{
    "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": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient has given written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient has given written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient is 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Patient is 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient has histologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "serum prostate-specific antigen (PSA) level at screening >2 ng/mL",
                    "criterion": "serum prostate-specific antigen (PSA) level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The prostate size is >30 cubic centimetres (cc), measured by TRUS",
            "criterions": [
                {
                    "exact_snippets": "The prostate size is >30 cubic centimetres (cc)",
                    "criterion": "prostate size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "cubic centimetres (cc)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient has had a bone-scan within 12 weeks before inclusion",
            "criterions": [
                {
                    "exact_snippets": "Patient has had a bone-scan within 12 weeks before inclusion",
                    "criterion": "bone-scan",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 12 weeks before inclusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient must be able to undergo transrectal examinations",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able to undergo transrectal examinations",
                    "criterion": "ability to undergo transrectal examinations",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient has an estimated life expectancy of at least 12 months",
            "criterions": [
                {
                    "exact_snippets": "estimated life expectancy of at least 12 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Any previous treatments for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "previous treatments for prostate cancer",
                    "criterion": "previous treatments for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous trans-urethral resection of the prostate (TURP)",
            "criterions": [
                {
                    "exact_snippets": "Previous trans-urethral resection of the prostate (TURP)",
                    "criterion": "trans-urethral resection of the prostate (TURP)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Is not considered a candidate for medical castration",
            "criterions": [
                {
                    "exact_snippets": "Is not considered a candidate for medical castration",
                    "criterion": "candidate for medical castration",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Use of urethral catheter",
            "criterions": [
                {
                    "exact_snippets": "Use of urethral catheter",
                    "criterion": "urethral catheter",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is currently treated with a 5-alpha reductase inhibitor",
            "criterions": [
                {
                    "exact_snippets": "currently treated with a 5-alpha reductase inhibitor",
                    "criterion": "5-alpha reductase inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Is currently treated with an alpha-adrenoceptor antagonist",
            "criterions": [
                {
                    "exact_snippets": "currently treated with an alpha-adrenoceptor antagonist",
                    "criterion": "alpha-adrenoceptor antagonist treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Treatment with botulinum toxin A (Botox)",
            "criterions": [
                {
                    "exact_snippets": "Treatment with botulinum toxin A (Botox)",
                    "criterion": "botulinum toxin A (Botox) treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Require radiotherapy during the trial",
            "criterions": [
                {
                    "exact_snippets": "Require radiotherapy during the trial",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema",
            "criterions": [
                {
                    "exact_snippets": "History of severe untreated asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "anaphylactic reactions",
                    "criterion": "anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe urticaria",
                    "criterion": "urticaria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "angioedema",
                    "criterion": "angioedema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Hypersensitivity towards any component of the investigational products or excipients",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity towards any component of the investigational products",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity towards any component of the ... excipients",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Previous history or presence of another malignancy",
            "criterions": [
                {
                    "exact_snippets": "Previous history ... of another malignancy",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of another malignancy",
                    "criterion": "presence of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. A clinically significant disorder",
            "criterions": [
                {
                    "exact_snippets": "clinically significant disorder",
                    "criterion": "disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. A corrected QT interval over 450 msec",
            "criterions": [
                {
                    "exact_snippets": "corrected QT interval over 450 msec",
                    "criterion": "corrected QT interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Mental incapacity or language barrier precluding adequate understanding or co-operation",
            "criterions": [
                {
                    "exact_snippets": "Mental incapacity",
                    "criterion": "mental capacity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "language barrier",
                    "criterion": "language barrier",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Receipt of an investigational drug within the last 28 days proceeding screening",
            "criterions": [
                {
                    "exact_snippets": "Receipt of an investigational drug within the last 28 days",
                    "criterion": "investigational drug receipt",
                    "requirements": [
                        {
                            "requirement_type": "time since last receipt",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Previous participation in any degarelix trial",
            "criterions": [
                {
                    "exact_snippets": "Previous participation in any degarelix trial",
                    "criterion": "previous participation in degarelix trial",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}