{
    "info": {
        "nct_id": "NCT01198548",
        "official_title": "A Phase II Clinical Trial of High Dose Vitamin D3 Supplementation in Combination With FOLFOX + Bevacizumab in the 1st Line Treatment of Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Patients should have untreated metastatic colorectal cancer; prior adjuvant chemotherapy is allowed as long as the development of metastatic disease occurred more than 6 months from completion of adjuvant treatment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Platelets >= 100,000/mm^3\n* Absolute neutrophil count (ANC) >= 1,500/mm^3\n* Hemoglobin > 9 gm/dl\n* Calculated creatinine clearance > 40 ml/min according to the Cockcroft-Gault formula OR per 24 hour urine collection\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases and < 5 x upper limit of normal (ULN) in the setting of liver metastases\n* Total bilirubin =< 1.5 x institutional upper normal level\n* Albumin >= 2.5 g/dl\n* Urine protein:creatinine (UPC) ratio < 1; in the event UPC is > 1, the patient will require a 24-hr urine protein and will be eligible if 24-hr urine collection has < 1,000 mg protein\n* Patients of child-hearing potential must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment\n* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure\n* Presence of measurable disease defined as a lesion >= 1 cm by computed tomography (CT); all sites of disease should be evaluated =< 3 weeks before treatment initiation\n* Baseline 25-D3 level of < 40 ng/ml\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 79 Years",
        "exclusion_criteria": "* Patients may not be receiving any other investigational agents that are not included in this study\n* Patients with known brain metastases\n* History of other invasive cancers with the exception of the following: a. Curatively resected or treated non-melanoma skin cancer; b. Curatively treated cervical carcinoma in situ; c. Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment, and in the investigator opinion, it is unlikely that there will be a recurrence =< 1 year post enrollment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, 5-FU, leucovorin, bevacizumab, and vitamin D3 and other agents used in study\n* History of clinically significant bleeding within 6 months of enrollment\n* Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent\n* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study\n* Major surgery within 28 days prior to enrollment or still recovering from prior surgery\n* Known dihydropyrimidine dehydrogenase (DpD) deficiency\n* History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)\n* Serious, nonhealing wound, ulcer, or bone fracture\n* Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg despite medications)\n* History of arterial thrombosis within the last 12 months\n* History of visceral arterial ischemia\n* Subjects unwilling or unable to comply with study requirements\n* Any condition that in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug\n* Received an investigational agent within 30 clays prior to enrollment\n* Treatment with vitamin D replacement with doses exceeding an average of 1000 IU/day (vitamin D3) within 60 days prior to enrollment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients should have untreated metastatic colorectal cancer; prior adjuvant chemotherapy is allowed as long as the development of metastatic disease occurred more than 6 months from completion of adjuvant treatment",
                "criterions": [
                    {
                        "exact_snippets": "untreated metastatic colorectal cancer",
                        "criterion": "metastatic colorectal cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "prior adjuvant chemotherapy is allowed",
                        "criterion": "prior adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "development of metastatic disease occurred more than 6 months from completion of adjuvant treatment",
                        "criterion": "time since adjuvant treatment completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "untreated metastatic colorectal cancer",
                                "criterion": "metastatic colorectal cancer",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "untreated"
                                }
                            },
                            {
                                "condition": {
                                    "exact_snippets": "prior adjuvant chemotherapy is allowed",
                                    "criterion": "prior adjuvant chemotherapy",
                                    "requirement": {
                                        "requirement_type": "allowance",
                                        "expected_value": true
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "development of metastatic disease occurred more than 6 months from completion of adjuvant treatment",
                                    "criterion": "time since adjuvant treatment completion",
                                    "requirement": {
                                        "requirement_type": "time since completion",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 6,
                                            "unit": "months"
                                        }
                                    }
                                },
                                "else_criteria": null
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets >= 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelets >= 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets >= 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) >= 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/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) >= 1,500/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin > 9 gm/dl",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin > 9 gm/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "gm/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin > 9 gm/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "gm/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin =< 1.5 x institutional upper normal level",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin =< 1.5 x institutional upper normal level",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper normal level"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin =< 1.5 x institutional upper normal level",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper normal level"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Albumin >= 2.5 g/dl",
                "criterions": [
                    {
                        "exact_snippets": "Albumin >= 2.5 g/dl",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Albumin >= 2.5 g/dl",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Urine protein:creatinine (UPC) ratio < 1; in the event UPC is > 1, the patient will require a 24-hr urine protein and will be eligible if 24-hr urine collection has < 1,000 mg protein",
                "criterions": [
                    {
                        "exact_snippets": "Urine protein:creatinine (UPC) ratio < 1",
                        "criterion": "UPC ratio",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "24-hr urine collection has < 1,000 mg protein",
                        "criterion": "24-hr urine protein",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Urine protein:creatinine (UPC) ratio < 1",
                    "criterion": "UPC ratio",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "operator": "<",
                            "value": 1,
                            "unit": "N/A"
                        }
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "24-hr urine collection has < 1,000 mg protein",
                    "criterion": "24-hr urine protein",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "operator": "<",
                            "value": 1000,
                            "unit": "mg"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients of child-hearing potential must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment",
                "criterions": [
                    {
                        "exact_snippets": "Patients of child-hearing potential",
                        "criterion": "child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients of child-hearing potential",
                        "criterion": "child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure",
                "criterions": [
                    {
                        "exact_snippets": "Patient or legal representative must understand the investigational nature of this study",
                        "criterion": "understanding of investigational nature",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form",
                        "criterion": "informed consent form",
                        "requirement": {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient or legal representative must understand the investigational nature of this study",
                        "criterion": "understanding of investigational nature",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form",
                        "criterion": "informed consent form",
                        "requirement": {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Presence of measurable disease defined as a lesion >= 1 cm by computed tomography (CT); all sites of disease should be evaluated =< 3 weeks before treatment initiation",
                "criterions": [
                    {
                        "exact_snippets": "Presence of measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lesion >= 1 cm by computed tomography (CT)",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "all sites of disease should be evaluated =< 3 weeks before treatment initiation",
                        "criterion": "disease evaluation timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of measurable disease",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "lesion >= 1 cm by computed tomography (CT)",
                                "criterion": "lesion size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "all sites of disease should be evaluated =< 3 weeks before treatment initiation",
                        "criterion": "disease evaluation timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Baseline 25-D3 level of < 40 ng/ml",
                "criterions": [
                    {
                        "exact_snippets": "Baseline 25-D3 level of < 40 ng/ml",
                        "criterion": "25-D3 level",
                        "requirement": {
                            "requirement_type": "baseline",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "ng/ml"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Baseline 25-D3 level of < 40 ng/ml",
                        "criterion": "25-D3 level",
                        "requirement": {
                            "requirement_type": "baseline",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "ng/ml"
                            }
                        }
                    }
                ]
            }
        },
        {
            "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 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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 79 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 79 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 79,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 79 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 79,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases and < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... < 2.5 x institutional upper normal level if no liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "x institutional upper normal level"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... < 2.5 x institutional upper normal level if no liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x upper limit of normal (ULN)"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "x institutional upper normal level"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x upper limit of normal (ULN)"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "liver metastases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "condition": {
                                    "exact_snippets": "Aspartate aminotransferase (AST) ... < 2.5 x institutional upper normal level if no liver metastases",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "condition",
                                        "expected_value": "no liver metastases"
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "Aspartate aminotransferase (AST) ... < 2.5 x institutional upper normal level if no liver metastases",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<",
                                                    "value": 2.5,
                                                    "unit": "x institutional upper normal level"
                                                }
                                            ]
                                        }
                                    }
                                },
                                "else_criteria": null
                            },
                            {
                                "condition": {
                                    "exact_snippets": "Aspartate aminotransferase (AST) ... < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "condition",
                                        "expected_value": "liver metastases"
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "Aspartate aminotransferase (AST) ... < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<",
                                                    "value": 5,
                                                    "unit": "x upper limit of normal (ULN)"
                                                }
                                            ]
                                        }
                                    }
                                },
                                "else_criteria": null
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "condition": {
                                    "exact_snippets": "alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "condition",
                                        "expected_value": "no liver metastases"
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<",
                                                    "value": 2.5,
                                                    "unit": "x institutional upper normal level"
                                                }
                                            ]
                                        }
                                    }
                                },
                                "else_criteria": null
                            },
                            {
                                "condition": {
                                    "exact_snippets": "alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "condition",
                                        "expected_value": "liver metastases"
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) in the setting of liver metastases",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<",
                                                    "value": 5,
                                                    "unit": "x upper limit of normal (ULN)"
                                                }
                                            ]
                                        }
                                    }
                                },
                                "else_criteria": null
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients may not be receiving any other investigational agents that are not included in this study",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents",
                        "criterion": "use of investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents",
                        "criterion": "use of investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "known brain metastases",
                    "criterion": "brain metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of other invasive cancers with the exception of the following: a. Curatively resected or treated non-melanoma skin cancer; b. Curatively treated cervical carcinoma in situ; c. Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment, and in the investigator opinion, it is unlikely that there will be a recurrence =< 1 year post enrollment",
                "criterions": [
                    {
                        "exact_snippets": "History of other invasive cancers",
                        "criterion": "history of invasive cancers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Curatively resected or treated non-melanoma skin cancer",
                        "criterion": "non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively resected or treated"
                        }
                    },
                    {
                        "exact_snippets": "Curatively treated cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    },
                    {
                        "exact_snippets": "Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment",
                        "criterion": "other primary solid tumors",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    },
                    {
                        "exact_snippets": "Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment",
                        "criterion": "other primary solid tumors",
                        "requirement": {
                            "requirement_type": "treatment administration time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in the investigator opinion, it is unlikely that there will be a recurrence =< 1 year post enrollment",
                        "criterion": "recurrence likelihood",
                        "requirement": {
                            "requirement_type": "likelihood of recurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "History of other invasive cancers",
                            "criterion": "history of invasive cancers",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Curatively resected or treated non-melanoma skin cancer",
                                "criterion": "non-melanoma skin cancer",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "curatively resected or treated"
                                }
                            },
                            {
                                "exact_snippets": "Curatively treated cervical carcinoma in situ",
                                "criterion": "cervical carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "curatively treated"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment",
                                        "criterion": "other primary solid tumors",
                                        "requirement": {
                                            "requirement_type": "treatment status",
                                            "expected_value": "curatively treated"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment",
                                        "criterion": "other primary solid tumors",
                                        "requirement": {
                                            "requirement_type": "treatment administration time",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "years"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "in the investigator opinion, it is unlikely that there will be a recurrence =< 1 year post enrollment",
                                        "criterion": "recurrence likelihood",
                                        "requirement": {
                                            "requirement_type": "likelihood of recurrence",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "year"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, 5-FU, leucovorin, bevacizumab, and vitamin D3 and other agents used in study",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin",
                        "criterion": "allergic reactions to oxaliplatin",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... 5-FU",
                        "criterion": "allergic reactions to 5-FU",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... leucovorin",
                        "criterion": "allergic reactions to leucovorin",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... bevacizumab",
                        "criterion": "allergic reactions to bevacizumab",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... vitamin D3",
                        "criterion": "allergic reactions to vitamin D3",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... other agents used in study",
                        "criterion": "allergic reactions to other agents used in study",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin",
                                "criterion": "allergic reactions to oxaliplatin",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... 5-FU",
                                "criterion": "allergic reactions to 5-FU",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... leucovorin",
                                "criterion": "allergic reactions to leucovorin",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... bevacizumab",
                                "criterion": "allergic reactions to bevacizumab",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... vitamin D3",
                                "criterion": "allergic reactions to vitamin D3",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... other agents used in study",
                                "criterion": "allergic reactions to other agents used in study",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of clinically significant bleeding within 6 months of enrollment",
                "criterions": [
                    {
                        "exact_snippets": "History of clinically significant bleeding within 6 months of enrollment",
                        "criterion": "clinically significant bleeding",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of clinically significant bleeding within 6 months of enrollment",
                        "criterion": "clinically significant bleeding",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of clinically significant bleeding within 6 months of enrollment",
                        "criterion": "clinically significant bleeding",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of clinically significant bleeding within 6 months of enrollment",
                        "criterion": "clinically significant bleeding",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant cardiovascular disease within 12 months prior to enrollment",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant cardiovascular disease within 12 months prior to enrollment",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 months prior to enrollment"
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "grade 2 or greater peripheral vascular disease",
                        "criterion": "peripheral vascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "transient ischemic attack",
                        "criterion": "transient ischemic attack",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "arrhythmias not controlled by outpatient medication",
                        "criterion": "arrhythmias",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "not controlled by outpatient medication"
                        }
                    },
                    {
                        "exact_snippets": "percutaneous transluminal coronary angioplasty/stent",
                        "criterion": "percutaneous transluminal coronary angioplasty/stent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically significant cardiovascular disease within 12 months prior to enrollment",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "Clinically significant cardiovascular disease within 12 months prior to enrollment",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 12 months prior to enrollment"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "grade 2 or greater peripheral vascular disease",
                                "criterion": "peripheral vascular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "cerebrovascular accident",
                                "criterion": "cerebrovascular accident",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "transient ischemic attack",
                                "criterion": "transient ischemic attack",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "arrhythmias not controlled by outpatient medication",
                                "criterion": "arrhythmias",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "not controlled by outpatient medication"
                                }
                            },
                            {
                                "exact_snippets": "percutaneous transluminal coronary angioplasty/stent",
                                "criterion": "percutaneous transluminal coronary angioplasty/stent",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery within 28 days prior to enrollment or still recovering from prior surgery",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 28 days prior to enrollment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "still recovering from prior surgery",
                        "criterion": "recovery from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Major surgery within 28 days prior to enrollment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "still recovering from prior surgery",
                        "criterion": "recovery from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known dihydropyrimidine dehydrogenase (DpD) deficiency",
                "criterions": [
                    {
                        "exact_snippets": "Known dihydropyrimidine dehydrogenase (DpD) deficiency",
                        "criterion": "dihydropyrimidine dehydrogenase (DpD) deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known dihydropyrimidine dehydrogenase (DpD) deficiency",
                    "criterion": "dihydropyrimidine dehydrogenase (DpD) deficiency",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)",
                "criterions": [
                    {
                        "exact_snippets": "History or evidence upon physical examination of central nervous system (CNS) disease",
                        "criterion": "central nervous system (CNS) disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "primary brain tumor",
                        "criterion": "primary brain tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seizures not controlled with standard medical therapy",
                        "criterion": "seizures",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "not controlled with standard medical therapy"
                        }
                    },
                    {
                        "exact_snippets": "any brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of stroke",
                        "criterion": "history of stroke",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History or evidence upon physical examination of central nervous system (CNS) disease",
                                "criterion": "central nervous system (CNS) disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "primary brain tumor",
                                        "criterion": "primary brain tumor",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "seizures not controlled with standard medical therapy",
                                        "criterion": "seizures",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": "not controlled with standard medical therapy"
                                        }
                                    },
                                    {
                                        "exact_snippets": "any brain metastases",
                                        "criterion": "brain metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "history of stroke",
                                        "criterion": "history of stroke",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serious, nonhealing wound, ulcer, or bone fracture",
                "criterions": [
                    {
                        "exact_snippets": "Serious, nonhealing wound",
                        "criterion": "wound",
                        "requirement": {
                            "requirement_type": "healing status",
                            "expected_value": "nonhealing"
                        }
                    },
                    {
                        "exact_snippets": "Serious, nonhealing wound",
                        "criterion": "wound",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious, nonhealing ... ulcer",
                        "criterion": "ulcer",
                        "requirement": {
                            "requirement_type": "healing status",
                            "expected_value": "nonhealing"
                        }
                    },
                    {
                        "exact_snippets": "Serious, nonhealing ... ulcer",
                        "criterion": "ulcer",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious, nonhealing ... bone fracture",
                        "criterion": "bone fracture",
                        "requirement": {
                            "requirement_type": "healing status",
                            "expected_value": "nonhealing"
                        }
                    },
                    {
                        "exact_snippets": "Serious, nonhealing ... bone fracture",
                        "criterion": "bone fracture",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious, nonhealing wound",
                                "criterion": "wound",
                                "requirement": {
                                    "requirement_type": "healing status",
                                    "expected_value": "nonhealing"
                                }
                            },
                            {
                                "exact_snippets": "Serious, nonhealing wound",
                                "criterion": "wound",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious, nonhealing ... ulcer",
                                "criterion": "ulcer",
                                "requirement": {
                                    "requirement_type": "healing status",
                                    "expected_value": "nonhealing"
                                }
                            },
                            {
                                "exact_snippets": "Serious, nonhealing ... ulcer",
                                "criterion": "ulcer",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious, nonhealing ... bone fracture",
                                "criterion": "bone fracture",
                                "requirement": {
                                    "requirement_type": "healing status",
                                    "expected_value": "nonhealing"
                                }
                            },
                            {
                                "exact_snippets": "Serious, nonhealing ... bone fracture",
                                "criterion": "bone fracture",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg despite medications)",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "systolic blood pressure > 150 mmHg",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "diastolic blood pressure > 95 mmHg",
                        "criterion": "diastolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 95,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled hypertension",
                                "criterion": "hypertension",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "systolic blood pressure > 150 mmHg",
                                        "criterion": "systolic blood pressure",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">",
                                                "value": 150,
                                                "unit": "mmHg"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "diastolic blood pressure > 95 mmHg",
                                        "criterion": "diastolic blood pressure",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">",
                                                "value": 95,
                                                "unit": "mmHg"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of arterial thrombosis within the last 12 months",
                "criterions": [
                    {
                        "exact_snippets": "History of arterial thrombosis within the last 12 months",
                        "criterion": "arterial thrombosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of arterial thrombosis within the last 12 months",
                        "criterion": "arterial thrombosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of arterial thrombosis within the last 12 months",
                        "criterion": "arterial thrombosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of arterial thrombosis within the last 12 months",
                        "criterion": "arterial thrombosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of visceral arterial ischemia",
                "criterions": [
                    {
                        "exact_snippets": "History of visceral arterial ischemia",
                        "criterion": "visceral arterial ischemia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of visceral arterial ischemia",
                    "criterion": "visceral arterial ischemia",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects unwilling or unable to comply with study requirements",
                "criterions": [
                    {
                        "exact_snippets": "Subjects unwilling ... to comply with study requirements",
                        "criterion": "willingness to comply with study requirements",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects ... unable to comply with study requirements",
                        "criterion": "ability to comply with study requirements",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Subjects unwilling ... to comply with study requirements",
                            "criterion": "willingness to comply with study requirements",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Subjects ... unable to comply with study requirements",
                            "criterion": "ability to comply with study requirements",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any condition that in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug",
                "criterions": [
                    {
                        "exact_snippets": "Any condition that in the Investigator's opinion deems the patient an unsuitable candidate",
                        "criterion": "suitability for study drug",
                        "requirement": {
                            "requirement_type": "opinion",
                            "expected_value": "Investigator's discretion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any condition that in the Investigator's opinion deems the patient an unsuitable candidate",
                    "criterion": "suitability for study drug",
                    "requirement": {
                        "requirement_type": "opinion",
                        "expected_value": "Investigator's discretion"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with vitamin D replacement with doses exceeding an average of 1000 IU/day (vitamin D3) within 60 days prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with vitamin D replacement",
                        "criterion": "vitamin D replacement treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "doses exceeding an average of 1000 IU/day (vitamin D3)",
                        "criterion": "vitamin D3 dose",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "IU/day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 60 days prior to enrollment",
                        "criterion": "time since vitamin D replacement treatment",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treatment with vitamin D replacement",
                                "criterion": "vitamin D replacement treatment",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "doses exceeding an average of 1000 IU/day (vitamin D3)",
                                "criterion": "vitamin D3 dose",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 1000,
                                        "unit": "IU/day"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "within 60 days prior to enrollment",
                        "criterion": "time since vitamin D replacement treatment",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Received an investigational agent within 30 clays prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Received an investigational agent within 30 days prior to enrollment",
                        "criterion": "investigational agent",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Received an investigational agent within 30 days prior to enrollment",
                    "criterion": "investigational agent",
                    "requirement": {
                        "requirement_type": "time since last administration",
                        "expected_value": {
                            "operator": "<=",
                            "value": 30,
                            "unit": "days"
                        }
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Calculated creatinine clearance > 40 ml/min according to the Cockcroft-Gault formula OR per 24 hour urine collection",
                "criterions": [
                    {
                        "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "calculation method",
                            "expected_value": [
                                "Cockcroft-Gault formula",
                                "24 hour urine collection"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "calculation method",
                                    "expected_value": "Cockcroft-Gault formula"
                                }
                            },
                            {
                                "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 40,
                                        "unit": "ml/min"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "calculation method",
                                    "expected_value": "24 hour urine collection"
                                }
                            },
                            {
                                "exact_snippets": "Calculated creatinine clearance > 40 ml/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 40,
                                        "unit": "ml/min"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant women are excluded",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding should be discontinued",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant women are excluded",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding should be discontinued",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}