{
    "info": {
        "nct_id": "NCT00239980",
        "official_title": "A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)",
        "inclusion_criteria": "Patients must meet all of the following criteria to be considered for enrolment:\n\n* Women with newly diagnosed, histologically proven EOC are potentially eligible. Patients with primary peritoneal or fallopian tube tumours of equivalent histology are also considered for enrolment. If open or true cut biopsy is not available, fine needle aspiration (FNA) showing an adenocarcinoma is considered diagnostic for EOC if all 4 (a to d) of the following conditions are satisfied:\n\n  1. Patient has a pelvic mass, AND\n  2. Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND\n  3. Normal mammography within 6 weeks of randomization, AND\n  4. Serum CA-125/CEA greater than or equal to 25. If the ratio is less than 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour.\n* Between the ages of 18 and 75.\n* FIGO stage IIB to IV disease.\n* A pre-study CA-125 level at least twice the upper limit of normal.\n* Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy by meeting all of the following laboratory findings within 7 days prior to randomization:\n\n  1. Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre).\n  2. Platelet count of at least 150 x 109/L (100,000 per cubic millimetre).\n  3. Serum creatinine no greater than 177 micromol/L (2.0 mg/dL).\n  4. Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre.\n  5. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal of the local centre.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Borderline ovarian tumours.\n* Received prior chemotherapy or radiation therapy for EOC.\n* Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level.\n* History of another malignancy, unless disease-free for 5 years or greater; non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted.\n* Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4.\n* Life expectancy less than 12 weeks.\n* Complete bowel obstruction at the time of study enrolment.\n* Receiving long-term anticoagulant therapy for an established indication (e.g., atrial fibrillation, mechanical heart valves).\n* Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder).\n* History of allergy to any heparin (e.g., heparin-induced thrombocytopenia).\n* Significant cardiac history including myocardial infarction within preceding 6 months, congestive heart failure, clinically relevant atrial or ventricular arrhythmias, history of 2nd or 3rd degree heart blocks unless pacemaker is implanted.\n* Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to:\n\n  1. Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues.\n  2. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up.\n  3. Uncontrolled hypertension despite optimal medical therapy.\n  4. Active, uncontrolled infection.\n* Women who are pregnant or lactating or are of childbearing potential but are not using effective contraception.\n* Total body weight of less than 40 kg.\n* Concurrent treatment with experimental or investigational drugs.\n* Unable or unwilling to attend scheduled follow-ups.\n* Unable (e.g., language barrier, mental illness) to provide informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women with newly diagnosed, histologically proven EOC are potentially eligible. Patients with primary peritoneal or fallopian tube tumours of equivalent histology are also considered for enrolment. If open or true cut biopsy is not available, fine needle aspiration (FNA) showing an adenocarcinoma is considered diagnostic for EOC if all 4 (a to d) of the following conditions are satisfied:",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically proven EOC",
                    "criterion": "histological confirmation of EOC",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with primary peritoneal or fallopian tube tumours of equivalent histology",
                    "criterion": "tumor location and histology",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": [
                                "primary peritoneal",
                                "fallopian tube"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "open or true cut biopsy is not available",
                    "criterion": "biopsy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "fine needle aspiration (FNA) showing an adenocarcinoma",
                    "criterion": "FNA result",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patient has a pelvic mass, AND",
            "criterions": [
                {
                    "exact_snippets": "Patient has a pelvic mass",
                    "criterion": "pelvic mass",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND",
            "criterions": [
                {
                    "exact_snippets": "evidence of disease larger than 1 cm in the upper abdomen",
                    "criterion": "disease in the upper abdomen",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Normal mammography within 6 weeks of randomization, AND",
            "criterions": [
                {
                    "exact_snippets": "Normal mammography within 6 weeks of randomization",
                    "criterion": "mammography",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "normal"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 weeks of randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Serum CA-125/CEA greater than or equal to 25. If the ratio is less than 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour.",
            "criterions": [
                {
                    "exact_snippets": "Serum CA-125/CEA greater than or equal to 25",
                    "criterion": "Serum CA-125/CEA ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "barium enema (or colonoscopy) ... must be negative for a primary tumour",
                    "criterion": "barium enema or colonoscopy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative for a primary tumour"
                        }
                    ]
                },
                {
                    "exact_snippets": "gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour",
                    "criterion": "gastroscopy or radiological examination of the stomach",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative for a primary tumour"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Between the ages of 18 and 75.",
            "criterions": [
                {
                    "exact_snippets": "Between the ages of 18 and 75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage IIB to IV disease.",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage IIB to IV disease",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "B"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A pre-study CA-125 level at least twice the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "pre-study CA-125 level at least twice the upper limit of normal",
                    "criterion": "CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy by meeting all of the following laboratory findings within 7 days prior to randomization:",
            "criterions": [
                {
                    "exact_snippets": "Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy",
                    "criterion": "eligibility for adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "taxane-based chemotherapy",
                                "platinum-based chemotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "meeting all of the following laboratory findings within 7 days prior to randomization",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre).",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre)",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10 9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Platelet count of at least 150 x 109/L (100,000 per cubic millimetre).",
            "criterions": [
                {
                    "exact_snippets": "Platelet count of at least 150 x 109/L (100,000 per cubic millimetre)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Serum creatinine no greater than 177 micromol/L (2.0 mg/dL).",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine no greater than 177 micromol/L (2.0 mg/dL)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 177,
                                "unit": "micromol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin level no greater than 1.5 times the upper limit of normal",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Borderline ovarian tumours.",
            "criterions": [
                {
                    "exact_snippets": "Borderline ovarian tumours",
                    "criterion": "borderline ovarian tumours",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received prior chemotherapy or radiation therapy for EOC.",
            "criterions": [
                {
                    "exact_snippets": "Received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received prior ... radiation therapy for EOC",
                    "criterion": "prior radiation therapy for EOC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level.",
            "criterions": [
                {
                    "exact_snippets": "Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level.",
                    "criterion": "mouse antibodies",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "28 days prior to the pre-study CA-125 level"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy, unless disease-free for 5 years or greater; non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted.",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless disease-free for 5 years or greater",
                    "criterion": "disease-free duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted",
                    "criterion": "non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4.",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy less than 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy less than 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Complete bowel obstruction at the time of study enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Complete bowel obstruction at the time of study enrolment.",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of study enrolment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving long-term anticoagulant therapy for an established indication (e.g., atrial fibrillation, mechanical heart valves).",
            "criterions": [
                {
                    "exact_snippets": "Receiving long-term anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        }
                    ]
                },
                {
                    "exact_snippets": "established indication (e.g., atrial fibrillation, mechanical heart valves)",
                    "criterion": "indication for anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "established",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "atrial fibrillation",
                                "mechanical heart valves"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder).",
            "criterions": [
                {
                    "exact_snippets": "Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder)",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergy to any heparin (e.g., heparin-induced thrombocytopenia).",
            "criterions": [
                {
                    "exact_snippets": "History of allergy to any heparin",
                    "criterion": "allergy to heparin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heparin-induced thrombocytopenia",
                    "criterion": "heparin-induced thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant cardiac history including myocardial infarction within preceding 6 months, congestive heart failure, clinically relevant atrial or ventricular arrhythmias, history of 2nd or 3rd degree heart blocks unless pacemaker is implanted.",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiac history including myocardial infarction within preceding 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant cardiac history including ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant cardiac history including ... clinically relevant atrial or ventricular arrhythmias",
                    "criterion": "atrial or ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant cardiac history including ... history of 2nd or 3rd degree heart blocks unless pacemaker is implanted",
                    "criterion": "2nd or 3rd degree heart blocks",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "pacemaker implantation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to:",
            "criterions": [
                {
                    "exact_snippets": "Serious medical conditions that preclude the administration of chemotherapy",
                    "criterion": "serious medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on chemotherapy",
                            "expected_value": "preclude"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious medical conditions that preclude the administration of ... anticoagulant therapy",
                    "criterion": "serious medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on anticoagulant therapy",
                            "expected_value": "preclude"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious medical conditions that preclude the administration of ... adherence to protocol",
                    "criterion": "serious medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on protocol adherence",
                            "expected_value": "preclude"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues.",
            "criterions": [
                {
                    "exact_snippets": "Allergic reactions to drugs containing cremophor",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "cremophor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergic reactions to ... compounds chemically related to taxanes",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "compounds chemically related to taxanes"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergic reactions to ... compounds chemically related to ... platinum analogues",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "compounds chemically related to platinum analogues"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Significant neurologic or psychiatric disorder",
                    "criterion": "neurologic or psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "impair obtaining informed consent",
                    "criterion": "ability to obtain informed consent",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "impair ... reliable follow-up",
                    "criterion": "ability to have reliable follow-up",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrolled hypertension despite optimal medical therapy.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "despite optimal medical therapy",
                    "criterion": "medical therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "optimal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active, uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "Active, uncontrolled infection.",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total body weight of less than 40 kg.",
            "criterions": [
                {
                    "exact_snippets": "Total body weight of less than 40 kg.",
                    "criterion": "total body weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with experimental or investigational drugs.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with experimental or investigational drugs.",
                    "criterion": "concurrent treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "experimental",
                                "investigational"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to attend scheduled follow-ups.",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to attend scheduled follow-ups.",
                    "criterion": "attendance at scheduled follow-ups",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable (e.g., language barrier, mental illness) to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Unable ... to provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "language barrier",
                    "criterion": "language barrier",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patients must meet all of the following criteria to be considered for enrolment:",
            "criterions": []
        },
        {
            "line": "5. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal of the local centre.",
            "criterions": [
                {
                    "exact_snippets": "Serum alanine aminotransferase (ALT) levels no greater than 3 times the upper limit of normal",
                    "criterion": "serum alanine aminotransferase (ALT) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) levels no greater than 3 times the upper limit of normal",
                    "criterion": "aspartate aminotransferase (AST) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal",
                    "criterion": "alkaline phosphatase (ALP) levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Women who are pregnant or lactating or are of childbearing potential but are not using effective contraception.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women ... of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not using effective contraception",
                    "criterion": "use of effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}