{
    "info": {
        "nct_id": "NCT00626548",
        "official_title": "A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients",
        "inclusion_criteria": "Patients who answer TRUE to the following criteria may be eligible to participate in this study.\n\n* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.\n* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment\n* 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 be eligible to participate in this study.\n\n* Currently using opiate based pain killers for cancer related pain\n* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial\n* Suffering from heart failure or had a myocardial infarction within last 6 months\n* 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 study.",
            "criterions": [
                {
                    "exact_snippets": "answer TRUE",
                    "criterion": "response to criteria",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "TRUE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has NOT spread to the other parts of the body (metastases)",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with lymph node involvement",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment",
            "criterions": [
                {
                    "exact_snippets": "Increasing Prostate Specific Antigen (PSA)",
                    "criterion": "Prostate Specific Antigen (PSA)",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "increasing"
                        }
                    ]
                },
                {
                    "exact_snippets": "collected within one year of enrollment",
                    "criterion": "PSA collection date",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within one year of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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 be eligible to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "answer TRUE",
                    "criterion": "response to a question",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "TRUE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently using opiate based pain killers for cancer related pain",
            "criterions": [
                {
                    "exact_snippets": "Currently using opiate based pain killers",
                    "criterion": "opiate based pain killers",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer related pain",
                    "criterion": "cancer related pain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial",
            "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"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior targeted cancer therapies are permitted if received during a previous clinical trial",
                    "criterion": "prior targeted cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "received during a previous clinical trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "* 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": []
}