[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"real-world-data\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:real-world-data":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100592890","caramel-retrospective-study-for-personalized-risk-assessment-of-cardiovascular-disease-in-menopausal-and-perimenopausal-women-using-real-world-data-100592890",false,"NCT06999317","CARAMEL: Retrospective Study for Personalized Risk Assessment of Cardiovascular Disease in Menopausal and Perimenopausal Women Using Real World Data","CARAMEL RS","Inclusion Criteria:\n\nSelf-identified as female in the electronic health record (EHR). Age between 40 and 60 years at the time of data collection\u002Findex date. Availability of at least 5-6 years of retrospective data in the EHR, depending on the research objective.\n\nAt least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range.\n\nFor imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range.\n\nFor signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up.\n\nExclusion Criteria:\n\nPrior diagnosis of cardiovascular disease before the observation window (only applicable to specific ROs, e.g., RO2, RO4).\n\nInsufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile).\n\nPatients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames).\n\nFor signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.","FEMALE","40 Years","60 Years",{"count":20,"type":21},1500000,"ESTIMATED","OBSERVATIONAL","This retrospective observational study, part of the EU-funded CARAMEL project, aims to develop and validate personalized cardiovascular disease (CVD) risk assessment models specifically designed for menopausal and perimenopausal women (ages 40-60). The study leverages Real World Data (RWD) collected from multiple international clinical partners, including electronic health records (EHR), diagnostic imaging data, and signal data.\n\nThe main objective is to improve the prediction of CVD precursors such as hypertension and dyslipidemia, as well as mid- and long-term risk of CVD events, through advanced artificial intelligence (AI) models. These models will be trained on multimodal data to capture complex, individualized risk trajectories that current risk calculators fail to address, particularly in women. Special focus is placed on under-researched, women-specific risk factors and their interactions with traditional predictors.\n\nThe study includes several research objectives: (1) predicting the onset of hypertension and dyslipidemia using EHR data; (2) modeling the long-term risk of fatal and non-fatal cardiovascular events and disease trajectories; (3) identifying novel imaging biomarkers from routine screening tests such as mammography, DXA, ultrasound, and cardiac MRI; (4) developing multimodal prediction models combining imaging and clinical data; (5) creating automated AI tools for imaging biomarker extraction; and (6) using signal data from cardiac devices to predict disease progression and events.\n\nThe study population consists of middle-aged women with retrospective data available across different health systems. The expected outcome is a validated set of stratified, personalized CVD risk models that can support targeted prevention strategies and enable more equitable, sex-specific care. This will contribute to reducing the burden of CVD in women and addressing critical gaps in early detection, clinical decision-making, and health policy.\n\nThis project has received funding from the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No 101156210.",[25,26,27,28],"Cardiovascular Risk Factors","Menopausal Women","Perimenopausal Women","Real World Data",[30,31,32,33,34,35,36,37],"Cardiovascular Disease","Cardiovascular risk factors","Menopausal women","Perimenopausal women","real world data","personalised prevention","computational modelling","women-specific risks","NOT_YET_RECRUITING","2026-01-13",{"date":41,"type":42},"2026-01-15","ACTUAL",{"date":44,"type":21},"2026-03-01",{"date":46,"type":21},"2028-04-30",{"name":48,"class":49},"Hospital Universitario Virgen Macarena","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100600180","clinical-and-radiographic-outcomes-of-the-jointmedica-custom-made-resurfacing-device-100600180","NCT07094139","Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device","Inclusion Criteria:\n\n* Age 21 or above at the time of the surgery.\n* Have had the JointMedica Custom-Made Hip Resurfacing device implanted between September 2020 to January 2025\n* Written informed consent given by subject\n\nExclusion Criteria:\n\n* There is no exclusion criteria for this study",true,"ALL","21 Years",{"count":60,"type":21},41,"The Custom Resurfacing (CR) Implants are indicated for use for the reduction or relief of pain and\u002For improved hip function all skeletally mature patients where a total joint replacement is indicated, and where there is no other suitable, commercially distributed device available.\n\nThe Resurfacing System is a metal-on-polyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.\n\nThe custom-Made Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component.\n\nThe goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis.\n\nThis study will assess the following endpoints:\n\n* The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up.\n* Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups.\n* Absence of subsequent surgical intervention at the acetabulum of there operated hip.\n* Absence of serious, device-related adverse events.\n* Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.",[63,28,64,65],"Healthy","Safety and Effectiveness","Patient Reported Outcome (PRO)",[67,68,69],"Custom-Made Hip Resurfacing","Hip Resurfacing","Hip Arthroplasty","2025-07-23",{"date":72,"type":42},"2025-07-30",{"date":74,"type":21},"2025-08",{"date":76,"type":21},"2026-12",{"name":78,"class":49},"JointMedica Inc.",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":5},"100599144","clinical-and-radiographic-outcomes-of-the-jointmedica-polymotion-resurfacing-phr-device-100599144","NCT07080671","Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device","Inclusion Criteria:\n\n* Age 21 or above at the time of the surgery.\n* Have had the Polymotion Hip Resurfacing (PHR) (implanted between September 2020 to January 2025\n* Written informed consent given by subject\n\nExclusion Criteria:\n\n* There is no exclusion criteria for this study",{"count":87,"type":21},105,"The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis.\n\nThis study will assess the following endpoints:\n\n* The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up.\n* Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups.\n* Absence of subsequent surgical intervention at the acetabulum of there operated hip.\n* Absence of serious, device-related adverse events.\n* Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.",[63,28,64,65],[91,92,93],"PHR","Polymotion Hip Resurfacing","Polymotion","2025-07-15",{"date":70,"type":42},{"date":97,"type":21},"2025-07-25",{"date":99,"type":21},"2026-12-31",{"name":78,"class":49}]