[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-health":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,52,77,117,146,176,208,232,262,293,323,356,412,435,458,488,516,546,573,609],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100644269","beetroot-extract-and-quality-of-life-in-adults-aged-75-and-over-100644269",false,"NCT07666685","Beetroot Extract and Quality of Life in Adults Aged 75 and Over","Assessment of the Benefits of Beetroot Extract for Improving the Quality of Life of Older People: a Randomised Clinical Trial.","BERS","Inclusion Criteria:\n\n1. Adults aged 75 years and older recruited from the Geriatrics Service of the Hospital Universitario de Navarra (HUN) or primary care settings.\n2. Ability to ambulate independently.\n3. Ability to communicate effectively.\n4. Ability to tolerate physical exercise.\n5. Barthel Index score greater than 60 points.\n\nExclusion Criteria:\n\n1. Refusal or inability of the participant, caregiver, or legal guardian to provide written informed consent.\n2. Advanced or severe dementia (Global Deterioration Scale \\[GDS\\] stages 6-7).\n3. Unstable medical condition or terminal illness with a life expectancy of less than 6 months.\n4. Ischemic heart disease or congestive heart failure.\n5. Severe renal insufficiency.\n6. Hypotension.",true,"ALL","75 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","The increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Beetroot extract (BE), derived from \"Beta vulgaris\", contains high levels of inorganic nitrate and other bioactive compounds that may positively influence vascular and neuromuscular function. In parallel, multicomponent physical exercise is recognized as an effective strategy to improve physical and cognitive outcomes in older adults. However, evidence on the independent and combined effects of BE supplementation and structured exercise in very old adults remains limited.\n\nThis randomized controlled trial is designed to evaluate the effects of BE supplementation, alone and in combination with a multicomponent physical exercise program, on blood pressure, functional performance, and cognitive function in adults aged 75 years and older. Participants will be randomly assigned to one of four groups: BE supplementation, multicomponent exercise, combined BE supplementation and exercise, or a control condition, over a predefined intervention period. The exercise program will include strength, balance, mobility, and aerobic components specifically adapted to the abilities and safety requirements of old adults.\n\nThe primary outcomes of the study will assess changes in cardiovascular health, physical and functional performance, and cognitive function using standardized and validated assessment tools. Secondary outcomes will include additional indicators of physical capacity and health-related quality of life. This trial aims to provide clinically relevant evidence on whether BE supplementation, alone or in combination with multicomponent exercise, represents a practical and scalable intervention to improve cardiovascular, functional, and cognitive health in adults aged 75 years and older.",[28,29,30,31],"Cardiovascular Health","Functional Health","Cognitive Function Decline","Physical Performance Decline in Older Adults",[33,34,35,36,37,38],"beetroot extract","dietary nitrate","cardiovascular health","functional health","quality of life","cognitive function","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2026-03-24",{"date":47,"type":22},"2027-11",{"name":49,"class":50},"Fundacion Miguel Servet","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":51},"100641037","mind-your-heart-intervention-for-american-indian-women-100641037","NCT07581899","Mind Your Heart Intervention for American Indian Women","MIND Your Heart Study for American Indian Women","MYH","Inclusion Criteria:\n\n* Women 18-55 years old who self-identify as Lumbee Indian and\n* Have one or more risk factors for cardiovascular disease:\n\n  * overweight\u002Fobese, defined as BMI \\>25 kg\u002Fm\\^2\n  * hypertensive as measured by study staff\n  * physical inactivity\n* Willing and able to follow study procedures\n\nExclusion Criteria:\n\n* Women currently enrolled in an organized weight-loss or mindfulness program\n* Pregnant women or women planning to become pregnant during the study period\n* Conditions that exclude study enrollment include:\n\n  * heart murmur\n  * congenital heart disease\n  * family history of sudden death\n  * or orthopedic limitations or health conditions precluding exercise","FEMALE","18 Years","55 Years",{"count":64,"type":22},70,[25],"The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women.\n\nThe main questions it aims to answer are:\n\n* Can this intervention realistically work for American Indian women?\n* Do American Indian women find the intervention acceptable?\n* Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves.\n\nParticipants will:\n\n* Attend 3 data collections over 3 months.\n* Be randomly assigned to either the intervention group or a control group.\n* (Intervention group participants) attend 8 weekly classes.",[28],"2026-06-22",{"date":70,"type":43},"2026-06-25",{"date":72,"type":43},"2026-04-07",{"date":74,"type":22},"2026-07",{"name":76,"class":50},"University of North Carolina, Chapel Hill",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":18,"minAge":61,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":97,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":51},"100587602","judicious-surveillance-for-trastuzumab-induced-cardiotoxicity-in-the-first-year-100587602","NCT06930521","JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year","JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial","JUSTIFY","Inclusion Criteria:\n\n1. Stage 1-3 breast cancer (BC).\n2. Age 18-79 years.\n3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.\n\nExclusion Criteria:\n\n1. Distant metastases detected clinically, radiographically, or histologically\n2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)\n3. Pre-existing cardiovascular disease, defined as:\n\n   1. Prior myocardial infarction (even if LVEF has normalized)\n   2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)\n   3. Baseline LVEF \\\u003C55%\n   4. Atrial fibrillation\n   5. Greater than moderate valvular disease (i.e., severe, or moderate-severe)\n4. Cumulative anthracycline exposure ≥250mg\u002Fm2 before starting HER2TT\n5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score \\>2\\*\n6. Symptoms potentially due to serious cardiac disease as per investigator's judgement\\* \\*Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.","79 Years",{"count":87,"type":22},300,[25],"This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.\n\nThe guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.\n\nTo address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.\n\nThe researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.",[28,91,92,93,94,95,96],"Breast Cancer","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Cardio-oncology","Circulatory and Respiratory Health","Clinical and Translational Cardiovascular Sciences","Health Services and Systems - Healthcare Effectiveness &Amp; Outcomes",[98,99,100,101,102,103,104,105,106,107],"Trastuzumab","Cardiac imaging","Her-2 positive breast cancer","Echocardiography","Cardiotoxicity","Left ventricular ejection fraction","Heart failure","Randomized controlled trial","Nuclear imaging","Non-inferiority","2026-06-11",{"date":110,"type":43},"2026-06-15",{"date":112,"type":43},"2026-04-22",{"date":114,"type":22},"2033-06",{"name":116,"class":50},"Women's College Hospital",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":17,"sex":18,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":51},"100642665","multidimensional-sleep-health-intervention-for-couples-100642665","NCT07603245","Multidimensional Sleep Health Intervention for Couples","DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention","DREAM-COUPLES","Inclusion Criteria:\n\n* Adults aged 30-65 years\n* English-speaking\n* Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad)\n* Sub-optimal sleep health (at minimum short\u002Flong sleep duration and\u002For irregular sleep patterns)\n\nExclusion Criteria:\n\n* Optimal sleep health\n* History of cardiovascular disease or cancer\n* Not cognitively able to complete study requirements\n* Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse\u002Fdependence)\n* History of severe depression or high risk of sleep apnea\u002Fuse of a Continuous Positive Airway Pressure (CPAP) device\n* Inability to provide informed consent","30 Years","65 Years",{"count":128,"type":22},50,[25],"The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects.\n\nCan a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners?\n\nCan a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners?\n\nAs this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.",[132,133,28],"Blood Pressure","Sleep",[132,133,28,135,136],"Couples","Dyads","2026-06-10",{"date":139,"type":43},"2026-06-12",{"date":141,"type":43},"2026-06-08",{"date":143,"type":22},"2027-06",{"name":145,"class":50},"Columbia University",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100598123","improving-the-heart-health-of-home-health-aides-100598123","NCT07067398","Improving the Heart Health of Home Health Aides","Improving the Cardiovascular Health of Home Health Aides","VITAL","Inclusion Criteria:\n\n* Currently working as a home health aide\n* Speak English or Spanish\n* ≥ 18 years of age\n* Have low CV Health as assessed by LE8 components made up by physical health measurements (blood pressure, BMI) and general self-reported health (physical activity, diet, smoking, sleep); calculated to be a score of 0-50 (the total score ranges from 0-100)\n\nExclusion Criteria:\n\n* Less than 1 year of job experience as a home health aide\n* Does not possess a smartphone\n* Gotten dizzy before with a finger stick blood sugar\u002Fcholesterol test\n* Have a history of syncope with a finger stick blood sugar\u002Fcholesterol test",{"count":155,"type":22},40,[25],"The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes. The program has been adapted specifically for home health aides and will be delivered by trained \"peer coaches,\" who are fellow home health aides who will help guide participants through the program.\n\nThe main questions the study aims to answer are:\n\n* Will the LE8 intervention, which provides cardiovascular health education and support with positive thinking, be used by home health aides and do they like it?\n* Does the LE8 intervention actually improve home health aides' cardiovascular health after the intervention's conclusion compared to baseline?\n\nParticipants will be paired with a trained peer coach and take part in the 10-week program over the course of 6 months. The program includes support for healthy behaviors and positive thinking, with the goal of making lasting improvements in cardiovascular health.",[159,160,161,28],"Cardiovascular","Cardiovascular (CV) Risk","Cardiovascular Disease (CVD) Risk Factors",[163,164,165],"cardiovascular health intervention","home health aide","peer coaching","2026-05-19",{"date":168,"type":43},"2026-05-22",{"date":170,"type":43},"2025-09-09",{"date":172,"type":22},"2026-09",{"name":174,"class":50},"Weill Medical College of Cornell University",2,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":17,"sex":60,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":194,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100606285","st-marys-assisted-reproductive-technology-and-cardiometabolic-health-modifiable-targets-for-multimorbidity-prevention-start-healthy-100606285","NCT07173569","St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)","START-HEALThY","Inclusion Criteria:\n\n* In pre-conception cohort:\n\n  * Aged between 16 and 45\n  * Able to provide informed consent\n  * Either: 1) Those with a history of infertility (failure to conceive after at least 1 year of unprotected intercourse\u002F3-6 cycles of Intra-Uterine Insemination (IUI) or diagnosed cause of infertility) and accepted for IVF at The Department of Reproductive Medicine, MFT or, 2) attending for a pre-conception appointment at MFT\n  * Nulliparous (no previous pregnancies beyond 20 weeks)\n  * No pre-existing heart disease, hypertensive disease, vascular disease or diabetes\n* In post-pregnancy cohort\n\n  * Aged between 16 and 45\n  * Able to provide informed consent\n  * Participant of START clinic study (achieved pregnancy via a) IVF with or without ICSI treatment, b) spontaneous conception without medical intervention within 12 months, or c) spontaneous conception following ovulation induction for delay in spontaneous conception \\>12 months or confirmed anovulation)\n\nExclusion Criteria:\n\n\\- In all participants:\n\n* Prisoners\n* Born male at birth\n* Language barrier not overcome by telephone or video interpretation services\n* Pregnant at time of study visit\n\nPre-conception participants only:\n\n• Accepted for IVF for non-infertility reasons i.e. egg donation, egg collection, egg banking, gestational surrogacy","16 Years","45 Years",{"count":21,"type":22},"OBSERVATIONAL","The main causes of death in women are conditions affecting the heart and blood vessels (cardiovascular disease, CVD). Women who have difficulties getting pregnant (infertility) may be at increased risk, but the reasons for this are not clear. Infertility itself may be linked with poorer heart and blood vessel health, or fertility treatments such as in vitro fertilisation (IVF) could increase the risk.\n\nThe study aims to understand the practicalities of obtaining detailed profiling of women's pre- and post- pregnancy heart, blood vessel and metabolic health. Two groups of women in Manchester University NHS Foundation Trust, will be recruited over 2 years: 1) women planning a pregnancy, either spontaneously or with IVF treatment after infertility, 2) women who previously took part in a pregnancy health study after IVF or non-IVF conception.\n\nParticipants will attend a single research appointment where they will undergo a cardiometabolic health assessment. They will have their BMI calculated, body composition measured, a measurement of how well their blood vessels work using a blood pressure cuff around the arm and\u002For finger and blood sampling performed. A blood pressure cuff as well as a blood sugar sensor may be fitted to be worn after the appointment. Participants will be asked to complete a questionnaire(s), with follow-up for up to 13 months.\n\nThe cardiometabolic health of those who conceived with or without IVF treatment and with or without a history of infertility will be compared at both time points to investigate the possibility of links between infertility, IVF processes and CVD risk and to understand any potential barriers to recruitment of individuals at either time point to guide future studies. This information could then be used in a full-scale study, including in pregnancy, to improve care and promote lifelong health for women with infertility.",[189,190,191,28,192,193],"Maternal Cardiometabolic Health","Infertility","Assisted Reproductive Technology","Metabolic Health","in Vitro Fertilisation",[195,196,197],"Feasibility study","Ambulatory cardiometabolic health monitoring","Cohort","NOT_YET_RECRUITING","2026-04-27",{"date":201,"type":43},"2026-04-28",{"date":203,"type":22},"2026-05-01",{"date":205,"type":22},"2028-10-31",{"name":207,"class":50},"University of Manchester",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":17,"sex":60,"minAge":61,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100536993","early-intervention-to-promote-cardiovascular-health-of-mothers-and-children-100536993","NCT06272045","Early Intervention to Promote Cardiovascular Health of Mothers and Children","Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)","ENRICH","Inclusion Criteria:\n\n1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH\n2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)\n3. Be 18 years of age or older\n4. Speak English or Spanish\n\nExclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.",{"count":217,"type":22},6618,[25],"Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \\& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6618 participants in total (i.e., 3309 mother-child dyads which includes 3309 mothers and 3309 children) from diverse community settings with a high burden of cardiovascular disease risk factors.",[28],[222],"Home visiting, cardiovascular health, prevention, maternal-child health",{"date":224,"type":43},"2026-04-13",{"date":226,"type":43},"2024-06-19",{"date":228,"type":22},"2029-03-30",{"name":230,"class":50},"JHSPH Center for Clinical Trials",9,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":17,"sex":60,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":51},"100631609","the-effect-of-womens-heart-health-awareness-program-100631609","NCT07502911","The Effect of Women's Heart Health Awareness Program","The Effect of a Heart Health Awareness Program on Women's Knowledge, Attitudes, and Practice Toward Cardiovascular Disease and Health Literacy: A Single-Blind Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* Being female,\n* Aged between 20 and 64 years (inclusive),\n* Being literate,\n* Regularly attending any course at the Family Center,\n* Active user of the WhatsApp application.\n\nExclusion Criteria:\n\n* Being an immigrant with a Turkish language barrier (unable to communicate in Turkish),\n* Being pregnant,\n* Being in the postpartum period,\n* Having a prior diagnosis of any cardiovascular disease,\n* Having a prior diagnosis of any type of cancer.","20 Years","64 Years",{"count":242,"type":22},207,[25],"The aim of this study is to examine the effect of a gender-specific heart health protection awareness program, incorporating video-supported reminder messages, on knowledge, attitudes, practices (KAP) regarding cardiovascular diseases and health literacy among adult women aged 20 to 64 with no prior diagnosis of cardiovascular disease. The centers where the study is conducted will be divided into intervention (n=4) and control (n=5) groups using cluster randomization. While the intervention group receives a heart health awareness program consisting of three sessions in total, including education, risk factor screening, and individual counseling over a period of three weeks, the control group will receive standard of care. Data will be collected at the beginning of the first session and after the completion of the final session.",[28,246,247],"Cardiovascular Risk Factors","Health Literacy",[249,250,251],"Cardiovascular diseases","women's health","health literacy","2026-03-25",{"date":254,"type":43},"2026-03-31",{"date":256,"type":22},"2026-04-06",{"date":258,"type":22},"2026-04-20",{"name":260,"class":261},"Lokman Hekim University","OTHER_GOV",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":18,"minAge":61,"maxAge":184,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":51},"100607292","phase-2-evaluation-of-a-novel-insulin-sensitizer-in-people-with-type-1-diabetes-100607292","NCT07186660","Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes","Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery","WBH003","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. History of type 1 diabetes for at least one year\n4. Age 18-45 years\n5. HbA1c \\\u003C10%\n\n   * BMI 18-35 kg\u002Fm2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units\u002Fkg\u002Fday.\n   * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.\n   * On stable regimen of non-diabetic medications for the last 6 months.\n   * All screening labs within normal limits or not clinically significant.\n   * Ability to take oral medication and be willing to adhere to the study drug\u002Fplacebo for 12 weeks.\n   * For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.\n   * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.\n   * Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Current Pregnancy or currently breastfeeding.\n* History of smoking tobacco products within the last two years.\n* History of alcohol abuse or illicit drug abuse within 6 months of screening.\n* Known history of human immunodeficiency virus (HIV).\n* History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes\n* Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.\n* Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).\n* Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).\n* Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).\n* Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).\n* Macroalbuminuria (i.e., urine albumin: creatinine \\>300 mg per g).\n* Retinopathy beyond mild, nonproliferative retinopathy.\n* History of Level 3 hypoglycemia within the last 12 months.\n* History of diabetic ketoacidosis (DKA) within the last 12 months.\n* Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.\n* Screening oxygen saturation \\\u003C90%\n* History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.\n* Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.\n* Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.",{"count":155,"type":22},[272],"PHASE2","The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and\u002For lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.",[275,276,277,278,28],"Type 1 Diabetes (T1D)","Glycemic Control for Diabetes Mellitus","Insulin","Ketones",[280,281,282,283,35],"Type 1 Diabetes","closed loop technology","time-in-range","adjunct therapy","2026-02-23",{"date":286,"type":43},"2026-02-25",{"date":288,"type":43},"2026-02-22",{"date":290,"type":22},"2028-09",{"name":292,"class":50},"University of Virginia",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":4},"100625860","my-heart-counts-cardiovascular-health-study-next-gen-100625860","NCT07428122","My Heart Counts Cardiovascular Health Study: Next Gen","My Heart Counts Cardiovascular Health Study","MHC","Inclusion Criteria:\n\n* 18 years of age or older\n* Resident of the United States\n* Able to read, understand and consent to study\n\nExclusion Criteria:\n\n• Not owning a compatible iOS or Android smartphone",{"count":302,"type":22},15000,[25],"The My Heart Counts Cardiovascular Health Study will utilize mobile health capabilities of smartphones to assess daily activity measures and compare these to measures of cardiovascular health risk factors and fitness. The study aims to collect cardiovascular health data on a diverse population by making the application available on both iOS and Android platforms. Using smartphone sensors and connected devices, the study will collect physical activity metrics, heart rate data, and responses to health questionnaires. The study includes a randomized crossover trial component examining the effectiveness of personalized activity coaching prompts generated by a language model compared to generic prompts.",[28,306],"Physical Activity",[308,309,310,311,312,313,314],"physical activity","fitness","heart health","mobile health","digital health","cardiovascular risk","behavioral interventions","2026-02-19",{"date":284,"type":43},{"date":318,"type":22},"2026-04-30",{"date":320,"type":22},"2035-12-31",{"name":322,"class":50},"Stanford University",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":51},"100620362","cardiovascular-effects-of-grieving-100620362","NCT07356635","Cardiovascular Effects of Grieving","Investigating Cardiovascular Reactivity and Recovery of Young Adults During Grief-Recall, With Self-Affirmation as Potential Intervention","SAGE","Inclusion Criteria:\n\n* Individuals aged 18 and older who have experienced the death of family member and\u002For friend within the last 2 to 18 months.\n* Participants must also be fluent in English as all procedures will be conducted in English.\n\nExclusion Criteria:\n\n\\- Individuals with a history of cardiovascular disease or disorders, those who report being pregnant, or are taking medication which may alter\u002Faffect cardiovascular and\u002For cognitive processes.",{"count":332,"type":22},140,[25],"Self-affirmation (SA) theory proposes that people are motivated to maintain a positive self-image of being worthy, stable, and capable. Self-affirmation (SA) manipulations have been shown to effectively increase self-worth as well as reduce cardiovascular reactivity while enhancing cardiovascular recovery in response to stress. While SA is discussed as a way to alleviate grief, its effect on cardiovascular reactivity (CVR) and recovery to grief recall has yet to be studied within laboratory settings. This study proposes an experimental design to examine how an in-lab manipulation promoting self-affirmation can improve patients' cardiovascular responses during and after a grief recall procedure. The investigators hypothesized that grief severity (a continuous variable) interacts with condition (a categorical variable with two levels, i.e., SA intervention vs. control) to predict CV reactivity and recovery as outcomes.\n\nPrimary Objective 1: To investigate effects of self-affirmation intervention on cardiovascular responses among grieving participants during and after grief recall.\n\nSecondary Objective 1: To investigate the relationship of grief severity with psychological stress.",[336,28,337],"Grief","Emotion",[339,340,35,341,342,343,344,345,346],"grief","cardiovascular reactivity","heart rate variability","psychophysiology","self-affirmation","value-affirmation","stress","mourning","2026-01-14",{"date":349,"type":43},"2026-01-21",{"date":351,"type":43},"2025-10-16",{"date":353,"type":22},"2027-03",{"name":355,"class":50},"University of South Florida",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":17,"sex":18,"minAge":362,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":365,"conditions":366,"keywords":380,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":4},"100609070","healthspan-connect-programme-of-research-100609070","NCT07209774","Healthspan Connect Programme of Research","Inclusion Criteria:\n\n* Age 12 years or older at time of enrollment.\n* Resident in the United Kingdom.\n* Able to participate in the study using digital tools (smartphone, tablet, or computer).\n* Able to provide informed consent (digital consent accepted).\n* For participants aged 12-15 years: must have parent\u002Fguardian consent in addition to their own assent.\n\nExclusion Criteria:\n\n* Individuals unable to provide informed consent (or parental consent where applicable).\n* Individuals not resident in the UK.\n* Individuals unable to complete study requirements due to lack of internet access, inability to use digital devices, or severe digital literacy barriers.","12 Years",{"count":364,"type":22},100000,"Healthspan Connect is a new research programme designed to understand what helps people stay healthy as they age. The programme will explore how lifestyle, environment, genetics, and social factors influence healthy ageing and overall wellbeing.\n\nThe programme will recruit participants aged 12 years and older across the UK. By including adolescents, the programme aims to understand how early life behaviours and experiences shape long-term health. There is no upper age limit, and people from all backgrounds are encouraged to participate. Special pathways ensure that young participants provide consent in an age-appropriate way.\n\nHealthspan Connect is a digital and home-based study, meaning participants can take part from home using smartphones, computers, and online surveys. Participants may also be asked to collect samples such as blood, saliva, stool, urine, or other biological specimens at home using easy-to-use kits. In some sub-studies, participants may be invited to attend research visits for additional tests, scans, or clinical assessments. Family members and close contacts may also be invited to participate in some studies.\n\nThrough Healthspan Connect, researchers aim to:\n\n* Identify the biological, environmental, and social factors that help people live longer, healthier lives.\n* Understand how different groups, including those historically underrepresented in research, experience ageing.\n* Explore ways to support behaviour changes that improve health over the lifespan.\n* Provide near real-time information to inform health policies and interventions.\n\nParticipants may also be asked for permission to link their information with health records, education records, and environmental data to better understand health outcomes over time.\n\nThis programme will serve as a flexible platform for multiple sub-studies, allowing participants to contribute to a wide range of research questions related to healthy ageing, resilience, and long-term health. All data and biological samples will be stored securely and used to advance scientific knowledge, with participant privacy carefully protected.",[367,368,369,370,371,372,373,28,192,374,375,376,377,378,379],"Cancer","Mental Health","Ageing Well","Resilience","Cognitive Health","Psychological Health","Environmental Health Effects","Neurological Health","Musculoskeletal Health","Respiratory Health","Allergies","Eye Health","Other",[381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402],"Healthy ageing","Healthspan","Longevity","Ageing resilience","Life course determinants","Multiple long-term conditions","Digital health research","Remote monitoring","Mobile health (mHealth)","Wearables","Biobank","Biological specimen collection","Home-based sample collection","Epidemiology","Longitudinal cohort study","Adolescents and ageing","Underrepresented populations in research","Behaviour change","Environmental exposures","Data linkage","Electronic health records (EHR)","United Kingdom","2025-09-29",{"date":405,"type":43},"2025-10-07",{"date":407,"type":22},"2026-01-05",{"date":409,"type":22},"2056-01-05",{"name":411,"class":50},"King's College London",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":51},"100535048","differences-in-ventilatory-function-body-composition-and-cardiorrespiratory-fitness-according-to-training-status-100535048","NCT06246760","Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status","Prestación de Servicios científicos, evaluación y Control Del Rendimiento","Inclusion Criteria:\n\n* Be in enough physical fitness to perform the incremental test to volitional exhaustion.\n\nExclusion Criteria:\n\n* Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.",{"count":420,"type":22},1272,[25],"The goal of this cross-over study is to evaluate the physiological response to exercise and body composition according to training status in participants with a wide spectrum of fitness states. The main questions it aims to answer are:\n\n* Which are the physiological differences across participants with different training status?\n* Which are the body composition differences across participants with different training status?",[424,28,425],"Body Composition","Ventilatory Physiology","2025-04-03",{"date":428,"type":43},"2025-04-08",{"date":430,"type":43},"2000-01-01",{"date":432,"type":22},"2030-01-01",{"name":434,"class":50},"Universidad Politecnica de Madrid",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":17,"sex":18,"minAge":239,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":51},"100582370","a-multi-language-smartphone-based-healthy-lifestyle-intervention-for-firefighters-100582370","NCT06862427","A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters","A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters: A Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* Career firefighters who are older than or equal 20 years old\n\nExclusion Criteria:\n\n* Career firefighters who are younger than 20 years old\n* Firefighters who are retired or are volunteer firefighters.",{"count":443,"type":22},1000,[25],"The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are:\n\n* Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care?\n* Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters?\n\nResearchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months.\n\nParticipants will:\n\n* Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan.\n* Be randomly assigned to either the intervention group (HLS App) or the control group (usual care).\n* Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention.\n\nAnticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.",[368,447,28,448],"Physical Performance","Lifestyle Intervention","2025-03-16",{"date":451,"type":43},"2025-03-20",{"date":453,"type":43},"2025-03-04",{"date":455,"type":22},"2025-12",{"name":457,"class":50},"National Yang Ming Chiao Tung University",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":125,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":474,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":51},"100581177","hiit-vs-snack-exercises-on-the-academic-stress-of-university-students-100581177","NCT06846918","HIIT Vs Snack Exercises on the Academic Stress of University Students","HIIT Vs Snack Exercises on the Academic Stress of University Students: a Randomized Controlled Trial","SHARP-Stress","Inclusion Criteria:\n\n* University students from the 1st to 4th year at the Metropolitan University of Education Sciences and Silva-Henriquez Catholic University\n\nExclusion Criteria:\n\n* High level of physical activity classification in the GPAQ questionnaire.\n* Musculoskeletal conditions that prevent normal physical activity.\n* Cardiac disease that contraindicates high-intensity exercise.\n* Diagnosed mental health condition.",{"count":467,"type":22},36,[25],"Mental health among Chilean university students has steadily deteriorated since 2020. One of the factors associated with mental health is the academic workload that comes with transitioning from high school to higher education, which may lead to an increase in stress levels due to university life referred to as academic stress. Academic stress has been linked to multiple negative outcomes in university students, such as a lower quality of life, as well as cardiovascular risk markers, including body composition (e.g., higher fat percentage), muscle function, aerobic capacity, and physical activity levels. Academic stress affecting more than 50% of university students represents a health issue that needs to be addressed, not only because it can lead to chronic stress, but also because it increases cardiovascular risk in a Chilean population where more than 10,000,000 people are overweight, obese, or have insufficient physical activity levels.\n\nAcademic stress and its associated complications represent a prevalent health issue among university students. It is essential to implement interventions that help reduce academic stress while also counteracting its negative effects on quality of life, body composition, muscle function, aerobic capacity, and physical activity levels.\n\nCost-effective tools, both in terms of financial resources and time, are needed. From this perspective, physical exercise meets both requirements, as it is inexpensive to implement and there are various protocols such as high-intensity interval training and \"exercise snacks\" that can require less than 40 minutes per week while providing beneficial effects on academic stress, body composition muscle function, aerobic capacity, and physical activity levels in university students.\n\nExpanding the body of evidence on these different training protocols would allow us to address multiple issues simultaneously. The primary one is academic stress and its related consequences, but also to generate new evidence on aspects not yet covered in the current literature, such as the impact on university students' quality of life, and to provide an accessible treatment tool for the future. Importantly, implementing these short-duration programs would also enable students to maintain their academic responsibilities, as the proposed protocols require no more than 40 minutes per week (\\\u003C10 minutes per day). Finally, these programs could be implemented within university facilities, which, in the long term, could become a permanent tool for improving students' university experience.",[368,471,472,473,28],"Mental Health Care","Physical Inactivity","Sedentary Behaviors",[475,476,477,478],"High-intensity Interval Training","Snack Exercises","Academic Stress","Mental Health Well-being","2025-02-25",{"date":481,"type":43},"2025-02-28",{"date":483,"type":22},"2025-04-15",{"date":485,"type":22},"2025-12-15",{"name":487,"class":50},"Universidad Metropolitana de Ciencias de la Educacion",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":503,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":51},"100579699","heat-therapy-and-peripheral-artery-disease-100579699","NCT06827691","Heat Therapy and Peripheral Artery Disease","Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.","Inclusion Criteria:\n\n* • Aged \\> 18 years\n\n  * ABPI \\\u003C 0.9 at rest or a drop of 20mmHG after exercise testing\n  * Diagnosed with IC\n  * Able to walk unaided\n  * English-speaking and able to follow instructions\n  * No previous history of heat syncope\n  * Post-Menopausal or not on hormone therapy\n  * Able to provide informed consent\n\nExclusion Criteria:\n\n* • Walking impairment for a reason other than PAD\n\n  * Critical limb ischaemia\u002Frest pain\n  * Asymptomatic PAD\n  * Active cancer treatment\n  * Clinically diagnosed diabetes or those with peripheral neuropathy\n  * Recent \u002F frequent heat exposure (e.g., sauna or hot tubs).\n  * severe aortic stenosis, unstable angina, recent MI, stroke or TIA",{"count":64,"type":22},[25],"The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.",[499,28,500,501,502],"Peripheral Arterial Disease","Vascular Function","Intermittent Claudication","Peripheral Vascular Diseases",[504,35,505,506],"heat therapy","endothelial function","heat intervention","2025-02-10",{"date":509,"type":43},"2025-02-14",{"date":511,"type":22},"2025-05-01",{"date":513,"type":22},"2028-01-01",{"name":515,"class":50},"Manchester Metropolitan University",{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":17,"sex":18,"minAge":524,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":51},"100571062","the-si-program-reintervention-for-elementary-schools-trial-100571062","NCT06715358","The SI! Program Reintervention for Elementary Schools Trial","Cluster Randomized Trial for the SI! Program Reintervention for Elementary Schools","PSIR","Inclusion Criteria:\n\n* Schools from the Madrid Region or Catalonia.\n* Public or charter schools\n* Schools having from 1st to 6th grades and at least one classroom in 1st grade.\n* Schools having a canteen\n* Children in the 1st grade.\n\nExclusion Criteria:\n\n* None","5 Years","8 Years",{"count":527,"type":22},840,[25],"Background and objectives:\n\nThe SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures were used to assess changes in lifestyle and cardiovascular health indicators. In the SI! Program for Preschool, children in the intervention group increased significantly more their knowledge, attitudes and habits after 4 months of the implementation of the SI! Program compared to children in the control group. However, until now, results have shown that improvements in cardiovascular health between 3 and 5 years old do not sustain overtime. For this reason, the new project of the SI! Program proposes a reinforcement of the children's environment to boost the effect of the intervention and a reinforcement in the classroom after 2 years to favor the sustainability of the effect. The main objective of this study is to assess the effect of the reintervention of the SI! Program in the SI!-Child health score in Elementary school children (7-12 years old) and compare its effect with a single late exposure to the SI! Program.\n\nMethodology:\n\nA cluster-randomized trial involving 50 elementary schools in Spain will be carried out. Schools will be 1:1 randomized to either implement the SI! Program from 2nd grade throughout the whole Elementary Education (5 years) with two classroom interventions (one at 2nd grade and one at 5th grade) or to implement the SI! Program from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Children in the first year of Elementary education at the beginning of the trial will be recruited. Participants will be evaluated at baseline, and after 3, 5 and 6 years using a battery of measurements on cardiovascular health parameters (anthropometry, bioimpedance, blood analysis, accelerometers, questionnaires). The primary endpoint will be the change in the SI!-Child score after 5 years. The SI! Child score includes sleep, diet, physical activity and nutritional status, and ranges from 0 to 100, with higher scores indicating better cardiovascular profiles. Secondary outcomes include the change in individual components of the SI!-Child score and other cardiovascular health indicators such as sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile and blood glucose, and to assess the effect of the SI! Program reintervention to maintain or improve all cardiovascular health indicators previously mentioned one year after the reintervention.\n\nExpected results:\n\nThe investigators expect to show that a school-based educational intervention with a reinforcement in the classroom after 2 years in addition to a school environment intervention will induce favorable and sustainable lifestyle changes in health behaviors among Spanish children. If successful, this strategy could be widely adopted having a meaningful effect on cardiovascular health promotion.",[28,531],"Obesity",[533,534,535,536],"Cardiovascular health","Health promotion","School-based intervention","Children","2024-12-03",{"date":539,"type":43},"2024-12-04",{"date":541,"type":43},"2023-10-24",{"date":543,"type":22},"2031-06",{"name":545,"class":50},"Foundation for Science, Health and Education, Spain",{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":18,"minAge":126,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":561,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":51},"100568823","acute-effects-of-intermittent-hypoxia-hyperoxia-in-older-adults-100568823","NCT06686238","Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults","Acute Effects of a Hypoxia-hyperoxia Exposure Session on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, and Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Being over 60 years old.\n* Having no previous experience in hypoxic training.\n* Engaging in less than 150 minutes of physical activity per week.\n\nExclusion Criteria:\n\n* Having any pathology that prevents the subject from being independent in terms of walking and functionality.\n* Subjects with impaired cognitive abilities.\n* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.\n* To have or have had cancer","90 Years",{"count":555,"type":22},16,[25],"The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.\n\nAccording to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, and arterial oxygen saturation.\n\nThe study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21%.",[559,28,132,560],"Older Adults","Sedentary",[562,563,341],"hypoxic exposure","older adults","2024-11-25",{"date":566,"type":43},"2024-11-27",{"date":568,"type":22},"2024-12-05",{"date":570,"type":22},"2024-12-26",{"name":572,"class":50},"Sierra Varona SL",{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":17,"sex":18,"minAge":61,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":597,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":4},"100552680","m4c-nutraceutical-intervention-human-health-effects-pilot-100552680","NCT06476236","M4C Nutraceutical Intervention Human Health Effects Pilot","M4C Pilot","Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* amputation\n* blood clotting disorder\n* metal implants or implanted electrical device(s)\n* known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension\n* inability to fast i.e. low blood sugar\n* pregnant or may be pregnant during the course of the study\n* amino acid metabolizing disorder i.e. phenylketonuria\n* severe edema\n* did not pass screening criteria as determined by MRI facility\n* allergies\u002Fintolerance to any nutraceutical ingredients: amino acids, vitamins, minerals, tapioca starch, sunflower lecithin, stevia, limes or fatty acids like docosahexaenoic acid","80 Years",{"count":5,"type":22},[25],"This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle\u002Ffat\u002Fwater composition), and metabolite\u002Fnovel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.",[585,586,587,588,589,590,28,591,592,593,594,595,531,596],"General Health and Wellness","Energy and Vitality","Cognitive Function and Mental Health","Weight Management","Digestive Health","Exercise Tolerance","Bone and Joint Health","Skin, Hair, and Nail Health","Immune Support","Sports Performance and Recovery","Sleep and Relaxation","Anti Inflammatory",[585,586,587,588,589,590,28,591,592,593,594,598,531,599],"Sleep and relaxation","anti inflammatory","2024-06-24",{"date":602,"type":43},"2024-06-26",{"date":604,"type":22},"2024-06-17",{"date":606,"type":22},"2025-06-17",{"name":608,"class":50},"Concordia University Wisconsin",{"id":610,"slug":611,"hasResults":11,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":11,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":175},"100536111","home-based-exercise-and-physical-activity-intervention-after-kidney-transplantation-impact-of-exercise-intensity-100536111","NCT06260579","Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity","A Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - a Multicenter Randomized Controlled Trial","PHOENIX-Kidney","Inclusion Criteria:\n\nDe novo adult KTRs\n\nExclusion Criteria:\n\n* Underlying heart disease, defined as aberrant CPET, unstable angina, non-revascularized lesions or life-threatening arrhythmias\n* Uncontrolled hypertension\n* Uncontrolled diabetes, defined as HbA1c ≥ 9%\n* Musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise\n* Multi-organ transplantation\n* Ongoing treatment for malignancies\n* Unable to understand Dutch\n* No access to smartphone and\u002For computer with internet access\n* Severe pulmonary disease defined as either forced vital capacity (FVC) \\\u003C50%, one-second value (FEV1) \\\u003C50%, or a diffusing capacity for carbon monoxide (DLCO) \\\u003C40% that excludes all serious underlying respiratory disease (pulmonary fibrosis, COPD GOLD II-IV, PAH).",{"count":618,"type":22},147,[25],"This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.",[306,622,623,624,28,625,626,627,628],"Exercise Training","Kidney Transplantation","Physical Fitness","Gut Microbiome","Health-related Quality of Life","Implementation","Cost-effectiveness","2024-02-07",{"date":631,"type":43},"2024-02-15",{"date":633,"type":43},"2022-11-14",{"date":635,"type":22},"2029-12",{"name":637,"class":50},"KU Leuven"]