[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"health-related-quality-of-life\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:health-related-quality-of-life":227},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,80,108,135,165,214,240,272,302,332,385,415,448,478,498,519,555,591,631,654,690,721,746,770,792],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":44,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100643981","health-ahead-comparative-effectiveness-study-100643981",false,"NCT07669168","Health Ahead Comparative Effectiveness Study","Health Ahead: Sequential Comparative-Effectiveness Studies Toward Automated, Universally Deployable Preventive Health Screening","HACE","Inclusion Criteria:\n\n* Age 18 years or older\n* Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative\n* Willing to participate in longitudinal follow-up.\n\nExclusion Criteria:\n\n\\- Age under 18 years.",true,"ALL","18 Years",{"count":22,"type":23},1000000,"ESTIMATED","INTERVENTIONAL",[26],"NA","The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform.\n\nThe first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Health Services Accessibility","Rural Health","Medically Underserved Area","Preventive Health Services","Patient Participation","Health Behavior","Aging","Cardiovascular Diseases","Metabolic Syndrome","Cognitive Dysfunction","Frailty","Activities of Daily Living","Health Related Quality of Life","Health Equity","Telemedecine",[45,46,47,48,49,42,30,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Sequential Platform Trial","Interactive Health Report","Health Activation","Mobile Health Screening","Comparative Effectiveness","Medically Underserved","Preventive Medicine","Patient Engagement","Cardiopulmonary Exercise Testing","Body Composition","DEXA","Health Ahead Bus","Mobile Clinic","Automated Screening","Medical Droids","Biological Age","Healthspan","Longevity","Life Expectancy","Chronic Disease","Cost-Effectiveness","Health Services Research","RECRUITING","2026-06-20",{"date":70,"type":71},"2026-06-25","ACTUAL",{"date":73,"type":23},"2026-06-09",{"date":75,"type":23},"2099-12-31",{"name":77,"class":78},"William Brandenburg, MD","INDUSTRY",1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":79},"100607258","symptom-monitoring-with-supported-feedback-in-advanced-chronic-kidney-disease-100607258","NCT07186218","Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease","Use of an Electronic Patient-Reported Outcome Measure for Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease","Inclusion Criteria:\n\n* Adults (age ≥ 18 years)\n* Advanced CKD, defined as at least two measurements of creatinine-based or cystatin C-based eGFR ≤ 30 mL\u002Fmin\u002F1.73m2 separated by at least 90 days in the preceding 12 months\n* Able to provide consent to participate in the study\n* Able to read and write in English\n* Under the care of a nephrologist at a Mass General Brigham nephrology clinic\n\nExclusion Criteria:\n\n* Terminal illness likely to lead to death within 6 months of participation\n* Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks\n* Patients scheduled to receive a kidney transplant in the next 6 months\n* Patients having their initial clinic visit (i.e., new to the clinic)\n* Cognitive deficits that would preclude understanding of consent form and\u002For questionnaires",{"count":88,"type":23},70,[26],"Patient-reported outcome measures (PROMs) are validated tools to reliably measure outcomes highly prioritized by patients, such as health-related quality of life (HRQOL) and symptoms, but the current clinical impact of PROMs is limited by a lack of evidence-based methods to incorporate them into routine care. Symptoms, which are highly prevalent among persons living with chronic kidney disease (CKD), substantially contribute to the reduced HRQOL experienced by this patient population. HRQOL spans several domains of wellbeing affected by disease, including physical, mental, and social health, functionality, and symptoms. Both HRQOL and symptom burden are consistently identified by patients with CKD as top clinical and research priorities. These issues are particularly salient to individuals living with advanced CKD, who suffer significant symptom burden that is often underrecognized and undertreated by nephrology providers, yet is a key factor considered by nephrologists for the timing of dialysis initiation. Randomized controlled trials of patients with other chronic illnesses show that routine assessment of symptoms with PROMs improves symptom burden, patient-provider communication, and HRQOL; yet, standardized approaches to regular symptom monitoring among patients with advanced CKD are lacking. This pilot, randomized trial of a PROM-based intervention for routine symptom reporting by patients with feedback of responses to nephrologists aims to address the lack of data on PROM use for symptom assessment in nephrology care. We will evaluate the implementation (reach, feasibility, and acceptability) and preliminary efficacy of monthly patient report of CKD-related symptoms using the electronic IPOS-Renal questionnaire with supported clinician follow-up for 12 months versus standard of care. This trial will utilize complementary quantitative and qualitative methods to evaluate the implementation of the PROM-based intervention. The results of this pilot study will inform a definitive, cluster-randomized trial on the effect of a PROM-based symptom assessment intervention to improve HRQOL and clinical outcomes among patients living with advanced CKD.",[92,41],"Chronic Kidney Disease (Stages 4 and 5)",[94,95,96,97],"chronic kidney disease","health related quality of life","patient-reported outcome measure","chronic kidney disease associated symptoms","2026-06-17",{"date":100,"type":71},"2026-06-22",{"date":102,"type":71},"2026-06-11",{"date":104,"type":23},"2030-02-28",{"name":106,"class":107},"Massachusetts General Hospital","OTHER",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":79},"100642287","mobile-based-telemedicine-and-health-related-quality-of-life-among-patients-with-chronic-heart-failure-mobile-hf-100642287","NCT07650474","Mobile-Based Telemedicine and Health-Related Quality of Life Among Patients With Chronic Heart Failure (MOBILE-HF)","Effectiveness of Mobile-Based Telemedicine on Health-Related Quality of Life Among Patients With Chronic Heart Failure: Protocol for a Quasi-Experimental Study","MOBILE-HF","Inclusion Criteria:\n\n* Adults aged 18-65 years who will be diagnosed with CHF (NYHA class II⁃III)\n* Patients with reduced left ventricular ejection fraction LVEF ≤ 40%\n* Patient who will have access to a mobile phone and will be able to use it\n* Patients who will be able to communicate in Amharic, Oromic, or English\n* Patients who will provide written informed consent\n* Patients who will be diagnosed with HF lasting ≥ 6 months, to be confirmed by echocardiography and clinical assessment\n* Patients with no contraindications for mild to moderate physical activity\n\nExclusion Criteria:\n\n* Patients with NYHA class IV or who will require intensive care at enrollment\n* Patients with other severe medical conditions (e.g., end-stage renal disease, \\& end stage liver disease)\n* Patients with severe cognitive impairment or psychiatric illness that will interfere with participation\n* Patients already enrolled in another telemedicine or intervention study\n* Pregnant and lactating women","65 Years",{"count":118,"type":23},72,[26],"Chronic heart failure (CHF) is a long-term condition in which the heart is unable to pump blood effectively. It can cause symptoms such as shortness of breath, fatigue, swelling in the legs, and reduced ability to perform daily activities. These problems often reduce a patient's quality of life and may lead to frequent hospital visits.\n\nThis study will assess whether a mobile-based telemedicine program can improve the health-related quality of life of patients with chronic heart failure in Ethiopia.\n\nIn this study, 70 adult patients with chronic heart failure will be included. They will be divided into two groups: 35 patients will receive routine care plus mobile-based telemedicine support, and 35 patients will receive routine care only.\n\nThe mobile-based telemedicine program will include health education, medication reminders, lifestyle advice, and follow-up support delivered through phone calls and text messages over an 8-week period.\n\nPatients' quality of life will be measured at the beginning of the study and again after 8 weeks using a standard questionnaire called the Minnesota Living with Heart Failure Questionnaire (MLHFQ).\n\nThe main goal of the study is to determine whether mobile-based telemedicine improves quality of life compared with routine care alone. The study may also help improve self-care behaviors, medication adherence, and symptom control among patients with heart failure.\n\nThe findings may provide evidence to support the use of mobile health technologies as a simple and scalable approach to improve heart failure care in Ethiopia.",[122,41],"Chronic Heart Failure",[124,125,126],"Health-related quality of life","Mobile-based telemedicine","Chronic heart failure","2026-06-15",{"date":98,"type":71},{"date":130,"type":71},"2026-03-02",{"date":132,"type":23},"2026-08-21",{"name":134,"class":107},"Select College",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":19,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":24,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":79},"100641376","improving-sexual-and-reproductive-health-communication-for-adolescent-and-young-adult-oncology-patients-100641376","NCT07658937","Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients","Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing","ReSPECT","Inclusion Criteria:\n\n* Age 15-25 years old\n* Has a cancer diagnosis\n* ≥2 months from diagnosis\u002Finitiation of therapy, whichever occurred later\n* Currently on cancer-directed therapy\n* Speaks and reads English\n* Approval from primary oncology team\n* Study participation by primary oncology clinician\n\nExclusion Criteria:\n\n* Not able to provide informed consent\u002Fassent\n* Insufficient cognitive functioning to complete study measures, as determined by a member of the patient's primary oncology team\n* Exceeds primary oncologist's participant limit (3 patients\u002Fclinician)","15 Years","25 Years",{"count":146,"type":23},30,[26],"The goal of this clinical trial is to learn if ReSPECT, which includes a pre-visit checklist for patients to complete and an informational website, can work well in practice to help adolescent and young adult oncology patients communicate with their clinicians about sexual and reproductive health (SRH). SRH includes topics such as how cancer may impact puberty and development, best methods for contraception during cancer treatment, fertility risk and fertility preservation strategies, and dating\u002Frelationships during and after cancer. The study will also help researchers better understand how to best measure the impact of ReSPECT on improving SRH communication for future testing of ReSPECT.\n\nThe main questions the study aims to answer are:\n\nHow well does ReSPECT work in practice? Do patients and clinicians like ReSPECT, and do they find it helpful? What are the best ways to test ReSPECT and measure whether it works?\n\nParticipants will:\n\nUse ReSPECT to support a conversation about SRH during an outpatient oncology clinic appointment Complete surveys before and after using ReSPECT Provide feedback on their experience using ReSPECT in a short interview",[150,151,152],"Health-Related Quality-of-Life","Cancer","Health Communication",[150,154,155,156,152,151],"Adolescent","Young Adult","Psychosocial Intervention","NOT_YET_RECRUITING",{"date":100,"type":71},{"date":160,"type":23},"2026-11-15",{"date":162,"type":23},"2029-06-30",{"name":164,"class":107},"Connecticut Children's Medical Center",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":175,"conditions":176,"keywords":187,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":79},"100641995","human-observatory-study-100641995","NCT07646782","Human Observatory Study","The Human Observatory: A Prospective Individual and Population-Level Study of Aging, Health, and Longevity","HOS","Inclusion Criteria:\n\n* Enrolled in the 100-Year Human Aging Study at any fixed or mobile clinical site; OR completion of online health screener with provision of geographic anchor data and consent.\n\nExclusion Criteria:\n\n* Age under 18 years (current protocol; pediatric amendment planned).",{"count":22,"type":23},"OBSERVATIONAL","The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level. Individual multi-system clinical data from enrolled participants are linked to a continuously-ingested ecological data infrastructure spanning environmental exposures, social determinants, genealogical and family history records, mortality data, and population health databases at geographic resolutions from home address to global scale and beyond. The resulting model generates individual screening recommendations informed by population-level causal estimates, and population-level causal forecasts anchored by present-timepoint individual clinical biology. Thus creating a feedback architecture designed to improve both simultaneously.",[35,177,178,63,36,179,38,37,39,180,181,182,40,41,183,184,185,42,186],"Mortality","All-cause Mortality","Neoplasms","Musculoskeletal Disease","Neurodegenerative Disease","Dementia","Disability Physical","Environmental Exposure","Occupational Diseases","Social Determinants of Health",[188,189,190,191,192,193,194,195,196,197,198,199,200,42,201,202,53,54,51,61,203,204,205,206,207],"longevity","biological aging","causal inference","life expectancy","exposome","Environmental Health","Social Determinants","Genealogy","Family History","Human Family Tree","Population Health","Neighborhood Health","Geographic Health Disparities","Mortality Prediction","Biomarker Validation","Functional Decline","Centenarian","Space Medicine","Aerospace Medicine","World Model",{"date":127,"type":71},{"date":210,"type":71},"2026-04-25",{"date":75,"type":23},{"name":213,"class":78},"Longevity Metrics, Inc.",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":222,"conditions":223,"keywords":229,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":79},"100636291","100-year-human-aging-study-100636291","NCT07563777","100-Year Human Aging Study","100-Year Human Aging Study: Prospective Longitudinal Validation of Multi-System Health Measurements Against Mortality and Aging Outcomes","Inclusion Criteria:\n\n* Age 18 years or older\n* Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative\n* Willing to participate in longitudinal follow-up\n\nExclusion Criteria:\n\n* Age under 18 years",{"count":22,"type":23},"The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed and mobile clinical sites to undergo comprehensive multi-system health screening and longitudinal follow-up until death. Participants are followed to determine whether measurements taken at enrollment and repeated across the lifespan - individually and in combination - predict all-cause mortality, cause-specific mortality, incident serious disease, and functional disability. The study is designed to generate the surrogate endpoint validation data that longevity medicine currently lacks.",[35,224,225,177,37,36,38,226,179,39,40,227,183,228,182],"Aging Well","All-Cause Mortality","Musculoskeletal Diseases","Health-Related Quality of Life","Neuro-Degenerative Disease",[62,53,54,51,230,201,203,61,63,231,232,233,202,234,198,204],"Surrogate Endpoint Validation","Biological Aging","Preventive Screening","Longitudinal Cohort","Human Performance",{"date":102,"type":71},{"date":237,"type":71},"2025-02-09",{"date":75,"type":23},{"name":213,"class":78},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":18,"sex":19,"minAge":116,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":24,"phases":249,"briefSummary":250,"conditions":251,"keywords":257,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":79},"100643409","music-breathing-in-enhancing-resilience-among-elders-at-risk-of-mental-health-problems-100643409","NCT07631845","Music Breathing in Enhancing Resilience Among Elders at Risk of Mental Health Problems","Effects of a Mindfulness-based Music Breathing Intervention in Enhancing Resilience Among Community-dwelling Elders at Risk of Mental Health Problems: A Pilot Randomised Controlled Trial","Inclusion Criteria:\n\n* Aged 65 years or above\n* Able to read Chinese and communicate in Cantonese\u002FMandarin.\n* Has mild to moderate anxiety and\u002For depressive symptoms, based on the - Hospital Anxiety and Depression Scale (HADS) (i.e., a score of 8 or higher on either the anxiety or depression subscale)\n\nExclusion Criteria:\n\n* Partcipants will be excluded if they have cognitive impairment, hearing loss, severe depression, known mental illness, or chronic illness.",{"count":248,"type":23},40,[26],"The goal of this pilot randomised controlled trial is to examine the effects of a mindfulness-based music breathing intervention in enhancing resilience (primary outcome), and in reducing anxiety, depressive symptoms, loneliness, and improving health-related quality of life (secondary outcomes) among community-dwelling older adults at risk of mental health problems.\n\nIt is hypothesised that compared with the control group, participants in the intervention group will report enhanced resilience, reduced anxiety, depressive symptoms, and loneliness, and improved health-related quality of life immediately post-intervention.",[252,253,254,255,256],"Resilience","Anxiety","Depressive Symptom","Loneliness","Health-related Quality of Life",[258,259,260,261,252,262],"Mindfulness","Msuic","Breathing","Community-dwelling elders","Mental health","2026-06-07",{"date":265,"type":71},"2026-06-10",{"date":267,"type":71},"2026-06-08",{"date":269,"type":23},"2026-08-31",{"name":271,"class":107},"Chinese University of Hong Kong",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":24,"phases":281,"briefSummary":282,"conditions":283,"keywords":288,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":79},"100637411","cansolve-20-theme-31-mind-the-gap---dialectical-behavioural-therapy-dbt-skills-training-program-pilot-100637411","NCT07628309","CanSOLVE 2.0 Theme 3.1 Mind the Gap - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot","CanSOLVE 2.0 Theme 3.1 Mind the Gap: Addressing Mental Health Care Gaps for Canadians Receiving Facility-Based Hemodialysis - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot Intervention","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Individuals followed in the Manitoba Kidney Health Program at Seven Oaks General Hospital or Health Sciences Centre sites with advanced chronic kidney disease not yet on facility-based hemodialysis but with plans to start within 1 month; OR\n* Individuals followed in the Manitoba Kidney Health Program at the SOGH or HSC sites who have initiated facility-based hemodialysis within the last 90 days\n* Able and willing to attend weekly DBT sessions (either virtually or in-person)\n* Experiencing self-reported psychological distress related to advanced kidney disease or initiation of hemodialysis\n* Deemed eligible to participate by study clinical psychologist\n\nExclusion Criteria:\n\n* Unable to complete intervention due to planned relocation\u002Ftransplant\u002Fmodality change\n* Unable to communicate in English\n* Deemed by hemodialysis unit staff\u002Fphysician\u002Fstudy psychologist to be unable to participate fully in study activities due to:\n\n  * Actively participating in psychiatric care with psychiatric (DSM-5) diagnosis\n  * Requiring referral for psychiatric care as per facility-based HD care provider assessment\n  * Current psychotic symptoms\n  * Cognitive impairment that would limit ability to participate in group or complete homework\n  * Safety risk to staff (e.g. physical aggression)\n  * Antisocial personality disorder or other issues that may limit ability to constructively participate in peer group\n  * Severe comorbid substance use disorder (if present will offer referral to addictions resources or Addictions Psychiatry)",{"count":280,"type":23},35,[26],"The goal of this pilot implementation study is to implement and evaluate a 13-week dialectical behavioural therapy (DBT) skills training program to address challenges to mental health and mental wellbeing in people who have recently started facility-based hemodialysis or those who may start within the next 6-12 months.",[284,285,286,287,41],"Mental Health","Mental Health Care","Hemodialysis","DIALYSIS SYMPTOMS AND ANXIETY",[289,290,291,292],"hemodialysis","mental health","dialysis anxiety","mental well-being","2026-05-29",{"date":295,"type":71},"2026-06-05",{"date":297,"type":71},"2026-03-05",{"date":299,"type":23},"2026-07-15",{"name":301,"class":107},"University of Manitoba",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":18,"sex":310,"minAge":311,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":79},"100492353","bile-acids-metabolism-and-genetic-mutation-profile-in-the-intrahepatic-cholestasis-of-pregnacy-in-indian-population-100492353","NCT05691036","Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population","Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in Indian Population- A Prospective Study","ICP","Inclusion Criteria -\n\n* Age \\> 21 years with consistent pruritus\n* Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \\> 40 U\u002FL or AST \\> 37 U\u002FL) or raised total serum bile acids (≥ 10 µmol\u002FL)\n* Able to understand and comply with the requirements of the study and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed\n* Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery\n* Agrees to provide information on perinatal and maternal outcomes at or after delivery\n\nExclusion Criteria:\n\n* Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) related liver disease, Epstein Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV) infection) hepatitis C virus (HBV), hepatitis E virus (HEV)\n* Primary dermatologic diseases associated with pruritus\n* Metabolic diseases (including alcohol abuse)\n* Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)\n* Autoimmune liver disease\n* Obstructive biliary diseases\n* Cholestatic drug-induced liver injury\n* Clinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseases\n* Twins and triplet pregnancy","FEMALE","21 Years","45 Years",{"count":314,"type":23},150,"Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol\u002FL (and elevated serum transaminases), with increased risks of perinatal complications, including spontaneous preterm labor, fetal distress, infant respiratory distress syndrome, meconium-stained liquor (MSL), and sudden intrauterine death (IUD). The Incidence of ICP varies from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).",[317,318,41],"Intrahepatic Cholestasis of Pregnancy","Genetic Mutation",[320,321,322],"Intrahepatic cholestasis of pregnancy","Genetic Mutations in pregnancy associated cholestasis","Pruritus","2026-05-13",{"date":325,"type":71},"2026-05-18",{"date":327,"type":71},"2022-12-08",{"date":329,"type":23},"2026-07",{"name":331,"class":107},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":24,"phases":341,"briefSummary":342,"conditions":343,"keywords":368,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":79},"100637694","assessing-the-effects-of-cool-roofs-on-indoor-environments-and-health-in-tavua-fiji-100637694","NCT07592117","Assessing the Effects of Cool Roofs on Indoor Environments and Health in Tavua, Fiji","A Cluster Randomised Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health, Environmental and Economic Outcomes in Tavua, Fiji","Inclusion Criteria:\n\n* Permanent household resident.\n\nExclusion Criteria:\n\n* Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.\n* Participant unable to provide written\u002Fverbal informed consent.",{"count":340,"type":23},800,[26],"Ambient air temperatures in Fiji are increasing due to climate change. Solutions are needed to build heat resilience in communities and adapt. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in Fiji are susceptible to increased heat exposure.\n\nHeat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants.\n\nThe long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Fiji. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Tavua, Fiji.",[344,345,346,347,348,349,350,150,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367],"Resting Heart Rate","Blood Glucose Control","Depression","Heat-related Symptoms","Physician Diagnosed Heat-related Illnesses","Food Insecurity","Diet Quality","Indoor Thermal Comfort","Coping Ability","Life Satisfaction","Healthcare Provider Utilization","Hospitalization","Systolic Blood Pressure","Diastolic Blood Pressure","Inner Ear Canal Temperature","Dehydration","Sleep Quality","Cognition","Productivity","Aggression","Indoor Air Temperature","Indoor Relative Humidity","Indoor Heat Index","Household Energy Expenditure",[369,370,371,372,373,346,262,374,375,376,377],"Hot temperature","Humidity","Housing","Heart rate","Cardiovascular","Blood glucose","Diabetes","Cool roof","Heat stress","2026-05-11",{"date":325,"type":71},{"date":325,"type":23},{"date":382,"type":23},"2027-09-01",{"name":384,"class":107},"Aditi Bunker",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":19,"minAge":393,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":24,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":4},"100639882","creating-encounters-between-generations---together-instead-of-alone-gemse-100639882","NCT07581171","Creating Encounters Between Generations - Together Instead of Alone (GemsE)","Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)","GemsE","Inclusion Criteria:\n\n* Older adults aged 60 years and older who are residents of Hamburg\n* Children and adolescents aged 12 to 21 years with at least one parent with a mental illness and who are residents of Hamburg\n* Sufficient German language proficiency\n* Ability and willingness to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Children and adolescents with severe acute psychological symptoms requiring inpatient treatment, including acute suicidality, acute substance use, or acute psychotic symptoms\n* Older adults with acute psychological crises or untreated severe mental illness preventing reliable participation\n* Older adults with cognitive impairment or dementia preventing reliable participation in the intervention","12 Years",{"count":395,"type":23},80,[26],"Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and quality of life of both groups. The aim of the study is to scientifically record the effect of these sponsorships and to find out how such encounters can be successfully organized.",[255,399,256],"Mental Well-being",[401,402,403,404,405],"elderly people","children of parents with mental illness","loneliness","psychosocial health","intergenerational tandems","2026-05-06",{"date":408,"type":71},"2026-05-12",{"date":410,"type":23},"2026-06-01",{"date":412,"type":23},"2026-12-01",{"name":414,"class":107},"Universitätsklinikum Hamburg-Eppendorf",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":19,"minAge":422,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100622022","phase-4-the-effect-of-corticosteroids-on-quality-of-life-following-total-hip-arthroplasty-hipster-study-100622022","NCT07378215","The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study","HIPSTER","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for elective total hip arthroplasty;\n* procedure under spinal anaesthesia.\n\nExclusion Criteria:\n\n* hip revision surgery (reoperation);\n* bilateral total hip arthroplasty during the same procedure;\n* known hypersensitivity to dexamethasone or other corticosteroids;\n* chronic systemic use of corticosteroids, defined as daily corticosteroid therapy for \\> 4 weeks within the last 3 months, with anticipated need for a perioperative stress dose of corticosteroids;\n* active gastric of intestinal ulcers;\n* lack of informed consent or inability to give informed consent;\n* urgent, non-elective surgery.","60 Years",{"count":424,"type":23},224,[426],"PHASE4","Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Dexamethasone, a potent glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery and incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA to reduce pain, PONV, and fatigue. While intermediate doses of dexamethasone (25 mg) are considered safe and beneficial in the short term, their long-term effects on health-related quality of life and persistent pain remain unclear.\n\nTherefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.",[429,150,430],"Postoperative Quality of Recovery","Quality of Life",[432,433,434,435,436,437],"Hip Arthroplasty","Older adult patients","Dexamethasone","Enhanced Recovery After Surgery (ERAS)","Quality of recovery","Quality of life","2026-04-07",{"date":440,"type":71},"2026-04-08",{"date":442,"type":71},"2026-01-30",{"date":444,"type":23},"2027-02",{"name":446,"class":107},"Ziekenhuis Oost-Limburg",2,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":457,"briefSummary":458,"conditions":459,"keywords":463,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":79},"100574087","decentralized-clinical-trial-of-effectiveness-of-energypoints-app-in-cancer-survivors-100574087","NCT06754722","Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors","Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors","Inclusion Criteria:\n\n* Have cancer or have been treated for cancer;\n* at least a moderate level of fatigue (greater than 4 on a 0 to 10 Likert-type scale);\n* able to read and speak in English;\n* age 18 years or older; Android 11 or later),\n* adequate hearing, vision, and functional ability to see, hear and use the app and participate in interviews,\n* willing to wear a provided Fitbit 24\u002F7 (except when charging) throughout the study.\n\nExclusion Criteria:\n\n* recent history of easy bruising or bleeding\n* previous use of the EnergyPoints app.\n\nNote: The functional ability questions will exclude anyone who is too sick to participate due to life-limiting disease.",{"count":456,"type":23},180,[26],"The purpose of the study is to evaluate whether EnergyPoints, a mobile phone health app that guides the participant to do self-acupressure, can decrease fatigue and improve sleep. Acupressure consists of applying physical pressure with fingers or a device to small locations on the body called acupoints.\n\n* The investigators will conduct this clinical trial remotely, allowing participants to use the app wherever they are. Participation will involve using the app daily while wearing a fitness tracker (a Fitbit) on the wrist, answering questions on the app and online, as well as completing a questionnaire and participating in an online interview at the end of the study. Participants will be assigned by chance to one of two groups. In both groups, participants will have a 1 week baseline week (Week 0) to get used to the Fitbit. Participants in the Immediate Group will start the 6 week trial of EnergyPoints immediately (Week 1). Participants in the Wait-List Group will be on a wait-list for 6 weeks during which time they will wear the Fitbit and answer online questions daily and weekly. At the end of the waiting period (week 7), these participants will begin the 6 week trial of EnergyPoints.\n* The risks to participating are minimal. There is a small risk of bruising or getting sore at a point where participants apply pressure. As with any mobile app, there is the possibility that electronic information could be viewed by third parties not involved in the study. The investigators cannot promise any benefits from participating in the study. However, it is possible that using acupressure might improve fatigue or sleep. Participants may use any other approaches to improve fatigue and sleep while in the study.\n\nA pilot study will be conducted first with 8 participants and 1 week periods (1 week baseline, 1 week waitlist, and 1 week intervention followed by an End of Study Questionnaire and Exit Interview",[460,461,462,256],"Cancer-related Problem\u002FCondition","Fatigue in Cancer Survivors","Sleep Disturbances",[464,465,466,467,468,469],"fatigue","sleep disturbances","acupressure","mobile health app","cancer survivors","cancer symptoms","2026-04-05",{"date":438,"type":71},{"date":473,"type":71},"2026-04-01",{"date":475,"type":23},"2027-12-31",{"name":477,"class":78},"5 Point App, Inc.",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":338,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":497,"locationsCount":79},"100580253","assessing-the-effects-of-cool-roofs-on-indoor-environments-and-health-in-colima-mexico-100580253","NCT06834893","Assessing the Effects of Cool Roofs on Indoor Environments and Health in Colima, Mexico","A Cluster Randomised Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health, Environmental and Economic Outcomes in Colima, Mexico","REFLECT",{"count":340,"type":23},[26],"Ambient air temperatures in Mexico have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the northern zone of Mexico are susceptible to increased heat exposure.\n\nHeat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants.\n\nThe long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Mexico. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Colima, Mexico.",[344,345,346,347,348,349,350,256,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367],[490,370,371,372,373,346,262,374,375,376,491],"Hot Temperature","Heat Stress","2026-03-10",{"date":494,"type":71},"2026-03-12",{"date":473,"type":23},{"date":382,"type":23},{"name":384,"class":107},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":484,"eligibilityCriteria":338,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":24,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100560653","assessing-the-effects-of-cool-roofs-on-indoor-environments-and-health-100560653","NCT06579950","Assessing the Effects of Cool Roofs on Indoor Environments and Health","The Effects of Cool Roofs on Health, Environmental, and Economic Outcomes: a Global Multi-center Cluster-randomized Controlled Trial",{"count":505,"type":23},3200,[26],"Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure.\n\nHeat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants.\n\nThe long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.",[344,345,346,347,348,349,350,256,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367],[490,370,371,372,373,346,262,374,375,376,491],"2026-02-25",{"date":512,"type":71},"2026-02-27",{"date":514,"type":71},"2024-09-04",{"date":516,"type":23},"2027-09-30",{"name":384,"class":107},5,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":422,"enrollmentInfo":526,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":528,"conditions":529,"keywords":532,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":4},"100621888","psychometric-validation-of-the-mqol-fr-and-descriptive-assessment-of-quality-of-life-in-patients-with-meningiomas-100621888","NCT07376473","Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas","MenQOL 2","Inclusion Criteria :\n\n* Inclusion Criteria:\n* Age ≥ 18 years\n* Diagnosis of intracranial meningioma on imaging and\u002For confirmed by surgery\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Individuals deprived of liberty by judicial\u002Fadministrative decision or under compulsory psychiatric care\n* Insufficient French language proficiency\u002Fcomprehension\n* Unable to complete the questionnaires independently\n* Unable to express non-opposition to participation",{"count":527,"type":23},238,"This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma.\n\nParticipants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care.\n\nThe study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and\u002For confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient\u002Fcommunity networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.",[530,531,256],"Intracranial Meningioma","Meningioma",[533,534,535,536,537,538,539,540,541,542,543,544,545,546],"meningioma","intracranial meningioma","quality of life","health-related quality of life","HRQoL","patient-reported outcomes","PRO","questionnaire validation","psychometric validation","MQOL","FACT-Br","EQ-5D-5L","REDCap","neurosurgery",{"date":548,"type":71},"2026-02-03",{"date":550,"type":23},"2026-02-02",{"date":552,"type":23},"2026-09-02",{"name":554,"class":107},"Centre Hospitalier St Anne",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":563,"targetDuration":565,"studyType":174,"phases":4,"briefSummary":566,"conditions":567,"keywords":572,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":79},"100611495","psychological-well-being-depression-and-health-related-quality-of-life-in-adults-with-type-2-diabetes-a-cross-sectional-study-100611495","NCT07241325","Psychological Well-Being, Depression, and Health-Related Quality of Life in Adults With Type 2 Diabetes: A Cross-Sectional Study","A Cross-Sectional Observational Study to Evaluate Psychological Well-Being, Depression, and Health-Related Quality of Life and Their Demographic and Clinical Correlates in Adults With Type 2 Diabetes Attending an Outpatient Metabolic Clinic","PWDQ-T2D","Inclusion Criteria:\n\n1. Adults aged 18 years or older with full legal capacity.\n2. Clinically diagnosed with Type 2 Diabetes Mellitus and receiving ongoing outpatient care.\n3. Able to read and understand Chinese questionnaires and complete self-administered forms.\n4. Understand the study purpose and procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder).\n2. Moderate to severe cognitive impairment or dementia, as assessed by the clinical physician, making it impossible to complete the questionnaires.\n3. Currently experiencing acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) or hospitalization.\n4. Severe language or other communication barriers preventing expression of consent or understanding of study content.",{"count":564,"type":23},500,"1 Day","This prospective cross-sectional observational study aims to explore the relationships among psychological well-being, depression, and quality of life in patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study will collect data using standardized instruments, including the EQ-5D Health-Related Quality of Life Questionnaire, the PHQ-9 Depression Scale, and the Shalom Scale of Psychological Well-Being, along with demographic and clinical variables such as age, sex, education, body mass index, HbA1c, disease duration, and psychosocial support indicators. Descriptive statistics, Pearson correlation analyses, ANOVA, and multiple linear regression modeling will be performed to identify factors associated with psychological well-being. The findings are expected to provide evidence-based insights to inform tailored interventions and improve the mental health and quality of life of patients with type 2 diabetes.",[568,256,569,570,571],"Type 2 Diabetes Mellitus (T2DM)","Depressive Symptoms","Psychological Well-being","Spiritual Well-being",[573,574,346,575,544,576,577,578,579,580,581],"Type 2 Diabetes Mellitus","Psychological Well-Being","PHQ-9","Shalom Scale","Spiritual Well-Being","Psychosocial Support","Cross-Sectional","Observational","Taiwan","2026-01-26",{"date":584,"type":71},"2026-01-28",{"date":586,"type":71},"2025-09-19",{"date":588,"type":23},"2026-10-01",{"name":590,"class":107},"National Taiwan University Hospital",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":24,"phases":600,"briefSummary":601,"conditions":602,"keywords":611,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":447},"100611237","cocreating-action-to-improve-rationality-in-the-health-system-100611237","NCT07237971","Cocreating Action to Improve Rationality in the Health System","CAIR","Survey general population:\n\nA representative population survey of adult (aged 18 years and over) who are residents in the Municipal District 2 of Elche (Spain).\n\nSurvey community pharmacies:\n\nIndividuals who visit the pharmacies collaborating in the Municipal District 2 of Elche (Spain) to obtain any of the medications, aged 18 years and over for three a priori established medication groups.\n\n* Group 1 (Antidepressants and Anxiolytics): N05B, N05C, N06A.\n* Group 2 (Cardiovascular disease risk factor medication): A10B (antidiabetics), C10A (cholesterol-lowering drugs), C07A, C09A, C03C, C08C (antihypertensives).\n* Group 3 (Antibiotics): J01\n\nHealth service data from primary care:\n\nA series of aggregate indicators will be collected from the electronic information systems of the regional health authorities (Conselleria de Sanidad de la Generalitat Valenciana), which hosts information on both prescriptions made by physicians and those dispensed in the community pharmacies of the Valencian Community. These indicators will be calculated for individuals aged 18 years and over for groups 2 and 3, and 12 years and over for group 1 using aggregate data from health system's registries and, therefore, not considering 12 years old as minimum age limit of the eligible participants in the present study protocol registry. Furthermore, aggregate data about the number of consultations will be collected in the two primary care facilities in the study area for individuals aged 18 and over.\n\nQualitative methods and cocreation procedure:\n\nFocus groups, sociograms and in-depth interviews will include 6-8 participants and last approximately 90 minutes. Participation in the co-creation process will be open, voluntary, and will depend on the interest of individuals and entities in the area. Eligibility criteria:\n\n* People aged 18 and over who are residents or have a job or family connection in the Municipal District 2 of Elche (Spain) who are interested in participating, wish to be actively involved in the co-creation, planning, and implementation of community initiatives, and are available to attend the conferences, meetings, and workshops.\n* Representatives from community institutions and associations, including professionals from the Elche Public Health Center, primary care teams in the area, Elche Council staff, as well as professionals and volunteers from NGOs and other local organizations with experience in community work in the district.",{"count":599,"type":23},4000,[26],"Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity.\n\nThe scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.\n\nThe goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.",[150,603,604,605,606,607,608,609,610,42],"Social Capital","Health Literacy","Community Based Participatory Research","Antibiotic Prescription","Mental Health Literacy","Cardio Vascular Disease","Antimicrobial Drug Resistance","Well-being",[612,613,614,615,616,617,618,619,620,124,621],"Community health","Cocreation action","Health system","Health literacy","Social capital","Community capital","Antibiotic drug use","Cardiovascular drug use","Psychotropic drug use","Health equity","2025-11-24",{"date":624,"type":71},"2025-12-02",{"date":626,"type":71},"2025-10-21",{"date":628,"type":23},"2029-04-01",{"name":630,"class":107},"Universidad Miguel Hernandez de Elche",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":24,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":79},"100562039","dyadic-sport-stacking-program-for-mild-dementia-and-their-family-caregivers-100562039","NCT06597981","Dyadic Sport Stacking Program for Mild Dementia and Their Family Caregivers","Development and Testing of a Dyadic Empowerment-based Sport Stacking Program to Improve Health Outcomes of People With Mild Dementia and Their Family Caregivers","Inclusion Criteria:\n\n\\- People living with dementia (PLwD) : i) Clinical diagnosis of dementia, in accordance with the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-V); ii) a minimum age of 60 years; iii) Clinical Dementia Rating (CDR) score of 1; iv) home-dwelling; v) able to communicate with the research personnel to understand training program and assessments; vi) have adequate hearing and visual function to enable skill learning; vii) informed consent.\n\n\\- Family caregivers: i) aged 18 years or above; ii) living with or providing care to PLwD at least 4 hours\u002Fday; iii) able to understand and communicate in Chinese; iv) have access to smartphone\u002FiPad\u002Flaptop and are users of one of these devices; v) consent to participate.\n\nExclusion Criteria:\n\n\\- People living with dementia (PLwD) : i) severe mental and behavioral disorders; ii) any acute medical condition precluding participation in the program (e.g., pneumonia and cardiac insufficiency); iii) concurrent participation in other studies.\n\n\\- Family caregivers: i) physically not able to participate in the sport stacking due to physical problems; ii) suffer from acute psychotic condition; iii) unable to support the PLwD in the delivery of sport stacking sessions.",{"count":639,"type":23},144,[26],"The goal of this clinical trial is to develop and test a dyadic empowerment-based sport stacking program to improve health outcomes of people with mild dementia and their family caregivers.\n\nThe research hypotheses to be tested are:\n\ni) People with dementia who receive the dyadic empowerment-based sport stacking program will report a greater improvement in cognitive function, a greater reduction in cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms, and a greater improvement in health-related quality of life (HRQOL) at T1 (12th week) and T2 (18th week), compared to the usual care group; ii) Caregivers who receive the dyadic empowerment-based sport stacking program will report less stressful in managing the cognitive and neuropsychiatric symptoms, a greater reduction in depressive symptoms and a greater improvement in HRQOL at T1 (12th week) and T2 (18th week), compared to the usual care group; iii) The care dyads who receive the dyadic empowerment-based sport stacking program will report less dyadic relationship strain at T1 (12th week) and T2 (18th week), compared to the usual care group.\n\nFor the intervention group, the care dyads will receive an 18-week dyadic empowerment-based sport stacking program, which is divided into two phases: the active phase (weeks 1-12) and the maintenance phase (weeks 13-18). In the active phase, the care dyads will engage in three online sessions in small groups (3-5 dyads\u002Fgroup) and three check-up\u002Fsupport sessions. Three online sessions will be scheduled at weeks 1, 3, and 9 during the 12-week active phase. They will also be required to engage in self-practice at home for at least 30 minutes per day, five times per week during this time according to their training schedule. In the maintenance phase, there will be three online sessions in small groups (3-5 dyads\u002Fgroup). Three online sessions will be scheduled at weeks 13, 16, and 18. The dyads will continue their self-practice at home (at least 30 minutes\u002Fday, five times\u002Fweek) for 6 weeks.\n\nParticipants in the control group will receive basic education on dementia caregiving, which will comprise three group-based (3-5 dyads\u002Fgroup) online meetings in the same schedule as the intervention group (1st, 3rd, 9th week).",[182,643,644,41,361],"Family Caregivers","Dyadic Intervention","2025-11-17",{"date":647,"type":71},"2025-11-20",{"date":649,"type":71},"2024-09-19",{"date":651,"type":23},"2026-05-31",{"name":653,"class":107},"The University of Hong Kong",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":18,"sex":19,"minAge":661,"maxAge":20,"enrollmentInfo":662,"targetDuration":4,"studyType":24,"phases":664,"briefSummary":665,"conditions":666,"keywords":672,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":447},"100608585","where-wild-things-grow-nature--and-activity-based-group-interventions-for-neurodivergent-children-and-youth-100608585","NCT07203469","Where Wild Things Grow: Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth","Where Wild Things Grow: Immediate and Long-term Impact of Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth in School, Health Care and Leisure Settings in Agder","Inclusion Criteria:\n\n* In PhD 1, participants are recruited on class-level (all) or individual (identified need).\n* In PhD 2, inclusion criteria are patients that participate in the specific interventions.\n\nExclusion Criteria:\n\n* In PhD 2, exclusion criteria include substance misuse, acute psychosis, current suicidal behavior\u002Fideation, and severe eating disorders.","5 Years",{"count":663,"type":23},240,[26],"The goal of this action research project is to develop and implement nature- and activity-based group interventions across health care, school and leisure settings in Southern Norway. The interventions are tailored to support the mental health, self-efficacy and daily life functioning of children and youth in the Agder region, with a particular focus on youngsters who struggle due to neurodivergence, such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD) or Tourette's syndrome.\n\nThe main questions we aim to answer are:\n\n1. To what extent does nature- and activity-based outdoor education contribute to improvements in children's quality of life?\n2. To what extent does nature- and activity-based interventions in a health care setting improve children's self-efficacy, self-esteem and quality of life?\n3. Is there a difference in physiological reactions between nature-based provision of education or therapy and traditional indoor provision of education or therapy?\n\nParticipants will take part in a 12-week school-based or health care intervention.",[667,668,669,670,150,671],"Neurodevelopmental Outcomes","ADHD - Attention Deficit Disorder With Hyperactivity","Autism","Tourette Syndrome","Heart Rate Variability (HRV)",[673,674,675,676,669,124,677,678,679],"Nature-based","Action research","child and adolescent mental health","ADHD","outdoor therapy","experiential education","heart rate variability","2025-10-01",{"date":682,"type":71},"2025-10-02",{"date":684,"type":71},"2025-09-01",{"date":686,"type":23},"2027-06-15",{"name":688,"class":689},"Sorlandet Hospital HF","OTHER_GOV",{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":18,"sex":19,"minAge":698,"maxAge":699,"enrollmentInfo":700,"targetDuration":4,"studyType":24,"phases":702,"briefSummary":703,"conditions":704,"keywords":707,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":713,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":79},"100603411","healthy-older-adults-through-movement-and-engagement-100603411","NCT07136168","Healthy Older Adults Through Movement and Engagement","Healthy Ageing - an Interdisciplinary Randomised Study of Health Dialogues in Primary Care","HOME","Inclusion Criteria:\n\n* Living in Borgholm municipality or in one of 7 matched Demographical Statistical Area in Kalmar county\n* Age between 67-84 years\n\nExclusion Criteria:\n\n* Living in a nursing home\n* Not speaking or understanding swedish language","67 Years","84 Years",{"count":701,"type":23},2952,[26],"The HOME Project evaluates the effects of structured health dialogues with individuals aged 67-84 years in the municipality of Borgholm, Sweden. A combination of registry data and survey responses will be used to monitor quality of life, morbidity, healthcare needs, and lifestyle factors over a six-year period. Outcomes will be compared between randomized groups within Borgholm municipality and a matched control group from seven other municipalities in Region Kalmar.\n\nThe project also includes an analysis of cost-effectiveness and the reach of the intervention. A qualitative interview study will explore participants' perceptions of their health, their motivations for health improvement, and their experiences of how the health dialogues may influence these aspects.\n\nIn a substudy, machine learning models will be developed to predict functional decline and high healthcare needs among older adults. These models will be validated against established risk assessment tools such as the Adjusted Clinical Groups (ACG) system and the Charlson Comorbidity Index. Digital motion analysis using Skeleton Avatar Technology will be employed both independently and in combination with other variables to support model development.",[39,705,706,41],"Ageing Well","Prevention Intervention",[708,709,710,711,712,95],"health dialogue","frailty","cost-effectiveness","ageing well","primary care",{"date":714,"type":71},"2025-10-07",{"date":716,"type":71},"2025-08-25",{"date":718,"type":23},"2031-12-31",{"name":720,"class":689},"Linkoeping University",{"id":722,"slug":723,"hasResults":12,"nctId":724,"briefTitle":725,"officialTitle":726,"acronym":727,"eligibilityCriteria":728,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":729,"targetDuration":731,"studyType":174,"phases":4,"briefSummary":732,"conditions":733,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":741,"completionDateStruct":743,"leadSponsor":744,"locationsCount":79},"100562580","somatic-dysfunction-in-patients-with-acute-cerebrovascular-disease-100562580","NCT06605014","Somatic Dysfunction in Patients With Acute Cerebrovascular Disease","Characterization of Somatic Dysfunction in Patients With Acute Cerebrovascular Disease","SOMADC-AC","Inclusion Criteria:\n\n* adults ≥18 years\n\nAdmission diagnosis:\n\n* ischemic stroke OR\n* transient ischemic attack (TIA). A prior history of TIA but without stroke may be enrolled.\n* Neurologic stability or lack of significant deterioration (i.e. ∆ NIHSS\\\u003C4) for at least 24 hours (defined by clinical documentation and\u002For communication with provider team(s)) in stroke subjects\n* Able to sit upright, lie supine, and when able lateral recumbent left\u002Fright positions with assist independently or with minimal person assist\n* Anticipated length of stay greater \\> or = 2 days for ischemic stroke. TIA patients average length of stay is \\\u003C 2 days, and can be enrolled in the study.\n\nExclusion Criteria:\n\n* Acute skeletal fracture or known dislocation; history of pathologic (osteoporotic or neoplastic) skeletal fracture of thoracic cage, hip\u002Fpelvis\u002Fsacrum, or vertebral column\n* Prior history of ICH, ischemic stroke, confirmed by imaging and\u002For clinical evaluation. Patients with imaging showing \"chronic stroke\" who have never received a diagnosis of stroke and\u002For have not been previously symptomatic may still be enrolled, based on the Investigator's clinical judgement.\n* Spinal column support brace (e.g. cervical collar)\n* Anticipated neurosurgical intervention during hospitalization: decompressive hemicraniectomy, hematoma evacuation (defined by clinical documentation and\u002For communication with provider team(s))\n* Current endotracheal intubation (\\*note: extubated patients can be evaluated for eligibility)\n* History of spinal cord injury with residual neuromuscular or sensory disability\n* History of recent trauma within the past 30 days\n* Known ligament, musculotendinous, or bone lesion\n* Clinical condition that would interfere with execution of movement or palpatory diagnostic testing, e.g. chronic pain\n* History of spinal surgery",{"count":730,"type":23},120,"90 Days","The goals of this observational study are to test the reliability of a new, standardized physical examination method to identify motion problems within joints or groups of joints among adult asymptomatic volunteers and in patients hospitalized with stroke or stroke-like episodes (e.g., transient ischemic attack, TIA). The main questions this investigation aims to answer are:\n\n* Can different, independent providers reliability quantify motion pattern problems using a systematic approach called, The Functional Pathology of the Musculoskeletal System (FPMSS) model?\n* Are there differences in joint(s) motion patterns among asymptomatic volunteers, patients with TIA (people with brain disease without new neurologic disability), and recent ischemic stroke (patients with new stroke-related-disability, e.g., paralysis)?\n* Is there an association between joint(s) motion impairment severity and stroke survivor outcomes?\n\nParticipants (asymptomatic and those with stroke) will undergo a set of repeated paired, musculoskeletal physical exams by independent providers blinded to each other's assessments and patient information. Researchers will compare the severity, location, and quantity of joint(s) motion impairment between these three groups with the physical examination methodology (FPMSS). Clinical information (e.g., test results, diagnoses, brain imaging, medical history) will be collected from patients admitted for TIA and stroke. Enrolled participants with recent stroke will complete a survey three months after hospitalization to determine their self-perceived quality-of-life.",[734,735,736,737,150],"Stroke, Acute","TIA","Reproducibility of Results","Osteopathic Manipulation","2025-09-24",{"date":740,"type":71},"2025-09-26",{"date":742,"type":71},"2023-09-01",{"date":269,"type":23},{"name":745,"class":107},"University of California, Davis",{"id":747,"slug":748,"hasResults":12,"nctId":749,"briefTitle":750,"officialTitle":751,"acronym":4,"eligibilityCriteria":752,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":753,"targetDuration":755,"studyType":174,"phases":4,"briefSummary":756,"conditions":757,"keywords":758,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":761,"lastUpdatePostDateStruct":762,"startDateStruct":764,"completionDateStruct":766,"leadSponsor":768,"locationsCount":79},"100595198","effectiveness-evaluation-of-social-prescribing-100595198","NCT07029334","Effectiveness Evaluation of Social Prescribing","Effectiveness Evaluation in the SHINE Research Programme - Social Prescribing for Adults and Elderly: The Path to Effective Implementation","All participants in the SP intervention are invited consecutively to participate in the effectiveness evaluation by the Link Worker. There are no exclusion or inclusion criteria in the effectiveness evaluation of the SP intervention.",{"count":754,"type":23},350,"9 Months","Social Prescribing (SP), or Social Henvisning (SH) in Denmark, integrates healthcare with social and cultural services to address social determinants of health. The 'Social Prescribing Vesterbro-Sydhavnen' initiative, launched in fall 2024 as part of usual care, aims to involve general practitioners (GP) as primary prescribers to social services through a dedicated link worker, enhancing early intervention and connecting healthcare with community support.\n\nThis evaluation aims to assess the effectiveness of the 'Social Prescribing Vesterbro-Sydhavnen' project as part of the Implementation Research Programme SHINE.\n\nThe primary outcomes are: changes in contacts with general practice, unplanned hospital contacts and emergency calls (1813) as well as change in patients' perception of loneliness and health-related Quality of life.",[255,41],[759,760],"Social Prescribing","Public Health","2025-07-23",{"date":763,"type":71},"2025-07-24",{"date":765,"type":71},"2025-07-04",{"date":767,"type":23},"2027-03-01",{"name":769,"class":107},"Hvidovre University Hospital",{"id":771,"slug":772,"hasResults":12,"nctId":773,"briefTitle":774,"officialTitle":775,"acronym":776,"eligibilityCriteria":777,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":778,"targetDuration":780,"studyType":174,"phases":4,"briefSummary":781,"conditions":782,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":783,"lastUpdatePostDateStruct":784,"startDateStruct":786,"completionDateStruct":788,"leadSponsor":790,"locationsCount":79},"100553769","the-impact-of-supervision-by-a-health-care-professional-on-quality-of-life-questionnaire-100553769","NCT06490393","The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire","The Impact of Supervision by a Health Care Professional on Quality of Life (QoL) Questionnaire Scoring and Completion:, Randomized, Cross-over Study in Cancer Patients Receiving Systemic Antineoplastic Therapy","IMSUP","Inclusion Criteria:\n\n* Patient is ≥18 years of age and legally competent\n* Signed informed consent available\n* Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)\n* Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval\n* Patient is ready and able to complete quality of life questionnaires in German (on paper\n\nExclusion Criteria:\n\n* One or more of the inclusion criteria not met.",{"count":779,"type":23},200,"2 Months","Effect of supervision on scoring and completion on Quality of Life Questionnaire",[256],"2024-07-04",{"date":785,"type":71},"2024-07-08",{"date":787,"type":71},"2024-04-17",{"date":789,"type":23},"2027-07-01",{"name":791,"class":107},"St. Claraspital AG",{"id":793,"slug":794,"hasResults":12,"nctId":795,"briefTitle":796,"officialTitle":797,"acronym":798,"eligibilityCriteria":799,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":800,"targetDuration":4,"studyType":24,"phases":802,"briefSummary":803,"conditions":804,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":813,"lastUpdatePostDateStruct":814,"startDateStruct":816,"completionDateStruct":818,"leadSponsor":820,"locationsCount":447},"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":801,"type":23},147,[26],"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.",[805,806,807,808,809,810,256,811,812],"Physical Activity","Exercise Training","Kidney Transplantation","Physical Fitness","Cardiovascular Health","Gut Microbiome","Implementation","Cost-effectiveness","2024-02-07",{"date":815,"type":71},"2024-02-15",{"date":817,"type":71},"2022-11-14",{"date":819,"type":23},"2029-12",{"name":821,"class":107},"KU Leuven"]