets": [ [ 1313, 1323 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T51", "type": "Drug", "text": [ "anti-TNFa agent" ], "offsets": [ [ 1350, 1365 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T52", "type": "Scope", "text": [ "tumor necrosis factor alpha (TNFa) inhibitor (not more than one)" ], "offsets": [ [ 1092, 1156 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T53", "type": "Scope", "text": [ "inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of an anti-TNFa agent" ], "offsets": [ [ 1182, 1365 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T54", "type": "Condition", "text": [ "Total ankylosis of the spine" ], "offsets": [ [ 1366, 1394 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T56", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1542, 1558 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T57", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 1573, 1584 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T58", "type": "Drug", "text": [ "excipients" ], "offsets": [ [ 1592, 1602 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T59", "type": "Drug", "text": [ "drugs of similar chemical classes" ], "offsets": [ [ 1609, 1642 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T60", "type": "Scope", "text": [ "study drugs or its excipients or to drugs of similar chemical classes" ], "offsets": [ [ 1573, 1642 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T61", "type": "Procedure", "text": [ "Chest x-ray" ], "offsets": [ [ 1644, 1655 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T62", "type": "Procedure", "text": [ "computerized tomography (CT) scan" ], "offsets": [ [ 1657, 1690 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T63", "type": "Procedure", "text": [ "chest magnetic resonance imaging (MRI)" ], "offsets": [ [ 1695, 1733 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T64", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 1751, 1758 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T65", "type": "Condition", "text": [ "infectious" ], "offsets": [ [ 1759, 1769 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T66", "type": "Condition", "text": [ "malignant process" ], "offsets": [ [ 1773, 1790 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T67", "type": "Temporal", "text": [ "within 3 months prior to screening" ], "offsets": [ [ 1801, 1835 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T68", "type": "Scope", "text": [ "infectious or malignant process" ], "offsets": [ [ 1759, 1790 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T69", "type": "Scope", "text": [ "Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI)" ], "offsets": [ [ 1644, 1733 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T70", "type": "Drug", "text": [ "secukinumab" ], "offsets": [ [ 1897, 1908 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T71", "type": "Drug", "text": [ "biologic drug" ], "offsets": [ [ 1922, 1935 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T72", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 1916, 1921 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T73", "type": "Drug", "text": [ "Interleukin-17 (IL-17)" ], "offsets": [ [ 1955, 1977 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T74", "type": "Condition", "text": [ "targeting" ], "offsets": [ [ 1945, 1954 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T75", "type": "Drug", "text": [ "Interleukin-12/23 (IL-12/23)" ], "offsets": [ [ 1979, 2007 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T76", "type": "Drug", "text": [ "IL-17 receptor" ], "offsets": [ [ 2016, 2030 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T77", "type": "Drug", "text": [ "biologic immunomodulating agent" ], "offsets": [ [ 2045, 2076 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T78", "type": "Negation", "text": [ "except" ], "offsets": [ [ 2078, 2084 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T79", "type": "Drug", "text": [ "TNFa" ], "offsets": [ [ 2101, 2105 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T80", "type": "Scope", "text": [ "Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent" ], "offsets": [ [ 1955, 2076 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T81", "type": "Scope", "text": [ "secukinumab or any other biologic drug" ], "offsets": [ [ 1897, 1935 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T82", "type": "Multiplier", "text": [ "more than one" ], "offsets": [ [ 2130, 2143 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T83", "type": "Drug", "text": [ "anti-TNFa agent" ], "offsets": [ [ 2144, 2159 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T84", "type": "Procedure", "text": [ "corticosteroid injection" ], "offsets": [ [ 2193, 2217 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T85", "type": "Qualifier", "text": [ "intravenous" ], "offsets": [ [ 2181, 2192 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T86", "type": "Qualifier", "text": [ "intramuscular" ], "offsets": [ [ 2164, 2177 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T87", "type": "Scope", "text": [ "intramuscular or intravenous" ], "offsets": [ [ 2164, 2192 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T88", "type": "Temporal", "text": [ "within 2 weeks before baseline" ], "offsets": [ [ 2218, 2248 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T89", "type": "Reference_point", "text": [ "baseline" ], "offsets": [ [ 2240, 2248 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T90", "type": "Procedure", "text": [ "intra-articular injections" ], "offsets": [ [ 2264, 2290 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T91", "type": "Drug", "text": [ "corticosteroid" ], "offsets": [ [ 2297, 2311 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T92", "type": "Temporal", "text": [ "within 4 weeks before baseline" ], "offsets": [ [ 2313, 2343 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T93", "type": "Procedure", "text": [ "cell-depleting therapies" ], "offsets": [ [ 2372, 2396 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T94", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 2344, 2352 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T95", "type": "Drug", "text": [ "high potency opioid analgesics" ], "offsets": [ [ 2413, 2443 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T96", "type": "Drug", "text": [ "methadone" ], "offsets": [ [ 2451, 2460 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T97", "type": "Drug", "text": [ "hydromorphone" ], "offsets": [ [ 2462, 2475 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T98", "type": "Drug", "text": [ "morphine" ], "offsets": [ [ 2477, 2485 ] ], "normalized": [] }, { "id": "NCT03350815_inc_T99", "type": "Scope", "text": [ "methadone, hydromorphone, morphine" ], "offsets": [ [ 2451, 2485 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03350815_inc_R1", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T5", "arg2_id": "NCT03350815_inc_T6", "normalized": [] }, { "id": "NCT03350815_inc_R2", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T7", "arg2_id": "NCT03350815_inc_T9", "normalized": [] }, { "id": "NCT03350815_inc_R4", "type": "Has_value", "arg1_id": "NCT03350815_inc_T10", "arg2_id": "NCT03350815_inc_T11", "normalized": [] }, { "id": "NCT03350815_inc_R5", "type": "AND", "arg1_id": "NCT03350815_inc_T7", "arg2_id": "NCT03350815_inc_T10", "normalized": [] }, { "id": "NCT03350815_inc_R6", "type": "AND", "arg1_id": "NCT03350815_inc_T5", "arg2_id": "NCT03350815_inc_T7", "normalized": [] }, { "id": "NCT03350815_inc_R7", "type": "Has_value", "arg1_id": "NCT03350815_inc_T14", "arg2_id": "NCT03350815_inc_T15", "normalized": [] }, { "id": "NCT03350815_inc_R8", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T14", "arg2_id": "NCT03350815_inc_T16", "normalized": [] }, { "id": "NCT03350815_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT03350815_inc_T12", "arg2_id": "NCT03350815_inc_T13", "normalized": [] }, { "id": "NCT03350815_inc_R10", "type": "AND", "arg1_id": "NCT03350815_inc_T12", "arg2_id": "NCT03350815_inc_T14", "normalized": [] }, { "id": "NCT03350815_inc_R11", "type": "Has_value", "arg1_id": "NCT03350815_inc_T18", "arg2_id": "NCT03350815_inc_T19", "normalized": [] }, { "id": "NCT03350815_inc_R12", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T18", "arg2_id": "NCT03350815_inc_T20", "normalized": [] }, { "id": "NCT03350815_inc_R13", "type": "AND", "arg1_id": "NCT03350815_inc_T17", "arg2_id": "NCT03350815_inc_T18", "normalized": [] }, { "id": "NCT03350815_inc_R14", "type": "Has_value", "arg1_id": "NCT03350815_inc_T21", "arg2_id": "NCT03350815_inc_T22", "normalized": [] }, { "id": "NCT03350815_inc_R15", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T21", "arg2_id": "NCT03350815_inc_T23", "normalized": [] }, { "id": "NCT03350815_inc_R16", "type": "AND", "arg1_id": "NCT03350815_inc_T24", "arg2_id": "NCT03350815_inc_T21", "normalized": [] }, { "id": "NCT03350815_inc_R17", "type": "Has_index", "arg1_id": "NCT03350815_inc_T27", "arg2_id": "NCT03350815_inc_T28", "normalized": [] }, { "id": "NCT03350815_inc_R18", "type": "Has_multiplier", "arg1_id": "NCT03350815_inc_T25", "arg2_id": "NCT03350815_inc_T26", "normalized": [] }, { "id": "NCT03350815_inc_R19", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T25", "arg2_id": "NCT03350815_inc_T27", "normalized": [] }, { "id": "NCT03350815_inc_R20", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T29", "arg2_id": "NCT03350815_inc_T30", "normalized": [] }, { "id": "NCT03350815_inc_R21", "type": "AND", "arg1_id": "NCT03350815_inc_T34", "arg2_id": "NCT03350815_inc_T29", "normalized": [] }, { "id": "NCT03350815_inc_R22", "type": "Has_index", "arg1_id": "NCT03350815_inc_T38", "arg2_id": "NCT03350815_inc_T39", "normalized": [] }, { "id": "NCT03350815_inc_R23", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T40", "arg2_id": "NCT03350815_inc_T38", "normalized": [] }, { "id": "NCT03350815_inc_R24", "type": "Has_multiplier", "arg1_id": "NCT03350815_inc_T41", "arg2_id": "NCT03350815_inc_T42", "normalized": [] }, { "id": "NCT03350815_inc_R25", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T44", "arg2_id": "NCT03350815_inc_T45", "normalized": [] }, { "id": "NCT03350815_inc_R26", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T46", "arg2_id": "NCT03350815_inc_T49", "normalized": [] }, { "id": "NCT03350815_inc_R27", "type": "AND", "arg1_id": "NCT03350815_inc_T43", "arg2_id": "NCT03350815_inc_T46", "normalized": [] }, { "id": "NCT03350815_inc_R28", "type": "Has_multiplier", "arg1_id": "NCT03350815_inc_T46", "arg2_id": "NCT03350815_inc_T44", "normalized": [] }, { "id": "NCT03350815_inc_R29", "type": "AND", "arg1_id": "NCT03350815_inc_T50", "arg2_id": "NCT03350815_inc_T51", "normalized": [] }, { "id": "NCT03350815_inc_R30", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T52", "arg2_id": "NCT03350815_inc_T53", "normalized": [] }, { "id": "NCT03350815_inc_R31", "type": "AND", "arg1_id": "NCT03350815_inc_T57", "arg2_id": "NCT03350815_inc_T58", "normalized": [] }, { "id": "NCT03350815_inc_R32", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T56", "arg2_id": "NCT03350815_inc_T60", "normalized": [] }, { "id": "NCT03350815_inc_R33", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T68", "arg2_id": "NCT03350815_inc_T64", "normalized": [] }, { "id": "NCT03350815_inc_R34", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T69", "arg2_id": "NCT03350815_inc_T68", "normalized": [] }, { "id": "NCT03350815_inc_R35", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T69", "arg2_id": "NCT03350815_inc_T67", "normalized": [] }, { "id": "NCT03350815_inc_R36", "type": "Has_qualifier", "arg1_id": "NCT03350815_inc_T71", "arg2_id": "NCT03350815_inc_T72", "normalized": [] }, { "id": "NCT03350815_inc_R37", "type": "Has_negation", "arg1_id": "NCT03350815_inc_T79", "arg2_id": "NCT03350815_inc_T78", "normalized": [] }, { "id": "NCT03350815_inc_R38", "type": "AND", "arg1_id": "NCT03350815_inc_T80", "arg2_id": "NCT03350815_inc_T79", "normalized": [] }, { "id": "NCT03350815_inc_R39", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T74", "arg2_id": "NCT03350815_inc_T80", "normalized": [] }, { "id": "NCT03350815_inc_R40", "type": "AND", "arg1_id": "NCT03350815_inc_T81", "arg2_id": "NCT03350815_inc_T74", "normalized": [] }, { "id": "NCT03350815_inc_R41", "type": "Has_multiplier", "arg1_id": "NCT03350815_inc_T83", "arg2_id": "NCT03350815_inc_T82", "normalized": [] }, { "id": "NCT03350815_inc_R42", "type": "Has_scope", "arg1_id": "NCT03350815_inc_T84", "arg2_id": "NCT03350815_inc_T87", "normalized": [] }, { "id": "NCT03350815_inc_R43", "type": "Has_index", "arg1_id": "NCT03350815_inc_T88", "arg2_id": "NCT03350815_inc_T89", "normalized": [] }, { "id": "NCT03350815_inc_R44", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T84", "arg2_id": "NCT03350815_inc_T88", "normalized": [] }, { "id": "NCT03350815_inc_R45", "type": "AND", "arg1_id": "NCT03350815_inc_T90", "arg2_id": "NCT03350815_inc_T91", "normalized": [] }, { "id": "NCT03350815_inc_R46", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T90", "arg2_id": "NCT03350815_inc_T92", "normalized": [] }, { "id": "NCT03350815_inc_R47", "type": "Has_temporal", "arg1_id": "NCT03350815_inc_T93", "arg2_id": "NCT03350815_inc_T94", "normalized": [] }, { "id": "NCT03350815_inc_R48", "type": "Subsumes", "arg1_id": "NCT03350815_inc_T95", "arg2_id": "NCT03350815_inc_T99", "normalized": [] } ]

[ { "id": "NCT03351608_exc_text", "type": "exclusion", "text": [ "Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.\nHas a neuromuscular disorder that may affect NMB and/or trial assessments.\nIs dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min).\nHas or is suspected of having a family or personal history of malignant hyperthermia.\nHas or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.\nHas received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment.\nHas been previously treated with sugammadex or has participated in a sugammadex clinical trial.\nIs currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.\n" ], "offsets": [ [ 0, 1265 ] ] } ]

[ { "id": "NCT03351608_exc_T1", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 8, 30 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T2", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 31, 40 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T3", "type": "Observation", "text": [ "situation" ], "offsets": [ [ 44, 53 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T4", "type": "Qualifier", "text": [ "anatomical malformation" ], "offsets": [ [ 59, 82 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T5", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 112, 122 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T6", "type": "Condition", "text": [ "the condition being studied" ], "offsets": [ [ 123, 150 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T7", "type": "Observation", "text": [ "interfere with the trial evaluations" ], "offsets": [ [ 199, 235 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T8", "type": "Observation", "text": [ "interfere with", "optimal participation" ], "offsets": [ [ 199, 213 ], [ 239, 260 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T9", "type": "Scope", "text": [ "condition or situation (eg, anatomical malformation that complicates intubation)" ], "offsets": [ [ 31, 111 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T10", "type": "Scope", "text": [ "interfere with the trial evaluations or optimal participation" ], "offsets": [ [ 199, 260 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T11", "type": "Condition", "text": [ "neuromuscular disorder" ], "offsets": [ [ 281, 303 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T12", "type": "Observation", "text": [ "affect NMB" ], "offsets": [ [ 313, 323 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T13", "type": "Observation", "text": [ "ffect", "rial assessments." ], "offsets": [ [ 314, 319 ], [ 332, 349 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T14", "type": "Scope", "text": [ "affect NMB and/or trial assessments" ], "offsets": [ [ 313, 348 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T15", "type": "Condition", "text": [ "dialysis-dependent" ], "offsets": [ [ 353, 371 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T16", "type": "Condition", "text": [ "severe renal insufficiency" ], "offsets": [ [ 407, 433 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T17", "type": "Measurement", "text": [ "estimated glomerular filtration rate (eGFR)" ], "offsets": [ [ 446, 489 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T18", "type": "Value", "text": [ "<30 ml/min" ], "offsets": [ [ 490, 500 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T19", "type": "Scope", "text": [ "severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min)" ], "offsets": [ [ 407, 501 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T20", "type": "Observation", "text": [ "personal history" ], "offsets": [ [ 545, 561 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T21", "type": "Observation", "text": [ "family" ], "offsets": [ [ 535, 541 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T22", "type": "Condition", "text": [ "malignant hyperthermia" ], "offsets": [ [ 565, 587 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T23", "type": "Scope", "text": [ "family or personal history" ], "offsets": [ [ 535, 561 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T24", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 622, 629 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T25", "type": "Procedure", "text": [ "study treatments" ], "offsets": [ [ 633, 649 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T27", "type": "Drug", "text": [ "opioids" ], "offsets": [ [ 678, 685 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T28", "type": "Drug", "text": [ "opiates" ], "offsets": [ [ 686, 693 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T29", "type": "Drug", "text": [ "muscle relaxants" ], "offsets": [ [ 695, 711 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T30", "type": "Drug", "text": [ "excipients" ], "offsets": [ [ 721, 731 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T31", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 742, 752 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T32", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 736, 741 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T33", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 768, 786 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T34", "type": "Temporal", "text": [ "during general anesthesia" ], "offsets": [ [ 761, 786 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T26", "type": "Drug", "text": [ "excipients" ], "offsets": [ [ 663, 673 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T35", "type": "Scope", "text": [ "study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia" ], "offsets": [ [ 633, 786 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T36", "type": "Drug", "text": [ "toremifene" ], "offsets": [ [ 826, 836 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T37", "type": "Mood", "text": [ "planned to" ], "offsets": [ [ 807, 817 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T38", "type": "Drug", "text": [ "fusidic acid" ], "offsets": [ [ 844, 856 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T39", "type": "Qualifier", "text": [ "IV administration" ], "offsets": [ [ 861, 878 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T40", "type": "Temporal", "text": [ "n 24 hours before or w", "istration of study treatment.\nHas" ], "offsets": [ [ 884, 906 ], [ 932, 965 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T41", "type": "Temporal", "text": [ "within 24 hours after administration of study treatment" ], "offsets": [ [ 905, 960 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T42", "type": "Reference_point", "text": [ "administration of study treatment" ], "offsets": [ [ 927, 960 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T43", "type": "Reference_point", "text": [ "administration of study treatment" ], "offsets": [ [ 927, 960 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T44", "type": "Scope", "text": [ "within 24 hours before or within 24 hours after administration of study treatment" ], "offsets": [ [ 879, 960 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T45", "type": "Scope", "text": [ "toremifene and/or fusidic acid" ], "offsets": [ [ 826, 856 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T46", "type": "Drug", "text": [ "sugammadex" ], "offsets": [ [ 995, 1005 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T47", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 971, 981 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T48", "type": "Observation", "text": [ "ipated in a sug", "al trial.\nIs c" ], "offsets": [ [ 1019, 1034 ], [ 1048, 1062 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T49", "type": "Drug", "text": [ "sugammadex" ], "offsets": [ [ 1031, 1041 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T50", "type": "Scope", "text": [ "sugammadex or has participated in a sugammadex clinical trial" ], "offsets": [ [ 995, 1056 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T51", "type": "Observation", "text": [ "has participated in an interventional clinical trial" ], "offsets": [ [ 1091, 1143 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T52", "type": "Observation", "text": [ "ly participating in or", "nterventional clinical trial with a" ], "offsets": [ [ 1068, 1090 ], [ 1115, 1150 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T53", "type": "Drug", "text": [ "investigational compound" ], "offsets": [ [ 1152, 1176 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T54", "type": "Device", "text": [ "device" ], "offsets": [ [ 1180, 1186 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T55", "type": "Temporal", "text": [ "within 30 days of signing the informed consent" ], "offsets": [ [ 1187, 1233 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T56", "type": "Reference_point", "text": [ "signing the informed consent" ], "offsets": [ [ 1205, 1233 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T57", "type": "Temporal", "text": [ "30 days of signing the informed consen", "for th" ], "offsets": [ [ 1194, 1232 ], [ 1241, 1247 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T58", "type": "Reference_point", "text": [ " the informed conse", "for th" ], "offsets": [ [ 1212, 1231 ], [ 1241, 1247 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T59", "type": "Scope", "text": [ "investigational compound or device" ], "offsets": [ [ 1152, 1186 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T60", "type": "Scope", "text": [ "currently participating in or has participated in an interventional clinical trial" ], "offsets": [ [ 1061, 1143 ] ], "normalized": [] }, { "id": "NCT03351608_exc_T61", "type": "Scope", "text": [ "within 30 days of signing the informed consent/assent" ], "offsets": [ [ 1187, 1240 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03351608_exc_R1", "type": "Has_negation", "arg1_id": "NCT03351608_exc_T6", "arg2_id": "NCT03351608_exc_T5", "normalized": [] }, { "id": "NCT03351608_exc_R2", "type": "Subsumes", "arg1_id": "NCT03351608_exc_T3", "arg2_id": "NCT03351608_exc_T4", "normalized": [] }, { "id": "NCT03351608_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03351608_exc_T9", "arg2_id": "NCT03351608_exc_T1", "normalized": [] }, { "id": "NCT03351608_exc_R4", "type": "AND", "arg1_id": "NCT03351608_exc_T9", "arg2_id": "NCT03351608_exc_T6", "normalized": [] }, { "id": "NCT03351608_exc_R5", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T9", "arg2_id": "NCT03351608_exc_T10", "normalized": [] }, { "id": "NCT03351608_exc_R6", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T11", "arg2_id": "NCT03351608_exc_T14", "normalized": [] }, { "id": "NCT03351608_exc_R7", "type": "Has_value", "arg1_id": "NCT03351608_exc_T17", "arg2_id": "NCT03351608_exc_T18", "normalized": [] }, { "id": "NCT03351608_exc_R8", "type": "Subsumes", "arg1_id": "NCT03351608_exc_T16", "arg2_id": "NCT03351608_exc_T17", "normalized": [] }, { "id": "NCT03351608_exc_R9", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T22", "arg2_id": "NCT03351608_exc_T23", "normalized": [] }, { "id": "NCT03351608_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT03351608_exc_T31", "arg2_id": "NCT03351608_exc_T32", "normalized": [] }, { "id": "NCT03351608_exc_R11", "type": "Has_temporal", "arg1_id": "NCT03351608_exc_T31", "arg2_id": "NCT03351608_exc_T34", "normalized": [] }, { "id": "NCT03351608_exc_R12", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T24", "arg2_id": "NCT03351608_exc_T35", "normalized": [] }, { "id": "NCT03351608_exc_R13", "type": "Has_index", "arg1_id": "NCT03351608_exc_T40", "arg2_id": "NCT03351608_exc_T43", "normalized": [] }, { "id": "NCT03351608_exc_R14", "type": "Has_index", "arg1_id": "NCT03351608_exc_T41", "arg2_id": "NCT03351608_exc_T42", "normalized": [] }, { "id": "NCT03351608_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT03351608_exc_T45", "arg2_id": "NCT03351608_exc_T39", "normalized": [] }, { "id": "NCT03351608_exc_R16", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T45", "arg2_id": "NCT03351608_exc_T44", "normalized": [] }, { "id": "NCT03351608_exc_R17", "type": "Has_mood", "arg1_id": "NCT03351608_exc_T45", "arg2_id": "NCT03351608_exc_T37", "normalized": [] }, { "id": "NCT03351608_exc_R18", "type": "AND", "arg1_id": "NCT03351608_exc_T48", "arg2_id": "NCT03351608_exc_T49", "normalized": [] }, { "id": "NCT03351608_exc_R19", "type": "Has_temporal", "arg1_id": "NCT03351608_exc_T50", "arg2_id": "NCT03351608_exc_T47", "normalized": [] }, { "id": "NCT03351608_exc_R20", "type": "Has_index", "arg1_id": "NCT03351608_exc_T55", "arg2_id": "NCT03351608_exc_T56", "normalized": [] }, { "id": "NCT03351608_exc_R21", "type": "Has_index", "arg1_id": "NCT03351608_exc_T57", "arg2_id": "NCT03351608_exc_T58", "normalized": [] }, { "id": "NCT03351608_exc_R22", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T60", "arg2_id": "NCT03351608_exc_T59", "normalized": [] }, { "id": "NCT03351608_exc_R23", "type": "Has_scope", "arg1_id": "NCT03351608_exc_T60", "arg2_id": "NCT03351608_exc_T61", "normalized": [] } ]

[ { "id": "NCT03351608_inc_text", "type": "inclusion", "text": [ "Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.\nHave a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.\nHave a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.\nAge between 2 to <17 years at Visit 2.\nIf female, may participate if she is not pregnant, not breastfeeding, and at least one of the following: 1) Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment.\n" ], "offsets": [ [ 0, 810 ] ] } ]

[ { "id": "NCT03351608_inc_T1", "type": "Measurement", "text": [ "American Society of Anesthesiologists (ASA) Physical Status Class" ], "offsets": [ [ 18, 83 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T2", "type": "Value", "text": [ "1" ], "offsets": [ [ 84, 85 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T3", "type": "Value", "text": [ "2" ], "offsets": [ [ 87, 88 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T4", "type": "Value", "text": [ "3" ], "offsets": [ [ 93, 94 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T5", "type": "Scope", "text": [ "1, 2, or 3" ], "offsets": [ [ 84, 94 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T6", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 103, 110 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T7", "type": "Qualifier", "text": [ "non-emergent" ], "offsets": [ [ 111, 123 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T8", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 124, 142 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T9", "type": "Condition", "text": [ "clinical situation" ], "offsets": [ [ 146, 164 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T10", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 172, 182 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T11", "type": "Scope", "text": [ "clinical situation (e.g., intubation)" ], "offsets": [ [ 146, 183 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T12", "type": "Procedure", "text": [ "NMB" ], "offsets": [ [ 215, 218 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T13", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 198, 206 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T14", "type": "Qualifier", "text": [ "deep" ], "offsets": [ [ 210, 214 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T15", "type": "Scope", "text": [ "moderate or deep" ], "offsets": [ [ 198, 214 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T16", "type": "Drug", "text": [ "rocuronium" ], "offsets": [ [ 231, 241 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T17", "type": "Drug", "text": [ "vecuronium" ], "offsets": [ [ 245, 255 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T18", "type": "Scope", "text": [ "rocuronium or vecuronium" ], "offsets": [ [ 231, 255 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T19", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 264, 271 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T20", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 272, 290 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T21", "type": "Condition", "text": [ "clinical situation" ], "offsets": [ [ 294, 312 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T22", "type": "Procedure", "text": [ "objective neuromuscular monitoring techniques" ], "offsets": [ [ 330, 375 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T23", "type": "Qualifier", "text": [ "that would allow objective neuromuscular monitoring techniques to be applied" ], "offsets": [ [ 313, 389 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T24", "type": "Scope", "text": [ "planned surgical procedure" ], "offsets": [ [ 264, 290 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T25", "type": "Person", "text": [ "Age" ], "offsets": [ [ 456, 459 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T26", "type": "Value", "text": [ "between 2 to <17 years" ], "offsets": [ [ 460, 482 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T27", "type": "Temporal", "text": [ "at Visit 2" ], "offsets": [ [ 483, 493 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T28", "type": "Person", "text": [ "female" ], "offsets": [ [ 498, 504 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T29", "type": "Negation", "text": [ "not" ], "offsets": [ [ 532, 535 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T30", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 536, 544 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T31", "type": "Negation", "text": [ "not" ], "offsets": [ [ 546, 549 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T32", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 550, 563 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T33", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 569, 581 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T34", "type": "Condition", "text": [ "woman of childbearing potential (WOCBP)" ], "offsets": [ [ 609, 648 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T35", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 603, 606 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T36", "type": "Condition", "text": [ "WOCBP" ], "offsets": [ [ 658, 663 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T37", "type": "Procedure", "text": [ "contraceptive guidance" ], "offsets": [ [ 695, 717 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T38", "type": "Temporal", "text": [ "during the treatment period" ], "offsets": [ [ 718, 745 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T39", "type": "Temporal", "text": [ "for at least 7 days after the last dose of study treatment" ], "offsets": [ [ 750, 808 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T40", "type": "Reference_point", "text": [ "the last dose of study treatment" ], "offsets": [ [ 776, 808 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T41", "type": "Reference_point", "text": [ "the treatment period" ], "offsets": [ [ 725, 745 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T42", "type": "Scope", "text": [ "during the treatment period and for at least 7 days after the last dose of study treatment" ], "offsets": [ [ 718, 808 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T43", "type": "Scope", "text": [ "WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment" ], "offsets": [ [ 658, 808 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T44", "type": "Scope", "text": [ "Not a woman of childbearing potential (WOCBP)" ], "offsets": [ [ 603, 648 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T45", "type": "Scope", "text": [ "Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment" ], "offsets": [ [ 603, 808 ] ], "normalized": [] }, { "id": "NCT03351608_inc_T46", "type": "Scope", "text": [ "not pregnant, not breastfeeding, and at least one of the following: 1) Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment" ], "offsets": [ [ 532, 808 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03351608_inc_R1", "type": "Has_scope", "arg1_id": "NCT03351608_inc_T1", "arg2_id": "NCT03351608_inc_T5", "normalized": [] }, { "id": "NCT03351608_inc_R2", "type": "Subsumes", "arg1_id": "NCT03351608_inc_T9", "arg2_id": "NCT03351608_inc_T10", "normalized": [] }, { "id": "NCT03351608_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT03351608_inc_T8", "arg2_id": "NCT03351608_inc_T7", "normalized": [] }, { "id": "NCT03351608_inc_R4", "type": "Has_mood", "arg1_id": "NCT03351608_inc_T8", "arg2_id": "NCT03351608_inc_T6", "normalized": [] }, { "id": "NCT03351608_inc_R5", "type": "Has_scope", "arg1_id": "NCT03351608_inc_T12", "arg2_id": "NCT03351608_inc_T15", "normalized": [] }, { "id": "NCT03351608_inc_R6", "type": "Has_scope", "arg1_id": "NCT03351608_inc_T12", "arg2_id": "NCT03351608_inc_T18", "normalized": [] }, { "id": "NCT03351608_inc_R7", "type": "AND", "arg1_id": "NCT03351608_inc_T8", "arg2_id": "NCT03351608_inc_T12", "normalized": [] }, { "id": "NCT03351608_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT03351608_inc_T24", "arg2_id": "NCT03351608_inc_T23", "normalized": [] }, { "id": "NCT03351608_inc_R10", "type": "Has_mood", "arg1_id": "NCT03351608_inc_T20", "arg2_id": "NCT03351608_inc_T19", "normalized": [] }, { "id": "NCT03351608_inc_R11", "type": "Has_temporal", "arg1_id": "NCT03351608_inc_T25", "arg2_id": "NCT03351608_inc_T27", "normalized": [] }, { "id": "NCT03351608_inc_R12", "type": "Has_value", "arg1_id": "NCT03351608_inc_T25", "arg2_id": "NCT03351608_inc_T26", "normalized": [] }, { "id": "NCT03351608_inc_R13", "type": "Has_negation", "arg1_id": "NCT03351608_inc_T30", "arg2_id": "NCT03351608_inc_T29", "normalized": [] }, { "id": "NCT03351608_inc_R14", "type": "Has_negation", "arg1_id": "NCT03351608_inc_T32", "arg2_id": "NCT03351608_inc_T31", "normalized": [] }, { "id": "NCT03351608_inc_R15", "type": "Has_index", "arg1_id": "NCT03351608_inc_T38", "arg2_id": "NCT03351608_inc_T41", "normalized": [] }, { "id": "NCT03351608_inc_R16", "type": "Has_index", "arg1_id": "NCT03351608_inc_T39", "arg2_id": "NCT03351608_inc_T40", "normalized": [] }, { "id": "NCT03351608_inc_R17", "type": "Has_scope", "arg1_id": "NCT03351608_inc_T37", "arg2_id": "NCT03351608_inc_T42", "normalized": [] }, { "id": "NCT03351608_inc_R18", "type": "Has_negation", "arg1_id": "NCT03351608_inc_T34", "arg2_id": "NCT03351608_inc_T35", "normalized": [] }, { "id": "NCT03351608_inc_R19", "type": "Has_multiplier", "arg1_id": "NCT03351608_inc_T45", "arg2_id": "NCT03351608_inc_T33", "normalized": [] }, { "id": "NCT03351608_inc_R20", "type": "Has_scope", "arg1_id": "NCT03351608_inc_T28", "arg2_id": "NCT03351608_inc_T46", "normalized": [] } ]

[ { "id": "NCT03351972_exc_text", "type": "exclusion", "text": [ "dysphagia\nsevere gastroparesis requiring endoscopic placement of capsule\nsmall bowel obstruction\npregnancy\n" ], "offsets": [ [ 0, 107 ] ] } ]

[ { "id": "NCT03351972_exc_T1", "type": "Condition", "text": [ "dysphagia" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T2", "type": "Condition", "text": [ "gastroparesis" ], "offsets": [ [ 17, 30 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T3", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 10, 16 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T4", "type": "Procedure", "text": [ "endoscopic placement" ], "offsets": [ [ 41, 61 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T5", "type": "Device", "text": [ "capsule" ], "offsets": [ [ 65, 72 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T6", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 31, 40 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T7", "type": "Condition", "text": [ "small bowel obstruction" ], "offsets": [ [ 73, 96 ] ], "normalized": [] }, { "id": "NCT03351972_exc_T8", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 97, 106 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03351972_exc_R1", "type": "AND", "arg1_id": "NCT03351972_exc_T4", "arg2_id": "NCT03351972_exc_T5", "normalized": [] }, { "id": "NCT03351972_exc_R2", "type": "Has_mood", "arg1_id": "NCT03351972_exc_T4", "arg2_id": "NCT03351972_exc_T6", "normalized": [] }, { "id": "NCT03351972_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03351972_exc_T2", "arg2_id": "NCT03351972_exc_T3", "normalized": [] }, { "id": "NCT03351972_exc_R4", "type": "AND", "arg1_id": "NCT03351972_exc_T2", "arg2_id": "NCT03351972_exc_T4", "normalized": [] } ]

[ { "id": "NCT03351972_inc_text", "type": "inclusion", "text": [ "Adult outpatients (18 years or older)\nroutinely referred for small bowel video capsule endoscopy (CE)\n" ], "offsets": [ [ 0, 102 ] ] } ]

[ { "id": "NCT03351972_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03351972_inc_T2", "type": "Visit", "text": [ "outpatients" ], "offsets": [ [ 6, 17 ] ], "normalized": [] }, { "id": "NCT03351972_inc_T3", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 19, 36 ] ], "normalized": [] }, { "id": "NCT03351972_inc_T4", "type": "Multiplier", "text": [ "routinely referred" ], "offsets": [ [ 38, 56 ] ], "normalized": [] }, { "id": "NCT03351972_inc_T5", "type": "Procedure", "text": [ "small bowel video capsule endoscopy" ], "offsets": [ [ 61, 96 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03351972_inc_R1", "type": "Has_value", "arg1_id": "NCT03351972_inc_T1", "arg2_id": "NCT03351972_inc_T3", "normalized": [] }, { "id": "NCT03351972_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT03351972_inc_T5", "arg2_id": "NCT03351972_inc_T4", "normalized": [] } ]

[ { "id": "NCT03352869_exc_text", "type": "exclusion", "text": [ "Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months)\nhigh blood pressure (>160/100mmHg)\nactive infection\nsecondary diabetes\npregnancy\nalcohol abuse\nallergic to GLP-1 receptor agonist\n" ], "offsets": [ [ 0, 256 ] ] } ]

[ { "id": "NCT03352869_exc_T1", "type": "Condition", "text": [ "serious complications" ], "offsets": [ [ 11, 32 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T2", "type": "Condition", "text": [ "cardiovascular events" ], "offsets": [ [ 34, 55 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T3", "type": "Condition", "text": [ "disease", "liver" ], "offsets": [ [ 101, 108 ], [ 79, 84 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T4", "type": "Condition", "text": [ "disease", "kidney" ], "offsets": [ [ 101, 108 ], [ 86, 92 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T5", "type": "Condition", "text": [ "lung disease" ], "offsets": [ [ 96, 108 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T6", "type": "Temporal", "text": [ "within 3 months" ], "offsets": [ [ 109, 124 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T7", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 67, 78 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T8", "type": "Scope", "text": [ "liver, kidney or lung disease" ], "offsets": [ [ 79, 108 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T9", "type": "Scope", "text": [ "cardiovascular events and recent significant liver, kidney or lung disease" ], "offsets": [ [ 34, 108 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T10", "type": "Scope", "text": [ "cardiovascular events and recent significant liver, kidney or lung disease within 3 months" ], "offsets": [ [ 34, 124 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T11", "type": "Condition", "text": [ "high blood pressure" ], "offsets": [ [ 126, 145 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T12", "type": "Value", "text": [ ">160/100mmHg" ], "offsets": [ [ 147, 159 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T13", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 131, 145 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T14", "type": "Condition", "text": [ "active infection" ], "offsets": [ [ 161, 177 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T15", "type": "Qualifier", "text": [ "secondary" ], "offsets": [ [ 178, 187 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T16", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 188, 196 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T17", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 197, 206 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T18", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 207, 220 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T19", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 221, 229 ] ], "normalized": [] }, { "id": "NCT03352869_exc_T20", "type": "Drug", "text": [ "GLP-1 receptor agonist" ], "offsets": [ [ 233, 255 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03352869_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03352869_exc_T8", "arg2_id": "NCT03352869_exc_T7", "normalized": [] }, { "id": "NCT03352869_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03352869_exc_T9", "arg2_id": "NCT03352869_exc_T6", "normalized": [] }, { "id": "NCT03352869_exc_R3", "type": "Subsumes", "arg1_id": "NCT03352869_exc_T1", "arg2_id": "NCT03352869_exc_T10", "normalized": [] }, { "id": "NCT03352869_exc_R4", "type": "Has_value", "arg1_id": "NCT03352869_exc_T13", "arg2_id": "NCT03352869_exc_T12", "normalized": [] }, { "id": "NCT03352869_exc_R5", "type": "Subsumes", "arg1_id": "NCT03352869_exc_T11", "arg2_id": "NCT03352869_exc_T13", "normalized": [] }, { "id": "NCT03352869_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT03352869_exc_T16", "arg2_id": "NCT03352869_exc_T15", "normalized": [] }, { "id": "NCT03352869_exc_R8", "type": "AND", "arg1_id": "NCT03352869_exc_T19", "arg2_id": "NCT03352869_exc_T20", "normalized": [] } ]

[ { "id": "NCT03352869_inc_text", "type": "inclusion", "text": [ "Overweight and obese PCOS patients with newly diagnosed IGR;\nPCOS diagnosis based on 2003 Rotterdam criteria\nOverweight / obesity diagnostic criteria according to WHO-WPR\nImpaired glucose regulation diagnostic criteria according to 1998 WHO diagnostic criteria.\n" ], "offsets": [ [ 0, 262 ] ] } ]

[ { "id": "NCT03352869_inc_T1", "type": "Condition", "text": [ "Overweight" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T2", "type": "Condition", "text": [ "obese" ], "offsets": [ [ 15, 20 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T3", "type": "Condition", "text": [ "PCOS" ], "offsets": [ [ 21, 25 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T4", "type": "Temporal", "text": [ "newly diagnosed" ], "offsets": [ [ 40, 55 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T5", "type": "Condition", "text": [ "IGR" ], "offsets": [ [ 56, 59 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T6", "type": "Condition", "text": [ "PCOS" ], "offsets": [ [ 61, 65 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T7", "type": "Qualifier", "text": [ "2003 Rotterdam criteria" ], "offsets": [ [ 85, 108 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T8", "type": "Condition", "text": [ "Overweight" ], "offsets": [ [ 109, 119 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T9", "type": "Condition", "text": [ "obesity" ], "offsets": [ [ 122, 129 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T10", "type": "Qualifier", "text": [ "WHO-WPR" ], "offsets": [ [ 163, 170 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T11", "type": "Scope", "text": [ "Overweight / obesity" ], "offsets": [ [ 109, 129 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T12", "type": "Condition", "text": [ "Impaired glucose regulation" ], "offsets": [ [ 171, 198 ] ], "normalized": [] }, { "id": "NCT03352869_inc_T13", "type": "Qualifier", "text": [ "1998 WHO diagnostic criteria" ], "offsets": [ [ 232, 260 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT03352869_inc_R1", "type": "Has_temporal", "arg1_id": "NCT03352869_inc_T5", "arg2_id": "NCT03352869_inc_T4", "normalized": [] }, { "id": "NCT03352869_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03352869_inc_T6", "arg2_id": "NCT03352869_inc_T7", "normalized": [] }, { "id": "NCT03352869_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT03352869_inc_T11", "arg2_id": "NCT03352869_inc_T10", "normalized": [] }, { "id": "NCT03352869_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03352869_inc_T12", "arg2_id": "NCT03352869_inc_T13", "normalized": [] } ]

[ { "id": "NCT03354572_exc_text", "type": "exclusion", "text": [ "Pregnancy or lactating\nAllergy to NAC\nHistory of chronic pain\nUse of opioids or neuropathic analgesics\nUse of NAC prior to trial (< 1 month of planned surgery)\nAlcoholism\nDiabetes Mellitus (insulin therapy)\nAsthma or Chronic Obstructive pulmonary Disease\nKnown renal function disorders (MDRD <ô0)\nKnown liver failure (bilirubin >1.Sx upper limit of normal)\nNo written lC by patient\n" ], "offsets": [ [ 0, 382 ] ] } ]

[ { "id": "NCT03354572_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T2", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 13, 22 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T3", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 23, 30 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T4", "type": "Drug", "text": [ "NAC" ], "offsets": [ [ 34, 37 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T5", "type": "Condition", "text": [ "chronic pain" ], "offsets": [ [ 49, 61 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T6", "type": "Observation", "text": [ "History" ], "offsets": [ [ 38, 45 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T7", "type": "Drug", "text": [ "opioids" ], "offsets": [ [ 69, 76 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T8", "type": "Drug", "text": [ "neuropathic analgesics" ], "offsets": [ [ 80, 102 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T9", "type": "Drug", "text": [ "NAC" ], "offsets": [ [ 110, 113 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T10", "type": "Temporal", "text": [ "prior to trial" ], "offsets": [ [ 114, 128 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T11", "type": "Reference_point", "text": [ "trial" ], "offsets": [ [ 123, 128 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T12", "type": "Temporal", "text": [ "< 1 month" ], "offsets": [ [ 130, 139 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T13", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 143, 150 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T14", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 151, 158 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T15", "type": "Scope", "text": [ "< 1 month of planned surgery" ], "offsets": [ [ 130, 158 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T16", "type": "Condition", "text": [ "Alcoholism" ], "offsets": [ [ 160, 170 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T17", "type": "Condition", "text": [ "Diabetes Mellitus" ], "offsets": [ [ 171, 188 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T18", "type": "Drug", "text": [ "insulin" ], "offsets": [ [ 190, 197 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T19", "type": "Condition", "text": [ "Asthma" ], "offsets": [ [ 207, 213 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T20", "type": "Condition", "text": [ "Chronic Obstructive pulmonary Disease" ], "offsets": [ [ 217, 254 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T21", "type": "Condition", "text": [ "renal function disorders" ], "offsets": [ [ 261, 285 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T22", "type": "Measurement", "text": [ "MDRD" ], "offsets": [ [ 287, 291 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T23", "type": "Value", "text": [ "<ô0" ], "offsets": [ [ 292, 295 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T24", "type": "Scope", "text": [ "MDRD <ô0" ], "offsets": [ [ 287, 295 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T25", "type": "Condition", "text": [ "liver failure" ], "offsets": [ [ 303, 316 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T26", "type": "Measurement", "text": [ "bilirubin" ], "offsets": [ [ 318, 327 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T27", "type": "Value", "text": [ ">1.Sx upper limit of normal" ], "offsets": [ [ 328, 355 ] ], "normalized": [] }, { "id": "NCT03354572_exc_T28", "type": "Scope", "text": [ "bilirubin >1.Sx upper limit of normal" ], "offsets": [ [ 318, 355 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT03354572_exc_R1", "type": "AND", "arg1_id": "NCT03354572_exc_T3", "arg2_id": "NCT03354572_exc_T4", "normalized": [] }, { "id": "NCT03354572_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03354572_exc_T5", "arg2_id": "NCT03354572_exc_T6", "normalized": [] }, { "id": "NCT03354572_exc_R3", "type": "Has_index", "arg1_id": "NCT03354572_exc_T10", "arg2_id": "NCT03354572_exc_T11", "normalized": [] }, { "id": "NCT03354572_exc_R4", "type": "Has_mood", "arg1_id": "NCT03354572_exc_T14", "arg2_id": "NCT03354572_exc_T13", "normalized": [] }, { "id": "NCT03354572_exc_R5", "type": "Has_temporal", "arg1_id": "NCT03354572_exc_T14", "arg2_id": "NCT03354572_exc_T12", "normalized": [] }, { "id": "NCT03354572_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03354572_exc_T9", "arg2_id": "NCT03354572_exc_T10", "normalized": [] }, { "id": "NCT03354572_exc_R7", "type": "Subsumes", "arg1_id": "NCT03354572_exc_T10", "arg2_id": "NCT03354572_exc_T15", "normalized": [] }, { "id": "NCT03354572_exc_R8", "type": "AND", "arg1_id": "NCT03354572_exc_T17", "arg2_id": "NCT03354572_exc_T18", "normalized": [] }, { "id": "NCT03354572_exc_R9", "type": "Has_value", "arg1_id": "NCT03354572_exc_T22", "arg2_id": "NCT03354572_exc_T23", "normalized": [] }, { "id": "NCT03354572_exc_R10", "type": "Subsumes", "arg1_id": "NCT03354572_exc_T21", "arg2_id": "NCT03354572_exc_T24", "normalized": [] }, { "id": "NCT03354572_exc_R11", "type": "Has_value", "arg1_id": "NCT03354572_exc_T26", "arg2_id": "NCT03354572_exc_T27", "normalized": [] }, { "id": "NCT03354572_exc_R12", "type": "Subsumes", "arg1_id": "NCT03354572_exc_T25", "arg2_id": "NCT03354572_exc_T28", "normalized": [] } ]

[ { "id": "NCT03354572_inc_text", "type": "inclusion", "text": [ "Subjects scheduled for laparoscopic unilateral inguinal hernia repair\nASA 1 or2.\nAge >18 years.\n" ], "offsets": [ [ 0, 96 ] ] } ]

[ { "id": "NCT03354572_inc_T1", "type": "Mood", "text": [ "scheduled" ], "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T2", "type": "Qualifier", "text": [ "laparoscopic" ], "offsets": [ [ 23, 35 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T3", "type": "Procedure", "text": [ "inguinal hernia repair" ], "offsets": [ [ 47, 69 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T4", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 36, 46 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T5", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 70, 73 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T6", "type": "Value", "text": [ "1 or2" ], "offsets": [ [ 74, 79 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T7", "type": "Person", "text": [ "Age" ], "offsets": [ [ 81, 84 ] ], "normalized": [] }, { "id": "NCT03354572_inc_T8", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 85, 94 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT03354572_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03354572_inc_T3", "arg2_id": "NCT03354572_inc_T4", "normalized": [] }, { "id": "NCT03354572_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03354572_inc_T3", "arg2_id": "NCT03354572_inc_T2", "normalized": [] }, { "id": "NCT03354572_inc_R3", "type": "Has_value", "arg1_id": "NCT03354572_inc_T5", "arg2_id": "NCT03354572_inc_T6", "normalized": [] }, { "id": "NCT03354572_inc_R4", "type": "Has_value", "arg1_id": "NCT03354572_inc_T7", "arg2_id": "NCT03354572_inc_T8", "normalized": [] }, { "id": "NCT03354572_inc_R5", "type": "Has_mood", "arg1_id": "NCT03354572_inc_T3", "arg2_id": "NCT03354572_inc_T1", "normalized": [] } ]

[ { "id": "NCT03355157_exc_text", "type": "exclusion", "text": [ "NA\n\n" ], "offsets": [ [ 0, 4 ] ] } ]

[]

[]

[]

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[ { "id": "NCT03355157_inc_text", "type": "inclusion", "text": [ "Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via wearable device and study mobile must be obtained and documented according to the local regulatory requirements.\nFemale or male patients.\nAge = 18 years old.\nMetastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).\nPatients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.\nSymptomatic or asymptomatic metastatic breast cancer.\nResolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\nLife-expectancy > 6 months.\nFor female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).\n" ], "offsets": [ [ 0, 1412 ] ] } ]

[ { "id": "NCT03355157_inc_T2", "type": "Person", "text": [ "Female" ], "offsets": [ [ 326, 332 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T3", "type": "Person", "text": [ "male" ], "offsets": [ [ 336, 340 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T4", "type": "Person", "text": [ "Age" ], "offsets": [ [ 351, 354 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T5", "type": "Value", "text": [ "= 18 years old" ], "offsets": [ [ 355, 369 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T6", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 435, 448 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T7", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 382, 390 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T8", "type": "Qualifier", "text": [ "Metastatic" ], "offsets": [ [ 371, 381 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T9", "type": "Qualifier", "text": [ "hormone receptor positive" ], "offsets": [ [ 391, 416 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T10", "type": "Qualifier", "text": [ "HER2 negative" ], "offsets": [ [ 421, 434 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T11", "type": "Scope", "text": [ "Metastatic invasive hormone receptor positive and HER2 negative" ], "offsets": [ [ 371, 434 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T14", "type": "Condition", "text": [ "metastatic breast cancer" ], "offsets": [ [ 825, 849 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T15", "type": "Qualifier", "text": [ "asymptomatic" ], "offsets": [ [ 812, 824 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T16", "type": "Qualifier", "text": [ "Symptomatic" ], "offsets": [ [ 797, 808 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T17", "type": "Scope", "text": [ "Symptomatic or asymptomatic" ], "offsets": [ [ 797, 824 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T18", "type": "Observation", "text": [ "Life-expectancy" ], "offsets": [ [ 1089, 1104 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T19", "type": "Value", "text": [ "> 6 months" ], "offsets": [ [ 1105, 1115 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T20", "type": "Measurement", "text": [ "NCI CTCAE version 4.0" ], "offsets": [ [ 944, 965 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T21", "type": "Value", "text": [ "grade = 1" ], "offsets": [ [ 966, 975 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T22", "type": "Observation", "text": [ "Resolution" ], "offsets": [ [ 851, 861 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T23", "type": "Condition", "text": [ "acute toxic effects" ], "offsets": [ [ 869, 888 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T24", "type": "Procedure", "text": [ "anti-cancer therapy" ], "offsets": [ [ 898, 917 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T25", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 921, 939 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T26", "type": "Scope", "text": [ "anti-cancer therapy or surgical procedures" ], "offsets": [ [ 898, 940 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T27", "type": "Qualifier", "text": [ "prior" ], "offsets": [ [ 892, 897 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T28", "type": "Negation", "text": [ "except" ], "offsets": [ [ 977, 983 ] ], "normalized": [] }, { "id": "NCT03355157_inc_T29", "type": "Condition", "text": [ "alopecia" ], "offsets": [ [ 984, 992 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT03355157_inc_R1", "type": "Has_value", "arg1_id": "NCT03355157_inc_T4", "arg2_id": "NCT03355157_inc_T5", "normalized": [] }, { "id": "NCT03355157_inc_R2", "type": "Has_scope", "arg1_id": "NCT03355157_inc_T6", "arg2_id": "NCT03355157_inc_T11", "normalized": [] }, { "id": "NCT03355157_inc_R3", "type": "Has_scope", "arg1_id": "NCT03355157_inc_T14", "arg2_id": "NCT03355157_inc_T17", "normalized": [] }, { "id": "NCT03355157_inc_R4", "type": "Has_value", "arg1_id": "NCT03355157_inc_T18", "arg2_id": "NCT03355157_inc_T19", "normalized": [] }, { "id": "NCT03355157_inc_R5", "type": "Has_value", "arg1_id": "NCT03355157_inc_T20", "arg2_id": "NCT03355157_inc_T21", "normalized": [] }, { "id": "NCT03355157_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT03355157_inc_T26", "arg2_id": "NCT03355157_inc_T27", "normalized": [] }, { "id": "NCT03355157_inc_R8", "type": "Has_scope", "arg1_id": "NCT03355157_inc_T23", "arg2_id": "NCT03355157_inc_T26", "normalized": [] }, { "id": "NCT03355157_inc_R9", "type": "AND", "arg1_id": "NCT03355157_inc_T23", "arg2_id": "NCT03355157_inc_T20", "normalized": [] } ]

[ { "id": "NCT03355326_exc_text", "type": "exclusion", "text": [ "Neurological Congenital malformations and/or those known to impair intestinal motility\nAdditional congenital gastrointestinal abnormalities requiring surgical intervention\nCongenital Cyanotic heart disease\nSurgical Closure of abdominal wall defect with prosthetic material (e.g. prosthetic or bio-prosthetic mesh)\n" ], "offsets": [ [ 0, 314 ] ] } ]

[ { "id": "NCT03355326_exc_T1", "type": "Condition", "text": [ "Neurological Congenital malformations" ], "offsets": [ [ 0, 37 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T2", "type": "Condition", "text": [ "impair intestinal motility" ], "offsets": [ [ 60, 86 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T3", "type": "Condition", "text": [ "gastrointestinal abnormalities" ], "offsets": [ [ 109, 139 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T4", "type": "Qualifier", "text": [ "Additional" ], "offsets": [ [ 87, 97 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T5", "type": "Procedure", "text": [ "surgical intervention" ], "offsets": [ [ 150, 171 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T6", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 140, 149 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T7", "type": "Qualifier", "text": [ "Congenital" ], "offsets": [ [ 172, 182 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T8", "type": "Condition", "text": [ "Cyanotic heart disease" ], "offsets": [ [ 183, 205 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T9", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 98, 108 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T10", "type": "Procedure", "text": [ "Surgical Closure" ], "offsets": [ [ 206, 222 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T11", "type": "Condition", "text": [ "abdominal wall defect" ], "offsets": [ [ 226, 247 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T12", "type": "Device", "text": [ "prosthetic material" ], "offsets": [ [ 253, 272 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T13", "type": "Device", "text": [ "sthetic or", "h)" ], "offsets": [ [ 282, 292 ], [ 311, 313 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T14", "type": "Device", "text": [ "bio-prosthetic mesh" ], "offsets": [ [ 293, 312 ] ], "normalized": [] }, { "id": "NCT03355326_exc_T15", "type": "Scope", "text": [ "prosthetic or bio-prosthetic mesh" ], "offsets": [ [ 279, 312 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03355326_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03355326_exc_T3", "arg2_id": "NCT03355326_exc_T4", "normalized": [] }, { "id": "NCT03355326_exc_R2", "type": "Has_mood", "arg1_id": "NCT03355326_exc_T5", "arg2_id": "NCT03355326_exc_T6", "normalized": [] }, { "id": "NCT03355326_exc_R3", "type": "AND", "arg1_id": "NCT03355326_exc_T3", "arg2_id": "NCT03355326_exc_T5", "normalized": [] }, { "id": "NCT03355326_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT03355326_exc_T3", "arg2_id": "NCT03355326_exc_T9", "normalized": [] }, { "id": "NCT03355326_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03355326_exc_T8", "arg2_id": "NCT03355326_exc_T7", "normalized": [] }, { "id": "NCT03355326_exc_R6", "type": "AND", "arg1_id": "NCT03355326_exc_T10", "arg2_id": "NCT03355326_exc_T11", "normalized": [] }, { "id": "NCT03355326_exc_R7", "type": "Subsumes", "arg1_id": "NCT03355326_exc_T12", "arg2_id": "NCT03355326_exc_T15", "normalized": [] }, { "id": "NCT03355326_exc_R8", "type": "AND", "arg1_id": "NCT03355326_exc_T10", "arg2_id": "NCT03355326_exc_T12", "normalized": [] } ]

[ { "id": "NCT03355326_inc_text", "type": "inclusion", "text": [ "Diagnosis of uncomplicated gastroschisis\nGestational age >33 weeks at time of delivery\nWeight >1900g at time of delivery\nTransfer of patient to Riley Hospital for Children prior to any abdominal surgery\n" ], "offsets": [ [ 0, 203 ] ] } ]

[ { "id": "NCT03355326_inc_T1", "type": "Qualifier", "text": [ "uncomplicated" ], "offsets": [ [ 13, 26 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T2", "type": "Condition", "text": [ "gastroschisis" ], "offsets": [ [ 27, 40 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T3", "type": "Measurement", "text": [ "Gestational age" ], "offsets": [ [ 41, 56 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T4", "type": "Value", "text": [ ">33 weeks" ], "offsets": [ [ 57, 66 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T5", "type": "Temporal", "text": [ "at time of delivery" ], "offsets": [ [ 67, 86 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T6", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 87, 93 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T7", "type": "Value", "text": [ ">1900g" ], "offsets": [ [ 94, 100 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T8", "type": "Temporal", "text": [ "at time of delivery" ], "offsets": [ [ 101, 120 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T9", "type": "Visit", "text": [ "Riley Hospital for Children" ], "offsets": [ [ 144, 171 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T10", "type": "Temporal", "text": [ "prior to any abdominal surgery" ], "offsets": [ [ 172, 202 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T11", "type": "Procedure", "text": [ "abdominal surgery" ], "offsets": [ [ 185, 202 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T12", "type": "Reference_point", "text": [ "any abdominal surgery" ], "offsets": [ [ 181, 202 ] ], "normalized": [] }, { "id": "NCT03355326_inc_T13", "type": "Procedure", "text": [ "Transfer" ], "offsets": [ [ 121, 129 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03355326_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03355326_inc_T2", "arg2_id": "NCT03355326_inc_T1", "normalized": [] }, { "id": "NCT03355326_inc_R2", "type": "Has_value", "arg1_id": "NCT03355326_inc_T3", "arg2_id": "NCT03355326_inc_T4", "normalized": [] }, { "id": "NCT03355326_inc_R3", "type": "Has_temporal", "arg1_id": "NCT03355326_inc_T3", "arg2_id": "NCT03355326_inc_T5", "normalized": [] }, { "id": "NCT03355326_inc_R4", "type": "Has_value", "arg1_id": "NCT03355326_inc_T6", "arg2_id": "NCT03355326_inc_T7", "normalized": [] }, { "id": "NCT03355326_inc_R5", "type": "Has_temporal", "arg1_id": "NCT03355326_inc_T6", "arg2_id": "NCT03355326_inc_T8", "normalized": [] }, { "id": "NCT03355326_inc_R6", "type": "Has_index", "arg1_id": "NCT03355326_inc_T10", "arg2_id": "NCT03355326_inc_T12", "normalized": [] }, { "id": "NCT03355326_inc_R8", "type": "AND", "arg1_id": "NCT03355326_inc_T13", "arg2_id": "NCT03355326_inc_T9", "normalized": [] }, { "id": "NCT03355326_inc_R9", "type": "Has_temporal", "arg1_id": "NCT03355326_inc_T13", "arg2_id": "NCT03355326_inc_T10", "normalized": [] } ]

[ { "id": "NCT03355469_exc_text", "type": "exclusion", "text": [ "Morbidly obese patients (BMI >47 kg/m2) and overweight/lean patients (BMI <27 kg/m2)\nEvidence of type 1 diabetes and diabetics requiring insulin therapy.\nSubjects who have not been weight stable (>2 kg weight change in past 3 months)\nSubjects who have been recently active (>30 min of moderate/high intensity exercise, 2 times/week).\nSubjects who are smokers or who have quit smoking <5 years ago\nSubjects prescribed metformin or have taken metformin within 1 year.\nSubjects with abnormal estimated glomerular filtration rate (eGFR).\nHypertriglyceridemic (>400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects\nHypertensive (>160/100 mmHg)\nSubjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).\nSubjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety.\nPregnant (as evidenced by positive pregnancy test) or nursing women\nSubjects with contraindications to participation in an exercise training program\nCurrently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine)\nKnown hypersensitivity to perflutren (contained in Definity)\n" ], "offsets": [ [ 0, 1488 ] ] } ]

[ { "id": "NCT03355469_exc_T1", "type": "Condition", "text": [ "Morbidly obese" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T2", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 25, 28 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T3", "type": "Value", "text": [ ">47 kg/m2" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T4", "type": "Condition", "text": [ "overweight" ], "offsets": [ [ 44, 54 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T5", "type": "Condition", "text": [ "lean" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T6", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 70, 73 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T7", "type": "Value", "text": [ "<27 kg/m2" ], "offsets": [ [ 74, 83 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T8", "type": "Scope", "text": [ "BMI >47 kg/m2" ], "offsets": [ [ 25, 38 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T9", "type": "Scope", "text": [ "BMI <27 kg/m2" ], "offsets": [ [ 70, 83 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T10", "type": "Scope", "text": [ "overweight/lean" ], "offsets": [ [ 44, 59 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T11", "type": "Scope", "text": [ "overweight/lean patients (BMI <27 kg/m2)" ], "offsets": [ [ 44, 84 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T12", "type": "Condition", "text": [ "type 1 diabetes" ], "offsets": [ [ 97, 112 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T13", "type": "Condition", "text": [ "diabetics" ], "offsets": [ [ 117, 126 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T14", "type": "Qualifier", "text": [ "requiring insulin therapy" ], "offsets": [ [ 127, 152 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T15", "type": "Procedure", "text": [ "insulin therapy" ], "offsets": [ [ 137, 152 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T16", "type": "Drug", "text": [ "insulin" ], "offsets": [ [ 137, 144 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T17", "type": "Negation", "text": [ "not" ], "offsets": [ [ 172, 175 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T18", "type": "Observation", "text": [ "weight stable" ], "offsets": [ [ 181, 194 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T19", "type": "Value", "text": [ ">2 kg" ], "offsets": [ [ 196, 201 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T20", "type": "Measurement", "text": [ "weight change" ], "offsets": [ [ 202, 215 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T21", "type": "Temporal", "text": [ "in past 3 months" ], "offsets": [ [ 216, 232 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T22", "type": "Scope", "text": [ ">2 kg weight change in past 3 months" ], "offsets": [ [ 196, 232 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T23", "type": "Scope", "text": [ "not been weight stable" ], "offsets": [ [ 172, 194 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T24", "type": "Temporal", "text": [ "recently" ], "offsets": [ [ 257, 265 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T25", "type": "Condition", "text": [ "active" ], "offsets": [ [ 266, 272 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T26", "type": "Value", "text": [ ">30 min" ], "offsets": [ [ 274, 281 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T27", "type": "Measurement", "text": [ "moderate/high intensity exercise" ], "offsets": [ [ 285, 317 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T28", "type": "Multiplier", "text": [ "2 times/week" ], "offsets": [ [ 319, 331 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T29", "type": "Scope", "text": [ ">30 min of moderate/high intensity exercise, 2 times/week" ], "offsets": [ [ 274, 331 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T30", "type": "Scope", "text": [ "active (>30 min of moderate/high intensity exercise, 2 times/week)" ], "offsets": [ [ 266, 332 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T31", "type": "Observation", "text": [ "smokers" ], "offsets": [ [ 351, 358 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T32", "type": "Observation", "text": [ "quit smoking" ], "offsets": [ [ 371, 383 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T33", "type": "Temporal", "text": [ "<5 years ago" ], "offsets": [ [ 384, 396 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T34", "type": "Drug", "text": [ "metformin" ], "offsets": [ [ 417, 426 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T35", "type": "Drug", "text": [ "metformin" ], "offsets": [ [ 441, 450 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T36", "type": "Temporal", "text": [ "within 1 year" ], "offsets": [ [ 451, 464 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T37", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 480, 488 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T38", "type": "Measurement", "text": [ "estimated glomerular filtration rate (eGFR)" ], "offsets": [ [ 489, 532 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T39", "type": "Condition", "text": [ "Hypertriglyceridemic" ], "offsets": [ [ 534, 554 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T40", "type": "Value", "text": [ ">400 mg/dl" ], "offsets": [ [ 556, 566 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T41", "type": "Measurement", "text": [ "Hypertriglyceridemic" ], "offsets": [ [ 534, 554 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T42", "type": "Condition", "text": [ "hypercholesterolemic" ], "offsets": [ [ 572, 592 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T43", "type": "Measurement", "text": [ "cholesterol" ], "offsets": [ [ 577, 588 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T44", "type": "Value", "text": [ ">260 mg/dl" ], "offsets": [ [ 594, 604 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T45", "type": "Condition", "text": [ "Hypertensive" ], "offsets": [ [ 615, 627 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T46", "type": "Value", "text": [ ">160/100 mmHg" ], "offsets": [ [ 629, 642 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T47", "type": "Measurement", "text": [ "Hypertensive" ], "offsets": [ [ 615, 627 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T48", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 670, 681 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T49", "type": "Qualifier", "text": [ "that affect heart rate" ], "offsets": [ [ 682, 704 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T50", "type": "Qualifier", "text": [ "ct heart rate and", ".e. Ca" ], "offsets": [ [ 691, 708 ], [ 718, 724 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T51", "type": "Drug", "text": [ "Ca++ channel blockers" ], "offsets": [ [ 722, 743 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T52", "type": "Drug", "text": [ "nitrates" ], "offsets": [ [ 745, 753 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T53", "type": "Drug", "text": [ " beta", ".\nSubjec" ], "offsets": [ [ 764, 769 ], [ 779, 787 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T54", "type": "Drug", "text": [ "beta-blockers" ], "offsets": [ [ 765, 778 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T55", "type": "Scope", "text": [ "Ca++ channel blockers, nitrates, alpha- or beta-blockers" ], "offsets": [ [ 722, 778 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T56", "type": "Scope", "text": [ "medications that affect heart rate and rhythm" ], "offsets": [ [ 670, 715 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T57", "type": "Observation", "text": [ "history" ], "offsets": [ [ 797, 804 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T58", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 808, 819 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T59", "type": "Qualifier", "text": [ "metabolic" ], "offsets": [ [ 820, 829 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T60", "type": "Qualifier", "text": [ "cardiac" ], "offsets": [ [ 831, 838 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T61", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 840, 864 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T62", "type": "Qualifier", "text": [ "cerebrovascular" ], "offsets": [ [ 866, 881 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T63", "type": "Qualifier", "text": [ "hematological" ], "offsets": [ [ 883, 896 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T64", "type": "Qualifier", "text": [ "pulmonary" ], "offsets": [ [ 898, 907 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T65", "type": "Qualifier", "text": [ "gastrointestinal" ], "offsets": [ [ 909, 925 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T66", "type": "Qualifier", "text": [ "liver" ], "offsets": [ [ 927, 932 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T67", "type": "Qualifier", "text": [ "renal" ], "offsets": [ [ 934, 939 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T68", "type": "Qualifier", "text": [ "endocrine" ], "offsets": [ [ 944, 953 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T69", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 954, 961 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T70", "type": "Scope", "text": [ "metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine" ], "offsets": [ [ 820, 953 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T71", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 965, 971 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T73", "type": "Scope", "text": [ " heart failure, cerebro", " cancer that in " ], "offsets": [ [ 850, 873 ], [ 964, 980 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T74", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 1085, 1093 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T75", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 1120, 1134 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T76", "type": "Value", "text": [ "positive" ], "offsets": [ [ 1111, 1119 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T77", "type": "Observation", "text": [ "nursing" ], "offsets": [ [ 1139, 1146 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T78", "type": "Person", "text": [ "women" ], "offsets": [ [ 1147, 1152 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T79", "type": "Condition", "text": [ "contraindications" ], "offsets": [ [ 1167, 1184 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T80", "type": "Observation", "text": [ "participation in an exercise training program" ], "offsets": [ [ 1188, 1233 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T81", "type": "Drug", "text": [ "active weight suppression medication" ], "offsets": [ [ 1251, 1287 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T82", "type": "Drug", "text": [ "phentermine" ], "offsets": [ [ 1294, 1305 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T83", "type": "Drug", "text": [ "orlistat" ], "offsets": [ [ 1306, 1314 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T84", "type": "Drug", "text": [ "lorcaserin" ], "offsets": [ [ 1316, 1326 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T85", "type": "Drug", "text": [ "naltrexone-bupropion in combination" ], "offsets": [ [ 1328, 1363 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T86", "type": "Drug", "text": [ "liraglutide" ], "offsets": [ [ 1365, 1376 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T87", "type": "Drug", "text": [ "benzephetamine" ], "offsets": [ [ 1378, 1392 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T88", "type": "Drug", "text": [ "diethylpropion" ], "offsets": [ [ 1394, 1408 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T89", "type": "Drug", "text": [ "phendimetrazine" ], "offsets": [ [ 1410, 1425 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T90", "type": "Scope", "text": [ "phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine" ], "offsets": [ [ 1294, 1425 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T91", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1433, 1449 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T92", "type": "Drug", "text": [ "perflutren" ], "offsets": [ [ 1453, 1463 ] ], "normalized": [] }, { "id": "NCT03355469_exc_T93", "type": "Drug", "text": [ "Definity" ], "offsets": [ [ 1478, 1486 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03355469_exc_R1", "type": "Has_value", "arg1_id": "NCT03355469_exc_T2", "arg2_id": "NCT03355469_exc_T3", "normalized": [] }, { "id": "NCT03355469_exc_R2", "type": "Has_value", "arg1_id": "NCT03355469_exc_T6", "arg2_id": "NCT03355469_exc_T7", "normalized": [] }, { "id": "NCT03355469_exc_R3", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T1", "arg2_id": "NCT03355469_exc_T8", "normalized": [] }, { "id": "NCT03355469_exc_R4", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T10", "arg2_id": "NCT03355469_exc_T9", "normalized": [] }, { "id": "NCT03355469_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT03355469_exc_T13", "arg2_id": "NCT03355469_exc_T14", "normalized": [] }, { "id": "NCT03355469_exc_R9", "type": "Has_value", "arg1_id": "NCT03355469_exc_T20", "arg2_id": "NCT03355469_exc_T19", "normalized": [] }, { "id": "NCT03355469_exc_R10", "type": "Has_temporal", "arg1_id": "NCT03355469_exc_T20", "arg2_id": "NCT03355469_exc_T21", "normalized": [] }, { "id": "NCT03355469_exc_R8", "type": "Has_negation", "arg1_id": "NCT03355469_exc_T18", "arg2_id": "NCT03355469_exc_T17", "normalized": [] }, { "id": "NCT03355469_exc_R11", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T23", "arg2_id": "NCT03355469_exc_T22", "normalized": [] }, { "id": "NCT03355469_exc_R12", "type": "Has_value", "arg1_id": "NCT03355469_exc_T27", "arg2_id": "NCT03355469_exc_T26", "normalized": [] }, { "id": "NCT03355469_exc_R13", "type": "Has_multiplier", "arg1_id": "NCT03355469_exc_T27", "arg2_id": "NCT03355469_exc_T28", "normalized": [] }, { "id": "NCT03355469_exc_R14", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T25", "arg2_id": "NCT03355469_exc_T29", "normalized": [] }, { "id": "NCT03355469_exc_R15", "type": "Has_temporal", "arg1_id": "NCT03355469_exc_T30", "arg2_id": "NCT03355469_exc_T24", "normalized": [] }, { "id": "NCT03355469_exc_R16", "type": "Has_temporal", "arg1_id": "NCT03355469_exc_T32", "arg2_id": "NCT03355469_exc_T33", "normalized": [] }, { "id": "NCT03355469_exc_R17", "type": "Has_temporal", "arg1_id": "NCT03355469_exc_T35", "arg2_id": "NCT03355469_exc_T36", "normalized": [] }, { "id": "NCT03355469_exc_R18", "type": "Has_value", "arg1_id": "NCT03355469_exc_T38", "arg2_id": "NCT03355469_exc_T37", "normalized": [] }, { "id": "NCT03355469_exc_R19", "type": "Has_value", "arg1_id": "NCT03355469_exc_T41", "arg2_id": "NCT03355469_exc_T40", "normalized": [] }, { "id": "NCT03355469_exc_R21", "type": "Has_value", "arg1_id": "NCT03355469_exc_T43", "arg2_id": "NCT03355469_exc_T44", "normalized": [] }, { "id": "NCT03355469_exc_R23", "type": "Has_value", "arg1_id": "NCT03355469_exc_T47", "arg2_id": "NCT03355469_exc_T46", "normalized": [] }, { "id": "NCT03355469_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT03355469_exc_T48", "arg2_id": "NCT03355469_exc_T50", "normalized": [] }, { "id": "NCT03355469_exc_R26", "type": "Has_qualifier", "arg1_id": "NCT03355469_exc_T48", "arg2_id": "NCT03355469_exc_T49", "normalized": [] }, { "id": "NCT03355469_exc_R27", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T56", "arg2_id": "NCT03355469_exc_T55", "normalized": [] }, { "id": "NCT03355469_exc_R28", "type": "Has_scope", "arg1_id": "NCT03355469_exc_T73", "arg2_id": "NCT03355469_exc_T70", "normalized": [] }, { "id": "NCT03355469_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT03355469_exc_T73", "arg2_id": "NCT03355469_exc_T58", "normalized": [] }, { "id": "NCT03355469_exc_R30", "type": "Has_temporal", "arg1_id": "NCT03355469_exc_T73", "arg2_id": "NCT03355469_exc_T57", "normalized": [] }, { "id": "NCT03355469_exc_R31", "type": "Has_value", "arg1_id": "NCT03355469_exc_T75", "arg2_id": "NCT03355469_exc_T76", "normalized": [] }, { "id": "NCT03355469_exc_R32", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T74", "arg2_id": "NCT03355469_exc_T75", "normalized": [] }, { "id": "NCT03355469_exc_R34", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T81", "arg2_id": "NCT03355469_exc_T90", "normalized": [] }, { "id": "NCT03355469_exc_R35", "type": "Subsumes", "arg1_id": "NCT03355469_exc_T92", "arg2_id": "NCT03355469_exc_T93", "normalized": [] }, { "id": "NCT03355469_exc_R36", "type": "AND", "arg1_id": "NCT03355469_exc_T91", "arg2_id": "NCT03355469_exc_T92", "normalized": [] } ]

[ { "id": "NCT03355469_inc_text", "type": "inclusion", "text": [ "Male or female >40 and <70 years old.\nHas a body mass index >27 and <47 kg/m2.\nNot diagnosed with Type 2 diabetes.\nNot currently engaged in > 60 min/wk of exercise\nMeet at least 3 of 5 National Cholesterol Education Adult Treatment Panel III\nIncreased waist circumference (=102 cm in men; =88 cm in women)\nElevated triglycerides (=150 mg/dl), or on medication for treating the condition\nReduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women), or on medication for treating the condition\nHigh blood pressure (=130 mmHg systolic or =85mmHg diastolic), or on medication for treating the condition\nElevated fasting glucose (=100 mg/dl), or on medication for treating the condition\n" ], "offsets": [ [ 0, 684 ] ] } ]

[ { "id": "NCT03355469_inc_T1", "type": "Person", "text": [ "Male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T2", "type": "Person", "text": [ "female" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T3", "type": "Value", "text": [ ">40 and <70 years" ], "offsets": [ [ 15, 32 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T4", "type": "Person", "text": [ "old" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T5", "type": "Measurement", "text": [ "body mass index" ], "offsets": [ [ 44, 59 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T6", "type": "Value", "text": [ ">27 and <47 kg/m2" ], "offsets": [ [ 60, 77 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T7", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 79, 82 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T8", "type": "Condition", "text": [ "Type 2 diabetes" ], "offsets": [ [ 98, 113 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T9", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 115, 118 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T10", "type": "Observation", "text": [ "aged in >", "rcise\nMe" ], "offsets": [ [ 132, 141 ], [ 158, 166 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T11", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 119, 128 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T12", "type": "Value", "text": [ "> 60 min/wk" ], "offsets": [ [ 140, 151 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T13", "type": "Value", "text": [ "at least 3 of 5" ], "offsets": [ [ 169, 184 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T14", "type": "Measurement", "text": [ "National Cholesterol Education Adult Treatment Panel III" ], "offsets": [ [ 185, 241 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T15", "type": "Measurement", "text": [ "waist circumference" ], "offsets": [ [ 252, 271 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T16", "type": "Value", "text": [ "Increased" ], "offsets": [ [ 242, 251 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T17", "type": "Value", "text": [ "=102 cm" ], "offsets": [ [ 273, 280 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T18", "type": "Value", "text": [ "=88 cm" ], "offsets": [ [ 289, 295 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T19", "type": "Person", "text": [ "women" ], "offsets": [ [ 299, 304 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T20", "type": "Person", "text": [ "men" ], "offsets": [ [ 284, 287 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T21", "type": "Scope", "text": [ "=102 cm in men; =88 cm in women" ], "offsets": [ [ 273, 304 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T22", "type": "Measurement", "text": [ "triglycerides" ], "offsets": [ [ 315, 328 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T23", "type": "Value", "text": [ "Elevated" ], "offsets": [ [ 306, 314 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T24", "type": "Value", "text": [ "=150 mg/dl" ], "offsets": [ [ 330, 340 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T25", "type": "Drug", "text": [ "medication for treating" ], "offsets": [ [ 349, 372 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T26", "type": "Qualifier", "text": [ "triglycerides" ], "offsets": [ [ 315, 328 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T27", "type": "Value", "text": [ "Reduced" ], "offsets": [ [ 387, 394 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T28", "type": "Measurement", "text": [ "HDL-cholesterol" ], "offsets": [ [ 395, 410 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T29", "type": "Value", "text": [ "<40mg/dl" ], "offsets": [ [ 412, 420 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T30", "type": "Value", "text": [ "<50 mg/dl" ], "offsets": [ [ 429, 438 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T31", "type": "Person", "text": [ "women" ], "offsets": [ [ 442, 447 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T32", "type": "Person", "text": [ "men" ], "offsets": [ [ 424, 427 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T33", "type": "Scope", "text": [ "<40mg/dl in men, <50 mg/dl in women" ], "offsets": [ [ 412, 447 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T34", "type": "Drug", "text": [ "medication for treating" ], "offsets": [ [ 456, 479 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T35", "type": "Qualifier", "text": [ "HDL-cholesterol" ], "offsets": [ [ 395, 410 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T36", "type": "Value", "text": [ "High" ], "offsets": [ [ 494, 498 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T37", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 499, 513 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T38", "type": "Condition", "text": [ "High blood pressure" ], "offsets": [ [ 494, 513 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T39", "type": "Value", "text": [ "=130 mmHg systolic" ], "offsets": [ [ 515, 533 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T40", "type": "Value", "text": [ "=85mmHg diastolic" ], "offsets": [ [ 537, 554 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T41", "type": "Scope", "text": [ "=130 mmHg systolic or =85mmHg diastolic" ], "offsets": [ [ 515, 554 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T42", "type": "Drug", "text": [ "medication for treating" ], "offsets": [ [ 563, 586 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T43", "type": "Value", "text": [ "Elevated" ], "offsets": [ [ 601, 609 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T44", "type": "Measurement", "text": [ "fasting glucose" ], "offsets": [ [ 610, 625 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T45", "type": "Value", "text": [ "=100 mg/dl" ], "offsets": [ [ 627, 637 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T46", "type": "Condition", "text": [ "Elevated fasting glucose" ], "offsets": [ [ 601, 625 ] ], "normalized": [] }, { "id": "NCT03355469_inc_T47", "type": "Drug", "text": [ "medication for treating" ], "offsets": [ [ 646, 669 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03355469_inc_R1", "type": "Has_value", "arg1_id": "NCT03355469_inc_T4", "arg2_id": "NCT03355469_inc_T3", "normalized": [] }, { "id": "NCT03355469_inc_R2", "type": "Has_value", "arg1_id": "NCT03355469_inc_T5", "arg2_id": "NCT03355469_inc_T6", "normalized": [] }, { "id": "NCT03355469_inc_R3", "type": "Has_negation", "arg1_id": "NCT03355469_inc_T8", "arg2_id": "NCT03355469_inc_T7", "normalized": [] }, { "id": "NCT03355469_inc_R4", "type": "Has_temporal", "arg1_id": "NCT03355469_inc_T10", "arg2_id": "NCT03355469_inc_T11", "normalized": [] }, { "id": "NCT03355469_inc_R5", "type": "Has_value", "arg1_id": "NCT03355469_inc_T10", "arg2_id": "NCT03355469_inc_T12", "normalized": [] }, { "id": "NCT03355469_inc_R6", "type": "Has_negation", "arg1_id": "NCT03355469_inc_T10", "arg2_id": "NCT03355469_inc_T9", "normalized": [] }, { "id": "NCT03355469_inc_R7", "type": "Has_value", "arg1_id": "NCT03355469_inc_T14", "arg2_id": "NCT03355469_inc_T13", "normalized": [] }, { "id": "NCT03355469_inc_R8", "type": "Has_value", "arg1_id": "NCT03355469_inc_T15", "arg2_id": "NCT03355469_inc_T16", "normalized": [] }, { "id": "NCT03355469_inc_R9", "type": "Has_value", "arg1_id": "NCT03355469_inc_T19", "arg2_id": "NCT03355469_inc_T18", "normalized": [] }, { "id": "NCT03355469_inc_R10", "type": "Has_value", "arg1_id": "NCT03355469_inc_T20", "arg2_id": "NCT03355469_inc_T17", "normalized": [] }, { "id": "NCT03355469_inc_R11", "type": "Subsumes", "arg1_id": "NCT03355469_inc_T16", "arg2_id": "NCT03355469_inc_T21", "normalized": [] }, { "id": "NCT03355469_inc_R12", "type": "Has_value", "arg1_id": "NCT03355469_inc_T22", "arg2_id": "NCT03355469_inc_T23", "normalized": [] }, { "id": "NCT03355469_inc_R13", "type": "Subsumes", "arg1_id": "NCT03355469_inc_T23", "arg2_id": "NCT03355469_inc_T24", "normalized": [] }, { "id": "NCT03355469_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT03355469_inc_T25", "arg2_id": "NCT03355469_inc_T26", "normalized": [] }, { "id": "NCT03355469_inc_R15", "type": "Has_value", "arg1_id": "NCT03355469_inc_T28", "arg2_id": "NCT03355469_inc_T27", "normalized": [] }, { "id": "NCT03355469_inc_R16", "type": "Has_value", "arg1_id": "NCT03355469_inc_T31", "arg2_id": "NCT03355469_inc_T30", "normalized": [] }, { "id": "NCT03355469_inc_R17", "type": "Has_value", "arg1_id": "NCT03355469_inc_T32", "arg2_id": "NCT03355469_inc_T29", "normalized": [] }, { "id": "NCT03355469_inc_R18", "type": "Has_scope", "arg1_id": "NCT03355469_inc_T27", "arg2_id": "NCT03355469_inc_T33", "normalized": [] }, { "id": "NCT03355469_inc_R19", "type": "Has_qualifier", "arg1_id": "NCT03355469_inc_T34", "arg2_id": "NCT03355469_inc_T35", "normalized": [] }, { "id": "NCT03355469_inc_R20", "type": "Subsumes", "arg1_id": "NCT03355469_inc_T38", "arg2_id": "NCT03355469_inc_T37", "normalized": [] }, { "id": "NCT03355469_inc_R21", "type": "Subsumes", "arg1_id": "NCT03355469_inc_T36", "arg2_id": "NCT03355469_inc_T41", "normalized": [] }, { "id": "NCT03355469_inc_R22", "type": "AND", "arg1_id": "NCT03355469_inc_T42", "arg2_id": "NCT03355469_inc_T38", "normalized": [] }, { "id": "NCT03355469_inc_R23", "type": "Has_value", "arg1_id": "NCT03355469_inc_T44", "arg2_id": "NCT03355469_inc_T43", "normalized": [] }, { "id": "NCT03355469_inc_R24", "type": "Subsumes", "arg1_id": "NCT03355469_inc_T43", "arg2_id": "NCT03355469_inc_T45", "normalized": [] }, { "id": "NCT03355469_inc_R27", "type": "AND", "arg1_id": "NCT03355469_inc_T47", "arg2_id": "NCT03355469_inc_T46", "normalized": [] } ]

[ { "id": "NCT03356834_exc_text", "type": "exclusion", "text": [ "Co-infected with HCV, HIV or other viral hepatitis,\nDiagnosis of HCC\n" ], "offsets": [ [ 0, 69 ] ] } ]

[ { "id": "NCT03356834_exc_T1", "type": "Condition", "text": [ "HCV" ], "offsets": [ [ 17, 20 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T2", "type": "Temporal", "text": [ "Co-infected" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T3", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T4", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 29, 34 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T5", "type": "Condition", "text": [ "viral hepatitis" ], "offsets": [ [ 35, 50 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T6", "type": "Scope", "text": [ "HCV, HIV or other viral hepatitis" ], "offsets": [ [ 17, 50 ] ], "normalized": [] }, { "id": "NCT03356834_exc_T7", "type": "Condition", "text": [ "HCC" ], "offsets": [ [ 65, 68 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03356834_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03356834_exc_T5", "arg2_id": "NCT03356834_exc_T4", "normalized": [] }, { "id": "NCT03356834_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03356834_exc_T6", "arg2_id": "NCT03356834_exc_T2", "normalized": [] } ]

[ { "id": "NCT03356834_inc_text", "type": "inclusion", "text": [ "Chronic hepatitis B,\nAntiviral experienced,\nCurrently on long term TDF anti-HBV treatment,\nHBV DNA < 6 log IU/ml (LLOD)\nAble to sign the consent form of anticipating in the study\n" ], "offsets": [ [ 0, 179 ] ] } ]

[ { "id": "NCT03356834_inc_T1", "type": "Condition", "text": [ "Chronic hepatitis B" ], "offsets": [ [ 0, 19 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T2", "type": "Drug", "text": [ "Antiviral" ], "offsets": [ [ 21, 30 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T3", "type": "Mood", "text": [ "experienced" ], "offsets": [ [ 31, 42 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T4", "type": "Observation", "text": [ "experienced" ], "offsets": [ [ 31, 42 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T5", "type": "Drug", "text": [ "TDF" ], "offsets": [ [ 67, 70 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T6", "type": "Procedure", "text": [ "TDF anti-HBV treatment" ], "offsets": [ [ 67, 89 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T7", "type": "Multiplier", "text": [ "long term" ], "offsets": [ [ 57, 66 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T8", "type": "Condition", "text": [ "HBV" ], "offsets": [ [ 76, 79 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T9", "type": "Measurement", "text": [ "HBV DNA" ], "offsets": [ [ 91, 98 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T10", "type": "Value", "text": [ "< 6 log IU/ml" ], "offsets": [ [ 99, 112 ] ], "normalized": [] }, { "id": "NCT03356834_inc_T11", "type": "Qualifier", "text": [ "LLOD" ], "offsets": [ [ 114, 118 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03356834_inc_R1", "type": "Has_mood", "arg1_id": "NCT03356834_inc_T2", "arg2_id": "NCT03356834_inc_T3", "normalized": [] }, { "id": "NCT03356834_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT03356834_inc_T5", "arg2_id": "NCT03356834_inc_T7", "normalized": [] }, { "id": "NCT03356834_inc_R6", "type": "Has_value", "arg1_id": "NCT03356834_inc_T9", "arg2_id": "NCT03356834_inc_T10", "normalized": [] }, { "id": "NCT03356834_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT03356834_inc_T9", "arg2_id": "NCT03356834_inc_T11", "normalized": [] } ]

[ { "id": "NCT03360214_exc_text", "type": "exclusion", "text": [ "Allergy to narcotic medications\nIntake of any chronic opioids or pain medications preoperatively\n" ], "offsets": [ [ 0, 97 ] ] } ]

[ { "id": "NCT03360214_exc_T1", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T2", "type": "Drug", "text": [ "narcotic medications" ], "offsets": [ [ 11, 31 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T3", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 46, 53 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T4", "type": "Drug", "text": [ "opioids" ], "offsets": [ [ 54, 61 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T5", "type": "Qualifier", "text": [ "any" ], "offsets": [ [ 42, 45 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T6", "type": "Drug", "text": [ "pain medications" ], "offsets": [ [ 65, 81 ] ], "normalized": [] }, { "id": "NCT03360214_exc_T7", "type": "Temporal", "text": [ "preoperatively" ], "offsets": [ [ 82, 96 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03360214_exc_R1", "type": "AND", "arg1_id": "NCT03360214_exc_T1", "arg2_id": "NCT03360214_exc_T2", "normalized": [] }, { "id": "NCT03360214_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03360214_exc_T4", "arg2_id": "NCT03360214_exc_T5", "normalized": [] }, { "id": "NCT03360214_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT03360214_exc_T4", "arg2_id": "NCT03360214_exc_T3", "normalized": [] }, { "id": "NCT03360214_exc_R4", "type": "Has_temporal", "arg1_id": "NCT03360214_exc_T6", "arg2_id": "NCT03360214_exc_T7", "normalized": [] } ]

[ { "id": "NCT03360214_inc_text", "type": "inclusion", "text": [ "Subjects must be female\nSubjects must be 18 years or older\nSubjects must be undergoing unilateral or bilateral mastectomy with tissue expander reconstruction\n" ], "offsets": [ [ 0, 158 ] ] } ]

[ { "id": "NCT03360214_inc_T1", "type": "Person", "text": [ "female" ], "offsets": [ [ 17, 23 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T2", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 41, 58 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T3", "type": "Person", "text": [ "older" ], "offsets": [ [ 53, 58 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T4", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 87, 97 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T5", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 101, 110 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T6", "type": "Procedure", "text": [ "mastectomy" ], "offsets": [ [ 111, 121 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T7", "type": "Procedure", "text": [ "tissue expander reconstruction" ], "offsets": [ [ 127, 157 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T8", "type": "Scope", "text": [ "unilateral or bilateral" ], "offsets": [ [ 87, 110 ] ], "normalized": [] }, { "id": "NCT03360214_inc_T9", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 76, 86 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03360214_inc_R1", "type": "Has_value", "arg1_id": "NCT03360214_inc_T3", "arg2_id": "NCT03360214_inc_T2", "normalized": [] }, { "id": "NCT03360214_inc_R2", "type": "AND", "arg1_id": "NCT03360214_inc_T6", "arg2_id": "NCT03360214_inc_T7", "normalized": [] }, { "id": "NCT03360214_inc_R3", "type": "Has_scope", "arg1_id": "NCT03360214_inc_T6", "arg2_id": "NCT03360214_inc_T8", "normalized": [] }, { "id": "NCT03360214_inc_R4", "type": "Has_temporal", "arg1_id": "NCT03360214_inc_T6", "arg2_id": "NCT03360214_inc_T9", "normalized": [] } ]

[ { "id": "NCT03360981_exc_text", "type": "exclusion", "text": [ "acute myocardial infarction, heart failure, neoplastic disease, chronic diseases that may affect the inflammatory profile both systemic and epicardial (cancer, chronic intestinal inflammation, hepatitis, AIDS); life expectancy < 6 months, previous CABG and/or other open heart surgery intervention, acute coronary syndrome\n" ], "offsets": [ [ 0, 323 ] ] } ]

[ { "id": "NCT03360981_exc_T1", "type": "Condition", "text": [ "acute myocardial infarction" ], "offsets": [ [ 0, 27 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T2", "type": "Condition", "text": [ "heart failure" ], "offsets": [ [ 29, 42 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T3", "type": "Condition", "text": [ "neoplastic disease" ], "offsets": [ [ 44, 62 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T4", "type": "Condition", "text": [ "chronic diseases" ], "offsets": [ [ 64, 80 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T5", "type": "Qualifier", "text": [ "may affect the inflammatory profile" ], "offsets": [ [ 86, 121 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T6", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 127, 135 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T7", "type": "Qualifier", "text": [ "epicardial" ], "offsets": [ [ 140, 150 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T8", "type": "Scope", "text": [ "systemic and epicardial" ], "offsets": [ [ 127, 150 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T9", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 152, 158 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T10", "type": "Condition", "text": [ "chronic intestinal inflammation" ], "offsets": [ [ 160, 191 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T11", "type": "Condition", "text": [ "hepatitis" ], "offsets": [ [ 193, 202 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T12", "type": "Condition", "text": [ "AIDS" ], "offsets": [ [ 204, 208 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T13", "type": "Scope", "text": [ "cancer, chronic intestinal inflammation, hepatitis, AIDS" ], "offsets": [ [ 152, 208 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T14", "type": "Scope", "text": [ "chronic diseases that may affect the inflammatory profile both systemic and epicardial" ], "offsets": [ [ 64, 150 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T15", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 211, 226 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T16", "type": "Value", "text": [ "< 6 months" ], "offsets": [ [ 227, 237 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T17", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 248, 252 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T18", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 239, 247 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T19", "type": "Procedure", "text": [ "open heart surgery intervention" ], "offsets": [ [ 266, 297 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T20", "type": "Condition", "text": [ "acute coronary syndrome" ], "offsets": [ [ 299, 322 ] ], "normalized": [] }, { "id": "NCT03360981_exc_T21", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 260, 265 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03360981_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03360981_exc_T4", "arg2_id": "NCT03360981_exc_T5", "normalized": [] }, { "id": "NCT03360981_exc_R2", "type": "Has_scope", "arg1_id": "NCT03360981_exc_T4", "arg2_id": "NCT03360981_exc_T8", "normalized": [] }, { "id": "NCT03360981_exc_R3", "type": "Subsumes", "arg1_id": "NCT03360981_exc_T14", "arg2_id": "NCT03360981_exc_T13", "normalized": [] }, { "id": "NCT03360981_exc_R4", "type": "Has_value", "arg1_id": "NCT03360981_exc_T15", "arg2_id": "NCT03360981_exc_T16", "normalized": [] }, { "id": "NCT03360981_exc_R5", "type": "Has_temporal", "arg1_id": "NCT03360981_exc_T17", "arg2_id": "NCT03360981_exc_T18", "normalized": [] }, { "id": "NCT03360981_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT03360981_exc_T19", "arg2_id": "NCT03360981_exc_T21", "normalized": [] } ]

[ { "id": "NCT03360981_inc_text", "type": "inclusion", "text": [ "patients aged >18, <75, left ventricle ejection fraction (LVEF) >50%, multivessel coronary disease detected by coronarography, indication to receive a CABG, stable CAD. All diabetics and non diabetics.\n" ], "offsets": [ [ 0, 202 ] ] } ]

[ { "id": "NCT03360981_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T2", "type": "Value", "text": [ ">18, <75" ], "offsets": [ [ 14, 22 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T3", "type": "Measurement", "text": [ "left ventricle ejection fraction" ], "offsets": [ [ 24, 56 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T4", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 58, 62 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T5", "type": "Value", "text": [ ">50%" ], "offsets": [ [ 64, 68 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T6", "type": "Condition", "text": [ "multivessel coronary disease" ], "offsets": [ [ 70, 98 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T7", "type": "Procedure", "text": [ "coronarography" ], "offsets": [ [ 111, 125 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T8", "type": "Procedure", "text": [ "CABG" ], "offsets": [ [ 151, 155 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T9", "type": "Mood", "text": [ "indication to receive" ], "offsets": [ [ 127, 148 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T10", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 157, 163 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T11", "type": "Condition", "text": [ "CAD" ], "offsets": [ [ 164, 167 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T12", "type": "Condition", "text": [ "diabetics" ], "offsets": [ [ 173, 182 ] ], "normalized": [] }, { "id": "NCT03360981_inc_T13", "type": "Condition", "text": [ "non diabetics" ], "offsets": [ [ 187, 200 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03360981_inc_R1", "type": "Has_value", "arg1_id": "NCT03360981_inc_T1", "arg2_id": "NCT03360981_inc_T2", "normalized": [] }, { "id": "NCT03360981_inc_R2", "type": "Subsumes", "arg1_id": "NCT03360981_inc_T3", "arg2_id": "NCT03360981_inc_T4", "normalized": [] }, { "id": "NCT03360981_inc_R3", "type": "Has_value", "arg1_id": "NCT03360981_inc_T3", "arg2_id": "NCT03360981_inc_T5", "normalized": [] }, { "id": "NCT03360981_inc_R4", "type": "Has_mood", "arg1_id": "NCT03360981_inc_T8", "arg2_id": "NCT03360981_inc_T9", "normalized": [] }, { "id": "NCT03360981_inc_R5", "type": "AND", "arg1_id": "NCT03360981_inc_T7", "arg2_id": "NCT03360981_inc_T6", "normalized": [] }, { "id": "NCT03360981_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT03360981_inc_T11", "arg2_id": "NCT03360981_inc_T10", "normalized": [] } ]

[ { "id": "NCT03363295_exc_text", "type": "exclusion", "text": [ "Diabetic patients\nPatients with any macular changes prior to the surgery (epiretinal membranes, age macular disease, macular edema...)\nPatients who had any complication during phacoemulsification surgery\n" ], "offsets": [ [ 0, 204 ] ] } ]

[ { "id": "NCT03363295_exc_T1", "type": "Condition", "text": [ "Diabetic" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T2", "type": "Condition", "text": [ "macular changes" ], "offsets": [ [ 36, 51 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T3", "type": "Qualifier", "text": [ "any" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T4", "type": "Temporal", "text": [ "prior to the surgery" ], "offsets": [ [ 52, 72 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T5", "type": "Reference_point", "text": [ "the surgery" ], "offsets": [ [ 61, 72 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T6", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 65, 72 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T7", "type": "Condition", "text": [ "epiretinal membranes" ], "offsets": [ [ 74, 94 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T8", "type": "Condition", "text": [ "age macular disease" ], "offsets": [ [ 96, 115 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T9", "type": "Condition", "text": [ "macular edema" ], "offsets": [ [ 117, 130 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T10", "type": "Scope", "text": [ "epiretinal membranes, age macular disease, macular edema" ], "offsets": [ [ 74, 130 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T11", "type": "Qualifier", "text": [ "any" ], "offsets": [ [ 152, 155 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T12", "type": "Condition", "text": [ "complication" ], "offsets": [ [ 156, 168 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T13", "type": "Procedure", "text": [ "phacoemulsification surgery" ], "offsets": [ [ 176, 203 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T14", "type": "Temporal", "text": [ "during phacoemulsification surgery" ], "offsets": [ [ 169, 203 ] ], "normalized": [] }, { "id": "NCT03363295_exc_T15", "type": "Reference_point", "text": [ "phacoemulsification surgery" ], "offsets": [ [ 176, 203 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03363295_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03363295_exc_T2", "arg2_id": "NCT03363295_exc_T3", "normalized": [] }, { "id": "NCT03363295_exc_R2", "type": "Has_index", "arg1_id": "NCT03363295_exc_T4", "arg2_id": "NCT03363295_exc_T5", "normalized": [] }, { "id": "NCT03363295_exc_R4", "type": "Has_temporal", "arg1_id": "NCT03363295_exc_T2", "arg2_id": "NCT03363295_exc_T4", "normalized": [] }, { "id": "NCT03363295_exc_R5", "type": "Subsumes", "arg1_id": "NCT03363295_exc_T2", "arg2_id": "NCT03363295_exc_T10", "normalized": [] }, { "id": "NCT03363295_exc_R6", "type": "Has_index", "arg1_id": "NCT03363295_exc_T14", "arg2_id": "NCT03363295_exc_T15", "normalized": [] }, { "id": "NCT03363295_exc_R8", "type": "Has_temporal", "arg1_id": "NCT03363295_exc_T12", "arg2_id": "NCT03363295_exc_T14", "normalized": [] }, { "id": "NCT03363295_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT03363295_exc_T12", "arg2_id": "NCT03363295_exc_T11", "normalized": [] } ]

[ { "id": "NCT03363295_inc_text", "type": "inclusion", "text": [ "Any patients that will be submitted to phacoemulsification surgery in the Hospital de Clinicas of State University of Campinas (BRAZIL)\nPatients over 18 years old\nPatients who are able to perform SD-OCT\nPatients who sign the consent form\n" ], "offsets": [ [ 0, 238 ] ] } ]

[ { "id": "NCT03363295_inc_T1", "type": "Procedure", "text": [ "phacoemulsification surgery" ], "offsets": [ [ 39, 66 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T2", "type": "Mood", "text": [ "will be submitted to" ], "offsets": [ [ 18, 38 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T3", "type": "Visit", "text": [ "Hospital de Clinicas of State University of Campinas (BRAZIL)" ], "offsets": [ [ 74, 135 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T4", "type": "Value", "text": [ "over 18 years" ], "offsets": [ [ 145, 158 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T5", "type": "Person", "text": [ "old" ], "offsets": [ [ 159, 162 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T6", "type": "Mood", "text": [ "able to perform" ], "offsets": [ [ 180, 195 ] ], "normalized": [] }, { "id": "NCT03363295_inc_T7", "type": "Procedure", "text": [ "SD-OCT" ], "offsets": [ [ 196, 202 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03363295_inc_R1", "type": "Has_mood", "arg1_id": "NCT03363295_inc_T1", "arg2_id": "NCT03363295_inc_T2", "normalized": [] }, { "id": "NCT03363295_inc_R2", "type": "AND", "arg1_id": "NCT03363295_inc_T1", "arg2_id": "NCT03363295_inc_T3", "normalized": [] }, { "id": "NCT03363295_inc_R3", "type": "Has_value", "arg1_id": "NCT03363295_inc_T5", "arg2_id": "NCT03363295_inc_T4", "normalized": [] }, { "id": "NCT03363295_inc_R4", "type": "Has_mood", "arg1_id": "NCT03363295_inc_T7", "arg2_id": "NCT03363295_inc_T6", "normalized": [] } ]

[ { "id": "NCT03364036_exc_text", "type": "exclusion", "text": [ "Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.\nPositive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).\nCurrent or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.\nCurrently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.\nHistory of tuberculosis , presence of active tuberculosis, or latent tuberculosis\nEvidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).\nActive malignancy or history of malignancy.\nOther protocol defined exclusion criteria could apply.\n" ], "offsets": [ [ 0, 873 ] ] } ]

[ { "id": "NCT03364036_exc_T1", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T2", "type": "Drug", "text": [ "drugs" ], "offsets": [ [ 21, 26 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T3", "type": "Drug", "text": [ "fingolimod" ], "offsets": [ [ 35, 45 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T4", "type": "Drug", "text": [ "natalizumab" ], "offsets": [ [ 47, 58 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T5", "type": "Drug", "text": [ "alemtuzumab" ], "offsets": [ [ 60, 71 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T6", "type": "Drug", "text": [ "mitoxantrone" ], "offsets": [ [ 73, 85 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T7", "type": "Drug", "text": [ "ocrelizumab" ], "offsets": [ [ 90, 101 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T8", "type": "Scope", "text": [ "fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab" ], "offsets": [ [ 35, 101 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T9", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 103, 111 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T10", "type": "Measurement", "text": [ "epatitis C", "urface antigen test" ], "offsets": [ [ 113, 123 ], [ 140, 159 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T11", "type": "Measurement", "text": [ "hepatitis B surface antigen test" ], "offsets": [ [ 127, 159 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T12", "type": "Measurement", "text": [ "hepatits B core antibody test" ], "offsets": [ [ 167, 196 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T13", "type": "Qualifier", "text": [ "immunoglobulin G (IgG)" ], "offsets": [ [ 201, 223 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T14", "type": "Qualifier", "text": [ "immunoglobulin M (IgM)" ], "offsets": [ [ 231, 253 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T15", "type": "Scope", "text": [ "immunoglobulin G (IgG) and/or immunoglobulin M (IgM)" ], "offsets": [ [ 201, 253 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T16", "type": "Scope", "text": [ "hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM)" ], "offsets": [ [ 112, 253 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T17", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 255, 262 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T18", "type": "Temporal", "text": [ "previous history" ], "offsets": [ [ 266, 282 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T20", "type": "Condition", "text": [ "immune deficiency disorders" ], "offsets": [ [ 286, 313 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T21", "type": "Measurement", "text": [ "human immunodeficiency virus (HIV)" ], "offsets": [ [ 335, 369 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T22", "type": "Value", "text": [ "positive" ], "offsets": [ [ 326, 334 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T19", "type": "Scope", "text": [ "Current or previous history" ], "offsets": [ [ 255, 282 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T23", "type": "Procedure", "text": [ "unosuppressive or", "rapy wi" ], "offsets": [ [ 401, 418 ], [ 439, 446 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T24", "type": "Procedure", "text": [ "myelosuppressive therapy" ], "offsets": [ [ 419, 443 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T25", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 378, 387 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T26", "type": "Drug", "text": [ "monoclonal antibodies" ], "offsets": [ [ 463, 484 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T27", "type": "Drug", "text": [ "methotrexate" ], "offsets": [ [ 486, 498 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T28", "type": "Drug", "text": [ "cyclophosphamide" ], "offsets": [ [ 500, 516 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T29", "type": "Drug", "text": [ "cyclosporine" ], "offsets": [ [ 518, 530 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T30", "type": "Drug", "text": [ "azathioprine" ], "offsets": [ [ 534, 546 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T31", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 566, 581 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T32", "type": "Multiplier", "text": [ "chronic use" ], "offsets": [ [ 551, 562 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T33", "type": "Scope", "text": [ "monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids" ], "offsets": [ [ 463, 581 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T34", "type": "Scope", "text": [ "immunosuppressive or myelosuppressive therapy" ], "offsets": [ [ 398, 443 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T35", "type": "Procedure", "text": [ "tuberculosis" ], "offsets": [ [ 594, 606 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T36", "type": "Procedure", "text": [ "tuberculosis" ], "offsets": [ [ 628, 640 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T37", "type": "Procedure", "text": [ "tuberculosis" ], "offsets": [ [ 652, 664 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T38", "type": "Qualifier", "text": [ "latent" ], "offsets": [ [ 645, 651 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T39", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 621, 627 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T40", "type": "Observation", "text": [ "History" ], "offsets": [ [ 583, 590 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T41", "type": "Condition", "text": [ "Progressive Multifocal Leukoencephalopathy (PML)" ], "offsets": [ [ 688, 736 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T42", "type": "Procedure", "text": [ "Magnetic Resonance Imaging (MRI)" ], "offsets": [ [ 740, 772 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T43", "type": "Mood", "text": [ "Evidence" ], "offsets": [ [ 665, 673 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T44", "type": "Mood", "text": [ "suspect" ], "offsets": [ [ 677, 684 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T45", "type": "Scope", "text": [ "Evidence or suspect" ], "offsets": [ [ 665, 684 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T46", "type": "Observation", "text": [ "history" ], "offsets": [ [ 795, 802 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T47", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 806, 816 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T48", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 781, 791 ] ], "normalized": [] }, { "id": "NCT03364036_exc_T49", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 774, 780 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03364036_exc_R1", "type": "Subsumes", "arg1_id": "NCT03364036_exc_T2", "arg2_id": "NCT03364036_exc_T8", "normalized": [] }, { "id": "NCT03364036_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03364036_exc_T2", "arg2_id": "NCT03364036_exc_T1", "normalized": [] }, { "id": "NCT03364036_exc_R3", "type": "Has_scope", "arg1_id": "NCT03364036_exc_T12", "arg2_id": "NCT03364036_exc_T15", "normalized": [] }, { "id": "NCT03364036_exc_R4", "type": "Has_value", "arg1_id": "NCT03364036_exc_T16", "arg2_id": "NCT03364036_exc_T9", "normalized": [] }, { "id": "NCT03364036_exc_R5", "type": "Has_value", "arg1_id": "NCT03364036_exc_T21", "arg2_id": "NCT03364036_exc_T22", "normalized": [] }, { "id": "NCT03364036_exc_R6", "type": "Subsumes", "arg1_id": "NCT03364036_exc_T20", "arg2_id": "NCT03364036_exc_T21", "normalized": [] }, { "id": "NCT03364036_exc_R7", "type": "Has_scope", "arg1_id": "NCT03364036_exc_T20", "arg2_id": "NCT03364036_exc_T19", "normalized": [] }, { "id": "NCT03364036_exc_R8", "type": "Has_multiplier", "arg1_id": "NCT03364036_exc_T31", "arg2_id": "NCT03364036_exc_T32", "normalized": [] }, { "id": "NCT03364036_exc_R9", "type": "Subsumes", "arg1_id": "NCT03364036_exc_T34", "arg2_id": "NCT03364036_exc_T33", "normalized": [] }, { "id": "NCT03364036_exc_R10", "type": "Has_temporal", "arg1_id": "NCT03364036_exc_T34", "arg2_id": "NCT03364036_exc_T25", "normalized": [] }, { "id": "NCT03364036_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT03364036_exc_T36", "arg2_id": "NCT03364036_exc_T39", "normalized": [] }, { "id": "NCT03364036_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT03364036_exc_T37", "arg2_id": "NCT03364036_exc_T38", "normalized": [] }, { "id": "NCT03364036_exc_R13", "type": "Has_temporal", "arg1_id": "NCT03364036_exc_T35", "arg2_id": "NCT03364036_exc_T40", "normalized": [] }, { "id": "NCT03364036_exc_R14", "type": "AND", "arg1_id": "NCT03364036_exc_T42", "arg2_id": "NCT03364036_exc_T41", "normalized": [] }, { "id": "NCT03364036_exc_R15", "type": "Has_scope", "arg1_id": "NCT03364036_exc_T41", "arg2_id": "NCT03364036_exc_T45", "normalized": [] }, { "id": "NCT03364036_exc_R16", "type": "Has_temporal", "arg1_id": "NCT03364036_exc_T47", "arg2_id": "NCT03364036_exc_T46", "normalized": [] }, { "id": "NCT03364036_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT03364036_exc_T48", "arg2_id": "NCT03364036_exc_T49", "normalized": [] } ]

[ { "id": "NCT03364036_inc_text", "type": "inclusion", "text": [ "Highly active RMS as defined by:\nOne relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)\nTwo or more relapses in the previous year, whether on DMD treatment or not.\nExpanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.\nOther protocol defined inclusion criteria could apply.\n" ], "offsets": [ [ 0, 399 ] ] } ]

[ { "id": "NCT03364036_inc_T1", "type": "Qualifier", "text": [ "Highly active" ], "offsets": [ [ 0, 13 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T2", "type": "Condition", "text": [ "RMS" ], "offsets": [ [ 14, 17 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T4", "type": "Multiplier", "text": [ "One" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T5", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 37, 44 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T6", "type": "Temporal", "text": [ "in the previous year" ], "offsets": [ [ 45, 65 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T7", "type": "Multiplier", "text": [ "at least 1" ], "offsets": [ [ 70, 80 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T8", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 101, 107 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T9", "type": "Qualifier", "text": [ "T1 Gadolinium (Gd)+" ], "offsets": [ [ 81, 100 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T10", "type": "Multiplier", "text": [ "9 or more" ], "offsets": [ [ 111, 120 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T11", "type": "Condition", "text": [ "T2 lesions" ], "offsets": [ [ 121, 131 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T12", "type": "Temporal", "text": [ "while on therapy" ], "offsets": [ [ 133, 149 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T13", "type": "Reference_point", "text": [ "therapy" ], "offsets": [ [ 142, 149 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T14", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 142, 149 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T15", "type": "Drug", "text": [ "disease modifying drugs (DMDs)" ], "offsets": [ [ 161, 191 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T16", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 155, 160 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T17", "type": "Scope", "text": [ "One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions" ], "offsets": [ [ 33, 131 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T18", "type": "Multiplier", "text": [ "Two or more" ], "offsets": [ [ 192, 203 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T19", "type": "Condition", "text": [ "relapses" ], "offsets": [ [ 204, 212 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T20", "type": "Temporal", "text": [ "in the previous year" ], "offsets": [ [ 213, 233 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T21", "type": "Measurement", "text": [ "Expanded Disability Status Scale (EDSS) score" ], "offsets": [ [ 268, 313 ] ], "normalized": [] }, { "id": "NCT03364036_inc_T22", "type": "Value", "text": [ "less than equals to (<=) 5.0" ], "offsets": [ [ 314, 342 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03364036_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03364036_inc_T2", "arg2_id": "NCT03364036_inc_T1", "normalized": [] }, { "id": "NCT03364036_inc_R2", "type": "Has_temporal", "arg1_id": "NCT03364036_inc_T5", "arg2_id": "NCT03364036_inc_T6", "normalized": [] }, { "id": "NCT03364036_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT03364036_inc_T5", "arg2_id": "NCT03364036_inc_T4", "normalized": [] }, { "id": "NCT03364036_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03364036_inc_T8", "arg2_id": "NCT03364036_inc_T9", "normalized": [] }, { "id": "NCT03364036_inc_R5", "type": "Has_index", "arg1_id": "NCT03364036_inc_T12", "arg2_id": "NCT03364036_inc_T13", "normalized": [] }, { "id": "NCT03364036_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT03364036_inc_T11", "arg2_id": "NCT03364036_inc_T10", "normalized": [] }, { "id": "NCT03364036_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT03364036_inc_T8", "arg2_id": "NCT03364036_inc_T7", "normalized": [] }, { "id": "NCT03364036_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT03364036_inc_T15", "arg2_id": "NCT03364036_inc_T16", "normalized": [] }, { "id": "NCT03364036_inc_R10", "type": "Has_temporal", "arg1_id": "NCT03364036_inc_T17", "arg2_id": "NCT03364036_inc_T12", "normalized": [] }, { "id": "NCT03364036_inc_R11", "type": "AND", "arg1_id": "NCT03364036_inc_T14", "arg2_id": "NCT03364036_inc_T15", "normalized": [] }, { "id": "NCT03364036_inc_R12", "type": "Has_temporal", "arg1_id": "NCT03364036_inc_T19", "arg2_id": "NCT03364036_inc_T20", "normalized": [] }, { "id": "NCT03364036_inc_R13", "type": "Has_multiplier", "arg1_id": "NCT03364036_inc_T19", "arg2_id": "NCT03364036_inc_T18", "normalized": [] }, { "id": "NCT03364036_inc_R14", "type": "Has_value", "arg1_id": "NCT03364036_inc_T21", "arg2_id": "NCT03364036_inc_T22", "normalized": [] } ]

[ { "id": "NCT03366779_exc_text", "type": "exclusion", "text": [ "Spondylolisthesis Grade II or higher.\nSubject requires uni or bilateral facetectomy to treat leg/back pain.\nSubject has back or non-radicular leg pain of unknown etiology.\nPrior surgery at the index lumbar level.\nSubject requiring a spine DEXA (i.e., patients with SCORE of = 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.\nSubject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.\nSubject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.\nSubject has scoliosis of greater than ten (10) degrees (both angular and rotational).\nAny metabolic disease bone disease that has not been stabilized for at least three months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder, etc.).\nSubject has an active infection either systemic or local.\nSubject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.\nSubject has severe arterial insufficiency of the legs (Screening on physical examination= patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other peripheral vascular disease).\nSubject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.\nSubject has insulin-dependent diabetes mellitus.\nSubject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).\nSubject has been diagnosed with active hepatitis, AIDS, or HIV.\nSubject has been diagnosed with rheumatoid arthritis or other autoimmune disease.\nSubject has a known allergy to titanium, polyethylene or polyester materials.\nSubject is pregnant or interested in becoming pregnant in the next two (2) years.\nSubject has active tuberculosis or has had tuberculosis in the past three (3) years.\nSubject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.\nSubject is immunologically suppressed, received steroids >1 month over the past year.\nCurrently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.\nSubject has a current chemical/alcohol dependency or significant psychosocial disturbance.\nSubject has a life expectancy of less than three (3) years.\nSubject is currently involved in another investigational study.\nSubject is incarcerated.\n" ], "offsets": [ [ 0, 3065 ] ] } ]

[ { "id": "NCT03366779_exc_T1", "type": "Condition", "text": [ "Spondylolisthesis" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T2", "type": "Measurement", "text": [ "Grade" ], "offsets": [ [ 18, 23 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T3", "type": "Value", "text": [ "II or higher" ], "offsets": [ [ 24, 36 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T4", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 62, 71 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T5", "type": "Procedure", "text": [ "facetectomy" ], "offsets": [ [ 72, 83 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T6", "type": "Qualifier", "text": [ "uni" ], "offsets": [ [ 55, 58 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T7", "type": "Condition", "text": [ "back pain" ], "offsets": [ [ 97, 106 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T8", "type": "Condition", "text": [ "ain.", "eg/" ], "offsets": [ [ 103, 107 ], [ 94, 97 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T9", "type": "Scope", "text": [ "uni or bilateral" ], "offsets": [ [ 55, 71 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T10", "type": "Scope", "text": [ "leg/back pain" ], "offsets": [ [ 93, 106 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T11", "type": "Condition", "text": [ "non-radicular leg pain" ], "offsets": [ [ 128, 150 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T12", "type": "Condition", "text": [ "ck o", "in o" ], "offsets": [ [ 122, 126 ], [ 148, 152 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T13", "type": "Qualifier", "text": [ "unknown etiology" ], "offsets": [ [ 154, 170 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T14", "type": "Scope", "text": [ "back or non-radicular leg pain" ], "offsets": [ [ 120, 150 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T15", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 178, 185 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T16", "type": "Qualifier", "text": [ "index lumbar level" ], "offsets": [ [ 193, 211 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T17", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 172, 177 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T18", "type": "Procedure", "text": [ "spine DEXA" ], "offsets": [ [ 233, 243 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T19", "type": "Measurement", "text": [ "SCORE" ], "offsets": [ [ 265, 270 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T20", "type": "Value", "text": [ "= 6" ], "offsets": [ [ 274, 277 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T21", "type": "Measurement", "text": [ "T Score" ], "offsets": [ [ 286, 293 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T22", "type": "Value", "text": [ "less than -2.0" ], "offsets": [ [ 294, 308 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T23", "type": "Qualifier", "text": [ "index level" ], "offsets": [ [ 316, 327 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T24", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 221, 230 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T25", "type": "Condition", "text": [ "herniation" ], "offsets": [ [ 349, 359 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T26", "type": "Qualifier", "text": [ "L5/S1" ], "offsets": [ [ 363, 368 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T27", "type": "Measurement", "text": [ "average T score" ], "offsets": [ [ 374, 389 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T28", "type": "Qualifier", "text": [ "L1-L4" ], "offsets": [ [ 393, 398 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T30", "type": "Scope", "text": [ "herniation at L5/S1" ], "offsets": [ [ 349, 368 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T31", "type": "Condition", "text": [ "clinically compromised vertebral bodies" ], "offsets": [ [ 426, 465 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T32", "type": "Qualifier", "text": [ "index level(s)" ], "offsets": [ [ 473, 487 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T33", "type": "Condition", "text": [ "infectious pathology" ], "offsets": [ [ 536, 556 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T34", "type": "Condition", "text": [ "olic, or", "logy.\nSub" ], "offsets": [ [ 527, 535 ], [ 552, 561 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T35", "type": "Condition", "text": [ "astic, met", "logy.\nSub" ], "offsets": [ [ 515, 525 ], [ 552, 561 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T36", "type": "Condition", "text": [ "atic, neo", "logy.\nSub" ], "offsets": [ [ 504, 513 ], [ 552, 561 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T37", "type": "Scope", "text": [ "traumatic, neoplastic, metabolic, or infectious pathology" ], "offsets": [ [ 499, 556 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T38", "type": "Condition", "text": [ "fractures of the vertebra" ], "offsets": [ [ 591, 616 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T39", "type": "Multiplier", "text": [ "multiple" ], "offsets": [ [ 620, 628 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T40", "type": "Condition", "text": [ "fractures of the vertebra" ], "offsets": [ [ 629, 654 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T41", "type": "Condition", "text": [ "res of the verte", "ubj" ], "offsets": [ [ 635, 651 ], [ 664, 667 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T42", "type": "Scope", "text": [ "fractures of the vertebra or hip" ], "offsets": [ [ 629, 661 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T43", "type": "Qualifier", "text": [ "pathologic" ], "offsets": [ [ 580, 590 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T44", "type": "Condition", "text": [ "scoliosis" ], "offsets": [ [ 675, 684 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T45", "type": "Qualifier", "text": [ "greater than ten (10) degrees" ], "offsets": [ [ 688, 717 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T46", "type": "Qualifier", "text": [ "angular" ], "offsets": [ [ 724, 731 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T47", "type": "Qualifier", "text": [ "rotational" ], "offsets": [ [ 736, 746 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T48", "type": "Scope", "text": [ "angular and rotational" ], "offsets": [ [ 724, 746 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T49", "type": "Condition", "text": [ "metabolic disease" ], "offsets": [ [ 753, 770 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T50", "type": "Observation", "text": [ "been stabilized" ], "offsets": [ [ 797, 812 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T51", "type": "Temporal", "text": [ "for at least three months" ], "offsets": [ [ 813, 838 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T52", "type": "Condition", "text": [ "Paget's disease" ], "offsets": [ [ 846, 861 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T53", "type": "Condition", "text": [ "osteomalacia" ], "offsets": [ [ 863, 875 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T54", "type": "Condition", "text": [ "osteogenesis imperfecta" ], "offsets": [ [ 877, 900 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T55", "type": "Condition", "text": [ "thyroid" ], "offsets": [ [ 902, 909 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T56", "type": "Condition", "text": [ "parathyroid gland disorder" ], "offsets": [ [ 917, 943 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T57", "type": "Scope", "text": [ "Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder" ], "offsets": [ [ 846, 943 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T58", "type": "Negation", "text": [ "not" ], "offsets": [ [ 793, 796 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T59", "type": "Condition", "text": [ "bone disease" ], "offsets": [ [ 771, 783 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T60", "type": "Scope", "text": [ "metabolic disease bone disease" ], "offsets": [ [ 753, 783 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T61", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 974, 983 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T62", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 967, 973 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T63", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 991, 999 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T64", "type": "Qualifier", "text": [ "local" ], "offsets": [ [ 1003, 1008 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T65", "type": "Scope", "text": [ "systemic or local" ], "offsets": [ [ 991, 1008 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T66", "type": "Condition", "text": [ "cauda equina syndrome" ], "offsets": [ [ 1022, 1043 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T67", "type": "Condition", "text": [ " bowel/bladder ", "n.\nSubject" ], "offsets": [ [ 1057, 1072 ], [ 1082, 1092 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T68", "type": "Condition", "text": [ " bowel/bl", "sfunction.\nSubject" ], "offsets": [ [ 1057, 1066 ], [ 1074, 1092 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T69", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1097, 1103 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T70", "type": "Condition", "text": [ "arterial insufficiency" ], "offsets": [ [ 1104, 1126 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T71", "type": "Qualifier", "text": [ "legs" ], "offsets": [ [ 1134, 1138 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T72", "type": "Condition", "text": [ "diminution or absence of dorsalis pedis" ], "offsets": [ [ 1189, 1228 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T73", "type": "Condition", "text": [ "or absence of dorsalis p", "ibialis pulses. If dimini" ], "offsets": [ [ 1200, 1224 ], [ 1243, 1268 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T74", "type": "Procedure", "text": [ "arterial ultrasound" ], "offsets": [ [ 1305, 1324 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T75", "type": "Procedure", "text": [ "vascular plethysmography" ], "offsets": [ [ 1342, 1366 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T76", "type": "Measurement", "text": [ "absolute arterial pressure" ], "offsets": [ [ 1375, 1401 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T77", "type": "Value", "text": [ "below 50mm of Hg" ], "offsets": [ [ 1405, 1421 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T78", "type": "Qualifier", "text": [ "le l", " th" ], "offsets": [ [ 1440, 1444 ], [ 1454, 1457 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T79", "type": "Qualifier", "text": [ "ankle level" ], "offsets": [ [ 1437, 1448 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T80", "type": "Scope", "text": [ "calf or ankle level" ], "offsets": [ [ 1429, 1448 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T81", "type": "Procedure", "text": [ "palpation" ], "offsets": [ [ 1286, 1295 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T82", "type": "Observation", "text": [ "diminished" ], "offsets": [ [ 1262, 1272 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T83", "type": "Observation", "text": [ "absent" ], "offsets": [ [ 1276, 1282 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T84", "type": "Scope", "text": [ "diminished or absent" ], "offsets": [ [ 1262, 1282 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T85", "type": "Condition", "text": [ "peripheral vascular disease" ], "offsets": [ [ 1495, 1522 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T86", "type": "Scope", "text": [ "diminished or absent by palpation" ], "offsets": [ [ 1262, 1295 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T87", "type": "Procedure", "text": [ "Screening on physical examination" ], "offsets": [ [ 1140, 1173 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T88", "type": "Scope", "text": [ "diminution or absence of dorsalis pedis or posterior tibialis pulses" ], "offsets": [ [ 1189, 1257 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T89", "type": "Negation", "text": [ "excluded" ], "offsets": [ [ 1476, 1484 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T90", "type": "Scope", "text": [ "absolute arterial pressure is below 50mm of Hg at the calf or ankle level" ], "offsets": [ [ 1375, 1448 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T91", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1537, 1548 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T92", "type": "Condition", "text": [ "peripheral neuropathy" ], "offsets": [ [ 1549, 1570 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T93", "type": "Qualifier", "text": [ "Type II" ], "offsets": [ [ 1616, 1623 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T94", "type": "Qualifier", "text": [ "Type I" ], "offsets": [ [ 1616, 1622 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T95", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 1624, 1632 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T96", "type": "Scope", "text": [ "Type I or Type II" ], "offsets": [ [ 1606, 1623 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T97", "type": "Condition", "text": [ "systemic metabolic condition" ], "offsets": [ [ 1644, 1672 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T98", "type": "Qualifier", "text": [ "similar" ], "offsets": [ [ 1636, 1643 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T99", "type": "Condition", "text": [ "decreased sensation" ], "offsets": [ [ 1681, 1700 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T100", "type": "Qualifier", "text": [ "e or non-radi", " in the low" ], "offsets": [ [ 1718, 1731 ], [ 1768, 1779 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T101", "type": "Qualifier", "text": [ "r and non-der", " in the low" ], "offsets": [ [ 1735, 1748 ], [ 1768, 1779 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T102", "type": "Qualifier", "text": [ "non-dermatomal distribution" ], "offsets": [ [ 1741, 1768 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T103", "type": "Qualifier", "text": [ "lower extremities" ], "offsets": [ [ 1776, 1793 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T104", "type": "Scope", "text": [ "stocking-like or non-radicular and non-dermatomal distribution" ], "offsets": [ [ 1706, 1768 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T105", "type": "Qualifier", "text": [ "insulin-dependent" ], "offsets": [ [ 1807, 1824 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T106", "type": "Condition", "text": [ "diabetes mellitus" ], "offsets": [ [ 1825, 1842 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T107", "type": "Condition", "text": [ "morbidly obese" ], "offsets": [ [ 1855, 1869 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T108", "type": "Measurement", "text": [ "body mass index" ], "offsets": [ [ 1884, 1899 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T109", "type": "Value", "text": [ ">40" ], "offsets": [ [ 1900, 1903 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T110", "type": "Measurement", "text": [ "weighs" ], "offsets": [ [ 1908, 1914 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T111", "type": "Value", "text": [ "more than 100 lbs over ideal body weight" ], "offsets": [ [ 1915, 1955 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T112", "type": "Scope", "text": [ "body mass index >40, or weighs more than 100 lbs over ideal body weight" ], "offsets": [ [ 1884, 1955 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T113", "type": "Condition", "text": [ "hepatitis" ], "offsets": [ [ 1997, 2006 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T114", "type": "Condition", "text": [ "AIDS" ], "offsets": [ [ 2008, 2012 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T115", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 2017, 2020 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T116", "type": "Scope", "text": [ "hepatitis, AIDS, or HIV" ], "offsets": [ [ 1997, 2020 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T117", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 1990, 1996 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T118", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 2054, 2074 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T119", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 2078, 2083 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T120", "type": "Condition", "text": [ "autoimmune disease" ], "offsets": [ [ 2084, 2102 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T121", "type": "Drug", "text": [ "titanium" ], "offsets": [ [ 2135, 2143 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T122", "type": "Drug", "text": [ "polyethylene" ], "offsets": [ [ 2145, 2157 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T123", "type": "Drug", "text": [ "polyester" ], "offsets": [ [ 2161, 2170 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T124", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 2124, 2131 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T125", "type": "Scope", "text": [ "titanium, polyethylene or polyester" ], "offsets": [ [ 2135, 2170 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T126", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 2228, 2236 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T127", "type": "Mood", "text": [ "interested in becoming" ], "offsets": [ [ 2205, 2227 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T128", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 2228, 2236 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T129", "type": "Temporal", "text": [ "in the next two (2) years" ], "offsets": [ [ 2237, 2262 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T130", "type": "Scope", "text": [ "pregnant or interested in becoming pregnant" ], "offsets": [ [ 2193, 2236 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T131", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 2307, 2319 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T132", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 2307, 2319 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T133", "type": "Temporal", "text": [ "in the past three (3) years" ], "offsets": [ [ 2320, 2347 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T134", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 2434, 2444 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T135", "type": "Condition", "text": [ "non-melanoma skin cancer" ], "offsets": [ [ 2453, 2477 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T136", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 2425, 2433 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T137", "type": "Condition", "text": [ "treated with curative intent" ], "offsets": [ [ 2503, 2531 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T138", "type": "Negation", "text": [ "no" ], "offsets": [ [ 2552, 2554 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T139", "type": "Condition", "text": [ "signs or symptoms of the malignancy" ], "offsets": [ [ 2555, 2590 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T140", "type": "Temporal", "text": [ "for at least two (2) years" ], "offsets": [ [ 2591, 2617 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T141", "type": "Scope", "text": [ "treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years" ], "offsets": [ [ 2503, 2617 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T142", "type": "Negation", "text": [ "except" ], "offsets": [ [ 2446, 2452 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T143", "type": "Condition", "text": [ "active malignancy" ], "offsets": [ [ 2374, 2391 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T144", "type": "Observation", "text": [ "history" ], "offsets": [ [ 2363, 2370 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T145", "type": "Scope", "text": [ "invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years" ], "offsets": [ [ 2425, 2617 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T146", "type": "Scope", "text": [ "history of active malignancy" ], "offsets": [ [ 2363, 2391 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T147", "type": "Condition", "text": [ "immunologically suppressed" ], "offsets": [ [ 2630, 2656 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T148", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 2667, 2675 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T149", "type": "Multiplier", "text": [ ">1 month" ], "offsets": [ [ 2676, 2684 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T150", "type": "Temporal", "text": [ "over the past year" ], "offsets": [ [ 2685, 2703 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T151", "type": "Drug", "text": [ "anticoagulants" ], "offsets": [ [ 2722, 2736 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T152", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 2749, 2756 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T153", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 2738, 2748 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T155", "type": "Condition", "text": [ "alcohol dependency" ], "offsets": [ [ 2856, 2874 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T156", "type": "Condition", "text": [ "ency or", "nt psychos" ], "offsets": [ [ 2870, 2877 ], [ 2887, 2897 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T157", "type": "Condition", "text": [ "psychosocial disturbance" ], "offsets": [ [ 2890, 2914 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T158", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2878, 2889 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T159", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 2930, 2945 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T160", "type": "Value", "text": [ "less than three (3) years" ], "offsets": [ [ 2949, 2974 ] ], "normalized": [] }, { "id": "NCT03366779_exc_T163", "type": "Observation", "text": [ "incarcerated" ], "offsets": [ [ 3051, 3063 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03366779_exc_R1", "type": "Has_value", "arg1_id": "NCT03366779_exc_T2", "arg2_id": "NCT03366779_exc_T3", "normalized": [] }, { "id": "NCT03366779_exc_R2", "type": "AND", "arg1_id": "NCT03366779_exc_T1", "arg2_id": "NCT03366779_exc_T2", "normalized": [] }, { "id": "NCT03366779_exc_R3", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T5", "arg2_id": "NCT03366779_exc_T9", "normalized": [] }, { "id": "NCT03366779_exc_R4", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T5", "arg2_id": "NCT03366779_exc_T10", "normalized": [] }, { "id": "NCT03366779_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T14", "arg2_id": "NCT03366779_exc_T13", "normalized": [] }, { "id": "NCT03366779_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T15", "arg2_id": "NCT03366779_exc_T17", "normalized": [] }, { "id": "NCT03366779_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T15", "arg2_id": "NCT03366779_exc_T16", "normalized": [] }, { "id": "NCT03366779_exc_R8", "type": "Has_value", "arg1_id": "NCT03366779_exc_T19", "arg2_id": "NCT03366779_exc_T20", "normalized": [] }, { "id": "NCT03366779_exc_R9", "type": "Has_value", "arg1_id": "NCT03366779_exc_T21", "arg2_id": "NCT03366779_exc_T22", "normalized": [] }, { "id": "NCT03366779_exc_R10", "type": "Subsumes", "arg1_id": "NCT03366779_exc_T18", "arg2_id": "NCT03366779_exc_T19", "normalized": [] }, { "id": "NCT03366779_exc_R11", "type": "Has_mood", "arg1_id": "NCT03366779_exc_T18", "arg2_id": "NCT03366779_exc_T24", "normalized": [] }, { "id": "NCT03366779_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T21", "arg2_id": "NCT03366779_exc_T23", "normalized": [] }, { "id": "NCT03366779_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T25", "arg2_id": "NCT03366779_exc_T26", "normalized": [] }, { "id": "NCT03366779_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T27", "arg2_id": "NCT03366779_exc_T28", "normalized": [] }, { "id": "NCT03366779_exc_R16", "type": "AND", "arg1_id": "NCT03366779_exc_T30", "arg2_id": "NCT03366779_exc_T27", "normalized": [] }, { "id": "NCT03366779_exc_R17", "type": "AND", "arg1_id": "NCT03366779_exc_T18", "arg2_id": "NCT03366779_exc_T21", "normalized": [] }, { "id": "NCT03366779_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T31", "arg2_id": "NCT03366779_exc_T32", "normalized": [] }, { "id": "NCT03366779_exc_R19", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T31", "arg2_id": "NCT03366779_exc_T37", "normalized": [] }, { "id": "NCT03366779_exc_R20", "type": "Has_multiplier", "arg1_id": "NCT03366779_exc_T42", "arg2_id": "NCT03366779_exc_T39", "normalized": [] }, { "id": "NCT03366779_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T38", "arg2_id": "NCT03366779_exc_T43", "normalized": [] }, { "id": "NCT03366779_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T44", "arg2_id": "NCT03366779_exc_T45", "normalized": [] }, { "id": "NCT03366779_exc_R23", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T44", "arg2_id": "NCT03366779_exc_T48", "normalized": [] }, { "id": "NCT03366779_exc_R24", "type": "Has_negation", "arg1_id": "NCT03366779_exc_T50", "arg2_id": "NCT03366779_exc_T58", "normalized": [] }, { "id": "NCT03366779_exc_R26", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T50", "arg2_id": "NCT03366779_exc_T51", "normalized": [] }, { "id": "NCT03366779_exc_R27", "type": "Subsumes", "arg1_id": "NCT03366779_exc_T60", "arg2_id": "NCT03366779_exc_T57", "normalized": [] }, { "id": "NCT03366779_exc_R28", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T61", "arg2_id": "NCT03366779_exc_T65", "normalized": [] }, { "id": "NCT03366779_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T61", "arg2_id": "NCT03366779_exc_T62", "normalized": [] }, { "id": "NCT03366779_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T70", "arg2_id": "NCT03366779_exc_T71", "normalized": [] }, { "id": "NCT03366779_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T70", "arg2_id": "NCT03366779_exc_T69", "normalized": [] }, { "id": "NCT03366779_exc_R32", "type": "Subsumes", "arg1_id": "NCT03366779_exc_T74", "arg2_id": "NCT03366779_exc_T75", "normalized": [] }, { "id": "NCT03366779_exc_R33", "type": "Has_value", "arg1_id": "NCT03366779_exc_T76", "arg2_id": "NCT03366779_exc_T77", "normalized": [] }, { "id": "NCT03366779_exc_R34", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T76", "arg2_id": "NCT03366779_exc_T80", "normalized": [] }, { "id": "NCT03366779_exc_R35", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T81", "arg2_id": "NCT03366779_exc_T84", "normalized": [] }, { "id": "NCT03366779_exc_R36", "type": "AND", "arg1_id": "NCT03366779_exc_T86", "arg2_id": "NCT03366779_exc_T74", "normalized": [] }, { "id": "NCT03366779_exc_R37", "type": "AND", "arg1_id": "NCT03366779_exc_T88", "arg2_id": "NCT03366779_exc_T87", "normalized": [] }, { "id": "NCT03366779_exc_R38", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T87", "arg2_id": "NCT03366779_exc_T86", "normalized": [] }, { "id": "NCT03366779_exc_R39", "type": "Has_negation", "arg1_id": "NCT03366779_exc_T90", "arg2_id": "NCT03366779_exc_T89", "normalized": [] }, { "id": "NCT03366779_exc_R40", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T92", "arg2_id": "NCT03366779_exc_T91", "normalized": [] }, { "id": "NCT03366779_exc_R41", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T95", "arg2_id": "NCT03366779_exc_T96", "normalized": [] }, { "id": "NCT03366779_exc_R42", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T97", "arg2_id": "NCT03366779_exc_T98", "normalized": [] }, { "id": "NCT03366779_exc_R43", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T99", "arg2_id": "NCT03366779_exc_T104", "normalized": [] }, { "id": "NCT03366779_exc_R44", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T99", "arg2_id": "NCT03366779_exc_T103", "normalized": [] }, { "id": "NCT03366779_exc_R45", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T106", "arg2_id": "NCT03366779_exc_T105", "normalized": [] }, { "id": "NCT03366779_exc_R46", "type": "Has_value", "arg1_id": "NCT03366779_exc_T108", "arg2_id": "NCT03366779_exc_T109", "normalized": [] }, { "id": "NCT03366779_exc_R47", "type": "Has_value", "arg1_id": "NCT03366779_exc_T110", "arg2_id": "NCT03366779_exc_T111", "normalized": [] }, { "id": "NCT03366779_exc_R48", "type": "Subsumes", "arg1_id": "NCT03366779_exc_T107", "arg2_id": "NCT03366779_exc_T112", "normalized": [] }, { "id": "NCT03366779_exc_R49", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T116", "arg2_id": "NCT03366779_exc_T117", "normalized": [] }, { "id": "NCT03366779_exc_R50", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T120", "arg2_id": "NCT03366779_exc_T119", "normalized": [] }, { "id": "NCT03366779_exc_R51", "type": "Has_scope", "arg1_id": "NCT03366779_exc_T124", "arg2_id": "NCT03366779_exc_T125", "normalized": [] }, { "id": "NCT03366779_exc_R52", "type": "Has_mood", "arg1_id": "NCT03366779_exc_T128", "arg2_id": "NCT03366779_exc_T127", "normalized": [] }, { "id": "NCT03366779_exc_R53", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T130", "arg2_id": "NCT03366779_exc_T129", "normalized": [] }, { "id": "NCT03366779_exc_R54", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T134", "arg2_id": "NCT03366779_exc_T136", "normalized": [] }, { "id": "NCT03366779_exc_R55", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T139", "arg2_id": "NCT03366779_exc_T140", "normalized": [] }, { "id": "NCT03366779_exc_R56", "type": "Has_negation", "arg1_id": "NCT03366779_exc_T139", "arg2_id": "NCT03366779_exc_T138", "normalized": [] }, { "id": "NCT03366779_exc_R57", "type": "Has_negation", "arg1_id": "NCT03366779_exc_T135", "arg2_id": "NCT03366779_exc_T142", "normalized": [] }, { "id": "NCT03366779_exc_R58", "type": "AND", "arg1_id": "NCT03366779_exc_T134", "arg2_id": "NCT03366779_exc_T135", "normalized": [] }, { "id": "NCT03366779_exc_R59", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T143", "arg2_id": "NCT03366779_exc_T144", "normalized": [] }, { "id": "NCT03366779_exc_R60", "type": "Subsumes", "arg1_id": "NCT03366779_exc_T146", "arg2_id": "NCT03366779_exc_T141", "normalized": [] }, { "id": "NCT03366779_exc_R61", "type": "Has_multiplier", "arg1_id": "NCT03366779_exc_T148", "arg2_id": "NCT03366779_exc_T149", "normalized": [] }, { "id": "NCT03366779_exc_R62", "type": "Has_temporal", "arg1_id": "NCT03366779_exc_T148", "arg2_id": "NCT03366779_exc_T150", "normalized": [] }, { "id": "NCT03366779_exc_R63", "type": "Has_negation", "arg1_id": "NCT03366779_exc_T152", "arg2_id": "NCT03366779_exc_T153", "normalized": [] }, { "id": "NCT03366779_exc_R64", "type": "AND", "arg1_id": "NCT03366779_exc_T151", "arg2_id": "NCT03366779_exc_T152", "normalized": [] }, { "id": "NCT03366779_exc_R65", "type": "Has_qualifier", "arg1_id": "NCT03366779_exc_T157", "arg2_id": "NCT03366779_exc_T158", "normalized": [] }, { "id": "NCT03366779_exc_R66", "type": "Has_value", "arg1_id": "NCT03366779_exc_T159", "arg2_id": "NCT03366779_exc_T160", "normalized": [] } ]

[ { "id": "NCT03366779_inc_text", "type": "inclusion", "text": [ "Age 18 to 75 years old (male or female).\nPatients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using CT and/or MRI.\nAt least six (6) weeks of failed, conservative treatment prior to surgery, or requires immediate surgery to prevent permanent disability.\nMinimum posterior disc height of 5mm at the index level(s).\nLower back pain and/or sciatica with or without spinal claudication.\nOswestry Questionnaire score of at least 40/100 at baseline.\nVAS leg pain of at least 40/100 at baseline.\nPsychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.\n" ], "offsets": [ [ 0, 728 ] ] } ]

[ { "id": "NCT03366779_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T2", "type": "Value", "text": [ "18 to 75 years old" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T3", "type": "Person", "text": [ "male" ], "offsets": [ [ 24, 28 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T4", "type": "Person", "text": [ "female" ], "offsets": [ [ 32, 38 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T5", "type": "Scope", "text": [ "male or female" ], "offsets": [ [ 24, 38 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T6", "type": "Qualifier", "text": [ "posterolateral" ], "offsets": [ [ 68, 82 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T7", "type": "Qualifier", "text": [ "posterior" ], "offsets": [ [ 55, 64 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T8", "type": "Condition", "text": [ "disc herniations" ], "offsets": [ [ 83, 99 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T9", "type": "Qualifier", "text": [ "one level between L1 and S1" ], "offsets": [ [ 103, 130 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T10", "type": "Procedure", "text": [ "radiographic" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T11", "type": "Qualifier", "text": [ "radiographic confirmation" ], "offsets": [ [ 136, 161 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T12", "type": "Condition", "text": [ "neural compression" ], "offsets": [ [ 165, 183 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T13", "type": "Procedure", "text": [ "CT" ], "offsets": [ [ 190, 192 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T14", "type": "Procedure", "text": [ "MRI" ], "offsets": [ [ 200, 203 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T15", "type": "Scope", "text": [ "CT and/or MRI" ], "offsets": [ [ 190, 203 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T16", "type": "Scope", "text": [ "posterior or posterolateral" ], "offsets": [ [ 55, 82 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T17", "type": "Multiplier", "text": [ "At least six (6) weeks" ], "offsets": [ [ 205, 227 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T18", "type": "Qualifier", "text": [ "failed" ], "offsets": [ [ 231, 237 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T19", "type": "Qualifier", "text": [ "conservative" ], "offsets": [ [ 239, 251 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T20", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 252, 261 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T21", "type": "Temporal", "text": [ "prior to surgery" ], "offsets": [ [ 262, 278 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T22", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 302, 309 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T23", "type": "Condition", "text": [ "permanent disability" ], "offsets": [ [ 321, 341 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T24", "type": "Mood", "text": [ "prevent" ], "offsets": [ [ 313, 320 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T25", "type": "Qualifier", "text": [ "immediate" ], "offsets": [ [ 292, 301 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T26", "type": "Measurement", "text": [ "posterior disc height" ], "offsets": [ [ 351, 372 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T27", "type": "Value", "text": [ "imum po", "5mm at" ], "offsets": [ [ 346, 353 ], [ 376, 382 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T28", "type": "Qualifier", "text": [ "index level(s)" ], "offsets": [ [ 387, 401 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T29", "type": "Condition", "text": [ "Lower back pain" ], "offsets": [ [ 403, 418 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T30", "type": "Condition", "text": [ "sciatica" ], "offsets": [ [ 426, 434 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T31", "type": "Condition", "text": [ "spinal claudication" ], "offsets": [ [ 451, 470 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T32", "type": "Scope", "text": [ "Lower back pain and/or sciatica" ], "offsets": [ [ 403, 434 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T33", "type": "Measurement", "text": [ "Oswestry Questionnaire score" ], "offsets": [ [ 472, 500 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T34", "type": "Value", "text": [ "at least 40/100" ], "offsets": [ [ 504, 519 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T35", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 520, 531 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T36", "type": "Measurement", "text": [ "VAS leg pain" ], "offsets": [ [ 533, 545 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T37", "type": "Value", "text": [ "at least 40/100" ], "offsets": [ [ 549, 564 ] ], "normalized": [] }, { "id": "NCT03366779_inc_T38", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 565, 576 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03366779_inc_R1", "type": "Has_value", "arg1_id": "NCT03366779_inc_T1", "arg2_id": "NCT03366779_inc_T2", "normalized": [] }, { "id": "NCT03366779_inc_R2", "type": "Has_scope", "arg1_id": "NCT03366779_inc_T1", "arg2_id": "NCT03366779_inc_T5", "normalized": [] }, { "id": "NCT03366779_inc_R3", "type": "Has_scope", "arg1_id": "NCT03366779_inc_T12", "arg2_id": "NCT03366779_inc_T15", "normalized": [] }, { "id": "NCT03366779_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T8", "arg2_id": "NCT03366779_inc_T9", "normalized": [] }, { "id": "NCT03366779_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T8", "arg2_id": "NCT03366779_inc_T11", "normalized": [] }, { "id": "NCT03366779_inc_R6", "type": "Has_scope", "arg1_id": "NCT03366779_inc_T8", "arg2_id": "NCT03366779_inc_T16", "normalized": [] }, { "id": "NCT03366779_inc_R7", "type": "AND", "arg1_id": "NCT03366779_inc_T11", "arg2_id": "NCT03366779_inc_T12", "normalized": [] }, { "id": "NCT03366779_inc_R8", "type": "Has_temporal", "arg1_id": "NCT03366779_inc_T20", "arg2_id": "NCT03366779_inc_T21", "normalized": [] }, { "id": "NCT03366779_inc_R9", "type": "Has_multiplier", "arg1_id": "NCT03366779_inc_T20", "arg2_id": "NCT03366779_inc_T17", "normalized": [] }, { "id": "NCT03366779_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T20", "arg2_id": "NCT03366779_inc_T19", "normalized": [] }, { "id": "NCT03366779_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T20", "arg2_id": "NCT03366779_inc_T18", "normalized": [] }, { "id": "NCT03366779_inc_R12", "type": "Has_mood", "arg1_id": "NCT03366779_inc_T23", "arg2_id": "NCT03366779_inc_T24", "normalized": [] }, { "id": "NCT03366779_inc_R13", "type": "AND", "arg1_id": "NCT03366779_inc_T22", "arg2_id": "NCT03366779_inc_T23", "normalized": [] }, { "id": "NCT03366779_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T22", "arg2_id": "NCT03366779_inc_T25", "normalized": [] }, { "id": "NCT03366779_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT03366779_inc_T26", "arg2_id": "NCT03366779_inc_T28", "normalized": [] }, { "id": "NCT03366779_inc_R16", "type": "Has_value", "arg1_id": "NCT03366779_inc_T26", "arg2_id": "NCT03366779_inc_T27", "normalized": [] }, { "id": "NCT03366779_inc_R17", "type": "AND", "arg1_id": "NCT03366779_inc_T32", "arg2_id": "NCT03366779_inc_T31", "normalized": [] }, { "id": "NCT03366779_inc_R18", "type": "Has_value", "arg1_id": "NCT03366779_inc_T33", "arg2_id": "NCT03366779_inc_T34", "normalized": [] }, { "id": "NCT03366779_inc_R19", "type": "Has_temporal", "arg1_id": "NCT03366779_inc_T33", "arg2_id": "NCT03366779_inc_T35", "normalized": [] }, { "id": "NCT03366779_inc_R20", "type": "Has_value", "arg1_id": "NCT03366779_inc_T36", "arg2_id": "NCT03366779_inc_T37", "normalized": [] }, { "id": "NCT03366779_inc_R21", "type": "Has_temporal", "arg1_id": "NCT03366779_inc_T36", "arg2_id": "NCT03366779_inc_T38", "normalized": [] } ]

[ { "id": "NCT03369379_exc_text", "type": "exclusion", "text": [ "Those subjects with previous use of vitamin D.\nKnown subjects with renal, liver, calcium metabolism disorders, malabsorption disorders, known neoplasms.\nSubjects with serum calcium levels equal to or greater than 10.2 mg / dl.\n" ], "offsets": [ [ 0, 227 ] ] } ]

[ { "id": "NCT03369379_exc_T1", "type": "Temporal", "text": [ "previous use" ], "offsets": [ [ 20, 32 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T2", "type": "Drug", "text": [ "vitamin D" ], "offsets": [ [ 36, 45 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T3", "type": "Condition", "text": [ "isorders,", "enal," ], "offsets": [ [ 101, 110 ], [ 68, 73 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T4", "type": "Condition", "text": [ "isorders,", "iver," ], "offsets": [ [ 101, 110 ], [ 75, 80 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T5", "type": "Condition", "text": [ "calcium metabolism disorders" ], "offsets": [ [ 81, 109 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T6", "type": "Condition", "text": [ "malabsorption disorders" ], "offsets": [ [ 111, 134 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T7", "type": "Condition", "text": [ "neoplasms" ], "offsets": [ [ 142, 151 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T8", "type": "Measurement", "text": [ "serum calcium levels" ], "offsets": [ [ 167, 187 ] ], "normalized": [] }, { "id": "NCT03369379_exc_T9", "type": "Value", "text": [ "equal to or greater than 10.2 mg / dl" ], "offsets": [ [ 188, 225 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03369379_exc_R1", "type": "Has_temporal", "arg1_id": "NCT03369379_exc_T2", "arg2_id": "NCT03369379_exc_T1", "normalized": [] }, { "id": "NCT03369379_exc_R2", "type": "Has_value", "arg1_id": "NCT03369379_exc_T8", "arg2_id": "NCT03369379_exc_T9", "normalized": [] } ]

[ { "id": "NCT03369379_inc_text", "type": "inclusion", "text": [ "Female patients older than 18 years.\nPatients who agree to participate in the study.\nThose that meet the ACR 1990 and 2010 criteria for Fibromyalgia.\nNo previous use of vitamin D.\nPatients diagnosed with primary or secondary fibromyalgia.\n" ], "offsets": [ [ 0, 239 ] ] } ]

[ { "id": "NCT03369379_inc_T1", "type": "Person", "text": [ "Female" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T2", "type": "Value", "text": [ "older than 18 years" ], "offsets": [ [ 16, 35 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 30, 35 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T5", "type": "Qualifier", "text": [ "ACR 1990" ], "offsets": [ [ 105, 113 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T6", "type": "Qualifier", "text": [ "R 1", "10 c" ], "offsets": [ [ 107, 110 ], [ 120, 124 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T7", "type": "Condition", "text": [ "Fibromyalgia" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T8", "type": "Scope", "text": [ "ACR 1990 and 2010" ], "offsets": [ [ 105, 122 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T9", "type": "Negation", "text": [ "No" ], "offsets": [ [ 150, 152 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T10", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 153, 161 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T11", "type": "Value", "text": [ "vitamin D" ], "offsets": [ [ 169, 178 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T12", "type": "Scope", "text": [ "previous use of vitamin D" ], "offsets": [ [ 153, 178 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T13", "type": "Condition", "text": [ "fibromyalgia" ], "offsets": [ [ 225, 237 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T14", "type": "Qualifier", "text": [ "secondary" ], "offsets": [ [ 215, 224 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T15", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 204, 211 ] ], "normalized": [] }, { "id": "NCT03369379_inc_T16", "type": "Scope", "text": [ "primary or secondary" ], "offsets": [ [ 204, 224 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03369379_inc_R1", "type": "Has_value", "arg1_id": "NCT03369379_inc_T3", "arg2_id": "NCT03369379_inc_T2", "normalized": [] }, { "id": "NCT03369379_inc_R2", "type": "Has_scope", "arg1_id": "NCT03369379_inc_T7", "arg2_id": "NCT03369379_inc_T8", "normalized": [] }, { "id": "NCT03369379_inc_R3", "type": "Has_temporal", "arg1_id": "NCT03369379_inc_T11", "arg2_id": "NCT03369379_inc_T10", "normalized": [] }, { "id": "NCT03369379_inc_R4", "type": "Has_negation", "arg1_id": "NCT03369379_inc_T12", "arg2_id": "NCT03369379_inc_T9", "normalized": [] }, { "id": "NCT03369379_inc_R5", "type": "Has_scope", "arg1_id": "NCT03369379_inc_T13", "arg2_id": "NCT03369379_inc_T16", "normalized": [] } ]

[ { "id": "NCT03372265_exc_text", "type": "exclusion", "text": [ "Allergy to LA\nInfection in or near insertion site of the peripheral nerve catheter\nAnatomical abnormalities preventing successful peripheral catheter insertion\nHabitual use of opioids\nPregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion)\n" ], "offsets": [ [ 0, 275 ] ] } ]

[ { "id": "NCT03372265_exc_T1", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T2", "type": "Drug", "text": [ "LA" ], "offsets": [ [ 11, 13 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T3", "type": "Qualifier", "text": [ "near insertion site" ], "offsets": [ [ 30, 49 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T4", "type": "Qualifier", "text": [ "n", "nsertion site" ], "offsets": [ [ 25, 26 ], [ 36, 49 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T5", "type": "Device", "text": [ "peripheral nerve catheter" ], "offsets": [ [ 57, 82 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T6", "type": "Scope", "text": [ "in or near insertion site" ], "offsets": [ [ 24, 49 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T7", "type": "Condition", "text": [ "Anatomical abnormalities" ], "offsets": [ [ 83, 107 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T8", "type": "Qualifier", "text": [ "successful" ], "offsets": [ [ 119, 129 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T9", "type": "Mood", "text": [ "preventing" ], "offsets": [ [ 108, 118 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T10", "type": "Device", "text": [ "peripheral catheter" ], "offsets": [ [ 130, 149 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T11", "type": "Procedure", "text": [ "insertion" ], "offsets": [ [ 150, 159 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T12", "type": "Negation", "text": [ "preventing" ], "offsets": [ [ 108, 118 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T13", "type": "Drug", "text": [ "opioids" ], "offsets": [ [ 176, 183 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T14", "type": "Multiplier", "text": [ "Habitual use" ], "offsets": [ [ 160, 172 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T15", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 184, 193 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T16", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 197, 210 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T17", "type": "Value", "text": [ "negative" ], "offsets": [ [ 227, 235 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T18", "type": "Procedure", "text": [ "pregnancy test" ], "offsets": [ [ 236, 250 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T19", "type": "Temporal", "text": [ "before trial inclusion" ], "offsets": [ [ 251, 273 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T20", "type": "Reference_point", "text": [ "trial inclusion" ], "offsets": [ [ 258, 273 ] ], "normalized": [] }, { "id": "NCT03372265_exc_T21", "type": "Negation", "text": [ "disproved by" ], "offsets": [ [ 212, 224 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03372265_exc_R1", "type": "AND", "arg1_id": "NCT03372265_exc_T1", "arg2_id": "NCT03372265_exc_T2", "normalized": [] }, { "id": "NCT03372265_exc_R2", "type": "Has_scope", "arg1_id": "NCT03372265_exc_T5", "arg2_id": "NCT03372265_exc_T6", "normalized": [] }, { "id": "NCT03372265_exc_R3", "type": "AND", "arg1_id": "NCT03372265_exc_T11", "arg2_id": "NCT03372265_exc_T10", "normalized": [] }, { "id": "NCT03372265_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT03372265_exc_T11", "arg2_id": "NCT03372265_exc_T8", "normalized": [] }, { "id": "NCT03372265_exc_R5", "type": "Has_mood", "arg1_id": "NCT03372265_exc_T11", "arg2_id": "NCT03372265_exc_T9", "normalized": [] }, { "id": "NCT03372265_exc_R7", "type": "AND", "arg1_id": "NCT03372265_exc_T7", "arg2_id": "NCT03372265_exc_T11", "normalized": [] }, { "id": "NCT03372265_exc_R8", "type": "Has_multiplier", "arg1_id": "NCT03372265_exc_T13", "arg2_id": "NCT03372265_exc_T14", "normalized": [] }, { "id": "NCT03372265_exc_R9", "type": "Has_value", "arg1_id": "NCT03372265_exc_T18", "arg2_id": "NCT03372265_exc_T17", "normalized": [] }, { "id": "NCT03372265_exc_R10", "type": "Has_index", "arg1_id": "NCT03372265_exc_T19", "arg2_id": "NCT03372265_exc_T20", "normalized": [] }, { "id": "NCT03372265_exc_R11", "type": "Has_temporal", "arg1_id": "NCT03372265_exc_T18", "arg2_id": "NCT03372265_exc_T19", "normalized": [] }, { "id": "NCT03372265_exc_R12", "type": "Has_negation", "arg1_id": "NCT03372265_exc_T18", "arg2_id": "NCT03372265_exc_T21", "normalized": [] } ]

[ { "id": "NCT03372265_inc_text", "type": "inclusion", "text": [ "Age = 18 years\nAmerican Society of Anesthesiologists Classification I-III\nNormal cognitive function in order to sign written, informed consent and to understand trial protocol\nAgreement to the trial protocol, including the randomized manner\n" ], "offsets": [ [ 0, 241 ] ] } ]

[ { "id": "NCT03372265_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T2", "type": "Value", "text": [ "= 18 years" ], "offsets": [ [ 4, 14 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T3", "type": "Observation", "text": [ "American Society of Anesthesiologists Classification" ], "offsets": [ [ 15, 67 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T4", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 68, 73 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T5", "type": "Value", "text": [ "Normal" ], "offsets": [ [ 74, 80 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T6", "type": "Measurement", "text": [ "cognitive function" ], "offsets": [ [ 81, 99 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T7", "type": "Observation", "text": [ "Agreement to the trial protocol" ], "offsets": [ [ 176, 207 ] ], "normalized": [] }, { "id": "NCT03372265_inc_T8", "type": "Observation", "text": [ "eement to th", " randomized manne" ], "offsets": [ [ 179, 191 ], [ 222, 239 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03372265_inc_R1", "type": "Has_value", "arg1_id": "NCT03372265_inc_T1", "arg2_id": "NCT03372265_inc_T2", "normalized": [] }, { "id": "NCT03372265_inc_R2", "type": "Has_value", "arg1_id": "NCT03372265_inc_T3", "arg2_id": "NCT03372265_inc_T4", "normalized": [] }, { "id": "NCT03372265_inc_R3", "type": "Has_value", "arg1_id": "NCT03372265_inc_T6", "arg2_id": "NCT03372265_inc_T5", "normalized": [] } ]

[ { "id": "NCT03372304_exc_text", "type": "exclusion", "text": [ "NA\n\n" ], "offsets": [ [ 0, 4 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT03372304_inc_text", "type": "inclusion", "text": [ "American Society of Anesthesiologists Classification I-III\nNormal cognitive function in order to sign written, informed consent and to understand trial protocol\nAgreement to the trial protocol, including the randomized manner\n" ], "offsets": [ [ 0, 226 ] ] } ]

[ { "id": "NCT03372304_inc_T1", "type": "Measurement", "text": [ "American Society of Anesthesiologists Classification" ], "offsets": [ [ 0, 52 ] ], "normalized": [] }, { "id": "NCT03372304_inc_T2", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 53, 58 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03372304_inc_R1", "type": "Has_value", "arg1_id": "NCT03372304_inc_T1", "arg2_id": "NCT03372304_inc_T2", "normalized": [] } ]

[ { "id": "NCT03373318_exc_text", "type": "exclusion", "text": [ "Patients who do not meet the inclusion criteria and those who have a history of allergic reactions to human albumin, as well as those who have received iodinated contrast during the 7 days prior to surgery and pregnant women, will be excluded from the study.\n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT03373318_exc_T1", "type": "Negation", "text": [ "not" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T2", "type": "Observation", "text": [ "meet the inclusion criteria" ], "offsets": [ [ 20, 47 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 69, 76 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T4", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 80, 88 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T5", "type": "Drug", "text": [ "human albumin" ], "offsets": [ [ 102, 115 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T6", "type": "Drug", "text": [ "iodinated contrast" ], "offsets": [ [ 152, 170 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T7", "type": "Temporal", "text": [ "during the 7 days prior to surgery" ], "offsets": [ [ 171, 205 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T8", "type": "Reference_point", "text": [ "surgery" ], "offsets": [ [ 198, 205 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T9", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 198, 205 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T10", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 210, 218 ] ], "normalized": [] }, { "id": "NCT03373318_exc_T11", "type": "Person", "text": [ "women" ], "offsets": [ [ 219, 224 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03373318_exc_R1", "type": "Has_negation", "arg1_id": "NCT03373318_exc_T2", "arg2_id": "NCT03373318_exc_T1", "normalized": [] }, { "id": "NCT03373318_exc_R2", "type": "AND", "arg1_id": "NCT03373318_exc_T4", "arg2_id": "NCT03373318_exc_T5", "normalized": [] }, { "id": "NCT03373318_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03373318_exc_T4", "arg2_id": "NCT03373318_exc_T3", "normalized": [] }, { "id": "NCT03373318_exc_R4", "type": "Has_index", "arg1_id": "NCT03373318_exc_T7", "arg2_id": "NCT03373318_exc_T8", "normalized": [] }, { "id": "NCT03373318_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03373318_exc_T6", "arg2_id": "NCT03373318_exc_T7", "normalized": [] } ]

[ { "id": "NCT03373318_inc_text", "type": "inclusion", "text": [ "Adult patients (> 18 years) scheduled for cardiopulmonary bypass surgery with Glomerular Filtration Rate (GFR) greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40%\n" ], "offsets": [ [ 0, 207 ] ] } ]

[ { "id": "NCT03373318_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T2", "type": "Value", "text": [ "> 18 years" ], "offsets": [ [ 16, 26 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T3", "type": "Person", "text": [ "years" ], "offsets": [ [ 21, 26 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T4", "type": "Scope", "text": [ "> 18 years" ], "offsets": [ [ 16, 26 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T5", "type": "Procedure", "text": [ "cardiopulmonary bypass surgery" ], "offsets": [ [ 42, 72 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T6", "type": "Measurement", "text": [ "Glomerular Filtration Rate (GFR)" ], "offsets": [ [ 78, 110 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T7", "type": "Value", "text": [ "greater than or equal to 60" ], "offsets": [ [ 111, 138 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T8", "type": "Measurement", "text": [ "left ventricular ejection fraction" ], "offsets": [ [ 143, 177 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T9", "type": "Value", "text": [ "greater than or equal to 40%" ], "offsets": [ [ 178, 206 ] ], "normalized": [] }, { "id": "NCT03373318_inc_T10", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 28, 41 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03373318_inc_R1", "type": "Has_value", "arg1_id": "NCT03373318_inc_T3", "arg2_id": "NCT03373318_inc_T2", "normalized": [] }, { "id": "NCT03373318_inc_R2", "type": "Subsumes", "arg1_id": "NCT03373318_inc_T1", "arg2_id": "NCT03373318_inc_T4", "normalized": [] }, { "id": "NCT03373318_inc_R3", "type": "Has_value", "arg1_id": "NCT03373318_inc_T6", "arg2_id": "NCT03373318_inc_T7", "normalized": [] }, { "id": "NCT03373318_inc_R4", "type": "Has_value", "arg1_id": "NCT03373318_inc_T8", "arg2_id": "NCT03373318_inc_T9", "normalized": [] }, { "id": "NCT03373318_inc_R5", "type": "Has_mood", "arg1_id": "NCT03373318_inc_T5", "arg2_id": "NCT03373318_inc_T10", "normalized": [] } ]

[ { "id": "NCT03373669_exc_text", "type": "exclusion", "text": [ "Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function, such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)\nEver having received oral cholera vaccine.\nReceipt of an investigational product (within 30 days before vaccination).\nHistory of diarrhoea in 7 days prior to first dose of vaccine (defined as =3 unformed loose stools in 24 hours).\nHistory of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)\nCurrent use of laxatives, antacids, or other agents to lower stomach acidity?\nPlanning to become pregnant in the next 2 years.\n" ], "offsets": [ [ 0, 764 ] ] } ]

[ { "id": "NCT03373669_exc_T1", "type": "Condition", "text": [ "psychiatric condition" ], "offsets": [ [ 37, 58 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T2", "type": "Condition", "text": [ "medical", "condition" ], "offsets": [ [ 26, 33 ], [ 49, 58 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T3", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T4", "type": "Scope", "text": [ "medical or psychiatric condition" ], "offsets": [ [ 26, 58 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T5", "type": "Condition", "text": [ "tuberculosis (TB)" ], "offsets": [ [ 105, 122 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T6", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 126, 129 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T7", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 92, 101 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T8", "type": "Condition", "text": [ "renal insufficiency" ], "offsets": [ [ 131, 150 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T9", "type": "Condition", "text": [ "hepatic disease" ], "offsets": [ [ 152, 167 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T10", "type": "Drug", "text": [ "parenteral medication" ], "offsets": [ [ 177, 198 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T11", "type": "Drug", "text": [ "oral", "medication" ], "offsets": [ [ 169, 173 ], [ 188, 198 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T12", "type": "Qualifier", "text": [ "known to affect the immune function" ], "offsets": [ [ 199, 234 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T13", "type": "Scope", "text": [ "oral or parenteral medication" ], "offsets": [ [ 169, 198 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T14", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 244, 259 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T15", "type": "Drug", "text": [ "immunosuppressant drugs" ], "offsets": [ [ 267, 290 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T16", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 261, 266 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T17", "type": "Condition", "text": [ "behavioural", "issues" ], "offsets": [ [ 295, 306 ], [ 317, 323 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T18", "type": "Condition", "text": [ "memory issues" ], "offsets": [ [ 310, 323 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T19", "type": "Scope", "text": [ "behavioural or memory issues" ], "offsets": [ [ 295, 323 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T20", "type": "Scope", "text": [ "corticosteroids, other immunosuppressant drugs; or behavioural or memory issues" ], "offsets": [ [ 244, 323 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T21", "type": "Scope", "text": [ "oral or parenteral medication known to affect the immune function" ], "offsets": [ [ 169, 234 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T22", "type": "Scope", "text": [ "treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function, such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues" ], "offsets": [ [ 92, 323 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T23", "type": "Drug", "text": [ "oral cholera vaccine" ], "offsets": [ [ 346, 366 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T25", "type": "Condition", "text": [ "diarrhoea" ], "offsets": [ [ 454, 463 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T26", "type": "Temporal", "text": [ "in 7 days prior to first dose of vaccine" ], "offsets": [ [ 464, 504 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T27", "type": "Reference_point", "text": [ "first dose of vaccine" ], "offsets": [ [ 483, 504 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T28", "type": "Value", "text": [ "=3" ], "offsets": [ [ 517, 519 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T29", "type": "Measurement", "text": [ "unformed loose stools in 24 hours" ], "offsets": [ [ 520, 553 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T30", "type": "Condition", "text": [ "chronic diarrhea" ], "offsets": [ [ 567, 583 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T31", "type": "Observation", "text": [ "History" ], "offsets": [ [ 556, 563 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T32", "type": "Observation", "text": [ "History" ], "offsets": [ [ 443, 450 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T33", "type": "Multiplier", "text": [ "lasting for more than 2 weeks" ], "offsets": [ [ 585, 614 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T34", "type": "Temporal", "text": [ "in the past 6 months" ], "offsets": [ [ 615, 635 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T35", "type": "Drug", "text": [ "laxatives" ], "offsets": [ [ 652, 661 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T36", "type": "Drug", "text": [ "antacids" ], "offsets": [ [ 663, 671 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T37", "type": "Drug", "text": [ "agents to lower stomach acidity" ], "offsets": [ [ 682, 713 ] ], "normalized": [] }, { "id": "NCT03373669_exc_T38", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 676, 681 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03373669_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03373669_exc_T4", "arg2_id": "NCT03373669_exc_T3", "normalized": [] }, { "id": "NCT03373669_exc_R2", "type": "AND", "arg1_id": "NCT03373669_exc_T7", "arg2_id": "NCT03373669_exc_T5", "normalized": [] }, { "id": "NCT03373669_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03373669_exc_T13", "arg2_id": "NCT03373669_exc_T12", "normalized": [] }, { "id": "NCT03373669_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT03373669_exc_T15", "arg2_id": "NCT03373669_exc_T16", "normalized": [] }, { "id": "NCT03373669_exc_R5", "type": "Subsumes", "arg1_id": "NCT03373669_exc_T21", "arg2_id": "NCT03373669_exc_T20", "normalized": [] }, { "id": "NCT03373669_exc_R6", "type": "Subsumes", "arg1_id": "NCT03373669_exc_T4", "arg2_id": "NCT03373669_exc_T22", "normalized": [] }, { "id": "NCT03373669_exc_R7", "type": "Has_index", "arg1_id": "NCT03373669_exc_T26", "arg2_id": "NCT03373669_exc_T27", "normalized": [] }, { "id": "NCT03373669_exc_R8", "type": "Has_value", "arg1_id": "NCT03373669_exc_T29", "arg2_id": "NCT03373669_exc_T28", "normalized": [] }, { "id": "NCT03373669_exc_R9", "type": "Subsumes", "arg1_id": "NCT03373669_exc_T25", "arg2_id": "NCT03373669_exc_T29", "normalized": [] }, { "id": "NCT03373669_exc_R10", "type": "Has_temporal", "arg1_id": "NCT03373669_exc_T25", "arg2_id": "NCT03373669_exc_T26", "normalized": [] }, { "id": "NCT03373669_exc_R11", "type": "Has_temporal", "arg1_id": "NCT03373669_exc_T25", "arg2_id": "NCT03373669_exc_T32", "normalized": [] }, { "id": "NCT03373669_exc_R12", "type": "Has_temporal", "arg1_id": "NCT03373669_exc_T30", "arg2_id": "NCT03373669_exc_T31", "normalized": [] }, { "id": "NCT03373669_exc_R13", "type": "Has_multiplier", "arg1_id": "NCT03373669_exc_T30", "arg2_id": "NCT03373669_exc_T33", "normalized": [] }, { "id": "NCT03373669_exc_R14", "type": "Has_temporal", "arg1_id": "NCT03373669_exc_T30", "arg2_id": "NCT03373669_exc_T34", "normalized": [] }, { "id": "NCT03373669_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT03373669_exc_T37", "arg2_id": "NCT03373669_exc_T38", "normalized": [] } ]

[ { "id": "NCT03373669_inc_text", "type": "inclusion", "text": [ "Age =1 year, stratified into different age groups\nLiving in the Waya Clinic Catchment Area\nGood health condition, without clinically significant medical history (by participant or guardian, in case of minor)\nNot pregnant for female subjects.\nAvailable to participate for the study duration, including all planned follow-up visits for up to 9 months from screening.\nSigned informed consent\n" ], "offsets": [ [ 0, 389 ] ] } ]

[ { "id": "NCT03373669_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T2", "type": "Value", "text": [ "=1 year" ], "offsets": [ [ 4, 11 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T4", "type": "Visit", "text": [ "Waya Clinic Catchment Area" ], "offsets": [ [ 64, 90 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T5", "type": "Person", "text": [ "Living" ], "offsets": [ [ 50, 56 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T6", "type": "Condition", "text": [ "Good health condition" ], "offsets": [ [ 91, 112 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T7", "type": "Negation", "text": [ "without" ], "offsets": [ [ 114, 121 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T8", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 122, 144 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T9", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 145, 160 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T10", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 208, 211 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T11", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 212, 220 ] ], "normalized": [] }, { "id": "NCT03373669_inc_T12", "type": "Person", "text": [ "female" ], "offsets": [ [ 225, 231 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03373669_inc_R1", "type": "Has_value", "arg1_id": "NCT03373669_inc_T1", "arg2_id": "NCT03373669_inc_T2", "normalized": [] }, { "id": "NCT03373669_inc_R2", "type": "AND", "arg1_id": "NCT03373669_inc_T5", "arg2_id": "NCT03373669_inc_T4", "normalized": [] }, { "id": "NCT03373669_inc_R3", "type": "Has_negation", "arg1_id": "NCT03373669_inc_T9", "arg2_id": "NCT03373669_inc_T7", "normalized": [] }, { "id": "NCT03373669_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03373669_inc_T9", "arg2_id": "NCT03373669_inc_T8", "normalized": [] }, { "id": "NCT03373669_inc_R5", "type": "AND", "arg1_id": "NCT03373669_inc_T12", "arg2_id": "NCT03373669_inc_T11", "normalized": [] }, { "id": "NCT03373669_inc_R6", "type": "Has_negation", "arg1_id": "NCT03373669_inc_T11", "arg2_id": "NCT03373669_inc_T10", "normalized": [] } ]

[ { "id": "NCT03376763_exc_text", "type": "exclusion", "text": [ "Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences.\nSubjects with a current DSM-<U+2163>-TR or 5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnesia, Borderline, Paranoid, Histrionic, Schizotypal, Schizoid, Antisocial or other cognitive or personality disorders.\nSubjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion.\nSubjects who have been treated with clozapine or long-acting injectable antipsychotic drugs within 3 months prior to the screening.\nSubjects who have been treated over maximum maintenance dose (as specified in each label) of oral antipsychotics at screening. (e.g. Aripiprazole>30mg/day, Olanzapine>20mg/day, Risperidone > 6mg/day, Quetiapine > 750mg/day)\nSubjects with a significant risk of violent behaviour or a significant risk of committing suicide based on history or investigator's judgment.\nSubjects had a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.\nSignificant history of drug abuse disorder (including alcohol, as defined in DSM-5 substance use disorder or in the opinion of the investigator) within the last 6 months prior to screening.\nSubjects participating another interventional clinical trial within 30 days prior to screening.\nWomen who are pregnant, nursing, or who plan to become pregnant while in the trial.\nSubjects having any other clinically significant finding of the physical examination or laboratory value that make investigator consider that it would be inappropriate to participate in this study.\n" ], "offsets": [ [ 0, 1862 ] ] } ]

[ { "id": "NCT03376763_exc_T1", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 59, 70 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T2", "type": "Condition", "text": [ "adverse events" ], "offsets": [ [ 41, 55 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T3", "type": "Qualifier", "text": [ "medically significant" ], "offsets": [ [ 19, 40 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T4", "type": "Drug", "text": [ "aripiprazole" ], "offsets": [ [ 76, 88 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T5", "type": "Temporal", "text": [ "during screening period" ], "offsets": [ [ 89, 112 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T6", "type": "Temporal", "text": [ "as prior experiences" ], "offsets": [ [ 116, 136 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T7", "type": "Scope", "text": [ "adverse events or intolerance" ], "offsets": [ [ 41, 70 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T8", "type": "Scope", "text": [ "during screening period or as prior experiences" ], "offsets": [ [ 89, 136 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T9", "type": "Qualifier", "text": [ "DSM-<U+2163>-TR" ], "offsets": [ [ 162, 177 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T10", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 204, 217 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T11", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 193, 203 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T12", "type": "Qualifier", "text": [ "SM-<", "" ], "offsets": [ [ 163, 167 ], [ 182, 182 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T13", "type": "Scope", "text": [ "DSM-<U+2163>-TR or 5" ], "offsets": [ [ 162, 182 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T14", "type": "Condition", "text": [ "schizoaffective disorder" ], "offsets": [ [ 229, 253 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T15", "type": "Condition", "text": [ "major depressive disorder" ], "offsets": [ [ 255, 280 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T16", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 282, 298 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T17", "type": "Condition", "text": [ "delirium" ], "offsets": [ [ 300, 308 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T18", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 310, 318 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T19", "type": "Condition", "text": [ "amnesia" ], "offsets": [ [ 320, 327 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T20", "type": "Condition", "text": [ "orderline,", "isorders." ], "offsets": [ [ 330, 340 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T21", "type": "Condition", "text": [ "aranoid,", "isorders." ], "offsets": [ [ 342, 350 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T22", "type": "Condition", "text": [ "istrionic,", "isorders." ], "offsets": [ [ 352, 362 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T23", "type": "Condition", "text": [ "chizotypal,", "isorders." ], "offsets": [ [ 364, 375 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T24", "type": "Condition", "text": [ "chizoid,", "isorders." ], "offsets": [ [ 377, 385 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T25", "type": "Condition", "text": [ "ntisocial", "isorders." ], "offsets": [ [ 387, 396 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T26", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 400, 405 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T27", "type": "Condition", "text": [ "ognitive", "isorders." ], "offsets": [ [ 407, 415 ], [ 432, 441 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T28", "type": "Condition", "text": [ "personality disorders" ], "offsets": [ [ 419, 440 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T29", "type": "Scope", "text": [ "cognitive or personality disorders" ], "offsets": [ [ 406, 440 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T30", "type": "Scope", "text": [ "schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnesia, Borderline, Paranoid, Histrionic, Schizotypal, Schizoid, Antisocial or other cognitive or personality disorders" ], "offsets": [ [ 229, 440 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T31", "type": "Scope", "text": [ "DSM-<U+2163>-TR or 5 diagnosis other than schizophrenia" ], "offsets": [ [ 162, 217 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T33", "type": "Drug", "text": [ "clozapine" ], "offsets": [ [ 619, 628 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T34", "type": "Drug", "text": [ "long-acting injectable antipsychotic drugs" ], "offsets": [ [ 632, 674 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T35", "type": "Temporal", "text": [ "within 3 months prior to the screening" ], "offsets": [ [ 675, 713 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T36", "type": "Reference_point", "text": [ "the screening" ], "offsets": [ [ 700, 713 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T37", "type": "Scope", "text": [ "clozapine or long-acting injectable antipsychotic drugs" ], "offsets": [ [ 619, 674 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T38", "type": "Multiplier", "text": [ "maximum maintenance dose" ], "offsets": [ [ 751, 775 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T39", "type": "Drug", "text": [ "oral antipsychotics" ], "offsets": [ [ 808, 827 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T40", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 828, 840 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T41", "type": "Drug", "text": [ "Aripiprazole" ], "offsets": [ [ 848, 860 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T42", "type": "Drug", "text": [ "Olanzapine" ], "offsets": [ [ 871, 881 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T43", "type": "Drug", "text": [ "Risperidone" ], "offsets": [ [ 892, 903 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T44", "type": "Drug", "text": [ "Quetiapine" ], "offsets": [ [ 915, 925 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T45", "type": "Value", "text": [ "> 750mg/day" ], "offsets": [ [ 926, 937 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T46", "type": "Value", "text": [ "> 6mg/day" ], "offsets": [ [ 904, 913 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T47", "type": "Value", "text": [ ">20mg/day" ], "offsets": [ [ 881, 890 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T48", "type": "Value", "text": [ ">30mg/day" ], "offsets": [ [ 860, 869 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T49", "type": "Scope", "text": [ "Aripiprazole>30mg/day, Olanzapine>20mg/day, Risperidone > 6mg/day, Quetiapine > 750mg/day" ], "offsets": [ [ 848, 937 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T50", "type": "Scope", "text": [ "maximum maintenance dose (as specified in each label) of oral antipsychotics" ], "offsets": [ [ 751, 827 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T51", "type": "Observation", "text": [ "violent behaviour" ], "offsets": [ [ 975, 992 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T52", "type": "Condition", "text": [ "committing suicide" ], "offsets": [ [ 1018, 1036 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T53", "type": "Mood", "text": [ "significant risk" ], "offsets": [ [ 998, 1014 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T54", "type": "Mood", "text": [ "significant risk" ], "offsets": [ [ 955, 971 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T55", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 1108, 1116 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T56", "type": "Condition", "text": [ "neuroleptic malignant syndrome" ], "offsets": [ [ 1118, 1148 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T57", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1150, 1172 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T58", "type": "Condition", "text": [ "tardive dyskinesia" ], "offsets": [ [ 1173, 1191 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T60", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1097, 1104 ] ], "normalized": [] }, { "id": "NCT03376763_exc_T61", "type": "Scope", "text": [ "seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia" ], "offsets": [ [ 1108, 1191 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03376763_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03376763_exc_T7", "arg2_id": "NCT03376763_exc_T3", "normalized": [] }, { "id": "NCT03376763_exc_R2", "type": "AND", "arg1_id": "NCT03376763_exc_T7", "arg2_id": "NCT03376763_exc_T4", "normalized": [] }, { "id": "NCT03376763_exc_R3", "type": "Has_scope", "arg1_id": "NCT03376763_exc_T7", "arg2_id": "NCT03376763_exc_T8", "normalized": [] }, { "id": "NCT03376763_exc_R4", "type": "Has_negation", "arg1_id": "NCT03376763_exc_T10", "arg2_id": "NCT03376763_exc_T11", "normalized": [] }, { "id": "NCT03376763_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03376763_exc_T29", "arg2_id": "NCT03376763_exc_T26", "normalized": [] }, { "id": "NCT03376763_exc_R6", "type": "Has_scope", "arg1_id": "NCT03376763_exc_T10", "arg2_id": "NCT03376763_exc_T13", "normalized": [] }, { "id": "NCT03376763_exc_R7", "type": "Subsumes", "arg1_id": "NCT03376763_exc_T31", "arg2_id": "NCT03376763_exc_T30", "normalized": [] }, { "id": "NCT03376763_exc_R8", "type": "Has_index", "arg1_id": "NCT03376763_exc_T35", "arg2_id": "NCT03376763_exc_T36", "normalized": [] }, { "id": "NCT03376763_exc_R9", "type": "Has_temporal", "arg1_id": "NCT03376763_exc_T37", "arg2_id": "NCT03376763_exc_T35", "normalized": [] }, { "id": "NCT03376763_exc_R10", "type": "Has_multiplier", "arg1_id": "NCT03376763_exc_T39", "arg2_id": "NCT03376763_exc_T38", "normalized": [] }, { "id": "NCT03376763_exc_R12", "type": "Has_value", "arg1_id": "NCT03376763_exc_T41", "arg2_id": "NCT03376763_exc_T48", "normalized": [] }, { "id": "NCT03376763_exc_R13", "type": "Has_value", "arg1_id": "NCT03376763_exc_T42", "arg2_id": "NCT03376763_exc_T47", "normalized": [] }, { "id": "NCT03376763_exc_R14", "type": "Has_value", "arg1_id": "NCT03376763_exc_T43", "arg2_id": "NCT03376763_exc_T46", "normalized": [] }, { "id": "NCT03376763_exc_R15", "type": "Has_value", "arg1_id": "NCT03376763_exc_T44", "arg2_id": "NCT03376763_exc_T45", "normalized": [] }, { "id": "NCT03376763_exc_R11", "type": "Subsumes", "arg1_id": "NCT03376763_exc_T50", "arg2_id": "NCT03376763_exc_T49", "normalized": [] }, { "id": "NCT03376763_exc_R16", "type": "Has_temporal", "arg1_id": "NCT03376763_exc_T50", "arg2_id": "NCT03376763_exc_T40", "normalized": [] }, { "id": "NCT03376763_exc_R17", "type": "Has_mood", "arg1_id": "NCT03376763_exc_T51", "arg2_id": "NCT03376763_exc_T54", "normalized": [] }, { "id": "NCT03376763_exc_R18", "type": "Has_mood", "arg1_id": "NCT03376763_exc_T52", "arg2_id": "NCT03376763_exc_T53", "normalized": [] }, { "id": "NCT03376763_exc_R19", "type": "Has_qualifier", "arg1_id": "NCT03376763_exc_T58", "arg2_id": "NCT03376763_exc_T57", "normalized": [] }, { "id": "NCT03376763_exc_R20", "type": "Has_temporal", "arg1_id": "NCT03376763_exc_T61", "arg2_id": "NCT03376763_exc_T60", "normalized": [] } ]

[ { "id": "NCT03376763_inc_text", "type": "inclusion", "text": [ "Subjects must be capable of providing signed and dated written informed consent by date of Visit 0 (-2 week).\nMale and female aged =19 and < 65 years.\nSubjects diagnosed of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision or 5th edition (DSM-<U+2163>-TR or 5) criteria, and a history of illness for at least for 3 years prior to screening.\nSubjects who take atypical antipsychotic drugs, and should be maintained on current antipsychotic drugs (including atypical antipsychotic drugs) and dose for at least 4 weeks prior to the screening.\nSubjects who need antipsychotic treatment (other than clozapine), and would be stable when switching to long-acting injectable aripiprazole in the investigator's judgement.\nSubjects must exhibit willingness, physiologic capability, and an educational level sufficient to comply with all protocol procedures.\n" ], "offsets": [ [ 0, 907 ] ] } ]

[ { "id": "NCT03376763_inc_T2", "type": "Person", "text": [ "Male" ], "offsets": [ [ 110, 114 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T3", "type": "Person", "text": [ "female" ], "offsets": [ [ 119, 125 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 126, 130 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T5", "type": "Value", "text": [ "=19 and < 65 years" ], "offsets": [ [ 131, 149 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T6", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 173, 186 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T7", "type": "Qualifier", "text": [ "Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision or 5th edition (DSM-<U+2163>-TR or 5) criteria" ], "offsets": [ [ 201, 328 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T8", "type": "Observation", "text": [ "history of illness" ], "offsets": [ [ 336, 354 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T9", "type": "Multiplier", "text": [ "for at least for 3 years" ], "offsets": [ [ 355, 379 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T10", "type": "Temporal", "text": [ "prior to screening" ], "offsets": [ [ 380, 398 ] ], "normalized": [] }, { "id": "NCT03376763_inc_T11", "type": "Drug", "text": [ "atypical antipsychotic drugs" ], "offsets": [ [ 418, 446 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03376763_inc_R1", "type": "Has_value", "arg1_id": "NCT03376763_inc_T4", "arg2_id": "NCT03376763_inc_T5", "normalized": [] }, { "id": "NCT03376763_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03376763_inc_T6", "arg2_id": "NCT03376763_inc_T7", "normalized": [] }, { "id": "NCT03376763_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT03376763_inc_T8", "arg2_id": "NCT03376763_inc_T9", "normalized": [] }, { "id": "NCT03376763_inc_R4", "type": "Has_temporal", "arg1_id": "NCT03376763_inc_T8", "arg2_id": "NCT03376763_inc_T10", "normalized": [] }, { "id": "NCT03376763_inc_R5", "type": "Has_temporal", "arg1_id": "NCT03376763_inc_T6", "arg2_id": "NCT03376763_inc_T8", "normalized": [] } ]

[ { "id": "NCT03380429_exc_text", "type": "exclusion", "text": [ "Subjects with a known or suspected alcohol or drug abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.\nHistory of life threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months.\nA lower respiratory tract infection within 7 days of the screening visit.\nConcurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.\nHistory of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.\nHistorical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.\nSubjects who have ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.\nSubjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer.\nA subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Propeller Health employee.\n" ], "offsets": [ [ 0, 2127 ] ] } ]

[ { "id": "NCT03380429_exc_T2", "type": "Qualifier", "text": [ "life threatening" ], "offsets": [ [ 191, 207 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T3", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 208, 214 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T4", "type": "Condition", "text": [ "asthma episode" ], "offsets": [ [ 230, 244 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T5", "type": "Qualifier", "text": [ "required intubation" ], "offsets": [ [ 250, 269 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T6", "type": "Procedure", "text": [ "intubation" ], "offsets": [ [ 259, 269 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T7", "type": "Condition", "text": [ "hypercapnea" ], "offsets": [ [ 297, 308 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T8", "type": "Condition", "text": [ "respiratory arrest" ], "offsets": [ [ 310, 328 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T9", "type": "Condition", "text": [ "hypoxic seizures" ], "offsets": [ [ 332, 348 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T10", "type": "Temporal", "text": [ "within the last 6 months" ], "offsets": [ [ 349, 373 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T11", "type": "Scope", "text": [ "hypercapnea, respiratory arrest or hypoxic seizures" ], "offsets": [ [ 297, 348 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T12", "type": "Scope", "text": [ "asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months" ], "offsets": [ [ 230, 373 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T13", "type": "Condition", "text": [ "lower respiratory tract infection" ], "offsets": [ [ 377, 410 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T14", "type": "Temporal", "text": [ "within 7 days of the screening visit" ], "offsets": [ [ 411, 447 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T15", "type": "Reference_point", "text": [ "screening visit" ], "offsets": [ [ 432, 447 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T16", "type": "Condition", "text": [ "chronic obstructive pulmonary disease (COPD)" ], "offsets": [ [ 473, 517 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T17", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 521, 526 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T18", "type": "Condition", "text": [ "respiratory disorders" ], "offsets": [ [ 527, 548 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T19", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 559, 565 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T20", "type": "Condition", "text": [ "tuberculosis" ], "offsets": [ [ 566, 578 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T21", "type": "Condition", "text": [ "lung cancer" ], "offsets": [ [ 580, 591 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T22", "type": "Condition", "text": [ "bronchiectasis" ], "offsets": [ [ 593, 607 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T23", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 609, 620 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T24", "type": "Condition", "text": [ "lung fibrosis" ], "offsets": [ [ 622, 635 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T25", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 637, 659 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T26", "type": "Condition", "text": [ "interstitial lung diseases" ], "offsets": [ [ 661, 687 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T27", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 691, 696 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T28", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 697, 703 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T29", "type": "Condition", "text": [ "pulmonary diseases" ], "offsets": [ [ 704, 722 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T30", "type": "Scope", "text": [ "chronic obstructive pulmonary disease (COPD) or other respiratory disorders" ], "offsets": [ [ 473, 548 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T31", "type": "Scope", "text": [ "active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases" ], "offsets": [ [ 559, 722 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T32", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 735, 751 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T33", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 752, 763 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T34", "type": "Drug", "text": [ "lactose" ], "offsets": [ [ 814, 821 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T35", "type": "Drug", "text": [ "magnesium stearate" ], "offsets": [ [ 823, 841 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T36", "type": "Drug", "text": [ "components of the study inhalers" ], "offsets": [ [ 771, 803 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T37", "type": "Scope", "text": [ "lactose, magnesium stearate" ], "offsets": [ [ 814, 841 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T38", "type": "Scope", "text": [ "hypersensitivity/intolerance" ], "offsets": [ [ 735, 763 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T39", "type": "Observation", "text": [ "history" ], "offsets": [ [ 873, 880 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T40", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 884, 890 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T41", "type": "Drug", "text": [ "milk protein" ], "offsets": [ [ 891, 903 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T42", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 904, 911 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T44", "type": "Condition", "text": [ "contraindicates participation" ], "offsets": [ [ 957, 986 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T45", "type": "Condition", "text": [ "hematological abnormalities" ], "offsets": [ [ 1259, 1286 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T46", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 1044, 1066 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T47", "type": "Qualifier", "text": [ "rapidly progressing" ], "offsets": [ [ 1070, 1089 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T48", "type": "Condition", "text": [ "ovascular, neu", "malities that" ], "offsets": [ [ 1107, 1121 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T49", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 1093, 1101 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T50", "type": "Scope", "text": [ "clinically significant or rapidly progressing or unstable" ], "offsets": [ [ 1044, 1101 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T51", "type": "Condition", "text": [ "logical, car", "malities that" ], "offsets": [ [ 1123, 1135 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T52", "type": "Condition", "text": [ "ovascular, neu", "malities that" ], "offsets": [ [ 1137, 1151 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T53", "type": "Condition", "text": [ "logical, ren", "malities that" ], "offsets": [ [ 1153, 1165 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T54", "type": "Condition", "text": [ ", hep", "malities that" ], "offsets": [ [ 1167, 1172 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T55", "type": "Condition", "text": [ "ic, imm", "malities that" ], "offsets": [ [ 1174, 1181 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T56", "type": "Condition", "text": [ "ological, end", "malities that" ], "offsets": [ [ 1183, 1196 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T57", "type": "Condition", "text": [ "rine (inc", "malities that" ], "offsets": [ [ 1198, 1207 ], [ 1278, 1291 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T58", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1214, 1226 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T59", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 1227, 1235 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T60", "type": "Condition", "text": [ "thyroid disease" ], "offsets": [ [ 1239, 1254 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T61", "type": "Scope", "text": [ "diabetes or thyroid disease" ], "offsets": [ [ 1227, 1254 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T62", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1296, 1308 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T63", "type": "Scope", "text": [ "cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities" ], "offsets": [ [ 1102, 1286 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T64", "type": "Observation", "text": [ "Historical" ], "offsets": [ [ 1010, 1020 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T65", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1024, 1031 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T66", "type": "Scope", "text": [ "Historical or current" ], "offsets": [ [ 1010, 1031 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T68", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1579, 1588 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T69", "type": "Drug", "text": [ "omalizumab" ], "offsets": [ [ 1628, 1638 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T70", "type": "Drug", "text": [ "mepolizumab" ], "offsets": [ [ 1640, 1651 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T71", "type": "Drug", "text": [ "asthma" ], "offsets": [ [ 1657, 1663 ] ], "normalized": [] }, { "id": "NCT03380429_exc_T72", "type": "Scope", "text": [ "omalizumab, mepolizumab, for asthma" ], "offsets": [ [ 1628, 1663 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03380429_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T3", "arg2_id": "NCT03380429_exc_T2", "normalized": [] }, { "id": "NCT03380429_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T4", "arg2_id": "NCT03380429_exc_T5", "normalized": [] }, { "id": "NCT03380429_exc_R4", "type": "Has_temporal", "arg1_id": "NCT03380429_exc_T11", "arg2_id": "NCT03380429_exc_T10", "normalized": [] }, { "id": "NCT03380429_exc_R5", "type": "Has_scope", "arg1_id": "NCT03380429_exc_T4", "arg2_id": "NCT03380429_exc_T11", "normalized": [] }, { "id": "NCT03380429_exc_R6", "type": "Subsumes", "arg1_id": "NCT03380429_exc_T3", "arg2_id": "NCT03380429_exc_T12", "normalized": [] }, { "id": "NCT03380429_exc_R7", "type": "Has_temporal", "arg1_id": "NCT03380429_exc_T13", "arg2_id": "NCT03380429_exc_T14", "normalized": [] }, { "id": "NCT03380429_exc_R9", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T29", "arg2_id": "NCT03380429_exc_T28", "normalized": [] }, { "id": "NCT03380429_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T29", "arg2_id": "NCT03380429_exc_T27", "normalized": [] }, { "id": "NCT03380429_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T20", "arg2_id": "NCT03380429_exc_T19", "normalized": [] }, { "id": "NCT03380429_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T18", "arg2_id": "NCT03380429_exc_T17", "normalized": [] }, { "id": "NCT03380429_exc_R13", "type": "Subsumes", "arg1_id": "NCT03380429_exc_T30", "arg2_id": "NCT03380429_exc_T31", "normalized": [] }, { "id": "NCT03380429_exc_R14", "type": "Subsumes", "arg1_id": "NCT03380429_exc_T36", "arg2_id": "NCT03380429_exc_T37", "normalized": [] }, { "id": "NCT03380429_exc_R15", "type": "AND", "arg1_id": "NCT03380429_exc_T38", "arg2_id": "NCT03380429_exc_T36", "normalized": [] }, { "id": "NCT03380429_exc_R16", "type": "AND", "arg1_id": "NCT03380429_exc_T42", "arg2_id": "NCT03380429_exc_T41", "normalized": [] }, { "id": "NCT03380429_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T42", "arg2_id": "NCT03380429_exc_T40", "normalized": [] }, { "id": "NCT03380429_exc_R18", "type": "Has_temporal", "arg1_id": "NCT03380429_exc_T42", "arg2_id": "NCT03380429_exc_T39", "normalized": [] }, { "id": "NCT03380429_exc_R19", "type": "AND", "arg1_id": "NCT03380429_exc_T42", "arg2_id": "NCT03380429_exc_T44", "normalized": [] }, { "id": "NCT03380429_exc_R20", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T61", "arg2_id": "NCT03380429_exc_T58", "normalized": [] }, { "id": "NCT03380429_exc_R21", "type": "Subsumes", "arg1_id": "NCT03380429_exc_T57", "arg2_id": "NCT03380429_exc_T61", "normalized": [] }, { "id": "NCT03380429_exc_R22", "type": "Has_scope", "arg1_id": "NCT03380429_exc_T63", "arg2_id": "NCT03380429_exc_T50", "normalized": [] }, { "id": "NCT03380429_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT03380429_exc_T63", "arg2_id": "NCT03380429_exc_T62", "normalized": [] }, { "id": "NCT03380429_exc_R24", "type": "Has_scope", "arg1_id": "NCT03380429_exc_T63", "arg2_id": "NCT03380429_exc_T66", "normalized": [] }, { "id": "NCT03380429_exc_R25", "type": "Has_scope", "arg1_id": "NCT03380429_exc_T68", "arg2_id": "NCT03380429_exc_T72", "normalized": [] } ]

[ { "id": "NCT03380429_inc_text", "type": "inclusion", "text": [ "Subjects aged 18 years or older, at the time of signing the informed consent.\nSubjects with documented physician diagnosis of asthma as their primary respiratory disease.\nACT score <20 at screening visit.\nNon-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked).\nMale or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days] after the last dose of study treatment.\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.\nSubject understands and is willing, able, and likely to comply with study procedures and restrictions.\nSubject must be able to read in a language supported by the smart phone app in their region.\nSubject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months, cannot have changed dose in the month prior to screening and be able to change to an equivalent dose of RELVAR/BREO for the duration of the study. Other background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.\nSubject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of the study and judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.\nSubject must have their own Android or iPhone operating system (IOS) smart phone and a data package suitable for the installation and running of the app and sending and receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB).\nSubjects must be willing and able to download the app on their personal smart phone and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Subjects will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred.\nACT score <20 at randomization visit (visit 2).\n" ], "offsets": [ [ 0, 2456 ] ] } ]

[ { "id": "NCT03380429_inc_T1", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T2", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 14, 31 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T3", "type": "Temporal", "text": [ "at the time of signing the informed consent" ], "offsets": [ [ 33, 76 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T4", "type": "Reference_point", "text": [ "signing the informed consent" ], "offsets": [ [ 48, 76 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T5", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 126, 132 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T7", "type": "Qualifier", "text": [ "primary respiratory disease" ], "offsets": [ [ 142, 169 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T6", "type": "Measurement", "text": [ "ACT score" ], "offsets": [ [ 171, 180 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T8", "type": "Value", "text": [ "<20" ], "offsets": [ [ 181, 184 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T9", "type": "Temporal", "text": [ "at screening visit" ], "offsets": [ [ 185, 203 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T10", "type": "Observation", "text": [ "Non-smokers" ], "offsets": [ [ 205, 216 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T11", "type": "Observation", "text": [ "never smoked" ], "offsets": [ [ 218, 230 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T12", "type": "Observation", "text": [ "not smoking" ], "offsets": [ [ 234, 245 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T13", "type": "Temporal", "text": [ "for >6 months" ], "offsets": [ [ 246, 259 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T14", "type": "Value", "text": [ "<10" ], "offsets": [ [ 265, 268 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T15", "type": "Measurement", "text": [ "pack years" ], "offsets": [ [ 269, 279 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T17", "type": "Scope", "text": [ "never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked" ], "offsets": [ [ 218, 369 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T18", "type": "Person", "text": [ "Male" ], "offsets": [ [ 372, 376 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T19", "type": "Person", "text": [ "female" ], "offsets": [ [ 380, 386 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T24", "type": "Procedure", "text": [ "maintenance therapy" ], "offsets": [ [ 1130, 1149 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T25", "type": "Multiplier", "text": [ "Fixed dose" ], "offsets": [ [ 1151, 1161 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T26", "type": "Drug", "text": [ "combination ICS/LABA" ], "offsets": [ [ 1162, 1182 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T27", "type": "Temporal", "text": [ "for 3 months" ], "offsets": [ [ 1184, 1196 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T28", "type": "Negation", "text": [ "cannot" ], "offsets": [ [ 1198, 1204 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T29", "type": "Multiplier", "text": [ "changed dose" ], "offsets": [ [ 1210, 1222 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T30", "type": "Temporal", "text": [ "in the month prior to screening" ], "offsets": [ [ 1223, 1254 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T31", "type": "Reference_point", "text": [ "the month prior to screening" ], "offsets": [ [ 1226, 1254 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T33", "type": "Mood", "text": [ "able to" ], "offsets": [ [ 1527, 1534 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T34", "type": "Procedure", "text": [ "change" ], "offsets": [ [ 1535, 1541 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T35", "type": "Drug", "text": [ "Salbutamol" ], "offsets": [ [ 1545, 1555 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T36", "type": "Drug", "text": [ "Albuterol" ], "offsets": [ [ 1556, 1565 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T37", "type": "Procedure", "text": [ "MDI rescue" ], "offsets": [ [ 1566, 1576 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T38", "type": "Temporal", "text": [ "for the duration of the study" ], "offsets": [ [ 1577, 1606 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T39", "type": "Reference_point", "text": [ "the duration of the study" ], "offsets": [ [ 1581, 1606 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T40", "type": "Condition", "text": [ "capable of withholding" ], "offsets": [ [ 1618, 1640 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T41", "type": "Drug", "text": [ "albuterol" ], "offsets": [ [ 1641, 1650 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T42", "type": "Drug", "text": [ "salbutamol" ], "offsets": [ [ 1651, 1661 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T43", "type": "Multiplier", "text": [ "for at least 6 hours" ], "offsets": [ [ 1662, 1682 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T44", "type": "Temporal", "text": [ "prior to study visits" ], "offsets": [ [ 1683, 1704 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T45", "type": "Scope", "text": [ "albuterol/salbutamol" ], "offsets": [ [ 1641, 1661 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T48", "type": "Measurement", "text": [ "ACT score" ], "offsets": [ [ 2408, 2417 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T49", "type": "Value", "text": [ "<20" ], "offsets": [ [ 2418, 2421 ] ], "normalized": [] }, { "id": "NCT03380429_inc_T50", "type": "Temporal", "text": [ "at randomization visit" ], "offsets": [ [ 2422, 2444 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03380429_inc_R1", "type": "Has_value", "arg1_id": "NCT03380429_inc_T1", "arg2_id": "NCT03380429_inc_T2", "normalized": [] }, { "id": "NCT03380429_inc_R2", "type": "Has_index", "arg1_id": "NCT03380429_inc_T3", "arg2_id": "NCT03380429_inc_T4", "normalized": [] }, { "id": "NCT03380429_inc_R3", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T1", "arg2_id": "NCT03380429_inc_T3", "normalized": [] }, { "id": "NCT03380429_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03380429_inc_T5", "arg2_id": "NCT03380429_inc_T7", "normalized": [] }, { "id": "NCT03380429_inc_R5", "type": "Has_value", "arg1_id": "NCT03380429_inc_T6", "arg2_id": "NCT03380429_inc_T8", "normalized": [] }, { "id": "NCT03380429_inc_R6", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T12", "arg2_id": "NCT03380429_inc_T13", "normalized": [] }, { "id": "NCT03380429_inc_R7", "type": "Has_value", "arg1_id": "NCT03380429_inc_T15", "arg2_id": "NCT03380429_inc_T14", "normalized": [] }, { "id": "NCT03380429_inc_R8", "type": "Subsumes", "arg1_id": "NCT03380429_inc_T10", "arg2_id": "NCT03380429_inc_T17", "normalized": [] }, { "id": "NCT03380429_inc_R9", "type": "Has_multiplier", "arg1_id": "NCT03380429_inc_T26", "arg2_id": "NCT03380429_inc_T25", "normalized": [] }, { "id": "NCT03380429_inc_R10", "type": "Subsumes", "arg1_id": "NCT03380429_inc_T24", "arg2_id": "NCT03380429_inc_T26", "normalized": [] }, { "id": "NCT03380429_inc_R11", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T24", "arg2_id": "NCT03380429_inc_T27", "normalized": [] }, { "id": "NCT03380429_inc_R12", "type": "Has_negation", "arg1_id": "NCT03380429_inc_T29", "arg2_id": "NCT03380429_inc_T28", "normalized": [] }, { "id": "NCT03380429_inc_R13", "type": "Has_index", "arg1_id": "NCT03380429_inc_T30", "arg2_id": "NCT03380429_inc_T31", "normalized": [] }, { "id": "NCT03380429_inc_R14", "type": "Has_multiplier", "arg1_id": "NCT03380429_inc_T24", "arg2_id": "NCT03380429_inc_T29", "normalized": [] }, { "id": "NCT03380429_inc_R15", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T29", "arg2_id": "NCT03380429_inc_T30", "normalized": [] }, { "id": "NCT03380429_inc_R16", "type": "AND", "arg1_id": "NCT03380429_inc_T37", "arg2_id": "NCT03380429_inc_T36", "normalized": [] }, { "id": "NCT03380429_inc_R17", "type": "AND", "arg1_id": "NCT03380429_inc_T37", "arg2_id": "NCT03380429_inc_T35", "normalized": [] }, { "id": "NCT03380429_inc_R18", "type": "AND", "arg1_id": "NCT03380429_inc_T34", "arg2_id": "NCT03380429_inc_T37", "normalized": [] }, { "id": "NCT03380429_inc_R19", "type": "Has_mood", "arg1_id": "NCT03380429_inc_T34", "arg2_id": "NCT03380429_inc_T33", "normalized": [] }, { "id": "NCT03380429_inc_R21", "type": "Has_scope", "arg1_id": "NCT03380429_inc_T40", "arg2_id": "NCT03380429_inc_T45", "normalized": [] }, { "id": "NCT03380429_inc_R22", "type": "Has_multiplier", "arg1_id": "NCT03380429_inc_T40", "arg2_id": "NCT03380429_inc_T43", "normalized": [] }, { "id": "NCT03380429_inc_R23", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T40", "arg2_id": "NCT03380429_inc_T44", "normalized": [] }, { "id": "NCT03380429_inc_R24", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T34", "arg2_id": "NCT03380429_inc_T38", "normalized": [] }, { "id": "NCT03380429_inc_R25", "type": "Has_value", "arg1_id": "NCT03380429_inc_T48", "arg2_id": "NCT03380429_inc_T49", "normalized": [] }, { "id": "NCT03380429_inc_R26", "type": "Has_temporal", "arg1_id": "NCT03380429_inc_T48", "arg2_id": "NCT03380429_inc_T50", "normalized": [] } ]

[ { "id": "NCT03381755_exc_text", "type": "exclusion", "text": [ "taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks\nPlatelet count <100g/L;\nA history of bleeding tendency;\nAspirin, ticagrelor or clopidogrel allergies;\nSevere liver injury.\n" ], "offsets": [ [ 0, 193 ] ] } ]

[ { "id": "NCT03381755_exc_T1", "type": "Drug", "text": [ "adenosine diphosphate (ADP) receptor antagonists" ], "offsets": [ [ 6, 54 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T2", "type": "Temporal", "text": [ "within 2 weeks" ], "offsets": [ [ 55, 69 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T3", "type": "Measurement", "text": [ "Platelet count" ], "offsets": [ [ 70, 84 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T4", "type": "Value", "text": [ "<100g/L" ], "offsets": [ [ 85, 92 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T5", "type": "Condition", "text": [ "bleeding tendency" ], "offsets": [ [ 107, 124 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 96, 103 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T7", "type": "Drug", "text": [ "Aspirin" ], "offsets": [ [ 126, 133 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T8", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 135, 145 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T9", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 149, 160 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T10", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 161, 170 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T11", "type": "Scope", "text": [ "Aspirin, ticagrelor or clopidogrel" ], "offsets": [ [ 126, 160 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T12", "type": "Condition", "text": [ "liver injury" ], "offsets": [ [ 179, 191 ] ], "normalized": [] }, { "id": "NCT03381755_exc_T13", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 172, 178 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03381755_exc_R1", "type": "Has_temporal", "arg1_id": "NCT03381755_exc_T1", "arg2_id": "NCT03381755_exc_T2", "normalized": [] }, { "id": "NCT03381755_exc_R2", "type": "Has_value", "arg1_id": "NCT03381755_exc_T3", "arg2_id": "NCT03381755_exc_T4", "normalized": [] }, { "id": "NCT03381755_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03381755_exc_T5", "arg2_id": "NCT03381755_exc_T6", "normalized": [] }, { "id": "NCT03381755_exc_R4", "type": "Has_scope", "arg1_id": "NCT03381755_exc_T10", "arg2_id": "NCT03381755_exc_T11", "normalized": [] }, { "id": "NCT03381755_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03381755_exc_T12", "arg2_id": "NCT03381755_exc_T13", "normalized": [] } ]

[ { "id": "NCT03381755_inc_text", "type": "inclusion", "text": [ "After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.\nplanned to undergo PCI recently\nplanned to DAPT for 1 year after PCI\n" ], "offsets": [ [ 0, 276 ] ] } ]

[ { "id": "NCT03381755_inc_T1", "type": "Multiplier", "text": [ "half-dose" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T2", "type": "Drug", "text": [ "ticagrelor" ], "offsets": [ [ 16, 26 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T3", "type": "Measurement", "text": [ "loading dose" ], "offsets": [ [ 28, 40 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T4", "type": "Value", "text": [ "90mg" ], "offsets": [ [ 41, 45 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T5", "type": "Multiplier", "text": [ "45mg bidpo." ], "offsets": [ [ 56, 67 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T6", "type": "Scope", "text": [ "loading dose 90mg, and then 45mg bidpo." ], "offsets": [ [ 28, 67 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T7", "type": "Temporal", "text": [ "treatment for 3 days" ], "offsets": [ [ 69, 89 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T8", "type": "Measurement", "text": [ "platelet aggregation" ], "offsets": [ [ 95, 115 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T9", "type": "Value", "text": [ "inhibited" ], "offsets": [ [ 131, 140 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T10", "type": "Qualifier", "text": [ "effectively" ], "offsets": [ [ 119, 130 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T11", "type": "Procedure", "text": [ "light transmission aggregometry" ], "offsets": [ [ 144, 175 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T12", "type": "Procedure", "text": [ "thromboela-stogram" ], "offsets": [ [ 187, 205 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T13", "type": "Scope", "text": [ "light transmission aggregometry method and thromboela-stogram" ], "offsets": [ [ 144, 205 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T14", "type": "Mood", "text": [ "planned to undergo" ], "offsets": [ [ 207, 225 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T15", "type": "Procedure", "text": [ "PCI" ], "offsets": [ [ 226, 229 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T16", "type": "Temporal", "text": [ "recently" ], "offsets": [ [ 230, 238 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T17", "type": "Scope", "text": [ "planned to undergo PCI" ], "offsets": [ [ 207, 229 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T18", "type": "Mood", "text": [ "planned to" ], "offsets": [ [ 239, 249 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T19", "type": "Procedure", "text": [ "DAPT" ], "offsets": [ [ 250, 254 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T20", "type": "Multiplier", "text": [ "for 1 year" ], "offsets": [ [ 255, 265 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T21", "type": "Temporal", "text": [ "after PCI" ], "offsets": [ [ 266, 275 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T22", "type": "Procedure", "text": [ "PCI" ], "offsets": [ [ 272, 275 ] ], "normalized": [] }, { "id": "NCT03381755_inc_T23", "type": "Reference_point", "text": [ "PCI" ], "offsets": [ [ 272, 275 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03381755_inc_R1", "type": "Has_value", "arg1_id": "NCT03381755_inc_T3", "arg2_id": "NCT03381755_inc_T4", "normalized": [] }, { "id": "NCT03381755_inc_R2", "type": "Subsumes", "arg1_id": "NCT03381755_inc_T1", "arg2_id": "NCT03381755_inc_T6", "normalized": [] }, { "id": "NCT03381755_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT03381755_inc_T2", "arg2_id": "NCT03381755_inc_T1", "normalized": [] }, { "id": "NCT03381755_inc_R4", "type": "Has_temporal", "arg1_id": "NCT03381755_inc_T2", "arg2_id": "NCT03381755_inc_T7", "normalized": [] }, { "id": "NCT03381755_inc_R5", "type": "Has_value", "arg1_id": "NCT03381755_inc_T8", "arg2_id": "NCT03381755_inc_T9", "normalized": [] }, { "id": "NCT03381755_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT03381755_inc_T9", "arg2_id": "NCT03381755_inc_T10", "normalized": [] }, { "id": "NCT03381755_inc_R7", "type": "Has_scope", "arg1_id": "NCT03381755_inc_T8", "arg2_id": "NCT03381755_inc_T13", "normalized": [] }, { "id": "NCT03381755_inc_R8", "type": "Has_mood", "arg1_id": "NCT03381755_inc_T15", "arg2_id": "NCT03381755_inc_T14", "normalized": [] }, { "id": "NCT03381755_inc_R9", "type": "Has_temporal", "arg1_id": "NCT03381755_inc_T17", "arg2_id": "NCT03381755_inc_T16", "normalized": [] }, { "id": "NCT03381755_inc_R10", "type": "Has_index", "arg1_id": "NCT03381755_inc_T21", "arg2_id": "NCT03381755_inc_T23", "normalized": [] }, { "id": "NCT03381755_inc_R12", "type": "Has_multiplier", "arg1_id": "NCT03381755_inc_T19", "arg2_id": "NCT03381755_inc_T20", "normalized": [] }, { "id": "NCT03381755_inc_R13", "type": "Has_temporal", "arg1_id": "NCT03381755_inc_T19", "arg2_id": "NCT03381755_inc_T21", "normalized": [] }, { "id": "NCT03381755_inc_R14", "type": "Has_mood", "arg1_id": "NCT03381755_inc_T19", "arg2_id": "NCT03381755_inc_T18", "normalized": [] } ]

[ { "id": "NCT03382106_exc_text", "type": "exclusion", "text": [ "Women only: Cannot be pregnant or nursing at baseline or plan to become pregnant during the course of the study\nBody Mass Index (BMI) > 32\nWeight > 220 pounds\nAllergies to shell fish, seafood, eggs or iodine\nHeart disease, kidney disease or diabetes\nDiagnosis of asthma\nAny metal in or on the body (that cannot be removed) between the nose and the abdomen\nAny major organ system disease (by judgment of the study medical team)\nA glomerular filtration rate of 60 cc per minute or less.\nNitroglycerin usage or nitrates and use of phosphodiesterase 5 (PDE5) inhibitors\nPrior history of hypersensitivity to sildenafil\nCurrently prescribed a phosphodiesterase (PDE) inhibitors medication (ex: Viagra, Cialis, etc)\nKnown Pulmonary Hypertension\nHas used e-cigarettes and marijuana <1 years\n" ], "offsets": [ [ 0, 783 ] ] } ]

[ { "id": "NCT03382106_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T3", "type": "Measurement", "text": [ "Body Mass Index (BMI)" ], "offsets": [ [ 112, 133 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T4", "type": "Value", "text": [ "> 32" ], "offsets": [ [ 134, 138 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T5", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 139, 145 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T6", "type": "Value", "text": [ "> 220 pounds" ], "offsets": [ [ 146, 158 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T7", "type": "Condition", "text": [ "Allergies" ], "offsets": [ [ 159, 168 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T8", "type": "Observation", "text": [ "shell fish" ], "offsets": [ [ 172, 182 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T9", "type": "Observation", "text": [ "seafood" ], "offsets": [ [ 184, 191 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T10", "type": "Observation", "text": [ "eggs" ], "offsets": [ [ 193, 197 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T11", "type": "Drug", "text": [ "iodine" ], "offsets": [ [ 201, 207 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T12", "type": "Scope", "text": [ "shell fish, seafood, eggs or iodine" ], "offsets": [ [ 172, 207 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T13", "type": "Condition", "text": [ "Heart disease" ], "offsets": [ [ 208, 221 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T14", "type": "Condition", "text": [ "kidney disease" ], "offsets": [ [ 223, 237 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T15", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 241, 249 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T16", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 263, 269 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T17", "type": "Device", "text": [ "in or on", "dy (that" ], "offsets": [ [ 280, 288 ], [ 295, 303 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T18", "type": "Device", "text": [ "in or", " body (tha" ], "offsets": [ [ 280, 285 ], [ 292, 302 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T19", "type": "Qualifier", "text": [ "between the nose and the abdomen" ], "offsets": [ [ 323, 355 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T20", "type": "Scope", "text": [ "metal in or on the body" ], "offsets": [ [ 274, 297 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T21", "type": "Condition", "text": [ "major organ system disease" ], "offsets": [ [ 360, 386 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T22", "type": "Measurement", "text": [ "glomerular filtration rate" ], "offsets": [ [ 429, 455 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T23", "type": "Value", "text": [ "60 cc per minute or less" ], "offsets": [ [ 459, 483 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T24", "type": "Drug", "text": [ "Nitroglycerin" ], "offsets": [ [ 485, 498 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T25", "type": "Drug", "text": [ "nitrates" ], "offsets": [ [ 508, 516 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T26", "type": "Drug", "text": [ "phosphodiesterase 5 (PDE5) inhibitors" ], "offsets": [ [ 528, 565 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T27", "type": "Scope", "text": [ "nitrates and use of phosphodiesterase 5 (PDE5) inhibitors" ], "offsets": [ [ 508, 565 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T28", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 583, 599 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T29", "type": "Drug", "text": [ "sildenafil" ], "offsets": [ [ 603, 613 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T30", "type": "Observation", "text": [ "Prior history" ], "offsets": [ [ 566, 579 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T31", "type": "Drug", "text": [ "phosphodiesterase (PDE) inhibitors" ], "offsets": [ [ 637, 671 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T32", "type": "Drug", "text": [ "Viagra" ], "offsets": [ [ 688, 694 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T33", "type": "Drug", "text": [ "Cialis" ], "offsets": [ [ 696, 702 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T34", "type": "Scope", "text": [ "Viagra, Cialis" ], "offsets": [ [ 688, 702 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T35", "type": "Condition", "text": [ "Pulmonary Hypertension" ], "offsets": [ [ 715, 737 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T36", "type": "Observation", "text": [ "used e-cigarettes" ], "offsets": [ [ 742, 759 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T37", "type": "Observation", "text": [ "ttes", "years" ], "offsets": [ [ 755, 759 ], [ 777, 782 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T38", "type": "Temporal", "text": [ "<1 years" ], "offsets": [ [ 774, 782 ] ], "normalized": [] }, { "id": "NCT03382106_exc_T39", "type": "Scope", "text": [ "used e-cigarettes and marijuana" ], "offsets": [ [ 742, 773 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03382106_exc_R2", "type": "Has_value", "arg1_id": "NCT03382106_exc_T3", "arg2_id": "NCT03382106_exc_T4", "normalized": [] }, { "id": "NCT03382106_exc_R3", "type": "Has_value", "arg1_id": "NCT03382106_exc_T5", "arg2_id": "NCT03382106_exc_T6", "normalized": [] }, { "id": "NCT03382106_exc_R4", "type": "Has_scope", "arg1_id": "NCT03382106_exc_T7", "arg2_id": "NCT03382106_exc_T12", "normalized": [] }, { "id": "NCT03382106_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03382106_exc_T20", "arg2_id": "NCT03382106_exc_T19", "normalized": [] }, { "id": "NCT03382106_exc_R6", "type": "Has_value", "arg1_id": "NCT03382106_exc_T22", "arg2_id": "NCT03382106_exc_T23", "normalized": [] }, { "id": "NCT03382106_exc_R7", "type": "AND", "arg1_id": "NCT03382106_exc_T28", "arg2_id": "NCT03382106_exc_T29", "normalized": [] }, { "id": "NCT03382106_exc_R8", "type": "Has_temporal", "arg1_id": "NCT03382106_exc_T28", "arg2_id": "NCT03382106_exc_T30", "normalized": [] }, { "id": "NCT03382106_exc_R9", "type": "Subsumes", "arg1_id": "NCT03382106_exc_T31", "arg2_id": "NCT03382106_exc_T34", "normalized": [] }, { "id": "NCT03382106_exc_R10", "type": "Has_temporal", "arg1_id": "NCT03382106_exc_T39", "arg2_id": "NCT03382106_exc_T38", "normalized": [] } ]

[ { "id": "NCT03382106_inc_text", "type": "inclusion", "text": [ "Between the age of 25 to 65 at baseline\nBe willing to participate in a smoking cessation program\nBe willing to attend all clinic visits\nMust be currently smoking at least ½ pack/day at baseline (confirmed with cotinine level and CO Smokerlyzer\n>5 pack-year history of smoking\nGlobal Initiative for Chronic Obstructive Lung Disease (GOLD) 0: FEV1=0.80 and FEV1/FVC>0.70 Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC)\nGOLD 1: FEV1=0.80 and FEV1/FVC < 0.70\nGOLD 2: 0.50=FEV1<0.80 and FEV1/FVC < 0.70\nBe willing to abstain from using any nicotine patches, e-cigarettes, or marijuana for the duration of the study.\n" ], "offsets": [ [ 0, 636 ] ] } ]

[ { "id": "NCT03382106_inc_T1", "type": "Value", "text": [ "Between", "25 to 65" ], "offsets": [ [ 0, 7 ], [ 19, 27 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 12, 15 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T3", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 28, 39 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T4", "type": "Mood", "text": [ "willing to participate" ], "offsets": [ [ 43, 65 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T5", "type": "Procedure", "text": [ "smoking cessation program" ], "offsets": [ [ 71, 96 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T7", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 154, 161 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T8", "type": "Value", "text": [ "at least ½" ], "offsets": [ [ 162, 172 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T9", "type": "Measurement", "text": [ "pack/day" ], "offsets": [ [ 173, 181 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T10", "type": "Temporal", "text": [ "at baseline" ], "offsets": [ [ 182, 193 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T11", "type": "Procedure", "text": [ "cotinine level" ], "offsets": [ [ 210, 224 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T12", "type": "Procedure", "text": [ "CO Smokerlyzer" ], "offsets": [ [ 229, 243 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T13", "type": "Measurement", "text": [ "pack-year" ], "offsets": [ [ 247, 256 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T14", "type": "Value", "text": [ ">5" ], "offsets": [ [ 244, 246 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T15", "type": "Observation", "text": [ "smoking" ], "offsets": [ [ 268, 275 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T16", "type": "Measurement", "text": [ "Global Initiative for Chronic Obstructive Lung Disease (GOLD)" ], "offsets": [ [ 276, 337 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T17", "type": "Value", "text": [ "0" ], "offsets": [ [ 346, 347 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T18", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 341, 345 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T19", "type": "Value", "text": [ "=0.80" ], "offsets": [ [ 345, 350 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T20", "type": "Measurement", "text": [ "FEV1/FVC" ], "offsets": [ [ 355, 363 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T21", "type": "Value", "text": [ ">0.70" ], "offsets": [ [ 363, 368 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T23", "type": "Scope", "text": [ "Global Initiative for Chronic Obstructive Lung Disease (GOLD) 0" ], "offsets": [ [ 276, 339 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T24", "type": "Scope", "text": [ "FEV1=0.80 and FEV1/FVC>0.70" ], "offsets": [ [ 341, 368 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T25", "type": "Measurement", "text": [ "GOLD" ], "offsets": [ [ 442, 446 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T26", "type": "Value", "text": [ "1" ], "offsets": [ [ 453, 454 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T27", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 450, 454 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T28", "type": "Value", "text": [ "=0.80" ], "offsets": [ [ 454, 459 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T29", "type": "Measurement", "text": [ "FEV1/FVC" ], "offsets": [ [ 464, 472 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T30", "type": "Value", "text": [ "< 0.70" ], "offsets": [ [ 473, 479 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T31", "type": "Scope", "text": [ "FEV1=0.80 and FEV1/FVC < 0.70" ], "offsets": [ [ 450, 479 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T32", "type": "Scope", "text": [ "GOLD 1" ], "offsets": [ [ 442, 448 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T33", "type": "Measurement", "text": [ "GOLD" ], "offsets": [ [ 480, 484 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T34", "type": "Value", "text": [ "2" ], "offsets": [ [ 485, 486 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T35", "type": "Scope", "text": [ "GOLD 2" ], "offsets": [ [ 480, 486 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T36", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 493, 497 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T37", "type": "Value", "text": [ "V1<0.", "nd FE" ], "offsets": [ [ 495, 500 ], [ 504, 509 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T38", "type": "Measurement", "text": [ "FEV1/FVC" ], "offsets": [ [ 507, 515 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T39", "type": "Value", "text": [ "< 0.70" ], "offsets": [ [ 516, 522 ] ], "normalized": [] }, { "id": "NCT03382106_inc_T40", "type": "Scope", "text": [ "0.50=FEV1<0.80 and FEV1/FVC < 0.70" ], "offsets": [ [ 488, 522 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03382106_inc_R1", "type": "Has_temporal", "arg1_id": "NCT03382106_inc_T2", "arg2_id": "NCT03382106_inc_T3", "normalized": [] }, { "id": "NCT03382106_inc_R2", "type": "Has_value", "arg1_id": "NCT03382106_inc_T2", "arg2_id": "NCT03382106_inc_T1", "normalized": [] }, { "id": "NCT03382106_inc_R3", "type": "Has_mood", "arg1_id": "NCT03382106_inc_T5", "arg2_id": "NCT03382106_inc_T4", "normalized": [] }, { "id": "NCT03382106_inc_R4", "type": "Has_value", "arg1_id": "NCT03382106_inc_T9", "arg2_id": "NCT03382106_inc_T8", "normalized": [] }, { "id": "NCT03382106_inc_R5", "type": "AND", "arg1_id": "NCT03382106_inc_T7", "arg2_id": "NCT03382106_inc_T9", "normalized": [] }, { "id": "NCT03382106_inc_R6", "type": "Has_temporal", "arg1_id": "NCT03382106_inc_T7", "arg2_id": "NCT03382106_inc_T10", "normalized": [] }, { "id": "NCT03382106_inc_R7", "type": "AND", "arg1_id": "NCT03382106_inc_T7", "arg2_id": "NCT03382106_inc_T11", "normalized": [] }, { "id": "NCT03382106_inc_R8", "type": "AND", "arg1_id": "NCT03382106_inc_T7", "arg2_id": "NCT03382106_inc_T12", "normalized": [] }, { "id": "NCT03382106_inc_R9", "type": "Has_value", "arg1_id": "NCT03382106_inc_T13", "arg2_id": "NCT03382106_inc_T14", "normalized": [] }, { "id": "NCT03382106_inc_R10", "type": "AND", "arg1_id": "NCT03382106_inc_T15", "arg2_id": "NCT03382106_inc_T13", "normalized": [] }, { "id": "NCT03382106_inc_R11", "type": "Has_value", "arg1_id": "NCT03382106_inc_T20", "arg2_id": "NCT03382106_inc_T21", "normalized": [] }, { "id": "NCT03382106_inc_R12", "type": "Has_value", "arg1_id": "NCT03382106_inc_T18", "arg2_id": "NCT03382106_inc_T19", "normalized": [] }, { "id": "NCT03382106_inc_R13", "type": "Has_value", "arg1_id": "NCT03382106_inc_T16", "arg2_id": "NCT03382106_inc_T17", "normalized": [] }, { "id": "NCT03382106_inc_R14", "type": "Subsumes", "arg1_id": "NCT03382106_inc_T23", "arg2_id": "NCT03382106_inc_T24", "normalized": [] }, { "id": "NCT03382106_inc_R15", "type": "Has_value", "arg1_id": "NCT03382106_inc_T25", "arg2_id": "NCT03382106_inc_T26", "normalized": [] }, { "id": "NCT03382106_inc_R16", "type": "Has_value", "arg1_id": "NCT03382106_inc_T29", "arg2_id": "NCT03382106_inc_T30", "normalized": [] }, { "id": "NCT03382106_inc_R17", "type": "Has_value", "arg1_id": "NCT03382106_inc_T27", "arg2_id": "NCT03382106_inc_T28", "normalized": [] }, { "id": "NCT03382106_inc_R18", "type": "Subsumes", "arg1_id": "NCT03382106_inc_T32", "arg2_id": "NCT03382106_inc_T31", "normalized": [] }, { "id": "NCT03382106_inc_R19", "type": "Has_value", "arg1_id": "NCT03382106_inc_T33", "arg2_id": "NCT03382106_inc_T34", "normalized": [] }, { "id": "NCT03382106_inc_R20", "type": "Has_value", "arg1_id": "NCT03382106_inc_T36", "arg2_id": "NCT03382106_inc_T37", "normalized": [] }, { "id": "NCT03382106_inc_R21", "type": "Has_value", "arg1_id": "NCT03382106_inc_T38", "arg2_id": "NCT03382106_inc_T39", "normalized": [] }, { "id": "NCT03382106_inc_R22", "type": "Subsumes", "arg1_id": "NCT03382106_inc_T35", "arg2_id": "NCT03382106_inc_T40", "normalized": [] } ]

[ { "id": "NCT03387059_exc_text", "type": "exclusion", "text": [ "Clinically significant systemic disease (such as diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy)\nPolycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European Society of Human Reproduction and Embryology [ESHRE]/American Society for Reproductive Medicine [ASRM], 2003)\nPoor ovarian response (POR) according to the European Society of Human Reproduction and Embryology (ESHRE) Criteria\nRIF (repeated implantation failure), defined as greater than or equals to (>=) 2 previous failed embryo transfers\nEndometriosis III-IV stage or adenomyosis\nClinically significant findings on exam or ultrasound, such as salpingitis, hydrosalpynx or evidence of ovarian cysts\nKnown hypersensitivity to any of the components of the solution\nKnown hypersensitivity to vaginal progesterone or its excipients\nOther protocol defined exclusion criteria could apply\n" ], "offsets": [ [ 0, 997 ] ] } ]

[ { "id": "NCT03387059_exc_T1", "type": "Condition", "text": [ "systemic disease" ], "offsets": [ [ 23, 39 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T2", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T3", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 49, 57 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T4", "type": "Condition", "text": [ "metabolic syndrome" ], "offsets": [ [ 59, 77 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T5", "type": "Condition", "text": [ "immunological diseases" ], "offsets": [ [ 79, 101 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T6", "type": "Condition", "text": [ "diagnosed thrombophilia" ], "offsets": [ [ 103, 126 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T7", "type": "Condition", "text": [ "porphyria" ], "offsets": [ [ 128, 137 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T8", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 152, 169 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T9", "type": "Drug", "text": [ "low-molecular weight heparin" ], "offsets": [ [ 191, 219 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T10", "type": "Scope", "text": [ "diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy" ], "offsets": [ [ 49, 227 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T11", "type": "Scope", "text": [ "Clinically significant systemic disease" ], "offsets": [ [ 0, 39 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T12", "type": "Condition", "text": [ "Polycystic ovary syndrome (PCOS)" ], "offsets": [ [ 229, 261 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T13", "type": "Qualifier", "text": [ "Rotterdam Consensus Criteria" ], "offsets": [ [ 275, 303 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T14", "type": "Qualifier", "text": [ "European Society of Human Reproduction and Embryology [ESHRE]/American Society for Reproductive Medicine [ASRM], 2003" ], "offsets": [ [ 305, 422 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T15", "type": "Condition", "text": [ "Poor ovarian response (POR)" ], "offsets": [ [ 424, 451 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T16", "type": "Qualifier", "text": [ "European Society of Human Reproduction and Embryology (ESHRE) Criteria" ], "offsets": [ [ 469, 539 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T17", "type": "Condition", "text": [ "RIF (repeated implantation failure)" ], "offsets": [ [ 540, 575 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T18", "type": "Value", "text": [ "greater than or equals to (>=) 2" ], "offsets": [ [ 588, 620 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T19", "type": "Measurement", "text": [ "previous failed embryo transfers" ], "offsets": [ [ 621, 653 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T20", "type": "Condition", "text": [ "Endometriosis" ], "offsets": [ [ 654, 667 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T21", "type": "Qualifier", "text": [ "III-IV stage" ], "offsets": [ [ 668, 680 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T22", "type": "Condition", "text": [ "adenomyosis" ], "offsets": [ [ 684, 695 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T23", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 696, 718 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T24", "type": "Procedure", "text": [ "exam" ], "offsets": [ [ 731, 735 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T25", "type": "Procedure", "text": [ "ultrasound" ], "offsets": [ [ 739, 749 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T26", "type": "Condition", "text": [ "salpingitis" ], "offsets": [ [ 759, 770 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T27", "type": "Condition", "text": [ "hydrosalpynx" ], "offsets": [ [ 772, 784 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T28", "type": "Condition", "text": [ "ovarian cysts" ], "offsets": [ [ 800, 813 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T29", "type": "Mood", "text": [ "evidence" ], "offsets": [ [ 788, 796 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T30", "type": "Scope", "text": [ "exam or ultrasound" ], "offsets": [ [ 731, 749 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T31", "type": "Observation", "text": [ "findings" ], "offsets": [ [ 719, 727 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T32", "type": "Scope", "text": [ "Clinically significant findings on exam or ultrasound" ], "offsets": [ [ 696, 749 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T33", "type": "Scope", "text": [ "salpingitis, hydrosalpynx or evidence of ovarian cysts" ], "offsets": [ [ 759, 813 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T34", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 820, 836 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T37", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 884, 900 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T35", "type": "Drug", "text": [ "vaginal progesterone" ], "offsets": [ [ 904, 924 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T38", "type": "Drug", "text": [ "excipients" ], "offsets": [ [ 932, 942 ] ], "normalized": [] }, { "id": "NCT03387059_exc_T39", "type": "Drug", "text": [ "components of the solution" ], "offsets": [ [ 851, 877 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03387059_exc_R1", "type": "AND", "arg1_id": "NCT03387059_exc_T8", "arg2_id": "NCT03387059_exc_T9", "normalized": [] }, { "id": "NCT03387059_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03387059_exc_T1", "arg2_id": "NCT03387059_exc_T2", "normalized": [] }, { "id": "NCT03387059_exc_R3", "type": "Subsumes", "arg1_id": "NCT03387059_exc_T11", "arg2_id": "NCT03387059_exc_T10", "normalized": [] }, { "id": "NCT03387059_exc_R4", "type": "Subsumes", "arg1_id": "NCT03387059_exc_T13", "arg2_id": "NCT03387059_exc_T14", "normalized": [] }, { "id": "NCT03387059_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03387059_exc_T12", "arg2_id": "NCT03387059_exc_T13", "normalized": [] }, { "id": "NCT03387059_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT03387059_exc_T15", "arg2_id": "NCT03387059_exc_T16", "normalized": [] }, { "id": "NCT03387059_exc_R7", "type": "Has_value", "arg1_id": "NCT03387059_exc_T19", "arg2_id": "NCT03387059_exc_T18", "normalized": [] }, { "id": "NCT03387059_exc_R8", "type": "AND", "arg1_id": "NCT03387059_exc_T17", "arg2_id": "NCT03387059_exc_T19", "normalized": [] }, { "id": "NCT03387059_exc_R9", "type": "AND", "arg1_id": "NCT03387059_exc_T21", "arg2_id": "NCT03387059_exc_T20", "normalized": [] }, { "id": "NCT03387059_exc_R10", "type": "Has_mood", "arg1_id": "NCT03387059_exc_T28", "arg2_id": "NCT03387059_exc_T29", "normalized": [] }, { "id": "NCT03387059_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT03387059_exc_T31", "arg2_id": "NCT03387059_exc_T23", "normalized": [] }, { "id": "NCT03387059_exc_R13", "type": "Subsumes", "arg1_id": "NCT03387059_exc_T32", "arg2_id": "NCT03387059_exc_T33", "normalized": [] }, { "id": "NCT03387059_exc_R14", "type": "AND", "arg1_id": "NCT03387059_exc_T37", "arg2_id": "NCT03387059_exc_T35", "normalized": [] }, { "id": "NCT03387059_exc_R15", "type": "AND", "arg1_id": "NCT03387059_exc_T34", "arg2_id": "NCT03387059_exc_T39", "normalized": [] } ]

[ { "id": "NCT03387059_inc_text", "type": "inclusion", "text": [ "All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization in Vitro and Embryo Transfer (FIVET)\nLess than or equal to (<=) 1 previous failed embryo transfer\nEumenorrheic normo-gonadotropic women\nBasal follicle-stimulating hormone (FSH) <=12 International unit per liter (IU/L)\nAnti-mullerian hormone (AMH) greater than (>) 1.1 nanogram per milliliter (ng/mL)\nOvarian Reserve: number of antral follicles 2 millimeter (mm) between 6 <= antral follicle count (AFC) <= 16\nFollicles > 16 mm at the triggering day between 5-14\nBody Mass Index (BMI) between 18 <= BMI <= 27 kilogram per meter square (kg/m^2)\nIndication for Fresh Embryo transfer\nNormal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)\nUndergoing Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering\nProgesterone (P4) serum level at the HCG triggering day <= 1.5 ng/mL (Day O/Randomization)\nEstradiol (E2) <= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin (HCG) triggering day (Day 0/Randomization)\nSubjects must have read and signed the Informed Consent Form prior to study-specific-procedures not part of standard of care\nOther protocol defined inclusion criteria could apply\n" ], "offsets": [ [ 0, 1264 ] ] } ]

[ { "id": "NCT03387059_inc_T1", "type": "Condition", "text": [ "infertile" ], "offsets": [ [ 4, 13 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 14, 19 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T3", "type": "Procedure", "text": [ "intracytoplasmic sperm injection (ICSI)" ], "offsets": [ [ 33, 72 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T4", "type": "Procedure", "text": [ "Fertilization in Vitro and Embryo Transfer (FIVET)" ], "offsets": [ [ 73, 123 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T5", "type": "Value", "text": [ "Less than or equal to (<=) 1" ], "offsets": [ [ 124, 152 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T6", "type": "Measurement", "text": [ "previous failed embryo transfer" ], "offsets": [ [ 153, 184 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T7", "type": "Condition", "text": [ "Eumenorrheic" ], "offsets": [ [ 185, 197 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T8", "type": "Condition", "text": [ "normo-gonadotropic" ], "offsets": [ [ 198, 216 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T9", "type": "Person", "text": [ "women" ], "offsets": [ [ 217, 222 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T10", "type": "Measurement", "text": [ "Basal follicle-stimulating hormone (FSH)" ], "offsets": [ [ 223, 263 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T11", "type": "Value", "text": [ "<=12 International unit per liter (IU/L)" ], "offsets": [ [ 264, 304 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T12", "type": "Measurement", "text": [ "Anti-mullerian hormone (AMH)" ], "offsets": [ [ 305, 333 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T13", "type": "Value", "text": [ "greater than (>) 1.1 nanogram per milliliter (ng/mL)" ], "offsets": [ [ 334, 386 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T14", "type": "Measurement", "text": [ "number of antral follicles 2 millimeter (mm)" ], "offsets": [ [ 404, 448 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T15", "type": "Value", "text": [ "between 6 <= antral follicle count (AFC) <= 16" ], "offsets": [ [ 449, 495 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T16", "type": "Measurement", "text": [ "Follicles > 16 mm" ], "offsets": [ [ 496, 513 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T17", "type": "Value", "text": [ "between 5-14" ], "offsets": [ [ 536, 548 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T18", "type": "Temporal", "text": [ "at the triggering day" ], "offsets": [ [ 514, 535 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T19", "type": "Measurement", "text": [ "Body Mass Index (BMI)" ], "offsets": [ [ 549, 570 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T20", "type": "Value", "text": [ "between 18 <= BMI <= 27 kilogram per meter square (kg/m^2)" ], "offsets": [ [ 571, 629 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T21", "type": "Mood", "text": [ "Indication for" ], "offsets": [ [ 630, 644 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T22", "type": "Procedure", "text": [ "Fresh Embryo transfer" ], "offsets": [ [ 645, 666 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T23", "type": "Procedure", "text": [ "ultrasound exam" ], "offsets": [ [ 692, 707 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T24", "type": "Observation", "text": [ "Normal uterine cavity" ], "offsets": [ [ 667, 688 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T25", "type": "Negation", "text": [ "no presence of" ], "offsets": [ [ 715, 729 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T26", "type": "Condition", "text": [ "hydrosalpinx" ], "offsets": [ [ 730, 742 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T27", "type": "Scope", "text": [ "no presence of hydrosalpinx" ], "offsets": [ [ 715, 742 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T28", "type": "Procedure", "text": [ "Assisted Reproductive Technique (ART)" ], "offsets": [ [ 755, 792 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T29", "type": "Procedure", "text": [ "oocyte maturation" ], "offsets": [ [ 797, 814 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T30", "type": "Procedure", "text": [ "human chorionic gonadotropin (HCG) triggering" ], "offsets": [ [ 818, 863 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T31", "type": "Temporal", "text": [ "Undergoing" ], "offsets": [ [ 744, 754 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T32", "type": "Scope", "text": [ "Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering" ], "offsets": [ [ 755, 863 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T33", "type": "Measurement", "text": [ "Progesterone (P4) serum level" ], "offsets": [ [ 864, 893 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T34", "type": "Temporal", "text": [ "at the HCG triggering day" ], "offsets": [ [ 894, 919 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T35", "type": "Reference_point", "text": [ "the HCG triggering day" ], "offsets": [ [ 897, 919 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T36", "type": "Value", "text": [ "<= 1.5 ng/mL" ], "offsets": [ [ 920, 932 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T37", "type": "Reference_point", "text": [ "Day O/Randomization" ], "offsets": [ [ 934, 953 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T38", "type": "Measurement", "text": [ "Estradiol (E2)" ], "offsets": [ [ 955, 969 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T39", "type": "Value", "text": [ "<= 3000 picogram/milliliter (pg/mL)" ], "offsets": [ [ 970, 1005 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T40", "type": "Reference_point", "text": [ "the human chorionic gonadotropin (HCG) triggering day" ], "offsets": [ [ 1009, 1062 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T41", "type": "Temporal", "text": [ "at the human chorionic gonadotropin (HCG) triggering day" ], "offsets": [ [ 1006, 1062 ] ], "normalized": [] }, { "id": "NCT03387059_inc_T42", "type": "Reference_point", "text": [ "Day 0/Randomization" ], "offsets": [ [ 1064, 1083 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03387059_inc_R1", "type": "Has_value", "arg1_id": "NCT03387059_inc_T6", "arg2_id": "NCT03387059_inc_T5", "normalized": [] }, { "id": "NCT03387059_inc_R2", "type": "Has_value", "arg1_id": "NCT03387059_inc_T12", "arg2_id": "NCT03387059_inc_T13", "normalized": [] }, { "id": "NCT03387059_inc_R3", "type": "Has_value", "arg1_id": "NCT03387059_inc_T10", "arg2_id": "NCT03387059_inc_T11", "normalized": [] }, { "id": "NCT03387059_inc_R4", "type": "Has_value", "arg1_id": "NCT03387059_inc_T14", "arg2_id": "NCT03387059_inc_T15", "normalized": [] }, { "id": "NCT03387059_inc_R5", "type": "Has_value", "arg1_id": "NCT03387059_inc_T16", "arg2_id": "NCT03387059_inc_T17", "normalized": [] }, { "id": "NCT03387059_inc_R6", "type": "Has_temporal", "arg1_id": "NCT03387059_inc_T16", "arg2_id": "NCT03387059_inc_T18", "normalized": [] }, { "id": "NCT03387059_inc_R7", "type": "Has_value", "arg1_id": "NCT03387059_inc_T19", "arg2_id": "NCT03387059_inc_T20", "normalized": [] }, { "id": "NCT03387059_inc_R8", "type": "Has_mood", "arg1_id": "NCT03387059_inc_T22", "arg2_id": "NCT03387059_inc_T21", "normalized": [] }, { "id": "NCT03387059_inc_R10", "type": "Has_negation", "arg1_id": "NCT03387059_inc_T26", "arg2_id": "NCT03387059_inc_T25", "normalized": [] }, { "id": "NCT03387059_inc_R11", "type": "Subsumes", "arg1_id": "NCT03387059_inc_T24", "arg2_id": "NCT03387059_inc_T27", "normalized": [] }, { "id": "NCT03387059_inc_R12", "type": "AND", "arg1_id": "NCT03387059_inc_T29", "arg2_id": "NCT03387059_inc_T30", "normalized": [] }, { "id": "NCT03387059_inc_R13", "type": "Has_temporal", "arg1_id": "NCT03387059_inc_T32", "arg2_id": "NCT03387059_inc_T31", "normalized": [] }, { "id": "NCT03387059_inc_R14", "type": "Has_index", "arg1_id": "NCT03387059_inc_T34", "arg2_id": "NCT03387059_inc_T35", "normalized": [] }, { "id": "NCT03387059_inc_R15", "type": "Subsumes", "arg1_id": "NCT03387059_inc_T35", "arg2_id": "NCT03387059_inc_T37", "normalized": [] }, { "id": "NCT03387059_inc_R16", "type": "Has_value", "arg1_id": "NCT03387059_inc_T34", "arg2_id": "NCT03387059_inc_T36", "normalized": [] }, { "id": "NCT03387059_inc_R17", "type": "Has_temporal", "arg1_id": "NCT03387059_inc_T33", "arg2_id": "NCT03387059_inc_T34", "normalized": [] }, { "id": "NCT03387059_inc_R18", "type": "Subsumes", "arg1_id": "NCT03387059_inc_T40", "arg2_id": "NCT03387059_inc_T42", "normalized": [] }, { "id": "NCT03387059_inc_R19", "type": "Has_index", "arg1_id": "NCT03387059_inc_T41", "arg2_id": "NCT03387059_inc_T40", "normalized": [] }, { "id": "NCT03387059_inc_R20", "type": "Has_value", "arg1_id": "NCT03387059_inc_T38", "arg2_id": "NCT03387059_inc_T39", "normalized": [] }, { "id": "NCT03387059_inc_R21", "type": "Has_temporal", "arg1_id": "NCT03387059_inc_T38", "arg2_id": "NCT03387059_inc_T41", "normalized": [] } ]

[ { "id": "NCT03388840_exc_text", "type": "exclusion", "text": [ "Patients with Non-androgenetic causes of hair loss.\nFemale patients with androgenetic alopecia.\nPatients who received anti-hair loss treatment within the past six months.\nPatients with history of bleeding disorders or on anticoagulant therapy.\nPatients with history of chronic liver disease, cancer or connective tissue disorders.\nPatients with current scalp infection.\n" ], "offsets": [ [ 0, 370 ] ] } ]

[ { "id": "NCT03388840_exc_T1", "type": "Condition", "text": [ "Non-androgenetic causes of hair loss" ], "offsets": [ [ 14, 50 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T2", "type": "Person", "text": [ "Female" ], "offsets": [ [ 52, 58 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T3", "type": "Condition", "text": [ "androgenetic alopecia" ], "offsets": [ [ 73, 94 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T4", "type": "Procedure", "text": [ "anti-hair loss treatment" ], "offsets": [ [ 118, 142 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T5", "type": "Temporal", "text": [ "within the past six months" ], "offsets": [ [ 143, 169 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T6", "type": "Condition", "text": [ "bleeding disorders" ], "offsets": [ [ 196, 214 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T7", "type": "Procedure", "text": [ "anticoagulant therapy" ], "offsets": [ [ 221, 242 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T8", "type": "Condition", "text": [ "chronic liver disease" ], "offsets": [ [ 269, 290 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T9", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 292, 298 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T10", "type": "Condition", "text": [ "connective tissue disorders" ], "offsets": [ [ 302, 329 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T11", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 345, 352 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T12", "type": "Condition", "text": [ "scalp infection" ], "offsets": [ [ 353, 368 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T13", "type": "Observation", "text": [ "history" ], "offsets": [ [ 185, 192 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T14", "type": "Observation", "text": [ "history" ], "offsets": [ [ 258, 265 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T15", "type": "Scope", "text": [ "bleeding disorders or on anticoagulant therapy" ], "offsets": [ [ 196, 242 ] ], "normalized": [] }, { "id": "NCT03388840_exc_T16", "type": "Scope", "text": [ "chronic liver disease, cancer or connective tissue disorders" ], "offsets": [ [ 269, 329 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03388840_exc_R1", "type": "Has_temporal", "arg1_id": "NCT03388840_exc_T4", "arg2_id": "NCT03388840_exc_T5", "normalized": [] }, { "id": "NCT03388840_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03388840_exc_T12", "arg2_id": "NCT03388840_exc_T11", "normalized": [] }, { "id": "NCT03388840_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03388840_exc_T15", "arg2_id": "NCT03388840_exc_T13", "normalized": [] }, { "id": "NCT03388840_exc_R4", "type": "Has_temporal", "arg1_id": "NCT03388840_exc_T16", "arg2_id": "NCT03388840_exc_T14", "normalized": [] } ]

[ { "id": "NCT03388840_inc_text", "type": "inclusion", "text": [ "male patients with androgenetic alopecia between 18 years and 60 years\n" ], "offsets": [ [ 0, 71 ] ] } ]

[ { "id": "NCT03388840_inc_T1", "type": "Person", "text": [ "male" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT03388840_inc_T2", "type": "Condition", "text": [ "androgenetic alopecia" ], "offsets": [ [ 19, 40 ] ], "normalized": [] }, { "id": "NCT03388840_inc_T3", "type": "Value", "text": [ "between 18 years and 60 years" ], "offsets": [ [ 41, 70 ] ], "normalized": [] }, { "id": "NCT03388840_inc_T4", "type": "Person", "text": [ "years" ], "offsets": [ [ 65, 70 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03388840_inc_R1", "type": "Has_value", "arg1_id": "NCT03388840_inc_T4", "arg2_id": "NCT03388840_inc_T3", "normalized": [] } ]

[ { "id": "NCT03389061_exc_text", "type": "exclusion", "text": [ "NA\n\n" ], "offsets": [ [ 0, 4 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT03389061_inc_text", "type": "inclusion", "text": [ "Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6.\nPatient is at least 18 at the day of screening.\nPatient is able and willing to sign the Informed Consent Form.\nPatient is able and willing to follow protocol requirements.\n" ], "offsets": [ [ 0, 259 ] ] } ]

[ { "id": "NCT03389061_inc_T1", "type": "Procedure", "text": [ "SOF/VEL treatment" ], "offsets": [ [ 14, 31 ] ], "normalized": [] }, { "id": "NCT03389061_inc_T2", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 53, 60 ] ], "normalized": [] }, { "id": "NCT03389061_inc_T3", "type": "Measurement", "text": [ "HCV genotype" ], "offsets": [ [ 61, 73 ] ], "normalized": [] }, { "id": "NCT03389061_inc_T4", "type": "Value", "text": [ "1 through 6" ], "offsets": [ [ 74, 85 ] ], "normalized": [] }, { "id": "NCT03389061_inc_T5", "type": "Temporal", "text": [ "at least 18 at the day of screening" ], "offsets": [ [ 98, 133 ] ], "normalized": [] }, { "id": "NCT03389061_inc_T6", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 124, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03389061_inc_R1", "type": "Has_value", "arg1_id": "NCT03389061_inc_T3", "arg2_id": "NCT03389061_inc_T4", "normalized": [] }, { "id": "NCT03389061_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03389061_inc_T3", "arg2_id": "NCT03389061_inc_T2", "normalized": [] }, { "id": "NCT03389061_inc_R3", "type": "AND", "arg1_id": "NCT03389061_inc_T1", "arg2_id": "NCT03389061_inc_T3", "normalized": [] }, { "id": "NCT03389061_inc_R4", "type": "Has_index", "arg1_id": "NCT03389061_inc_T5", "arg2_id": "NCT03389061_inc_T6", "normalized": [] } ]

[ { "id": "NCT03390933_exc_text", "type": "exclusion", "text": [ "on hemodialysis for less than 3 months\ncomorbid psychotic, bipolar, substance use dependence, Alzheimer's or dementia\n" ], "offsets": [ [ 0, 118 ] ] } ]

[ { "id": "NCT03390933_exc_T1", "type": "Procedure", "text": [ "hemodialysis" ], "offsets": [ [ 3, 15 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T2", "type": "Temporal", "text": [ "for less than 3 months" ], "offsets": [ [ 16, 38 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T3", "type": "Condition", "text": [ "psychotic" ], "offsets": [ [ 48, 57 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T4", "type": "Condition", "text": [ "bipolar" ], "offsets": [ [ 59, 66 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T5", "type": "Condition", "text": [ "substance use dependence" ], "offsets": [ [ 68, 92 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T6", "type": "Condition", "text": [ "Alzheimer's" ], "offsets": [ [ 94, 105 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T7", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 109, 117 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T8", "type": "Temporal", "text": [ "comorbid" ], "offsets": [ [ 39, 47 ] ], "normalized": [] }, { "id": "NCT03390933_exc_T9", "type": "Scope", "text": [ "psychotic, bipolar, substance use dependence, Alzheimer's or dementia" ], "offsets": [ [ 48, 117 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03390933_exc_R1", "type": "Has_temporal", "arg1_id": "NCT03390933_exc_T1", "arg2_id": "NCT03390933_exc_T2", "normalized": [] }, { "id": "NCT03390933_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03390933_exc_T9", "arg2_id": "NCT03390933_exc_T8", "normalized": [] } ]

[ { "id": "NCT03390933_inc_text", "type": "inclusion", "text": [ "currently on hemodialysis at a CDC dialysis unit\nEnglish speaking\nable to provide informed consent\n" ], "offsets": [ [ 0, 99 ] ] } ]

[ { "id": "NCT03390933_inc_T1", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03390933_inc_T2", "type": "Procedure", "text": [ "hemodialysis" ], "offsets": [ [ 13, 25 ] ], "normalized": [] }, { "id": "NCT03390933_inc_T3", "type": "Visit", "text": [ "CDC dialysis unit" ], "offsets": [ [ 31, 48 ] ], "normalized": [] }, { "id": "NCT03390933_inc_T4", "type": "Observation", "text": [ "English speaking" ], "offsets": [ [ 49, 65 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03390933_inc_R1", "type": "AND", "arg1_id": "NCT03390933_inc_T2", "arg2_id": "NCT03390933_inc_T3", "normalized": [] }, { "id": "NCT03390933_inc_R2", "type": "Has_temporal", "arg1_id": "NCT03390933_inc_T2", "arg2_id": "NCT03390933_inc_T1", "normalized": [] } ]

[ { "id": "NCT03397914_exc_text", "type": "exclusion", "text": [ "Age less than one year or over 18 years\nPatients with renal impairment\nColistin use less than 72 hours\n" ], "offsets": [ [ 0, 103 ] ] } ]

[ { "id": "NCT03397914_exc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T2", "type": "Value", "text": [ "less than one year" ], "offsets": [ [ 4, 22 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T3", "type": "Value", "text": [ "over 18 years" ], "offsets": [ [ 26, 39 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T4", "type": "Scope", "text": [ "less than one year or over 18 years" ], "offsets": [ [ 4, 39 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T5", "type": "Condition", "text": [ "renal impairment" ], "offsets": [ [ 54, 70 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T6", "type": "Drug", "text": [ "Colistin" ], "offsets": [ [ 71, 79 ] ], "normalized": [] }, { "id": "NCT03397914_exc_T7", "type": "Temporal", "text": [ "less than 72 hours" ], "offsets": [ [ 84, 102 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT03397914_exc_R1", "type": "Has_scope", "arg1_id": "NCT03397914_exc_T1", "arg2_id": "NCT03397914_exc_T4", "normalized": [] }, { "id": "NCT03397914_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03397914_exc_T6", "arg2_id": "NCT03397914_exc_T7", "normalized": [] } ]

[ { "id": "NCT03397914_inc_text", "type": "inclusion", "text": [ "Age between one year and 18 years\nSepsis due to MDR or minimally susceptible gram-negative bacteria\nHistory of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.\nCulture result consistent with MDR gram negative for this febrile neutropenic episode.\nPatient in sepsis and colistin was administered empirically to increase antibiotic coverage.\n" ], "offsets": [ [ 0, 369 ] ] } ]

[ { "id": "NCT03397914_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T2", "type": "Value", "text": [ "between one year and 18 years" ], "offsets": [ [ 4, 33 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T3", "type": "Condition", "text": [ "Sepsis" ], "offsets": [ [ 34, 40 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T4", "type": "Qualifier", "text": [ "MDR" ], "offsets": [ [ 48, 51 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T5", "type": "Condition", "text": [ "minimally susceptible gram-negative bacteria" ], "offsets": [ [ 55, 99 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T6", "type": "Qualifier", "text": [ "MDR" ], "offsets": [ [ 111, 114 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T7", "type": "Condition", "text": [ "gram-negative infection" ], "offsets": [ [ 115, 138 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T8", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 142, 148 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T9", "type": "Scope", "text": [ "gram-negative infection or sepsis" ], "offsets": [ [ 115, 148 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T10", "type": "Qualifier", "text": [ "sensitive to colistin" ], "offsets": [ [ 166, 187 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T11", "type": "Observation", "text": [ "organisms" ], "offsets": [ [ 156, 165 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T12", "type": "Qualifier", "text": [ "MDR" ], "offsets": [ [ 220, 223 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T13", "type": "Condition", "text": [ "gram negative" ], "offsets": [ [ 224, 237 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T14", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 287, 293 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T15", "type": "Drug", "text": [ "colistin" ], "offsets": [ [ 298, 306 ] ], "normalized": [] }, { "id": "NCT03397914_inc_T16", "type": "Procedure", "text": [ "administered empirically" ], "offsets": [ [ 311, 335 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03397914_inc_R1", "type": "Has_value", "arg1_id": "NCT03397914_inc_T1", "arg2_id": "NCT03397914_inc_T2", "normalized": [] }, { "id": "NCT03397914_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03397914_inc_T3", "arg2_id": "NCT03397914_inc_T4", "normalized": [] }, { "id": "NCT03397914_inc_R3", "type": "AND", "arg1_id": "NCT03397914_inc_T5", "arg2_id": "NCT03397914_inc_T3", "normalized": [] }, { "id": "NCT03397914_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT03397914_inc_T9", "arg2_id": "NCT03397914_inc_T6", "normalized": [] }, { "id": "NCT03397914_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT03397914_inc_T11", "arg2_id": "NCT03397914_inc_T10", "normalized": [] }, { "id": "NCT03397914_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT03397914_inc_T13", "arg2_id": "NCT03397914_inc_T12", "normalized": [] }, { "id": "NCT03397914_inc_R7", "type": "AND", "arg1_id": "NCT03397914_inc_T16", "arg2_id": "NCT03397914_inc_T15", "normalized": [] } ]

[ { "id": "NCT03400735_exc_text", "type": "exclusion", "text": [ "Pregnancy or breastfeeding\nAllergy against to penicillin or cephalosporins\nRenal impairment\nActive hepatic disease\nAntibiotic use except study drugs\nImmunosuppressive therapy before 6 months of study initiation\nUse of probenecid like drugs\n" ], "offsets": [ [ 0, 240 ] ] } ]

[ { "id": "NCT03400735_exc_T1", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T2", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 13, 26 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T3", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 27, 34 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T4", "type": "Drug", "text": [ "penicillin" ], "offsets": [ [ 46, 56 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T5", "type": "Drug", "text": [ "cephalosporins" ], "offsets": [ [ 60, 74 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T6", "type": "Scope", "text": [ "penicillin or cephalosporins" ], "offsets": [ [ 46, 74 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T7", "type": "Condition", "text": [ "Renal impairment" ], "offsets": [ [ 75, 91 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T8", "type": "Condition", "text": [ "hepatic disease" ], "offsets": [ [ 99, 114 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T9", "type": "Qualifier", "text": [ "Active" ], "offsets": [ [ 92, 98 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T10", "type": "Drug", "text": [ "Antibiotic" ], "offsets": [ [ 115, 125 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T11", "type": "Negation", "text": [ "except" ], "offsets": [ [ 130, 136 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T12", "type": "Drug", "text": [ "study drugs" ], "offsets": [ [ 137, 148 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T13", "type": "Procedure", "text": [ "Immunosuppressive therapy" ], "offsets": [ [ 149, 174 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T14", "type": "Temporal", "text": [ "before 6 months of study initiation" ], "offsets": [ [ 175, 210 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T15", "type": "Reference_point", "text": [ "study initiation" ], "offsets": [ [ 194, 210 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T16", "type": "Drug", "text": [ "probenecid like drugs" ], "offsets": [ [ 218, 239 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T17", "type": "Drug", "text": [ "probenecid" ], "offsets": [ [ 218, 228 ] ], "normalized": [] }, { "id": "NCT03400735_exc_T18", "type": "Qualifier", "text": [ "probenecid like" ], "offsets": [ [ 218, 233 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03400735_exc_R1", "type": "Has_scope", "arg1_id": "NCT03400735_exc_T3", "arg2_id": "NCT03400735_exc_T6", "normalized": [] }, { "id": "NCT03400735_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03400735_exc_T8", "arg2_id": "NCT03400735_exc_T9", "normalized": [] }, { "id": "NCT03400735_exc_R3", "type": "Has_negation", "arg1_id": "NCT03400735_exc_T12", "arg2_id": "NCT03400735_exc_T11", "normalized": [] }, { "id": "NCT03400735_exc_R4", "type": "AND", "arg1_id": "NCT03400735_exc_T10", "arg2_id": "NCT03400735_exc_T12", "normalized": [] }, { "id": "NCT03400735_exc_R5", "type": "Has_index", "arg1_id": "NCT03400735_exc_T14", "arg2_id": "NCT03400735_exc_T15", "normalized": [] }, { "id": "NCT03400735_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03400735_exc_T13", "arg2_id": "NCT03400735_exc_T14", "normalized": [] } ]

[ { "id": "NCT03400735_inc_text", "type": "inclusion", "text": [ "The diagnosis of chronic bronchitis\nThe diagnosis of community-acquired pneumoniae\nFEV1 value = 30-80%\nThe diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)\nOxygen saturation < 90%\n" ], "offsets": [ [ 0, 204 ] ] } ]

[ { "id": "NCT03400735_inc_T1", "type": "Condition", "text": [ "chronic bronchitis" ], "offsets": [ [ 17, 35 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T2", "type": "Condition", "text": [ "community-acquired pneumoniae" ], "offsets": [ [ 53, 82 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T3", "type": "Measurement", "text": [ "FEV1 value" ], "offsets": [ [ 83, 93 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T4", "type": "Value", "text": [ "= 30-80%" ], "offsets": [ [ 94, 102 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T5", "type": "Qualifier", "text": [ "mild-severe" ], "offsets": [ [ 120, 131 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T6", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 132, 137 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T7", "type": "Condition", "text": [ "exacerbation of chronic bronchitis" ], "offsets": [ [ 138, 172 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T8", "type": "Scope", "text": [ "mild-severe acute exacerbation of chronic bronchitis" ], "offsets": [ [ 120, 172 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T9", "type": "Condition", "text": [ "AECB" ], "offsets": [ [ 174, 178 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T10", "type": "Measurement", "text": [ "Oxygen saturation" ], "offsets": [ [ 180, 197 ] ], "normalized": [] }, { "id": "NCT03400735_inc_T11", "type": "Value", "text": [ "< 90%" ], "offsets": [ [ 198, 203 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03400735_inc_R1", "type": "Has_value", "arg1_id": "NCT03400735_inc_T3", "arg2_id": "NCT03400735_inc_T4", "normalized": [] }, { "id": "NCT03400735_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03400735_inc_T7", "arg2_id": "NCT03400735_inc_T6", "normalized": [] }, { "id": "NCT03400735_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT03400735_inc_T7", "arg2_id": "NCT03400735_inc_T5", "normalized": [] }, { "id": "NCT03400735_inc_R4", "type": "Subsumes", "arg1_id": "NCT03400735_inc_T8", "arg2_id": "NCT03400735_inc_T9", "normalized": [] }, { "id": "NCT03400735_inc_R5", "type": "Has_value", "arg1_id": "NCT03400735_inc_T10", "arg2_id": "NCT03400735_inc_T11", "normalized": [] } ]

[ { "id": "NCT03402945_exc_text", "type": "exclusion", "text": [ "On systemic antibiotics or with an active bacterial infection at the time of surgery\nPatients previously enrolled in this trial\nPatients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena\nParticipation in other studies that may interfere with this trial\n" ], "offsets": [ [ 0, 451 ] ] } ]

[ { "id": "NCT03402945_exc_T1", "type": "Drug", "text": [ "systemic antibiotics" ], "offsets": [ [ 3, 23 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T2", "type": "Condition", "text": [ "bacterial infection" ], "offsets": [ [ 42, 61 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T3", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 35, 41 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T4", "type": "Temporal", "text": [ "at the time of surgery" ], "offsets": [ [ 62, 84 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T5", "type": "Reference_point", "text": [ "the time of surgery" ], "offsets": [ [ 65, 84 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T6", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 77, 84 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T7", "type": "Observation", "text": [ "previously enrolled in this trial" ], "offsets": [ [ 94, 127 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T8", "type": "Qualifier", "text": [ "Methicillin-resistant S. aureus (MRSA)" ], "offsets": [ [ 164, 202 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T9", "type": "Condition", "text": [ "colonized" ], "offsets": [ [ 149, 158 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T11", "type": "Drug", "text": [ "beta-lactam" ], "offsets": [ [ 247, 258 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T12", "type": "Drug", "text": [ "vancomycin" ], "offsets": [ [ 262, 272 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T13", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 273, 280 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T14", "type": "Scope", "text": [ "ta-lactam or vancomycin a", "fazolin or vancomycin, respectively, or to silver p" ], "offsets": [ [ 249, 274 ], [ 305, 356 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T15", "type": "Drug", "text": [ "cefazolin" ], "offsets": [ [ 303, 312 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T16", "type": "Drug", "text": [ "vancomycin" ], "offsets": [ [ 316, 326 ] ], "normalized": [] }, { "id": "NCT03402945_exc_T17", "type": "Drug", "text": [ "silver" ], "offsets": [ [ 348, 354 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03402945_exc_R2", "type": "Has_index", "arg1_id": "NCT03402945_exc_T4", "arg2_id": "NCT03402945_exc_T5", "normalized": [] }, { "id": "NCT03402945_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03402945_exc_T2", "arg2_id": "NCT03402945_exc_T4", "normalized": [] }, { "id": "NCT03402945_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT03402945_exc_T2", "arg2_id": "NCT03402945_exc_T3", "normalized": [] }, { "id": "NCT03402945_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03402945_exc_T9", "arg2_id": "NCT03402945_exc_T8", "normalized": [] }, { "id": "NCT03402945_exc_R6", "type": "Has_scope", "arg1_id": "NCT03402945_exc_T13", "arg2_id": "NCT03402945_exc_T14", "normalized": [] } ]

[ { "id": "NCT03402945_inc_text", "type": "inclusion", "text": [ "≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies)\n" ], "offsets": [ [ 0, 103 ] ] } ]

[ { "id": "NCT03402945_inc_T1", "type": "Value", "text": [ "≥18 years" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 13, 16 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T3", "type": "Procedure", "text": [ "open-heart surgery" ], "offsets": [ [ 28, 46 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T4", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 17, 27 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T5", "type": "Procedure", "text": [ "sternotomy" ], "offsets": [ [ 48, 58 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T6", "type": "Procedure", "text": [ "minimally-invasive sternotomies" ], "offsets": [ [ 70, 101 ] ], "normalized": [] }, { "id": "NCT03402945_inc_T7", "type": "Scope", "text": [ "sternotomy, including minimally-invasive sternotomies" ], "offsets": [ [ 48, 101 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03402945_inc_R1", "type": "Has_value", "arg1_id": "NCT03402945_inc_T2", "arg2_id": "NCT03402945_inc_T1", "normalized": [] }, { "id": "NCT03402945_inc_R2", "type": "Has_temporal", "arg1_id": "NCT03402945_inc_T3", "arg2_id": "NCT03402945_inc_T4", "normalized": [] }, { "id": "NCT03402945_inc_R3", "type": "Subsumes", "arg1_id": "NCT03402945_inc_T5", "arg2_id": "NCT03402945_inc_T6", "normalized": [] }, { "id": "NCT03402945_inc_R4", "type": "Subsumes", "arg1_id": "NCT03402945_inc_T3", "arg2_id": "NCT03402945_inc_T5", "normalized": [] } ]

[ { "id": "NCT03404479_exc_text", "type": "exclusion", "text": [ "Secondary knee osteoarthritis\nOther inflammatory Knee Osteoarthritis (e.g. gout, rheumatoid arthritis, etc.)\nPatients presenting with gastroesophageal reflux disease, peptic ulcer.\nHelicobacter infected patients who have not been treated for eradication (recruitment if negative in re-examination after treatment).\nShort bowel syndrome that can cause inflammatory bowel disease (ulcerative colitis, Crohn's disease) and drug absorption disorder.\nIntestinal obstruction syndrome\nUnexplained abdominal pain\nALT(Alanine aminotransferase) level of liver function test exceeded 5 times of reference range\nTotal bilirubin level exceeded 2 mg / dL\nSerum albumin level less than 2 g / dL\nAscites\nHepatic encephalopathy\nHepatitis B, hepatitis C (excluding healthy carriers) or HIV positive\nMDRD(Modification of Diet in Renal Disease) Estimated Glomerular filtration rate less than 60 mL / m2\nPatients with hyperkalemia (over 5.5 meq / L)\nhistory of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs(including COX-2 inhibitors).\nMalignant tumors other than basal cell or squamous cell carcinoma of the skin, CIN(Cervical Intraepitherial Neoplasia) and CIS(Carcinoma in situ) of the cervix, and intraepithelial carcinoma of other areas Within 5 years of consent date.\nMedical history of hypersensitivity to the components of the investigational products. (The components of test drug 1 and 2, including the Rhein-based drug)\nPatients with an allergic reaction to sulfonamide.\nPatients with galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.\nSubjects who have not reached the prescribed period after receiving contraindicated medication or treatment before participation in this clinical trial.\nPatients receiving contraindicated medication.\nAlcohol and other drug abuse cases based on 6 months before screening.\nPregnant women or nursing mothers who are not willing to stop breastfeeding.\n(1) Menopause (non-therapy-induced amenorrhea of more than 12 months) Female\n(2) Female infertility due to surgery (no ovaries and / or uterus)\n(3) If you have sexual intercourse with only one male partner who has been confirmed to have no semen after fertilization.\n(4) Female subjects who agreed to abstinence during the clinical trial period.\nIf the subject is assured of an abstinence throughout the trial period.(e.g. clergy)\nHowever, intermittent abstinence (eg, contraception using ovulation period, symptothermal) or coitus interrupts is not a case of consent for abstinence.\n(5) For women of childbearing age, the following methods or methods of contraception use the effective method of contraception to be used during the period of this clinical trial:\nOral contraceptive\nThe contraceptive patch\nIntra uterine device (IUD)\ncontraceptive implant\ncontraceptive injection\nintrauterine hormonal apparatus\nTubal ligation and infertility surgery\nIf 30 days have not elapsed after the date of signing of the previous clinical trial or currently participating in other clinical trials.\nPatients who are scheduled for surgery during the clinical trial period or who have difficulties in completing the protocol during this clinical trial due to other reasons.\nIn addition to the above, other diseases that the investigator judges to be inappropriate.\n" ], "offsets": [ [ 0, 3353 ] ] } ]

[ { "id": "NCT03404479_exc_T1", "type": "Qualifier", "text": [ "Secondary" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T2", "type": "Condition", "text": [ "knee osteoarthritis" ], "offsets": [ [ 10, 29 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T3", "type": "Qualifier", "text": [ "Other" ], "offsets": [ [ 30, 35 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T4", "type": "Condition", "text": [ "inflammatory Knee Osteoarthritis" ], "offsets": [ [ 36, 68 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T5", "type": "Condition", "text": [ "gout" ], "offsets": [ [ 75, 79 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T6", "type": "Condition", "text": [ "rheumatoid arthritis" ], "offsets": [ [ 81, 101 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T7", "type": "Scope", "text": [ "gout, rheumatoid arthritis" ], "offsets": [ [ 75, 101 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T8", "type": "Scope", "text": [ "Other inflammatory Knee Osteoarthritis" ], "offsets": [ [ 30, 68 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T9", "type": "Condition", "text": [ "gastroesophageal reflux disease" ], "offsets": [ [ 134, 165 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T10", "type": "Condition", "text": [ "peptic ulcer" ], "offsets": [ [ 167, 179 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T11", "type": "Condition", "text": [ "Helicobacter infected" ], "offsets": [ [ 181, 202 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T12", "type": "Negation", "text": [ "not" ], "offsets": [ [ 221, 224 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T13", "type": "Procedure", "text": [ "treated for eradication" ], "offsets": [ [ 230, 253 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T14", "type": "Condition", "text": [ "Short bowel syndrome" ], "offsets": [ [ 315, 335 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T15", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 351, 377 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T16", "type": "Mood", "text": [ "can cause" ], "offsets": [ [ 341, 350 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T17", "type": "Qualifier", "text": [ "that can cause inflammatory bowel disease" ], "offsets": [ [ 336, 377 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T18", "type": "Condition", "text": [ "ulcerative colitis" ], "offsets": [ [ 379, 397 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T19", "type": "Condition", "text": [ "Crohn's disease" ], "offsets": [ [ 399, 414 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T20", "type": "Condition", "text": [ "drug absorption disorder" ], "offsets": [ [ 420, 444 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T21", "type": "Scope", "text": [ "ulcerative colitis, Crohn's disease" ], "offsets": [ [ 379, 414 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T22", "type": "Scope", "text": [ "Short bowel syndrome that can cause inflammatory bowel disease" ], "offsets": [ [ 315, 377 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T23", "type": "Condition", "text": [ "Intestinal obstruction syndrome" ], "offsets": [ [ 446, 477 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T24", "type": "Qualifier", "text": [ "Unexplained" ], "offsets": [ [ 478, 489 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T25", "type": "Condition", "text": [ "abdominal pain" ], "offsets": [ [ 490, 504 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T26", "type": "Measurement", "text": [ "ALT(Alanine aminotransferase) level" ], "offsets": [ [ 505, 540 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T27", "type": "Procedure", "text": [ "liver function test" ], "offsets": [ [ 544, 563 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T28", "type": "Value", "text": [ "exceeded 5 times of reference range" ], "offsets": [ [ 564, 599 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T29", "type": "Measurement", "text": [ "Total bilirubin level" ], "offsets": [ [ 600, 621 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T30", "type": "Value", "text": [ "exceeded 2 mg / dL" ], "offsets": [ [ 622, 640 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T31", "type": "Measurement", "text": [ "Serum albumin level" ], "offsets": [ [ 641, 660 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T32", "type": "Value", "text": [ "ess than 2 g / dL" ], "offsets": [ [ 662, 679 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T33", "type": "Condition", "text": [ "Ascites" ], "offsets": [ [ 680, 687 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T34", "type": "Condition", "text": [ "Hepatic encephalopathy" ], "offsets": [ [ 688, 710 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T35", "type": "Condition", "text": [ "Hepatitis B" ], "offsets": [ [ 711, 722 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T36", "type": "Condition", "text": [ "hepatitis C" ], "offsets": [ [ 724, 735 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T37", "type": "Condition", "text": [ "HIV positive" ], "offsets": [ [ 768, 780 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T38", "type": "Negation", "text": [ "excluding" ], "offsets": [ [ 737, 746 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T39", "type": "Condition", "text": [ "healthy carriers" ], "offsets": [ [ 747, 763 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T40", "type": "Qualifier", "text": [ "MDRD(Modification of Diet in Renal Disease)" ], "offsets": [ [ 781, 824 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T41", "type": "Measurement", "text": [ "Estimated Glomerular filtration rate" ], "offsets": [ [ 825, 861 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T42", "type": "Value", "text": [ "less than 60 mL / m2" ], "offsets": [ [ 862, 882 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T43", "type": "Condition", "text": [ "hyperkalemia" ], "offsets": [ [ 897, 909 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T44", "type": "Value", "text": [ "over 5.5 meq / L" ], "offsets": [ [ 911, 927 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T45", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 940, 946 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T46", "type": "Condition", "text": [ "acute rhinitis" ], "offsets": [ [ 948, 962 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T47", "type": "Condition", "text": [ "nasal polyps" ], "offsets": [ [ 964, 976 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T48", "type": "Condition", "text": [ "angioedema" ], "offsets": [ [ 978, 988 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T49", "type": "Condition", "text": [ "urticaria" ], "offsets": [ [ 990, 999 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T50", "type": "Condition", "text": [ "allergic reactions" ], "offsets": [ [ 1003, 1021 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T51", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 1025, 1032 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T52", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 1036, 1041 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T53", "type": "Drug", "text": [ "non-steroidal anti-inflammatory drugs" ], "offsets": [ [ 1042, 1079 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T54", "type": "Drug", "text": [ "COX-2 inhibitors" ], "offsets": [ [ 1090, 1106 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T55", "type": "Scope", "text": [ "aspirin or other non-steroidal anti-inflammatory drugs(including COX-2 inhibitors)" ], "offsets": [ [ 1025, 1107 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T56", "type": "Condition", "text": [ "Malignant tumors" ], "offsets": [ [ 1109, 1125 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T57", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1126, 1136 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T58", "type": "Condition", "text": [ "uamous cel", " skin, CIN(Cervical " ], "offsets": [ [ 1153, 1163 ], [ 1181, 1201 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T59", "type": "Condition", "text": [ "squamous cell carcinoma of the skin" ], "offsets": [ [ 1151, 1186 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T60", "type": "Scope", "text": [ "basal cell or squamous cell carcinoma of the skin" ], "offsets": [ [ 1137, 1186 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T61", "type": "Condition", "text": [ "CIN(Cervical Intraepitherial Neoplasia)" ], "offsets": [ [ 1188, 1227 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T62", "type": "Condition", "text": [ "CIS(Carcinoma in situ) of the cervix" ], "offsets": [ [ 1232, 1268 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T63", "type": "Condition", "text": [ "intraepithelial carcinoma" ], "offsets": [ [ 1274, 1299 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T64", "type": "Temporal", "text": [ "Within 5 years of consent date" ], "offsets": [ [ 1315, 1345 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T65", "type": "Reference_point", "text": [ "consent date" ], "offsets": [ [ 1333, 1345 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T66", "type": "Scope", "text": [ "Malignant tumors other than basal cell or squamous cell carcinoma of the skin, CIN(Cervical Intraepitherial Neoplasia) and CIS(Carcinoma in situ) of the cervix, and intraepithelial carcinoma" ], "offsets": [ [ 1109, 1299 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T67", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1366, 1382 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T68", "type": "Drug", "text": [ "components of the investigational products" ], "offsets": [ [ 1390, 1432 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T69", "type": "Drug", "text": [ "components of test drug 1" ], "offsets": [ [ 1439, 1464 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T70", "type": "Drug", "text": [ "t drug 1 and 2, includi", "R" ], "offsets": [ [ 1456, 1479 ], [ 1486, 1487 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T71", "type": "Drug", "text": [ "Rhein-based drug" ], "offsets": [ [ 1486, 1502 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T72", "type": "Scope", "text": [ "components of test drug 1 and 2, including the Rhein-based drug" ], "offsets": [ [ 1439, 1502 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T73", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 1521, 1538 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T74", "type": "Drug", "text": [ "sulfonamide" ], "offsets": [ [ 1542, 1553 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T75", "type": "Condition", "text": [ "galactose intolerance" ], "offsets": [ [ 1569, 1590 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T76", "type": "Condition", "text": [ "lapp lactase deficiency" ], "offsets": [ [ 1592, 1615 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T77", "type": "Condition", "text": [ "glucose-galactose malabsorption" ], "offsets": [ [ 1619, 1650 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T79", "type": "Drug", "text": [ "contraindicated medication" ], "offsets": [ [ 1824, 1850 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T80", "type": "Condition", "text": [ " abus", " mon" ], "offsets": [ [ 1874, 1879 ], [ 1897, 1901 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T81", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 1870, 1880 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T82", "type": "Temporal", "text": [ "6 months before screening" ], "offsets": [ [ 1896, 1921 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T83", "type": "Scope", "text": [ "Alcohol and other drug abuse" ], "offsets": [ [ 1852, 1880 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T85", "type": "Condition", "text": [ "Menopause" ], "offsets": [ [ 2004, 2013 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T86", "type": "Qualifier", "text": [ "non-therapy-induced" ], "offsets": [ [ 2015, 2034 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T87", "type": "Condition", "text": [ "amenorrhea" ], "offsets": [ [ 2035, 2045 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T88", "type": "Multiplier", "text": [ "more than 12 months" ], "offsets": [ [ 2049, 2068 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T89", "type": "Scope", "text": [ "non-therapy-induced amenorrhea of more than 12 months" ], "offsets": [ [ 2015, 2068 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T90", "type": "Person", "text": [ "Female" ], "offsets": [ [ 2081, 2087 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T91", "type": "Person", "text": [ "Female" ], "offsets": [ [ 2081, 2087 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T92", "type": "Condition", "text": [ "infertility" ], "offsets": [ [ 2088, 2099 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T93", "type": "Qualifier", "text": [ "due to surgery" ], "offsets": [ [ 2100, 2114 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T94", "type": "Condition", "text": [ "no ovaries" ], "offsets": [ [ 2116, 2126 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T95", "type": "Condition", "text": [ "s)", "exual" ], "offsets": [ [ 2141, 2143 ], [ 2161, 2166 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T96", "type": "Scope", "text": [ "infertility due to surgery" ], "offsets": [ [ 2088, 2114 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T97", "type": "Scope", "text": [ "no ovaries and / or uterus" ], "offsets": [ [ 2116, 2142 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T103", "type": "Drug", "text": [ "Oral contraceptive" ], "offsets": [ [ 2764, 2782 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T107", "type": "Device", "text": [ "contraceptive patch" ], "offsets": [ [ 2787, 2806 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T108", "type": "Device", "text": [ "Intra uterine device (IUD)" ], "offsets": [ [ 2807, 2833 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T109", "type": "Device", "text": [ "contraceptive implant" ], "offsets": [ [ 2834, 2855 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T110", "type": "Device", "text": [ "contraceptive injection" ], "offsets": [ [ 2856, 2879 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T111", "type": "Device", "text": [ "intrauterine hormonal apparatus" ], "offsets": [ [ 2880, 2911 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T112", "type": "Procedure", "text": [ "Tubal ligation" ], "offsets": [ [ 2912, 2926 ] ], "normalized": [] }, { "id": "NCT03404479_exc_T113", "type": "Procedure", "text": [ "infertility surgery" ], "offsets": [ [ 2931, 2950 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03404479_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T2", "arg2_id": "NCT03404479_exc_T1", "normalized": [] }, { "id": "NCT03404479_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T4", "arg2_id": "NCT03404479_exc_T3", "normalized": [] }, { "id": "NCT03404479_exc_R3", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T8", "arg2_id": "NCT03404479_exc_T7", "normalized": [] }, { "id": "NCT03404479_exc_R4", "type": "Has_negation", "arg1_id": "NCT03404479_exc_T13", "arg2_id": "NCT03404479_exc_T12", "normalized": [] }, { "id": "NCT03404479_exc_R5", "type": "AND", "arg1_id": "NCT03404479_exc_T11", "arg2_id": "NCT03404479_exc_T13", "normalized": [] }, { "id": "NCT03404479_exc_R6", "type": "Has_mood", "arg1_id": "NCT03404479_exc_T15", "arg2_id": "NCT03404479_exc_T16", "normalized": [] }, { "id": "NCT03404479_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T14", "arg2_id": "NCT03404479_exc_T17", "normalized": [] }, { "id": "NCT03404479_exc_R9", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T22", "arg2_id": "NCT03404479_exc_T21", "normalized": [] }, { "id": "NCT03404479_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T25", "arg2_id": "NCT03404479_exc_T24", "normalized": [] }, { "id": "NCT03404479_exc_R11", "type": "AND", "arg1_id": "NCT03404479_exc_T27", "arg2_id": "NCT03404479_exc_T26", "normalized": [] }, { "id": "NCT03404479_exc_R12", "type": "Has_value", "arg1_id": "NCT03404479_exc_T26", "arg2_id": "NCT03404479_exc_T28", "normalized": [] }, { "id": "NCT03404479_exc_R13", "type": "Has_value", "arg1_id": "NCT03404479_exc_T29", "arg2_id": "NCT03404479_exc_T30", "normalized": [] }, { "id": "NCT03404479_exc_R14", "type": "Has_value", "arg1_id": "NCT03404479_exc_T31", "arg2_id": "NCT03404479_exc_T32", "normalized": [] }, { "id": "NCT03404479_exc_R15", "type": "Has_negation", "arg1_id": "NCT03404479_exc_T39", "arg2_id": "NCT03404479_exc_T38", "normalized": [] }, { "id": "NCT03404479_exc_R16", "type": "AND", "arg1_id": "NCT03404479_exc_T36", "arg2_id": "NCT03404479_exc_T39", "normalized": [] }, { "id": "NCT03404479_exc_R17", "type": "Has_value", "arg1_id": "NCT03404479_exc_T41", "arg2_id": "NCT03404479_exc_T42", "normalized": [] }, { "id": "NCT03404479_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T41", "arg2_id": "NCT03404479_exc_T40", "normalized": [] }, { "id": "NCT03404479_exc_R19", "type": "Has_value", "arg1_id": "NCT03404479_exc_T43", "arg2_id": "NCT03404479_exc_T44", "normalized": [] }, { "id": "NCT03404479_exc_R20", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T53", "arg2_id": "NCT03404479_exc_T54", "normalized": [] }, { "id": "NCT03404479_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T53", "arg2_id": "NCT03404479_exc_T52", "normalized": [] }, { "id": "NCT03404479_exc_R22", "type": "Has_scope", "arg1_id": "NCT03404479_exc_T50", "arg2_id": "NCT03404479_exc_T55", "normalized": [] }, { "id": "NCT03404479_exc_R23", "type": "Has_negation", "arg1_id": "NCT03404479_exc_T60", "arg2_id": "NCT03404479_exc_T57", "normalized": [] }, { "id": "NCT03404479_exc_R24", "type": "Has_scope", "arg1_id": "NCT03404479_exc_T56", "arg2_id": "NCT03404479_exc_T60", "normalized": [] }, { "id": "NCT03404479_exc_R25", "type": "Has_index", "arg1_id": "NCT03404479_exc_T64", "arg2_id": "NCT03404479_exc_T65", "normalized": [] }, { "id": "NCT03404479_exc_R26", "type": "Has_temporal", "arg1_id": "NCT03404479_exc_T66", "arg2_id": "NCT03404479_exc_T64", "normalized": [] }, { "id": "NCT03404479_exc_R27", "type": "AND", "arg1_id": "NCT03404479_exc_T67", "arg2_id": "NCT03404479_exc_T68", "normalized": [] }, { "id": "NCT03404479_exc_R28", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T68", "arg2_id": "NCT03404479_exc_T72", "normalized": [] }, { "id": "NCT03404479_exc_R29", "type": "AND", "arg1_id": "NCT03404479_exc_T73", "arg2_id": "NCT03404479_exc_T74", "normalized": [] }, { "id": "NCT03404479_exc_R30", "type": "Has_multiplier", "arg1_id": "NCT03404479_exc_T87", "arg2_id": "NCT03404479_exc_T88", "normalized": [] }, { "id": "NCT03404479_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T87", "arg2_id": "NCT03404479_exc_T86", "normalized": [] }, { "id": "NCT03404479_exc_R32", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T85", "arg2_id": "NCT03404479_exc_T89", "normalized": [] }, { "id": "NCT03404479_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT03404479_exc_T92", "arg2_id": "NCT03404479_exc_T93", "normalized": [] }, { "id": "NCT03404479_exc_R34", "type": "Subsumes", "arg1_id": "NCT03404479_exc_T96", "arg2_id": "NCT03404479_exc_T97", "normalized": [] } ]

[ { "id": "NCT03404479_inc_text", "type": "inclusion", "text": [ "Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.\nAdult over 50 years of age.\nAt least one of the knee pain VAS score is 40mm or more.\nPatients who require medication for more than 12 weeks due to osteoarthritis symptoms.\nThose who are able to follow the requirements of this clinical trial, such as being able to trace during the clinical trial period and to read and write the VAS questionnaire.\nThose who weigh more than 40kg\n" ], "offsets": [ [ 0, 494 ] ] } ]

[ { "id": "NCT03404479_inc_T2", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T3", "type": "Value", "text": [ "over 50 years" ], "offsets": [ [ 121, 134 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 138, 141 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T5", "type": "Multiplier", "text": [ "At least one" ], "offsets": [ [ 143, 155 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T6", "type": "Condition", "text": [ "knee pain" ], "offsets": [ [ 163, 172 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T7", "type": "Measurement", "text": [ "VAS score" ], "offsets": [ [ 173, 182 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T8", "type": "Value", "text": [ "40mm or more" ], "offsets": [ [ 186, 198 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T9", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 221, 231 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T10", "type": "Multiplier", "text": [ "more than 12 weeks" ], "offsets": [ [ 236, 254 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T11", "type": "Condition", "text": [ "osteoarthritis symptoms" ], "offsets": [ [ 262, 285 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T13", "type": "Measurement", "text": [ "weigh" ], "offsets": [ [ 473, 478 ] ], "normalized": [] }, { "id": "NCT03404479_inc_T14", "type": "Value", "text": [ "more than 40kg" ], "offsets": [ [ 479, 493 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03404479_inc_R1", "type": "Has_value", "arg1_id": "NCT03404479_inc_T4", "arg2_id": "NCT03404479_inc_T3", "normalized": [] }, { "id": "NCT03404479_inc_R2", "type": "Has_value", "arg1_id": "NCT03404479_inc_T7", "arg2_id": "NCT03404479_inc_T8", "normalized": [] }, { "id": "NCT03404479_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT03404479_inc_T6", "arg2_id": "NCT03404479_inc_T5", "normalized": [] }, { "id": "NCT03404479_inc_R4", "type": "AND", "arg1_id": "NCT03404479_inc_T6", "arg2_id": "NCT03404479_inc_T7", "normalized": [] }, { "id": "NCT03404479_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT03404479_inc_T9", "arg2_id": "NCT03404479_inc_T10", "normalized": [] }, { "id": "NCT03404479_inc_R6", "type": "AND", "arg1_id": "NCT03404479_inc_T11", "arg2_id": "NCT03404479_inc_T9", "normalized": [] }, { "id": "NCT03404479_inc_R7", "type": "Has_value", "arg1_id": "NCT03404479_inc_T13", "arg2_id": "NCT03404479_inc_T14", "normalized": [] } ]

[ { "id": "NCT03404804_exc_text", "type": "exclusion", "text": [ "Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).\nAny contraindication to allergy testing will also result in exclusion\n(i.e. history of a severe allergic reaction to skin tests,,\nanaphylaxis in the past six weeks,\npregnancy,\nchild took any antihistamine in the past three days [including diphenhydramine (Benadryl®), cetirizine (Zyrtec®), loratadine (Claritin®), fexofenadine (Allegra®), levocetirizine (Xyzal®), and desloratadine (Clarinex®)] or\nchild has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).\nChildren who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.\nPatients being admitted to the hospital or those who are deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.\nDuring this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.\nChildren who are wards of the state, in foster care or police custody or detention will be excluded.\nChildren with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.\n" ], "offsets": [ [ 0, 1679 ] ] } ]

[ { "id": "NCT03404804_exc_T1", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T2", "type": "Condition", "text": [ "developmental delay" ], "offsets": [ [ 52, 71 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T3", "type": "Condition", "text": [ "inability to communicate the effects" ], "offsets": [ [ 75, 111 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T4", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 118, 135 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T5", "type": "Qualifier", "text": [ "non-verbal" ], "offsets": [ [ 137, 147 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T6", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 154, 170 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T7", "type": "Procedure", "text": [ "allergy testing" ], "offsets": [ [ 174, 189 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T8", "type": "Condition", "text": [ "severe allergic reaction" ], "offsets": [ [ 239, 263 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T9", "type": "Procedure", "text": [ "skin tests" ], "offsets": [ [ 267, 277 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T10", "type": "Observation", "text": [ "history" ], "offsets": [ [ 226, 233 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T11", "type": "Condition", "text": [ "anaphylaxis" ], "offsets": [ [ 280, 291 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T12", "type": "Temporal", "text": [ "in the past six weeks" ], "offsets": [ [ 292, 313 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T13", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 315, 324 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T14", "type": "Drug", "text": [ "antihistamine" ], "offsets": [ [ 341, 354 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T15", "type": "Temporal", "text": [ "in the past three days" ], "offsets": [ [ 355, 377 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T16", "type": "Drug", "text": [ "diphenhydramine" ], "offsets": [ [ 389, 404 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T17", "type": "Drug", "text": [ "Benadryl" ], "offsets": [ [ 406, 414 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T18", "type": "Drug", "text": [ "cetirizine" ], "offsets": [ [ 418, 428 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T19", "type": "Drug", "text": [ "Zyrtec" ], "offsets": [ [ 430, 436 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T20", "type": "Drug", "text": [ "loratadine" ], "offsets": [ [ 440, 450 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T21", "type": "Drug", "text": [ "Claritin" ], "offsets": [ [ 452, 460 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T22", "type": "Drug", "text": [ "fexofenadine" ], "offsets": [ [ 464, 476 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T23", "type": "Drug", "text": [ "Allegra" ], "offsets": [ [ 478, 485 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T24", "type": "Drug", "text": [ "levocetirizine" ], "offsets": [ [ 489, 503 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T25", "type": "Drug", "text": [ "Xyzal" ], "offsets": [ [ 505, 510 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T26", "type": "Drug", "text": [ "desloratadine" ], "offsets": [ [ 518, 531 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T27", "type": "Drug", "text": [ "Clarinex" ], "offsets": [ [ 533, 541 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T28", "type": "Scope", "text": [ "diphenhydramine (Benadryl®), cetirizine (Zyrtec®), loratadine (Claritin®), fexofenadine (Allegra®), levocetirizine (Xyzal®), and desloratadine (Clarinex®)" ], "offsets": [ [ 389, 543 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T29", "type": "Drug", "text": [ "beta blocker medicine" ], "offsets": [ [ 599, 620 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T30", "type": "Condition", "text": [ "cardiac conditions" ], "offsets": [ [ 625, 643 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T31", "type": "Condition", "text": [ "high blood pressure" ], "offsets": [ [ 645, 664 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T32", "type": "Condition", "text": [ "migraine headaches" ], "offsets": [ [ 666, 684 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T33", "type": "Condition", "text": [ "glaucoma" ], "offsets": [ [ 703, 711 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T34", "type": "Drug", "text": [ "eye drops" ], "offsets": [ [ 689, 698 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T35", "type": "Drug", "text": [ "propranolol" ], "offsets": [ [ 718, 729 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T36", "type": "Drug", "text": [ "metoprolol" ], "offsets": [ [ 731, 741 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T37", "type": "Drug", "text": [ "atenolol" ], "offsets": [ [ 743, 751 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T38", "type": "Drug", "text": [ "Timoptic" ], "offsets": [ [ 756, 764 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T39", "type": "Drug", "text": [ "Betoptic" ], "offsets": [ [ 770, 778 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T40", "type": "Drug", "text": [ "eye drops" ], "offsets": [ [ 780, 789 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T41", "type": "Scope", "text": [ "cardiac conditions, high blood pressure, migraine headaches" ], "offsets": [ [ 625, 684 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T42", "type": "Scope", "text": [ "propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops" ], "offsets": [ [ 718, 789 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T43", "type": "Person", "text": [ "Children" ], "offsets": [ [ 792, 800 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T44", "type": "Visit", "text": [ "PED" ], "offsets": [ [ 820, 823 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T45", "type": "Condition", "text": [ "rash" ], "offsets": [ [ 831, 835 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T46", "type": "Condition", "text": [ "vomiting" ], "offsets": [ [ 837, 845 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T47", "type": "Condition", "text": [ "asthma symptoms" ], "offsets": [ [ 857, 872 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T48", "type": "Condition", "text": [ "coughing" ], "offsets": [ [ 883, 891 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T49", "type": "Condition", "text": [ "wheezing" ], "offsets": [ [ 893, 901 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T50", "type": "Condition", "text": [ "breathing problems" ], "offsets": [ [ 905, 923 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T51", "type": "Scope", "text": [ "coughing, wheezing or breathing problems" ], "offsets": [ [ 883, 923 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T52", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 849, 856 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T54", "type": "Observation", "text": [ "non-English speaking" ], "offsets": [ [ 1245, 1265 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T56", "type": "Observation", "text": [ "wards of the state" ], "offsets": [ [ 1377, 1395 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T57", "type": "Observation", "text": [ "foster care" ], "offsets": [ [ 1400, 1411 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T58", "type": "Observation", "text": [ "police custody" ], "offsets": [ [ 1415, 1429 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T59", "type": "Observation", "text": [ "detention" ], "offsets": [ [ 1433, 1442 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T60", "type": "Condition", "text": [ "basal condition" ], "offsets": [ [ 1479, 1494 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T61", "type": "Condition", "text": [ "trauma" ], "offsets": [ [ 1496, 1502 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T62", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 1504, 1513 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T63", "type": "Condition", "text": [ "minor accidents" ], "offsets": [ [ 1515, 1530 ] ], "normalized": [] }, { "id": "NCT03404804_exc_T64", "type": "Scope", "text": [ "trauma, infection, minor accidents" ], "offsets": [ [ 1496, 1530 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03404804_exc_R1", "type": "AND", "arg1_id": "NCT03404804_exc_T3", "arg2_id": "NCT03404804_exc_T4", "normalized": [] }, { "id": "NCT03404804_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03404804_exc_T3", "arg2_id": "NCT03404804_exc_T5", "normalized": [] }, { "id": "NCT03404804_exc_R3", "type": "AND", "arg1_id": "NCT03404804_exc_T6", "arg2_id": "NCT03404804_exc_T7", "normalized": [] }, { "id": "NCT03404804_exc_R4", "type": "AND", "arg1_id": "NCT03404804_exc_T8", "arg2_id": "NCT03404804_exc_T9", "normalized": [] }, { "id": "NCT03404804_exc_R5", "type": "Has_temporal", "arg1_id": "NCT03404804_exc_T8", "arg2_id": "NCT03404804_exc_T10", "normalized": [] }, { "id": "NCT03404804_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03404804_exc_T11", "arg2_id": "NCT03404804_exc_T12", "normalized": [] }, { "id": "NCT03404804_exc_R7", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T16", "arg2_id": "NCT03404804_exc_T17", "normalized": [] }, { "id": "NCT03404804_exc_R8", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T18", "arg2_id": "NCT03404804_exc_T19", "normalized": [] }, { "id": "NCT03404804_exc_R9", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T20", "arg2_id": "NCT03404804_exc_T21", "normalized": [] }, { "id": "NCT03404804_exc_R10", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T22", "arg2_id": "NCT03404804_exc_T23", "normalized": [] }, { "id": "NCT03404804_exc_R11", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T24", "arg2_id": "NCT03404804_exc_T25", "normalized": [] }, { "id": "NCT03404804_exc_R12", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T26", "arg2_id": "NCT03404804_exc_T27", "normalized": [] }, { "id": "NCT03404804_exc_R13", "type": "Has_temporal", "arg1_id": "NCT03404804_exc_T14", "arg2_id": "NCT03404804_exc_T15", "normalized": [] }, { "id": "NCT03404804_exc_R14", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T14", "arg2_id": "NCT03404804_exc_T28", "normalized": [] }, { "id": "NCT03404804_exc_R15", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T40", "arg2_id": "NCT03404804_exc_T39", "normalized": [] }, { "id": "NCT03404804_exc_R16", "type": "AND", "arg1_id": "NCT03404804_exc_T33", "arg2_id": "NCT03404804_exc_T34", "normalized": [] }, { "id": "NCT03404804_exc_R17", "type": "AND", "arg1_id": "NCT03404804_exc_T41", "arg2_id": "NCT03404804_exc_T29", "normalized": [] }, { "id": "NCT03404804_exc_R18", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T34", "arg2_id": "NCT03404804_exc_T42", "normalized": [] }, { "id": "NCT03404804_exc_R19", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T47", "arg2_id": "NCT03404804_exc_T51", "normalized": [] }, { "id": "NCT03404804_exc_R20", "type": "Has_temporal", "arg1_id": "NCT03404804_exc_T47", "arg2_id": "NCT03404804_exc_T52", "normalized": [] }, { "id": "NCT03404804_exc_R21", "type": "Subsumes", "arg1_id": "NCT03404804_exc_T60", "arg2_id": "NCT03404804_exc_T64", "normalized": [] } ]

[ { "id": "NCT03404804_inc_text", "type": "inclusion", "text": [ "Children aged 3-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.\nOnly children well enough to be discharged to home at the conclusion of the PED visit are eligible.\n" ], "offsets": [ [ 0, 324 ] ] } ]

[ { "id": "NCT03404804_inc_T1", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T2", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T3", "type": "Value", "text": [ "3-16" ], "offsets": [ [ 14, 18 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T4", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 88, 95 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T5", "type": "Drug", "text": [ "penicillin antibiotic" ], "offsets": [ [ 101, 122 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T6", "type": "Temporal", "text": [ "at least six months prior to the current PED visit" ], "offsets": [ [ 172, 222 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T7", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 145, 162 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T8", "type": "Condition", "text": [ "well enough to be discharged to home" ], "offsets": [ [ 238, 274 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T9", "type": "Temporal", "text": [ "at the conclusion of the PED visit" ], "offsets": [ [ 275, 309 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T10", "type": "Reference_point", "text": [ "the conclusion of the PED visit" ], "offsets": [ [ 278, 309 ] ], "normalized": [] }, { "id": "NCT03404804_inc_T11", "type": "Visit", "text": [ "PED" ], "offsets": [ [ 300, 303 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03404804_inc_R1", "type": "Has_value", "arg1_id": "NCT03404804_inc_T2", "arg2_id": "NCT03404804_inc_T3", "normalized": [] }, { "id": "NCT03404804_inc_R2", "type": "AND", "arg1_id": "NCT03404804_inc_T4", "arg2_id": "NCT03404804_inc_T5", "normalized": [] }, { "id": "NCT03404804_inc_R3", "type": "Has_temporal", "arg1_id": "NCT03404804_inc_T7", "arg2_id": "NCT03404804_inc_T6", "normalized": [] }, { "id": "NCT03404804_inc_R4", "type": "AND", "arg1_id": "NCT03404804_inc_T4", "arg2_id": "NCT03404804_inc_T7", "normalized": [] }, { "id": "NCT03404804_inc_R6", "type": "Has_index", "arg1_id": "NCT03404804_inc_T9", "arg2_id": "NCT03404804_inc_T10", "normalized": [] }, { "id": "NCT03404804_inc_R7", "type": "Has_temporal", "arg1_id": "NCT03404804_inc_T8", "arg2_id": "NCT03404804_inc_T9", "normalized": [] } ]

[ { "id": "NCT03407625_exc_text", "type": "exclusion", "text": [ "latex allergy\nnon-reassuring fetal status\nHIV\nactive herpes outbreak\nPrior uterine scar\nContraindication to prostaglandins according to current Parkland protocol\nContraindication to vaginal delivery\n" ], "offsets": [ [ 0, 199 ] ] } ]

[ { "id": "NCT03407625_exc_T1", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 6, 13 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T2", "type": "Drug", "text": [ "latex" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T3", "type": "Condition", "text": [ "fetal status" ], "offsets": [ [ 29, 41 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T4", "type": "Qualifier", "text": [ "non-reassuring" ], "offsets": [ [ 14, 28 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T5", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 42, 45 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T6", "type": "Condition", "text": [ "herpes" ], "offsets": [ [ 53, 59 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T7", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 46, 52 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T8", "type": "Condition", "text": [ "uterine scar" ], "offsets": [ [ 75, 87 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T9", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 88, 104 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T10", "type": "Drug", "text": [ "prostaglandins" ], "offsets": [ [ 108, 122 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T11", "type": "Procedure", "text": [ "Parkland protocol" ], "offsets": [ [ 144, 161 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T12", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 162, 178 ] ], "normalized": [] }, { "id": "NCT03407625_exc_T13", "type": "Procedure", "text": [ "vaginal delivery" ], "offsets": [ [ 182, 198 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03407625_exc_R1", "type": "AND", "arg1_id": "NCT03407625_exc_T1", "arg2_id": "NCT03407625_exc_T2", "normalized": [] }, { "id": "NCT03407625_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03407625_exc_T3", "arg2_id": "NCT03407625_exc_T4", "normalized": [] }, { "id": "NCT03407625_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03407625_exc_T6", "arg2_id": "NCT03407625_exc_T7", "normalized": [] }, { "id": "NCT03407625_exc_R4", "type": "AND", "arg1_id": "NCT03407625_exc_T9", "arg2_id": "NCT03407625_exc_T10", "normalized": [] }, { "id": "NCT03407625_exc_R5", "type": "AND", "arg1_id": "NCT03407625_exc_T9", "arg2_id": "NCT03407625_exc_T11", "normalized": [] }, { "id": "NCT03407625_exc_R6", "type": "AND", "arg1_id": "NCT03407625_exc_T12", "arg2_id": "NCT03407625_exc_T13", "normalized": [] } ]

[ { "id": "NCT03407625_inc_text", "type": "inclusion", "text": [ "37 weeks gestation or greater\nLiving, singleton fetus\nNo major fetal malformations\nCephalic presentation\nNo prior uterine scar\nIntact fetal membranes\nQualifies for prostaglandin administration according to current Parkland protocol\nHave a cervical dilation of 2 centimeters or less, measured at the level of the internal os\nHave an indication for induction or attempted induction of labor according to Parkland protocol\n" ], "offsets": [ [ 0, 420 ] ] } ]

[ { "id": "NCT03407625_inc_T1", "type": "Condition", "text": [ "gestation" ], "offsets": [ [ 9, 18 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T2", "type": "Value", "text": [ "37 weeks", "greater" ], "offsets": [ [ 0, 8 ], [ 22, 29 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T3", "type": "Condition", "text": [ "singleton fetus" ], "offsets": [ [ 38, 53 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T4", "type": "Qualifier", "text": [ "Living" ], "offsets": [ [ 30, 36 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T5", "type": "Condition", "text": [ "major fetal malformations" ], "offsets": [ [ 57, 82 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T6", "type": "Negation", "text": [ "No" ], "offsets": [ [ 54, 56 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T7", "type": "Condition", "text": [ "Cephalic presentation" ], "offsets": [ [ 83, 104 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T8", "type": "Negation", "text": [ "No" ], "offsets": [ [ 105, 107 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T9", "type": "Condition", "text": [ "uterine scar" ], "offsets": [ [ 114, 126 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T10", "type": "Condition", "text": [ "fetal membranes" ], "offsets": [ [ 134, 149 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T11", "type": "Qualifier", "text": [ "Intact" ], "offsets": [ [ 127, 133 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T12", "type": "Procedure", "text": [ "prostaglandin administration" ], "offsets": [ [ 164, 192 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T13", "type": "Procedure", "text": [ "Parkland protocol" ], "offsets": [ [ 214, 231 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T14", "type": "Condition", "text": [ "cervical dilation" ], "offsets": [ [ 239, 256 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T15", "type": "Multiplier", "text": [ "2 centimeters or less" ], "offsets": [ [ 260, 281 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T16", "type": "Qualifier", "text": [ "internal os" ], "offsets": [ [ 312, 323 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T17", "type": "Condition", "text": [ "indication" ], "offsets": [ [ 332, 342 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T18", "type": "Procedure", "text": [ "n or atte", " accord" ], "offsets": [ [ 355, 364 ], [ 388, 395 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T19", "type": "Qualifier", "text": [ "attempted" ], "offsets": [ [ 360, 369 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T20", "type": "Procedure", "text": [ "Parkland protocol" ], "offsets": [ [ 402, 419 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T21", "type": "Procedure", "text": [ "induction" ], "offsets": [ [ 370, 379 ] ], "normalized": [] }, { "id": "NCT03407625_inc_T22", "type": "Scope", "text": [ "induction or attempted induction of labor" ], "offsets": [ [ 347, 388 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03407625_inc_R1", "type": "Has_value", "arg1_id": "NCT03407625_inc_T1", "arg2_id": "NCT03407625_inc_T2", "normalized": [] }, { "id": "NCT03407625_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03407625_inc_T3", "arg2_id": "NCT03407625_inc_T4", "normalized": [] }, { "id": "NCT03407625_inc_R3", "type": "Has_negation", "arg1_id": "NCT03407625_inc_T5", "arg2_id": "NCT03407625_inc_T6", "normalized": [] }, { "id": "NCT03407625_inc_R4", "type": "Has_negation", "arg1_id": "NCT03407625_inc_T9", "arg2_id": "NCT03407625_inc_T8", "normalized": [] }, { "id": "NCT03407625_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT03407625_inc_T10", "arg2_id": "NCT03407625_inc_T11", "normalized": [] }, { "id": "NCT03407625_inc_R6", "type": "AND", "arg1_id": "NCT03407625_inc_T13", "arg2_id": "NCT03407625_inc_T12", "normalized": [] }, { "id": "NCT03407625_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT03407625_inc_T14", "arg2_id": "NCT03407625_inc_T15", "normalized": [] }, { "id": "NCT03407625_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT03407625_inc_T14", "arg2_id": "NCT03407625_inc_T16", "normalized": [] }, { "id": "NCT03407625_inc_R9", "type": "AND", "arg1_id": "NCT03407625_inc_T20", "arg2_id": "NCT03407625_inc_T17", "normalized": [] }, { "id": "NCT03407625_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT03407625_inc_T21", "arg2_id": "NCT03407625_inc_T19", "normalized": [] }, { "id": "NCT03407625_inc_R10", "type": "Has_scope", "arg1_id": "NCT03407625_inc_T17", "arg2_id": "NCT03407625_inc_T22", "normalized": [] } ]

[ { "id": "NCT03413891_exc_text", "type": "exclusion", "text": [ "Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.\nPregnancy or lactation\nKnown allergic reaction to tranexamic acid\n" ], "offsets": [ [ 0, 216 ] ] } ]

[ { "id": "NCT03413891_exc_T3", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 179, 187 ] ], "normalized": [] }, { "id": "NCT03413891_exc_T4", "type": "Drug", "text": [ "tranexamic acid" ], "offsets": [ [ 200, 215 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03413891_exc_R1", "type": "AND", "arg1_id": "NCT03413891_exc_T3", "arg2_id": "NCT03413891_exc_T4", "normalized": [] } ]

[ { "id": "NCT03413891_inc_text", "type": "inclusion", "text": [ "Patients scheduled for dental extraction and treated with edoxaban, apixaban, rivaroxaban or dabigatran\nNot having taken the direct oral anticoagulant on the day of the extraction\nProvision of signed and dated informed consent form\nStated willingness to comply with all study procedures and availability for the duration of the study\n" ], "offsets": [ [ 0, 334 ] ] } ]

[ { "id": "NCT03413891_inc_T1", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 9, 22 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T2", "type": "Procedure", "text": [ "dental extraction" ], "offsets": [ [ 23, 40 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T3", "type": "Drug", "text": [ "edoxaban" ], "offsets": [ [ 58, 66 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T4", "type": "Drug", "text": [ "apixaban" ], "offsets": [ [ 68, 76 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T5", "type": "Drug", "text": [ "rivaroxaban" ], "offsets": [ [ 78, 89 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T6", "type": "Drug", "text": [ "dabigatran" ], "offsets": [ [ 93, 103 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T7", "type": "Scope", "text": [ "edoxaban, apixaban, rivaroxaban or dabigatran" ], "offsets": [ [ 58, 103 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T8", "type": "Temporal", "text": [ "on the day of the extraction" ], "offsets": [ [ 151, 179 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T9", "type": "Reference_point", "text": [ "extraction" ], "offsets": [ [ 169, 179 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T10", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 104, 107 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T11", "type": "Drug", "text": [ "anticoagulant" ], "offsets": [ [ 137, 150 ] ], "normalized": [] }, { "id": "NCT03413891_inc_T12", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 132, 136 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03413891_inc_R1", "type": "Has_mood", "arg1_id": "NCT03413891_inc_T2", "arg2_id": "NCT03413891_inc_T1", "normalized": [] }, { "id": "NCT03413891_inc_R2", "type": "Has_index", "arg1_id": "NCT03413891_inc_T8", "arg2_id": "NCT03413891_inc_T9", "normalized": [] }, { "id": "NCT03413891_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT03413891_inc_T11", "arg2_id": "NCT03413891_inc_T12", "normalized": [] }, { "id": "NCT03413891_inc_R4", "type": "Has_negation", "arg1_id": "NCT03413891_inc_T11", "arg2_id": "NCT03413891_inc_T10", "normalized": [] }, { "id": "NCT03413891_inc_R5", "type": "Has_temporal", "arg1_id": "NCT03413891_inc_T11", "arg2_id": "NCT03413891_inc_T8", "normalized": [] } ]

[ { "id": "NCT03416413_exc_text", "type": "exclusion", "text": [ "Current DVT\nRecurrent varicose veins\nArterial disease (ABPI<0.8)\nVein diameter < 3mm\nPreference for one of the treatment options\nPatient who are unwilling to participate\nInability or unwillingness to complete questionnaires\nInability to attend follow-up appointments\nPatient currently included in a study of varicose vein treatment\n" ], "offsets": [ [ 0, 332 ] ] } ]

[ { "id": "NCT03416413_exc_T1", "type": "Procedure", "text": [ "DVT" ], "offsets": [ [ 8, 11 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T2", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T3", "type": "Condition", "text": [ "varicose veins" ], "offsets": [ [ 22, 36 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T4", "type": "Multiplier", "text": [ "Recurrent" ], "offsets": [ [ 12, 21 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T5", "type": "Condition", "text": [ "Arterial disease" ], "offsets": [ [ 37, 53 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T6", "type": "Measurement", "text": [ "ABPI" ], "offsets": [ [ 55, 59 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T7", "type": "Value", "text": [ "<0.8" ], "offsets": [ [ 59, 63 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T8", "type": "Scope", "text": [ "ABPI<0.8" ], "offsets": [ [ 55, 63 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T9", "type": "Measurement", "text": [ "Vein diameter" ], "offsets": [ [ 65, 78 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T10", "type": "Value", "text": [ "< 3mm" ], "offsets": [ [ 79, 84 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T12", "type": "Observation", "text": [ "unwilling to participate" ], "offsets": [ [ 145, 169 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T13", "type": "Observation", "text": [ "unwillingness to complete questionnaires" ], "offsets": [ [ 183, 223 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T14", "type": "Observation", "text": [ "ity or un", "plete questionnaires\nInabi" ], "offsets": [ [ 176, 185 ], [ 203, 229 ] ], "normalized": [] }, { "id": "NCT03416413_exc_T15", "type": "Observation", "text": [ "Inability to attend follow-up appointments" ], "offsets": [ [ 224, 266 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03416413_exc_R1", "type": "Has_temporal", "arg1_id": "NCT03416413_exc_T1", "arg2_id": "NCT03416413_exc_T2", "normalized": [] }, { "id": "NCT03416413_exc_R2", "type": "Has_multiplier", "arg1_id": "NCT03416413_exc_T3", "arg2_id": "NCT03416413_exc_T4", "normalized": [] }, { "id": "NCT03416413_exc_R3", "type": "Has_value", "arg1_id": "NCT03416413_exc_T6", "arg2_id": "NCT03416413_exc_T7", "normalized": [] }, { "id": "NCT03416413_exc_R4", "type": "Subsumes", "arg1_id": "NCT03416413_exc_T5", "arg2_id": "NCT03416413_exc_T8", "normalized": [] }, { "id": "NCT03416413_exc_R5", "type": "Has_value", "arg1_id": "NCT03416413_exc_T9", "arg2_id": "NCT03416413_exc_T10", "normalized": [] } ]

[ { "id": "NCT03416413_inc_text", "type": "inclusion", "text": [ "Adults over 18 years of age\nSymptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex\nVaricose vein tributary requiring treatment\n" ], "offsets": [ [ 0, 138 ] ] } ]

[ { "id": "NCT03416413_inc_T1", "type": "Person", "text": [ "Adults" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T2", "type": "Value", "text": [ "over 18 years of age" ], "offsets": [ [ 7, 27 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 24, 27 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T4", "type": "Condition", "text": [ "SV", "ein reflux" ], "offsets": [ [ 41, 43 ], [ 52, 62 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T5", "type": "Condition", "text": [ "SSV vein reflux" ], "offsets": [ [ 47, 62 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T6", "type": "Qualifier", "text": [ "> 0.5 seconds" ], "offsets": [ [ 63, 76 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T7", "type": "Procedure", "text": [ "colour Duplex" ], "offsets": [ [ 80, 93 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T8", "type": "Scope", "text": [ "GSV or SSV vein reflux" ], "offsets": [ [ 40, 62 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T9", "type": "Qualifier", "text": [ "Varicose vein tributary" ], "offsets": [ [ 94, 117 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T10", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 118, 127 ] ], "normalized": [] }, { "id": "NCT03416413_inc_T11", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 128, 137 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03416413_inc_R1", "type": "Has_value", "arg1_id": "NCT03416413_inc_T3", "arg2_id": "NCT03416413_inc_T2", "normalized": [] }, { "id": "NCT03416413_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03416413_inc_T8", "arg2_id": "NCT03416413_inc_T6", "normalized": [] }, { "id": "NCT03416413_inc_R3", "type": "Has_scope", "arg1_id": "NCT03416413_inc_T7", "arg2_id": "NCT03416413_inc_T8", "normalized": [] }, { "id": "NCT03416413_inc_R4", "type": "Has_mood", "arg1_id": "NCT03416413_inc_T11", "arg2_id": "NCT03416413_inc_T10", "normalized": [] }, { "id": "NCT03416413_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT03416413_inc_T11", "arg2_id": "NCT03416413_inc_T9", "normalized": [] } ]

[ { "id": "NCT03420638_exc_text", "type": "exclusion", "text": [ "Presence of severe systemic disease\nPresence of coagulation disorders\nCurrent or previous history of analgesic dependence\nAllergy to any of the drugs used in the study\nWomen pregnant or lactating, or women planning to become pregnant\nPresence of hearing loss\nPresence of cardiovascular comorbidities\nPresence of hepatic comorbidities\nPresence of kidney comorbidities\nPresence of cognitive disabilities\n" ], "offsets": [ [ 0, 402 ] ] } ]

[ { "id": "NCT03420638_exc_T1", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 12, 18 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T2", "type": "Condition", "text": [ "systemic disease" ], "offsets": [ [ 19, 35 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T3", "type": "Condition", "text": [ "coagulation disorders" ], "offsets": [ [ 48, 69 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T4", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 70, 77 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T5", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 81, 89 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 90, 97 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T7", "type": "Scope", "text": [ "Current or previous" ], "offsets": [ [ 70, 89 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T8", "type": "Condition", "text": [ "analgesic dependence" ], "offsets": [ [ 101, 121 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T9", "type": "Drug", "text": [ "analgesic" ], "offsets": [ [ 101, 110 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T10", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 122, 129 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T11", "type": "Drug", "text": [ "drugs used in the study" ], "offsets": [ [ 144, 167 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T12", "type": "Person", "text": [ "Women" ], "offsets": [ [ 168, 173 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T13", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 174, 182 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T14", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 186, 195 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T15", "type": "Person", "text": [ "women" ], "offsets": [ [ 200, 205 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T16", "type": "Mood", "text": [ "planning to become" ], "offsets": [ [ 206, 224 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T17", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 225, 233 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T18", "type": "Condition", "text": [ "hearing loss" ], "offsets": [ [ 246, 258 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T19", "type": "Condition", "text": [ "cardiovascular comorbidities" ], "offsets": [ [ 271, 299 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T20", "type": "Condition", "text": [ "cognitive disabilities" ], "offsets": [ [ 379, 401 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T21", "type": "Condition", "text": [ "kidney comorbidities" ], "offsets": [ [ 346, 366 ] ], "normalized": [] }, { "id": "NCT03420638_exc_T22", "type": "Condition", "text": [ "hepatic comorbidities" ], "offsets": [ [ 312, 333 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03420638_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03420638_exc_T2", "arg2_id": "NCT03420638_exc_T1", "normalized": [] }, { "id": "NCT03420638_exc_R2", "type": "Has_scope", "arg1_id": "NCT03420638_exc_T6", "arg2_id": "NCT03420638_exc_T7", "normalized": [] }, { "id": "NCT03420638_exc_R4", "type": "Has_temporal", "arg1_id": "NCT03420638_exc_T8", "arg2_id": "NCT03420638_exc_T6", "normalized": [] }, { "id": "NCT03420638_exc_R5", "type": "AND", "arg1_id": "NCT03420638_exc_T10", "arg2_id": "NCT03420638_exc_T11", "normalized": [] }, { "id": "NCT03420638_exc_R6", "type": "Has_mood", "arg1_id": "NCT03420638_exc_T17", "arg2_id": "NCT03420638_exc_T16", "normalized": [] } ]

[ { "id": "NCT03420638_inc_text", "type": "inclusion", "text": [ "Scheduled to undergo bilateral palatine tonsillectomy as the only procedure\n" ], "offsets": [ [ 0, 76 ] ] } ]

[ { "id": "NCT03420638_inc_T1", "type": "Mood", "text": [ "Scheduled to undergo" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT03420638_inc_T2", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 21, 30 ] ], "normalized": [] }, { "id": "NCT03420638_inc_T3", "type": "Procedure", "text": [ "palatine tonsillectomy" ], "offsets": [ [ 31, 53 ] ], "normalized": [] }, { "id": "NCT03420638_inc_T4", "type": "Multiplier", "text": [ "only procedure" ], "offsets": [ [ 61, 75 ] ], "normalized": [] }, { "id": "NCT03420638_inc_T5", "type": "Procedure", "text": [ "procedure" ], "offsets": [ [ 66, 75 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03420638_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT03420638_inc_T3", "arg2_id": "NCT03420638_inc_T4", "normalized": [] }, { "id": "NCT03420638_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT03420638_inc_T3", "arg2_id": "NCT03420638_inc_T2", "normalized": [] }, { "id": "NCT03420638_inc_R4", "type": "Has_mood", "arg1_id": "NCT03420638_inc_T3", "arg2_id": "NCT03420638_inc_T1", "normalized": [] } ]

[ { "id": "NCT03424733_exc_text", "type": "exclusion", "text": [ "prior allergic reaction to interferon products, congestive heart failure, elevated liver enzymes\n" ], "offsets": [ [ 0, 97 ] ] } ]

[ { "id": "NCT03424733_exc_T1", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03424733_exc_T2", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 6, 23 ] ], "normalized": [] }, { "id": "NCT03424733_exc_T3", "type": "Drug", "text": [ "interferon products" ], "offsets": [ [ 27, 46 ] ], "normalized": [] }, { "id": "NCT03424733_exc_T4", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 48, 72 ] ], "normalized": [] }, { "id": "NCT03424733_exc_T5", "type": "Condition", "text": [ "elevated liver enzymes" ], "offsets": [ [ 74, 96 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03424733_exc_R1", "type": "AND", "arg1_id": "NCT03424733_exc_T2", "arg2_id": "NCT03424733_exc_T3", "normalized": [] }, { "id": "NCT03424733_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03424733_exc_T2", "arg2_id": "NCT03424733_exc_T1", "normalized": [] } ]

[ { "id": "NCT03424733_inc_text", "type": "inclusion", "text": [ "diagnosed any form of MS (relapsing remitting, primary progressive, secondary progressive), any EDSS (expanded stability status scale) score\n" ], "offsets": [ [ 0, 141 ] ] } ]

[ { "id": "NCT03424733_inc_T1", "type": "Condition", "text": [ "MS" ], "offsets": [ [ 22, 24 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T2", "type": "Qualifier", "text": [ "relapsing remitting" ], "offsets": [ [ 26, 45 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T3", "type": "Qualifier", "text": [ "primary progressive" ], "offsets": [ [ 47, 66 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T4", "type": "Qualifier", "text": [ "secondary progressive" ], "offsets": [ [ 68, 89 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T5", "type": "Qualifier", "text": [ "any form" ], "offsets": [ [ 10, 18 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T6", "type": "Scope", "text": [ "relapsing remitting, primary progressive, secondary progressive" ], "offsets": [ [ 26, 89 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T7", "type": "Value", "text": [ "any" ], "offsets": [ [ 92, 95 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T8", "type": "Measurement", "text": [ "score", "EDSS" ], "offsets": [ [ 135, 140 ], [ 96, 100 ] ], "normalized": [] }, { "id": "NCT03424733_inc_T9", "type": "Measurement", "text": [ "expanded stability status scale" ], "offsets": [ [ 102, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03424733_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03424733_inc_T1", "arg2_id": "NCT03424733_inc_T5", "normalized": [] }, { "id": "NCT03424733_inc_R2", "type": "Subsumes", "arg1_id": "NCT03424733_inc_T5", "arg2_id": "NCT03424733_inc_T6", "normalized": [] }, { "id": "NCT03424733_inc_R3", "type": "Subsumes", "arg1_id": "NCT03424733_inc_T8", "arg2_id": "NCT03424733_inc_T9", "normalized": [] }, { "id": "NCT03424733_inc_R4", "type": "Has_value", "arg1_id": "NCT03424733_inc_T8", "arg2_id": "NCT03424733_inc_T7", "normalized": [] } ]

[ { "id": "NCT03424993_exc_text", "type": "exclusion", "text": [ "Abnormal resting ECG\nCurrent abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).\nHypertension (currently taking anti-hypertensive medications or resting blood pressure >140/90 mmHg)\nMedical history of cardiovascular disease, malignant cancer, diabetes or kidney disease\nObesity (Body Mass Index > 30)\nCurrent pregnancy\nUnable to provide consent\n" ], "offsets": [ [ 0, 397 ] ] } ]

[ { "id": "NCT03424993_exc_T1", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T2", "type": "Procedure", "text": [ "resting ECG" ], "offsets": [ [ 9, 20 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T3", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 21, 28 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T4", "type": "Value", "text": [ "abnormal" ], "offsets": [ [ 29, 37 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T5", "type": "Procedure", "text": [ "blood panel" ], "offsets": [ [ 38, 49 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T6", "type": "Procedure", "text": [ "metabolic panel" ], "offsets": [ [ 77, 92 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T7", "type": "Procedure", "text": [ "lipid panel" ], "offsets": [ [ 94, 105 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T8", "type": "Procedure", "text": [ "complete blood count" ], "offsets": [ [ 110, 130 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T9", "type": "Scope", "text": [ "metabolic panel, lipid panel and complete blood count" ], "offsets": [ [ 77, 130 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T10", "type": "Condition", "text": [ "Hypertension" ], "offsets": [ [ 133, 145 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T11", "type": "Drug", "text": [ "anti-hypertensive medications" ], "offsets": [ [ 164, 193 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T12", "type": "Measurement", "text": [ "resting blood pressure" ], "offsets": [ [ 197, 219 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T13", "type": "Value", "text": [ ">140/90 mmHg" ], "offsets": [ [ 220, 232 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T14", "type": "Scope", "text": [ "anti-hypertensive medications or resting blood pressure >140/90 mmHg" ], "offsets": [ [ 164, 232 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T15", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 253, 275 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T16", "type": "Condition", "text": [ "malignant cancer" ], "offsets": [ [ 277, 293 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T17", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 295, 303 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T18", "type": "Condition", "text": [ "kidney disease" ], "offsets": [ [ 307, 321 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T19", "type": "Condition", "text": [ "Obesity" ], "offsets": [ [ 322, 329 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T20", "type": "Measurement", "text": [ "Body Mass Index" ], "offsets": [ [ 331, 346 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T21", "type": "Value", "text": [ "> 30" ], "offsets": [ [ 347, 351 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T22", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 361, 370 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T23", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 353, 360 ] ], "normalized": [] }, { "id": "NCT03424993_exc_T24", "type": "Scope", "text": [ "Body Mass Index > 30" ], "offsets": [ [ 331, 351 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03424993_exc_R1", "type": "Has_value", "arg1_id": "NCT03424993_exc_T2", "arg2_id": "NCT03424993_exc_T1", "normalized": [] }, { "id": "NCT03424993_exc_R2", "type": "Has_value", "arg1_id": "NCT03424993_exc_T5", "arg2_id": "NCT03424993_exc_T4", "normalized": [] }, { "id": "NCT03424993_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03424993_exc_T5", "arg2_id": "NCT03424993_exc_T3", "normalized": [] }, { "id": "NCT03424993_exc_R4", "type": "Subsumes", "arg1_id": "NCT03424993_exc_T5", "arg2_id": "NCT03424993_exc_T9", "normalized": [] }, { "id": "NCT03424993_exc_R5", "type": "Has_value", "arg1_id": "NCT03424993_exc_T12", "arg2_id": "NCT03424993_exc_T13", "normalized": [] }, { "id": "NCT03424993_exc_R6", "type": "Subsumes", "arg1_id": "NCT03424993_exc_T10", "arg2_id": "NCT03424993_exc_T14", "normalized": [] }, { "id": "NCT03424993_exc_R7", "type": "Has_value", "arg1_id": "NCT03424993_exc_T20", "arg2_id": "NCT03424993_exc_T21", "normalized": [] }, { "id": "NCT03424993_exc_R8", "type": "Has_temporal", "arg1_id": "NCT03424993_exc_T22", "arg2_id": "NCT03424993_exc_T23", "normalized": [] }, { "id": "NCT03424993_exc_R9", "type": "Subsumes", "arg1_id": "NCT03424993_exc_T19", "arg2_id": "NCT03424993_exc_T24", "normalized": [] } ]

[ { "id": "NCT03424993_inc_text", "type": "inclusion", "text": [ "Habitual dietary sodium intake > 3400mg per day\n" ], "offsets": [ [ 0, 48 ] ] } ]

[ { "id": "NCT03424993_inc_T1", "type": "Measurement", "text": [ "dietary sodium intake" ], "offsets": [ [ 9, 30 ] ], "normalized": [] }, { "id": "NCT03424993_inc_T2", "type": "Value", "text": [ "> 3400mg per day" ], "offsets": [ [ 31, 47 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03424993_inc_R1", "type": "Has_value", "arg1_id": "NCT03424993_inc_T1", "arg2_id": "NCT03424993_inc_T2", "normalized": [] } ]

[ { "id": "NCT03430284_exc_text", "type": "exclusion", "text": [ "type 1 diabetes,specific types of diabetes,gestational diabetes or pregestational diabetes;\nacute cardiovascular or cerebrovascular accidents within past 3 months;\nsevere hepatic or renal dysfunction;\nmalignant tumor;\nallergic history or contraindication for any drugs in trials;\ntaking part in other clinical trials;\nobviously poor compliance.\n" ], "offsets": [ [ 0, 345 ] ] } ]

[ { "id": "NCT03430284_exc_T1", "type": "Condition", "text": [ "type 1 diabetes" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T2", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T3", "type": "Qualifier", "text": [ "specific types" ], "offsets": [ [ 16, 30 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T4", "type": "Condition", "text": [ "gestational diabetes" ], "offsets": [ [ 43, 63 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T5", "type": "Condition", "text": [ "pregestational diabetes" ], "offsets": [ [ 67, 90 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T6", "type": "Condition", "text": [ "ccidents", "ardiovascular" ], "offsets": [ [ 133, 141 ], [ 99, 112 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T7", "type": "Condition", "text": [ "cerebrovascular accidents" ], "offsets": [ [ 116, 141 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T8", "type": "Qualifier", "text": [ "acute" ], "offsets": [ [ 92, 97 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T9", "type": "Scope", "text": [ "cardiovascular or cerebrovascular accidents" ], "offsets": [ [ 98, 141 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T10", "type": "Temporal", "text": [ "within past 3 months" ], "offsets": [ [ 142, 162 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T11", "type": "Condition", "text": [ "renal dysfunction" ], "offsets": [ [ 182, 199 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T12", "type": "Condition", "text": [ "patic o", "sfunction;" ], "offsets": [ [ 173, 180 ], [ 190, 200 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T13", "type": "Scope", "text": [ "hepatic or renal dysfunction" ], "offsets": [ [ 171, 199 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T14", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 164, 170 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T15", "type": "Condition", "text": [ "malignant tumor" ], "offsets": [ [ 201, 216 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T16", "type": "Condition", "text": [ "allergic" ], "offsets": [ [ 218, 226 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T17", "type": "Temporal", "text": [ "history" ], "offsets": [ [ 227, 234 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T18", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 238, 254 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T19", "type": "Drug", "text": [ "drugs in trials" ], "offsets": [ [ 263, 278 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T20", "type": "Qualifier", "text": [ "any" ], "offsets": [ [ 259, 262 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T22", "type": "Qualifier", "text": [ "obviously" ], "offsets": [ [ 318, 327 ] ], "normalized": [] }, { "id": "NCT03430284_exc_T23", "type": "Observation", "text": [ "poor compliance" ], "offsets": [ [ 328, 343 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03430284_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03430284_exc_T2", "arg2_id": "NCT03430284_exc_T3", "normalized": [] }, { "id": "NCT03430284_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03430284_exc_T9", "arg2_id": "NCT03430284_exc_T8", "normalized": [] }, { "id": "NCT03430284_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03430284_exc_T9", "arg2_id": "NCT03430284_exc_T10", "normalized": [] }, { "id": "NCT03430284_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT03430284_exc_T13", "arg2_id": "NCT03430284_exc_T14", "normalized": [] }, { "id": "NCT03430284_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03430284_exc_T19", "arg2_id": "NCT03430284_exc_T20", "normalized": [] }, { "id": "NCT03430284_exc_R6", "type": "AND", "arg1_id": "NCT03430284_exc_T18", "arg2_id": "NCT03430284_exc_T19", "normalized": [] }, { "id": "NCT03430284_exc_R7", "type": "Has_temporal", "arg1_id": "NCT03430284_exc_T16", "arg2_id": "NCT03430284_exc_T17", "normalized": [] }, { "id": "NCT03430284_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT03430284_exc_T23", "arg2_id": "NCT03430284_exc_T22", "normalized": [] } ]

[ { "id": "NCT03430284_inc_text", "type": "inclusion", "text": [ "35-75 years old;\ndiagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.\n" ], "offsets": [ [ 0, 114 ] ] } ]

[ { "id": "NCT03430284_inc_T1", "type": "Value", "text": [ "35-75 years old" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT03430284_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 12, 15 ] ], "normalized": [] }, { "id": "NCT03430284_inc_T3", "type": "Condition", "text": [ "type 2 diabetes" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT03430284_inc_T4", "type": "Qualifier", "text": [ "criteria of the World Health Organization in 1999" ], "offsets": [ [ 63, 112 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03430284_inc_R1", "type": "Has_value", "arg1_id": "NCT03430284_inc_T2", "arg2_id": "NCT03430284_inc_T1", "normalized": [] }, { "id": "NCT03430284_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03430284_inc_T3", "arg2_id": "NCT03430284_inc_T4", "normalized": [] } ]

[ { "id": "NCT03431831_exc_text", "type": "exclusion", "text": [ "Inability to understand and read English.\nWomen pregnant or lactating.\npersons with terminal illness\n" ], "offsets": [ [ 0, 101 ] ] } ]

[ { "id": "NCT03431831_exc_T1", "type": "Observation", "text": [ "Inability to understand and read English" ], "offsets": [ [ 0, 40 ] ], "normalized": [] }, { "id": "NCT03431831_exc_T2", "type": "Person", "text": [ "Women" ], "offsets": [ [ 42, 47 ] ], "normalized": [] }, { "id": "NCT03431831_exc_T3", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 48, 56 ] ], "normalized": [] }, { "id": "NCT03431831_exc_T4", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 60, 69 ] ], "normalized": [] }, { "id": "NCT03431831_exc_T5", "type": "Condition", "text": [ "terminal illness" ], "offsets": [ [ 84, 100 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT03431831_inc_text", "type": "inclusion", "text": [ "Overweight/Obese Adult patients (age 19 years -65)\neligible based on WALI screening tool\n" ], "offsets": [ [ 0, 89 ] ] } ]

[ { "id": "NCT03431831_inc_T1", "type": "Condition", "text": [ "Overweight" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T2", "type": "Condition", "text": [ "Obese" ], "offsets": [ [ 11, 16 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T3", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 17, 22 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T5", "type": "Value", "text": [ "19 years -65" ], "offsets": [ [ 37, 49 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T6", "type": "Procedure", "text": [ "WALI screening tool" ], "offsets": [ [ 69, 88 ] ], "normalized": [] }, { "id": "NCT03431831_inc_T7", "type": "Value", "text": [ "eligible" ], "offsets": [ [ 51, 59 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03431831_inc_R1", "type": "Has_value", "arg1_id": "NCT03431831_inc_T4", "arg2_id": "NCT03431831_inc_T5", "normalized": [] }, { "id": "NCT03431831_inc_R2", "type": "Subsumes", "arg1_id": "NCT03431831_inc_T3", "arg2_id": "NCT03431831_inc_T4", "normalized": [] }, { "id": "NCT03431831_inc_R3", "type": "Has_value", "arg1_id": "NCT03431831_inc_T6", "arg2_id": "NCT03431831_inc_T7", "normalized": [] } ]

[ { "id": "NCT03434951_exc_text", "type": "exclusion", "text": [ "rearthroplasty\nASA IV-V\ninadequate spoken finnish for reliable pain assessment\nDementia or otherwise impaired cognition\ncontraindication for any medication or substance used in survey protocol\nweight <50kg or BMI =35 kg/m2\npreoperative SpO2 less than 93%\nclinical suspicion that subject can not use PCA adequately\nhistory of substance abuse or current excessive use of alcohol\npreoperative use of either pregabalin, gabapentin or strong opiates\n" ], "offsets": [ [ 0, 445 ] ] } ]

[ { "id": "NCT03434951_exc_T1", "type": "Procedure", "text": [ "rearthroplasty" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T2", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 15, 18 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T3", "type": "Value", "text": [ "IV-V" ], "offsets": [ [ 19, 23 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T4", "type": "Observation", "text": [ "inadequate spoken finnish" ], "offsets": [ [ 24, 49 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T5", "type": "Procedure", "text": [ "reliable pain assessment" ], "offsets": [ [ 54, 78 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T6", "type": "Condition", "text": [ "Dementia" ], "offsets": [ [ 79, 87 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T7", "type": "Condition", "text": [ "impaired cognition" ], "offsets": [ [ 101, 119 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T8", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 120, 136 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T9", "type": "Drug", "text": [ "cation or", " in survey protocol\nwe" ], "offsets": [ [ 149, 158 ], [ 173, 195 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T10", "type": "Drug", "text": [ "substance used in survey protocol" ], "offsets": [ [ 159, 192 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T11", "type": "Scope", "text": [ "medication or substance used in survey protocol" ], "offsets": [ [ 145, 192 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T12", "type": "Measurement", "text": [ "weight" ], "offsets": [ [ 193, 199 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T13", "type": "Value", "text": [ "<50kg" ], "offsets": [ [ 200, 205 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T14", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 209, 212 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T15", "type": "Value", "text": [ "=35 kg/m2" ], "offsets": [ [ 213, 222 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T16", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 223, 235 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T17", "type": "Measurement", "text": [ "SpO2" ], "offsets": [ [ 236, 240 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T18", "type": "Value", "text": [ "less than 93%" ], "offsets": [ [ 241, 254 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T19", "type": "Mood", "text": [ "clinical suspicion" ], "offsets": [ [ 255, 273 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T20", "type": "Observation", "text": [ "subject can not use PCA adequately" ], "offsets": [ [ 279, 313 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T21", "type": "Observation", "text": [ "history" ], "offsets": [ [ 314, 321 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T22", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 325, 340 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T23", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 344, 351 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T24", "type": "Condition", "text": [ "excessive use of alcohol" ], "offsets": [ [ 352, 376 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T25", "type": "Temporal", "text": [ "preoperative" ], "offsets": [ [ 377, 389 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T26", "type": "Drug", "text": [ "pregabalin" ], "offsets": [ [ 404, 414 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T27", "type": "Drug", "text": [ "gabapentin" ], "offsets": [ [ 416, 426 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T28", "type": "Drug", "text": [ "strong opiates" ], "offsets": [ [ 430, 444 ] ], "normalized": [] }, { "id": "NCT03434951_exc_T29", "type": "Scope", "text": [ "pregabalin, gabapentin or strong opiates" ], "offsets": [ [ 404, 444 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03434951_exc_R1", "type": "Has_value", "arg1_id": "NCT03434951_exc_T2", "arg2_id": "NCT03434951_exc_T3", "normalized": [] }, { "id": "NCT03434951_exc_R2", "type": "AND", "arg1_id": "NCT03434951_exc_T4", "arg2_id": "NCT03434951_exc_T5", "normalized": [] }, { "id": "NCT03434951_exc_R3", "type": "Has_scope", "arg1_id": "NCT03434951_exc_T8", "arg2_id": "NCT03434951_exc_T11", "normalized": [] }, { "id": "NCT03434951_exc_R4", "type": "Has_value", "arg1_id": "NCT03434951_exc_T14", "arg2_id": "NCT03434951_exc_T15", "normalized": [] }, { "id": "NCT03434951_exc_R5", "type": "Has_value", "arg1_id": "NCT03434951_exc_T12", "arg2_id": "NCT03434951_exc_T13", "normalized": [] }, { "id": "NCT03434951_exc_R6", "type": "Has_value", "arg1_id": "NCT03434951_exc_T17", "arg2_id": "NCT03434951_exc_T18", "normalized": [] }, { "id": "NCT03434951_exc_R7", "type": "Has_temporal", "arg1_id": "NCT03434951_exc_T17", "arg2_id": "NCT03434951_exc_T16", "normalized": [] }, { "id": "NCT03434951_exc_R8", "type": "Has_mood", "arg1_id": "NCT03434951_exc_T20", "arg2_id": "NCT03434951_exc_T19", "normalized": [] }, { "id": "NCT03434951_exc_R9", "type": "Has_temporal", "arg1_id": "NCT03434951_exc_T24", "arg2_id": "NCT03434951_exc_T23", "normalized": [] }, { "id": "NCT03434951_exc_R10", "type": "Has_temporal", "arg1_id": "NCT03434951_exc_T22", "arg2_id": "NCT03434951_exc_T21", "normalized": [] }, { "id": "NCT03434951_exc_R11", "type": "Has_temporal", "arg1_id": "NCT03434951_exc_T29", "arg2_id": "NCT03434951_exc_T25", "normalized": [] } ]

[ { "id": "NCT03434951_inc_text", "type": "inclusion", "text": [ "elective primary total knee arthroplasty\nASA I-III\nwritten consent\n" ], "offsets": [ [ 0, 67 ] ] } ]

[ { "id": "NCT03434951_inc_T1", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03434951_inc_T2", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 9, 16 ] ], "normalized": [] }, { "id": "NCT03434951_inc_T3", "type": "Procedure", "text": [ "total knee arthroplasty" ], "offsets": [ [ 17, 40 ] ], "normalized": [] }, { "id": "NCT03434951_inc_T4", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 41, 44 ] ], "normalized": [] }, { "id": "NCT03434951_inc_T5", "type": "Value", "text": [ "I-III" ], "offsets": [ [ 45, 50 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03434951_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03434951_inc_T3", "arg2_id": "NCT03434951_inc_T2", "normalized": [] }, { "id": "NCT03434951_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03434951_inc_T3", "arg2_id": "NCT03434951_inc_T1", "normalized": [] }, { "id": "NCT03434951_inc_R3", "type": "Has_value", "arg1_id": "NCT03434951_inc_T4", "arg2_id": "NCT03434951_inc_T5", "normalized": [] } ]

[ { "id": "NCT03444142_exc_text", "type": "exclusion", "text": [ "Women with confirmed or suspected pregnancy\nWomen under lactation and/or puerperium\nHypersensibility to ingredients of intervention\nPhysical impossibility for apply the drug\nKnown pancreatic, renal, hepatic, heart or thyroid diseased\nHypertension diagnosis\nPrevious treatment for glucose\nBody Mass Index =39.9 kg/m2\nTriglycerides =500 mg/dL\nTotal cholesterol =300 mg/dL\nNight or rotating shift workers\nBlood Pressure =140/90 mmHg\n" ], "offsets": [ [ 0, 430 ] ] } ]

[ { "id": "NCT03444142_exc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 44, 49 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T2", "type": "Person", "text": [ "Women" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T3", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 34, 43 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T4", "type": "Qualifier", "text": [ "confirmed" ], "offsets": [ [ 11, 20 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T5", "type": "Qualifier", "text": [ "suspected" ], "offsets": [ [ 24, 33 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T6", "type": "Scope", "text": [ "confirmed or suspected" ], "offsets": [ [ 11, 33 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T7", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 56, 65 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T8", "type": "Condition", "text": [ "puerperium" ], "offsets": [ [ 73, 83 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T9", "type": "Condition", "text": [ "Hypersensibility" ], "offsets": [ [ 84, 100 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T10", "type": "Drug", "text": [ "ingredients of intervention" ], "offsets": [ [ 104, 131 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T12", "type": "Condition", "text": [ "thyroid disease" ], "offsets": [ [ 217, 232 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T13", "type": "Condition", "text": [ "t or", "ased\nHy" ], "offsets": [ [ 212, 216 ], [ 229, 236 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T14", "type": "Condition", "text": [ "tic, he", "ased\nHy" ], "offsets": [ [ 203, 210 ], [ 229, 236 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T15", "type": "Condition", "text": [ "l, he", "ased\nHy" ], "offsets": [ [ 196, 201 ], [ 229, 236 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T16", "type": "Condition", "text": [ "reatic, re", "ased\nHy" ], "offsets": [ [ 184, 194 ], [ 229, 236 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T17", "type": "Condition", "text": [ "Hypertension" ], "offsets": [ [ 234, 246 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T18", "type": "Procedure", "text": [ "treatment for glucose" ], "offsets": [ [ 266, 287 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T19", "type": "Temporal", "text": [ "Previous" ], "offsets": [ [ 257, 265 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T20", "type": "Measurement", "text": [ "Body Mass Index" ], "offsets": [ [ 288, 303 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T21", "type": "Value", "text": [ "=39.9 kg/m2" ], "offsets": [ [ 304, 315 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T22", "type": "Measurement", "text": [ "Triglycerides" ], "offsets": [ [ 316, 329 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T23", "type": "Value", "text": [ "=500 mg/dL" ], "offsets": [ [ 330, 340 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T24", "type": "Measurement", "text": [ "Total cholesterol" ], "offsets": [ [ 341, 358 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T25", "type": "Value", "text": [ "=300 mg/dL" ], "offsets": [ [ 359, 369 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T26", "type": "Person", "text": [ "rotating shift workers" ], "offsets": [ [ 379, 401 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T27", "type": "Person", "text": [ "otati", "ers\nBlood Pre" ], "offsets": [ [ 380, 385 ], [ 398, 411 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T28", "type": "Measurement", "text": [ "Blood Pressure" ], "offsets": [ [ 402, 416 ] ], "normalized": [] }, { "id": "NCT03444142_exc_T29", "type": "Value", "text": [ "=140/90 mmHg" ], "offsets": [ [ 417, 429 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03444142_exc_R1", "type": "Has_scope", "arg1_id": "NCT03444142_exc_T3", "arg2_id": "NCT03444142_exc_T6", "normalized": [] }, { "id": "NCT03444142_exc_R2", "type": "AND", "arg1_id": "NCT03444142_exc_T9", "arg2_id": "NCT03444142_exc_T10", "normalized": [] }, { "id": "NCT03444142_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03444142_exc_T18", "arg2_id": "NCT03444142_exc_T19", "normalized": [] }, { "id": "NCT03444142_exc_R4", "type": "Has_value", "arg1_id": "NCT03444142_exc_T20", "arg2_id": "NCT03444142_exc_T21", "normalized": [] }, { "id": "NCT03444142_exc_R5", "type": "Has_value", "arg1_id": "NCT03444142_exc_T22", "arg2_id": "NCT03444142_exc_T23", "normalized": [] }, { "id": "NCT03444142_exc_R6", "type": "Has_value", "arg1_id": "NCT03444142_exc_T24", "arg2_id": "NCT03444142_exc_T25", "normalized": [] }, { "id": "NCT03444142_exc_R7", "type": "Has_value", "arg1_id": "NCT03444142_exc_T28", "arg2_id": "NCT03444142_exc_T29", "normalized": [] } ]

[ { "id": "NCT03444142_inc_text", "type": "inclusion", "text": [ "Patients both sexes\nAge between 31 and 60 years\nDiagnosis of diabetes according ADA criteria:\n" ], "offsets": [ [ 0, 94 ] ] } ]

[ { "id": "NCT03444142_inc_T1", "type": "Person", "text": [ "both sexes" ], "offsets": [ [ 9, 19 ] ], "normalized": [] }, { "id": "NCT03444142_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT03444142_inc_T3", "type": "Measurement", "text": [ "between 31 and 60 years" ], "offsets": [ [ 24, 47 ] ], "normalized": [] }, { "id": "NCT03444142_inc_T4", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 61, 69 ] ], "normalized": [] }, { "id": "NCT03444142_inc_T5", "type": "Qualifier", "text": [ "ADA criteria" ], "offsets": [ [ 80, 92 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03444142_inc_R1", "type": "AND", "arg1_id": "NCT03444142_inc_T2", "arg2_id": "NCT03444142_inc_T3", "normalized": [] }, { "id": "NCT03444142_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT03444142_inc_T4", "arg2_id": "NCT03444142_inc_T5", "normalized": [] } ]

[ { "id": "NCT03445949_exc_text", "type": "exclusion", "text": [ "indications to dual antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. coronary artery disease)\nindications to anticoagulation at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. pulmonary embolism)\nknown allergy to clopidogrel or acetylsalicylic acid precluding its administration as specified by the protocol\nany known inborn or acquired coagulation disorders\npoor tolerance of or technical difficulties with performing transesophageal echocardiography\nperidevice leak >5mm on transesophageal echocardiography study preceding enrollment\nleft atrial thrombus on transesophageal echocardiography study performed after successful left atrial appendage closure but before enrollment\nlife expectancy of less than 18months\nparticipation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months\nchronic kidney disease stage IV and V\nwomen who are pregnant or breast feeding; women of childbearing potential who do not consent to apply at least to methods of contraception. This criterion does not apply to postmenopausal women\n" ], "offsets": [ [ 0, 1268 ] ] } ]

[ { "id": "NCT03445949_exc_T1", "type": "Procedure", "text": [ "dual antiplatelet therapy" ], "offsets": [ [ 15, 40 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T2", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 41, 51 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T3", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 52, 71 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T4", "type": "Condition", "text": [ "indications" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T5", "type": "Condition", "text": [ "left atrial appendage occlusion" ], "offsets": [ [ 75, 106 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T6", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 107, 132 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T7", "type": "Mood", "text": [ "predicted appearance" ], "offsets": [ [ 136, 156 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T8", "type": "Temporal", "text": [ "within the duration of the trial" ], "offsets": [ [ 177, 209 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T9", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 215, 238 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T10", "type": "Scope", "text": [ "predicted appearance of such indications within the duration of the trial" ], "offsets": [ [ 136, 209 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T11", "type": "Scope", "text": [ "atrial fibrillation or left atrial appendage occlusion" ], "offsets": [ [ 52, 106 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T12", "type": "Scope", "text": [ "at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. coronary artery disease)" ], "offsets": [ [ 107, 239 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T13", "type": "Condition", "text": [ "indications" ], "offsets": [ [ 240, 251 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T14", "type": "Procedure", "text": [ "anticoagulation" ], "offsets": [ [ 255, 270 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T15", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 271, 296 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T16", "type": "Mood", "text": [ "predicted appearance" ], "offsets": [ [ 300, 320 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T17", "type": "Temporal", "text": [ "within the duration of the trial" ], "offsets": [ [ 341, 373 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T18", "type": "Scope", "text": [ "predicted appearance of such indications within the duration of the trial" ], "offsets": [ [ 300, 373 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T19", "type": "Condition", "text": [ "pulmonary embolism" ], "offsets": [ [ 379, 397 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T20", "type": "Scope", "text": [ "at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. pulmonary embolism)" ], "offsets": [ [ 271, 398 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T21", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 416, 427 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T22", "type": "Drug", "text": [ "acetylsalicylic acid" ], "offsets": [ [ 431, 451 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T23", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 405, 412 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T25", "type": "Scope", "text": [ "clopidogrel or acetylsalicylic acid" ], "offsets": [ [ 416, 451 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T26", "type": "Condition", "text": [ "coagulation disorders" ], "offsets": [ [ 540, 561 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T27", "type": "Condition", "text": [ "poor tolerance" ], "offsets": [ [ 562, 576 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T28", "type": "Observation", "text": [ "technical difficulties" ], "offsets": [ [ 583, 605 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T29", "type": "Procedure", "text": [ "transesophageal echocardiography" ], "offsets": [ [ 622, 654 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T30", "type": "Scope", "text": [ "poor tolerance of or technical difficulties" ], "offsets": [ [ 562, 605 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T31", "type": "Measurement", "text": [ "peridevice leak" ], "offsets": [ [ 655, 670 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T32", "type": "Value", "text": [ ">5mm" ], "offsets": [ [ 671, 675 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T33", "type": "Procedure", "text": [ "transesophageal echocardiography study" ], "offsets": [ [ 679, 717 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T34", "type": "Condition", "text": [ "left atrial thrombus" ], "offsets": [ [ 739, 759 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T35", "type": "Procedure", "text": [ "transesophageal echocardiography" ], "offsets": [ [ 763, 795 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T36", "type": "Procedure", "text": [ "left atrial appendage closure" ], "offsets": [ [ 829, 858 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T37", "type": "Temporal", "text": [ "after successful left atrial appendage closure" ], "offsets": [ [ 812, 858 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T38", "type": "Reference_point", "text": [ "successful left atrial appendage closure" ], "offsets": [ [ 818, 858 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T39", "type": "Qualifier", "text": [ "successful" ], "offsets": [ [ 818, 828 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T40", "type": "Temporal", "text": [ "before enrollment" ], "offsets": [ [ 863, 880 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T41", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 870, 880 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T42", "type": "Scope", "text": [ "after successful left atrial appendage closure but before enrollment" ], "offsets": [ [ 812, 880 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T43", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 881, 896 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T44", "type": "Value", "text": [ "less than 18months" ], "offsets": [ [ 900, 918 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T46", "type": "Condition", "text": [ "chronic kidney disease" ], "offsets": [ [ 1036, 1058 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T47", "type": "Qualifier", "text": [ "stage IV" ], "offsets": [ [ 1059, 1067 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T48", "type": "Qualifier", "text": [ "and V", "h" ], "offsets": [ [ 1068, 1073 ], [ 1081, 1082 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T49", "type": "Scope", "text": [ "stage IV and V" ], "offsets": [ [ 1059, 1073 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T50", "type": "Person", "text": [ "women" ], "offsets": [ [ 1074, 1079 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T51", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1088, 1096 ] ], "normalized": [] }, { "id": "NCT03445949_exc_T52", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 1100, 1114 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03445949_exc_R1", "type": "AND", "arg1_id": "NCT03445949_exc_T4", "arg2_id": "NCT03445949_exc_T1", "normalized": [] }, { "id": "NCT03445949_exc_R2", "type": "Has_negation", "arg1_id": "NCT03445949_exc_T11", "arg2_id": "NCT03445949_exc_T2", "normalized": [] }, { "id": "NCT03445949_exc_R3", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T4", "arg2_id": "NCT03445949_exc_T11", "normalized": [] }, { "id": "NCT03445949_exc_R4", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T4", "arg2_id": "NCT03445949_exc_T12", "normalized": [] }, { "id": "NCT03445949_exc_R5", "type": "Subsumes", "arg1_id": "NCT03445949_exc_T10", "arg2_id": "NCT03445949_exc_T9", "normalized": [] }, { "id": "NCT03445949_exc_R6", "type": "Subsumes", "arg1_id": "NCT03445949_exc_T18", "arg2_id": "NCT03445949_exc_T19", "normalized": [] }, { "id": "NCT03445949_exc_R7", "type": "AND", "arg1_id": "NCT03445949_exc_T13", "arg2_id": "NCT03445949_exc_T14", "normalized": [] }, { "id": "NCT03445949_exc_R8", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T13", "arg2_id": "NCT03445949_exc_T20", "normalized": [] }, { "id": "NCT03445949_exc_R9", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T23", "arg2_id": "NCT03445949_exc_T25", "normalized": [] }, { "id": "NCT03445949_exc_R10", "type": "AND", "arg1_id": "NCT03445949_exc_T30", "arg2_id": "NCT03445949_exc_T29", "normalized": [] }, { "id": "NCT03445949_exc_R11", "type": "Has_value", "arg1_id": "NCT03445949_exc_T31", "arg2_id": "NCT03445949_exc_T32", "normalized": [] }, { "id": "NCT03445949_exc_R12", "type": "AND", "arg1_id": "NCT03445949_exc_T33", "arg2_id": "NCT03445949_exc_T31", "normalized": [] }, { "id": "NCT03445949_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT03445949_exc_T36", "arg2_id": "NCT03445949_exc_T39", "normalized": [] }, { "id": "NCT03445949_exc_R15", "type": "Has_index", "arg1_id": "NCT03445949_exc_T37", "arg2_id": "NCT03445949_exc_T38", "normalized": [] }, { "id": "NCT03445949_exc_R16", "type": "AND", "arg1_id": "NCT03445949_exc_T35", "arg2_id": "NCT03445949_exc_T34", "normalized": [] }, { "id": "NCT03445949_exc_R17", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T35", "arg2_id": "NCT03445949_exc_T42", "normalized": [] }, { "id": "NCT03445949_exc_R18", "type": "Has_value", "arg1_id": "NCT03445949_exc_T43", "arg2_id": "NCT03445949_exc_T44", "normalized": [] }, { "id": "NCT03445949_exc_R19", "type": "Has_scope", "arg1_id": "NCT03445949_exc_T46", "arg2_id": "NCT03445949_exc_T49", "normalized": [] } ]

[ { "id": "NCT03445949_inc_text", "type": "inclusion", "text": [ "successful left atrial appendage occlusion with Amulet device within 37 days prior to randomization.\ntreatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization\nparticipant's age 18 years or older at the time of signing the informed consent form\nparticipant is willing to follow all study procedures; especially randomized antiplatelet treatment regimen and follow-up visits with transesophageal echocardiography when applicable\nparticipant is willing to sign the study informed consent form\n" ], "offsets": [ [ 0, 568 ] ] } ]

[ { "id": "NCT03445949_inc_T1", "type": "Procedure", "text": [ "left atrial appendage occlusion" ], "offsets": [ [ 11, 42 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T2", "type": "Qualifier", "text": [ "successful" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T3", "type": "Device", "text": [ "Amulet device" ], "offsets": [ [ 48, 61 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T4", "type": "Temporal", "text": [ "within 37 days prior to randomization" ], "offsets": [ [ 62, 99 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T5", "type": "Procedure", "text": [ "dual antiplatelet therapy" ], "offsets": [ [ 116, 141 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T6", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 143, 154 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T7", "type": "Drug", "text": [ "acetylsalicylic acid" ], "offsets": [ [ 159, 179 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T8", "type": "Scope", "text": [ "clopidogrel and acetylsalicylic acid" ], "offsets": [ [ 143, 179 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T9", "type": "Procedure", "text": [ "left atrial appendage closure" ], "offsets": [ [ 189, 218 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T10", "type": "Temporal", "text": [ "between left atrial appendage closure and randomization" ], "offsets": [ [ 181, 236 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T11", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 223, 236 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T12", "type": "Reference_point", "text": [ "left atrial appendage closure" ], "offsets": [ [ 189, 218 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T13", "type": "Scope", "text": [ "left atrial appendage closure and randomization" ], "offsets": [ [ 189, 236 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T14", "type": "Person", "text": [ "age" ], "offsets": [ [ 251, 254 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T15", "type": "Value", "text": [ "18 years or older" ], "offsets": [ [ 255, 272 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T16", "type": "Temporal", "text": [ "at the time of signing the informed consent form" ], "offsets": [ [ 273, 321 ] ], "normalized": [] }, { "id": "NCT03445949_inc_T17", "type": "Reference_point", "text": [ "signing the informed consent form" ], "offsets": [ [ 288, 321 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03445949_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT03445949_inc_T1", "arg2_id": "NCT03445949_inc_T2", "normalized": [] }, { "id": "NCT03445949_inc_R2", "type": "AND", "arg1_id": "NCT03445949_inc_T1", "arg2_id": "NCT03445949_inc_T3", "normalized": [] }, { "id": "NCT03445949_inc_R3", "type": "Has_temporal", "arg1_id": "NCT03445949_inc_T1", "arg2_id": "NCT03445949_inc_T4", "normalized": [] }, { "id": "NCT03445949_inc_R4", "type": "Has_scope", "arg1_id": "NCT03445949_inc_T5", "arg2_id": "NCT03445949_inc_T8", "normalized": [] }, { "id": "NCT03445949_inc_R6", "type": "Has_scope", "arg1_id": "NCT03445949_inc_T10", "arg2_id": "NCT03445949_inc_T13", "normalized": [] }, { "id": "NCT03445949_inc_R7", "type": "Has_index", "arg1_id": "NCT03445949_inc_T16", "arg2_id": "NCT03445949_inc_T17", "normalized": [] }, { "id": "NCT03445949_inc_R8", "type": "Has_value", "arg1_id": "NCT03445949_inc_T14", "arg2_id": "NCT03445949_inc_T15", "normalized": [] }, { "id": "NCT03445949_inc_R9", "type": "Has_temporal", "arg1_id": "NCT03445949_inc_T14", "arg2_id": "NCT03445949_inc_T16", "normalized": [] } ]

[ { "id": "NCT03446885_exc_text", "type": "exclusion", "text": [ "any medical condition that would contraindicate use of stimulant medication\nany prior adverse response to lisdexamfetamine dimesylate or other stimulant medication\nuse of concurrent,non-stimulant psychoactive medication\ndiagnosis of schizophrenia or presence of thought disorder symptoms\nautism spectrum disorder\n" ], "offsets": [ [ 0, 313 ] ] } ]

[ { "id": "NCT03446885_exc_T1", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 4, 21 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T2", "type": "Condition", "text": [ "contraindicate" ], "offsets": [ [ 33, 47 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T3", "type": "Drug", "text": [ "stimulant medication" ], "offsets": [ [ 55, 75 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T4", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 80, 85 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T5", "type": "Condition", "text": [ "adverse response" ], "offsets": [ [ 86, 102 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T6", "type": "Drug", "text": [ "lisdexamfetamine dimesylate" ], "offsets": [ [ 106, 133 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T7", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 137, 142 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T8", "type": "Drug", "text": [ "stimulant medication" ], "offsets": [ [ 143, 163 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T9", "type": "Scope", "text": [ "lisdexamfetamine dimesylate or other stimulant medication" ], "offsets": [ [ 106, 163 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T10", "type": "Temporal", "text": [ "concurrent" ], "offsets": [ [ 171, 181 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T11", "type": "Drug", "text": [ "non-stimulant psychoactive medication" ], "offsets": [ [ 182, 219 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T12", "type": "Condition", "text": [ "schizophrenia" ], "offsets": [ [ 233, 246 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T13", "type": "Condition", "text": [ "thought disorder" ], "offsets": [ [ 262, 278 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T14", "type": "Mood", "text": [ "symptoms" ], "offsets": [ [ 279, 287 ] ], "normalized": [] }, { "id": "NCT03446885_exc_T15", "type": "Condition", "text": [ "autism spectrum disorder" ], "offsets": [ [ 288, 312 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03446885_exc_R1", "type": "AND", "arg1_id": "NCT03446885_exc_T2", "arg2_id": "NCT03446885_exc_T3", "normalized": [] }, { "id": "NCT03446885_exc_R2", "type": "AND", "arg1_id": "NCT03446885_exc_T1", "arg2_id": "NCT03446885_exc_T2", "normalized": [] }, { "id": "NCT03446885_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03446885_exc_T8", "arg2_id": "NCT03446885_exc_T7", "normalized": [] }, { "id": "NCT03446885_exc_R4", "type": "Has_scope", "arg1_id": "NCT03446885_exc_T5", "arg2_id": "NCT03446885_exc_T9", "normalized": [] }, { "id": "NCT03446885_exc_R5", "type": "Has_temporal", "arg1_id": "NCT03446885_exc_T5", "arg2_id": "NCT03446885_exc_T4", "normalized": [] }, { "id": "NCT03446885_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03446885_exc_T11", "arg2_id": "NCT03446885_exc_T10", "normalized": [] }, { "id": "NCT03446885_exc_R7", "type": "Has_mood", "arg1_id": "NCT03446885_exc_T13", "arg2_id": "NCT03446885_exc_T14", "normalized": [] } ]

[ { "id": "NCT03446885_inc_text", "type": "inclusion", "text": [ "diagnosis of ADHD\nparental permission and/or teen consent/assent as appropriate\nbetween 16-25 years of age\nIQ greater than or equal to 70\npermit or license to drive\nability to read and understand English\n" ], "offsets": [ [ 0, 204 ] ] } ]

[ { "id": "NCT03446885_inc_T1", "type": "Condition", "text": [ "ADHD" ], "offsets": [ [ 13, 17 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T3", "type": "Value", "text": [ "16-25 years" ], "offsets": [ [ 88, 99 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T4", "type": "Person", "text": [ "age" ], "offsets": [ [ 103, 106 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T5", "type": "Measurement", "text": [ "IQ" ], "offsets": [ [ 107, 109 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T6", "type": "Value", "text": [ "greater than or equal to 70" ], "offsets": [ [ 110, 137 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T7", "type": "Observation", "text": [ "license to drive" ], "offsets": [ [ 148, 164 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T8", "type": "Observation", "text": [ "it or", "rive\nabi" ], "offsets": [ [ 142, 147 ], [ 160, 168 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T9", "type": "Observation", "text": [ "ty to read and", "sh" ], "offsets": [ [ 170, 184 ], [ 201, 203 ] ], "normalized": [] }, { "id": "NCT03446885_inc_T10", "type": "Observation", "text": [ "ty to read", "stand English" ], "offsets": [ [ 170, 180 ], [ 190, 203 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03446885_inc_R1", "type": "Has_value", "arg1_id": "NCT03446885_inc_T4", "arg2_id": "NCT03446885_inc_T3", "normalized": [] }, { "id": "NCT03446885_inc_R2", "type": "Has_value", "arg1_id": "NCT03446885_inc_T5", "arg2_id": "NCT03446885_inc_T6", "normalized": [] } ]

[ { "id": "NCT03460002_exc_text", "type": "exclusion", "text": [ "the child has temperature > 39.0◦C or a severe acute illness as defined by the examining nurse\nthe child has as a mid upper arm circumference < 110 mm and is older than 6 months (most feasible local indicator of AIDS and chronic immunosuppressive disease)\nthe child has experienced a severe allergic reaction after previous vaccination, drug or food.\nthe child is enrolled in an ongoing study of Bacillus Calmette Guerin vaccine and is < 2 months old\nFor the RECAMP-MV trial: the child is enrolled in RECAMP-OPV\n" ], "offsets": [ [ 0, 512 ] ] } ]

[ { "id": "NCT03460002_exc_T1", "type": "Measurement", "text": [ "temperature" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T2", "type": "Value", "text": [ "> 39.0◦C" ], "offsets": [ [ 26, 34 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T3", "type": "Person", "text": [ "child" ], "offsets": [ [ 4, 9 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T4", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 40, 46 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T5", "type": "Condition", "text": [ "acute illness" ], "offsets": [ [ 47, 60 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T6", "type": "Qualifier", "text": [ "as defined by the examining nurse" ], "offsets": [ [ 61, 94 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T7", "type": "Person", "text": [ "child" ], "offsets": [ [ 99, 104 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T8", "type": "Measurement", "text": [ "mid upper arm circumference" ], "offsets": [ [ 114, 141 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T9", "type": "Value", "text": [ "< 110 mm" ], "offsets": [ [ 142, 150 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T10", "type": "Value", "text": [ "is older than 6 months" ], "offsets": [ [ 155, 177 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T11", "type": "Person", "text": [ "old" ], "offsets": [ [ 158, 161 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T13", "type": "Person", "text": [ "child" ], "offsets": [ [ 260, 265 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T14", "type": "Condition", "text": [ "severe allergic reaction" ], "offsets": [ [ 284, 308 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T15", "type": "Temporal", "text": [ "after previous vaccination, drug or food" ], "offsets": [ [ 309, 349 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T16", "type": "Reference_point", "text": [ "previous vaccination, drug or food" ], "offsets": [ [ 315, 349 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T17", "type": "Procedure", "text": [ "vaccination" ], "offsets": [ [ 324, 335 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T18", "type": "Procedure", "text": [ "drug" ], "offsets": [ [ 337, 341 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T19", "type": "Procedure", "text": [ "food" ], "offsets": [ [ 345, 349 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T20", "type": "Scope", "text": [ "vaccination, drug or food" ], "offsets": [ [ 324, 349 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T21", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 315, 323 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T23", "type": "Observation", "text": [ "RECAMP-MV trial" ], "offsets": [ [ 459, 474 ] ], "normalized": [] }, { "id": "NCT03460002_exc_T24", "type": "Observation", "text": [ "enrolled in RECAMP-OPV" ], "offsets": [ [ 489, 511 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03460002_exc_R1", "type": "Has_value", "arg1_id": "NCT03460002_exc_T1", "arg2_id": "NCT03460002_exc_T2", "normalized": [] }, { "id": "NCT03460002_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT03460002_exc_T5", "arg2_id": "NCT03460002_exc_T4", "normalized": [] }, { "id": "NCT03460002_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03460002_exc_T5", "arg2_id": "NCT03460002_exc_T6", "normalized": [] }, { "id": "NCT03460002_exc_R4", "type": "Has_value", "arg1_id": "NCT03460002_exc_T8", "arg2_id": "NCT03460002_exc_T9", "normalized": [] }, { "id": "NCT03460002_exc_R5", "type": "Has_value", "arg1_id": "NCT03460002_exc_T11", "arg2_id": "NCT03460002_exc_T10", "normalized": [] }, { "id": "NCT03460002_exc_R6", "type": "Has_index", "arg1_id": "NCT03460002_exc_T15", "arg2_id": "NCT03460002_exc_T16", "normalized": [] }, { "id": "NCT03460002_exc_R7", "type": "Has_temporal", "arg1_id": "NCT03460002_exc_T20", "arg2_id": "NCT03460002_exc_T21", "normalized": [] }, { "id": "NCT03460002_exc_R9", "type": "Has_temporal", "arg1_id": "NCT03460002_exc_T14", "arg2_id": "NCT03460002_exc_T15", "normalized": [] } ]

[ { "id": "NCT03460002_inc_text", "type": "inclusion", "text": [ "Children aged 0-59 months living with families registered in the rural Bandim Health Project Health and Demographic Surveillance Site are included, provided a parent/guardian consent.\n" ], "offsets": [ [ 0, 184 ] ] } ]

[ { "id": "NCT03460002_inc_T1", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT03460002_inc_T2", "type": "Person", "text": [ "aged" ], "offsets": [ [ 9, 13 ] ], "normalized": [] }, { "id": "NCT03460002_inc_T3", "type": "Value", "text": [ "0-59 months" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT03460002_inc_T4", "type": "Observation", "text": [ "living with families registered in the rural Bandim Health Project Health" ], "offsets": [ [ 26, 99 ] ], "normalized": [] }, { "id": "NCT03460002_inc_T5", "type": "Visit", "text": [ "Demographic Surveillance Site" ], "offsets": [ [ 104, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03460002_inc_R1", "type": "Has_value", "arg1_id": "NCT03460002_inc_T2", "arg2_id": "NCT03460002_inc_T3", "normalized": [] } ]

[ { "id": "NCT03461679_exc_text", "type": "exclusion", "text": [ "Unable to consent\nChronic opioid consumption\nAllergy to study medication\nLower limb surgery preceding year\nUnable to complete baseline testing, pre-existing neurological deficit\nContraindication to spinal anaesthesia\n" ], "offsets": [ [ 0, 217 ] ] } ]

[ { "id": "NCT03461679_exc_T2", "type": "Condition", "text": [ "opioid consumption" ], "offsets": [ [ 26, 44 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T3", "type": "Qualifier", "text": [ "Chronic" ], "offsets": [ [ 18, 25 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T4", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 45, 52 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T5", "type": "Drug", "text": [ "study medication" ], "offsets": [ [ 56, 72 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T6", "type": "Procedure", "text": [ "Lower limb surgery" ], "offsets": [ [ 73, 91 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T8", "type": "Condition", "text": [ "neurological deficit" ], "offsets": [ [ 157, 177 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T9", "type": "Qualifier", "text": [ "pre-existing" ], "offsets": [ [ 144, 156 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T10", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 178, 194 ] ], "normalized": [] }, { "id": "NCT03461679_exc_T11", "type": "Procedure", "text": [ "spinal anaesthesia" ], "offsets": [ [ 198, 216 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03461679_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03461679_exc_T2", "arg2_id": "NCT03461679_exc_T3", "normalized": [] }, { "id": "NCT03461679_exc_R2", "type": "AND", "arg1_id": "NCT03461679_exc_T4", "arg2_id": "NCT03461679_exc_T5", "normalized": [] }, { "id": "NCT03461679_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT03461679_exc_T8", "arg2_id": "NCT03461679_exc_T9", "normalized": [] }, { "id": "NCT03461679_exc_R4", "type": "AND", "arg1_id": "NCT03461679_exc_T10", "arg2_id": "NCT03461679_exc_T11", "normalized": [] } ]

[ { "id": "NCT03461679_inc_text", "type": "inclusion", "text": [ "Patients undergoing total knee arthroplasty under spinal anaesthesia\n45y or older\nASA 1-3\nBMI 18-35\n" ], "offsets": [ [ 0, 100 ] ] } ]

[ { "id": "NCT03461679_inc_T1", "type": "Procedure", "text": [ "total knee arthroplasty" ], "offsets": [ [ 20, 43 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T2", "type": "Procedure", "text": [ "spinal anaesthesia" ], "offsets": [ [ 50, 68 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T3", "type": "Value", "text": [ "5y", "r older" ], "offsets": [ [ 70, 72 ], [ 74, 81 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T4", "type": "Person", "text": [ "y" ], "offsets": [ [ 71, 72 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T5", "type": "Measurement", "text": [ "ASA" ], "offsets": [ [ 82, 85 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T6", "type": "Value", "text": [ "1-3" ], "offsets": [ [ 86, 89 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T7", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 90, 93 ] ], "normalized": [] }, { "id": "NCT03461679_inc_T8", "type": "Value", "text": [ "18-35" ], "offsets": [ [ 94, 99 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03461679_inc_R1", "type": "AND", "arg1_id": "NCT03461679_inc_T1", "arg2_id": "NCT03461679_inc_T2", "normalized": [] }, { "id": "NCT03461679_inc_R2", "type": "Has_value", "arg1_id": "NCT03461679_inc_T4", "arg2_id": "NCT03461679_inc_T3", "normalized": [] }, { "id": "NCT03461679_inc_R3", "type": "Has_value", "arg1_id": "NCT03461679_inc_T5", "arg2_id": "NCT03461679_inc_T6", "normalized": [] }, { "id": "NCT03461679_inc_R4", "type": "Has_value", "arg1_id": "NCT03461679_inc_T7", "arg2_id": "NCT03461679_inc_T8", "normalized": [] } ]

[ { "id": "NCT03463564_exc_text", "type": "exclusion", "text": [ "previous use of insulin pump\npregnancy or planning to become pregnant in the next 2 years,\nlack of ability to use the study devices\nhistory of severe chronic diseases\nrecent or concomitant use of corticosteroids\ndrug or alcohol abuse\npsychiatric complaints that interfere with the correct use of the devices\n" ], "offsets": [ [ 0, 308 ] ] } ]

[ { "id": "NCT03463564_exc_T1", "type": "Device", "text": [ "insulin pump" ], "offsets": [ [ 16, 28 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T2", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 29, 38 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T3", "type": "Mood", "text": [ "planning to become" ], "offsets": [ [ 42, 60 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T4", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 61, 69 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T5", "type": "Temporal", "text": [ "in the next 2 years" ], "offsets": [ [ 70, 89 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T6", "type": "Negation", "text": [ "lack of" ], "offsets": [ [ 91, 98 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T7", "type": "Observation", "text": [ "ability to use the study devices" ], "offsets": [ [ 99, 131 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T8", "type": "Device", "text": [ "study devices" ], "offsets": [ [ 118, 131 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 143, 149 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T10", "type": "Condition", "text": [ "chronic diseases" ], "offsets": [ [ 150, 166 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T11", "type": "Observation", "text": [ "history" ], "offsets": [ [ 132, 139 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T12", "type": "Temporal", "text": [ "recent" ], "offsets": [ [ 167, 173 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T13", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 177, 188 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T14", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 196, 211 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T15", "type": "Scope", "text": [ "recent or concomitant" ], "offsets": [ [ 167, 188 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T16", "type": "Drug", "text": [ "or a", "\npsy" ], "offsets": [ [ 217, 221 ], [ 233, 237 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T17", "type": "Drug", "text": [ "alcohol abuse" ], "offsets": [ [ 220, 233 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T18", "type": "Condition", "text": [ "psychiatric complaints" ], "offsets": [ [ 234, 256 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T19", "type": "Observation", "text": [ "correct use of the devices" ], "offsets": [ [ 281, 307 ] ], "normalized": [] }, { "id": "NCT03463564_exc_T20", "type": "Mood", "text": [ "interfere with" ], "offsets": [ [ 262, 276 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03463564_exc_R1", "type": "Has_mood", "arg1_id": "NCT03463564_exc_T4", "arg2_id": "NCT03463564_exc_T3", "normalized": [] }, { "id": "NCT03463564_exc_R2", "type": "Has_temporal", "arg1_id": "NCT03463564_exc_T3", "arg2_id": "NCT03463564_exc_T5", "normalized": [] }, { "id": "NCT03463564_exc_R3", "type": "Has_negation", "arg1_id": "NCT03463564_exc_T7", "arg2_id": "NCT03463564_exc_T6", "normalized": [] }, { "id": "NCT03463564_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT03463564_exc_T10", "arg2_id": "NCT03463564_exc_T9", "normalized": [] }, { "id": "NCT03463564_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03463564_exc_T10", "arg2_id": "NCT03463564_exc_T11", "normalized": [] }, { "id": "NCT03463564_exc_R7", "type": "Has_scope", "arg1_id": "NCT03463564_exc_T14", "arg2_id": "NCT03463564_exc_T15", "normalized": [] }, { "id": "NCT03463564_exc_R8", "type": "Has_mood", "arg1_id": "NCT03463564_exc_T19", "arg2_id": "NCT03463564_exc_T20", "normalized": [] } ]

[ { "id": "NCT03463564_inc_text", "type": "inclusion", "text": [ "T1DM for at least 12 months\npersistent HbA1c levels = 7.5% (58 mmol/mol) despite optimized education therapy,\nrecurrent severe hypoglycemic episodes or high glucose variability\nwillingness to wear the insulin pump\n" ], "offsets": [ [ 0, 214 ] ] } ]

[ { "id": "NCT03463564_inc_T1", "type": "Condition", "text": [ "T1DM" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T2", "type": "Temporal", "text": [ "for at least 12 months" ], "offsets": [ [ 5, 27 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T3", "type": "Measurement", "text": [ "HbA1c levels" ], "offsets": [ [ 39, 51 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T4", "type": "Multiplier", "text": [ "persistent" ], "offsets": [ [ 28, 38 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T5", "type": "Value", "text": [ "= 7.5%" ], "offsets": [ [ 52, 58 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T6", "type": "Value", "text": [ "58 mmol/mol" ], "offsets": [ [ 60, 71 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T7", "type": "Procedure", "text": [ "optimized education therapy" ], "offsets": [ [ 81, 108 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T8", "type": "Multiplier", "text": [ "recurrent" ], "offsets": [ [ 110, 119 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T9", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 120, 126 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T10", "type": "Condition", "text": [ "hypoglycemic episodes" ], "offsets": [ [ 127, 148 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T11", "type": "Condition", "text": [ "high glucose variability" ], "offsets": [ [ 152, 176 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T12", "type": "Scope", "text": [ "hypoglycemic episodes or high glucose variability" ], "offsets": [ [ 127, 176 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T13", "type": "Mood", "text": [ "willingness" ], "offsets": [ [ 177, 188 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T14", "type": "Procedure", "text": [ "wear the insulin pump" ], "offsets": [ [ 192, 213 ] ], "normalized": [] }, { "id": "NCT03463564_inc_T15", "type": "Device", "text": [ "insulin pump" ], "offsets": [ [ 201, 213 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03463564_inc_R1", "type": "Has_temporal", "arg1_id": "NCT03463564_inc_T1", "arg2_id": "NCT03463564_inc_T2", "normalized": [] }, { "id": "NCT03463564_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT03463564_inc_T3", "arg2_id": "NCT03463564_inc_T4", "normalized": [] }, { "id": "NCT03463564_inc_R3", "type": "Subsumes", "arg1_id": "NCT03463564_inc_T5", "arg2_id": "NCT03463564_inc_T6", "normalized": [] }, { "id": "NCT03463564_inc_R4", "type": "Has_value", "arg1_id": "NCT03463564_inc_T3", "arg2_id": "NCT03463564_inc_T5", "normalized": [] }, { "id": "NCT03463564_inc_R5", "type": "AND", "arg1_id": "NCT03463564_inc_T3", "arg2_id": "NCT03463564_inc_T7", "normalized": [] }, { "id": "NCT03463564_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT03463564_inc_T12", "arg2_id": "NCT03463564_inc_T9", "normalized": [] }, { "id": "NCT03463564_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT03463564_inc_T12", "arg2_id": "NCT03463564_inc_T8", "normalized": [] }, { "id": "NCT03463564_inc_R9", "type": "Has_mood", "arg1_id": "NCT03463564_inc_T14", "arg2_id": "NCT03463564_inc_T13", "normalized": [] } ]

[ { "id": "NCT03464552_exc_text", "type": "exclusion", "text": [ "A known allergy to Celecoxib, aspirin or another NSAID.\nActive peptic ulceration or gastrointestinal bleeding.\nInflammatory bowel disease.\nCongestive heart failure (NYHA II-IV).\nEstablished ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.\nHistory of neurologic deficit.\nKnown hepatic or renal impairment.\nPregnancy.\nBreast-feeding.\nPost-hysterectomy.\nBleeding disorders.\nDrug abuse.\nCervical and vaginal infection.\n" ], "offsets": [ [ 0, 450 ] ] } ]

[ { "id": "NCT03464552_exc_T1", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 8, 15 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T2", "type": "Drug", "text": [ "Celecoxib" ], "offsets": [ [ 19, 28 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T3", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 30, 37 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T4", "type": "Drug", "text": [ "NSAID" ], "offsets": [ [ 49, 54 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T5", "type": "Qualifier", "text": [ "another" ], "offsets": [ [ 41, 48 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T6", "type": "Scope", "text": [ "Celecoxib, aspirin or another NSAID" ], "offsets": [ [ 19, 54 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T7", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 56, 62 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T8", "type": "Condition", "text": [ "peptic ulceration" ], "offsets": [ [ 63, 80 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T9", "type": "Condition", "text": [ "gastrointestinal bleeding" ], "offsets": [ [ 84, 109 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T10", "type": "Scope", "text": [ "peptic ulceration or gastrointestinal bleeding" ], "offsets": [ [ 63, 109 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T11", "type": "Condition", "text": [ "Inflammatory bowel disease" ], "offsets": [ [ 111, 137 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T12", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 139, 163 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T13", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 165, 169 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T14", "type": "Value", "text": [ "II-IV" ], "offsets": [ [ 170, 175 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T15", "type": "Scope", "text": [ "NYHA II-IV" ], "offsets": [ [ 165, 175 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T16", "type": "Condition", "text": [ "ischemic heart disease" ], "offsets": [ [ 190, 212 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T17", "type": "Condition", "text": [ "peripheral arterial disease" ], "offsets": [ [ 214, 241 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T18", "type": "Condition", "text": [ "cerebrovascular disease" ], "offsets": [ [ 249, 272 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T19", "type": "Condition", "text": [ "neurologic deficit" ], "offsets": [ [ 285, 303 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T20", "type": "Observation", "text": [ "History" ], "offsets": [ [ 274, 281 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T21", "type": "Condition", "text": [ "renal impairment" ], "offsets": [ [ 322, 338 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T22", "type": "Condition", "text": [ "c or re", "ment.\nPreg" ], "offsets": [ [ 317, 324 ], [ 334, 344 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T23", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 340, 349 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T24", "type": "Observation", "text": [ "Breast-feeding" ], "offsets": [ [ 351, 365 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T25", "type": "Procedure", "text": [ "hysterectomy" ], "offsets": [ [ 372, 384 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T26", "type": "Temporal", "text": [ "Post" ], "offsets": [ [ 367, 371 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T27", "type": "Condition", "text": [ "Bleeding disorders" ], "offsets": [ [ 386, 404 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T28", "type": "Condition", "text": [ "Drug abuse" ], "offsets": [ [ 406, 416 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T29", "type": "Condition", "text": [ " vagina", "" ], "offsets": [ [ 430, 437 ], [ 451, 451 ] ], "normalized": [] }, { "id": "NCT03464552_exc_T30", "type": "Condition", "text": [ "vaginal infection" ], "offsets": [ [ 431, 448 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03464552_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT03464552_exc_T4", "arg2_id": "NCT03464552_exc_T5", "normalized": [] }, { "id": "NCT03464552_exc_R2", "type": "Has_scope", "arg1_id": "NCT03464552_exc_T1", "arg2_id": "NCT03464552_exc_T6", "normalized": [] }, { "id": "NCT03464552_exc_R3", "type": "Has_temporal", "arg1_id": "NCT03464552_exc_T10", "arg2_id": "NCT03464552_exc_T7", "normalized": [] }, { "id": "NCT03464552_exc_R4", "type": "Has_value", "arg1_id": "NCT03464552_exc_T13", "arg2_id": "NCT03464552_exc_T14", "normalized": [] }, { "id": "NCT03464552_exc_R5", "type": "Has_scope", "arg1_id": "NCT03464552_exc_T12", "arg2_id": "NCT03464552_exc_T15", "normalized": [] }, { "id": "NCT03464552_exc_R6", "type": "Has_temporal", "arg1_id": "NCT03464552_exc_T19", "arg2_id": "NCT03464552_exc_T20", "normalized": [] }, { "id": "NCT03464552_exc_R7", "type": "Has_temporal", "arg1_id": "NCT03464552_exc_T25", "arg2_id": "NCT03464552_exc_T26", "normalized": [] } ]

[ { "id": "NCT03464552_inc_text", "type": "inclusion", "text": [ "Females 18-65 years old who undergoing colposcopic directed biopsy\n" ], "offsets": [ [ 0, 67 ] ] } ]

[ { "id": "NCT03464552_inc_T1", "type": "Person", "text": [ "Females" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT03464552_inc_T2", "type": "Value", "text": [ "18-65 years" ], "offsets": [ [ 8, 19 ] ], "normalized": [] }, { "id": "NCT03464552_inc_T3", "type": "Person", "text": [ "old" ], "offsets": [ [ 20, 23 ] ], "normalized": [] }, { "id": "NCT03464552_inc_T4", "type": "Procedure", "text": [ "colposcopic directed biopsy" ], "offsets": [ [ 39, 66 ] ], "normalized": [] }, { "id": "NCT03464552_inc_T5", "type": "Temporal", "text": [ "undergoing" ], "offsets": [ [ 28, 38 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT03464552_inc_R1", "type": "Has_value", "arg1_id": "NCT03464552_inc_T3", "arg2_id": "NCT03464552_inc_T2", "normalized": [] }, { "id": "NCT03464552_inc_R2", "type": "Has_temporal", "arg1_id": "NCT03464552_inc_T4", "arg2_id": "NCT03464552_inc_T5", "normalized": [] } ]

[ { "id": "NCT03465397_exc_text", "type": "exclusion", "text": [ "Patients with a calculated PRA higher than 0% per solid phase and / or anti-HLA class I and / or class II antibodies detectable by single antigen test (Luminex®).\nPositive result of Cross Match.\nPatients who receive a graft from a cadaver donor.\nIdentical HLA patients\nPatients who have undergone a previous solid organ transplant (including kidney transplant) or who are going to receive another solid organ transplant concomitantly.\nGlomerular primary focal and segmental sclerosis\nAtypical hemolytic uremic syndrome (aHUS) / thrombotic thrombocytopenic purpura syndrome.\nPatients with chronic infection with Hepatitis B virus (HBV) and / or active infection with Hepatitis C virus (positive PCR result) at the time of transplant.\nPatients with infection with the known Human Immunodeficiency Virus (HIV).\nPatients with active systemic infection that requires the continued administration of antibiotics.\nPatients with any neoplasm except localized skin cancer and who is receiving adequate treatment.\nPatients with severe anemia (hemoglobin <6g / dl), leukopenia (WBC <2500 / mm3) and / or thrombocytopenia (platelets <80,000 / mm3).\nPatients who are hemodynamically unstable even if they have hemoglobin levels> 6g / dL.\nPatients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.\nPatients with known hypersensitivity to any of the drugs used in this study.\nPatients who have received any investigational drug in the 30 days prior to their inclusion in this study.\nPotentially fertile women who do not agree to use reliable contraceptive measures during the trial, who are pregnant, breastfeeding or who present a positive pregnancy test at the time of their inclusion in the study.\nPatients who are legally detained in an official institution.\n" ], "offsets": [ [ 0, 1803 ] ] } ]

[ { "id": "NCT03465397_exc_T1", "type": "Measurement", "text": [ "calculated PRA" ], "offsets": [ [ 16, 30 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T2", "type": "Value", "text": [ "higher than 0% per solid phase" ], "offsets": [ [ 31, 61 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T3", "type": "Procedure", "text": [ "single antigen test" ], "offsets": [ [ 131, 150 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T4", "type": "Value", "text": [ "anti-HLA class I" ], "offsets": [ [ 71, 87 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T5", "type": "Value", "text": [ "anti-HLA", "class II" ], "offsets": [ [ 71, 79 ], [ 97, 105 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T6", "type": "Scope", "text": [ "anti-HLA class I and / or class I" ], "offsets": [ [ 71, 104 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T7", "type": "Procedure", "text": [ "Luminex" ], "offsets": [ [ 152, 159 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T8", "type": "Procedure", "text": [ "graft from a cadaver donor" ], "offsets": [ [ 218, 244 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T9", "type": "Condition", "text": [ "Identical HLA" ], "offsets": [ [ 246, 259 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T10", "type": "Procedure", "text": [ "Cross Match" ], "offsets": [ [ 182, 193 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T11", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 163, 171 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T12", "type": "Procedure", "text": [ "solid organ transplant" ], "offsets": [ [ 308, 330 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T13", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 299, 307 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T14", "type": "Procedure", "text": [ "kidney transplant" ], "offsets": [ [ 342, 359 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T15", "type": "Qualifier", "text": [ "another" ], "offsets": [ [ 389, 396 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T16", "type": "Procedure", "text": [ "solid organ transplant" ], "offsets": [ [ 397, 419 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T17", "type": "Temporal", "text": [ "concomitantly" ], "offsets": [ [ 420, 433 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T18", "type": "Condition", "text": [ "rular primary focal and", "osis\nAtyp" ], "offsets": [ [ 440, 463 ], [ 479, 488 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T19", "type": "Condition", "text": [ "rular prim", "ntal sclerosis\nAtyp" ], "offsets": [ [ 440, 450 ], [ 469, 488 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T20", "type": "Condition", "text": [ "Atypical hemolytic uremic syndrome (aHUS)" ], "offsets": [ [ 484, 525 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T21", "type": "Condition", "text": [ "thrombotic thrombocytopenic purpura syndrome" ], "offsets": [ [ 528, 572 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T22", "type": "Condition", "text": [ "Hepatitis B virus (HBV)" ], "offsets": [ [ 611, 634 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T23", "type": "Condition", "text": [ "Hepatitis C virus" ], "offsets": [ [ 666, 683 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T24", "type": "Procedure", "text": [ "PCR result" ], "offsets": [ [ 694, 704 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T25", "type": "Value", "text": [ "positive" ], "offsets": [ [ 685, 693 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T26", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 588, 595 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T27", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 644, 650 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T28", "type": "Scope", "text": [ "positive PCR result" ], "offsets": [ [ 685, 704 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T29", "type": "Scope", "text": [ "chronic infection with Hepatitis B virus (HBV) and / or active infection with Hepatitis C virus" ], "offsets": [ [ 588, 683 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T30", "type": "Temporal", "text": [ "at the time of transplant" ], "offsets": [ [ 706, 731 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T31", "type": "Condition", "text": [ "Human Immunodeficiency Virus (HIV)" ], "offsets": [ [ 772, 806 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T32", "type": "Condition", "text": [ "systemic infection" ], "offsets": [ [ 829, 847 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T33", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 822, 828 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T34", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 894, 905 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T35", "type": "Multiplier", "text": [ "continued administration" ], "offsets": [ [ 866, 890 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T36", "type": "Condition", "text": [ "neoplasm" ], "offsets": [ [ 925, 933 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T37", "type": "Negation", "text": [ "except" ], "offsets": [ [ 934, 940 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T38", "type": "Condition", "text": [ "localized skin cancer" ], "offsets": [ [ 941, 962 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T39", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1018, 1024 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T40", "type": "Condition", "text": [ "anemia" ], "offsets": [ [ 1025, 1031 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T41", "type": "Measurement", "text": [ "hemoglobin" ], "offsets": [ [ 1033, 1043 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T42", "type": "Value", "text": [ "<6g / dl" ], "offsets": [ [ 1044, 1052 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T43", "type": "Condition", "text": [ "leukopenia" ], "offsets": [ [ 1055, 1065 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T44", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 1067, 1070 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T45", "type": "Value", "text": [ "<2500 / mm3" ], "offsets": [ [ 1071, 1082 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T46", "type": "Scope", "text": [ "hemoglobin <6g / dl" ], "offsets": [ [ 1033, 1052 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T47", "type": "Scope", "text": [ "WBC <2500 / mm3" ], "offsets": [ [ 1067, 1082 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T48", "type": "Scope", "text": [ "severe anemia" ], "offsets": [ [ 1018, 1031 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T49", "type": "Condition", "text": [ "thrombocytopenia" ], "offsets": [ [ 1093, 1109 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T50", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 1111, 1120 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T51", "type": "Value", "text": [ "<80,000 / mm3" ], "offsets": [ [ 1121, 1134 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T52", "type": "Scope", "text": [ "platelets <80,000 / mm3" ], "offsets": [ [ 1111, 1134 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T53", "type": "Condition", "text": [ "hemodynamically unstable" ], "offsets": [ [ 1154, 1178 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T54", "type": "Measurement", "text": [ "hemoglobin levels" ], "offsets": [ [ 1197, 1214 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T55", "type": "Value", "text": [ "> 6g / dL" ], "offsets": [ [ 1214, 1223 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T56", "type": "Condition", "text": [ "intestinal pathology" ], "offsets": [ [ 1239, 1259 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T57", "type": "Condition", "text": [ "severe diarrhea" ], "offsets": [ [ 1263, 1278 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T58", "type": "Observation", "text": [ "may decrease absorption" ], "offsets": [ [ 1284, 1307 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T59", "type": "Scope", "text": [ "intestinal pathology or severe diarrhea" ], "offsets": [ [ 1239, 1278 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T60", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1359, 1375 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T61", "type": "Drug", "text": [ "drugs used in this study" ], "offsets": [ [ 1390, 1414 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T64", "type": "Observation", "text": [ "legally detained" ], "offsets": [ [ 1758, 1774 ] ], "normalized": [] }, { "id": "NCT03465397_exc_T65", "type": "Visit", "text": [ "official institution" ], "offsets": [ [ 1781, 1801 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT03465397_inc_text", "type": "inclusion", "text": [ "Adult men and women (=18 years).\nReceptors of a first kidney transplant from an incompatible HLA living donor (at least 1 mismatch HLA at any antigenic level).\nAB0 compatible transplant.\nPatients with a calculated PRA of 0% by solid phase technique and absence of anti-HLA class I and class II antibodies by single antigen test (Luminex®).\nPatients who agree to participate in the Trial by signing the Specific Informed Consent of this study.\nPotentially fertile women should use high reliability contraceptive methods (Pearl-Index <1) in order to avoid pregnancy during the entire duration of the study and up to 6 weeks after the end of their treatment with Mycophenolate Mofetil (MMF). Potentially Fertile Women include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or who is not post-menopausal (defined as amenorrhea = 12 consecutive months, or women who are receiving hormone replacement therapy with a documented level of follicle stimulating hormone (FSH)> 35 mlU / ml). Potentially fertile women must have a pregnancy test with a negative result in the 72 hours prior to the start of the trial.\nSexually active males (including vasectomized males) who are being treated with MMF must accept the use of barrier contraceptive methods during MMF treatment and for 90 days thereafter. Potentially fertile partners of these patients should use a reliable contraceptive method during the same period, in order to minimize the risk of pregnancy.\nPatients must agree not to donate blood during treatment with MMF and during the 6 subsequent weeks. Males should not make a sperm donation during MMF treatment and up to 90 days after completion.\n" ], "offsets": [ [ 0, 1765 ] ] } ]

[ { "id": "NCT03465397_inc_T1", "type": "Person", "text": [ "men" ], "offsets": [ [ 6, 9 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T2", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T3", "type": "Person", "text": [ "women" ], "offsets": [ [ 14, 19 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T4", "type": "Value", "text": [ "=18 years" ], "offsets": [ [ 21, 30 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T5", "type": "Person", "text": [ "years" ], "offsets": [ [ 25, 30 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T6", "type": "Procedure", "text": [ "first kidney transplant" ], "offsets": [ [ 48, 71 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T7", "type": "Qualifier", "text": [ "incompatible HLA" ], "offsets": [ [ 80, 96 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T8", "type": "Qualifier", "text": [ "living donor" ], "offsets": [ [ 97, 109 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T9", "type": "Multiplier", "text": [ "at least 1" ], "offsets": [ [ 111, 121 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T10", "type": "Observation", "text": [ "mismatch HLA" ], "offsets": [ [ 122, 134 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T11", "type": "Qualifier", "text": [ "AB0 compatible" ], "offsets": [ [ 160, 174 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T12", "type": "Procedure", "text": [ "transplant" ], "offsets": [ [ 175, 185 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T13", "type": "Measurement", "text": [ "calculated PRA" ], "offsets": [ [ 203, 217 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T14", "type": "Value", "text": [ "0%" ], "offsets": [ [ 221, 223 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T15", "type": "Qualifier", "text": [ "solid phase technique" ], "offsets": [ [ 227, 248 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T16", "type": "Procedure", "text": [ "single antigen test (Luminex®)" ], "offsets": [ [ 308, 338 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T17", "type": "Observation", "text": [ "absence of anti-HLA class I" ], "offsets": [ [ 253, 280 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T18", "type": "Observation", "text": [ "ence of an", "ss II an" ], "offsets": [ [ 256, 266 ], [ 288, 296 ] ], "normalized": [] }, { "id": "NCT03465397_inc_T19", "type": "Scope", "text": [ "absence of anti-HLA class I and class II" ], "offsets": [ [ 253, 293 ] ], "normalized": [] } ]

[]

[]

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