Nctid:
NCT06230419
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002543", "term"=>"Cerebral Hemorrhage"}, {"id"=>"D000006470", "term"=>"Hemorrhage"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020300", "term"=>"Intracranial Hemorrhages"}, {"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M9556", "name"=>"Hemorrhage", "asFound"=>"Hemorrhage", "relevance"=>"HIGH"}, {"id"=>"M5792", "name"=>"Cerebral Hemorrhage", "asFound"=>"Cerebral Hemorrhage", "relevance"=>"HIGH"}, {"id"=>"M22113", "name"=>"Intracranial Hemorrhages", "relevance"=>"LOW"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>208}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2023-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-02-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The identification completeness of the annotated images.", "timeFrame"=>"1 months", "description"=>"Use Photoshop to calculate the area of hemorrhage and the marked area, and then computing the ratio, import into Graphpad Prism for further analysis of the mean percentage and the standard deviation."}], "secondaryOutcomes"=>[{"measure"=>"The evaluations from professionals for outcomes produced by AIs", "timeFrame"=>"1 months", "description"=>"The outputs will be evaluated by professional radiologists on a 4-point scale questionnaire from the completeness, accuracy and success of the annotation. Then the results of the questionnaire will be further analyzed in the Graphpad Prism to get the average score and the standard deviation."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Artificial Intelligence", "Computed Tomography"], "conditions"=>["Cerebral Hemorrhage"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational retrospective study is to evaluate artificial intelligences (AI)'s proficiency in identifying and annotating brain bleeds in computed tomography (CT) images.\n\nThe main questions it aims to answer are:\n\n* Whether AIs at present are capable of analyzing and recognizing cerebral traumas in CT images?\n* If they are, how competent are they and how can humans take advantages of that? CT images were selected during the normal diagnosis and treatment process of patients, and no one needed to undergo any additional procedures connected to the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"92 years", "minimumAge"=>"16 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"The study population ranges from 16 years old to 92 years old, both female and male, who mostly are the elderly.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* People who had cerebral traumas with brain bleedings shown in CT images.\n\nExclusion Criteria:\n\n* Brain bleedings were not clear or representative in CT images."}, "identificationModule"=>{"nctId"=>"NCT06230419", "briefTitle"=>"Retrospective Study on the Direction of Artificial Intelligence in Identifying Cranial Trauma CT Imaging", "organization"=>{"class"=>"OTHER", "fullName"=>"RenJi Hospital"}, "officialTitle"=>"Evaluation of Artificial Intelligence's Ability to Analyze and Recognize Cranial Trauma CT Imaging", "orgStudyIdInfo"=>{"id"=>"83760142"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"The cerebral trauma group"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"201114", "city"=>"Shanghai", "state"=>"Shanghai", "country"=>"China", "facility"=>"Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"RenJi Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of Brain Injury Center", "investigatorFullName"=>"Junfeng Feng", "investigatorAffiliation"=>"RenJi Hospital"}}}}
