[96a5a0]: / output / allTrials / identified / NCT01292291_identified.json

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{
"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": [
{
"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"
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"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",
"requirements": [
{
"requirement_type": "risk",
"expected_value": true
}
]
},
{
"exact_snippets": "advised to have a prostate biopsy",
"criterion": "advice for prostate biopsy",
"requirements": [
{
"requirement_type": "advice",
"expected_value": true
}
]
}
]
},
{
"line": "* Suspected stage ≤ T2 on rectal examination (organ confined)",
"criterions": [
{
"exact_snippets": "Suspected stage ≤ T2 on rectal examination",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "suspected stage",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "T"
}
}
]
},
{
"exact_snippets": "(organ confined)",
"criterion": "tumor confinement",
"requirements": [
{
"requirement_type": "confinement",
"expected_value": "organ confined"
}
]
}
]
},
{
"line": "* Serum PSA ≤ 15 ng/mL within the past 3 months",
"criterions": [
{
"exact_snippets": "Serum PSA ≤ 15 ng/mL",
"criterion": "serum PSA",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 15,
"unit": "ng/mL"
}
}
]
},
{
"exact_snippets": "within the past 3 months",
"criterion": "serum PSA measurement time frame",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within the past 3 months"
}
]
}
]
},
{
"line": "* Fit for general/spinal anesthesia",
"criterions": [
{
"exact_snippets": "Fit for general/spinal anesthesia",
"criterion": "anesthesia fitness",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"general",
"spinal"
]
}
]
}
]
},
{
"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",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": true
}
]
},
{
"exact_snippets": "including a transrectal ultrasound",
"criterion": "fitness for transrectal ultrasound",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": true
}
]
}
]
},
{
"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",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "history of acute prostatitis within the past 3 months",
"criterion": "acute prostatitis",
"requirements": [
{
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)",
"criterions": [
{
"exact_snippets": "contraindication to MRI",
"criterion": "MRI contraindication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "claustrophobia",
"criterion": "claustrophobia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "pacemaker",
"criterion": "pacemaker",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "estimated GFR ≤ 50",
"criterion": "estimated GFR",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 50,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* No other medical condition precluding procedures described in the protocol",
"criterions": [
{
"exact_snippets": "No other medical condition precluding procedures",
"criterion": "other medical condition",
"requirements": [
{
"requirement_type": "impact on procedures",
"expected_value": "not precluding"
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"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",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... prostate surgery",
"criterion": "prior prostate surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... treatment for prostate cancer",
"criterion": "prior treatment for prostate cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No prior hip replacement surgery",
"criterions": [
{
"exact_snippets": "No prior hip replacement surgery",
"criterion": "hip replacement surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
}
]
}