[96a5a0]: / output / allTrials / identified / NCT00059020_identified.json

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{
"info": {
"nct_id": "NCT00059020",
"official_title": "EGF Polymorphisms and Gliomagenesis",
"inclusion_criteria": "Healthy volunteers allowed",
"exclusion_criteria": "",
"miscellaneous_criteria": "INCLUSION CRITERIA:\n\nRadiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with known primary neoplasms of the CNS.\n\nMedically indicated diagnostic and/or therapeutic tumor resection.\n\nInformed consent from patient, age 18 or older to 75 years of age.\n\nFemales of child-bearing capacity: Pregnant women will be entered into the study for tumor collection, but blood will not be drawn at the time of surgery. Six weeks or more after the completion of pregnancy, these women will be contacted and 10cc (2 tsp) of blood will be collected for genotyping.\n\nNo racial or ethnic group or gender is excluded.\n\nEXCLUSION CRITERIA:\n\nInability to provide informed consent prior to surgery.\n\nMedical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery."
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with known primary neoplasms of the CNS.",
"criterions": [
{
"exact_snippets": "Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV)",
"criterion": "primary glial neoplasm of the CNS",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": "radiographic"
},
{
"requirement_type": "WHO grade",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "any patient with known primary neoplasms of the CNS",
"criterion": "primary neoplasms of the CNS",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Medically indicated diagnostic and/or therapeutic tumor resection.",
"criterions": [
{
"exact_snippets": "Medically indicated diagnostic and/or therapeutic tumor resection.",
"criterion": "tumor resection",
"requirements": [
{
"requirement_type": "indication",
"expected_value": [
"diagnostic",
"therapeutic"
]
}
]
}
]
},
{
"line": "Informed consent from patient, age 18 or older to 75 years of age.",
"criterions": [
{
"exact_snippets": "Informed consent from patient",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "age 18 or older to 75 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "Females of child-bearing capacity: Pregnant women will be entered into the study for tumor collection, but blood will not be drawn at the time of surgery. Six weeks or more after the completion of pregnancy, these women will be contacted and 10cc (2 tsp) of blood will be collected for genotyping.",
"criterions": [
{
"exact_snippets": "Females of child-bearing capacity",
"criterion": "gender and reproductive status",
"requirements": [
{
"requirement_type": "gender",
"expected_value": "female"
},
{
"requirement_type": "reproductive status",
"expected_value": "child-bearing capacity"
}
]
},
{
"exact_snippets": "Pregnant women will be entered into the study",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "pregnant"
}
]
},
{
"exact_snippets": "blood will not be drawn at the time of surgery",
"criterion": "blood draw timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "not at the time of surgery"
}
]
},
{
"exact_snippets": "Six weeks or more after the completion of pregnancy",
"criterion": "post-pregnancy period",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "10cc (2 tsp) of blood will be collected for genotyping",
"criterion": "blood collection for genotyping",
"requirements": [
{
"requirement_type": "volume",
"expected_value": {
"operator": "=",
"value": 10,
"unit": "cc"
}
}
]
}
]
},
{
"line": "No racial or ethnic group or gender is excluded.",
"criterions": [
{
"exact_snippets": "No racial or ethnic group ... is excluded.",
"criterion": "racial or ethnic group",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": false
}
]
},
{
"exact_snippets": "No ... gender is excluded.",
"criterion": "gender",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": false
}
]
}
]
},
{
"line": "Inability to provide informed consent prior to surgery.",
"criterions": [
{
"exact_snippets": "Inability to provide informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.",
"criterions": [
{
"exact_snippets": "Medical conditions that cannot be corrected prior to surgery",
"criterion": "medical conditions",
"requirements": [
{
"requirement_type": "correctability",
"expected_value": false
}
]
},
{
"exact_snippets": "standard contraindications for neurosurgery",
"criterion": "standard contraindications for neurosurgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "INCLUSION CRITERIA:",
"criterions": []
},
{
"line": "EXCLUSION CRITERIA:",
"criterions": []
}
]
}