{
    "info": {
        "nct_id": "NCT01292291",
        "official_title": "PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Men at risk of prostate cancer who have been advised to have a prostate biopsy\n* Suspected stage ≤ T2 on rectal examination (organ confined)\n* Serum PSA ≤ 15 ng/mL within the past 3 months\n\nPATIENT CHARACTERISTICS:\n\n* Fit for general/spinal anesthesia\n* Fit to undergo all protocol procedures including a transrectal ultrasound\n* No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months\n* No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)\n* No other medical condition precluding procedures described in the protocol\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)\n* No prior hip replacement surgery"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
                "criterions": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Men at risk of prostate cancer who have been advised to have a prostate biopsy",
                "criterions": [
                    {
                        "exact_snippets": "Men at risk of prostate cancer",
                        "criterion": "risk of prostate cancer",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "advised to have a prostate biopsy",
                        "criterion": "advice for prostate biopsy",
                        "requirement": {
                            "requirement_type": "advice",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Men at risk of prostate cancer",
                        "criterion": "risk of prostate cancer",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "advised to have a prostate biopsy",
                        "criterion": "advice for prostate biopsy",
                        "requirement": {
                            "requirement_type": "advice",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fit for general/spinal anesthesia",
                "criterions": [
                    {
                        "exact_snippets": "Fit for general/spinal anesthesia",
                        "criterion": "anesthesia fitness",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "general",
                                "spinal"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Fit for general/spinal anesthesia",
                        "criterion": "anesthesia fitness",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "general",
                                "spinal"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fit to undergo all protocol procedures including a transrectal ultrasound",
                "criterions": [
                    {
                        "exact_snippets": "Fit to undergo all protocol procedures",
                        "criterion": "fitness for protocol procedures",
                        "requirement": {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including a transrectal ultrasound",
                        "criterion": "fitness for transrectal ultrasound",
                        "requirement": {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Fit to undergo all protocol procedures",
                        "criterion": "fitness for protocol procedures",
                        "requirement": {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including a transrectal ultrasound",
                        "criterion": "fitness for transrectal ultrasound",
                        "requirement": {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of a urinary tract infection",
                        "criterion": "urinary tract infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of acute prostatitis within the past 3 months",
                        "criterion": "acute prostatitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of a urinary tract infection",
                        "criterion": "urinary tract infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "history of acute prostatitis within the past 3 months",
                            "criterion": "acute prostatitis",
                            "requirement": {
                                "requirement_type": "history",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 3,
                                    "unit": "months"
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No other medical condition precluding procedures described in the protocol",
                "criterions": [
                    {
                        "exact_snippets": "No other medical condition precluding procedures",
                        "criterion": "other medical condition",
                        "requirement": {
                            "requirement_type": "impact on procedures",
                            "expected_value": "not precluding"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No other medical condition precluding procedures",
                        "criterion": "other medical condition",
                        "requirement": {
                            "requirement_type": "impact on procedures",
                            "expected_value": "not precluding"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
                "criterions": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)",
                "criterions": [
                    {
                        "exact_snippets": "No prior prostate biopsy",
                        "criterion": "prior prostate biopsy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... prostate surgery",
                        "criterion": "prior prostate surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... treatment for prostate cancer",
                        "criterion": "prior treatment for prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No prior prostate biopsy",
                                "criterion": "prior prostate biopsy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No prior ... prostate surgery",
                                "criterion": "prior prostate surgery",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No prior ... treatment for prostate cancer",
                                "criterion": "prior treatment for prostate cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Suspected stage ≤ T2 on rectal examination (organ confined)",
                "criterions": [
                    {
                        "exact_snippets": "Suspected stage ≤ T2 on rectal examination",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "suspected stage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "T"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(organ confined)",
                        "criterion": "tumor confinement",
                        "requirement": {
                            "requirement_type": "confinement",
                            "expected_value": "organ confined"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Suspected stage \u0010 T2 on rectal examination",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "suspected stage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "T"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(organ confined)",
                        "criterion": "tumor confinement",
                        "requirement": {
                            "requirement_type": "confinement",
                            "expected_value": "organ confined"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum PSA ≤ 15 ng/mL within the past 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Serum PSA ≤ 15 ng/mL",
                        "criterion": "serum PSA",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "ng/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within the past 3 months",
                        "criterion": "serum PSA measurement time frame",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 3 months"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum PSA \u0010 15 ng/mL",
                        "criterion": "serum PSA",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "ng/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within the past 3 months",
                        "criterion": "serum PSA measurement time frame",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 3 months"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)",
                "criterions": [
                    {
                        "exact_snippets": "contraindication to MRI",
                        "criterion": "MRI contraindication",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "claustrophobia",
                        "criterion": "claustrophobia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "pacemaker",
                        "criterion": "pacemaker",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "estimated GFR ≤ 50",
                        "criterion": "estimated GFR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "claustrophobia",
                                    "criterion": "claustrophobia",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "pacemaker",
                                    "criterion": "pacemaker",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "estimated GFR ≤ 50",
                                    "criterion": "estimated GFR",
                                    "requirement": {
                                        "requirement_type": "value",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 50,
                                            "unit": "N/A"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior hip replacement surgery",
                "criterions": [
                    {
                        "exact_snippets": "No prior hip replacement surgery",
                        "criterion": "hip replacement surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No prior hip replacement surgery",
                    "criterion": "hip replacement surgery",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ]
}