{
"info": {
"nct_id": "NCT00244894",
"official_title": "Acupuncture for Hot Flashes in Prostate Cancer Patients",
"inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of prostate cancer\n* Hot flash score ≥ 4 per day\n* Prior or concurrent treatment with 1 of the following :\n\n * Bilateral orchiectomy\n * Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy\n * Antiandrogen therapy\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No mental impairment\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior estrogen or progestational drugs\n\nSurgery\n\n* See Disease Characteristics\n* No prior placement of a pacemaker or other implantable electrical device\n\nOther\n\n* More than 4 weeks since prior gabapentin\n* No concurrent antidepressant drugs"
},
"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": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 120 Years",
"criterions": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
}
}
],
"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": "* Confirmed diagnosis of prostate cancer",
"criterions": [
{
"exact_snippets": "Confirmed diagnosis of prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Confirmed diagnosis of prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Hot flash score ≥ 4 per day",
"criterions": [
{
"exact_snippets": "Hot flash score ≥ 4 per day",
"criterion": "hot flash score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "per day"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hot flash score ≥ 4 per day",
"criterion": "hot flash score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "per day"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Prior or concurrent treatment with 1 of the following :",
"criterions": [
{
"exact_snippets": "Prior or concurrent treatment",
"criterion": "treatment",
"requirement": {
"requirement_type": "timing",
"expected_value": [
"prior",
"concurrent"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior or concurrent treatment",
"criterion": "treatment",
"requirement": {
"requirement_type": "timing",
"expected_value": [
"prior",
"concurrent"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Bilateral orchiectomy",
"criterions": [
{
"exact_snippets": "Bilateral orchiectomy",
"criterion": "bilateral orchiectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilateral orchiectomy",
"criterion": "bilateral orchiectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Antiandrogen therapy",
"criterions": [
{
"exact_snippets": "Antiandrogen therapy",
"criterion": "antiandrogen therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Antiandrogen therapy",
"criterion": "antiandrogen therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Performance status",
"criterions": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Renal",
"criterions": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No mental impairment",
"criterions": [
{
"exact_snippets": "No mental impairment",
"criterion": "mental impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No mental impairment",
"criterion": "mental impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"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": "Chemotherapy",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
}
},
{
"identified_line": {
"line": "* More than 4 weeks since prior estrogen or progestational drugs",
"criterions": [
{
"exact_snippets": "More than 4 weeks since prior estrogen or progestational drugs",
"criterion": "time since prior estrogen or progestational drugs",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 4 weeks since prior estrogen or progestational drugs",
"criterion": "time since prior estrogen or progestational drugs",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
}
},
{
"identified_line": {
"line": "* No prior placement of a pacemaker or other implantable electrical device",
"criterions": [
{
"exact_snippets": "No prior placement of a pacemaker",
"criterion": "pacemaker placement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior placement of ... other implantable electrical device",
"criterion": "implantable electrical device placement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No prior placement of a pacemaker",
"criterion": "pacemaker placement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior placement of ... other implantable electrical device",
"criterion": "implantable electrical device placement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* More than 4 weeks since prior gabapentin",
"criterions": [
{
"exact_snippets": "More than 4 weeks since prior gabapentin",
"criterion": "gabapentin",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 4 weeks since prior gabapentin",
"criterion": "gabapentin",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No concurrent antidepressant drugs",
"criterions": [
{
"exact_snippets": "No concurrent antidepressant drugs",
"criterion": "antidepressant drugs",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No concurrent antidepressant drugs",
"criterion": "antidepressant drugs",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Other",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Other",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy",
"criterions": [
{
"exact_snippets": "Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy",
"criterion": "GnRH therapy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"agonist",
"antagonist"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy",
"criterion": "GnRH therapy",
"requirement": {
"requirement_type": "type",
"expected_value": "agonist"
}
},
{
"exact_snippets": "Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy",
"criterion": "GnRH therapy",
"requirement": {
"requirement_type": "type",
"expected_value": "antagonist"
}
}
]
}
},
{
"identified_line": {
"line": "* No concurrent chemotherapy",
"criterions": [
{
"exact_snippets": "No concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}