[96a5a0]: / output / allTrials / logical / NCT01668082_logical.json

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{
"info": {
"nct_id": "NCT01668082",
"official_title": "An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection",
"inclusion_criteria": "* Male or female, any age and any racial or ethnic group\n* Spanish-speaking patients will be eligible\n* Pre-operative brain MR imaging suggestive of a brain tumor or pre-operative imaging showing a tumor or biopsy of a tumor mass prior to planned resection of the mass\n* Patient able and willing to provide informed consent or Legal parent or guardian willing and able to provide informed consent for patient under age 18.\n* Karnofsky Performance status > 70%\n* Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient or legal parent/guardian unable to provide informed consent\n* Karnofsky Performance status < 70%\n* Patients who are claustrophobic or have other contraindications to MRI, such as impanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants\n* NYHA class III and IV congestive heart failure\n* Psychiatric or addictive disorders that preclude obtaining informed consent\n* Unstable angina\n* Pregnant or lactating women\n* Women of childbearing potential who refuse a pregnancy test (performed during screening)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Male or female, any age and any racial or ethnic group",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
},
{
"exact_snippets": "any age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": []
}
}
},
{
"exact_snippets": "any racial or ethnic group",
"criterion": "racial or ethnic group",
"requirement": {
"requirement_type": "presence",
"expected_value": "any"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
},
{
"exact_snippets": "any racial or ethnic group",
"criterion": "racial or ethnic group",
"requirement": {
"requirement_type": "presence",
"expected_value": "any"
}
}
]
},
{
"exact_snippets": "any age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": []
}
}
}
]
}
},
{
"identified_line": {
"line": "* Spanish-speaking patients will be eligible",
"criterions": [
{
"exact_snippets": "Spanish-speaking patients",
"criterion": "language",
"requirement": {
"requirement_type": "language",
"expected_value": "Spanish"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Spanish-speaking patients",
"criterion": "language",
"requirement": {
"requirement_type": "language",
"expected_value": "Spanish"
}
}
]
}
},
{
"identified_line": {
"line": "* Pre-operative brain MR imaging suggestive of a brain tumor or pre-operative imaging showing a tumor or biopsy of a tumor mass prior to planned resection of the mass",
"criterions": [
{
"exact_snippets": "Pre-operative brain MR imaging suggestive of a brain tumor",
"criterion": "brain tumor",
"requirement": {
"requirement_type": "suggestive imaging",
"expected_value": true
}
},
{
"exact_snippets": "pre-operative imaging showing a tumor",
"criterion": "tumor",
"requirement": {
"requirement_type": "imaging evidence",
"expected_value": true
}
},
{
"exact_snippets": "biopsy of a tumor mass",
"criterion": "tumor mass",
"requirement": {
"requirement_type": "biopsy",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pre-operative brain MR imaging suggestive of a brain tumor",
"criterion": "brain tumor",
"requirement": {
"requirement_type": "suggestive imaging",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "pre-operative imaging showing a tumor",
"criterion": "tumor",
"requirement": {
"requirement_type": "imaging evidence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "biopsy of a tumor mass",
"criterion": "tumor mass",
"requirement": {
"requirement_type": "biopsy",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient able and willing to provide informed consent or Legal parent or guardian willing and able to provide informed consent for patient under age 18.",
"criterions": [
{
"exact_snippets": "Patient able and willing to provide informed consent",
"criterion": "patient consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Patient able and willing to provide informed consent",
"criterion": "patient consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "applicability",
"expected_value": "patient under age 18"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patient able and willing to provide informed consent",
"criterion": "patient consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Patient able and willing to provide informed consent",
"criterion": "patient consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"not_criteria": {
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "applicability",
"expected_value": "patient under age 18"
}
}
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Legal parent or guardian willing and able to provide informed consent for patient under age 18",
"criterion": "parent/guardian consent for minors",
"requirement": {
"requirement_type": "applicability",
"expected_value": "patient under age 18"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky Performance status > 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance status > 70%",
"criterion": "Karnofsky Performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky Performance status > 70%",
"criterion": "Karnofsky Performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control",
"criterions": [
{
"exact_snippets": "Negative serum pregnancy test",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "child bearing potential terminated by surgery, radiation, menopause",
"criterion": "child bearing potential",
"requirement": {
"requirement_type": "status",
"expected_value": "terminated"
}
},
{
"exact_snippets": "current use of two approved methods of birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "methods"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Negative serum pregnancy test",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "current use of two approved methods of birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "methods"
}
}
}
]
},
{
"exact_snippets": "child bearing potential terminated by surgery, radiation, menopause",
"criterion": "child bearing potential",
"requirement": {
"requirement_type": "status",
"expected_value": "terminated"
}
}
]
}
},
{
"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 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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patient or legal parent/guardian unable to provide informed consent",
"criterions": [
{
"exact_snippets": "Patient or legal parent/guardian unable to provide informed consent",
"criterion": "ability to provide informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patient or legal parent/guardian unable to provide informed consent",
"criterion": "ability to provide informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Karnofsky Performance status < 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance status < 70%",
"criterion": "Karnofsky Performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky Performance status < 70%",
"criterion": "Karnofsky Performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are claustrophobic or have other contraindications to MRI, such as impanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants",
"criterions": [
{
"exact_snippets": "claustrophobic",
"criterion": "claustrophobia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "contraindications to MRI",
"criterion": "contraindications to MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "impanted pacemaker device",
"criterion": "implanted pacemaker device",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "vascular clips",
"criterion": "vascular clips",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "surgical clips",
"criterion": "surgical clips",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "prosthetic valves",
"criterion": "prosthetic valves",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pacemakers",
"criterion": "pacemakers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "otologic implants",
"criterion": "otologic implants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "claustrophobic",
"criterion": "claustrophobia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "contraindications to MRI",
"criterion": "contraindications to MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "impanted pacemaker device",
"criterion": "implanted pacemaker device",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "vascular clips",
"criterion": "vascular clips",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "surgical clips",
"criterion": "surgical clips",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "prosthetic valves",
"criterion": "prosthetic valves",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pacemakers",
"criterion": "pacemakers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "otologic implants",
"criterion": "otologic implants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* NYHA class III and IV congestive heart failure",
"criterions": [
{
"exact_snippets": "NYHA class III and IV congestive heart failure",
"criterion": "NYHA class",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "NYHA class III and IV congestive heart failure",
"criterion": "NYHA class",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Unstable angina",
"criterions": [
{
"exact_snippets": "Unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Women of childbearing potential who refuse a pregnancy test (performed during screening)",
"criterions": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "refuse a pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "refusal",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "refuse a pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "refusal",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Psychiatric or addictive disorders that preclude obtaining informed consent",
"criterions": [
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "psychiatric disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "addictive disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "psychiatric disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "obtaining informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "addictive disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Psychiatric or addictive disorders",
"criterion": "obtaining informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Pregnant or lactating women",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}