{
    "info": {
        "nct_id": "NCT02910882",
        "official_title": "A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma",
        "inclusion_criteria": "Subjects must satisfy all the following inclusion criteria to be enrolled in the study:\n\n1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form;\n2. For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study;\n3. Patients with previously untreated localized, unresectable histologically confirmed pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or when patients cannot have or refuse surgery);\n4. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L;\n5. Platelets ≥ 100 x 109/L;\n6. Hgb ≥ 9 g/dL;\n7. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x [Upper Limit of Normal (ULN)];\n8. Bilirubin ≤ 1.5 x ULN;\n9. GFR ≥ 30 mL/min;\n10. Patient has no clinically significant abnormalities in urinalysis results;\n11. Patient has acceptable coagulation status as indicated by a Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within 15% of normal limits;\n12. Eastern Cooperative Oncology Group (ECOG) ≤ 2\nHealthy volunteers allowed\nMust have maximum age of 90 Years",
        "exclusion_criteria": "Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:\n\n1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period;\n2. Any prior history of cerebrovascular accident, transient ischemic attack, or pre-existing carotid artery disease.\n3. Known allergy to hyaluronidase;\n4. Current use of megestrol acetate (use within 10 days of Day 1);\n5. Contraindication to heparin including prior heparin induced thrombocytopenia (HIT), recent CNS bleed; intracranial or spinal lesion at high risk for bleeding; severe platelet dysfunction; recent major operation at high risk for bleeding; underlying hemorrhagic coagulopathy; high risk for falls; potential need for spinal anesthesia/lumbar puncture; active bleeding;\n6. Women currently pregnant or breastfeeding;\n7. Intolerance to dexamethasone;\n8. Inability to comply with study and follow-up procedures as judged by the Investigator;\n9. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;\n10. Patient has known infection with HIV, hepatitis B, or hepatitis C;\n11. Patient has a history of allergy or hypersensitivity to any of the agents they are supposed to receive (or to any of the excipients for those agents);\n12. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug, these can include New York Heart Association Functional Class ≥ 3, myocardial infarction within the past 12 months before screening, pre-existing atrial fibrillation, symptomatic COPD.\n13. Patient is unwilling or unable to comply with study procedures.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form;",
                "criterions": [
                    {
                        "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                        "criterion": "Informed Consent Form",
                        "requirement": {
                            "requirement_type": "approval",
                            "expected_value": [
                                "Institutional Review Board",
                                "Ethics Committee"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                        "criterion": "Informed Consent Form",
                        "requirement": {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    },
                    {
                        "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                        "criterion": "Informed Consent Form",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                                        "criterion": "Informed Consent Form",
                                        "requirement": {
                                            "requirement_type": "approval",
                                            "expected_value": [
                                                "Institutional Review Board",
                                                "Ethics Committee"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                                        "criterion": "Informed Consent Form",
                                        "requirement": {
                                            "requirement_type": "format",
                                            "expected_value": "written"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form",
                                "criterion": "Informed Consent Form",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "signed"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study;",
                "criterions": [
                    {
                        "exact_snippets": "men and women of reproductive potential",
                        "criterion": "reproductive potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agreement to use an effective contraceptive method",
                        "criterion": "use of effective contraceptive method",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods",
                        "criterion": "effective contraceptive methods",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "prior sterilization",
                                "intra-uterine device",
                                "oral contraceptives",
                                "injectable contraceptives",
                                "barrier methods"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Abstinence alone is not considered an adequate contraceptive measure",
                        "criterion": "abstinence",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "men and women of reproductive potential",
                                                "criterion": "reproductive potential",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "agreement to use an effective contraceptive method",
                                                "criterion": "use of effective contraceptive method",
                                                "requirement": {
                                                    "requirement_type": "agreement",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods",
                                        "criterion": "effective contraceptive methods",
                                        "requirement": {
                                            "requirement_type": "types",
                                            "expected_value": [
                                                "prior sterilization",
                                                "intra-uterine device",
                                                "oral contraceptives",
                                                "injectable contraceptives",
                                                "barrier methods"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Abstinence alone is not considered an adequate contraceptive measure",
                                    "criterion": "abstinence",
                                    "requirement": {
                                        "requirement_type": "adequacy",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients with previously untreated localized, unresectable histologically confirmed pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or when patients cannot have or refuse surgery);",
                "criterions": [
                    {
                        "exact_snippets": "previously untreated",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    },
                    {
                        "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        }
                    },
                    {
                        "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "previously untreated",
                                "criterion": "treatment history",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "untreated"
                                }
                            },
                            {
                                "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                                "criterion": "pancreatic adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "localization",
                                    "expected_value": "localized"
                                }
                            },
                            {
                                "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                                "criterion": "pancreatic adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": "histologically confirmed"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                                "criterion": "pancreatic adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "resectability",
                                    "expected_value": "unresectable"
                                }
                            },
                            {
                                "exact_snippets": "localized, unresectable histologically confirmed pancreatic adenocarcinoma",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "eligibility",
                                    "expected_value": "cannot have or refuse"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L;",
                "criterions": [
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L",
                        "criterion": "Absolute Neutrophil Count (ANC)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Platelets ≥ 100 x 109/L;",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Hgb ≥ 9 g/dL;",
                "criterions": [
                    {
                        "exact_snippets": "Hgb ≥ 9 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x [Upper Limit of Normal (ULN)];",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate Aminotransferase (AST) ... ≤ 2.5 x [Upper Limit of Normal (ULN)]",
                        "criterion": "Aspartate Aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine Aminotransferase (ALT) ≤ 2.5 x [Upper Limit of Normal (ULN)]",
                        "criterion": "Alanine Aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Bilirubin ≤ 1.5 x ULN;",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 x ULN",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. GFR ≥ 30 mL/min;",
                "criterions": [
                    {
                        "exact_snippets": "GFR ≥ 30 mL/min",
                        "criterion": "GFR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Patient has no clinically significant abnormalities in urinalysis results;",
                "criterions": [
                    {
                        "exact_snippets": "no clinically significant abnormalities in urinalysis results",
                        "criterion": "urinalysis results",
                        "requirement": {
                            "requirement_type": "abnormalities",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Patient has acceptable coagulation status as indicated by a Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within 15% of normal limits;",
                "criterions": [
                    {
                        "exact_snippets": "acceptable coagulation status ... Prothrombin Time (PT) ... within 15% of normal limits",
                        "criterion": "Prothrombin Time (PT)",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "acceptable coagulation status ... Partial Thromboplastin Time (PTT) ... within 15% of normal limits",
                        "criterion": "Partial Thromboplastin Time (PTT)",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Eastern Cooperative Oncology Group (ECOG) ≤ 2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) ≤ 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 90 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 90 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Subjects must satisfy all the following inclusion criteria to be enrolled in the study:",
                "criterions": []
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period;",
                "criterions": [
                    {
                        "exact_snippets": "Clinical evidence of deep vein thrombosis (DVT) ... present during the screening period",
                        "criterion": "deep vein thrombosis (DVT)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Clinical evidence of ... pulmonary embolism (PE) ... present during the screening period",
                        "criterion": "pulmonary embolism (PE)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Clinical evidence of ... other known thromboembolic (TE) event present during the screening period",
                        "criterion": "other known thromboembolic (TE) event",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Any prior history of cerebrovascular accident, transient ischemic attack, or pre-existing carotid artery disease.",
                "criterions": [
                    {
                        "exact_snippets": "prior history of cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior history of ... transient ischemic attack",
                        "criterion": "transient ischemic attack",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pre-existing carotid artery disease",
                        "criterion": "carotid artery disease",
                        "requirement": {
                            "requirement_type": "pre-existing condition",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Known allergy to hyaluronidase;",
                "criterions": [
                    {
                        "exact_snippets": "Known allergy to hyaluronidase",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "hyaluronidase"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Current use of megestrol acetate (use within 10 days of Day 1);",
                "criterions": [
                    {
                        "exact_snippets": "Current use of megestrol acetate (use within 10 days of Day 1)",
                        "criterion": "megestrol acetate use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Contraindication to heparin including prior heparin induced thrombocytopenia (HIT), recent CNS bleed; intracranial or spinal lesion at high risk for bleeding; severe platelet dysfunction; recent major operation at high risk for bleeding; underlying hemorrhagic coagulopathy; high risk for falls; potential need for spinal anesthesia/lumbar puncture; active bleeding;",
                "criterions": [
                    {
                        "exact_snippets": "Contraindication to heparin including prior heparin induced thrombocytopenia (HIT)",
                        "criterion": "contraindication to heparin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior heparin induced thrombocytopenia (HIT)",
                        "criterion": "prior heparin induced thrombocytopenia (HIT)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recent CNS bleed",
                        "criterion": "recent CNS bleed",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intracranial or spinal lesion at high risk for bleeding",
                        "criterion": "intracranial or spinal lesion",
                        "requirement": {
                            "requirement_type": "risk for bleeding",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "severe platelet dysfunction",
                        "criterion": "severe platelet dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recent major operation at high risk for bleeding",
                        "criterion": "recent major operation",
                        "requirement": {
                            "requirement_type": "risk for bleeding",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "underlying hemorrhagic coagulopathy",
                        "criterion": "underlying hemorrhagic coagulopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "high risk for falls",
                        "criterion": "risk for falls",
                        "requirement": {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "potential need for spinal anesthesia/lumbar puncture",
                        "criterion": "potential need for spinal anesthesia/lumbar puncture",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active bleeding",
                        "criterion": "active bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Women currently pregnant or breastfeeding;",
                "criterions": [
                    {
                        "exact_snippets": "Women currently pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Intolerance to dexamethasone;",
                "criterions": [
                    {
                        "exact_snippets": "Intolerance to dexamethasone",
                        "criterion": "dexamethasone intolerance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Inability to comply with study and follow-up procedures as judged by the Investigator;",
                "criterions": [
                    {
                        "exact_snippets": "Inability to comply with study and follow-up procedures",
                        "criterion": "compliance with study and follow-up procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;",
                "criterions": [
                    {
                        "exact_snippets": "active, uncontrolled bacterial, viral, or fungal infection(s)",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active and uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "active, uncontrolled bacterial, viral, or fungal infection(s)",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "bacterial",
                                "viral",
                                "fungal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "requiring systemic therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Patient has known infection with HIV, hepatitis B, or hepatitis C;",
                "criterions": [
                    {
                        "exact_snippets": "known infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known infection with ... hepatitis B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known infection with ... hepatitis C",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Patient has a history of allergy or hypersensitivity to any of the agents they are supposed to receive (or to any of the excipients for those agents);",
                "criterions": [
                    {
                        "exact_snippets": "history of allergy or hypersensitivity to any of the agents they are supposed to receive",
                        "criterion": "allergy or hypersensitivity to agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of allergy or hypersensitivity ... to any of the excipients for those agents",
                        "criterion": "allergy or hypersensitivity to excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug, these can include New York Heart Association Functional Class ≥ 3, myocardial infarction within the past 12 months before screening, pre-existing atrial fibrillation, symptomatic COPD.",
                "criterions": [
                    {
                        "exact_snippets": "serious medical risk factors involving any of the major organ systems",
                        "criterion": "serious medical risk factors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association Functional Class ≥ 3",
                        "criterion": "New York Heart Association Functional Class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within the past 12 months before screening",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "pre-existing atrial fibrillation",
                        "criterion": "atrial fibrillation",
                        "requirement": {
                            "requirement_type": "pre-existence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic COPD",
                        "criterion": "COPD",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "13. Patient is unwilling or unable to comply with study procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Patient is unwilling ... to comply with study procedures.",
                        "criterion": "willingness to comply with study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient is ... unable to comply with study procedures.",
                        "criterion": "ability to comply with study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}