{
"info": {
"nct_id": "NCT01770340",
"official_title": "Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial",
"inclusion_criteria": "* Localized intermediate-risk or high-risk prostate cancer cT3\n* Gleason score ≥ 7 (3+4 and/or 4+3) and/or\n* PSA ≥ 20 ng/ml\n* intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* IIEF < 21\n* Operations in the past 6 months which could limit the erectile function\n* Erectile dysfunction in the history or current medication for erectile dysfunction\n* Current involvement in another comparable study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Localized intermediate-risk or high-risk prostate cancer cT3",
"criterions": [
{
"exact_snippets": [
"Localized intermediate-risk or high-risk prostate cancer"
],
"criterion": "prostate cancer",
"requirement_type": "risk level",
"expected_value": [
"intermediate-risk",
"high-risk"
]
},
{
"exact_snippets": [
"cT3"
],
"criterion": "clinical stage",
"requirement_type": "stage",
"expected_value": "cT3"
}
]
},
{
"line": "* Gleason score ≥ 7 (3+4 and/or 4+3) and/or",
"criterions": [
{
"exact_snippets": [
"Gleason score ≥ 7"
],
"criterion": "Gleason score",
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 7
}
]
}
}
]
},
{
"line": "* PSA ≥ 20 ng/ml",
"criterions": [
{
"exact_snippets": [
"PSA ≥ 20 ng/ml"
],
"criterion": "PSA",
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20
}
]
}
}
]
},
{
"line": "* intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).",
"criterions": [
{
"exact_snippets": [
"intact preoperative erectile function"
],
"criterion": "preoperative erectile function",
"requirement_type": "intact",
"expected_value": true
},
{
"exact_snippets": [
"IIEF ≥ 21"
],
"criterion": "IIEF",
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 21
}
]
}
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowance",
"expected_value": true
}
]
},
{
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": [
"Must be MALE"
],
"criterion": "gender",
"requirement_type": "specific value",
"expected_value": "male"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
],
"exclusion_lines": [
{
"line": "* IIEF < 21",
"criterions": [
{
"exact_snippets": [
"IIEF < 21"
],
"criterion": "IIEF",
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 21
}
]
}
}
]
},
{
"line": "* Operations in the past 6 months which could limit the erectile function",
"criterions": [
{
"exact_snippets": [
"Operations in the past 6 months"
],
"criterion": "operations",
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6
}
]
}
},
{
"exact_snippets": [
"limit the erectile function"
],
"criterion": "erectile function",
"requirement_type": "limitation",
"expected_value": true
}
]
},
{
"line": "* Erectile dysfunction in the history or current medication for erectile dysfunction",
"criterions": [
{
"exact_snippets": [
"Erectile dysfunction in the history"
],
"criterion": "erectile dysfunction",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"current medication for erectile dysfunction"
],
"criterion": "erectile dysfunction medication",
"requirement_type": "current use",
"expected_value": true
}
]
},
{
"line": "* Current involvement in another comparable study.",
"criterions": [
{
"exact_snippets": [
"Current involvement in another comparable study"
],
"criterion": "involvement in another study",
"requirement_type": "current status",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}