{
    "info": {
        "nct_id": "NCT01248273",
        "official_title": "Phase I Trial of Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission",
        "inclusion_criteria": "* Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.\n* History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.\n* Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.\n* Adequate organ function defined by\n* Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.\n* Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.\n* Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN\n* Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.\n* TSH not elevated above normal range\n* KPS > or = to 80%.\n* Patients have signed the informed consent document and signed the authorization permitting release of personal health information.\n* Age > 18 years\n* Patients must have recovered from clinically significant side effects from prior chemotherapy\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Pregnant or nursing women\n* Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.\n* Patients with a history of a seafood allergy.\n* Patients who have previously received a vaccine with any of the antigens in the current trial.\n* Patients with a history of immunodeficiency or autoimmune disease (excluding treated hypothyroidism).\n* Patients with active CNS tumor.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.",
                "criterions": [
                    {
                        "exact_snippets": "histologically documented",
                        "criterion": "histological documentation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stage III or IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "epithelial carcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "epithelial carcinoma"
                        }
                    },
                    {
                        "exact_snippets": "arising in the ovary, fallopian tube or peritoneum",
                        "criterion": "cancer origin",
                        "requirement": {
                            "requirement_type": "origin",
                            "expected_value": [
                                "ovary",
                                "fallopian tube",
                                "peritoneum"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically documented",
                        "criterion": "histological documentation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stage III or IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "epithelial carcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "epithelial carcinoma"
                        }
                    },
                    {
                        "exact_snippets": "arising in the ovary, fallopian tube or peritoneum",
                        "criterion": "cancer origin",
                        "requirement": {
                            "requirement_type": "origin",
                            "expected_value": [
                                "ovary",
                                "fallopian tube",
                                "peritoneum"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.",
                "criterions": [
                    {
                        "exact_snippets": "History of cytoreductive surgery",
                        "criterion": "cytoreductive surgery",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least one platinum-based chemotherapy regimen",
                        "criterion": "platinum-based chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "as part of primary treatment",
                        "criterion": "primary treatment",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of cytoreductive surgery",
                                "criterion": "cytoreductive surgery",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... chemotherapy",
                                "criterion": "chemotherapy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "at least one platinum-based chemotherapy regimen",
                                "criterion": "platinum-based chemotherapy regimen",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimen"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "as part of primary treatment",
                                "criterion": "primary treatment",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.",
                "criterions": [
                    {
                        "exact_snippets": "first complete clinical remission",
                        "criterion": "clinical remission status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "first complete clinical remission"
                        }
                    },
                    {
                        "exact_snippets": "serum CA-125 within institutional normal limits",
                        "criterion": "serum CA-125 level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within institutional normal limits"
                        }
                    },
                    {
                        "exact_snippets": "negative physical examination",
                        "criterion": "physical examination result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis",
                        "criterion": "evidence of disease by CT",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": "no definite evidence"
                        }
                    },
                    {
                        "exact_snippets": "Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm ... will not be considered definite evidence of disease",
                        "criterion": "lymph nodes and/or soft tissue abnormalities",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Eligibility is determined by anatomical imaging only (ie. MRI or CT)",
                        "criterion": "eligibility determination method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "MRI",
                                "CT"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative",
                        "criterion": "PET image result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "first complete clinical remission",
                                                                "criterion": "clinical remission status",
                                                                "requirement": {
                                                                    "requirement_type": "status",
                                                                    "expected_value": "first complete clinical remission"
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "serum CA-125 within institutional normal limits",
                                                                "criterion": "serum CA-125 level",
                                                                "requirement": {
                                                                    "requirement_type": "level",
                                                                    "expected_value": "within institutional normal limits"
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "negative physical examination",
                                                        "criterion": "physical examination result",
                                                        "requirement": {
                                                            "requirement_type": "result",
                                                            "expected_value": "negative"
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "or_criteria": [
                                                    {
                                                        "exact_snippets": "no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis",
                                                        "criterion": "evidence of disease by CT",
                                                        "requirement": {
                                                            "requirement_type": "evidence",
                                                            "expected_value": "no definite evidence"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm ... will not be considered definite evidence of disease",
                                                        "criterion": "lymph nodes and/or soft tissue abnormalities",
                                                        "requirement": {
                                                            "requirement_type": "size",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 1.0,
                                                                "unit": "cm"
                                                            }
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Eligibility is determined by anatomical imaging only (ie. MRI or CT)",
                                "criterion": "eligibility determination method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "MRI",
                                        "CT"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative",
                                "criterion": "PET image result",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis",
                                        "criterion": "evidence of disease by CT",
                                        "requirement": {
                                            "requirement_type": "evidence",
                                            "expected_value": "no definite evidence"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm ... will not be considered definite evidence of disease",
                                        "criterion": "lymph nodes and/or soft tissue abnormalities",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.0,
                                                "unit": "cm"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ function defined by",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm³"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets greater than or equal to 100,000/mm³",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm³"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets greater than or equal to 100,000/mm³",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.",
                "criterions": [
                    {
                        "exact_snippets": "Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit normal (ULN)"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CTCAE v4.0 grade 1",
                        "criterion": "CTCAE grade",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit normal (ULN)"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CTCAE v4.0 grade 1",
                        "criterion": "CTCAE grade",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin ... less than or equal to 2.5 x ULN",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT ... less than or equal to 2.5 x ULN",
                        "criterion": "SGOT level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase less than or equal to 2.5 x ULN",
                        "criterion": "alkaline phosphatase level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin ... less than or equal to 2.5 x ULN",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT ... less than or equal to 2.5 x ULN",
                        "criterion": "SGOT level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase less than or equal to 2.5 x ULN",
                        "criterion": "alkaline phosphatase level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.",
                "criterions": [
                    {
                        "exact_snippets": "Negative stool hemoccult",
                        "criterion": "stool hemoccult",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "negative endoscopic evaluation if positive",
                        "criterion": "endoscopic evaluation",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Negative stool hemoccult",
                    "criterion": "stool hemoccult",
                    "requirement": {
                        "requirement_type": "result",
                        "expected_value": "negative"
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "negative endoscopic evaluation if positive",
                    "criterion": "endoscopic evaluation",
                    "requirement": {
                        "requirement_type": "result",
                        "expected_value": "negative"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* TSH not elevated above normal range",
                "criterions": [
                    {
                        "exact_snippets": "TSH not elevated above normal range",
                        "criterion": "TSH",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "normal range"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "TSH not elevated above normal range",
                        "criterion": "TSH",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "normal range"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* KPS > or = to 80%.",
                "criterions": [
                    {
                        "exact_snippets": "KPS > or = to 80%",
                        "criterion": "Karnofsky Performance Status (KPS)",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 80,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "KPS > or = to 80%",
                        "criterion": "Karnofsky Performance Status (KPS)",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 80,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients have signed the informed consent document and signed the authorization permitting release of personal health information.",
                "criterions": [
                    {
                        "exact_snippets": "signed the informed consent document",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "signed the authorization permitting release of personal health information",
                        "criterion": "authorization for release of personal health information",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "signed the informed consent document",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "signed the authorization permitting release of personal health information",
                        "criterion": "authorization for release of personal health information",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age > 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have recovered from clinically significant side effects from prior chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "recovered from clinically significant side effects from prior chemotherapy",
                        "criterion": "side effects from prior chemotherapy",
                        "requirement": {
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                        "exact_snippets": "recovered from clinically significant side effects from prior chemotherapy",
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                            "requirement_type": "recovery",
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            "identified_line": {
                "line": "Healthy volunteers allowed",
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                        "criterion": "volunteer health status",
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            "identified_line": {
                "line": "Must be FEMALE",
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                        "exact_snippets": "Must be FEMALE",
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                            "expected_value": "female"
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                            "expected_value": "female"
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 19 Years",
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                        "exact_snippets": "minimum age of 19 Years",
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                            "requirement_type": "minimum",
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                                "value": 19,
                                "unit": "Years"
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                        "criterion": "pregnancy status",
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                        "exact_snippets": "Pregnant",
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            }
        },
        {
            "identified_line": {
                "line": "* Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.",
                "criterions": [
                    {
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                                                        "operator": "<=",
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                                                        "unit": "years"
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        },
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    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}