{
    "info": {
        "nct_id": "NCT00811031",
        "official_title": "A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer",
        "inclusion_criteria": "1. Patients with adenocarcinoma of the prostate (ductal or acinar).\n2. Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.\n3. Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.\n4. Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.\n5. Surgically resectable disease as assessed by the collaborating urological oncologist.\n6. Patients must be >/= 18 years of age.\n7. Patients must have a performance status of </= 2 (ECOG).\n8. Patients must have an expected survival from cancer or co-morbidity of six months.\n9. Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.\n10. Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months or have been defined as docetaxel-resistant or intolerant previously.\n11. Patients must have adequate bone marrow function defined as an Hgb >/= 8.0 g/dl, absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 100,000/mm^3.\n12. Patients must have adequate hepatic function defined with a bilirubin of </= upper limits of normal. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used (see chart below in Study Plan).\n13. Patients must have adequate renal function defined as creatinine clearance >/= 30 cc/min (measured or calculated by Cockcroft and Gault formula).\n14. Must be fully recovered from any previous surgery, in terms of wound healing.\n15. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.\n16. Men with the ability to father a child must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.\n2. Patients with small cell or sarcomatoid variant of prostate cancer.\n3. Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.\n4. Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.\n5. Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.\n6. Patients who are unwilling to provide blood or tissue specimens required for the primary objectives of the study.\n7. Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.\n8. Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with adenocarcinoma of the prostate (ductal or acinar).",
            "criterions": [
                {
                    "exact_snippets": "adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal or acinar",
                    "criterion": "adenocarcinoma subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "ductal",
                                "acinar"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic or evidence of progressive disease in the primary tumor",
                    "criterion": "progressive disease in the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "digital rectal examination",
                    "criterion": "digital rectal examination",
                    "requirements": [
                        {
                            "requirement_type": "method of assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cystoscopy",
                    "criterion": "cystoscopy",
                    "requirements": [
                        {
                            "requirement_type": "method of assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiological imaging",
                    "criterion": "radiological imaging",
                    "requirements": [
                        {
                            "requirement_type": "method of assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without symptomatic or objective evidence of systemic disease progression",
                    "criterion": "systemic disease progression",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "objective evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.",
            "criterions": [
                {
                    "exact_snippets": "castrate serum testosterone level (</= 50ng/ml)",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 50,
                                        "unit": "ng/ml"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "documented in the last six weeks",
                    "criterion": "documentation of serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "last six weeks"
                        }
                    ]
                },
                {
                    "exact_snippets": "medically castrated",
                    "criterion": "medical castration",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "luteinizing hormone releasing hormone analog must continue",
                    "criterion": "luteinizing hormone releasing hormone analog",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "maintain testicular suppression",
                    "criterion": "testicular suppression",
                    "requirements": [
                        {
                            "requirement_type": "maintenance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks",
                    "criterion": "discontinuation from flutamide, nilutamide or cyproterone acetate",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinued from ... bicalutamide for 6 weeks",
                    "criterion": "discontinuation from bicalutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If localized progression is documented during or after this time interval, patients are eligible",
                    "criterion": "localized progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period",
                    "criterion": "response to deferred (secondary) therapy with antiandrogens",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Surgically resectable disease as assessed by the collaborating urological oncologist.",
            "criterions": [
                {
                    "exact_snippets": "Surgically resectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "surgical resectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients must be >/= 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be >/= 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients must have a performance status of </= 2 (ECOG).",
            "criterions": [
                {
                    "exact_snippets": "performance status of </= 2 (ECOG)",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients must have an expected survival from cancer or co-morbidity of six months.",
            "criterions": [
                {
                    "exact_snippets": "expected survival from cancer or co-morbidity of six months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy.",
                    "criterion": "concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "biological",
                                "immunological",
                                "second-line hormonal",
                                "chemotherapy"
                            ]
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "replacement or therapeutic doses for non-malignant disease"
                        },
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months or have been defined as docetaxel-resistant or intolerant previously.",
            "criterions": [
                {
                    "exact_snippets": "Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months",
                    "criterion": "recent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have been defined as docetaxel-resistant",
                    "criterion": "docetaxel resistance",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant previously",
                    "criterion": "docetaxel intolerance",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients must have adequate bone marrow function defined as an Hgb >/= 8.0 g/dl, absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 100,000/mm^3.",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow function defined as an Hgb >/= 8.0 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate bone marrow function defined as ... absolute peripheral granulocyte count of >/= 1,500/mm^3",
                    "criterion": "absolute peripheral granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate bone marrow function defined as ... platelet count of >/= 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients must have adequate hepatic function defined with a bilirubin of </= upper limits of normal. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used (see chart below in Study Plan).",
            "criterions": [
                {
                    "exact_snippets": "adequate hepatic function defined with a bilirubin of </= upper limits of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within eligibility range"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility",
                    "criterion": "ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within eligibility range"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility",
                    "criterion": "Alkaline Phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within eligibility range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients must have adequate renal function defined as creatinine clearance >/= 30 cc/min (measured or calculated by Cockcroft and Gault formula).",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function defined as creatinine clearance >/= 30 cc/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "cc/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Must be fully recovered from any previous surgery, in terms of wound healing.",
            "criterions": [
                {
                    "exact_snippets": "fully recovered from any previous surgery, in terms of wound healing",
                    "criterion": "recovery from previous surgery",
                    "requirements": [
                        {
                            "requirement_type": "wound healing",
                            "expected_value": "fully recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that they are aware of the investigational nature of this study",
                    "criterion": "awareness of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Men with the ability to father a child must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.",
            "criterions": [
                {
                    "exact_snippets": "Men with the ability to father a child",
                    "criterion": "ability to father a child",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to consent to using effective contraception",
                    "criterion": "willingness to use contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while on treatment and for at least 3 months thereafter",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on treatment and for at least 3 months thereafter"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic",
                    "criterion": "infection symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring intravenous antibiotics",
                    "criterion": "intravenous antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with small cell or sarcomatoid variant of prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "small cell ... variant of prostate cancer",
                    "criterion": "prostate cancer variant",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "small cell"
                        }
                    ]
                },
                {
                    "exact_snippets": "sarcomatoid variant of prostate cancer",
                    "criterion": "prostate cancer variant",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sarcomatoid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic congestive heart failure (CHF)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolus",
                    "criterion": "pulmonary embolus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular thrombosis",
                    "criterion": "vascular thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MI in the last 6 months",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of active myocardial ischemia by symptoms or ECG",
                    "criterion": "active myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "symptoms",
                                "ECG"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.",
            "criterions": [
                {
                    "exact_snippets": "Oxygen-dependent lung disease",
                    "criterion": "lung disease",
                    "requirements": [
                        {
                            "requirement_type": "oxygen-dependence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "> grade 2 peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.",
            "criterions": [
                {
                    "exact_snippets": "Active second malignancies",
                    "criterion": "second malignancies",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder",
                    "criterion": "superficial low-grade transitional cell carcinoma of the bladder",
                    "requirements": [
                        {
                            "requirement_type": "threat level",
                            "expected_value": "non-threatening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-threatening second malignancies such as ... Rai Stage 0 chronic lymphocytic leukemia",
                    "criterion": "Rai Stage 0 chronic lymphocytic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "threat level",
                            "expected_value": "non-threatening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-threatening second malignancies such as ... stable small renal cell carcinomas",
                    "criterion": "stable small renal cell carcinomas",
                    "requirements": [
                        {
                            "requirement_type": "threat level",
                            "expected_value": "non-threatening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who are unwilling to provide blood or tissue specimens required for the primary objectives of the study.",
            "criterions": [
                {
                    "exact_snippets": "unwilling to provide blood ... required for the primary objectives of the study",
                    "criterion": "blood specimens",
                    "requirements": [
                        {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to provide ... tissue specimens required for the primary objectives of the study",
                    "criterion": "tissue specimens",
                    "requirements": [
                        {
                            "requirement_type": "willingness to provide",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.",
            "criterions": [
                {
                    "exact_snippets": "Overt psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disability",
                    "criterion": "mental disability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "otherwise incompetent to give informed consent",
                    "criterion": "competence to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "competence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of non-compliance with medical regimens",
                    "criterion": "compliance with medical regimens",
                    "requirements": [
                        {
                            "requirement_type": "history of non-compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "considered potentially unreliable",
                    "criterion": "reliability",
                    "requirements": [
                        {
                            "requirement_type": "potential unreliability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": "history of severe hypersensitivity reaction to Taxotere®",
                    "criterion": "hypersensitivity reaction to Taxotere®",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
                    "criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}