{
"info": {
"nct_id": "NCT04151082",
"official_title": "Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: a Phase I/II Dose Finding Trial and Data Registry",
"inclusion_criteria": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy >= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck [MDASI-HN]) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer\n* INCLUSION CRITERIA FOR REGISTRY: >= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR REGISTRY: Late lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic > 160; diastolic > 90)\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic > 160; diastolic > 90)\n* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis\n* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women\n* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer",
"criterions": [
{
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"criterion": "disease status",
"requirement": {
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{
"exact_snippets": "adult",
"criterion": "age group",
"requirement": {
"requirement_type": "group",
"expected_value": "adult"
}
},
{
"exact_snippets": "survivors of oropharyngeal cancer",
"criterion": "cancer history",
"requirement": {
"requirement_type": "type",
"expected_value": "oropharyngeal cancer"
}
},
{
"exact_snippets": "survivors of oropharyngeal cancer",
"criterion": "cancer history",
"requirement": {
"requirement_type": "status",
"expected_value": "survivor"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Disease free",
"criterion": "disease status",
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},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy >= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)",
"criterions": [
{
"exact_snippets": "Treated with radiotherapy >= 2 years post treatment",
"criterion": "radiotherapy treatment duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
},
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"value": 2,
"unit": "years"
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},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)",
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{
"exact_snippets": "Late radiation-associated lower cranial neuropathy of XII",
"criterion": "lower cranial neuropathy of XII",
"requirement": {
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"expected_value": "late radiation-associated"
}
},
{
"exact_snippets": "with or without X nerve",
"criterion": "X nerve involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
},
{
"exact_snippets": "imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source",
"criterion": "structural or malignant source",
"requirement": {
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"expected_value": false
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Late radiation-associated lower cranial neuropathy of XII",
"criterion": "lower cranial neuropathy of XII",
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},
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"exact_snippets": "with or without X nerve",
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}
},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy",
"criterions": [
{
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"criterion": "willingness and ability to return for assessment",
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"expected_value": true
}
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"expected_value": true
}
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}
},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck [MDASI-HN]) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese",
"criterions": [
{
"exact_snippets": "Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck [MDASI-HN])",
"criterion": "ability to complete symptom survey",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese",
"criterion": "language proficiency",
"requirement": {
"requirement_type": "languages",
"expected_value": [
"English",
"simplified Chinese",
"Filipino",
"Greek",
"Japanese",
"Korean",
"Russian",
"Spanish",
"Taiwanese"
]
}
}
]
},
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"requirement": {
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"expected_value": true
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},
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"Korean",
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"Taiwanese"
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}
}
]
}
},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer",
"criterions": [
{
"exact_snippets": "Disease-free",
"criterion": "disease status",
"requirement": {
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"expected_value": "disease-free"
}
},
{
"exact_snippets": "adult",
"criterion": "age group",
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"expected_value": "adult"
}
},
{
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"criterion": "cancer history",
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}
}
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}
},
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"criterion": "age group",
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}
}
]
}
},
{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR REGISTRY: >= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)",
"criterions": [
{
"exact_snippets": "INCLUSION CRITERIA FOR REGISTRY: >= 2 years post treatment",
"criterion": "time since treatment",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
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"value": 2,
"unit": "years"
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"line": "* INCLUSION CRITERIA FOR REGISTRY: Late lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)",
"criterions": [
{
"exact_snippets": "Late lower cranial neuropathy of XII",
"criterion": "late lower cranial neuropathy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "with or without X nerve",
"criterion": "X nerve involvement",
"requirement": {
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"criterion": "structural or malignant source",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
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"and_criteria": [
{
"exact_snippets": "Late lower cranial neuropathy of XII",
"criterion": "late lower cranial neuropathy",
"requirement": {
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"expected_value": true
}
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"exact_snippets": "with or without X nerve",
"criterion": "X nerve involvement",
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}
}
}
]
}
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{
"identified_line": {
"line": "* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese",
"criterions": [
{
"exact_snippets": "Able to complete symptom survey (MDASI-HN)",
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"expected_value": true
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{
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"criterion": "language proficiency",
"requirement": {
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"expected_value": [
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"simplified Chinese",
"Filipino",
"Greek",
"Japanese",
"Korean",
"Russian",
"Spanish",
"Taiwanese"
]
}
}
]
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}
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{
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"criterion": "language proficiency",
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]
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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}
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}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
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"exact_snippets": "minimum age of 18 Years",
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"value": 18,
"unit": "Years"
}
}
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}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes",
"criterions": [
{
"exact_snippets": "Uncontrolled diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
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}
}
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}
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"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic > 160; diastolic > 90)",
"criterions": [
{
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
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"unit": "N/A"
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"exact_snippets": "diastolic > 90",
"criterion": "diastolic blood pressure",
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"unit": "N/A"
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"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer",
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"exact_snippets": "Known gastrointestinal ulcer",
"criterion": "gastrointestinal ulcer",
"requirement": {
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}
}
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"expected_value": false
}
}
}
},
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"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis",
"criterions": [
{
"exact_snippets": "History of psychosis",
"criterion": "psychosis",
"requirement": {
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"expected_value": true
}
}
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
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"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder",
"criterions": [
{
"exact_snippets": "Known history or diagnosis of bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
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"expected_value": true
}
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"exact_snippets": "Known history or diagnosis of bipolar disorder",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path",
"criterions": [
{
"exact_snippets": "History of surgery near hypoglossal nerve path",
"criterion": "surgery near hypoglossal nerve path",
"requirement": {
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes",
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{
"exact_snippets": "Uncontrolled diabetes",
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}
]
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Uncontrolled hypertension (systolic > 160; diastolic > 90)",
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"unit": "mmHg"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer",
"criterions": [
{
"exact_snippets": "Known gastrointestinal ulcer",
"criterion": "gastrointestinal ulcer",
"requirement": {
"requirement_type": "presence",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis",
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{
"exact_snippets": "History of psychosis",
"criterion": "psychosis",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
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}
}
}
},
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder",
"criterions": [
{
"exact_snippets": "Known history or diagnosis of bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "history or diagnosis",
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}
]
},
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}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture",
"criterions": [
{
"exact_snippets": "Untreated or treatment refractory obstructive pharyngoesophageal stricture",
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}
]
},
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{
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]
}
},
{
"identified_line": {
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}