[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Nepal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":706},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,58,0,25,[9,49,74,104,136,164,194,224,249,280,301,326,348,374,406,431,466,497,526,552,578,606,634,660,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100634462","phase-4-the-intervening-for-lung-health-trial-100634462",false,"NCT07540000","The INTERvening for LUNG Health Trial","The INTERvening for LUNG Health (INTERLUNG) Trial: A Pragmatic Hybrid Implementation-Effectiveness Trial of Community-Based Interventions to Improve Respiratory Health in Bhaktapur, Nepal","INTERLUNG","Inclusion Criteria\n\n* Age ≥9 years at enrollment.\n* Resident of the Bhaktapur district and member of a household willing to participate in study procedures.\n* Pre-bronchodilator FEV1\u002FFVC at or below the 10th percentile (Z-score ≤ -1.28) based on Global Lung Function Initiative reference equations.\n* Presence of at least one respiratory risk factor, including:\n* usual cough or phlegm, wheezing in the past 12 months, self-reported prior pulmonary tuberculosis, physician-diagnosed asthma, ever smoking, or occupational exposure to dust or smoke.\n* Willing and able to provide written informed consent (or assent with parental\u002Fguardian permission for participants \\\u003C18 years).\n* Willing to participate in study assessments and follow-up visits during the 40-month study period.\n\nExclusion Criteria\n\n* Medical condition that precludes safe performance of spirometry.\n* Acute respiratory illness at the time of enrollment that would prevent reliable baseline spirometry testing.\n* Plans to move out of the study area during the follow-up period. Inability or unwillingness to comply with study procedures or follow-up visits.\n* Any other condition that, in the opinion of the investigators, would interfere with participation or interpretation of study results.\n\nHousehold members:\n\n* Household members of enrolled index participants may participate in certain assessments and receive selected intervention components if the index participant is randomized to the intervention arm and provides informed consent or assent.","ALL","9 Years",{"count":21,"type":22},800,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung health for people at risk of chronic respiratory diseases (such as asthma or COPD) in Bhaktapur, Nepal. The program focuses on reducing tobacco smoke exposure, reducing indoor and outdoor air pollution exposure, preventing respiratory infections (including vaccination and mask use during viral seasons), and encouraging safe physical activity. The \"index participant\" is the main enrolled participant in the household who is randomized to the intervention or control arm.\n\nThe participant will be in the study for about 40 months and will have 11 research visits: one at baseline and then every 4 months through month 40. At visits, staff will do breathing tests (spirometry before and after an inhaled medicine), measure exhaled carbon monoxide, check blood pressure, measure height\u002Fweight at selected visits, and ask questions about symptoms, smoking, infections, vaccines, and quality of life. The participant will also wear an activity monitor (accelerometer) for 2 weeks at baseline and at follow-up visits. If individual is a household member (not the index participant), the participant may be asked to complete baseline and follow-up assessments every 4 months through month 40, will receive the influenza vaccine and will primarily be asked to use masks and handwashing during household respiratory illness episodes (only if the index participant is randomized to the intervention) and will not be asked to wear an activity monitor. If the participant is in the pilot phase, participation will last about 2 months. the participant will complete baseline procedures and pilot follow-up visits during those 2 months instead of the full 40-month schedule.",[28],"Spirometry",[30,31,32,33,34,35],"Tobacco Prevention","Air Pollution","Physical Activity","Behavioral Intervention","Human-Centered Design","Infectious Risk","NOT_YET_RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-12","ACTUAL",{"date":42,"type":22},"2026-09-15",{"date":44,"type":22},"2030-07-01",{"name":46,"class":47},"Johns Hopkins University","OTHER",2,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100594198","phase-2-emetine-for-viral-outbreaks-aka-evolve-antiviral-initiative-100594198","NCT07016321","Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)","Emetine for Viral Outbreaks: A Phase 2\u002F3 Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Emetine for Dengue Fever (a.k.a. EVOLVE Antiviral Initiative)","Inclusion Criteria:\n\n1. Age 18 to 65 years\n2. Admitted to the hospital\n3. Laboratory-confirmed infection with dengue virus within the last 5 days and preferably within the last 3 days. Testing for dengue virus using positive Nonstructural protein 1(NS1) strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR)\n4. Having two or more clinical symptoms (fever, headache, retro-orbital pain, myalgia, arthralgia, rash, hemorrhagic manifestations, or leucopenia, gastrointestinal symptoms) with the onset of fever within 72 hours of presentation, and\n5. Able to provide voluntary informed consent and comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Age ≥65 years\n2. Pregnant or breastfeeding\n3. Current or recent use of the study drug\n4. Known allergy to study drug\n5. Current or planned participation in another pharmacological interventional trial in the next 10 days\n6. Participants with known past history of dengue infection\n7. Participants on aspirin, anticoagulants, or with other conditions that might increase the risk of bleeding\n8. Participants on immunosuppressive agents, including long-term steroids\n9. Severe dengue as defined by the WHO 2009 revised case classification.\n10. Individuals with long-term immunosuppressive agents such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or those on systemic corticosteroid therapy\n11. History of prior vaccination against dengue fever within one year.\n12. Patients who have recently used ayurvedic or herbal medications for dengue or any other conditions in the last 7 days (eg, Papaya leaf extract)","18 Years","65 Years",{"count":59,"type":22},600,[61,62],"PHASE2","PHASE3","The goal of this study is to evaluate the efficacy and safety of emetine administered orally for symptomatic patients aged 18-65 years infected with the dengue virus. The main questions it aims to answer are:\n\n1. Does emetine reduce 28-day mortality or progression to severe dengue (severe plasma leakage, severe bleeding, or severe organ involvement)?\n2. What are the safety outcomes of emetine, including serious adverse events and toxicities?\n\nParticipants will be asked to:\n\n1. Take either 6mg emetine, 12mg emetine, or a placebo pill for 7 consecutive days as part of the treatment regimen.\n2. Have blood samples taken for at least 5 days to monitor viral load, inflammatory markers, and safety parameters.\n3. Be monitored by healthcare staff for daily vital signs and symptoms for clinical assessments for 28 days.",[65],"Dengue","2026-08-03",{"date":68,"type":40},"2026-08-04",{"date":70,"type":22},"2026-09-01",{"date":72,"type":22},"2029-05-03",{"name":46,"class":47},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100631922","nurse-led-intervention-on-self-care-adherence-and-quality-of-life-100631922","NCT07506980","Nurse Led Intervention on Self Care Adherence and Quality of Life","Effect of Nurse-led Intervention on Self-care Adherence and Quality of Life Among Patients Undergoing Hemodialysis.","Selfcare","Inclusion Criteria:\n\nAge 18-69 years. Have interdialytic weight gain more than or equal to 1.5 kg. In dialysis treatment twice a week for the last 3 months. Provide consent in verbal and written form Having a mobile phone to use on one's own or with family members.\n\nExclusion Criteria: Self-reported hearing difficulty and visual difficulty.Cognitive problems such as memory loss, language difficulties, and forgetfulness. Having heart problems like dysrhythmia, ventricular heart disease, or reduced ejection fraction requires oxygen at the time of dialysis.","69 Years",{"count":84,"type":22},112,[86],"NA","Background: Hemodialysis is the most common treatment modality in patients with chronic kidney disease. The majority of people with dialysis have a below-average quality of life. Adherence to diet and fluid intake, engagement in physical activity, and feeling blue and anxious will all affect quality of life. Nurses play a key role in patient education and behavioral support. Nurse-led interventions, especially educational programs (laptop-based), combined with reminders and educational materials, may improve patients' knowledge, adherence to treatment, and improvement in quality of life.\n\nMethodology The study will adopt the quantitative research design .The study will be conducted in a single private tertiary care center. First, the day and shift were randomized, and participants belonging to the particular day and shift will be considered as Group A and Group B. After this, the eligibility criteria will be assessed, and the baseline assessment will be done. A convenient sampling technique will be used to select the study sample. The sample will be a minimum of 56 in each arm. Therefore, altogether there will be at least 112 participants. One group will receive nurse-led interventions (Group A), and the control group (Group B) will receive usual routine care.\n\nNurse-led intervention comprises 4 laptop-based educational and counseling sessions, 4-6 telephone reminders, and the distribution of the booklet on self-care. All four sessions will be conducted by the specialist nurse or nurse with at least one year of working experience in a dialysis unit. Each session will be conducted once every one to two weeks. The primary outcome will be self-care adherence. The self-care adherence will be measured by direct assessment of clinical parameters (interdialytic weight gain) of adherence and subjectively through face-to-face interviews. Patients' medical records will be reviewed. The secondary outcome will be the quality of life score. An independent assessor (enumerator) will measure the outcome at T1 and T2, which will be done at 4 months (T1) and 6 months (T2) from the baseline.\n\nAnalysis will be done through the Stata software version 14. Descriptive statistics like frequency, percentage, mean±sd, median, inter quartile range are based on the nature of the data. Similarly, inferential statistics such t t-test and linear regression analysis will be used to find out the difference in mean score between two groups. The findings will be considered statistically significant at level p\\\u003C0.05 at 95% CI.\n\nThe strength of this study will be the inclusion of both clinical and subjective parameters of adherence and assessment of quality of life. Use of a qualitative approach in explaining the factors, like appropriateness of the education and counselling session, along with the facilitators and barriers to adherence, will further help to modify the interventions. If the method is found to be effective, this will be an effective measure to improve quality of life cost-effectively. This can be continued on a regular basis in the same center and can be utilized in others, too.",[89,90,91,92,93],"Nurse Led Interventions","Patients on Hemodialysis","Self Care","Quality of Life","Interdialytic Weight Gain","RECRUITING","2026-07-29",{"date":97,"type":40},"2026-07-31",{"date":99,"type":40},"2026-03-30",{"date":101,"type":22},"2026-11-30",{"name":103,"class":47},"Kathmandu University School of Medical Sciences",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":112,"minAge":56,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100611692","mobile-based-obstetric-monitoring-for-pregnancies-complicated-by-hypertension-andor-diabetes-mom-hd-100611692","NCT07243886","Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and\u002For Diabetes (MOM-HD)","Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and\u002For Diabetes (MOM-HD): a Type II Hybrid Implementation-Effectiveness Trial","MOM-HD","Inclusion Criteria:\n\n* Pregnant women receiving antenatal care at RCT site\n* Diagnosed with one of the following:\n\n  * Chronic hypertension (sustained systolic BP ≥140 mm Hg and\u002For diastolic BP ≥90 mm Hg, or on antihypertensive treatment before 20 weeks of gestation)\n  * Gestational hypertension or preeclampsia without severe features (sustained systolic BP ≥140 mm Hg and\u002For diastolic BP ≥90 mm Hg after 20 weeks of gestation)\n  * Gestational diabetes\n* Age 18 years or older\n* Access to a smartphone\n* Gestational age ≤ 34 weeks at enrollment\n* Able to read and write\n\nExclusion Criteria:\n\n* Multifetal pregnancies\n* Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants\n* Unable to understand the Nepali language\n* Severe maternal illness or any condition that precludes active study participation (e.g., preeclampsia with severe features, eclampsia, HELLP syndrome, or other conditions requiring inpatient management)\n* Declines to provide informed consent","FEMALE",{"count":114,"type":22},864,[86],"Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) are among the leading complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. (1,2,3) Effective management of HDP and GDM hinges on regular monitoring of blood pressure (BP) and blood glucose (BG) to ensure adequate control and timely interventions for maternal and fetal well-being. Telemonitoring offers a promising and cost-effective alternative by enabling pregnant individuals to monitor BP and BG at home and share real-time results with healthcare providers, facilitating informed clinical decision-making and timely interventions.\n\nHere the investigators propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of the MOM-HD (Mobile-based Obstetric Monitoring for Hypertension and\u002For Diabetes) program, a mobile app-based perinatal telemonitoring program, in real-world clinical settings in Nepal. To address the study aims, the investigators will recruit 864 women who are newly diagnosed with HDP and GDM from three metropolitan hospitals and randomly assign them to either (i) MOM-HD + standard care or (ii) standard care alone, from enrolment in pregnancy to 6 weeks postpartum. Primary and secondary clinical outcomes will be assessed at delivery, and at 6 weeks postpartum. The investigators hypothesize that compared to standard care, the use of MOM-HD in addition to standard care will result in lower systolic BP levels, lower incidence rate for the composite adverse perinatal outcome of either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction, and lower proportion of days with elevated systolic BP or BG readings between recruitment and 6 weeks postpartum. A convergent mixed-methods approach will be used to assess implementation and maintenance outcomes using the RE-AIM framework (4), and economic sustainability will be assessed by collecting primary cost data.",[118,119],"Gestational Diabetes","Hypertensive Disorder of Pregnancy",[121,122,123,124,125,126,127],"pregnancy","telemonitoring","mHealth","GDM","HDP","Nepal","implementation",{"date":97,"type":40},{"date":130,"type":40},"2026-06-30",{"date":132,"type":22},"2030-12-31",{"name":134,"class":47},"Rutgers, The State University of New Jersey",3,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":112,"minAge":56,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":48},"100607180","postpartum-preeclampsia-early-detection-and-treatment-nepal-pilot-study-100607180","NCT07185204","Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study","Postpartum Preeclampsia Early Detection and Treatment: Using Biomarkers to Implement Risk-stratified Intervention (Nepal Pilot Randomized Controlled Trial)","PREDiCT-NPL","Inclusion Criteria:\n\n* Pregnant patients ≥ 36 weeks gestation without major fetal anomalies\n* Age ≥ 18 years\n* Admitted for labor at Dhulikhel Hospital, or intend to deliver at Dhulikhel Hospital\n* At risk for preeclampsia, using the Clinical Risk Assessment for Preeclampsia according to ACOG and USPSTF\n\n  * 1 or more high risk factors:\n\n    * History of preeclampsia\n    * Type 1 or 2 diabetes\n    * Multifetal gestation?\n    * Renal disease\n    * Autoimmune disease\n  * 2 or more moderate risk factors:\n\n    * Nulliparity\n    * BMI \\> 30\n    * First-degree relative with a history of preeclampsia\n    * African American race\n    * Low socioeconomic status\n    * Age \\> 35 years\n    * History of low birthweight or small for gestational age\n    * Previous adverse pregnancy outcome\n    * Interpregnancy interval \\> 10 years\n\nExclusion Criteria:\n\n* Antenatal hypertensive disorder of pregnancy diagnosis, including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines\n* Chronic hypertension, according to ACOG guidelines\n* Known allergy or contraindication to nifedipine\n* Inability or unwillingness to provide informed consent\n* Two or more blood pressures with an SBP ≥140 or DBP ≥90 after consent and prior to sFlt-1\u002FPlGF testing (screen failure criteria)",{"count":145,"type":22},60,[86],"The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1\u002FPlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.",[149],"Postpartum Preeclampsia",[151,152,153,154],"Preeclampsia","Hypertension","Pregnancy","Postpartum","2026-07-16",{"date":157,"type":40},"2026-07-20",{"date":159,"type":40},"2026-03-03",{"date":161,"type":22},"2027-06",{"name":163,"class":47},"Medical College of Wisconsin",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":112,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100648014","antenatal-high-risk-pregnancy-intervention-bundle-in-rural-nepal-100648014","NCT07717619","Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal","Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal","Inclusion Criteria:\n\n* all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center\n\nExclusion Criteria:\n\n* life-threatening maternal or fetal conditions requiring immediate tertiary-level care\n* unable to provide informed consent due to cognitive or language barriers\n* do not have access to a mobile phone for telehealth consultations.",true,"0 Years",{"count":174,"type":22},100,[86],"The proposed study will assess and implement a comprehensive antenatal HRP screening and telehealth follow-up program in rural Nepal. The main questions it aims to answer are:\n\n1. To estimate the burden of HRPs using the existing Antenatal Risk-Score Checklist in rural Nepal\n2. Assess acceptability, feasibility, preliminary effectiveness, and implementation outcomes of the HRP bundle at the primary healthcare in Nepal",[178],"High Risk Pregnancy",[180,181,182,183],"high risk pregnancy","low and middle income countries","teleheatlh","pregnancy checklist","2026-07-15",{"date":186,"type":40},"2026-07-21",{"date":188,"type":22},"2026-08-01",{"date":190,"type":22},"2028-07-31",{"name":192,"class":47},"University of California, San Francisco",1,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":171,"sex":18,"minAge":56,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":48},"100514489","effectiveness-and-adoption-of-the-teltex4bp-intervention-among-adults-with-hypertension-in-nepal-100514489","NCT05979168","Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal","Effectiveness and Adoption of the Structured mHealth Intervention for Improving Blood Pressure Control (TelTex4BP) Among Adults With Hypertension in Nepal: A Randomized Controlled Trial","TelTex4BP","Inclusion Criteria:\n\n* Clinical diagnosis of hypertension\n* Currently receiving\u002Fprescribed blood pressure-lowering medication for more than three months\n* With uncontrolled blood pressure (\\>130\u002F80mm of Hg)\n* Should have access to a mobile phone\n* Able to read text messages ( by themselves\u002Fwith the help of family)\n\nExclusion Criteria:\n\n* Diagnosed with myocardial infarction, stroke, and kidney failure\n* Severe mental illness, cognitive impairment\n* Pregnant women or in the postpartum period","70 Years",{"count":204,"type":22},500,[86],"Despite evidence of preventing cardiovascular disease (CVD) risk through lifestyle changes, many patients with hypertension (HTN) do not comply with this and suffer from CVD and other complications. A previous study using a structured lifestyle intervention program has reported a 14% decrease in the 10-year risk of developing CVD at one year among hypertensive and diabetes patients. Low and Middle-Income countries (LMICs) struggle with a shortage of health workers to deliver such interventions. In this context, mobile phones can contribute to bridging this gap by incorporating them into the health system for health intervention delivery. There is a need to develop contextual mHealth intervention adapted to local needs and culture and test its effectiveness in LMIC settings like Nepal. Our previous small-scale pilot mHealth (text messages) study reported promising evidence in reducing blood pressure among hypertensive patients in the intervention arm \\[adjusted reduction in systolic blood pressure (BP) -6.50 (95% CI, -12.6; -0.33) and diastolic BP -4.60 (95% CI, -8.16; -1.04)\\], with a greater proportion achieving target BP (70% vs 48% in the control arm, p = 0.006)\\] and improving treatment compliance (p \\\u003C 0.001) in Nepal. This finding supports the expansion to a large-scale trial of a structured mHealth intervention to see its long-term effectiveness and sustainability for patients with HTN to improve BP control and reduce CVD risk. Hence, this study aims to assess the effectiveness of a behavioural intervention through mHealth (telephone\u002Fmobile phone calls and text messages) informed by the RE-AIM framework for improving blood pressure control among patients with hypertension in a hospital (Manamohan Cardiothoracic Vascular and Transplant Center) of Kathmandu, Nepal.",[152,208,209,210],"Medication Adherence","Blood Pressure","Cardiovascular Diseases",[212,213,152,214],"Mobile Intervention","Blood Pressure Control","Randomized Controlled Trial","2026-07-07",{"date":217,"type":40},"2026-07-08",{"date":219,"type":40},"2025-11-02",{"date":221,"type":22},"2027-12-31",{"name":223,"class":47},"Central Department of Public Health",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":193},"100645259","peer-delivered-youth-suicide-prevention-in-nepal-100645259","NCT07680179","Peer Delivered Youth Suicide Prevention in Nepal","Innovations for Peer-delivered and Family-engaged Brief Interventions for Youth Suicide in Nepal: A Pilot Hybrid Type 2 Implementation Study","Inclusion Criteria:\n\nPeer Volunteers\n\n* Age ≥18 years\n* No current untreated mental disorder or suicide risk, as assessed and confirmed by a Nepali mental health specialist (MD or PhD)\n* Meets hiring and eligibility criteria of the local implementing partner NGO\n* Fluent in spoken Nepali\n\nTrial Youth Patient Participants\n\n* Age 12-24 years\n* Resident of the study site\n* Screens positive to the Nepali Ask Suicide Screening Questions or a lifetime history of a suicide attempt\n* Ability to provide informed consent or assent\n* For participants under 18 years of age, written informed consent from a legal guardian\n* Fluent in Nepali\n\nFamily Members (intervention group only)\n\n* Family member (defined as any individual that is a parent, grandparent, aunt\u002Funcle, or cousin as well as significant others) selected by the youth participants enrolled in the study\n* Resident of the study site\n* Over 18 years of age\n* Ability to provide informed consent or assent\n* Fluent in Nepali\n\nExclusion Criteria:\n\nPeer Volunteers\n\n* Plans to leave the peer volunteer role within the next 6 months\n* Unable to provide voluntary informed consent for any reason\n\nTrial Youth Patient Participants\n\n* Requires immediate psychiatric hospitalization at the time of assessment\n* Unable to provide informed consent or assent due to impaired decision-making capacity\n* Participants under 18 years of age without written informed consent from a legal guardian\n* Planning to leave the study area in the next 6 months\n\nFamily Members\n\n* Requires immediate psychiatric hospitalization at the time of assessment\n* Unable to provide informed consent or assent due to impaired decision-making capacity\n* Planning to leave the study area in the next 6 months","12 Years","24 Years",{"count":234,"type":22},160,[86],"South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high.\n\nUsing experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.",[238,239],"Suicide","Suicide Prevention","2026-06-25",{"date":242,"type":40},"2026-07-02",{"date":244,"type":22},"2026-06",{"date":246,"type":22},"2028-06",{"name":248,"class":47},"Yale University",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":112,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":193},"100642268","phase-3-how-precision-diets-through-gut-bacteria-affect-anemia-in-nepalese-adolescent-100642268","NCT07661602","How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent","Gut Microbiota-Mediated Effects of Precision Dietary Interventions on Anemia Among Nepalese Adolescents","Inclusion Criteria:\n\n* Female adolescents aged 15-19 years\n* Enrolled in selected schools\n* Resident in Kathmandu for at least 6 months\n* Provision of written informed assent and parental consent\n\nExclusion Criteria:\n\n* Current pregnancy\n* Known genetic blood disorders (thalassemia, sickle cell disease)\n* Chronic metabolic, inflammatory, or infectious diseases affecting hematological parameters\n* Acute illness at time of screening\n* Use of iron, folic acid, vitamin B12 supplements, antibiotics, or probiotics within the past 3 months\n* History of helminth infection or deworming treatment within the past 6 months\n* Participation in other nutrition intervention studies","15 Years","19 Years",{"count":145,"type":22},[62],"This study aims to evaluate whether a food-based nutrition intervention using goat liver can improve anemia among adolescent girls in Kathmandu, Nepal, and compare its effectiveness with the current standard iron and folic acid supplementation. It will also investigate how diet and the gut microbiota (the community of beneficial microorganisms living in the intestine) may influence iron absorption and response to treatment.\n\nAnemia is a major public health problem among adolescent girls in Nepal. During adolescence, rapid growth and the onset of menstruation increase the body's need for iron and other nutrients involved in blood formation. If left untreated, anemia can impair physical growth, reduce learning ability and concentration, decrease work capacity, weaken immunity, and negatively affect future reproductive health. Although weekly iron-folic acid supplementation programs are widely implemented, anemia remains common, suggesting that additional strategies may be needed.\n\nRecent research indicates that gut microbiota may affect iron metabolism by influencing nutrient absorption, inflammation, and overall intestinal health. Dietary habits can alter the composition of gut bacteria, which may partly explain why individuals respond differently to iron interventions. However, little is known about these relationships among Nepalese adolescents. This study seeks to fill that knowledge gap and explore whether a locally available food-based intervention can provide a practical and sustainable alternative or complement to conventional supplementation.\n\nThe research will be conducted among adolescent girls aged 15 to 19 years enrolled in selected schools in Kathmandu. The study has two phases. In the first phase, you will undergo screening to determine the prevalence and types of anemia. Blood samples will be collected to measure hemoglobin, iron status, vitamin B12, folate, and inflammation-related biomarkers. Stool samples will be collected to analyze gut microbiota composition. Information on dietary intake, food frequency, dietary diversity, and other relevant characteristics will also be obtained through structured questionnaires.\n\nGirls identified with anemia and meeting the eligibility criteria will be invited to participate in the randomized intervention phase. You will be randomly assigned to receive either the standard iron-folic acid supplementation recommended by national programs or a goat liver-based dietary intervention for 12 weeks. Random assignment ensures a fair comparison between interventions and minimizes bias.\n\nGoat liver was selected because it is rich in highly bioavailable heme iron as well as vitamin B12, folate, vitamin A, and other nutrients important for blood production. As a commonly available food in Nepal, it may represent a culturally acceptable and sustainable nutrition-based strategy for improving anemia.\n\nDuring the intervention, you will be monitored regularly to assess adherence and wellbeing. At the end of the 12-week period, blood and stool samples will be collected again to evaluate changes in hemoglobin levels, iron-related biomarkers, nutritional status, and gut microbiota composition. The study will compare improvements between intervention groups and examine whether changes in gut microbiota are associated with better anemia outcomes.\n\nParticipation is entirely voluntary. Written informed consent from parents or guardians and informed assent from adolescent participants will be obtained before enrollment. You may withdraw from the study at any time without penalty. All personal information and laboratory results will remain confidential and will be stored using coded identifiers to protect privacy.\n\nBlood collection will be performed by trained healthcare professionals using standard safety procedures, and stool samples will be collected using appropriate collection kits and instructions. Participants found to have severe anemia or other important medical conditions during the study will be referred for appropriate medical care according to national guidelines.\n\nThe findings from this study are expected to provide important evidence on whether a locally available food-based intervention can effectively improve anemia among adolescent girls while also enhancing understanding of the relationship between diet, gut microbiota, and iron metabolism. The results may help inform future nutrition policies, school health programs, and precision nutrition strategies for anemia prevention and treatment in Nepal and other similar settings.",[262],"Anemia",[264,265,266,267,268,269,270,271],"Anaemia","iron deficiency anemia","adolescent girls","goat liver supplementation","food-based intervention","precision nutrition","gut microbiome","dietary intervention","2026-06-22",{"date":240,"type":40},{"date":275,"type":22},"2026-07",{"date":277,"type":22},"2026-11",{"name":279,"class":47},"Southern Medical University, China",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":112,"minAge":56,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":193},"100549251","effect-of-a-mobile-health-intervention-on-birth-outcomes-100549251","NCT06431581","Effect of a Mobile Health Intervention on Birth Outcomes","Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal","Inclusion Criteria:\n\n* Pregnant women of age 18 years and above;\n* Pregnant with 13 to 27 weeks of gestation;\n* Planned to deliver a child at selected hospital;\n* Pregnant women who use smart phone;\n* Can read and understand Nepali language\n\nExclusion Criteria:\n\n* Pregnant women with vision impairment and diagnosed learning difficulties",{"count":288,"type":22},494,[86],"Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviours for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery.\n\nAccordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women.\n\nA two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up).\n\nFollow-up will be done from the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.",[292],"Birth Outcomes","2026-06-19",{"date":295,"type":40},"2026-06-24",{"date":297,"type":40},"2024-09-09",{"date":299,"type":22},"2027-04",{"name":103,"class":47},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100429589","phase-3-prevention-of-persistent-pain-with-lidocaine-infusions-in-breast-cancer-surgery-plan-100429589","NCT04874038","Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)\n\nExclusion Criteria:\n\n1. Previous breast surgery within 6 months of index surgery\n2. Undergoing any autologous flap procedure during index surgery\n3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery\n4. Documented hypersensitivity or allergy to lidocaine\n5. Surgery not planned to be performed under general anesthesia and\u002For planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)\n6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker\n7. Known cirrhotic liver disease\n8. Pregnant\n9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)","100 Years",{"count":309,"type":22},1602,[62],"Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.",[313,314,315,316],"Post-mastectomy Pain Syndrome","Breast Cancer","Pain, Postoperative","Pain, Chronic","2026-06-17",{"date":272,"type":40},{"date":320,"type":40},"2021-09-22",{"date":322,"type":22},"2026-11-01",{"name":324,"class":47},"University Health Network, Toronto",17,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":345,"locationsCount":193},"100643548","phase-4-randomized-clinical-trial-of-artificial-tears-with-and-without-preservatives-in-patients-with-dry-eye-disease-100643548","NCT07635849","Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease","Comparative Effectiveness of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical diagnosis of Dry Eye Disease (OSDI \\>13 and TBUT \\\u003C10 seconds)\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Contact lens use\n* Active ocular infection or inflammation\n* History of ocular surgery within the past 6 months\n* Use of systemic immunosuppressive therapy",{"count":334,"type":22},80,[25],"Dry Eye Disease (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro complex (SOC) which may cause ocular surface toxicity with long-term use. Preservative-free artificial tears are considered safer alternatives, but comparative clinical evidence from Nepal is limited. This study aims to compare the clinical efficacy and safety of preservative-free versus preserved carboxymethylcellulose (CMC) artificial tears in patients with Dry Eye Disease. This will be a hospital-based, randomized, double-blinded controlled clinical trial conducted in the ophthalmology outpatient department of a tertiary care hospital in Nepal. A total of 80 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive either preservative-free CMC artificial tears or preserved CMC artificial tears for a duration of eight weeks. Participant, investigators, outcome assessors and data analysts will remain blinded to minimize assessment bias. Baseline assessments will include the Ocular Surface Disease Index (OSDI) questionnaire, Tear Film Break-Up Time (TBUT), Schirmer's test (without anesthesia), and corneal fluorescein staining. These outcomes will be reassessed at four and eight weeks. Safety and tolerability will be evaluated by documenting patient-reported adverse effects. Data will be analyzed using appropriate statistical methods, with a p-value of less than 0.05 considered statistically significant. The study is expected to demonstrate superior safety and improved ocular surface outcomes with preservative-free artificial tears compared to preserved formulations. Findings from this research will provide local evidence to guide rational prescribing practices and improve the management of Dry Eye Disease in Nepal.",[338],"Dry Eye Disease (DED)","2026-06-08",{"date":341,"type":40},"2026-06-10",{"date":275,"type":22},{"date":344,"type":22},"2027-03",{"name":346,"class":347},"Pokhara Academy of Health Sciences, Western Regional Hospital","OTHER_GOV",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":202,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":193},"100621968","follow-up-compliance-for-corneal-ulcer-patients-with-sms-reminder-100621968","NCT07377513","Follow-up Compliance for Corneal Ulcer Patients With SMS Reminder","Follow-up Compliance for Medically Managed Corneal Ulcer Patients With SMS Reminders in a Tertiary Eye Care Setting in Western Nepal: A Quasi Experimental Study","Inclusion Criteria:\n\n* Newly diagnosed patients (18 to 70 years) of corneal ulcer in one or both eye, who are medically managed, visiting the OPD at LEIRC and have access to a mobile phone.\n\nExclusion Criteria:\n\n* Less than 18 years or more than 70 years Patients who do not have a access to a mobile phone.",{"count":356,"type":22},310,[86],"Corneal ulcer is defined as the loss of corneal epithelium with underlying stromal infiltration and suppuration, accompanied by signs of inflammation, with or without hypopyon1. The condition may be caused by bacterial, fungal, viral or parasitic pathogens and carries a significant risk of corneal perforation and subsequent visual impairment2. These risks highlight the importance of timely treatment plans and consistent referral networks3.\n\nA lot of patients choose to self-medicate and postpone seeking professional assistance due either their lack of awareness or forgetfulness, which results in inadequate follow-up compliance4,5. Scheduling appointments regularly is still a significant barrier to successful treatment and visual recovery.\n\nSMS reminders have shown encouraging real-world success in improving follow-up attendance with in ophthalmology. Mobile health tools, such as the peek Community Eye Health system, have proven increased follow-up rates and improved access to eye care services in low-resource setting through automated appointment reminders and patient monitoring6.\n\nThe aim of this operational research study to evaluated the feasibility, scalability, and effectiveness of SMS reminders in improving follow-up compliance among patients with corneal ulcer at the Lumbini Eye Institute and Research Center (LEIRC), Western Nepal. The findings are expected to inform the integration of cost-effective digital health strategies to strengthen patient adherence, optimize clinical outcomes, and support eye health programs in resource limited environments.",[360],"Corneal Ulcer",[362,363,364],"Corneal ulcer","Follow-up compliance","SMS reminder","2026-05-11",{"date":367,"type":40},"2026-05-12",{"date":369,"type":40},"2026-02-23",{"date":371,"type":22},"2027-12",{"name":373,"class":47},"Seva Canada Society",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":381,"maxAge":307,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":395,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100640770","national-institute-for-health-and-care-research-global-health-research-centre-for-multiple-long-term-conditions-100640770","NCT07582380","National Institute for Health and Care Research Global Health Research Centre for Multiple Long-Term Conditions","NIHR-GHRC MLTC","Inclusion Criteria:\n\n* Adults aged 40 years or above\n* Attending the Primary Health Centre (PHC) during the enrollment period\n* Diagnosed with two or more of the following chronic conditions:\n\n  1. Hypertension\n  2. Diabetes mellitus\n  3. Depression\n  4. Anxiety\n  5. Chronic obstructive pulmonary disease (COPD)\n  6. Asthma\n  7. Vision impairment\n  8. Hearing impairment\n  9. Osteoarthritis\n  10. Chronic back pain\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years\n* Presence of only one or none of the listed chronic conditions\n* Pregnant or breastfeeding women\n* Severe cognitive impairment or dementia that prevents informed consent or or reliable participation\n* Bedridden or terminally ill individuals with a life expectancy \\\u003C 6 month\n* Current participation in another clinical or interventional research study may interfere with study outcomes\n* Severe psychiatric illness (e.g., psychosis or bipolar disorder) other than depression or anxiety\n* Unable or unwilling to provide written informed consent\n* Severe communication barriers that prevent participation in interviews or questionnaires, even with assistance","40 Years",{"count":383,"type":22},3600,[86],"Multiple Long-Term Conditions (MLTC), defined as the coexistence of two or more chronic conditions, is increasingly prevalent in India. Despite this, the healthcare system remains largely focused on single-disease management, underscoring the urgent need for integrated, patient-centred approaches that are context-specific, equitable, and resource-sensitive.\n\nIndia's public health infrastructure is undergoing significant reform through the Ayushman Bharat Yojana, which aims to upgrade 150,000 sub-centres and primary health centres into Health and Wellness Centres (HWCs). These centres are designed to provide comprehensive care including prevention, treatment, and rehabilitation to underserved populations. This transformation presents a strategic opportunity to embed multi-morbidity care into the evolving system, supported by the establishment of a Global Health Research Centre dedicated to MLTC.\n\nThe NIHR Global Health Research Centre for Multiple Long-Term Conditions aims to transform the health system in India and Nepal by improving care for individuals living with MLTC. With chronic conditions on the rise due to epidemiological transitions, particularly among adults aged ≥40, there is an urgent need for integrated, people-centred care models. This project is being implemented in Anakapalli district (Andhra Pradesh), Jodhpur (Rajasthan), Sonipat (Haryana) and Nepal, encompassing both rural and urban contexts.\n\nThe study is conducted among adult patients with MLTCs attending rural primary providers (Medical officers and Staff Nurse) delivering services at these facilities in India and Nepal. The intervention comprises an electronic decision support system (EDSS) to facilitate evidence-based clinical decision-making, assisted telemedicine model to enable timely specialist consultations, and a patient-facing mobile application-supported by community champions and care coordinators to enhance care coordination, self-management, and treatment adherence.\n\nAt this stage, we have completed the case-mix and health facility assessments, alongside the in-depth interviews to identify challenges faced by patients, caregivers, and health care providers. Currently, we are pilot testing the health intervention in 4 PHCs in India and 2 PHCs in Nepal among 180 participants (30 participants per site). Findings from this pilot will inform refinement of the intervention, study tools, and implementation strategies, and will provide critical evidence on contextual adaptability to support the design of a subsequent cluster randomized controlled trial (RCT).\n\nIn the full RCT, we will evaluate the effectiveness of a health system intervention comprising an electronic clinical decision support system, assisted telemedicine, a patient-facing application, and community champions. The study will be conducted across selected sites in India and Nepal using a cluster randomized controlled design, in which Primary Health Centres (PHCs) are allocated to either the intervention or usual care arm. The intervention includes structured clinical workflows, a digital decision support system, assisted telemedicine, and patient-facing mobile health tools to strengthen continuity and coordination of care.\n\nParticipants will engage with these components over a six-month implementation period. Data collection will include participant surveys and qualitative interviews, complemented by routine supervision checklists and system usage analytics to assess implementation processes and usability.\n\nThe study findings will generate robust evidence to inform scalable and context-appropriate models of integrated care for multiple long-term conditions (MLTCs) in primary care settings in low- and middle-income countries. By embedding digital tools and strengthening PHC systems, the intervention aims to improve quality of life, reduce fragmentation of care, and establish a sustainable model for MLTC management.",[387,388,389,390,391,392,393,394],"Chronic Conditions, Multiple","Diseases of the Circulatory System","Diseases of the Respiratory System","Endocrine, Nutritional and Metabolic Diseases","Mental, Behavioral and Neurodevelopmental Disorders","Diseases of the Musculoskeletal System and Connective Tissue","Diseases of the Ear and Mastoid Process","Diseases of the Eye and Adnexa",[396],"Multiple long term conditions, MLTC, digital health, mHealth","2026-05-07",{"date":367,"type":40},{"date":400,"type":22},"2026-05-05",{"date":402,"type":22},"2028-08-30",{"name":404,"class":47},"Centre for Chronic Disease Control, India",120,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":171,"sex":18,"minAge":56,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":421,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":193},"100627057","does-orientation-on-eye-health-to-female-health-volunteers-increase-footfall-in-a-vision-center-100627057","NCT07443683","Does Orientation On Eye Health To Female Health Volunteers Increase Footfall In A Vision Center","Assessing The Effectiveness Of Eye Health Orientation On Service Uptake: A Study Among Female Health Volunteers In Sudurpashchim Province, Nepal","Inclusion Criteria:\n\n* Female Community Health Volunteers of Dipayal Silgadhi Municiplality\n\nExclusion Criteria:\n\n* Female Community Health Volunteers of other Municipalities","58 Years",{"count":415,"type":22},149,[86],"The goal of this interventional comparative study is to see if one day eye health orientation to Female Community Health Volunteers will increase footfall of patients in a Vision Center. Total of 58 Female Community Health Volunteers of Dipayal Silagadhi Municipality will receive eye health education. There is one Vision Center at Dipayal Silagadhi. Similarly there is one Vision Center at Chainpur Bajhang. Here FCHV will not receive one day eye health orientation. Currently both Vision Centers provide similar number of services. We shall compare and see if there will be any change in the number of people coming to these vision center.\n\nFemale Community Health Volunteers in Dipayal Silgadhi will be asked to refer eye patients to the nearest Vision Center. They will be given\n\n1. Eye health orientation session\n2. Referral slip",[419,420],"Female Community Health Volunteers","Eye Disorders",[419,422,126],"Eye health awareness","2026-04-29",{"date":425,"type":40},"2026-04-30",{"date":427,"type":40},"2026-02-02",{"date":429,"type":22},"2026-12-30",{"name":373,"class":47},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":439,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":442,"briefSummary":443,"conditions":444,"keywords":452,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":465},"100634728","phase-3-therapeutics-for-moderate-and-severe-dengue-100634728","NCT07543458","Therapeutics for Moderate and Severe Dengue","A Randomised Platform Trial to Evaluate Therapeutics in Patients With Moderate or Severe Dengue (DEN-HOST)","DEN-HOST","Inclusion Criteria:\n\n* Age ≥5 years\n* Decision to hospitalise\n* Clinical diagnosis of dengue\n* Participants must also have at least one of the following:\n\n  1. Severe abdominal pain or tenderness\n  2. Vomiting more than 3 times in the past 24 hours\n  3. Pleural effusion or ascites on clinical or radiological examination\n  4. Absolute haematocrit \\>50%\n  5. 15% increase in haematocrit compared with a baseline sample (defined as the first sample taken during the current illness)\n  6. Absolute platelet count \\\u003C50 × 10⁹\u002FL\n  7. Absolute platelet count \\\u003C100 × 10⁹\u002FL AND a drop \\>50 × 10⁹\u002FL in the past 32 hours\n  8. ALT or AST \\>400 IU\u002FL\n  9. Pulse pressure \\\u003C20mmHg or hypotension for age AND at least one of: peripheral capillary refill time \\>2 seconds; urine output 0.5ml\u002Fkg\u002Fhr; cold\u002Fclammy peripheries; agitation or altered mental state\n  10. Bleeding leading to hypotension for age or requiring blood transfusion or medical intervention (e.g. surgery, endoscopy, or vasoactive drugs)\n  11. Symptomatic bleeding into a critical site (intracranial, intraspinal, intraocular with visual impairment, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome)\n  12. Requirement for organ support, including vasopressors or inotropes, assisted ventilation, dialysis or haemofiltration, or coma (unresponsive to pain without sedation) or requirement for intravenous antiseizure medications\n\nExclusion Criteria:\n\n* Patients on ≥ day 10 of illness or who are clinically improving in the opinion of the managing doctor (the 'recovery phase') will be excluded from recruitment. Other exclusion criteria are specific to individual treatment comparisons, and do not preclude randomisation to other arms of the study.\n* A participant may not enter a specific treatment comparison if that treatment is considered to be indicated or contraindicated by the responsible clinician.","5 Years",{"count":441,"type":22},8800,[62],"The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.",[65,445,446,447,448,449,450,451],"Severe Dengue","Mosquito-Borne Diseases","Vector Borne Diseases","Arbovirus Infections","Flavivirus Infections","RNA Virus Infections","Hemorrhagic Fever",[453,454,455],"dengue treatment","host-directed therapy","host-targeted therapeutics","2026-04-15",{"date":458,"type":40},"2026-04-21",{"date":460,"type":22},"2026-10-01",{"date":462,"type":22},"2031-07-31",{"name":464,"class":47},"Oxford University Clinical Research Unit, Vietnam",18,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":172,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100391818","phase-3-randomised-evaluation-of-covid-19-therapy-100391818","NCT04381936","Randomised Evaluation of COVID-19 Therapy","RECOVERY","Eligibility Criteria (as per Protocol v28.0):\n\nPatients are eligible for the study if all of the following are true:\n\n(i) Hospitalised\n\n(ii) Pneumonia syndrome\n\nIn general, pneumonia should be suspected when a patient presents with:\n\n1. typical symptoms of a new respiratory tract infection (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and\n2. objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and\n3. alternative causes have been considered unlikely or excluded (e.g. heart failure).\n\nHowever, the diagnosis remains a clinical one based on the opinion of the managing doctor (the above criteria are just a guide).\n\n(iii) One of the following diagnoses:\n\n1. Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection)\n2. Community-acquired pneumonia (CAP) with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia)\n\n(iv) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he\u002Fshe were to participate in the trial\n\nPatients with suspected or confirmed active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia (also known as PCP or PJP) are excluded from the CAP comparison, as these infections are caused by specific organisms with distinct pathologies, and so are not usually categorised as CAP. Eligibility for the CAP comparison also requires planned antibiotic treatment, so patients being treated solely for fungal or viral pneumonia are not eligible.\n\nPatients with SARS-CoV-2 and influenza co-infection are eligible, but would be excluded from certain comparisons if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol Appendix 2, Appendix 3 for children, and Appendix 4 for pregnant and breastfeeding women), or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient. For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial.\n\nPatients who have been previously recruited into RECOVERY are eligible to be recruited again as long as their previous randomisation was \\>6 months ago. Patients will not be recruited into the same randomised comparison (e.g. sotrovimab vs. usual care) on more than one occasion, regardless of how far apart they occur.\n\nIn some locations, children (aged \\\u003C18 years) will not be recruited, to comply with local and national regulatory approvals (see Appendix 6).\n\nNote: the eligibility criteria has changed from COVID-19 to pneumonia (Influenza \\& CAP). For detailed information about previous eligibility criteria please see the previous Protocol's on the study website: https:\u002F\u002Fwww.recoverytrial.net\u002Fuk\u002Ffor-site-staff\u002Fsite-set-up-1\u002Fregulatory-documents",{"count":474,"type":22},70000,[62],"RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia.\n\nThe treatments being investigated are:\n\nCOVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only)\n\nInfluenza: Baloxavir marboxil, Oseltamivir, Corticosteroids (dexamethasone)\n\nCommunity-acquired pneumonia: Corticosteroids (dexamethasone)",[478],"Pneumonia",[480,481,482,483,484,485,486,487,488],"COVID-19","SARS-CoV-2","SARS coronavirus 2","SARS","Viral pneumonia syndrome","Community-acquired pneumonia","Bacterial pneumonia syndrome","Influenza A","Influenza B",{"date":458,"type":40},{"date":491,"type":40},"2020-03-19",{"date":493,"type":22},"2038-09-30",{"name":495,"class":47},"University of Oxford",16,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":256,"maxAge":232,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":193},"100580251","multi-component-family-intervention-to-lower-depression-and-address-intimate-partner-violence-in-nepal-100580251","NCT06834867","Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal","A Randomized Controlled Trial of a Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence (MILAP) Among Young Women in Nepal","MILAP","Inclusion Criteria:\n\n* Married women aged 15-24 years, their husbands and MILs sharing a household;\n* Living in the catchment area with no stated intention of leaving during the study period;\n* Participants speaking in Maithili or Nepali;\n* Wife reporting Intimate Partner Violence (physical, sexual or abusive control) in last 12 months as measured by three questions from the International Violence Against Women Survey (IVAWS);\n* Expressing desire to remain in the current relationship\u002Ffamily\n\nExclusion Criteria:\n\n* Pregnant women;\n* History of IPV severe enough to result in hospitalization in the past 12 months;\n* Significant cognitive problems\u002Fdisability precluding participation;\n* Any participant with Severe Alcohol Dependence, defined as Severity of Alcohol Dependence Questionnaire (SADQ) \\> 31 (those with mild to moderate dependance will be referred but not excluded)",{"count":506,"type":22},900,[86],"Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health.\n\nThis study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to \"unity and reconciliation\" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are:\n\nAIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal.\n\nAIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness.\n\nAIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV.\n\nParticipants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.",[510,511,512],"Intimate Partner Violence (IPV)","Depression","PTSD - Post Traumatic Stress Disorder",[514,511,515,516,126,503],"Intimate Partner Violence","Family Intervention","Mental Health","2026-04-09",{"date":519,"type":40},"2026-04-14",{"date":521,"type":40},"2025-04-04",{"date":523,"type":22},"2028-04-01",{"name":525,"class":47},"Possible",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100489079","phase-2-a-phase-2-trial-comparing-antiviral-treatments-in-early-symptomatic-influenza-100489079","NCT05648448","A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza","ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)","AD ASTRA","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study\n* Adults, male or female, aged 18 to 60 years at time of consent.\n* Early symptomatic Influenza (A or B); at least one reported symptom of influenza (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)\n* Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza viruses within the last 24hrs with a Ct value of \\\u003C30\n* Able to walk unaided and unimpeded in activities of daily living (ADLs)\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity\n* Presence of any chronic illness\u002Fcondition requiring long term treatment or other significant comorbidity\n* BMI ≥35 Kg\u002Fm2\n* Clinically relevant laboratory abnormalities discovered at screening\n\n  * Haemoglobin \\\u003C10g\u002FdL\n  * Platelet count \\\u003C100,000\u002FuL\n  * ALT \\> 2x ULN\n  * Total bilirubin \\>1.5 x ULN\n  * eGFR \\\u003C70mls\u002Fmin\u002F1.73m2\n* For females: pregnancy, actively trying to become pregnant or lactation (healthy women on OCP are eligible to join)\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics\n* Currently participating in another interventional influenza or COVID-19 therapeutic trial\n* Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations (imaging not required)\n* Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)\n* Received live attenuated influenza virus vaccine within 3 weeks prior to study entry","60 Years",{"count":536,"type":22},3000,[61],"This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other.\n\nAD ASTRA study is supported by the Wellcome Trust Grant ref: 223195\u002FZ\u002F21\u002FZ through the COVID-19 Therapeutics Accelerator",[540,541],"Influenza","Influenza, Human",[540,543,544],"Phase 2","Antiviral Pharmacodynamics",{"date":519,"type":40},{"date":547,"type":40},"2023-02-22",{"date":549,"type":22},"2027-01-01",{"name":495,"class":47},4,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":171,"sex":112,"minAge":56,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":193},"100578372","reducing-anemia-among-preconception-women-in-nepal-through-a-group-norm-and-micronutrient-supplementation-intervention-100578372","NCT06810440","Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention","Reducing Anemia Among Young Preconception Women in Nepal Through a Group Household Norm and Micronutrient Supplementation Intervention","Sumadhur","Inclusion Criteria:\n\n* the newly married couple having been married in the last four months\n* women being under 25 years old\n* never pregnant and not currently pregnant\n* co-residing with the mother-in-law in a household as defined by sharing meals together.\n* all triad-household members must also be willing to participate\n* husbands must not be planning to migrate in the next 6 months.\n\nExclusion Criteria:\n\n* Over 25, under 18 years old\n* Currently or ever pregnant\n* married more than 4 months before\n* not co-residing\n* not being willing to participate.\n* do not consent to blood-draws\n* women who are severely anemic (hemoglobin \\\u003C 8.0 g\u002FdL) at baseline based on hemoglobin via Hemocue assessment of a fingerprick blood sample at the time of enrollment","25 Years",{"count":562,"type":22},2100,[86],"Preconception micronutrient status (including anemia) is a critical determinant of maternal, newborn, and child health that remains undervalued in Nepal. However, providing micronutrient supplements (MMS) alone is not enough. In the Nepali context, the gap between marriage and the first birth is short and newly married women have the lowest household status. Addressing the intersectional barriers to health for newly married women, including inequitable gender norms and women's empowerment, household relationships, nutrition knowledge and practices-is essential for improving maternal and infant outcomes in Nepal. To mitigate the community, household, and individual factors resulting in poor nutrition, the team developed and pilot-tested an educational group intervention (Sumadhur, meaning \"Best Relationship\") for newly married women, husbands, and mothers-in-law triads. Sumadhur aims to provide information on nutrition and women's health, address inequitable gender norms and practices, strengthen household relationships and communication, and improve the household status of newly married women. The pilot study of Sumadhur brought triads of several households together for 16 interrelated sessions over four-months. Findings suggest that participants (N=90) found the intervention to be highly feasible and acceptable and nutritional norms and practices improved.\n\nWe propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster RCT (cRCT). The intervention participants will receive the Sumadhur group intervention and will be provided MMS directly at group sessions. In control villages who do not receive the Sumadhur group intervention, we will facilitate access to MMS at primary health centers. We will randomize 70 villages to each arm (with one group per village). Each village has one group of five women (total of 700 women). Newly married women, their husbands and mothers-in-laws (total=2,100), will be followed four times for 18 months post-intervention through surveys, hemoglobin tests and blood draws (women only). The specific aims are to estimate the effectiveness of Sumadhur on women's anemia and micronutrient status, including the cost-benefit of the intervention (Aim 1); explore the impact on intermediate outcomes such as gender norms, household relationships and eating practices and characterize the individual and household-level mechanisms of impact (Aim 2); understand triadic experiences and impact over time of Sumadhur (Aim 3).\n\nAccomplishing these aims will provide evidence for how to improve micronutrient and anemia status among women before they become pregnant-thereby ensuring that women are not deficient in the critical early phases of pregnancy. These findings will also advance the field by testing novel approaches (household and community level behavior and norm change intervention) that, when combined with supplements, may lead to better adherence, uptake, and, ultimately, health outcomes, and have additional longer-term benefits.",[566,567,568,569,570],"Anemia, Iron-Deficiency","Nutritional Deficiencies","Adherence","Norms, Social","Knowledge, Attitudes, Practice","2026-03-24",{"date":99,"type":40},{"date":574,"type":40},"2025-10-08",{"date":576,"type":22},"2029-04-01",{"name":192,"class":47},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":584,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":193},"100626168","community-health-workers-led-integrated-management-of-hypertension-and-diabetes-in-nepal-100626168","NCT07432126","Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal","Inclusion Criteria:\n\n* 30 years or older\n* have a high blood pressure of 140\u002F90 mmHg or under hypertension medication\n* have a high blood sugar of 6.5% or more (hba1c) or under diabetes medication are able to provide informed consent\n\nExclusion Criteria:\n\n* any form of disabilities limiting participation in the study\n* severe illness requiring bed rest, and\n* pregnant women, due to their special health needs.","30 Years",{"count":586,"type":22},398,[86],"Hypertension (HTN) and diabetes mellitus are significant global public health challenges, contributing to 13.5% of premature deaths, 54% of incident strokes, and 47% of coronary heart disease cases (HTN), and increasing risks of cardiovascular diseases, kidney failure, and other complications (diabetes). In Nepal, HTN prevalence is 24.5% and diabetes affects 5.8% of adults (2019 Nepal STEPS Survey), with many cases undiagnosed or poorly managed, and an estimated 60% co-morbidity among diabetic individuals. Nepal's Package of Essential Non-Communicable Diseases (PEN), implemented since 2017, targets both conditions, but multi-level barriers limit its facility-based effectiveness. This study addresses the need for cost-effective, evidence-based strategies for HTN and diabetes management in low-resource settings, focusing on marginalized populations. It proposes a Type II hybrid implementation-effectiveness study with two objectives: (1) evaluate implementation outcomes (reach, adoption, implementation, maintenance) of the Female Community Health Volunteers (FCHVs)-led integrated HTN and diabetes management using the RE-AIM framework; (2) assess effectiveness compared to facility-based PEN on systolic blood pressure and fasting blood sugar at 12 months. FCHVs will deliver integrated health education, form peer groups, and coordinate care. Using a mixed-method approach, the study involves a cluster randomized controlled trial with participants, collecting quantitative data on implementation, supplemented by in-depth interviews (8-16 patients) and focus group discussions (2 FGDs with FCHVs), with qualitative tracking logs. The intervention adapts a prior FCHV-led HTN trial to integrate diabetes management. FCHVs will receive 3-day training on screening, counseling, BP and blood sugar monitoring, and referrals for both conditions. Mass screening will identify HTN and diabetes cases, forming monthly FCHV groups for lifestyle counseling, BP, and glucose tracking, with family involvement. Monthly referrals will link uncontrolled cases to facilities. This aims to enhance integrated HTN and diabetes management, fostering community engagement and healthcare coordination, with findings to inform scalable NCD strategies in Nepal.",[590,591],"Hypertension (HTN)","Diabetes (DM)",[593,594,595,596,597],"disease management","hypertension","diabetes","community health workers","intervention","2026-03-07",{"date":600,"type":40},"2026-03-10",{"date":602,"type":40},"2025-12-14",{"date":604,"type":22},"2027-11",{"name":103,"class":47},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":616,"phases":4,"briefSummary":617,"conditions":618,"keywords":621,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":633},"100626750","icu-related-out-of-pocket-expenses-icope-100626750","NCT07439692","ICU-related Out of Pocket Expenses (ICOPE)","ICU-related Out of Pocket Expenses (ICOPE) - A Multinational Prospective Study In African And Asian Countries.","ICOPE","Inclusion Criteria:\n\nAll patients admitted to the participating ICUs during a predefined window of 14 days and expected to have a duration of stay \\>24 hours will be eligible for the study.\n\nExclusion Criteria:\n\nlack informed consent.",{"count":615,"type":22},354,"OBSERVATIONAL","The ICU-related Out-of-Pocket Expenses (ICOPE) study is a multinational, prospective observational study conducted in African and Asian countries to quantify ICU-related out-of-pocket expenditures and catastrophic health expenditure among patients and families. The study will include all patients admitted to participating ICUs during a predefined 14-day recruitment window, provided they have an ICU stay longer than 24 hours and informed consent is obtained. A minimum sample size of 354 patients is planned, including both ventilated and non-ventilated patients. Participants will be followed until ICU discharge, with additional follow-up at 30 days and 6 months after admission, resulting in a total study duration of 18 months. The primary objective is to quantify ICU-related out-of-pocket costs and assess the proportion of patients experiencing catastrophic health expenditure, comparing ventilated and non-ventilated groups, while secondary objectives include identifying risk factors for catastrophic expenditure and documenting coping strategies used by families to manage ICU costs.",[619,620],"Cost of ICU","Out of Pocket Expenses",[622,623,624,625],"OOPE","ICU-cost","LMIC","Critical Care",{"date":627,"type":40},"2026-02-27",{"date":629,"type":40},"2024-12-01",{"date":97,"type":22},{"name":632,"class":47},"Nat Intensive Care Surveillance - MORU",44,{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":23,"phases":644,"briefSummary":645,"conditions":646,"keywords":648,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":193},"100626726","group-care-for-hypertension-and-diabetes-management-in-nepal-100626726","NCT07439380","Group-Care for Hypertension and Diabetes Management in Nepal","Group-Care for Hypertension and Diabetes Management in Nepal: A Cluster Randomized Implementation Trial","GCHD- Nepal","Inclusion Criteria:\n\n* Adults aged 18 years and above living in the catchment areas of the 37 health facilities participating in the trial, across the 4 specified municipalities\n* Individuals who are newly diagnosed with hypertension (defined as systolic blood pressure 140 mmhg or higher and\u002For diastolic blood pressure 90 mmHg or higher.) and\u002For diabetes (defined as fasting blood glucose ≥126 mg\u002FdL, random blood glucose ≥200 mg\u002FdL, or Hgb A1c≥6.5).\n* Individuals with previously known diagnoses of hypertension and\u002For diabetes with records from health facilities record or patient card of individuals.\n* Residents of the catchment areas served by the enrolled health facilities in the study sites.\n\nExclusion Criteria:\n\n* Individuals with physical or verbal disabilities that would impede their participation in the intervention activities, such as attending and participating in group discussions, counseling sessions, or self-reporting during data collection.\n* Pregnant women\n* People who may migrate within a year",{"count":643,"type":22},1110,[86],"Hypertension and diabetes represent significant and growing public health challenges in Nepal, particularly in underserved communities. Traditional individual-based care approaches may not adequately address the multifaceted needs of patients with these chronic conditions in resource-limited settings. The group care model, which combines peer support, education, and clinical care, offers a promising alternative that could enhance patient outcomes. This protocol outlines a dual cluster randomized controlled trial (DRCT) using a hybrid type II design to evaluate the effectiveness of a group care model for improving the control and management of hypertension and diabetes in four municipalities in Nepal. The trial will also evaluate the implementation outcomes of fidelity and economic costs.\n\nThe researchers will assess the effect of the group care model on clinical outcomes. The primary outcomes will be the proportion of patients with controlled versus uncontrolled blood pressure (among patients with hypertension) and the proportion of patients with controlled versus uncontrolled hemoglobin A1c (among patients with diabetes) at 6 and 12 months. The researchers will conduct a three-arm comparison (control vs. low intensity strategies vs. high intensity strategies), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also evaluate intervention fidelity in the two intervention groups and conduct an economic analysis. Each cluster, representing a health facility, will be randomly allocated to one of the three arms after baseline data collection and prior to initiating the intervention phase. The low intensity arm will receive the group care model with standard implementation support, while the high intensity arm will receive the group care model with enhanced implementation strategies. The control arm will continue with the standard of care offered in the nearest health facility, including hypertension and diabetes detection and management based on PEN protocols 1 and 2. After study completion, control facilities will be offered training on the group care model.",[152,647],"Diabetes",[649,650,152,647,651,652],"Dual randomized control trial","Group-based care","Implementation science","NCDs",{"date":627,"type":40},{"date":655,"type":22},"2026-04-01",{"date":657,"type":22},"2027-08-01",{"name":659,"class":47},"Icahn School of Medicine at Mount Sinai",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":534,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":682},"100442478","phase-2-finding-treatments-for-covid-19-a-trial-of-antiviral-pharmacodynamics-in-early-symptomatic-covid-19-platcov-100442478","NCT05041907","Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","PLATCOV","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study.\n* Previously healthy adults, male or female, aged 18 to 60 years at time of consent with early symptomatic COVID-19\n* SARS-CoV-2 positive by lateral flow antigen test OR a positive PCR test for SARS-CoV-2 within the last 24hrs with a Ct value of less than 25 (all viral targets)\n* Symptoms of COVID-19 (including fever, or history of fever) for less than 4 days (96 hours).\n* Oxygen saturation ≥96% measured by pulse-oximetry at time of screening.\n* Able to walk unaided and unimpeded in ADLs\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs (see appendix 4)†\n* Presence of any chronic illness\u002F condition requiring long term treatment, or other significant comorbidity (e.g. diabetes, obesity but see appendix 4 for the full list)\n* Laboratory abnormalities discovered at screening (see appendix 4)\n* For females: pregnancy, actively trying to become pregnant, or lactation\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics (see appendix 4)\n* Currently participating in another COVID-19 therapeutic or vaccine trial\n* Evidence of pneumonia (although imaging is NOT required)\n\n  * healthy women on the oral contraceptive pill are eligible to join the study",{"count":669,"type":22},3800,[61],"The trial will develop and validate a platform for quantitative assessment of antiviral effects in low-risk patients with high viral burdens and uncomplicated COVID-19 to determine in-vivo antiviral activity. In this randomized open label, controlled, group sequential adaptive platform trial, we will assess the performance of three distinct types of intervention relative to control (no treatment):\n\nA: Small molecule drugs; B: Monoclonal antibodies; C: Dose finding for the constituent parts of nirmatrelvir\u002Fritonavir\n\nPLATCOV study is supported by the Wellcome Trust Grant ref: 223195\u002FZ\u002F21\u002FZ through the COVID-19 Therapeutics Accelerator.",[480],[480,543,544],"2026-02-16",{"date":676,"type":40},"2026-02-19",{"date":678,"type":40},"2021-09-30",{"date":680,"type":22},"2027-01",{"name":495,"class":47},7,{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":584,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":23,"phases":693,"briefSummary":694,"conditions":695,"keywords":696,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":705,"locationsCount":193},"100522314","fchv-htn-implementation-trial-in-nepal-100522314","NCT06081010","FCHV-HTN Implementation Trial in Nepal","Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial","CHPC","Inclusion Criteria:\n\n-High blood pressure (BP) of 140\u002F90 mmHg or higher.\n\nExclusion Criteria:\n\n* Severe illness requiring bed rest\n* Pregnant women, due to their special health needs",{"count":692,"type":22},3572,[86],"The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are:\n\n1\\. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels?\n\n2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial.\n\n3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy?\n\nParticipants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.",[152],[152,697,698],"Community Health Worker","Implementation Trial","2026-02-04",{"date":701,"type":40},"2026-02-06",{"date":703,"type":40},"2024-12-02",{"date":221,"type":22},{"name":248,"class":47},""]