{
    "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": [
        {
            "line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer",
            "criterions": [
                {
                    "exact_snippets": "Disease free",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "disease free"
                        }
                    ]
                },
                {
                    "exact_snippets": "adult",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "survivors of oropharyngeal cancer",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "oropharyngeal cancer"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "survivor"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "disease status per surveillance imaging and clinical surveillance",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": [
                                "surveillance imaging",
                                "clinical surveillance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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)",
            "criterions": [
                {
                    "exact_snippets": "Late radiation-associated lower cranial neuropathy of XII",
                    "criterion": "lower cranial neuropathy of XII",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "late radiation-associated"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without X nerve",
                    "criterion": "X nerve involvement",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "demonstration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to return for assessment post-steroid therapy",
                    "criterion": "willingness and ability to return for assessment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "simplified Chinese",
                                "Filipino",
                                "Greek",
                                "Japanese",
                                "Korean",
                                "Russian",
                                "Spanish",
                                "Taiwanese"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer",
            "criterions": [
                {
                    "exact_snippets": "Disease-free",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "disease-free"
                        }
                    ]
                },
                {
                    "exact_snippets": "adult",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "survivors of head and neck cancer",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "head and neck cancer"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "disease status per surveillance imaging and clinical surveillance",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": [
                                "surveillance imaging",
                                "clinical surveillance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without X nerve",
                    "criterion": "X nerve involvement",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "demonstration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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)",
                    "criterion": "ability to complete symptom survey",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "simplified Chinese",
                                "Filipino",
                                "Greek",
                                "Japanese",
                                "Korean",
                                "Russian",
                                "Spanish",
                                "Taiwanese"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic > 160; diastolic > 90)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic > 160",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic > 90",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer",
            "criterions": [
                {
                    "exact_snippets": "Known gastrointestinal ulcer",
                    "criterion": "gastrointestinal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis",
            "criterions": [
                {
                    "exact_snippets": "History of psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture",
            "criterions": [
                {
                    "exact_snippets": "Untreated or treatment refractory obstructive pharyngoesophageal stricture",
                    "criterion": "obstructive pharyngoesophageal stricture",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "untreated",
                                "treatment refractory"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic > 160; diastolic > 90)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (systolic > 160; diastolic > 90)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer",
            "criterions": [
                {
                    "exact_snippets": "Known gastrointestinal ulcer",
                    "criterion": "gastrointestinal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis",
            "criterions": [
                {
                    "exact_snippets": "History of psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture",
            "criterions": [
                {
                    "exact_snippets": "Untreated or treatment refractory obstructive pharyngoesophageal stricture",
                    "criterion": "obstructive pharyngoesophageal stricture",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "untreated",
                                "treatment refractory"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "history or diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}