{
    "info": {
        "nct_id": "NCT01229865",
        "official_title": "",
        "inclusion_criteria": "1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);\n2. Absence of sensitivity to therapeutic radioiodine;\n3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan\n4. Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;\n5. Subjects with a normal/acceptable hematological profile\n6. Subjects with adequate renal function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Presence of any of the following:\n\n   * Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed)\n   * Radiotherapy to ≥25% of bone marrow;\n2. Major surgery <4 weeks prior to baseline visit;\n3. Any other ongoing investigational agents within 4 weeks before dosing;\n4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting;\n5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);\n6. Subjects with active vascular disease, either myocardial or peripheral;\n7. Subjects with proliferative and/or vascular retinopathy;\n8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;\n9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible);\n10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV;\n11. Any of the following conditions:\n\n    * Serious or non-healing wound, ulcer, or bone fracture;\n    * History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing;\n    * Any history of cerebrovascular accident (CVA) within 6 months of dosing;\n    * Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted);\n    * History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding;\n    * Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation;\n12. Subjects with an ongoing requirement for immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before dosing;\n13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced DTC (papillary, follicular, Hurthle cell)",
                    "criterion": "advanced DTC subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "papillary",
                                "follicular",
                                "Hurthle cell"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Absence of sensitivity to therapeutic radioiodine;",
            "criterions": [
                {
                    "exact_snippets": "Absence of sensitivity to therapeutic radioiodine",
                    "criterion": "sensitivity to therapeutic radioiodine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, defined as at least one non-bony lesion",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "at least one non-bony lesion"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one non-bony lesion that can be accurately measured in at least one dimension",
                    "criterion": "non-bony lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "accurately measured in at least one dimension"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed with spiral CT scan",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "spiral CT scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status (PS) 0, 1, or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky performance status of ≥60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects with a normal/acceptable hematological profile",
            "criterions": [
                {
                    "exact_snippets": "normal/acceptable hematological profile",
                    "criterion": "hematological profile",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "normal",
                                "acceptable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects with adequate renal function",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Presence of any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Presence of any of the following",
                    "criterion": "condition presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed)",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy ... <4 weeks prior to baseline visit",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy <4 weeks prior to baseline visit",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent and/or prior therapy with octreotide ... tumor progression on this therapy has been demonstrated",
                    "criterion": "octreotide therapy",
                    "requirements": [
                        {
                            "requirement_type": "tumor progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent and/or prior therapy with biphosphonates will be allowed",
                    "criterion": "biphosphonates therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy to ≥25% of bone marrow;",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy to ≥25% of bone marrow",
                    "criterion": "radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "% of bone marrow"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Major surgery <4 weeks prior to baseline visit;",
            "criterions": [
                {
                    "exact_snippets": "Major surgery <4 weeks prior to baseline visit",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any other ongoing investigational agents within 4 weeks before dosing;",
            "criterions": [
                {
                    "exact_snippets": "Any other ongoing investigational agents within 4 weeks before dosing",
                    "criterion": "ongoing investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting;",
            "criterions": [
                {
                    "exact_snippets": "acute cardiac event within the last 12 months",
                    "criterion": "acute cardiac event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "admission for unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "admission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac angioplasty",
                    "criterion": "cardiac angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stenting",
                    "criterion": "stenting",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);",
            "criterions": [
                {
                    "exact_snippets": "QTc prolongation (defined as QTc interval ≥500 msecs)",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "msecs"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia)",
                    "criterion": "ECG abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "frequent ventricular ectopy",
                                "evidence of ongoing myocardial ischemia"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects with active vascular disease, either myocardial or peripheral;",
            "criterions": [
                {
                    "exact_snippets": "active vascular disease",
                    "criterion": "vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial",
                    "criterion": "myocardial disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;",
            "criterions": [
                {
                    "exact_snippets": "known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)",
                    "criterion": "active liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "alcoholic",
                                "drug/toxin induced",
                                "genetic",
                                "autoimmune"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "other than related to tumor metastases",
                    "criterion": "liver disease related to tumor metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible);",
            "criterions": [
                {
                    "exact_snippets": "known CNS metastatic disease",
                    "criterion": "CNS metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered",
                    "criterion": "treated CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV;",
            "criterions": [
                {
                    "exact_snippets": "Subjects testing positive to one of the following viruses: HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects testing positive to one of the following viruses: ... HBV",
                    "criterion": "HBV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects testing positive to one of the following viruses: ... HCV",
                    "criterion": "HCV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious or non-healing wound, ulcer, or bone fracture;",
            "criterions": [
                {
                    "exact_snippets": "Serious or non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing;",
            "criterions": [
                {
                    "exact_snippets": "History of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... gastro-intestinal perforation",
                    "criterion": "gastro-intestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active diverticulitis",
                    "criterion": "diverticulitis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastro-intestinal tract bleeding within 6 months of dosing",
                    "criterion": "gastro-intestinal tract bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any history of cerebrovascular accident (CVA) within 6 months of dosing;",
            "criterions": [
                {
                    "exact_snippets": "Any history of cerebrovascular accident (CVA) within 6 months of dosing",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted);",
            "criterions": [
                {
                    "exact_snippets": "Current use of therapeutic warfarin",
                    "criterion": "therapeutic warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Low molecular weight heparin ... are permitted",
                    "criterion": "low molecular weight heparin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted",
                    "criterion": "prophylactic low-dose warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "INR level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.2,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding;",
            "criterions": [
                {
                    "exact_snippets": "History of bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemophilia",
                    "criterion": "hemophilia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disseminated intravascular coagulation (DIC)",
                    "criterion": "disseminated intravascular coagulation (DIC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other abnormality of coagulation potentially predisposing subjects to bleeding",
                    "criterion": "abnormality of coagulation",
                    "requirements": [
                        {
                            "requirement_type": "potential to predispose to bleeding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation;",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled depression",
                    "criterion": "depression",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "anxiety disorder",
                    "criterion": "anxiety disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent (within the previous 6 months) suicidal ideation",
                    "criterion": "suicidal ideation",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Subjects with an ongoing requirement for immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before dosing;",
            "criterions": [
                {
                    "exact_snippets": "ongoing requirement for immunosuppressive treatment",
                    "criterion": "immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "use of glucocorticoids",
                    "criterion": "glucocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of ... cyclosporin",
                    "criterion": "cyclosporin",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of chronic use of any such medication within the last 4 weeks before dosing",
                    "criterion": "chronic use of immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "within the last 4 weeks before dosing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations that would limit compliance with study requirements",
                    "criterion": "social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "7. Subjects with proliferative and/or vascular retinopathy;",
            "criterions": [
                {
                    "exact_snippets": "proliferative retinopathy",
                    "criterion": "proliferative retinopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular retinopathy",
                    "criterion": "vascular retinopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Any of the following conditions:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}