[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545107":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":20,"armGroups":21,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":16,"id":63,"slug":16,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":16,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":16,"maxAge":16,"enrollmentInfo":69,"targetDuration":16,"studyType":72,"phases":16,"briefSummary":73,"conditions":74,"keywords":16,"overallStatus":46,"whyStopped":16,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"GramEye","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Advanced level of blood culture Gram stain analysis AI accuracy","Analyzing Gram-stained microscopic images of blood culture-positive specimens using AI and evaluating the accuracy of bacterial species estimation For example, classify GPC clusters as S. aureus or CNS.","Day1",{"measure":14,"description":15,"timeFrame":12},"Ordinary level of blood culture Gram stain analysis AI accuracy","Gram-stained microscopic images of blood culture-positive specimens are analyzed using AI, and bacteria are classified based on morphological classification.\n\nFor example, gram-positive cocci (GPC) are classified into gram-positive staphylococci (GCP clusters) and gram-positive streptococci (GPC chains).",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":18,"timePerspective":19,"maskingInfo":16},"CASE_ONLY","RETROSPECTIVE","Specimens for microbiological testing, such as Gram staining, ordered at the hospital.",[22],{"label":23,"type":16,"description":16,"interventionNames":24},"Groups providing specimens for development of Gram Stain analysis AI",[25],"Other: Sample collection without intervention",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":16},"OTHER","Sample collection without intervention","No Intervention",[23],[33],{"name":34,"affiliation":35,"role":36},"Satoshi Kutsuna, PhD, MD","Osaka University Medical Hospital","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":16,"email":42},"Tatsuya Yamada, M.D.","CONTACT","7028060149","tatsuya.yamada@grameye.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Osaka University Hospital","RECRUITING","Suita","Osaka","5650871","Japan","JP",{"type":53,"coordinates":54},"Point",[55,56],135.51567,34.76143,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":16,"phoneExt":16,"email":16},"Go Yamamoto",{"type":62,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100545107",false,"NCT06377592","Development and Accuracy Evaluation of Gram Staining Analysis AI","Inclusion Criteria:\n\n* Patients in whom a Gram stain test was ordered\n\nExclusion Criteria:\n\n* No exclusion criteria","ALL",{"count":70,"type":71},18000,"ESTIMATED","OBSERVATIONAL","The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI",[75],"Bacterial Infections","2024-04-17",{"date":78,"type":79},"2024-04-22","ACTUAL",{"date":81,"type":79},"2023-05-10",{"date":83,"type":71},"2027-03-31",{"name":5,"class":6},1]