[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-disease-risk-factor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-disease-risk-factor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,81,124,161,188,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100640514","risk-prediction-scores-for-cardiotoxicity-in-cancer-patients-treated-with-cardiotoxic-anticancer-therapies-in-europe-100640514",false,"NCT07621289","Risk Prediction Scores for Cardiotoxicity in Cancer Patients Treated With Cardiotoxic Anticancer Therapies in Europe","EUCARTOXSCORES","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of cancer\n* Planned cardio-oncology follow-up as part of pre-treatment assessment prior to cardiotoxic anticancer therapy, as defined in the 2022 ESC Cardio-Oncology Guidelines\n\nExclusion Criteria:\n\n* Patients for whom 12-month follow-up is planned to be conducted outside the center that performed the baseline pre-treatment evaluation","ALL","18 Years",{"count":19,"type":20},10000,"ESTIMATED","OBSERVATIONAL","Cancer management has undergone major advances over the past 30 years. Several anticancer therapies are now highly effective, allowing many cancers to become chronic diseases through sequential lines of treatment. However, these therapies may be associated with severe cardiovascular adverse events.\n\nIt is therefore essential to better understand the factors that determine, for a given patient and a given anticancer therapy, the occurrence of cardiovascular toxicity, and ideally to predict which patients are at highest risk.\n\nThe 2022 ESC Cardio-Oncology Guidelines strongly recommend risk stratification prior to the initiation of cardiotoxic anticancer therapies. Current recommendations suggest the use of risk scores known as \"HFA-ICOS\" scores. However:\n\nNot all cardiotoxic anticancer therapies currently have an associated risk score; Existing scores are derived from small retrospective or prospective cohorts (typically fewer than 100 patients), and most have not undergone rigorous validation, leaving considerable room for improvement.\n\nThe EU-CARTOX-SCORES protocol aims to develop new prediction scores for cardiotoxicity occurring within the first year after initiation of cardiotoxic anticancer therapies. This protocol is innovative through the integration of artificial intelligence and\u002For machine learning approaches alongside conventional statistical methods. These models will be interfaced with a dedicated cardio-oncology digital platform (CardioOncoPilot), currently being deployed across the European Union, ensuring standardized and high-quality data collection within routine clinical care.\n\nThis is a prospective, multicenter, observational study designed as a European cardio-oncology registry, involving all European cardiologists using the platform in routine practice. The inclusion period will last 3 years, with a 12-month follow-up for each patient. At the time of data extraction, all available cases recorded in the CardioOncoPilot platform will be analyzed.\n\nOverall, it is anticipated that between 1,000 and 5,000 patients across Europe will be included by the end of 2027. These patients will be managed in cardio-oncology clinics as part of routine care during treatment with cardiotoxic anticancer therapies, with follow-up conducted at the same center throughout the study.\n\nThe primary endpoint will be the occurrence of cardiotoxicity as defined by the 2022 ESC Guidelines. Additionally, the performance of newly developed prediction models will be compared with existing HFA-ICOS risk scores (when available) in the same patient population.\n\nPatients will be followed according to routine clinical practice and in accordance with the 2022 ESC Cardio-Oncology Guidelines, which recommend both a baseline pre-treatment assessment and a follow-up evaluation at 1 year, regardless of the type of cardiotoxic therapy.\n\nPatient management will not be modified by the study. This research will consist solely of secondary use of data collected during routine care.\n\nWe anticipate that this study will significantly improve prognostic risk stratification tools in patients treated with cardiotoxic anticancer therapies, thereby enhancing identification of those at highest risk of clinically relevant cardiovascular adverse events during follow-up.\n\nThis project will be conducted in collaboration with the ESC Council of Cardio-Oncology, chaired by Prof. Teresa Lopez-Fernandez, ensuring optimal dissemination through appropriate scientific channels. The developed scores will be shared with the scientific community, particularly the European Society of Cardiology (ESC), with the aim of informing future guideline updates.",[24,25,26,27,28],"Cancer","Anticancer Treatment","Cardiovascular Disease Risk Factor","Cardiovascular Diseases","Hematological Malignancies","NOT_YET_RECRUITING","2026-05-27",{"date":32,"type":33},"2026-06-02","ACTUAL",{"date":35,"type":20},"2026-06-22",{"date":37,"type":20},"2030-12-31",{"name":39,"class":40},"University Hospital, Caen","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100639290","new-taipei-city-888-digital-medical-ai-platform-for-prevention-and-care-of-the-three-highs-and-cardio-renal-vascular-diseases-100639290","NCT07588256","New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases","New Taipei City 888 Digital Medical AI Platform for the Prevention and Treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia) and Cardio-Renal-Vascular Diseases: Validation and Implementation Through Large-Scale Cluster Randomized Clinical Trials: T-888-DIGICARE-DREAM","DIGICARE-DREAM","Inclusion Criteria:\n\nI.T-888-DIGICARE：\n\nEligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of the weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Urine albumin-to-creatinine ratio (UACR) \\>30 mg\u002Fg\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   * Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\nII. DREAM-G:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Measurable urinary microalbumin-to-creatinine ratio\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   • Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\n   Participants must meet at least one of the above chronic disease conditions and:\n6. Untreated Hypertension:\n\n   * Morning home blood pressure (HBP) \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n7. Treated Hypertension:\n\n   * Morning home blood pressure \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n   * Average home blood pressure ≤130\u002F80 mmHg (used to determine treatment strategy)\n\nExclusion Criteria:\n\nI. T-888-DIGICARE\n\n1. Symptomatic heart failure (New York Heart Association functional class II-IV)\n2. End-stage renal disease requiring long-term dialysis\n3. Pregnant women or those planning pregnancy\n\nII. DREAM-G:\n\n1. Life expectancy \\\u003C1 year\n2. End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care\n3. Severe liver cirrhosis\n4. Malignancy under active treatment",{"count":50,"type":20},4162,"INTERVENTIONAL",[53],"NA","Non-communicable diseases (NCDs), or chronic diseases, are a major public health burden globally and in Taiwan, and control of the \"three highs\" (hypertension, dyslipidemia, and hyperglycemia) is a national priority. Nearly half of the 10 leading causes of death in Taiwan are directly or indirectly related to atherosclerotic cardiovascular disease (ASCVD), for which hypertension, dyslipidemia, and abnormal blood glucose are the major risk factors. National health insurance data indicate that over 70% of middle-aged and older adults have at least one of these chronic conditions. Early stages are often asymptomatic, and inadequate control may lead to complications of cardiovascular disease, stroke, renal vascular disease, and retinopathy, causing irreversible organ damage and death.\n\nFor blood pressure, large clinical trials such as SPRINT and STEP have shown that targeting systolic blood pressure below 130 mmHg significantly reduces ASCVD events. For LDL cholesterol, \"the lower, the better\" applies, with guideline-recommended LDL-C targets determined by baseline ASCVD risk, with levels below 55 mg\u002FdL for very high-risk patients. For diabetes, treatment goals generally include fasting plasma glucose below 130 mg\u002FdL and glycated hemoglobin (HbA1c) below 7%.\n\nAlthough antihypertensive therapy has been proven effective in preventing cardiovascular disease and chronic kidney disease attributable to hypertension, fewer than one-third of patients receiving antihypertensive medications achieve current guideline-recommended blood pressure targets. No randomized clinical trial to date has used home blood pressure as the primary therapeutic reference. Moreover, long-term evidence is lacking regarding the organ-protective effects of strategies targeting morning hypertension and of bedtime dosing regimens. Although the TIME study is currently the largest and longest-followed trial addressing dosing time, its bedtime-dosing arm was not specifically targeted to patients with morning hypertension. Therefore, we propose a clinical trial to investigate management strategies for morning hypertension. Aligned with the 2022 Taiwan Hypertension Guidelines, we will employ the \"722 protocol\" for home blood pressure monitoring and enroll patients with morning home blood pressure ≥130\u002F80 mmHg to compare selective nocturnal administration of antihypertensive agents versus exclusive morning dosing, assessing differences in morning home blood pressure control rates, end-organ damage, and atherosclerotic cardiovascular disease (ASCVD) events.\n\nThis project will implement two large-scale cluster-randomized clinical trials within the New Taipei City healthcare network. The first trial (T-888-DIGICARE) will evaluate whether a mobile digital health platform augmented with interactive digital modules can more effectively achieve the \"888\" targets for prevention and treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia). The second trial (DREAM-G) will use the same mobile health delivery model to investigate whether the timing of antihypertensive medication administration (nocturnal versus morning dosing) differentially affects patients with poor morning home blood pressure control. Beyond generating rigorous evidence through a novel clinical approach, this program is expected to have substantial global clinical impact and to showcase Taiwan's healthcare capabilities internationally. Operational challenges encountered and solutions developed during the trials will also provide critical feasibility data for the concurrent real-world implementation registry (T-888-DIGICARE-Registry). The registry will run in parallel with the cluster trials and will enroll individuals who decline trial participation at baseline as well as participants after trial completion, thereby serving as a continuity and real-world evidence platform.",[56,57,26,58,59,60,61,62],"Microalbuminuria","Microalbuminuria \u002FCreatinine Ratios ACR","Cardiovascular Disease Prevention","Digital Medicine","Hypertension","Hyperglycaemia (Diabetic)","Hyperlipidemia",[64,65,66,67,68,69],"digital medicine","hypertension","home blood pressure monitoring","dyslipidemia","microalbuminuria","diabetes","RECRUITING","2026-05-11",{"date":73,"type":33},"2026-05-14",{"date":75,"type":33},"2026-02-05",{"date":77,"type":20},"2029-02-05",{"name":79,"class":40},"New Taipei City Medical Association",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":80},"100640329","glp-1-medication--behavioral-health-programs-on-weight--metabolic-outcomes-flourish-and-thrive-prospective-cohort-study-100640329","NCT07588984","GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study","GLP-1 Medication & Behavioral Health on Weight and Metabolic Outcomes: FLOURISH (Functional Longitudinal Outcomes Under Intentional Small Habits) & THRIVE (Trajectories of Health, Resilience & Integrated Vitality Evaluation) Cohort Study","FLOURISH","Inclusion Criteria:\n\n* Speaks English\n* Community-dwelling, community-living status\n* Able to ambulate independently, with or without aids or devices\n* Unless medically indicated, willingness to stay on current program for 12 months and participate in all study activities\n* Provides informed consent for study participation\n* Commitment and willingness to participate, as assessed by completion of decisional balance exercise\n* Program-specific eligibility:\n* Medication arms only: Meets standard of care program enrollment criteria for GLP-1 medication. Did not add other products or programs to Noom subscription.\n* Noom Weight only: Individual who is not interested in medication\n* Education-only Control Group: Individual who is interested in weight loss who is not currently enrolled in a structured weight loss program or medication program and does not intend to for the duration of the study Free Tier only: Willingness to use Free Tier\n\nExclusion Criteria:\n\n* Study screener completed more than 11 days after Noom program enrollment if participating in a Noom program (GLP-1 programs, Noom Weight, and Free Tier)\n* GLP-1 use in the last 24 weeks (prior to Noom program enrollment if in GLP-1 arm)\n* Female who is pregnant, breast-feeding, or intends to become pregnant during the 12-month program\n* Previous or planned (during the 12-month study) bariatric surgery\n* Active eating disorder\n* Active cancer\n* Type 1 diabetes or current Insulin use\n* Currently taking a medication known to cause weight gain (e.g., antipsychotics, antidepressants, diabetes medication, or corticosteroids)\n* Depression screen results in a PHQ-8 score of 20 or greater.\n\nAll medicated arms and Noom Weight arms (only):\n\n\\- Purchased more than the base Noom program offered for participant's specific arm\n\nGLP-1 Medication Arms Only:\n\n* GLP-1 agonist use is contraindicated (per program criteria) in members with:\n* Personal or family history of medullary thyroid cancer\n* Personal or family history of Multiple Endocrine Neoplasia Type 2 (MEN2)\n* Personal history of Pancreatitis","64 Years",{"count":91,"type":20},2310,"This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement.\n\nFLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Plus Microdose).\n\nTHRIVE is a nested 2-arm prospective study comparing a Proactive Health program to a Noom Free Tier control.\n\nParticipants complete monthly surveys, remote biomarker collection (Tasso device), connected-scale weigh-ins, and in-app biometric assessments (FaceScan, BodyScan). Microdose and Free Tier arms also use wearable fitness trackers. Primary outcomes are changes in cardiometabolic biomarkers, weight, body composition, and GLP-1 side effect profile. Total N = 2,310; 24-month duration.",[94,95,96,97,26],"Obesity & Overweight","Weight Loss","Preventative Health","Body Weight",[99,100,101,102,103,104,105,106,107,108,109,110,111,112,113],"GLP-1","Microdose","weight","body composition","metabolic","biomarkers","longevity","glucagon-like peptide-1","semaglutide","tirzepatide","microdosing","digital health","weight loss","behavioral health","real world evidence","2026-05-08",{"date":116,"type":33},"2026-05-15",{"date":118,"type":20},"2026-04-30",{"date":120,"type":20},"2029-05",{"name":122,"class":123},"Noom Inc.","INDUSTRY",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":80},"100623816","assessment-and-prediction-of-cardiovascular-health-and-disease-risk-using-wearable-biometrics-100623816","NCT07401550","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.","BEACON-HEART","Inclusion Criteria:\n\n* Adults aged 18 years, or older\n* Internet access\n* Possession of a smartphone compatible with the Fitbit mobile app\n\nExclusion Criteria:\n\n* Pregnancy\n* Unstable medical condition\n* Inability to provide informed consent\n* Mental or cognitive impairment precluding adherence to study protocol\n* Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)",true,{"count":134,"type":20},100,"This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.",[137,58,26,138],"Cardiovascular Diseases (CVD)","Coronary Artery Disease (CAD)",[140,141,142,143,144,145,146,147,148,149,150,151],"wearables","wearable devices","cardiovascular health","cardiovascular disease","wearable technology","fitbit","fitabase","remote monitoring","cardiovascular disease prevention","cardiovascular risk reduction","digital biomarker","coronary artery disease","2026-02-03",{"date":154,"type":33},"2026-02-10",{"date":156,"type":33},"2025-12-09",{"date":158,"type":20},"2026-12",{"name":160,"class":40},"University College Dublin",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":51,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":80},"100619375","the-effect-of-endodontic-treatment-on-cardiovascular-risk-biomarkers-in-patients-with-stable-coronary-artery-disease-100619375","NCT07343804","THE EFFECT OF ENDODONTIC TREATMENT ON CARDIOVASCULAR RISK BIOMARKERS IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE","THE EFFECT OF ENDODONTIC TREATMENT ON CARDIOVASCULAR RISK BIOMARKERS IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE : A RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n1. Individuals 30 years of age and older, with a diagnosis of stable coronary artery disease (CAD) and chronic apical periodontitis.\n2. All patients had to present with CAD defined by the Brazilian Society of Cardiology (Xavier et al., 2013) as the documented occurrence of one or more of the following events 6 months before entering the study: history of myocardial infarction, stable angina or ischaemia in non-invasive tests; surgical or percutaneous myocardial revascularization and lesion size of greater than 50% in at least one major coronary artery, as assessed by angiography; presence of angina and positive results of non-invasive testing of ischaemia.\n3. Presence of apical periodontitis defined by the presence of at least 1 radiographic radiolucency ( ≥ 3mm) in teeth as assessed both clinically and radiographically ,with periapical index (PAI) scores ≥3 in a single permanent tooth and pulp necrosis verified by cold and electric pulp test.\n\n   \\-\n\nExclusion Criteria:\n\n1. Chronic conditions associated with periodontitis or with changes in systemic inflammation (e.g. diabetes mellitus, rheumatoid arthritis, rheumatic fever, malignancy, respiratory diseases, renal diseases).\n2. Presence of localized or diffuse periodontal disease.\n3. Acute symptomatic patients\n4. Presence of CV risk factor - history of smoking\n5. Acute conditions known to affect systemic inflammatory markers (orthopaedic trauma, surgery ,viral infections)\n6. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids,immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics\n7. Obesity (body mass index \\[BMI\\]≥30 kg\u002Fm2\n8. Pregnancy \\& Lactation.37","30 Years",{"count":170,"type":20},80,[53],"Study subjects were obtained from the pool of OPD patients in the Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, and the Department of Cardiology, PGIMS, Rohtak. Baseline clinical, radiographic, and laboratory parameters (hsCRP and IL-6) were recorded. Patients were then randomly allocated to one of the two groups. In the test group, single-sitting root canal treatment was performed immediately, while in the control group, delayed endodontic intervention (after 3 months) was performed after three months. Clinical and laboratory parameters were again assessed at the end of 3 months in both groups. hsCRP and IL-6 indices were again done in the delayed treatment group after 3 months of root canal treatment.",[26,174],"Periapical Periodontitis",[143,176,177,178],"endodontic therapy","hs-CRP","IL-6","2026-01-07",{"date":181,"type":33},"2026-01-15",{"date":183,"type":33},"2025-11-01",{"date":185,"type":20},"2026-03",{"name":187,"class":40},"Postgraduate Institute of Dental Sciences Rohtak",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":198,"conditions":199,"keywords":205,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":80},"100607391","cardiovascular-health-of-transgender-individuals-during-the-gender-affirming-pathway-100607391","NCT07187947","Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway","Cardiovascular Health of Transgender Individuals During the Clinical Gender-affirming Pathway","CV-TGD","Inclusion Criteria:\n\n* Diagnosis of gender incongruence\n* Age 18 years or older at the start of therapy\n* Undergoing gender-affirming (replacement or suppressive) hormone therapy with testosterone or with estradiol plus anti-androgens for at least 12 months\n* Provision of informed consent for study participation and for the processing of personal and sensitive data\n\nExclusion Criteria:\n\n* Any hormone therapy received before recruitment\n* History of cardiovascular events prior to the initiation of hormone therapy",{"count":197,"type":20},500,"Gender incongruence, now classified in ICD-11 as a \"marked and persistent incongruence between an individual's experienced gender and the gender assigned at birth,\" is managed in dedicated, multidisciplinary centres that coordinate psychological support with medical-surgical care.\n\nGender-affirming hormone therapy (GAHT) is central to this care pathway. In particular, masculinising GAHT for people assigned female at birth (AFAB) relies mainly on testosterone, and feminising or demasculinising GAHT for people assigned male at birth (AMAB) combines oestradiol with androgen-lowering agents such as cyproterone acetate or GnRH analogues (triptorelin, leuprorelin). In addition, Gender-affirming surgery (GAS) offers further individualised options: \"Top\" procedures- chest masculinisation for AFAB or breast augmentation for AMAB, and \"Bottom\" procedures\\*\\* such as hysterectomy with or without oophorectomy, phalloplasty or metoidioplasty for AFAB; orchiectomy or vaginoplasty for AMAB. Other ancillary interventions include facial feminisation or voice surgery.\n\nGAHT aims to suppress endogenous sex-hormone levels and secondary sex characteristics while inducing those consistent with the affirmed gender. Despite its widespread use, cardiovascular (CV) safety data are scant and largely observational. Sex-steroid receptors are ubiquitous in the vasculature and contribute to the sex-dimorphic patterns of CV risk seen in cisgender populations; GAHT is therefore biologically plausible as a modifier of CV outcomes in transgender people, yet robust evidence remains limited.\n\nCurrent literature suggests that AFAB individuals on testosterone exhibit an up to 2.66-fold higher composite CV risk than cisgender AFAB comparators. The most consistent changes are higher blood pressure and lower HDL cholesterol; clinically significant polycythaemia is uncommon and treatable. Instead, AMAB individuals on feminising therapy do not show a clearly increased overall CV risk compared with cisgender AMAB peers, though data are inconsistent. An observational study reported that within four months of GAHT initiation, systolic blood pressure rose by 2.6 mmHg in trans men and fell by 4 mmHg in trans women, with no diastolic change in either group.\n\nThe current evidence base is weakened by small cohorts, inadequate control groups, and reliance on surrogate biochemical markers rather than hard clinical endpoints. Many studies also overlook GAHT exposure altogether, hampering meaningful interpretation. Moreover, social determinants-mental-health burden, substance use, and healthcare inequities-compound CV risk but are seldom accounted for.\n\nKey unanswered questions include the long-term CV effects of GAHT, age-specific interactions with blood pressure and lipids, optimal therapeutic targets, and underlying mechanisms. Addressing these gaps demands rigorously designed, large-scale, prospective studies that actively involve transgender participants.\n\nIn summary, while GAHT is indispensable for gender affirmation, its cardiovascular implications-especially for AFAB individuals-warrant caution and systematic monitoring. Future evidence should inform tailored protocols that balance gender-affirming benefits against potential CV risks and integrate biomedical parameters with the broader social context impacting transgender health.",[200,201,26,202,203,204,58],"Gender Incongruence","Cardiovascular (CV) Risk","Cardiovascular Disease Acute","Cardiovascular Health Status","Cardiovascular Disease (CVD)",[206,207,208,209,210],"cardiovascular risk","transgender","GAHT","GAS","hormones","2025-09-19",{"date":213,"type":33},"2025-09-23",{"date":215,"type":33},"2025-07-18",{"date":217,"type":20},"2035-12-31",{"name":219,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":232,"conditions":233,"keywords":237,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":80},"100590436","mitigation-of-cardiovascular-disease-risks-in-children-with-extreme-obesity-100590436","NCT06967389","Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity","Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)","MODERN","Inclusion Criteria:\n\n* Patient seen at University of Kentucky Pediatric High BMI Clinic\n* Diagnosis of Obesity Class 2 or 3\n* Meeting the clinical criteria for the medical intervention with semaglutide for weight loss\n\nExclusion Criteria:\n\n* Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine\u002FTopiramate), Liraglutide, Semaglutide, and Setmelanotide\n* Any current prescribed anti-hypertensive medications\n* Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease).\n* Any active infections at enrollment.\n* Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical).\n* Any limitations that would make exercise testing not possible.\n* Any congenital abnormality or genetic syndrome known to be associated with obesity\n* Pregnancy\n* Inability to receive an MRI\n* Personal or family history of medullary thyroid carcinoma (per product insert)\n* Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)","12 Years","17 Years",{"count":231,"type":20},50,"The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are:\n\n* How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment?\n* How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss?\n* Are there differences in the above factors between males and females and are there key factors to help improve the outcomes?\n\nParticipants will be given semaglutide for this study. During the course of the study, participants will:\n\n* have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug)\n* have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured\n* have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study)\n* have follow up visits with the study doctor\n* be asked to take a pregnancy test if they are female and have started menstruation",[234,235,236,95,26],"Obesity and Overweight","Obese Adolescents","Weight Management",[107,238,239,240,241,242,243,111],"Wegovy","Ozempic","obesity","overweight","adolescent","weight management","2025-07-01",{"date":246,"type":33},"2025-07-04",{"date":248,"type":33},"2025-06-12",{"date":250,"type":20},"2027-07",{"name":252,"class":40},"John Bauer"]