{
    "info": {
        "nct_id": "NCT00554229",
        "official_title": "A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.",
        "inclusion_criteria": "Patients who answer TRUE to the following criteria may be eligible to participate in this trial.\n\n1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)\n2. Increasing Prostate Specific Antigen (PSA) over a one month period\n3. No pain, or mild pain from prostate cancer\n4. Currently receiving treatment with surgical or medical castration\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Patients who answer TRUE to the following may NOT eligible to participate in this trial.\n\n1. Currently using opiates based pain killers)\n2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)\n3. Suffering from heart failure or had a myocardial infarction within last 6 months\n4. A history of epilepsy or seizures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Patients who answer TRUE to the following criteria may be eligible to participate in this trial.",
            "criterions": [
                {
                    "exact_snippets": "answer TRUE",
                    "criterion": "response to criteria",
                    "requirements": [
                        {
                            "requirement_type": "expected response",
                            "expected_value": "TRUE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has spread to the bone (bone metastases)",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Increasing Prostate Specific Antigen (PSA) over a one month period",
            "criterions": [
                {
                    "exact_snippets": "Increasing Prostate Specific Antigen (PSA) over a one month period",
                    "criterion": "Prostate Specific Antigen (PSA)",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "increasing"
                        },
                        {
                            "requirement_type": "time period",
                            "expected_value": "one month"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No pain, or mild pain from prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "No pain, or mild pain from prostate cancer",
                    "criterion": "pain from prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "none",
                                "mild"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Currently receiving treatment with surgical or medical castration",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving treatment with surgical or medical castration",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgical castration",
                                "medical castration"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "currently receiving"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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": "Patients who answer TRUE to the following may NOT eligible to participate in this trial.",
            "criterions": [
                {
                    "exact_snippets": "Patients who answer TRUE",
                    "criterion": "response to eligibility questions",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "TRUE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Currently using opiates based pain killers)",
            "criterions": [
                {
                    "exact_snippets": "Currently using opiates based pain killers",
                    "criterion": "use of opiate-based pain killers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)",
                    "criterion": "previous chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "paclitaxel",
                                "docetaxel",
                                "mitoxantrone"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Suffering from heart failure or had a myocardial infarction within last 6 months",
            "criterions": [
                {
                    "exact_snippets": "Suffering from heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had a myocardial infarction within last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. A history of epilepsy or seizures",
            "criterions": [
                {
                    "exact_snippets": "A history of epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of ... seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}