{
    "info": {
        "nct_id": "NCT05818631",
        "official_title": "Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer",
        "inclusion_criteria": "* Male patients between 18 and 80 years\n* BpMRI performed in a 3 months period before the prostatic biopsy\n* First transrectal prostatic biopsy\n* PSA > 4 ng/mL and < 20 ng/mL\n* Patients acceptance to participate in the study signing a written specific informed consent\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Not having all the inclusion criteria described\n* Suspicious digital rectal examination of prostate cancer\n* Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter\n* Previous prostatic surgery in any of its variants\n* Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male patients between 18 and 80 years",
            "criterions": [
                {
                    "exact_snippets": "Male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "between 18 and 80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* BpMRI performed in a 3 months period before the prostatic biopsy",
            "criterions": [
                {
                    "exact_snippets": "BpMRI performed in a 3 months period before the prostatic biopsy",
                    "criterion": "BpMRI",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 months before prostatic biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* First transrectal prostatic biopsy",
            "criterions": [
                {
                    "exact_snippets": "First transrectal prostatic biopsy",
                    "criterion": "transrectal prostatic biopsy",
                    "requirements": [
                        {
                            "requirement_type": "order",
                            "expected_value": "first"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA > 4 ng/mL and < 20 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "PSA > 4 ng/mL and < 20 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 4,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 20,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients acceptance to participate in the study signing a written specific informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients acceptance to participate in the study signing a written specific informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "Must be 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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Not having all the inclusion criteria described",
            "criterions": [
                {
                    "exact_snippets": "Not having all the inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suspicious digital rectal examination of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Suspicious digital rectal examination of prostate cancer",
                    "criterion": "digital rectal examination",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter",
            "criterions": [
                {
                    "exact_snippets": "Previous urinary tract infection in the last six months",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "acute urinary retention",
                    "criterion": "urinary retention",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic carrier of bladder catheter",
                    "criterion": "bladder catheter",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": "chronic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous prostatic surgery in any of its variants",
            "criterions": [
                {
                    "exact_snippets": "Previous prostatic surgery",
                    "criterion": "prostatic surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue",
                    "criterion": "Luteinizing hormone-releasing hormone (LHRH) analogue treatment",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant treatment with ... antiandrogens",
                    "criterion": "antiandrogens treatment",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant treatment with ... 5-alfa-reductase inhibitors",
                    "criterion": "5-alfa-reductase inhibitors treatment",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}