{
"info": {
"nct_id": "NCT02334722",
"official_title": "A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial",
"inclusion_criteria": "* Adult (>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves.\n* Able to be randomized prior to or up to 48 hours after surgery.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* No known history of seizure activity.\n* Pregnant or breastfeeding.\n* Renal dysfunction (CrCl < 30ml/min).\n* Beck's Depression Inventory (BDI) ≥14\n* Allergy to levetiracetam.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Adult (>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves.",
"criterions": [
{
"exact_snippets": [
"Adult (>18 years of age and older)"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 18
}
]
}
},
{
"exact_snippets": [
"undergone surgical resection or biopsy of a supratentorial brain tumor"
],
"criterion": "surgical resection or biopsy",
"requirement_type": "procedure",
"expected_value": true
},
{
"exact_snippets": [
"supratentorial brain tumor"
],
"criterion": "supratentorial brain tumor",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"able to consent for themselves"
],
"criterion": "ability to consent",
"requirement_type": "capability",
"expected_value": true
}
]
},
{
"line": "* Able to be randomized prior to or up to 48 hours after surgery.",
"criterions": [
{
"exact_snippets": [
"Able to be randomized prior to or up to 48 hours after surgery"
],
"criterion": "randomization",
"requirement_type": "timing",
"expected_value": "prior to or up to 48 hours after surgery"
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"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": "* No known history of seizure activity.",
"criterions": [
{
"exact_snippets": [
"No known history of seizure activity"
],
"criterion": "seizure activity",
"requirement_type": "history",
"expected_value": false
}
]
},
{
"line": "* Pregnant or breastfeeding.",
"criterions": [
{
"exact_snippets": [
"Pregnant"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": true
},
{
"exact_snippets": [
"breastfeeding"
],
"criterion": "breastfeeding",
"requirement_type": "status",
"expected_value": true
}
]
},
{
"line": "* Renal dysfunction (CrCl < 30ml/min).",
"criterions": [
{
"exact_snippets": [
"Renal dysfunction"
],
"criterion": "renal function",
"requirement_type": "status",
"expected_value": "dysfunction"
},
{
"exact_snippets": [
"CrCl < 30ml/min"
],
"criterion": "creatinine clearance",
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 30
}
}
]
},
{
"line": "* Beck's Depression Inventory (BDI) ≥14",
"criterions": [
{
"exact_snippets": [
"Beck's Depression Inventory (BDI) ≥14"
],
"criterion": "Beck's Depression Inventory (BDI)",
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 14
}
]
}
}
]
},
{
"line": "* Allergy to levetiracetam.",
"criterions": [
{
"exact_snippets": [
"Allergy to levetiracetam"
],
"criterion": "levetiracetam",
"requirement_type": "allergy",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}