{
"info": {
"nct_id": "NCT02415257",
"official_title": "Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function",
"inclusion_criteria": "* Vestibular schwannoma advised to surgical treatment\n* No measurable remaining vestibular function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* impaired decision making\n* neurofibromatosis\n* signs for central dysfunction\n* remaining vestibular function\n* Patients are advised not to participate in the gentamicin arm if\n* hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%\n* the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Vestibular schwannoma advised to surgical treatment",
"criterions": [
{
"exact_snippets": [
"Vestibular schwannoma"
],
"criterion": "vestibular schwannoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"advised to surgical treatment"
],
"criterion": "surgical treatment",
"requirement_type": "recommendation",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Vestibular schwannoma"
],
"criterion": "vestibular schwannoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"advised to surgical treatment"
],
"criterion": "surgical treatment",
"requirement_type": "recommendation",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* No measurable remaining vestibular function",
"criterions": [
{
"exact_snippets": [
"No measurable remaining vestibular function"
],
"criterion": "vestibular function",
"requirement_type": "quantity",
"expected_value": false
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"No measurable remaining vestibular function"
],
"criterion": "vestibular function",
"requirement_type": "quantity",
"expected_value": false
}
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowance",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowance",
"expected_value": true
}
]
}
},
{
"identified_line": {
"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
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* impaired decision making",
"criterions": [
{
"exact_snippets": [
"impaired decision making"
],
"criterion": "decision making",
"requirement_type": "impairment",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"impaired decision making"
],
"criterion": "decision making",
"requirement_type": "impairment",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* neurofibromatosis",
"criterions": [
{
"exact_snippets": [
"neurofibromatosis"
],
"criterion": "neurofibromatosis",
"requirement_type": "presence",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"neurofibromatosis"
],
"criterion": "neurofibromatosis",
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* signs for central dysfunction",
"criterions": [
{
"exact_snippets": [
"signs for central dysfunction"
],
"criterion": "central dysfunction",
"requirement_type": "signs",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"signs for central dysfunction"
],
"criterion": "central dysfunction",
"requirement_type": "signs",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* remaining vestibular function",
"criterions": [
{
"exact_snippets": [
"remaining vestibular function"
],
"criterion": "vestibular function",
"requirement_type": "presence",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"remaining vestibular function"
],
"criterion": "vestibular function",
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Patients are advised not to participate in the gentamicin arm if",
"criterions": [
{
"exact_snippets": [
"Patients are advised not to participate in the gentamicin arm"
],
"criterion": "gentamicin arm participation",
"requirement_type": "advisability",
"expected_value": false
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Patients are advised not to participate in the gentamicin arm"
],
"criterion": "gentamicin arm participation",
"requirement_type": "advisability",
"expected_value": false
}
}
},
{
"identified_line": {
"line": "* hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%",
"criterions": [
{
"exact_snippets": [
"hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz)"
],
"criterion": "hearing",
"requirement_type": "pure tone average",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 30
}
]
}
},
{
"exact_snippets": [
"speech discrimination better than 70%"
],
"criterion": "speech discrimination",
"requirement_type": "percentage",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 70
}
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz)"
],
"criterion": "hearing",
"requirement_type": "pure tone average",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 30
}
]
}
},
{
"exact_snippets": [
"speech discrimination better than 70%"
],
"criterion": "speech discrimination",
"requirement_type": "percentage",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 70
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss",
"criterions": [
{
"exact_snippets": [
"hearing preservation surgery"
],
"criterion": "hearing preservation surgery",
"requirement_type": "aim",
"expected_value": true
},
{
"exact_snippets": [
"gentamicin associated hearing loss"
],
"criterion": "gentamicin associated hearing loss",
"requirement_type": "risk",
"expected_value": false
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": [
"hearing preservation surgery"
],
"criterion": "hearing preservation surgery",
"requirement_type": "aim",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": [
"gentamicin associated hearing loss"
],
"criterion": "gentamicin associated hearing loss",
"requirement_type": "risk",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}