{
"info": {
"nct_id": "NCT01876082",
"official_title": "PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial",
"inclusion_criteria": "1. Written consent;\n2. Age ≥ 18 years;\n3. ECOG ≤ 1;\n4. Histologically confirmed desmoid tumor;\n5. Disease progression before the patient's inclusion : completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)\n6. Measurable target lesion (RECIST criteria) ;\n7. Left ventricular ejection fraction (MUGA or ECHO) within the normal;\n8. Normal hematological, renal and liver functions :\n\n 1. Hemoglobin ≥ 9 g / dl; neutrophils ≥ 1.5 x 109 / l; platelets ≥ 100 x 109 / l; prothrombin time or INR1 ≤ 1.2 ULN or activated partial thromboplastin time ≤ 1.2 ULN;\n 2. Amino alanine transferase and aspartate amino transferase ≤ 2.5 ULN;\n 3. Total bilirubin ≤ 1.5 ULN;\n 4. Creatinine ≤ 1.5 mg/dl or, if creatinine> 1.5 mg/dl, Creatinine clearance ≥ 50 m/min;\n 5. Urinary protein / urinary creatinine (Pu / Cu) <1. If PU/Cu ≥ 1, patients must have a proteinuria below 1g/24 h\n9. Women are eligible provided they:\n\n 1. Physiologically incapable of childbearing (hysterectomy, oophorectomy, bilateral tubal ligation, menopause).\n 2. Of childbearing age if they have had a negative pregnancy test in the week before the first dose of treatment.\n 3. Women of childbearing potential and men must agree to take an adequate method of contraception. Permitted contraceptive methods : IUD with a documented failure rate of 1% per year, Partner's vasectomy, complete sex abstinence (for 14 days before inclusion, the test period and after cessation of treatment according to the chemotherapy as described below), dual contraception, oral contraceptives.\n\n Effective contraception must be implemented:\n * Up to 6 months after treatment with vinblastine\n * Up to 5 months after treatment with Methotrexate for men and up to 3 months after treatment with Methotrexate for women\n * For the duration of treatment with Pazopanib;\n10. Affiliated to a social security system\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Personal history of malignancy except:\n\n 1. Cervical intraepithelial neoplasia;\n 2. Skin basal cell carcinoma;\n 3. Treated localized prostate carcinoma with PSA <1;\n 4. Neoplasia treated with curative intent, in remission for at least five years and considered at low risk of relapse.\n2. Pretreatement by Pazopanib or Methotrexate - vinblastine;\n3. Known allergy to Pazopanib, Methotrexate or vinblastine;\n4. Histological sampling not available for review or biological study;\n5. Clinical abnormalities which may increase the risk of gastric bleeding (not exhaustive list);\n\n 1. Gastric tumor with known risk of bleeding;\n 2. Inflammatory bowel disease or other gastrointestinal disease may increase the risk of gastric perforation.\n6. Pathologies that can lead to impaired intestinal absorption (not exhaustive):\n\n 1. Malabsorption;\n 2. Major resection of small intestine or stomach.\n7. Active uncontrolled infectious disease;\n8. Corrected QT interval> 480 ms;\n9. History of cardiovascular disease in the last 6 months:\n\n 1. Cardiac angioplasty;\n 2. Myocardial infarction;\n 3. Unstable angina;\n 4. Bypass surgery;\n 5. Symptomatic arterial disease.\n10. Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification;\n11. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);\n12. History of stroke or transient ischemic attack, pulmonary embolism or deep vein thrombosis not treated, within 6 months;\n13. History of major surgery or trauma within 28 days prior the first day of treatment, or presence of a wound, fracture or non-healed ulcer;\n14. Evidence of active bleeding or bleeding tendency;\n15. Known endobronchial lesions and / or infiltrative lesions of the large vessels lung;\n16. History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy;\n17. Pulmonary dysfunction, asthma, emphysema, chronic obstructive pulmonary bronchitis, pneumonia, pneumothorax, pulmonary contusion, hemothorax, distress acute respiratory syndrome, pulmonary fibrosis;\n18. Severe renal dysfunction;\n19. Severe hepatic dysfunction;\n20. History of psoriasis, rheumatoid arthritis, alcoholism, illness or chronic liver dysfunction;\n21. Any pre-existing severe or unstable medical or psychiatric condition, or other condition that may interfere with patient safety, the collection of its informed consent or adherence to treatment;\n22. Patient who refused or could not stop taking banned drugs for at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy and for the duration of the study;\n23. During cancer treatment:\n\n 1. Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B);\n 2. Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A) or chemotherapy with methotrexate, vinblastine (arm B).\n24. History of cancer treatment toxicity> grade 1 and / or whose the intensity increases, outside of alopecia.\n25. Pregnancy and lactation\n26. Concomitant treatment which can't be interrupted or replaced and which is not indicated with methotrexate:\n\n 1. Probenecid (alone or associated with sulfamethoxazole),\n 2. Trimethoprim,\n 3. Acetylsalicylic acid (for methotrexate doses above 20 mg per week with the acetylsalicylic acid and used at doses analgesics or antipyretics (≥ 500 mg per dose and/or <3 g per day)or anti-inflammatory (≥ 1 g per dose and / or > 3 g per day),\n 4. Phenylbutazone,\n 5. Yellow fever vaccine.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Written consent;",
"criterions": [
{
"exact_snippets": "Written consent",
"criterion": "consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Written consent",
"criterion": "consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
}
},
{
"identified_line": {
"line": "2. Age ≥ 18 years;",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. ECOG ≤ 1;",
"criterions": [
{
"exact_snippets": "ECOG ≤ 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG ≤ 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Histologically confirmed desmoid tumor;",
"criterions": [
{
"exact_snippets": "Histologically confirmed desmoid tumor",
"criterion": "desmoid tumor",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically confirmed desmoid tumor",
"criterion": "desmoid tumor",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "5. Disease progression before the patient's inclusion : completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterions": [
{
"exact_snippets": "Disease progression before the patient's inclusion",
"criterion": "disease progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "before inclusion"
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "similarity",
"expected_value": true
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "tolerance",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "similarity",
"expected_value": true
}
},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
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},
{
"exact_snippets": "completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)",
"criterion": "imaging",
"requirement": {
"requirement_type": "tolerance",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
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]
},
{
"exact_snippets": "Disease progression before the patient's inclusion",
"criterion": "disease progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "before inclusion"
}
}
]
}
},
{
"identified_line": {
"line": "6. Measurable target lesion (RECIST criteria) ;",
"criterions": [
{
"exact_snippets": "Measurable target lesion (RECIST criteria)",
"criterion": "target lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": "RECIST criteria"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable target lesion (RECIST criteria)",
"criterion": "target lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": "RECIST criteria"
}
}
]
}
},
{
"identified_line": {
"line": "7. Left ventricular ejection fraction (MUGA or ECHO) within the normal;",
"criterions": [
{
"exact_snippets": "Left ventricular ejection fraction (MUGA or ECHO) within the normal",
"criterion": "left ventricular ejection fraction",
"requirement": {
"requirement_type": "measurement",
"expected_value": "within the normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Left ventricular ejection fraction (MUGA or ECHO) within the normal",
"criterion": "left ventricular ejection fraction",
"requirement": {
"requirement_type": "measurement",
"expected_value": "within the normal"
}
}
]
}
},
{
"identified_line": {
"line": "8. Normal hematological, renal and liver functions :",
"criterions": [
{
"exact_snippets": "Normal hematological ... functions",
"criterion": "hematological functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... renal ... functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... liver functions",
"criterion": "liver functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Normal hematological ... functions",
"criterion": "hematological functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... renal ... functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... liver functions",
"criterion": "liver functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
}
},
{
"identified_line": {
"line": "2. Amino alanine transferase and aspartate amino transferase ≤ 2.5 ULN;",
"criterions": [
{
"exact_snippets": "Amino alanine transferase ... ≤ 2.5 ULN",
"criterion": "amino alanine transferase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "aspartate amino transferase ≤ 2.5 ULN",
"criterion": "aspartate amino transferase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Amino alanine transferase ... ≤ 2.5 ULN",
"criterion": "amino alanine transferase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "aspartate amino transferase ≤ 2.5 ULN",
"criterion": "aspartate amino transferase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Total bilirubin ≤ 1.5 ULN;",
"criterions": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 ULN",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 ULN",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Creatinine ≤ 1.5 mg/dl or, if creatinine> 1.5 mg/dl, Creatinine clearance ≥ 50 m/min;",
"criterions": [
{
"exact_snippets": "Creatinine ≤ 1.5 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "creatinine> 1.5 mg/dl ... Creatinine clearance ≥ 50 m/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "clearance",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "m/min"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "creatinine> 1.5 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "mg/dl"
}
}
},
"then_criteria": {
"exact_snippets": "creatinine> 1.5 mg/dl ... Creatinine clearance ≥ 50 m/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "clearance",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "m/min"
}
}
},
"else_criteria": {
"exact_snippets": "Creatinine ≤ 1.5 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
}
}
},
{
"identified_line": {
"line": "5. Urinary protein / urinary creatinine (Pu / Cu) <1. If PU/Cu ≥ 1, patients must have a proteinuria below 1g/24 h",
"criterions": [
{
"exact_snippets": "Urinary protein / urinary creatinine (Pu / Cu) <1",
"criterion": "urinary protein / urinary creatinine ratio",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "If PU/Cu ≥ 1, patients must have a proteinuria below 1g/24 h",
"criterion": "proteinuria",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "g/24 h"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Urinary protein / urinary creatinine (Pu / Cu) <1",
"criterion": "urinary protein / urinary creatinine ratio",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "N/A"
}
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "If PU/Cu ≥ 1, patients must have a proteinuria below 1g/24 h",
"criterion": "proteinuria",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "g/24 h"
}
}
}
}
},
{
"identified_line": {
"line": "9. Women are eligible provided they:",
"criterions": [
{
"exact_snippets": "Women are eligible",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women are eligible",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "1. Physiologically incapable of childbearing (hysterectomy, oophorectomy, bilateral tubal ligation, menopause).",
"criterions": [
{
"exact_snippets": "Physiologically incapable of childbearing (hysterectomy, oophorectomy, bilateral tubal ligation, menopause)",
"criterion": "childbearing capability",
"requirement": {
"requirement_type": "physiological capability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Physiologically incapable of childbearing (hysterectomy, oophorectomy, bilateral tubal ligation, menopause)",
"criterion": "childbearing capability",
"requirement": {
"requirement_type": "physiological capability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "2. Of childbearing age if they have had a negative pregnancy test in the week before the first dose of treatment.",
"criterions": [
{
"exact_snippets": "Of childbearing age",
"criterion": "childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "negative pregnancy test in the week before the first dose of treatment",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "negative pregnancy test in the week before the first dose of treatment",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "timing",
"expected_value": "in the week before the first dose of treatment"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Of childbearing age",
"criterion": "childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "negative pregnancy test in the week before the first dose of treatment",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "negative pregnancy test in the week before the first dose of treatment",
"criterion": "pregnancy test",
"requirement": {
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"expected_value": "in the week before the first dose of treatment"
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "3. Women of childbearing potential and men must agree to take an adequate method of contraception. Permitted contraceptive methods : IUD with a documented failure rate of 1% per year, Partner's vasectomy, complete sex abstinence (for 14 days before inclusion, the test period and after cessation of treatment according to the chemotherapy as described below), dual contraception, oral contraceptives.",
"criterions": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "men must agree to take an adequate method of contraception",
"criterion": "men contraception agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "adequate method of contraception",
"criterion": "contraception method",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Permitted contraceptive methods : IUD with a documented failure rate of 1% per year",
"criterion": "IUD failure rate",
"requirement": {
"requirement_type": "failure rate",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "% per year"
}
}
},
{
"exact_snippets": "Partner's vasectomy",
"criterion": "partner's vasectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "complete sex abstinence (for 14 days before inclusion, the test period and after cessation of treatment",
"criterion": "complete sex abstinence",
"requirement": {
"requirement_type": "duration",
"expected_value": "14 days before inclusion, the test period and after cessation of treatment"
}
},
{
"exact_snippets": "dual contraception",
"criterion": "dual contraception",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "oral contraceptives",
"criterion": "oral contraceptives",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "men must agree to take an adequate method of contraception",
"criterion": "men contraception agreement",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "adequate method of contraception",
"criterion": "contraception method",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Permitted contraceptive methods : IUD with a documented failure rate of 1% per year",
"criterion": "IUD failure rate",
"requirement": {
"requirement_type": "failure rate",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "% per year"
}
}
},
{
"exact_snippets": "Partner's vasectomy",
"criterion": "partner's vasectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "complete sex abstinence (for 14 days before inclusion, the test period and after cessation of treatment",
"criterion": "complete sex abstinence",
"requirement": {
"requirement_type": "duration",
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}
},
{
"exact_snippets": "dual contraception",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "oral contraceptives",
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"requirement_type": "presence",
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}
}
]
}
]
}
},
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"identified_line": {
"line": "Effective contraception must be implemented:",
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{
"exact_snippets": "Effective contraception must be implemented",
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"requirement_type": "implementation",
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}
}
]
},
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{
"exact_snippets": "Effective contraception must be implemented",
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"requirement_type": "implementation",
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}
}
]
}
},
{
"identified_line": {
"line": "* Up to 6 months after treatment with vinblastine",
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{
"exact_snippets": "Up to 6 months after treatment with vinblastine",
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"requirement_type": "time since treatment",
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"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
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{
"exact_snippets": "Up to 6 months after treatment with vinblastine",
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"requirement_type": "time since treatment",
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"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Up to 5 months after treatment with Methotrexate for men and up to 3 months after treatment with Methotrexate for women",
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{
"exact_snippets": "Up to 5 months after treatment with Methotrexate for men",
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{
"operator": "<=",
"value": 5,
"unit": "months"
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]
}
}
},
{
"exact_snippets": "up to 3 months after treatment with Methotrexate for women",
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"requirement_type": "duration",
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{
"operator": "<=",
"value": 3,
"unit": "months"
}
]
}
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Up to 5 months after treatment with Methotrexate for men",
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"requirement_type": "duration",
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{
"operator": "<=",
"value": 5,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "up to 3 months after treatment with Methotrexate for women",
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{
"operator": "<=",
"value": 3,
"unit": "months"
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}
}
}
]
}
},
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"identified_line": {
"line": "* For the duration of treatment with Pazopanib;",
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{
"exact_snippets": "duration of treatment with Pazopanib",
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}
}
]
},
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{
"exact_snippets": "duration of treatment with Pazopanib",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "10. Affiliated to a social security system",
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{
"exact_snippets": "Affiliated to a social security system",
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"requirement_type": "affiliation",
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}
}
]
},
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{
"exact_snippets": "Affiliated to a social security system",
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"requirement_type": "affiliation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"requirement_type": "minimum",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Cervical intraepithelial neoplasia;",
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{
"exact_snippets": "Cervical intraepithelial neoplasia",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Cervical intraepithelial neoplasia",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Skin basal cell carcinoma;",
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{
"exact_snippets": "Skin basal cell carcinoma",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Skin basal cell carcinoma",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "3. Treated localized prostate carcinoma with PSA <1;",
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{
"exact_snippets": "Treated localized prostate carcinoma",
"criterion": "prostate carcinoma",
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"requirement_type": "treatment status",
"expected_value": "treated"
}
},
{
"exact_snippets": "Treated localized prostate carcinoma",
"criterion": "prostate carcinoma",
"requirement": {
"requirement_type": "localization",
"expected_value": "localized"
}
},
{
"exact_snippets": "PSA <1",
"criterion": "PSA level",
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"requirement_type": "level",
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"operator": "<",
"value": 1,
"unit": "N/A"
}
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Treated localized prostate carcinoma",
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"requirement_type": "treatment status",
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}
},
{
"exact_snippets": "Treated localized prostate carcinoma",
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"requirement": {
"requirement_type": "localization",
"expected_value": "localized"
}
}
]
},
{
"exact_snippets": "PSA <1",
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"requirement_type": "level",
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"operator": "<",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Neoplasia treated with curative intent, in remission for at least five years and considered at low risk of relapse.",
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{
"exact_snippets": "Neoplasia treated with curative intent",
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"requirement_type": "intent",
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}
},
{
"exact_snippets": "in remission for at least five years",
"criterion": "neoplasia remission duration",
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"requirement_type": "duration",
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"operator": ">=",
"value": 5,
"unit": "years"
}
}
},
{
"exact_snippets": "considered at low risk of relapse",
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"requirement_type": "risk",
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}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Neoplasia treated with curative intent",
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}
},
{
"exact_snippets": "in remission for at least five years",
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"requirement_type": "duration",
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"operator": ">=",
"value": 5,
"unit": "years"
}
}
}
]
},
{
"exact_snippets": "considered at low risk of relapse",
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}
}
]
}
},
{
"identified_line": {
"line": "2. Pretreatement by Pazopanib or Methotrexate - vinblastine;",
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"exact_snippets": "Pretreatement by Pazopanib",
"criterion": "pretreatment with Pazopanib",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "Pretreatement by ... Methotrexate - vinblastine",
"criterion": "pretreatment with Methotrexate - vinblastine",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"exact_snippets": "Pretreatement by Pazopanib",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "Pretreatement by ... Methotrexate - vinblastine",
"criterion": "pretreatment with Methotrexate - vinblastine",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Known allergy to Pazopanib, Methotrexate or vinblastine;",
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{
"exact_snippets": "Known allergy to Pazopanib",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "Known allergy to ... Methotrexate",
"criterion": "allergy to Methotrexate",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known allergy to ... vinblastine",
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"requirement_type": "presence",
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}
}
]
},
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{
"exact_snippets": "Known allergy to Pazopanib",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known allergy to ... Methotrexate",
"criterion": "allergy to Methotrexate",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known allergy to ... vinblastine",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Histological sampling not available for review or biological study;",
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{
"exact_snippets": "Histological sampling not available",
"criterion": "histological sampling",
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"requirement_type": "availability",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Histological sampling not available",
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"requirement_type": "availability",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "5. Clinical abnormalities which may increase the risk of gastric bleeding (not exhaustive list);",
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{
"exact_snippets": "Clinical abnormalities which may increase the risk of gastric bleeding",
"criterion": "clinical abnormalities",
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"requirement_type": "risk of gastric bleeding",
"expected_value": "increase"
}
}
]
},
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"and_criteria": [
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"exact_snippets": "Clinical abnormalities which may increase the risk of gastric bleeding",
"criterion": "clinical abnormalities",
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"requirement_type": "risk of gastric bleeding",
"expected_value": "increase"
}
}
]
}
},
{
"identified_line": {
"line": "1. Gastric tumor with known risk of bleeding;",
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{
"exact_snippets": "Gastric tumor",
"criterion": "gastric tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "known risk of bleeding",
"criterion": "risk of bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": "known"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Gastric tumor",
"criterion": "gastric tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "known risk of bleeding",
"criterion": "risk of bleeding",
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"requirement_type": "severity",
"expected_value": "known"
}
}
]
}
},
{
"identified_line": {
"line": "2. Inflammatory bowel disease or other gastrointestinal disease may increase the risk of gastric perforation.",
"criterions": [
{
"exact_snippets": "Inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other gastrointestinal disease",
"criterion": "gastrointestinal disease",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "other gastrointestinal disease",
"criterion": "gastrointestinal disease",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "6. Pathologies that can lead to impaired intestinal absorption (not exhaustive):",
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{
"exact_snippets": "Pathologies that can lead to impaired intestinal absorption",
"criterion": "intestinal absorption",
"requirement": {
"requirement_type": "impairment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pathologies that can lead to impaired intestinal absorption",
"criterion": "intestinal absorption",
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"requirement_type": "impairment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Malabsorption;",
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{
"exact_snippets": "Malabsorption",
"criterion": "malabsorption",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Malabsorption",
"criterion": "malabsorption",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Major resection of small intestine or stomach.",
"criterions": [
{
"exact_snippets": "Major resection of small intestine",
"criterion": "small intestine resection",
"requirement": {
"requirement_type": "severity",
"expected_value": "major"
}
},
{
"exact_snippets": "Major resection of ... stomach",
"criterion": "stomach resection",
"requirement": {
"requirement_type": "severity",
"expected_value": "major"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Major resection of small intestine",
"criterion": "small intestine resection",
"requirement": {
"requirement_type": "severity",
"expected_value": "major"
}
},
{
"exact_snippets": "Major resection of ... stomach",
"criterion": "stomach resection",
"requirement": {
"requirement_type": "severity",
"expected_value": "major"
}
}
]
}
},
{
"identified_line": {
"line": "7. Active uncontrolled infectious disease;",
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{
"exact_snippets": "Active uncontrolled infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Active uncontrolled infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Active uncontrolled infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Active uncontrolled infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
}
]
}
},
{
"identified_line": {
"line": "8. Corrected QT interval> 480 ms;",
"criterions": [
{
"exact_snippets": "Corrected QT interval> 480 ms",
"criterion": "Corrected QT interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 480,
"unit": "ms"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Corrected QT interval> 480 ms",
"criterion": "Corrected QT interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 480,
"unit": "ms"
}
}
}
]
}
},
{
"identified_line": {
"line": "9. History of cardiovascular disease in the last 6 months:",
"criterions": [
{
"exact_snippets": "History of cardiovascular disease in the last 6 months",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of cardiovascular disease in the last 6 months",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "last 6 months"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "History of cardiovascular disease in the last 6 months",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of cardiovascular disease in the last 6 months",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "last 6 months"
}
}
]
}
},
{
"identified_line": {
"line": "1. Cardiac angioplasty;",
"criterions": [
{
"exact_snippets": "Cardiac angioplasty",
"criterion": "cardiac angioplasty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Cardiac angioplasty",
"criterion": "cardiac angioplasty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. Myocardial infarction;",
"criterions": [
{
"exact_snippets": "Myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "3. Unstable angina;",
"criterions": [
{
"exact_snippets": "Unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. Bypass surgery;",
"criterions": [
{
"exact_snippets": "Bypass surgery",
"criterion": "bypass surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Bypass surgery",
"criterion": "bypass surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "5. Symptomatic arterial disease.",
"criterions": [
{
"exact_snippets": "Symptomatic arterial disease",
"criterion": "arterial disease",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Symptomatic arterial disease",
"criterion": "arterial disease",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "10. Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification;",
"criterions": [
{
"exact_snippets": "Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"II",
"III",
"IV"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification",
"criterion": "congestive heart failure",
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"requirement_type": "severity",
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"II",
"III",
"IV"
]
}
}
]
}
},
{
"identified_line": {
"line": "11. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);",
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{
"exact_snippets": "Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)",
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"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "systolic blood pressure ≥ 140 mmHg",
"criterion": "systolic blood pressure",
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"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic blood pressure ≥ 90 mmHg",
"criterion": "diastolic blood pressure",
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"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "mmHg"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)",
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"requirement_type": "control",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "systolic blood pressure ≥ 140 mmHg",
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"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic blood pressure ≥ 90 mmHg",
"criterion": "diastolic blood pressure",
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"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "mmHg"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "12. History of stroke or transient ischemic attack, pulmonary embolism or deep vein thrombosis not treated, within 6 months;",
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{
"exact_snippets": "History of stroke or transient ischemic attack",
"criterion": "history of stroke or transient ischemic attack",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pulmonary embolism or deep vein thrombosis not treated, within 6 months",
"criterion": "pulmonary embolism or deep vein thrombosis",
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"requirement_type": "treatment",
"expected_value": false
}
},
{
"exact_snippets": "pulmonary embolism or deep vein thrombosis not treated, within 6 months",
"criterion": "pulmonary embolism or deep vein thrombosis",
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"requirement_type": "time frame",
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"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of stroke or transient ischemic attack",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "pulmonary embolism or deep vein thrombosis not treated, within 6 months",
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"requirement_type": "treatment",
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}
},
{
"exact_snippets": "pulmonary embolism or deep vein thrombosis not treated, within 6 months",
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"requirement_type": "time frame",
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{
"operator": "<=",
"value": 6,
"unit": "months"
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]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "13. History of major surgery or trauma within 28 days prior the first day of treatment, or presence of a wound, fracture or non-healed ulcer;",
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{
"exact_snippets": "History of major surgery or trauma within 28 days prior the first day of treatment",
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"requirement_type": "history",
"expected_value": true
}
},
{
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"criterion": "major surgery or trauma",
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"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "presence of a wound",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of a ... fracture",
"criterion": "fracture",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of a ... non-healed ulcer",
"criterion": "non-healed ulcer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of major surgery or trauma within 28 days prior the first day of treatment",
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"requirement_type": "history",
"expected_value": true
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},
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}
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}
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},
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},
{
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of a ... non-healed ulcer",
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"requirement_type": "presence",
"expected_value": true
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}
]
}
},
{
"identified_line": {
"line": "14. Evidence of active bleeding or bleeding tendency;",
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{
"exact_snippets": "Evidence of active bleeding",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "bleeding tendency",
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"requirement_type": "presence",
"expected_value": true
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}
]
},
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{
"exact_snippets": "Evidence of active bleeding",
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"expected_value": true
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},
{
"exact_snippets": "bleeding tendency",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "15. Known endobronchial lesions and / or infiltrative lesions of the large vessels lung;",
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{
"exact_snippets": "Known endobronchial lesions",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "infiltrative lesions of the large vessels lung",
"criterion": "infiltrative lesions of the large vessels lung",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Known endobronchial lesions",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "infiltrative lesions of the large vessels lung",
"criterion": "infiltrative lesions of the large vessels lung",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "16. History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy;",
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{
"exact_snippets": "History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy",
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"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy",
"criterion": "hemoptysis",
"requirement": {
"requirement_type": "quantity",
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"operator": ">",
"value": 2.5,
"unit": "ml"
}
}
},
{
"exact_snippets": "History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy",
"criterion": "hemoptysis",
"requirement": {
"requirement_type": "time frame",
"expected_value": "eight weeks preceding the first day of chemotherapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy",
"criterion": "hemoptysis",
"requirement": {
"requirement_type": "history",
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},
{
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"criterion": "hemoptysis",
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"operator": ">",
"value": 2.5,
"unit": "ml"
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}
}
]
},
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}
]
}
},
{
"identified_line": {
"line": "17. Pulmonary dysfunction, asthma, emphysema, chronic obstructive pulmonary bronchitis, pneumonia, pneumothorax, pulmonary contusion, hemothorax, distress acute respiratory syndrome, pulmonary fibrosis;",
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"exact_snippets": "Pulmonary dysfunction",
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"requirement_type": "presence",
"expected_value": false
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"exact_snippets": "asthma",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "emphysema",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "chronic obstructive pulmonary bronchitis",
"criterion": "chronic obstructive pulmonary bronchitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pneumonia",
"criterion": "pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pneumothorax",
"criterion": "pneumothorax",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pulmonary contusion",
"criterion": "pulmonary contusion",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hemothorax",
"criterion": "hemothorax",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "distress acute respiratory syndrome",
"criterion": "acute respiratory distress syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pulmonary fibrosis",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
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{
"exact_snippets": "Pulmonary dysfunction",
"criterion": "pulmonary dysfunction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "asthma",
"criterion": "asthma",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "emphysema",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "chronic obstructive pulmonary bronchitis",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pneumonia",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pneumothorax",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "pulmonary contusion",
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"requirement_type": "presence",
"expected_value": false
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},
{
"exact_snippets": "hemothorax",
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"requirement_type": "presence",
"expected_value": false
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},
{
"exact_snippets": "distress acute respiratory syndrome",
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"requirement_type": "presence",
"expected_value": false
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},
{
"exact_snippets": "pulmonary fibrosis",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "18. Severe renal dysfunction;",
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{
"exact_snippets": "Severe renal dysfunction",
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"requirement_type": "severity",
"expected_value": "severe"
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]
},
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"and_criteria": [
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"exact_snippets": "Severe renal dysfunction",
"criterion": "renal dysfunction",
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"requirement_type": "severity",
"expected_value": "severe"
}
}
]
}
},
{
"identified_line": {
"line": "19. Severe hepatic dysfunction;",
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{
"exact_snippets": "Severe hepatic dysfunction",
"criterion": "hepatic dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Severe hepatic dysfunction",
"criterion": "hepatic dysfunction",
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"requirement_type": "severity",
"expected_value": "severe"
}
}
}
},
{
"identified_line": {
"line": "20. History of psoriasis, rheumatoid arthritis, alcoholism, illness or chronic liver dysfunction;",
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{
"exact_snippets": "History of psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... rheumatoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... alcoholism",
"criterion": "alcoholism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... illness",
"criterion": "illness",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... chronic liver dysfunction",
"criterion": "chronic liver dysfunction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... rheumatoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... alcoholism",
"criterion": "alcoholism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... illness",
"criterion": "illness",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... chronic liver dysfunction",
"criterion": "chronic liver dysfunction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "21. Any pre-existing severe or unstable medical or psychiatric condition, or other condition that may interfere with patient safety, the collection of its informed consent or adherence to treatment;",
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"exact_snippets": "pre-existing severe or unstable medical or psychiatric condition",
"criterion": "medical or psychiatric condition",
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"requirement_type": "severity",
"expected_value": "severe or unstable"
}
},
{
"exact_snippets": "other condition that may interfere with patient safety",
"criterion": "condition interfering with patient safety",
"requirement": {
"requirement_type": "interference",
"expected_value": "may interfere"
}
},
{
"exact_snippets": "condition that may interfere with ... the collection of its informed consent",
"criterion": "condition interfering with informed consent",
"requirement": {
"requirement_type": "interference",
"expected_value": "may interfere"
}
},
{
"exact_snippets": "condition that may interfere with ... adherence to treatment",
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"requirement": {
"requirement_type": "interference",
"expected_value": "may interfere"
}
}
]
},
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"or_criteria": [
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"and_criteria": [
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"exact_snippets": "pre-existing severe or unstable medical or psychiatric condition",
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}
},
{
"exact_snippets": "other condition that may interfere with patient safety",
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"requirement": {
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}
}
]
},
{
"exact_snippets": "condition that may interfere with ... the collection of its informed consent",
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"requirement_type": "interference",
"expected_value": "may interfere"
}
},
{
"exact_snippets": "condition that may interfere with ... adherence to treatment",
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"requirement_type": "interference",
"expected_value": "may interfere"
}
}
]
}
},
{
"identified_line": {
"line": "23. During cancer treatment:",
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{
"exact_snippets": "During cancer treatment",
"criterion": "cancer treatment",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "During cancer treatment",
"criterion": "cancer treatment",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B);",
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{
"exact_snippets": "Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B)",
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"requirement_type": "time since treatment",
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"comparisons": [
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"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
}
]
},
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"exact_snippets": "Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B)",
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"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A) or chemotherapy with methotrexate, vinblastine (arm B).",
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{
"exact_snippets": "Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A)",
"criterion": "prior treatment before pazopanib (arm A)",
"requirement": {
"requirement_type": "treatment type",
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"immunotherapy",
"biological treatment",
"experimental therapy",
"hormone therapy"
]
}
},
{
"exact_snippets": "Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A)",
"criterion": "prior treatment before pazopanib (arm A)",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A)",
"criterion": "prior treatment before pazopanib (arm A)",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "half-lives of medication"
}
]
}
}
},
{
"exact_snippets": "chemotherapy with methotrexate, vinblastine (arm B)",
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"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"methotrexate",
"vinblastine"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
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"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A)",
"criterion": "prior treatment before pazopanib (arm A)",
"requirement": {
"requirement_type": "treatment type",
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"immunotherapy",
"biological treatment",
"experimental therapy",
"hormone therapy"
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}
},
{
"or_criteria": [
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"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
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"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A)",
"criterion": "prior treatment before pazopanib (arm A)",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "half-lives of medication"
}
]
}
}
}
]
}
]
}
]
},
{
"exact_snippets": "chemotherapy with methotrexate, vinblastine (arm B)",
"criterion": "prior chemotherapy before arm B",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"methotrexate",
"vinblastine"
]
}
}
]
}
},
{
"identified_line": {
"line": "24. History of cancer treatment toxicity> grade 1 and / or whose the intensity increases, outside of alopecia.",
"criterions": [
{
"exact_snippets": "History of cancer treatment toxicity> grade 1",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "grade"
}
}
},
{
"exact_snippets": "intensity increases, outside of alopecia",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "intensity",
"expected_value": "increases"
}
},
{
"exact_snippets": "intensity increases, outside of alopecia",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "alopecia"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of cancer treatment toxicity> grade 1",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "grade"
}
}
},
{
"exact_snippets": "intensity increases, outside of alopecia",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "alopecia"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "intensity increases, outside of alopecia",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "intensity",
"expected_value": "increases"
}
},
{
"exact_snippets": "intensity increases, outside of alopecia",
"criterion": "cancer treatment toxicity",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "alopecia"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "25. Pregnancy and lactation",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "26. Concomitant treatment which can't be interrupted or replaced and which is not indicated with methotrexate:",
"criterions": [
{
"exact_snippets": "Concomitant treatment which can't be interrupted or replaced",
"criterion": "concomitant treatment",
"requirement": {
"requirement_type": "interruptibility",
"expected_value": false
}
},
{
"exact_snippets": "Concomitant treatment which can't be interrupted or replaced",
"criterion": "concomitant treatment",
"requirement": {
"requirement_type": "replaceability",
"expected_value": false
}
},
{
"exact_snippets": "treatment ... which is not indicated with methotrexate",
"criterion": "treatment compatibility with methotrexate",
"requirement": {
"requirement_type": "compatibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Concomitant treatment which can't be interrupted or replaced",
"criterion": "concomitant treatment",
"requirement": {
"requirement_type": "interruptibility",
"expected_value": false
}
},
{
"exact_snippets": "Concomitant treatment which can't be interrupted or replaced",
"criterion": "concomitant treatment",
"requirement": {
"requirement_type": "replaceability",
"expected_value": false
}
}
]
},
{
"exact_snippets": "treatment ... which is not indicated with methotrexate",
"criterion": "treatment compatibility with methotrexate",
"requirement": {
"requirement_type": "compatibility",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "1. Probenecid (alone or associated with sulfamethoxazole),",
"criterions": [
{
"exact_snippets": "Probenecid (alone or associated with sulfamethoxazole)",
"criterion": "Probenecid",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Probenecid (alone or associated with sulfamethoxazole)",
"criterion": "sulfamethoxazole",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Probenecid (alone or associated with sulfamethoxazole)",
"criterion": "Probenecid",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Probenecid (alone or associated with sulfamethoxazole)",
"criterion": "sulfamethoxazole",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Probenecid (alone or associated with sulfamethoxazole)",
"criterion": "Probenecid",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "2. Trimethoprim,",
"criterions": [
{
"exact_snippets": "Trimethoprim",
"criterion": "Trimethoprim",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Trimethoprim",
"criterion": "Trimethoprim",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. Phenylbutazone,",
"criterions": [
{
"exact_snippets": "Phenylbutazone",
"criterion": "Phenylbutazone",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Phenylbutazone",
"criterion": "Phenylbutazone",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "5. Yellow fever vaccine.",
"criterions": [
{
"exact_snippets": "Yellow fever vaccine",
"criterion": "yellow fever vaccine",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Yellow fever vaccine",
"criterion": "yellow fever vaccine",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "1. Hemoglobin ≥ 9 g / dl; neutrophils ≥ 1.5 x 109 / l; platelets ≥ 100 x 109 / l; prothrombin time or INR1 ≤ 1.2 ULN or activated partial thromboplastin time ≤ 1.2 ULN;",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥ 9 g / dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9,
"unit": "g/dl"
}
}
},
{
"exact_snippets": "neutrophils ≥ 1.5 x 109 / l",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x 10^9/l"
}
}
},
{
"exact_snippets": "platelets ≥ 100 x 109 / l",
"criterion": "platelet count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 10^9/l"
}
}
},
{
"exact_snippets": "prothrombin time or INR1 ≤ 1.2 ULN",
"criterion": "prothrombin time or INR1",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "ULN"
}
}
},
{
"exact_snippets": "activated partial thromboplastin time ≤ 1.2 ULN",
"criterion": "activated partial thromboplastin time",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "prothrombin time or INR1 ≤ 1.2 ULN",
"criterion": "prothrombin time or INR1",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "ULN"
}
}
},
{
"exact_snippets": "activated partial thromboplastin time ≤ 1.2 ULN",
"criterion": "activated partial thromboplastin time",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<=",
"value": 1.2,
"unit": "ULN"
}
}
}
]
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "1. Personal history of malignancy except:",
"criterions": [
{
"exact_snippets": "Personal history of malignancy",
"criterion": "personal history of malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Personal history of malignancy",
"criterion": "personal history of malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "22. Patient who refused or could not stop taking banned drugs for at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy and for the duration of the study;",
"criterions": [
{
"exact_snippets": "refused or could not stop taking banned drugs",
"criterion": "banned drug use",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy",
"criterion": "banned drug cessation period before chemotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 14,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "for the duration of the study",
"criterion": "banned drug cessation period during study",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of the study"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "refused or could not stop taking banned drugs",
"criterion": "banned drug use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy",
"criterion": "banned drug cessation period before chemotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 14,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "for the duration of the study",
"criterion": "banned drug cessation period during study",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of the study"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Acetylsalicylic acid (for methotrexate doses above 20 mg per week with the acetylsalicylic acid and used at doses analgesics or antipyretics (≥ 500 mg per dose and/or <3 g per day)or anti-inflammatory (≥ 1 g per dose and / or > 3 g per day),",
"criterions": [
{
"exact_snippets": "Acetylsalicylic acid ... methotrexate doses above 20 mg per week",
"criterion": "acetylsalicylic acid use with methotrexate",
"requirement": {
"requirement_type": "methotrexate dose",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "mg per week"
}
}
},
{
"exact_snippets": "acetylsalicylic acid ... doses analgesics or antipyretics (≥ 500 mg per dose and/or <3 g per day)",
"criterion": "acetylsalicylic acid dose for analgesic or antipyretic use",
"requirement": {
"requirement_type": "dose per administration",
"expected_value": {
"operator": ">=",
"value": 500,
"unit": "mg"
}
}
},
{
"exact_snippets": "acetylsalicylic acid ... doses analgesics or antipyretics (≥ 500 mg per dose and/or <3 g per day)",
"criterion": "acetylsalicylic acid dose for analgesic or antipyretic use",
"requirement": {
"requirement_type": "daily dose",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "g"
}
}
},
{
"exact_snippets": "acetylsalicylic acid ... anti-inflammatory (≥ 1 g per dose and / or > 3 g per day)",
"criterion": "acetylsalicylic acid dose for anti-inflammatory use",
"requirement": {
"requirement_type": "dose per administration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "g"
}
}
},
{
"exact_snippets": "acetylsalicylic acid ... anti-inflammatory (≥ 1 g per dose and / or > 3 g per day)",
"criterion": "acetylsalicylic acid dose for anti-inflammatory use",
"requirement": {
"requirement_type": "daily dose",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "g"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}