{
    "info": {
        "nct_id": "NCT00884273",
        "official_title": "A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration",
        "inclusion_criteria": "1. Patient has given written informed consent\n2. Patient is 18 years or older\n3. Patient has histologically confirmed prostate cancer\n4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL\n5. The prostate size is >30 cubic centimetres (cc), measured by TRUS\n6. Patient has had a bone-scan within 12 weeks before inclusion\n7. Patient must be able to undergo transrectal examinations\n8. Patient has an estimated life expectancy of at least 12 months\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any previous treatments for prostate cancer\n2. Previous trans-urethral resection of the prostate (TURP)\n3. Is not considered a candidate for medical castration\n4. Use of urethral catheter\n5. Is currently treated with a 5-alpha reductase inhibitor\n6. Is currently treated with an alpha-adrenoceptor antagonist\n7. Treatment with botulinum toxin A (Botox)\n8. Require radiotherapy during the trial\n9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema\n10. Hypersensitivity towards any component of the investigational products or excipients\n11. Previous history or presence of another malignancy\n12. A clinically significant disorder\n13. A corrected QT interval over 450 msec\n14. Mental incapacity or language barrier precluding adequate understanding or co-operation\n15. Receipt of an investigational drug within the last 28 days proceeding screening\n16. Previous participation in any degarelix trial",
        "miscellaneous_criteria": ""
    },
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                                "value": 18,
                                "unit": "years"
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                    }
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                        "exact_snippets": "histologically confirmed prostate cancer",
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                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
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                            "requirement_type": "value",
                            "expected_value": {
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                                "value": 2,
                                "unit": "ng/mL"
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                        }
                    }
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                                "unit": "ng/mL"
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        },
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                                "unit": "cubic centimetres (cc)"
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                        }
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                            "requirement_type": "duration",
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                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
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                                "unit": "months"
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                        }
                    }
                ]
            }
        }
    ],
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    "miscellaneous_lines": [],
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                            "requirement_type": "status",
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                                "unit": "Years"
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        {
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                            "requirement_type": "eligibility",
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                "line": "8. Require radiotherapy during the trial",
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                            "requirement_type": "necessity",
                            "expected_value": true
                        }
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                        "criterion": "asthma",
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                            "expected_value": "severe"
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                    },
                    {
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                        "criterion": "asthma",
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                            "requirement_type": "treatment status",
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                    },
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                    },
                    {
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        {
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                        "criterion": "hypersensitivity",
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                    },
                    {
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        {
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                "line": "12. A clinically significant disorder",
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                            "expected_value": "clinically significant"
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                "line": "13. A corrected QT interval over 450 msec",
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                        "exact_snippets": "corrected QT interval over 450 msec",
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                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
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                "line": "14. Mental incapacity or language barrier precluding adequate understanding or co-operation",
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                        "criterion": "mental capacity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "language barrier",
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        {
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                        "criterion": "investigational drug receipt",
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                            "requirement_type": "time since last receipt",
                            "expected_value": {
                                "operator": "<=",
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                                "unit": "days"
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    ],
    "failed_miscellaneous": []
}