{
    "info": {
        "nct_id": "NCT02379260",
        "official_title": "Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy",
        "inclusion_criteria": "* Patients followed in urology department Lyon Sud CH:\n* Aged over 18 year\n* Having a prostate cancer\n* Treated with radical prostatectomy with or without conservation strips neuro vascular\n* More than 1 month postoperative\n* Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.\n* And who signed the informed consent form for participation in the study\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Score preoperative IIEF EF <26\n* Refusal of participation, signed consent major patients protected under guardianship.\n* Patients unable to understand the course of the study\n* Patient (s) with a documented history of cognitive or psychiatric disorders.\n* Geographical remoteness of more than 100 Kms.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients followed in urology department Lyon Sud CH:",
            "criterions": [
                {
                    "exact_snippets": "followed in urology department Lyon Sud CH",
                    "criterion": "follow-up location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "urology department Lyon Sud CH"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged over 18 year",
            "criterions": [
                {
                    "exact_snippets": "Aged over 18 year",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having a prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Having a prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treated with radical prostatectomy with or without conservation strips neuro vascular",
            "criterions": [
                {
                    "exact_snippets": "Treated with radical prostatectomy",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radical prostatectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without conservation strips neuro vascular",
                    "criterion": "conservation strips neuro vascular",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 1 month postoperative",
            "criterions": [
                {
                    "exact_snippets": "More than 1 month postoperative",
                    "criterion": "postoperative period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.",
            "criterions": [
                {
                    "exact_snippets": "normal preoperative erectile function defined by a score IIEF EF ≥ 26",
                    "criterion": "preoperative erectile function",
                    "requirements": [
                        {
                            "requirement_type": "IIEF EF score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 26,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* And who signed the informed consent form for participation in the study",
            "criterions": [
                {
                    "exact_snippets": "signed the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Score preoperative IIEF EF <26",
            "criterions": [
                {
                    "exact_snippets": "Score preoperative IIEF EF <26",
                    "criterion": "preoperative IIEF EF score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 26,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refusal of participation, signed consent major patients protected under guardianship.",
            "criterions": [
                {
                    "exact_snippets": "Refusal of participation",
                    "criterion": "participation refusal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed consent",
                    "criterion": "signed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "major patients protected under guardianship",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "protected under guardianship"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to understand the course of the study",
            "criterions": [
                {
                    "exact_snippets": "unable to understand the course of the study",
                    "criterion": "understanding of the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient (s) with a documented history of cognitive or psychiatric disorders.",
            "criterions": [
                {
                    "exact_snippets": "documented history of cognitive ... disorders",
                    "criterion": "cognitive disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented history of ... psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Geographical remoteness of more than 100 Kms.",
            "criterions": [
                {
                    "exact_snippets": "Geographical remoteness of more than 100 Kms.",
                    "criterion": "geographical remoteness",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "Kms"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}