{
    "info": {
        "nct_id": "NCT06483048",
        "official_title": "Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded from Peripheral Blood in Patients with Relapsed and Resistant Ovarian Cancer",
        "inclusion_criteria": "* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET/CT\n\n  * Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler\n* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring < 183 days after the last dose of platinum-based chemotherapy:\n\n  * Development of measurable disease (per RECIST 1.1)\n  * Progression of radiographic disease (per RECIST 1.1)\n  * Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits [WNL] at the completion of platinum-based chemotherapy)\n  * Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)\n  * If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma\n* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study\n* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months\n* REGISTRATION: Willingness and ability to provide written informed consent\n* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study\n* REGISTRATION: Willing to undergo leukapheresis for blood component collection\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Lymphocyte count ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 8.0 g/dL (performed ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 30,000/mm^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis [DVT]/pulmonary embolism [PE] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)\n* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air\n* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for > 30 days, and not requiring steroid therapy for > 14 days\n* Prior treatment targeting MUC1\n* Subjects with known plasma cell leukemia (PCL)\n* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate birth control measures\n* History of myocardial infarction ≤ 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias\n* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Inability to clear an ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled psychiatric problems\n  * Inability to have a caregiver for active oversight during treatment period\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements\n* Evidence of clinical immunocompromise and/or HIV positivity and currently receiving antiretroviral therapy\n* Patients requiring chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)\n* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm\n* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence\n* Diagnosis of autoimmune disease\n\n  * Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Age ≥ 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis or history of epithelial ovarian",
                        "criterion": "epithelial ovarian cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... fallopian tube",
                        "criterion": "fallopian tube cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... carcinosarcoma",
                        "criterion": "carcinosarcoma",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... primary peritoneal cancer",
                        "criterion": "primary peritoneal cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Diagnosis or history of epithelial ovarian",
                        "criterion": "epithelial ovarian cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... fallopian tube",
                        "criterion": "fallopian tube cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... carcinosarcoma",
                        "criterion": "carcinosarcoma",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis or history of ... primary peritoneal cancer",
                        "criterion": "primary peritoneal cancer",
                        "requirement": {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET/CT",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
                        }
                    },
                    {
                        "exact_snippets": "at least 1 lesion that has a single diameter of ≥ 1 cm",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 1 lesion that has a single diameter of ≥ 1 cm",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "measured by CT or MRI or the CT portion of the PET/CT",
                        "criterion": "measurement method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "CT portion of the PET/CT"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "criteria",
                                    "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "at least 1 lesion that has a single diameter of ≥ 1 cm",
                                        "criterion": "lesion",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "lesion"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "at least 1 lesion that has a single diameter of ≥ 1 cm",
                                        "criterion": "lesion",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "cm"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "measured by CT or MRI or the CT portion of the PET/CT",
                        "criterion": "measurement method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "CT portion of the PET/CT"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler",
                "criterions": [
                    {
                        "exact_snippets": "Skin lesions can be used ... area is ≥ 1cm in at least one diameter",
                        "criterion": "skin lesions",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Skin lesions can be used ... measured with a ruler",
                        "criterion": "skin lesions",
                        "requirement": {
                            "requirement_type": "measurement method",
                            "expected_value": "ruler"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Skin lesions can be used ... area is ≥ 1cm in at least one diameter",
                        "criterion": "skin lesions",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Skin lesions can be used ... measured with a ruler",
                        "criterion": "skin lesions",
                        "requirement": {
                            "requirement_type": "measurement method",
                            "expected_value": "ruler"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Development of measurable disease (per RECIST 1.1)",
                "criterions": [
                    {
                        "exact_snippets": "Development of measurable disease (per RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "development",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Development of measurable disease (per RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "measurement criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Development of measurable disease (per RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "development",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Development of measurable disease (per RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "measurement criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progression of radiographic disease (per RECIST 1.1)",
                "criterions": [
                    {
                        "exact_snippets": "Progression of radiographic disease (per RECIST 1.1)",
                        "criterion": "radiographic disease progression",
                        "requirement": {
                            "requirement_type": "assessment method",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Progression of radiographic disease (per RECIST 1.1)",
                        "criterion": "radiographic disease progression",
                        "requirement": {
                            "requirement_type": "assessment method",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits [WNL] at the completion of platinum-based chemotherapy)",
                "criterions": [
                    {
                        "exact_snippets": "Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN)",
                        "criterion": "CA-125 level",
                        "requirement": {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "if within normal limits [WNL] at the completion of platinum-based chemotherapy",
                        "criterion": "CA-125 level",
                        "requirement": {
                            "requirement_type": "status at completion of platinum-based chemotherapy",
                            "expected_value": "within normal limits"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "if within normal limits [WNL] at the completion of platinum-based chemotherapy",
                    "criterion": "CA-125 level",
                    "requirement": {
                        "requirement_type": "status at completion of platinum-based chemotherapy",
                        "expected_value": "within normal limits"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN)",
                    "criterion": "CA-125 level",
                    "requirement": {
                        "requirement_type": "increase",
                        "expected_value": {
                            "operator": ">=",
                            "value": 2,
                            "unit": "x ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)",
                "criterions": [
                    {
                        "exact_snippets": "Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)",
                        "criterion": "CA-125 level",
                        "requirement": {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "x nadir"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)",
                        "criterion": "CA-125 level",
                        "requirement": {
                            "requirement_type": "nadir",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)",
                    "criterion": "CA-125 level",
                    "requirement": {
                        "requirement_type": "nadir",
                        "expected_value": {
                            "operator": ">",
                            "value": 0,
                            "unit": "ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Increase in CA-125 level to ≥ 2 x nadir (if nadir > ULN)",
                    "criterion": "CA-125 level",
                    "requirement": {
                        "requirement_type": "increase",
                        "expected_value": {
                            "operator": ">=",
                            "value": 2,
                            "unit": "x nadir"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval",
                "criterions": [
                    {
                        "exact_snippets": "CA-125 is used to determine the date of progression",
                        "criterion": "CA-125 usage",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": "determine the date of progression"
                        }
                    },
                    {
                        "exact_snippets": "CA-125 value ≥ 7 days after the first level",
                        "criterion": "CA-125 confirmation",
                        "requirement": {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "concurrent with imaging changes",
                        "criterion": "imaging changes",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "CA-125 is used to determine the date of progression",
                    "criterion": "CA-125 usage",
                    "requirement": {
                        "requirement_type": "usage",
                        "expected_value": "determine the date of progression"
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "CA-125 value ≥ 7 days after the first level",
                            "criterion": "CA-125 confirmation",
                            "requirement": {
                                "requirement_type": "time interval",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 7,
                                    "unit": "days"
                                }
                            }
                        },
                        {
                            "exact_snippets": "concurrent with imaging changes",
                            "criterion": "imaging changes",
                            "requirement": {
                                "requirement_type": "concurrency",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Provide written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research",
                "criterions": [
                    {
                        "exact_snippets": "Willingness to provide mandatory blood specimens",
                        "criterion": "blood specimens",
                        "requirement": {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness to provide ... biopsy tissue",
                        "criterion": "biopsy tissue",
                        "requirement": {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willingness to provide mandatory blood specimens",
                        "criterion": "blood specimens",
                        "requirement": {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness to provide ... biopsy tissue",
                        "criterion": "biopsy tissue",
                        "requirement": {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study",
                "criterions": [
                    {
                        "exact_snippets": "MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC)",
                        "criterion": "MUC1 expression",
                        "requirement": {
                            "requirement_type": "verification method",
                            "expected_value": "immunohistochemistry (IHC)"
                        }
                    },
                    {
                        "exact_snippets": "MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC)",
                        "criterion": "MUC1 expression",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "ovarian cancer tumor cells"
                        }
                    },
                    {
                        "exact_snippets": "MUC1 expression in ovarian cancer tumor cells ... in a Clinical Laboratory Improvement Act (CLIA) laboratory",
                        "criterion": "MUC1 expression verification",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "Clinical Laboratory Improvement Act (CLIA) laboratory"
                        }
                    },
                    {
                        "exact_snippets": "Heterogeneous tumor expression of MUC1 is acceptable",
                        "criterion": "heterogeneous tumor expression of MUC1",
                        "requirement": {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MUC1 expression by staining score greater than 0 is deemed positive",
                        "criterion": "MUC1 expression staining score",
                        "requirement": {
                            "requirement_type": "positivity threshold",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "score"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC)",
                                "criterion": "MUC1 expression",
                                "requirement": {
                                    "requirement_type": "verification method",
                                    "expected_value": "immunohistochemistry (IHC)"
                                }
                            },
                            {
                                "exact_snippets": "MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC)",
                                "criterion": "MUC1 expression",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "ovarian cancer tumor cells"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "MUC1 expression in ovarian cancer tumor cells ... in a Clinical Laboratory Improvement Act (CLIA) laboratory",
                        "criterion": "MUC1 expression verification",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "Clinical Laboratory Improvement Act (CLIA) laboratory"
                        }
                    },
                    {
                        "exact_snippets": "Heterogeneous tumor expression of MUC1 is acceptable",
                        "criterion": "heterogeneous tumor expression of MUC1",
                        "requirement": {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MUC1 expression by staining score greater than 0 is deemed positive",
                        "criterion": "MUC1 expression staining score",
                        "requirement": {
                            "requirement_type": "positivity threshold",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "score"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months",
                "criterions": [
                    {
                        "exact_snippets": "Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 6,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months",
                    "criterion": "investigational therapy effectiveness",
                    "requirement": {
                        "requirement_type": "effectiveness",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months",
                    "criterion": "expected survival",
                    "requirement": {
                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 6,
                                    "unit": "months"
                                },
                                {
                                    "operator": "<",
                                    "value": 24,
                                    "unit": "months"
                                }
                            ]
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Willingness and ability to provide written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Willingness and ability to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willingness and ability to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study",
                "criterions": [
                    {
                        "exact_snippets": "Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study",
                        "criterion": "willingness to return for follow-up",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study",
                        "criterion": "willingness to return for follow-up",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Willing to undergo leukapheresis for blood component collection",
                "criterions": [
                    {
                        "exact_snippets": "Willing to undergo leukapheresis for blood component collection",
                        "criterion": "leukapheresis",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing to undergo leukapheresis for blood component collection",
                        "criterion": "leukapheresis",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1500/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1500/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "ANC test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to registration"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Lymphocyte count ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Lymphocyte count ≥ 1500/mm^3",
                        "criterion": "lymphocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Lymphocyte count ≥ 1500/mm^3",
                        "criterion": "lymphocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "lymphocyte count test date",
                        "requirement": {
                            "requirement_type": "time since test",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Hemoglobin ≥ 8.0 g/dL (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Platelet count ≥ 30,000/mm^3 (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 30,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30000,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥ 30,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30000,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 2.0 mg/dL",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless patient has documented Gilbert's syndrome",
                        "criterion": "Gilbert's syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN",
                        "criterion": "total bilirubin in patients with Gilbert's syndrome",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "direct bilirubin ≤ 1.5 x ULN",
                        "criterion": "direct bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Total bilirubin ≤ 2.0 mg/dL",
                                    "criterion": "total bilirubin",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 2.0,
                                            "unit": "mg/dL"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "performed ≤ 14 days prior to registration",
                                    "criterion": "test timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 14,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "unless patient has documented Gilbert's syndrome",
                            "criterion": "Gilbert's syndrome",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN",
                                    "criterion": "total bilirubin in patients with Gilbert's syndrome",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 3.0,
                                            "unit": "x ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "direct bilirubin ≤ 1.5 x ULN",
                                    "criterion": "direct bilirubin",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1.5,
                                            "unit": "x ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "performed ≤ 14 days prior to registration",
                                    "criterion": "test timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 14,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver involvement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                        "criterion": "aspartate amino transferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                        "criterion": "aspartate amino transferase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver involvement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                                            "criterion": "Alanine aminotransferase (ALT)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 3,
                                                            "unit": "x ULN"
                                                        }
                                                    ]
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                                            "criterion": "aspartate amino transferase (AST)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 3,
                                                            "unit": "x ULN"
                                                        }
                                                    ]
                                                }
                                            }
                                        }
                                    ]
                                }
                            ]
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "performed ≤ 14 days prior to registration",
                                    "criterion": "test timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 14,
                                                    "unit": "days"
                                                }
                                            ]
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                                            "criterion": "Alanine aminotransferase (ALT)",
                                            "requirement": {
                                                "requirement_type": "level with liver involvement",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 5,
                                                            "unit": "x ULN"
                                                        }
                                                    ]
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)",
                                            "criterion": "aspartate amino transferase (AST)",
                                            "requirement": {
                                                "requirement_type": "level with liver involvement",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 5,
                                                            "unit": "x ULN"
                                                        }
                                                    ]
                                                }
                                            }
                                        }
                                    ]
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis [DVT]/pulmonary embolism [PE] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN",
                        "criterion": "PT, INR, aPTT",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy",
                        "criterion": "anticoagulation therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy",
                        "criterion": "anticoagulation therapy",
                        "requirement": {
                            "requirement_type": "INR or aPTT target range",
                            "expected_value": "within target range"
                        }
                    },
                    {
                        "exact_snippets": "for patients receiving anticoagulation, there should be no prior history of bleeding",
                        "criterion": "prior history of bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no recent deep vein thrombosis [DVT]/pulmonary embolism [PE] ≤ 6 months prior to registration",
                        "criterion": "recent DVT/PE",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "time since test",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN",
                                                                "criterion": "PT, INR, aPTT",
                                                                "requirement": {
                                                                    "requirement_type": "value",
                                                                    "expected_value": {
                                                                        "comparisons": [
                                                                            {
                                                                                "operator": "<=",
                                                                                "value": 1.5,
                                                                                "unit": "x ULN"
                                                                            }
                                                                        ]
                                                                    }
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "performed ≤ 14 days prior to registration",
                                                                "criterion": "test timing",
                                                                "requirement": {
                                                                    "requirement_type": "time since test",
                                                                    "expected_value": {
                                                                        "comparisons": [
                                                                            {
                                                                                "operator": "<=",
                                                                                "value": 14,
                                                                                "unit": "days"
                                                                            }
                                                                        ]
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy",
                                                                        "criterion": "anticoagulation therapy",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": true
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy",
                                                                        "criterion": "anticoagulation therapy",
                                                                        "requirement": {
                                                                            "requirement_type": "INR or aPTT target range",
                                                                            "expected_value": "within target range"
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "for patients receiving anticoagulation, there should be no prior history of bleeding",
                                                                "criterion": "prior history of bleeding",
                                                                "requirement": {
                                                                    "requirement_type": "presence",
                                                                    "expected_value": false
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "no recent deep vein thrombosis [DVT]/pulmonary embolism [PE] ≤ 6 months prior to registration",
                                                        "criterion": "recent DVT/PE",
                                                        "requirement": {
                                                            "requirement_type": "time since event",
                                                            "expected_value": {
                                                                "comparisons": [
                                                                    {
                                                                        "operator": "<=",
                                                                        "value": 6,
                                                                        "unit": "months"
                                                                    }
                                                                ]
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "performed ≤ 14 days prior to registration",
                                                "criterion": "test timing",
                                                "requirement": {
                                                    "requirement_type": "time since test",
                                                    "expected_value": {
                                                        "comparisons": [
                                                            {
                                                                "operator": "<=",
                                                                "value": 14,
                                                                "unit": "days"
                                                            }
                                                        ]
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "test timing",
                        "requirement": {
                            "requirement_type": "time since test",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)",
                "criterions": [
                    {
                        "exact_snippets": "Calculated creatinine clearance ≥ 30 ml/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "time of creatinine clearance calculation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Calculated creatinine clearance ≥ 30 ml/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "performed ≤ 14 days prior to registration",
                        "criterion": "time of creatinine clearance calculation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air",
                "criterions": [
                    {
                        "exact_snippets": "Baseline oxygen saturation ≥ 90%",
                        "criterion": "oxygen saturation",
                        "requirement": {
                            "requirement_type": "baseline",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Baseline oxygen saturation ≥ 90%",
                        "criterion": "oxygen saturation",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "on room air"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Baseline oxygen saturation ≥ 90%",
                        "criterion": "oxygen saturation",
                        "requirement": {
                            "requirement_type": "baseline",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Baseline oxygen saturation ≥ 90%",
                        "criterion": "oxygen saturation",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "on room air"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Negative urine or serological pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "≤ 7 days prior to registration",
                        "criterion": "timing of pregnancy test",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Negative urine or serological pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "≤ 7 days prior to registration",
                        "criterion": "timing of pregnancy test",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for > 30 days, and not requiring steroid therapy for > 14 days",
                "criterions": [
                    {
                        "exact_snippets": "Clinically unresolved central nervous system (CNS) metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with a prior history of brain metastases ... focally treated",
                        "criterion": "prior brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "focally treated"
                        }
                    },
                    {
                        "exact_snippets": "Patients with a prior history of brain metastases ... radiographically stable for > 30 days",
                        "criterion": "prior brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients with a prior history of brain metastases ... not requiring steroid therapy for > 14 days",
                        "criterion": "steroid therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with a prior history of brain metastases ... not requiring steroid therapy for > 14 days",
                        "criterion": "steroid therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically unresolved central nervous system (CNS) metastases",
                                "criterion": "CNS metastases",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients with a prior history of brain metastases ... focally treated",
                                "criterion": "prior brain metastases",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "focally treated"
                                }
                            },
                            {
                                "exact_snippets": "Patients with a prior history of brain metastases ... radiographically stable for > 30 days",
                                "criterion": "prior brain metastases",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Patients with a prior history of brain metastases ... not requiring steroid therapy for > 14 days",
                                "criterion": "steroid therapy",
                                "requirement": {
                                    "requirement_type": "requirement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients with a prior history of brain metastases ... not requiring steroid therapy for > 14 days",
                                "criterion": "steroid therapy",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment targeting MUC1",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment targeting MUC1",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "target",
                            "expected_value": "MUC1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment targeting MUC1",
                    "criterion": "prior treatment",
                    "requirement": {
                        "requirement_type": "target",
                        "expected_value": "MUC1"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with known plasma cell leukemia (PCL)",
                "criterions": [
                    {
                        "exact_snippets": "known plasma cell leukemia (PCL)",
                        "criterion": "plasma cell leukemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "known plasma cell leukemia (PCL)",
                        "criterion": "plasma cell leukemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects:",
                "criterions": [
                    {
                        "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                        "criterion": "genotoxic effects",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                        "criterion": "mutagenic effects",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                        "criterion": "teratogenic effects",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "genotoxic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "mutagenic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "genotoxic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "teratogenic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "mutagenic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "genotoxic, mutagenic and/or teratogenic effects",
                                "criterion": "teratogenic effects",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant persons",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant persons",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Pregnant persons",
                    "criterion": "pregnancy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Nursing persons",
                "criterions": [
                    {
                        "exact_snippets": "Nursing persons",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Nursing persons",
                    "criterion": "nursing status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "nursing"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Persons of childbearing potential who are unwilling to employ adequate birth control measures",
                "criterions": [
                    {
                        "exact_snippets": "Persons of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwilling to employ adequate birth control measures",
                        "criterion": "willingness to employ birth control measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Persons of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwilling to employ adequate birth control measures",
                        "criterion": "willingness to employ birth control measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy",
                        "criterion": "recovery from acute, reversible effects of prior therapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": "grade 1 or baseline"
                        }
                    },
                    {
                        "exact_snippets": "Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment",
                        "criterion": "peripheral (sensory) neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "2"
                        }
                    },
                    {
                        "exact_snippets": "Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment",
                        "criterion": "peripheral (sensory) neuropathy",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy",
                                    "criterion": "recovery from acute, reversible effects of prior therapy",
                                    "requirement": {
                                        "requirement_type": "recovery",
                                        "expected_value": "grade 1 or baseline"
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment",
                                                "criterion": "peripheral (sensory) neuropathy",
                                                "requirement": {
                                                    "requirement_type": "grade",
                                                    "expected_value": "2"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment",
                                                "criterion": "peripheral (sensory) neuropathy",
                                                "requirement": {
                                                    "requirement_type": "stability duration",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 3,
                                                        "unit": "months"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled concurrent illness including, but not limited to:",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled concurrent illness",
                        "criterion": "concurrent illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Uncontrolled concurrent illness",
                        "criterion": "concurrent illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inability to clear an ongoing or active infection",
                "criterions": [
                    {
                        "exact_snippets": "Inability to clear an ongoing or active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing or active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Inability to clear an ongoing or active infection",
                    "criterion": "infection",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "ongoing or active"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic congestive heart failure",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirement": {
                        "requirement_type": "symptomatic",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Unstable angina pectoris",
                "criterions": [
                    {
                        "exact_snippets": "Unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled psychiatric problems",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled psychiatric problems",
                        "criterion": "psychiatric problems",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled psychiatric problems",
                    "criterion": "psychiatric problems",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Inability to have a caregiver for active oversight during treatment period",
                "criterions": [
                    {
                        "exact_snippets": "Inability to have a caregiver for active oversight during treatment period",
                        "criterion": "caregiver availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Inability to have a caregiver for active oversight during treatment period",
                    "criterion": "caregiver availability",
                    "requirement": {
                        "requirement_type": "availability",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy",
                "criterions": [
                    {
                        "exact_snippets": "Dyspnea at rest",
                        "criterion": "dyspnea",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "at rest"
                        }
                    },
                    {
                        "exact_snippets": "complications of advanced malignancy",
                        "criterion": "advanced malignancy",
                        "requirement": {
                            "requirement_type": "complications",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other disease that requires continuous oxygen therapy",
                        "criterion": "other disease",
                        "requirement": {
                            "requirement_type": "oxygen therapy requirement",
                            "expected_value": "continuous"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Dyspnea at rest",
                                "criterion": "dyspnea",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "at rest"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "complications of advanced malignancy",
                                        "criterion": "advanced malignancy",
                                        "requirement": {
                                            "requirement_type": "complications",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "other disease that requires continuous oxygen therapy",
                                        "criterion": "other disease",
                                        "requirement": {
                                            "requirement_type": "oxygen therapy requirement",
                                            "expected_value": "continuous"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements",
                "criterions": [
                    {
                        "exact_snippets": "Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements",
                        "criterion": "conditions limiting compliance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements",
                    "criterion": "conditions limiting compliance",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of clinical immunocompromise and/or HIV positivity and currently receiving antiretroviral therapy",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of clinical immunocompromise",
                        "criterion": "clinical immunocompromise",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HIV positivity",
                        "criterion": "HIV positivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "currently receiving antiretroviral therapy",
                        "criterion": "antiretroviral therapy",
                        "requirement": {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Evidence of clinical immunocompromise",
                                "criterion": "clinical immunocompromise",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "HIV positivity",
                                "criterion": "HIV positivity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "currently receiving antiretroviral therapy",
                                "criterion": "antiretroviral therapy",
                                "requirement": {
                                    "requirement_type": "current treatment",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm",
                "criterions": [
                    {
                        "exact_snippets": "Patients receiving any other investigational agent which could be considered a treatment for the neoplasm",
                        "criterion": "investigational agent",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "treatment for the neoplasm"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients receiving any other investigational agent which could be considered a treatment for the neoplasm",
                    "criterion": "investigational agent",
                    "requirement": {
                        "requirement_type": "purpose",
                        "expected_value": "treatment for the neoplasm"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence",
                "criterions": [
                    {
                        "exact_snippets": "Other active malignancy first documented ≤ 4 years prior to registration",
                        "criterion": "other active malignancy",
                        "requirement": {
                            "requirement_type": "first documented",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "years prior to registration"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Non-melanotic skin cancer or carcinoma-in-situ of the cervix",
                        "criterion": "exceptions to other active malignancy",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "Non-melanotic skin cancer",
                                "carcinoma-in-situ of the cervix"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence",
                        "criterion": "treatment for other malignancy",
                        "requirement": {
                            "requirement_type": "receiving treatment",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "not_criteria": {
                                        "exact_snippets": "Non-melanotic skin cancer or carcinoma-in-situ of the cervix",
                                        "criterion": "exceptions to other active malignancy",
                                        "requirement": {
                                            "requirement_type": "exceptions",
                                            "expected_value": [
                                                "Non-melanotic skin cancer",
                                                "carcinoma-in-situ of the cervix"
                                            ]
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "Other active malignancy first documented ≤ 4 years prior to registration",
                                    "criterion": "other active malignancy",
                                    "requirement": {
                                        "requirement_type": "first documented",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 4,
                                            "unit": "years prior to registration"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence",
                    "criterion": "treatment for other malignancy",
                    "requirement": {
                        "requirement_type": "receiving treatment",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of autoimmune disease",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Diagnosis of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirement": {
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",
                "criterions": [
                    {
                        "exact_snippets": "Known history of active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has required systemic treatment in the ≤ 30 days",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded",
                        "criterion": "vitiligo, Graves' disease, or psoriasis",
                        "requirement": {
                            "requirement_type": "systemic treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with Celiac disease controlled with diet modification are not excluded",
                        "criterion": "Celiac disease",
                        "requirement": {
                            "requirement_type": "control with diet modification",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Known history of active autoimmune disease",
                                    "criterion": "active autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "history",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "has required systemic treatment in the ≤ 30 days",
                                    "criterion": "systemic treatment for autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "time since treatment",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 30,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "not_criteria": {
                                "exact_snippets": "Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded",
                                "criterion": "vitiligo, Graves' disease, or psoriasis",
                                "requirement": {
                                    "requirement_type": "systemic treatment",
                                    "expected_value": false
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "Patients with Celiac disease controlled with diet modification are not excluded",
                                "criterion": "Celiac disease",
                                "requirement": {
                                    "requirement_type": "control with diet modification",
                                    "expected_value": true
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring < 183 days after the last dose of platinum-based chemotherapy:",
                "criterions": [
                    {
                        "exact_snippets": "Relapsed or refractory ovarian cancer",
                        "criterion": "ovarian cancer",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy",
                        "criterion": "prior therapy with platinum chemotherapy",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "treated",
                                "intolerant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy",
                        "criterion": "prior therapy with platinum chemotherapy",
                        "requirement": {
                            "requirement_type": "minimum number of prior lines",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum",
                        "criterion": "tumor evaluability for response",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "evaluable for response"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor",
                        "criterion": "BRCA1/2 mutation",
                        "requirement": {
                            "requirement_type": "prior treatment with PARP inhibitor",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Platinum-resistance is defined as any of the following occurring < 183 days after the last dose of platinum-based chemotherapy",
                        "criterion": "platinum-resistance",
                        "requirement": {
                            "requirement_type": "time since last dose of platinum-based chemotherapy",
                            "expected_value": {
                                "operator": "<",
                                "value": 183,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "histological confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "epithelial ovarian",
                                "fallopian tube",
                                "carcinosarcoma",
                                "primary peritoneal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Histologic confirmation of the primary tumor is required",
                        "criterion": "primary tumor",
                        "requirement": {
                            "requirement_type": "histological confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma",
                        "criterion": "histology type",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "serous",
                                "endometrioid",
                                "clear cell",
                                "mucinous",
                                "transitional cell",
                                "undifferentiated",
                                "mixed carcinoma"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* History of myocardial infarction ≤ 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias",
                "criterions": [
                    {
                        "exact_snippets": "History of myocardial infarction ≤ 6 months prior to registration",
                        "criterion": "history of myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of myocardial infarction \u0014 6 months prior to registration",
                                "criterion": "history of myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "treatment requirement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients requiring chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)",
                "criterions": [
                    {
                        "exact_snippets": "chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)",
                        "criterion": "steroid dosage",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "mg prednisone or prednisolone"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "mg Decadron"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "mg hydrocortisol"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)",
                                        "criterion": "steroid dosage",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">",
                                                        "value": 10,
                                                        "unit": "mg prednisone or prednisolone"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)",
                                        "criterion": "steroid dosage",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 4,
                                                        "unit": "mg Decadron"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)",
                                "criterion": "steroid dosage",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 50,
                                                "unit": "mg hydrocortisol"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}