{
"info": {
"nct_id": "NCT03297125",
"official_title": "Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI",
"inclusion_criteria": "* Newly diagnosed glioblastoma (GBM), World Health Organization (WHO) grade IV.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Optune compliance < 75%; they would be excluded from the final analyses.\n* History of craniectomy or significant skull defect (contraindication to Optune).\n* Active implantable medical device (e.g., deep brain stimulator (DBS), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).\n* Karnofsky Performance Status (KPS) < 60.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
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"criterions": [
{
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],
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"requirement_type": "diagnosis status",
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},
{
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],
"criterion": "glioblastoma",
"requirement_type": "grade",
"expected_value": "World Health Organization (WHO) grade IV"
}
]
},
"logical_structure": {
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],
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{
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"requirement_type": "grade",
"expected_value": "World Health Organization (WHO) grade IV"
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": [
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],
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"requirement_type": "participation",
"expected_value": true
}
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},
"logical_structure": {
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},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
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"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18
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}
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},
"logical_structure": {
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"expected_value": {
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"value": 18
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}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Optune compliance < 75%; they would be excluded from the final analyses.",
"criterions": [
{
"exact_snippets": [
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],
"criterion": "Optune compliance",
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
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"operator": "<",
"value": 75
}
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}
}
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"logical_structure": {
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],
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"value": 75
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},
{
"identified_line": {
"line": "* History of craniectomy or significant skull defect (contraindication to Optune).",
"criterions": [
{
"exact_snippets": [
"History of craniectomy"
],
"criterion": "craniectomy",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"significant skull defect"
],
"criterion": "skull defect",
"requirement_type": "severity",
"expected_value": "significant"
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},
"logical_structure": {
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"expected_value": true
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{
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}
},
{
"identified_line": {
"line": "* Active implantable medical device (e.g., deep brain stimulator (DBS), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).",
"criterions": [
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"requirement_type": "presence",
"expected_value": true
},
{
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],
"criterion": "deep brain stimulator",
"requirement_type": "presence",
"expected_value": true
},
{
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"requirement_type": "presence",
"expected_value": true
},
{
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"criterion": "pacemaker",
"requirement_type": "presence",
"expected_value": true
},
{
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"criterion": "defibrillator",
"requirement_type": "presence",
"expected_value": true
},
{
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"criterion": "vagus nerve stimulator",
"requirement_type": "presence",
"expected_value": true
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{
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"criterion": "programmable shunt",
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"expected_value": true
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"expected_value": true
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"expected_value": true
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{
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"expected_value": true
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{
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"criterion": "defibrillator",
"requirement_type": "presence",
"expected_value": true
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{
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"criterion": "vagus nerve stimulator",
"requirement_type": "presence",
"expected_value": true
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{
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"criterion": "programmable shunt",
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"expected_value": true
}
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}
},
{
"identified_line": {
"line": "* Karnofsky Performance Status (KPS) < 60.",
"criterions": [
{
"exact_snippets": [
"Karnofsky Performance Status (KPS) < 60"
],
"criterion": "Karnofsky Performance Status",
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60
}
}
]
},
"logical_structure": {
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"Karnofsky Performance Status (KPS) < 60"
],
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"expected_value": {
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}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}