{
    "info": {
        "nct_id": "NCT01411072",
        "official_title": "Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer",
        "inclusion_criteria": "* Histologically documented pancreatic adenocarcinoma not previously treated with systemic therapy.\n* Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the pancreas with no evidence of malignant ascites, peritoneal metastases or distant metastases. Lack of recurrent and/metastatic disease must be confirmed radiologically with CT chest, abdomen, and pelvis prior to enrolment.\n* Adequate tissue available for IHC testing of hENT1. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute (CCI) is required. Paraffin block sufficient for preparing ≥ 6 unstained slides for central storage and testing if required by oncologist.\n* ECOG performance status of 0 - 2. (Appendix B)\n* Age ≥ 18 years\n* Life expectancy of at least 6 months based on discretion of treating\n* Adequate hematologic function defined by the following laboratory parameters: Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5.\n* Adequate hepatic and renal function defined by the following laboratory parameters: AST and ALT ≤ 2.5 X upper limit of institutional normal, bilirubin ≤ upper limit of institutional normal, and calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR ≥ 50 mL/min as determined.\n* Patients may have received prior curative radiotherapy for a different malignancy (unless radiation was curative therapy to ≥ 25% of bone marrow stores) and patients must have recovered from the toxic effects of this treatment.\n* Patients must be started on protocol ≤ 10 weeks from the date of curative surgical resection, and patients must have recovered from the toxic effects of surgery.\n* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have received prior chemotherapy or radiation delivered as parts of initial curative therapy for pancreas cancer (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are not permitted. Metastatic patients are not permitted.\n* Prior treatment for a different malignancy with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.\n* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.\n* Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.\n* Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that.\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs.\n* Any other reason the investigator considers the patient should not participate in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically documented pancreatic adenocarcinoma not previously treated with systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically documented pancreatic adenocarcinoma",
                    "criterion": "pancreatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "not previously treated with systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the pancreas with no evidence of malignant ascites, peritoneal metastases or distant metastases. Lack of recurrent and/metastatic disease must be confirmed radiologically with CT chest, abdomen, and pelvis prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the pancreas",
                    "criterion": "resection for ductal adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "macroscopic",
                                "microscopic (R0)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of malignant ascites",
                    "criterion": "malignant ascites",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of ... peritoneal metastases",
                    "criterion": "peritoneal metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of ... distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recurrent and/metastatic disease must be confirmed radiologically with CT chest, abdomen, and pelvis",
                    "criterion": "recurrent and/or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "radiologically with CT chest, abdomen, and pelvis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate tissue available for IHC testing of hENT1. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute (CCI) is required. Paraffin block sufficient for preparing ≥ 6 unstained slides for central storage and testing if required by oncologist.",
            "criterions": [
                {
                    "exact_snippets": "Adequate tissue available for IHC testing of hENT1",
                    "criterion": "tissue availability for IHC testing of hENT1",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological/cytological confirmation of tissue",
                    "criterion": "histological/cytological confirmation of tissue",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient material is available for hENT1 analysis",
                    "criterion": "sufficient material for hENT1 analysis",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Paraffin block sufficient for preparing ≥ 6 unstained slides",
                    "criterion": "paraffin block for preparing unstained slides",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "unstained slides"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 - 2. (Appendix B)",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 - 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 6 months based on discretion of treating",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function defined by the following laboratory parameters: Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 100",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count > 100",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute granulocyte count > 1.5",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic and renal function defined by the following laboratory parameters: AST and ALT ≤ 2.5 X upper limit of institutional normal, bilirubin ≤ upper limit of institutional normal, and calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR ≥ 50 mL/min as determined.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic and renal function defined by the following laboratory parameters: AST and ALT ≤ 2.5 X upper limit of institutional normal",
                    "criterion": "AST and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X upper limit of institutional normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin ≤ upper limit of institutional normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "upper limit of institutional normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if just below 50 mL/min based on this formula then GFR ≥ 50 mL/min as determined",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may have received prior curative radiotherapy for a different malignancy (unless radiation was curative therapy to ≥ 25% of bone marrow stores) and patients must have recovered from the toxic effects of this treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients may have received prior curative radiotherapy for a different malignancy",
                    "criterion": "prior curative radiotherapy for a different malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless radiation was curative therapy to ≥ 25% of bone marrow stores",
                    "criterion": "radiation to bone marrow stores",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "curative",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have recovered from the toxic effects of this treatment",
                    "criterion": "recovery from toxic effects of prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be started on protocol ≤ 10 weeks from the date of curative surgical resection, and patients must have recovered from the toxic effects of surgery.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be started on protocol ≤ 10 weeks from the date of curative surgical resection",
                    "criterion": "time from surgical resection to protocol start",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have recovered from the toxic effects of surgery",
                    "criterion": "recovery from toxic effects of surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.",
            "criterions": [
                {
                    "exact_snippets": "ability to read, understand, and sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": [
                                "read",
                                "understand",
                                "sign"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to comply with study treatment and follow-up",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have received prior chemotherapy or radiation delivered as parts of initial curative therapy for pancreas cancer (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are not permitted. Metastatic patients are not permitted.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... radiation delivered as parts of initial curative therapy for pancreas cancer",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic patients are not permitted",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment for a different malignancy with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment for a different malignancy with > 6 cycles of traditional alkylating agent-based chemotherapy",
                    "criterion": "prior treatment with traditional alkylating agent-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment for a different malignancy with ... > 2 cycles of carboplatin-based chemotherapy",
                    "criterion": "prior treatment with carboplatin-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment for a different malignancy with ... concurrent treatment with other experimental drugs or anti-cancer therapy",
                    "criterion": "concurrent treatment with other experimental drugs or anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.",
            "criterions": [
                {
                    "exact_snippets": "Lack of physical integrity of the upper gastrointestinal tract",
                    "criterion": "physical integrity of the upper gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "short gut syndrome",
                    "criterion": "short gut syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of bowel obstruction due to peritoneal metastases",
                    "criterion": "history of bowel obstruction due to peritoneal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent malignancies",
                    "criterion": "malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless at least 5 years have elapsed since last treatment and the patient is considered cured",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that.",
            "criterions": [
                {
                    "exact_snippets": "serious medical condition within 6 months prior to study entry",
                    "criterion": "serious medical condition",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active cardiomyopathy",
                    "criterion": "cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular diseases",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled psychiatric disorder",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known dihydropyrimidine dehydrogenase (DPD) deficiency.",
            "criterions": [
                {
                    "exact_snippets": "Known dihydropyrimidine dehydrogenase (DPD) deficiency.",
                    "criterion": "dihydropyrimidine dehydrogenase (DPD) deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "not lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of trial registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women or men of child bearing potential must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "effective contraception"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other reason the investigator considers the patient should not participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Any other reason the investigator considers the patient should not participate",
                    "criterion": "investigator's discretion",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "reason to exclude"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}