Nctid:
NCT06221215
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001930", "term"=>"Brain Injuries"}, {"id"=>"D000070642", "term"=>"Brain Injuries, Traumatic"}, {"id"=>"D000002543", "term"=>"Cerebral Hemorrhage"}, {"id"=>"D000014474", "term"=>"Unconsciousness"}, {"id"=>"D000006470", "term"=>"Hemorrhage"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020300", "term"=>"Intracranial Hemorrhages"}, {"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000003244", "term"=>"Consciousness Disorders"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Injury", "relevance"=>"HIGH"}, {"id"=>"M5207", "name"=>"Brain Injuries", "asFound"=>"Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M628", "name"=>"Brain Injuries, Traumatic", "asFound"=>"Traumatic Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M9556", "name"=>"Hemorrhage", "asFound"=>"Hemorrhage", "relevance"=>"HIGH"}, {"id"=>"M5792", "name"=>"Cerebral Hemorrhage", "asFound"=>"Cerebral Hemorrhage", "relevance"=>"HIGH"}, {"id"=>"M17224", "name"=>"Unconsciousness", "asFound"=>"Loss of Consciousness", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}, {"id"=>"M22113", "name"=>"Intracranial Hemorrhages", "relevance"=>"LOW"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M6468", "name"=>"Consciousness Disorders", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M9912", "name"=>"Hydrocortisone", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M155245", "name"=>"Hydrocortisone 17-butyrate 21-propionate", "relevance"=>"LOW"}, {"id"=>"M228609", "name"=>"Hydrocortisone acetate", "relevance"=>"LOW"}, {"id"=>"M263259", "name"=>"Hydrocortisone hemisuccinate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}, "targetDuration"=>"2 Weeks", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-14", "studyFirstSubmitDate"=>"2023-12-30", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change of GH", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones (growth hormone) were measured in patients with TBI."}, {"measure"=>"Change of pituitary prolactin", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones (pituitary prolactin) were measured in patients with TBI."}, {"measure"=>"Change of ACTH", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones ( ACTH) were measured in patients with TBI."}, {"measure"=>"Change of cortisol", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones (cortisol) were measured in patients with TBI."}, {"measure"=>"Change of FSH", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones (FSH) were measured in patients with TBI."}, {"measure"=>"Change of thyroid hormone", "timeFrame"=>"1st, 7th and 14th day.", "description"=>"The levels of related hormones (thyroid hormone) were measured in patients with TBI."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Traumatic brain injury", "Cerebral hemorrhage", "hormone", "trauma"], "conditions"=>["Brain Injury Traumatic Diffuse With Loss of Consciousness"]}, "descriptionModule"=>{"briefSummary"=>"Our understanding of neurosecretory dysfunction after TBI is still insufficient, and the number of patients with neuroendocrine dysfunction caused by craniocerebral trauma may be underestimated, especially the neuroendocrine changes related to HPA axis in the early stage after craniocerebral trauma. Moreover, there are few and fragmentary literature data on the benefits of hormone replacement therapy in patients with neuroendocrine disorders after traumatic brain injury. This requires more studies to further determine the characteristics of pituitary function or hormone disorders in the early stage after traumatic brain injury, which makes it necessary for us to further study the neuroendocrine dysfunction (hormone disorder) in the early stage after craniocerebral injury. To explore the relationship between craniocerebral injury and early hormone disorder by measuring the changes of early hormone levels in patients with TBI is of great significance for the early detection of related complications after craniocerebral injury and the evaluation of the prognosis of patients with craniocerebral injury, and can provide a new diagnosis and treatment plan for early intervention of related complications after TBI."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Qualified inpatients hospitalized in our hospital", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. The patient was clearly diagnosed as craniocerebral injury.\n3. The Glasgow score on admission was 3-12 (moderate and severe).\n4. It has complete preclinical data.\n\nExclusion Criteria:\n\n1. Complicated with other severe visceral injuries or severe systemic fractures.\n2. Suffered from craniocerebral tumors, endocrine diseases, cardiovascular diseases, depression, sleep and mental disorders.\n3. In the past month, there are people who receive immune and hormone therapy.\n4. Women during pregnancy and lactation.\n5. Where there is a logical or common sense error in the data entered.\n6. The lack of too much clinical data related to this study."}, "identificationModule"=>{"nctId"=>"NCT06221215", "briefTitle"=>"Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage", "organization"=>{"class"=>"OTHER", "fullName"=>"General Hospital of Ningxia Medical University"}, "officialTitle"=>"Clinical Analysis of the Hormone Between Patients With Moderate and Severe Traumatic Brain Injury and Cerebral Hemorrhage", "orgStudyIdInfo"=>{"id"=>"GHNingxia"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Traumatic brain injury Group", "description"=>"The levels of related hormones (growth hormone, pituitary prolactin, ACTH, cortisol, FSH, thyroid hormone, etc.) were measured in patients with traumatic brain injury on the 1st, 7th and 14th day.", "interventionNames"=>["Procedure: trauma"]}, {"label"=>"Spontaneous cerebral hemorrhage roup", "description"=>"The levels of related hormones (growth hormone, pituitary prolactin, ACTH, cortisol, FSH, thyroid hormone, etc.) were measured in patients with spontaneous craniocerebral injury on the 1st, 7th and 14th day."}], "interventions"=>[{"name"=>"trauma", "type"=>"PROCEDURE", "description"=>"The main purpose of this study is to observe whether the early hormone changes and trends in the two groups of patients with or without trauma.", "armGroupLabels"=>["Traumatic brain injury Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"750004", "city"=>"Yinchuan", "state"=>"Ningxia", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Zhanfeng Niu, Doctor", "role"=>"CONTACT", "email"=>"niuzfeng228626@163.com", "phone"=>"13995297581"}], "facility"=>"The General Hospital of Ningxia Medical University", "geoPoint"=>{"lat"=>38.46806, "lon"=>106.27306}}], "centralContacts"=>[{"name"=>"Zhanfeng Niu, Doctor", "role"=>"CONTACT", "email"=>"niuzfeng228626@163.com", "phone"=>"+8613995297581"}], "overallOfficials"=>[{"name"=>"Zhanfeng Niu, Doctor", "role"=>"STUDY_DIRECTOR", "affiliation"=>"General Hospital of Ningxia Medical University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"General Hospital of Ningxia Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
