[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Ghana\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":699},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,42,64,93,125,162,188,220,248,271,298,325,348,374,400,430,455,484,518,540,569,594,623,643,668],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100563138","phase-3-a-study-to-evaluate-how-well-etavopivat-works-in-people-with-sickle-cell-disease-100563138",false,"NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.","ALL","12 Years",{"count":21,"type":22},408,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.",[28],"Sickle Cell Disease","RECRUITING","2026-08-12",{"date":32,"type":33},"2026-08-13","ACTUAL",{"date":35,"type":33},"2025-02-17",{"date":37,"type":22},"2029-08-12",{"name":39,"class":40},"Novo Nordisk A\u002FS","INDUSTRY",175,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100562904","phase-3-a-research-study-looking-at-long-term-treatment-with-etavopivat-in-people-with-sickle-cell-disease-or-thalassaemia-100562904","NCT06609226","A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia","An Open-label, Multi-centre, Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study","FLORAL","Inclusion Criteria:\n\n* Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.\n* Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.\n* Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring.\n* Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status.\n\nExclusion Criteria:\n\n* Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.\n* Participants on permanent dose reduction (greater than \\[\\>\\] 28 days or more) or ongoing temporary treatment discontinuation.\n* Use of any of the following within the timeframes prior to the transfer visit as stated:\n* Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.\n* Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.\n* Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study.\n* Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.\n* Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.","2 Years",{"count":52,"type":22},480,[25],"Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.",[28,56],"Thalassemia",{"date":32,"type":33},{"date":59,"type":33},"2025-01-10",{"date":61,"type":22},"2030-12-30",{"name":39,"class":40},106,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":18,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100463298","phase-2-phase-23-adaptive-study-of-vx-147-in-adult-and-pediatric-participants-with-apol1-mediated-proteinuric-kidney-disease-100463298","NCT05312879","Phase 2\u002F3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease","A Phase 2\u002F3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease","AMPLITUDE","Key Inclusion Criteria:\n\nPart A:\n\n* APOL1 genotype of G1\u002FG1, G2\u002FG2, or G1\u002FG2\n* Proteinuric kidney disease\n\nPart B:\n\n\\- Completion of Treatment Period in Part A and no permanent discontinuation of study drug.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Solid organ or bone marrow transplant\n* Uncontrolled hypertension\n* History of diabetes mellitus\n* Known underlying cause of kidney disease including but not limited to sickle cell disease\n\nPart B:\n\n* ESKD (End Stage Kidney Disease) as defined in the protocol.\n* Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator.\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.","10 Years","65 Years",{"count":75,"type":22},466,[77,25],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.",[80],"Proteinuric Kidney Disease",[82],"APOL1-mediated kidney disease (AMKD)","2026-08-03",{"date":85,"type":33},"2026-08-04",{"date":87,"type":33},"2022-03-30",{"date":89,"type":22},"2030-05-07",{"name":91,"class":40},"Vertex Pharmaceuticals Incorporated",318,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":100,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100650252","evaluating-interventions-for-breast-cancer-screening-in-ghana-100650252","NCT07745517","Evaluating Interventions for Breast Cancer Screening in Ghana","EVALUATING THE EFFECTIVENESS OF COMMUNITY HEALTH NURSE-LED AND TEXT MESSAGING INTERVENTIONS TO IMPROVE BREAST CANCER SCREENING IN GHANA: A MULTI-ARM RANDOMISED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Must be a female aged 25 years or older\n* Must be resident in the Danfa community\n* Must be someone who can confirm their availability for at least the next eight months after the initiation of the trial\n\nExclusion Criteria:\n\n* Males\n* Females aged \\\u003C25 years\n* Women who are not resident in the study setting\n* Women who cannot be available for at least the next eight months after the initiation of the trial","FEMALE","25 Years",{"count":103,"type":22},828,[105],"NA","This study aims to implement two interventions to determine the most effective one that can improve Ghanaian women's decision to get their breasts examined by a healthcare professional. The two interventions are (1) a system where community health nurses will be leveraged to educate women on breast cancer screening; (2) a system where women will be sent text messages about breast cancer screening. Both interventions will be carried out over five months. A survey will be conducted before the intervention is introduced. Then, after the sixth month, another survey will be implemented to determine whether there have been changes. Only women who are 25 years or older will be included in the study.",[108],"Breast Cancer Screening",[110,111,112,113],"Breast cancer","Screening","Literacy","Experimental Studies","NOT_YET_RECRUITING","2026-07-29",{"date":85,"type":33},{"date":118,"type":22},"2026-10-01",{"date":120,"type":22},"2027-11-30",{"name":122,"class":123},"University of Huddersfield","OTHER",1,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":136,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":144,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100327946","icareme-global-registry-multinational-real-world-evidence-in-cardiorenal-and-metabolic-diseases-100327946","NCT03549754","iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases","Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and\u002For Chronic Kidney Diseases","iCaReMe","Inclusion Criteria:\n\n1. Being 18 years or older\n2. Having type 2 diabetes, Hypertension, Heart Failure and\u002For chronic kidney disease\n3. Providing written informed consent to participate in the registry\n\nExclusion Criteria:\n\n1. Having a life-threatening co-morbidity with life expectancy below 1 year\n2. Participating in an interventional trial requiring informed consent","18 Years",{"count":135,"type":22},35000,"3 Years","OBSERVATIONAL","To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and\u002For Chronic kidney diseases",[140,141,142,143],"Type 2 Diabetes","Hypertension","Chronic Kidney Disease","Heart Failure",[145,140,146,142,147,141,148,149,143,150,151],"Registry","T2DM","CKD","HTN","Adult population","HF","Early cardiorenal complications","2026-07-20",{"date":154,"type":33},"2026-07-22",{"date":156,"type":33},"2018-02-17",{"date":158,"type":22},"2030-12-31",{"name":160,"class":40},"AstraZeneca",76,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":100,"minAge":133,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":124},"100625271","cardiometabolic-risk-in-pregnancy-and-postpartum-100625271","NCT07420465","Cardiometabolic Risk in Pregnancy and Postpartum","Inclusion Criteria:\n\n* Singleton pregnancy\n* 18 years and older\n* 3rd trimester of pregnancy at enrollment\n* Will be living in the area for the study duration\n* Women with or without pregnancy complications (e.g., gestational hypertension, preeclampsia, gestational diabetes)\n\nExclusion Criteria:\n\n* Multiple births\n* Diagnosed CVD or diabetes prior to pregnancy\n* Renal or other serious maternal diseases pre-pregnancy",true,"45 Years",{"count":171,"type":22},200,[105],"The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.",[175,176,177,178],"Hypertensive Disorders of Pregnancy","Postpartum Hypertension","Cardiovascular Disease Risk","High Blood Pressure","2026-07-14",{"date":181,"type":33},"2026-07-16",{"date":183,"type":33},"2026-04-01",{"date":185,"type":22},"2027-12",{"name":187,"class":123},"Forgive Avorgbedor",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":100,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":206,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100473408","effectiveness-and-acceptability-of-insertable-devices-for-obstetric-fistula-management-100473408","NCT05444504","Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management","Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial","COPE","Inclusion criteria:\n\n* VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)\n* Willing to insert and remove cup\u002Fcup+\n* Clear understanding of the study procedures\n* Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery\n* If previous fistula repair, ≥3mo post-delivery\n* If recent birth, age 18+ or emancipated minor\n* Speak English or local language\n\nExclusion criteria:\n\n* Any rectovaginal fistula\n* Urinary leakage \\\u003C6ml over 6 hours\n* Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \\\u003C3mo post-delivery.","15 Years",{"count":198,"type":22},100,[105],"The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.",[202,203,204,205],"Obstetric Fistula","Fistula","Fistula, Urinary","Fistula, Vaginal",[207,208,203,202,205,204,209,210],"Menstrual cup","Urinary incontinence","Women's health","Quality of LIfe","2026-07-13",{"date":179,"type":33},{"date":214,"type":33},"2023-04-15",{"date":216,"type":22},"2026-12-31",{"name":218,"class":123},"University of California, San Francisco",3,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":168,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":124},"100602868","assessing-the-performance-of-7-day-vs-1-day-packaging-for-small-quantity-lipid-based-nutrient-supplements-in-ghana-sqlns7d-1d-comparison-100602868","NCT07129109","Assessing the Performance of 7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)","Assessing the Performance of 7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7Dv1D Comparison)","SQLNS:7Dv1D","Inclusion Criteria:\n\n* Primary caregiver of a child aged 6-24 months attending growth monitoring and promotion (GMP) services at one of the participating health facilities\n* Willing and able to provide informed consent\n* Plans to remain in the area for the duration of the study period\n* Agrees to participate in surveys and\u002For interviews related to supplement use\n\nExclusion Criteria:\n\n* Caregiver of a child with a diagnosed severe illness requiring hospitalization\n* Caregiver under the age of 18",{"count":229,"type":22},505,[105],"This cluster-randomized crossover trial evaluates the impact of two different packaging formats for small-quantity lipid-based nutrient supplements (SQ-LNS) on adherence and acceptability among caregivers of young children in Northern Ghana. SQ-LNS are a proven intervention for reducing child malnutrition, but optimizing packaging formats may improve adherence and scalability.\n\nSixteen health facilities participating in growth monitoring services will each receive both formats: a 1-day sachet (20g daily) and a 7-day bulk container (140g weekly), with the order of delivery randomized. Each packaging format will be distributed for one month before cross-over. The primary outcomes are adherence (measured through caregiver self-report and sachet counts) and acceptability (assessed via caregiver interviews). Secondary outcomes include caregiver preference, ease of use, and qualitative insights into feeding practices, beliefs, and packaging usability.\n\nThis implementation research study uses a convergent mixed-methods design, integrating quantitative adherence and acceptability data with in-depth interviews and structured observations to inform real-world program implementation. Findings will guide policy and program decisions for integrating SQ-LNS into child health platforms in Ghana and other low-resource settings.",[233],"Child Malnutrition",[235,236,237,238],"Small-quantity lipid-based nutrient supplements (SQ-LNS)","Ghana","Infant and young child feeding","Growth monitoring and promotion (GMP)","2026-07-09",{"date":241,"type":33},"2026-07-10",{"date":243,"type":22},"2026-09",{"date":245,"type":22},"2026-12",{"name":247,"class":123},"Boston University Charles River Campus",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100513292","phase-3-stroke-minimization-through-additive-anti-atherosclerotic-agents-in-routine-treatment-ii-study-smaart-ii-100513292","NCT05963568","Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)","Inclusion Criteria:\n\n* Above the age of 18 years; male or female\n* Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible\n* Subjects with stroke may present with at least one of the following additional conditions:\n\nDocumented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n\n* Legally competent to sign informed consent.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindications to any of the components of the polypill\n* Hemorrhagic stroke\n* Severe cognitive impairment\u002Fdementia or severe global disability limiting the capacity of self-care\n* Severe congestive cardiac failure (NYHA III-IV)\n* Severe renal disease, eGFR \\\u003C30ml\u002Fmin\u002F1.73m2), renal dialysis; awaiting renal transplant or transplant recipient\n* Cancer diagnosis or treatment in past 2 years\n* Need for oral anticoagulation at the time of randomization or planned in the future months;\n* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)\n* Nursing\u002Fpregnant mothers\n* Do not agree to the filing, forwarding and use of his\u002Fher pseudonymized data.","100 Years",{"count":256,"type":22},1000,[25],"The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.",[260,261],"Stroke","Medication Adherence","2026-07-01",{"date":264,"type":33},"2026-07-06",{"date":183,"type":33},{"date":267,"type":22},"2029-02-01",{"name":269,"class":123},"Northern California Institute of Research and Education",4,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":101,"maxAge":73,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":124},"100577620","home-based-self-sampling-for-cervical-cancer-prevention-education-intervention-in-ghana-100577620","NCT06800664","Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana","The Impact of an Evidence-Based, Behavioral Cervical Cancer Screening Intervention Among Women Living With HIV in Ghana (HOPE-inG): A Type 2 Hybrid Effectiveness Implementation Trial","HOPE-inG","Inclusion Criteria:\n\nGeneral criteria\n\n* ability to give consent per Institutional Review Board stipulations\n* residing in the Central Region\n* having no medical characteristics that would interfere with the ability to participate fully\n* the willingness to participate in this study.\n\n  (a) Healthcare provider eligibility: Inclusion criteria include an individual (no gender restrictions) who\n* possesses healthcare qualifications (i.e., patient navigators, physicians, nurses, health facility management),\n* works at the HIV health facility at study sites,\n* is ≥18 years old. (b) Eligibility for women living with HIV (Patients)\n* identified female at birth) who\n* are living with HIV between 25 and 65 years old (age consistent with WHO CC screening guidelines)\n* have never had CC screening (Pap or HPV test),\n* have not had a screening for the past 5 years\n\nExclusion Criteria:\n\n* Women will be excluded if they are pregnant or have had a hysterectomy.\n* WLWH who have a cervix are the main target population to develop the HOPE toolkit.\n* Women who are below 25 and those who are above 65 years will be excluded.",{"count":280,"type":22},1500,[105],"The investigators propose to develop and\u002For adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana.\n\nThese \"implementation support strategies (ISS)\" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice.\n\nThe ultimate goal is to facilitate health system adoption and sustainment.",[284,285,286,287,288,289],"Cervical Cancer Screening","HIV","Self-sampling","Implementation Science","Intervention (Training) Condition","Implementation Strategies","2026-06-30",{"date":262,"type":33},{"date":293,"type":33},"2025-11-11",{"date":295,"type":22},"2029-05",{"name":297,"class":123},"Baylor University",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":100,"minAge":133,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100644093","phase-3-optimizing-the-use-of-aspirin-for-the-prevention-of-preeclampsia-100644093","NCT07665853","Optimizing the Use of Aspirin for the Prevention of Preeclampsia","Optim-PRE","Inclusion Criteria:\n\n* Age 18 years or older at time of enrollment.\n* Singleton pregnancy.\n* Ability to read and understand the informed consent form.\n* Having undergone first-trimester preeclampsia screening between 11+0 and 13+6 weeks of gestation using a validated multiparametric algorithm (FMF algorithm at a risk cutoff of 1:100, or Gaussian algorithm at a cutoff of 1:170) and being classified as high risk for preterm preeclampsia.\n* Currently taking aspirin 150 mg\u002Fday initiated after first-trimester high-risk classification, in accordance with standard clinical practice.\n* Voluntary signing of the informed consent form and willingness to comply with the study requirements, including acceptance of the assigned aspirin treatment duration, additional blood tests, and additional ultrasound assessments.\n\nExclusion Criteria:\n\n* Early pregnancy loss, intrauterine fetal death, or fetus with major structural malformations diagnosed at the time of enrollment.\n* Fetus affected by a known genetic or chromosomal disease.\n* Contraindication, allergy, or intolerance to aspirin (acetylsalicylic acid).\n* Any medical condition that makes aspirin discontinuation unsafe or impossible (e.g., antiphospholipid syndrome, mechanical heart valve, or other conditions requiring indefinite antiplatelet or anticoagulant therapy).",{"count":306,"type":22},15160,[25],"Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk.\n\nAspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established.\n\nThis is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.",[310],"Preeclampsia",[310,312,313,314,315],"First Trimester Screening","Placental Growth Factor","Ophthalmic Artery Doppler","Acetyl Salicylic Acid (ASA)","2026-06-18",{"date":318,"type":33},"2026-06-24",{"date":262,"type":22},{"date":321,"type":22},"2028-05",{"name":323,"class":123},"Hospital Universitari Vall d'Hebron Research Institute",38,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":332,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":124},"100586780","phase-3-cilostazol-for-prevention-of-recurrent-stroke-in-africa-100586780","NCT06919835","CiLostAzol for pReventIon of Recurrent sTroke in Africa","CLARITY-Africa","Inclusion Criteria:\n\n1. Above the age of 30 years; male or female (sex is a biological variable of interest)\n2. Ischemic stroke or high-risk TIA (ABCD2 score \\>= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)\n3. Aspirin or clopidogrel monotherapy\n4. Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n5. Legally competent to sign informed consent or have a LARs who is able to provide consent for them\n6. In the opinion of the treating physician, patient is medically stable, capable of participating in a randomized trial, and willing and able to attend follow-up.\n7. Able to do labs at all study intervals (7 visits total)\n\nExclusion Criteria:\n\n1. Unable to provide a valid informed consent\n2. Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)\n3. Hemorrhagic stroke survivor within the last 2 years\n4. Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)\n5. On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)\n6. Modified Rankin Scale 5\n7. Thrombocytopenia (platelet count \\\u003C1000,000)\n8. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)\n9. Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)\n10. Nursing\u002Fpregnant mothers","30 Years",{"count":334,"type":22},1100,[25],"Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Stroke survivors in Africa are at an inordinately high (and worsening) risk of adverse outcomes including recurrent stroke and cardiac events over the medium- to longterm. Given the paucity of resources in the region, testing of therapies, which are potentially highly clinically efficacious and cost-effective, while developing local stroke research capacity and contributing to the global secondary stroke prevention evidence base, is urgently needed. Cilostazol, a phosphodiesterase 3 inhibitor, has shown promising efficacy and safety mainly among an Asian population by cutting risk of major adverse cardiovascular events including stroke, in half, when added to aspirin or clopidogrel (8% vs. 4%, HR 0.52, 95% CI 0.35-0.77), with no increased risk in bleeding or serious adverse events. Cilostazol's potentially strong efficacy, presumed pleiotropic effects, and relatively low cost, make it a highly appealing agent for use in stroke-prone, low-resource settings. Therefore, the overall objective of the CiLostAzol for pReventIon of recurrent sTroke in Africa (CLARITY-AFRICA) study is to deploy a hybrid study design to demonstrate the efficacy and safety of cilostazol twice daily in reducing MACE over 24 months vs. placebo among 1100 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, CLARITY-AFRICA also seeks to develop an implementation strategy for routine integration and policy adoption of cilostazol for post-stroke cardiovascular risk reduction in an under-resourced system. Given its compelling efficacy among a predominantly Asian population, the National Institute of Neurological Disorders and Stroke (NINDS) is poised to fund a US-based clinical trial to assess the longer-term efficacy and safety of cilostazol in a study titled CiLostAzol for pReventIon of recurrent sTroke (CLARITY). The investigators are also aware that European and Australian funding agencies are considering stroke trials of cilostazol. A concurrently executed CLARITYAfrica trial would allow recruitment of a historically underrepresented and high-risk group (Africans), test a therapy that if efficacious could be affordable for broader regional implementation, permit transcontinental mentorship\u002Fcollaborations, and leverage NINDS impending investment. CLARITY-AFRICA will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of cilostazol in Ghana to inform policy. Regardless of its outcome, findings from CLARITYAFRICA will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of cilostazol into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization. This application will focus on the first 2 aims of CLARITY-AFRICA to conduct the trial and assess secondary outcomes.",[260],[260,339,340],"Africa","post-stroke","2026-06-17",{"date":316,"type":33},{"date":344,"type":22},"2026-08-01",{"date":346,"type":22},"2029-08-31",{"name":269,"class":123},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":357,"conditions":358,"keywords":363,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":371,"leadSponsor":373,"locationsCount":270},"100642009","a-study-of-a-urine-test-to-detect-colorectal-cancer-100642009","NCT07649057","A Study of a Urine Test to Detect Colorectal Cancer","Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa","Inclusion Criteria:\n\n* Patient presents with one of the following:\n\n  * Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-\n  * Patients who present for a screening colonoscopy -OR-\n  * Has received one of the following within 3 weeks of the planned urine collection\n\n    * Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-\n    * Patients with colonoscopy demonstrating adenomatous polyps -OR-\n    * Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology\n* Age ≥ 18\n* Willingness to participate in the study",{"count":356,"type":22},210,"The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.",[359,360,361,362],"Colorectal Cancer","Precancerous Polyp","Rectal Bleeding","CRC",[359,360,361,364,362,365,366],"Symptoms of Colorectal Cancer","Memorial Sloan Kettering Cancer Center","26-187","2026-06-11",{"date":369,"type":33},"2026-06-15",{"date":367,"type":33},{"date":372,"type":22},"2028-06-11",{"name":365,"class":123},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":168,"sex":100,"minAge":196,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100508724","prisma-maternal-and-newborn-health-study-100508724","NCT05904145","PRISMA Maternal and Newborn Health Study","Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health","PRiSMA-MNH","A woman who meets the following inclusion criteria during screening may be enrolled:\n\n* Lives within the study catchment area;\n* Meets minimum age requirement in study site country:\n\n  * Ghana: 15 years of age;\n  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;\n  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;\n  * Zambia: 15 years of age;\n  * India: 18 years of age\n* Intrauterine pregnancy \\\u003C20 weeks gestation verified via ultrasound;\n* Provides informed consent.\n\nA woman who meets the following exclusion criteria during screening may NOT be enrolled:\n\n* Nonviable (e.g. ectopic or molar) pregnancy;\n* Plans to relocate outside of the study catchment area during pregnancy and\u002For postpartum.",{"count":383,"type":22},267897,"Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.\n\nAdditionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.\n\nThe Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.",[386],"Pregnancy, High Risk",[388,389,390],"Antenatal Care (ANC)","Postnatal Care (PNC)","Maternal Newborn Health","2026-06-09",{"date":367,"type":33},{"date":394,"type":33},"2022-08-01",{"date":396,"type":22},"2028-12-31",{"name":398,"class":123},"George Washington University",5,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":168,"sex":18,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":429,"locationsCount":124},"100621979","phase-2-strengthening-hpv-immunization-through-epi-leveraged-delivery-100621979","NCT07377656","Strengthening HPV Immunization Through EPI Leveraged Delivery","A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana","SHIELD","Inclusion Criteria:\n\n* Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination\n* Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.\n* Residing within the area of the study and planning to stay for the study duration.\n* Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).\n* Unmarried females with a negative pregnancy test at screening practicing\u002Fwilling to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana\n* Able and willing to comply with all study requirements.\n* Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's\u002FLAR's consent.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose\n* Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)\n* Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)\n* Planning to migrate out of the study areas before the end of the study follow-up\n* Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study.\n* Administration of immunoglobulins and\u002F or any blood products within the three months preceding the administration of the study vaccine.\n* Known history of allergy or anaphylaxis to study vaccine components and\u002For excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.\n* Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment (topical steroids may be allowed).\n* Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.","9 Months","20 Years",{"count":411,"type":22},115,[77],"This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.",[415],"HPV Vaccine",[417,418,236,406,419,420,421,422],"HPV","Proof of concept","IVI","International Vaccine Institute","Karolinska Institutet","Dodowa Health Research Center","2026-05-14",{"date":425,"type":33},"2026-05-18",{"date":427,"type":33},"2026-04-30",{"date":396,"type":22},{"name":420,"class":123},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":168,"sex":100,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100589539","phase-3-a-clinical-trial-on-safety-in-pregnant-women-and-how-well-the-infant-is-protected-against-rsv-associated-lower-respiratory-tract-infection-when-the-pregnant-woman-receives-the-approved-rsv-vaccine-compared-to-a-placebo-100589539","NCT06955728","A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.","A Phase-IIIb Individually Randomized, Placebo-controlled Trial on Safety of RSVA\u002FB-preF Vaccine in Pregnant Women and Efficacy Against Severe RSV-associated Lower Respiratory Tract Infection in Infants","Inclusion Criteria:\n\n* Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn\n* At a gestational age in keeping with in-country approval of the vaccine administration, and not in active labour. Gestational age will be based on GAIA LOC 1 to 2B criteria\n* Mother is able to understand and comply with planned trial procedures\n* Mother is attending ante-natal clinic\n* Mother has documented test for HIV and syphilis during the current pregnancy,\n* Provides written informed consent prior to initiation of trial. If the maternal participant is illiterate, a witnessed thumb-printed informed consent is acceptable\n* Intention to deliver at a hospital or birthing facility where trial procedures can be obtained (for immunogenicity cohort)\n* Expected to be available for the duration of the trial and can be contacted by telephone or by physical visit during trial participation\n* Participant is willing to give informed consent for her infant to participate in the trial\n\nExclusion Criteria:\n\n* Body mass index of \\>40 kg\u002Fm2 at the time of the first obstetric visit during the current pregnancy\n* Bleeding diathesis or condition (past or present) associated with prolonged bleeding that would, in the opinion of the investigator, contra-indicate intramuscular injection\n* History of severe adverse reaction associated with a vaccine\n* Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:\n\n  1. More than two fetuses (i.e. twins will be allowed)\n  2. Preeclampsia, eclampsia, or uncontrolled gestational hypertension\n  3. Known placental abnormality.\n  4. Known polyhydramnios or oligohydramnios\n  5. Known endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism, or uncontrolled diabetes mellitus at the time of consent.\n  6. Any signs of premature labour with the current pregnancy or having ongoing intervention (medical\u002F surgical) in the current pregnancy to prevent preterm birth.\n* At least THREE prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:\n\n  1. Prior preterm delivery between 18 to ≤34 weeks gestation, or birth weight \\\u003C2200 grams; (may be based on maternal history of prior preterm delivery where these details are not otherwise documented)\n  2. Prior stillbirth or neonatal death within 7 days of birth.\n  3. Previous infant with a known genetic disorder or major congenital anomaly\n* Mother who is positive for syphilis and untreated at time of enrolment\n* Mother living with HIV\u002FAIDS considered to have WHO Clinical Stage 3 or 4 AIDS, or considered to be clinically unstable\n* Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal participant's participation in, and completion of, the trial\n* Known or history of congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrolment\n* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with trial participation and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial\n* Participation in other studies involving investigational drug(s) within 28 days prior to consent and\u002For during trial participation.\n* Use of systemic corticosteroids for \\>14 days within 28 days prior to trial enrolment. Prednisone use of \\\u003C20 mg\u002Fday for ≤14 days is permitted. Inhaled\u002Fnebulized, intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted\n* Current alcohol abuse or illicit drug use\n* Receipt of blood or plasma products or immunoglobulin (Ig) in past 60 days or planned receipt through delivery, with exception of Rho(D) immune globulin (eg, RhoGAM), which can be given at any time\n* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during trial participation","14 Years","55 Years",{"count":440,"type":22},13000,[25],"Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries.\n\nA way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life.\n\nOne of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries.\n\nHowever, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies.\n\nThis RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.",[444,445,446],"RSV Infections","RSV Immunisation","Preterm Labour",{"date":425,"type":33},{"date":449,"type":33},"2025-09-03",{"date":451,"type":22},"2028-02-29",{"name":453,"class":123},"University of Witwatersrand, South Africa",11,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":100,"minAge":133,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":124},"100585129","ghana-mhl-project-tamale-100585129","NCT06898346","Ghana MHL Project, Tamale","Maternal Health, Literacy and Pregnancy Outcomes: The Role of Specialized Nutrition Education","Inclusion Criteria:\n\n* Nulliparous pregnant (first-time) mothers (BMI\\\u003C20kg\u002Fm2) between the ages of 18 and 40 attending antenatal sessions and in their second trimester, gestational ages (GA) of 16 weeks to 20 weeks, who are not carrying multiple fetuses\n\nExclusion Criteria:\n\n* Women with pregnancies greater than 20 weeks gestation, to ensure adequate exposure to the intervention; mothers presenting with significant morbidity or who are admitted due to complications and mothers who cannot confirm an address or contact information and do not plan to deliver at a health facility as well as those who indicate that they would not deliver in the study region (those who will be out of town at time of delivery).","40 Years",{"count":464,"type":22},250,[105],"This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.",[468],"Pregnancy",[470,471,472,473,236,474],"Maternal Health Literacy","Dietary Diversity","Nutrition Education","RCT","Nutrition Knowledge","2026-05-05",{"date":477,"type":33},"2026-05-08",{"date":479,"type":33},"2026-03-31",{"date":481,"type":22},"2027-04",{"name":483,"class":123},"Yale University",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":491,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"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","0 Years",{"count":493,"type":22},70000,[25],"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)",[497],"Pneumonia",[499,500,501,502,503,504,505,506,507],"COVID-19","SARS-CoV-2","SARS coronavirus 2","SARS","Viral pneumonia syndrome","Community-acquired pneumonia","Bacterial pneumonia syndrome","Influenza A","Influenza B","2026-04-15",{"date":510,"type":33},"2026-04-21",{"date":512,"type":33},"2020-03-19",{"date":514,"type":22},"2038-09-30",{"name":516,"class":123},"University of Oxford",16,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":168,"sex":18,"minAge":524,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":124},"100614387","testing-the-impact-of-family-based-intervention-to-improve-developmental-and-health-outcomes-for-female-adolescents-100614387","NCT07278934","Testing the Impact of Family-Based Intervention to Improve Developmental and Health Outcomes for Female Adolescents","Inclusion Criteria:\n\nAdolescent girls' inclusion criteria are:\n\n* Enrolled in school and living within a family (defined broadly -not necessarily biological parents)\n* Ages 11 to 14\n* Skipping school in the past academic term (with at least 10% of unexcused absences).\n* Capable of giving assent\n\nThe caregiver inclusion criteria\n\n* Age 18 or older\n* Self-identified as primary caregiver of the adolescent girl\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n\\- Participants that do not meet the criteria or exhibit a lack of understanding of the study procedures and hence not able to provide informed consent will be excluded.","11 Years",{"count":526,"type":22},1920,[105],"This study seeks to address the urgent need for theoretically and empirically informed interventions that would address the increasing numbers of unaccompanied minors migrating from rural to urban centers in developing countries for better economic opportunities. This process often results in hazardous child labor defined as work that is mentally, physically, socially or morally dangerous and harmful; interfering with schooling and health and mental health functioning, and leading to several other disproportionate risks. Unaccompanied migrant child laborers' vulnerability is further intensified by the lack of parental protection and community belonging in the host urban center. The International Labor Organization (ILO) estimates that 9.6% of children (ages 5 to 17) across the globe are child laborers and draws attention to migrant child laborers as an underreported and highly vulnerable group, a significant portion of which are female with no education. Poverty has been identified as the main driver of child labor, with family context also being a critical contributing factor. Sub-Saharan Africa (SSA) has the highest rates of child labor (24%), with Ghana -the focus of this study- registering one of the highest child labor prevalence at 22%, including unaccompanied child migrant laborers. In Ghana, unaccompanied adolescent girls migrate from the Northern region to urban centers in the south to work in the informal economy. Load carrying is the most common type of labor for this population and exposes migrant girls to multiple developmental and health risks. Building on the recently concluded R21 study (with 97 adolescent girls aged 11 to 14 years and their caregivers) that showed high feasibility and acceptability, and promising preliminary impact of the ANZANSI (resilience in Dagbani -local language) combination intervention in the same region, we propose to test its effectiveness in a larger two-arm cluster randomized clinical trial among 960 adolescent girls (age 11 to 14 years) at risk of school dropout nested within 32 public junior high schools in the Northern region of Ghana and their caregivers. The schools will be randomly assigned to one of two study conditions: 1) ANZANSI (FEE+MFG) and 2) bolstered usual care. The intervention will be delivered for 12 months, with assessments conducted at baseline and at 12-, 24-, and 36-month follow-ups post-intervention initiation. The study specific aims are: Aim 1: Examine the short- and medium-term impacts of ANZANSI intervention on the incidence of unaccompanied migration for child labor (primary outcome), and academic progress and psychosocial outcomes (secondary); Aim 2: Examine the impact of the ANZANSI intervention on potential mechanisms of change at the individual, family, and community levels; Aim 3: Evaluate the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine participants, facilitators, and school leadership's experiences with the intervention.",[530],"Unaccompanied Migration","2026-04-08",{"date":533,"type":33},"2026-04-13",{"date":535,"type":33},"2026-04-07",{"date":537,"type":22},"2030-08-15",{"name":539,"class":123},"New York University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":547,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100558699","phase-4-pragmatic-evaluation-of-respiratory-distress-syndrome-treatment-in-africa-100558699","NCT06554522","Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa","Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa","Inclusion Criteria:\n\n* Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.\n* Silverman Anderson Score ≥5 before or after CPAP treatment.\n* Admitted to a study site within 24 hours of life.\n\nExclusion Criteria:\n\n* Major congenital or genetic anomalies.\n* Active pulmonary hemorrhage.\n* Major craniofacial anomalies that preclude the successful use of CPAP","1 Hour","24 Hours",{"count":550,"type":22},1512,[552],"PHASE4","The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:\n\nDoes surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?\n\nResearchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.\n\nParticipants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:\n\nReceive surfactant replacement therapy by the less invasive surfactant administration technique.\n\nBe monitored for complications Be followed throughout their hospitalization to determine their survival rate.",[555,556,557,558],"Respiratory Distress Syndrome in Premature Infant","RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","Premature Birth","2026-03-23",{"date":561,"type":33},"2026-03-27",{"date":563,"type":33},"2025-01-01",{"date":565,"type":22},"2027-12-30",{"name":567,"class":123},"Indiana University",8,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":100,"minAge":133,"maxAge":169,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":124},"100630470","multi-disciplinary-sickle-cell-disease-obstetrics-care-program-in-ghana-100630470","NCT07488091","Multi Disciplinary Sickle Cell Disease Obstetrics Care Program in Ghana","Multi Disciplinary Sickle Cell Disease Obstetrics Care Program in Ghana: Non-academic vs Academic Hospital (Pilot Study)","SCOB III","Inclusion criteria\n\n* Pregnant women with a confirmed laboratory diagnosis of sickle cell disease\n* Pregnancy confirmed by a pelvic ultrasound scan\n* Pregnancy should be 34 weeks' gestation or less\n* Pregnant women should be aged 18 - 45 years\n* Pregnant women should be attendants at the non-academic hospital\n\nExclusion criteria\n\n* All pregnant women with sickle cell disease who do not provide informed consent\n* All pregnant women with sickle cell disease who are referred for management of acute complications and hospital admission\n* All pregnant women with sickle cell disease who are referred for labor and delivery\n* All pregnant women with SCD who plan on delivering outside the non-academic hospital and won't be able to adhere to the follow-up procedures during the puerperium (the first six weeks after childbirth)",{"count":578,"type":22},198,[105],"The goal of this observational study is to determine the feasibility and effectiveness of initiating a multidisciplinary sickle cell disease (SCD) obstetrics program for women with SCD in a non-academic hospital.\n\nThe main question it aims to answer is: In a before-and-after study design, we will test the hypothesis that multidisciplinary care for pregnant women with SCD in a non-academic hospital will result in a 50% relative risk reduction in mortality compared to the mortality rate in pregnant women with SCD in the same hospital before the multidisciplinary care.\n\nParticipants will be managed using the academic hospital's multidisciplinary sickle cell disease obstetrics protocol adapted for the non-academic hospital",[582],"Sickle Cell Disease and Pregnancy",[584,28,585],"Maternal Mortality","Pregnant women","2026-03-18",{"date":559,"type":33},{"date":589,"type":33},"2026-01-22",{"date":591,"type":22},"2028-03-15",{"name":593,"class":123},"University of Ghana Medical School",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"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":603,"type":22},354,"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.",[606,607],"Cost of ICU","Out of Pocket Expenses",[609,610,611,612],"OOPE","ICU-cost","LMIC","Critical Care","2026-02-23",{"date":615,"type":33},"2026-02-27",{"date":617,"type":33},"2024-12-01",{"date":619,"type":22},"2026-07-31",{"name":621,"class":123},"Nat Intensive Care Surveillance - MORU",44,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":168,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":124},"100619955","african-survey-on-sepsis-knowledge-ask-100619955","NCT07351344","African Survey on Sepsis Knowledge (ASK)","ASK","Inclusion Criteria:\n\n* Occupation: adult members of a healthcare profession (e.g., doctors, nurses, midwifes) or their trainees\n* Place of work: employment in a healthcare facility in one of the seven partner countries (Uganda, Ethiopia, Democratic Republic of the Congo, Mozambique, Ghana, Sierra Leone, Nigeria).\n* Consent: Willingness to participate voluntarily in the anonymous online survey.\n\nExclusion Criteria:\n\n* Not employed in a healthcare profession (e.g., administrative staff, non-medical professionals)\n* Not employed in one of the participating countries. Incomplete questionnaires (\\\u003C 50% of questions answered)\n* No internet access or technical limitations that make participation impossible. To complete the survey online.\n* Language skills: Sufficient language skills in the survey language (English or French)",{"count":631,"type":22},300,"This study is an anonymous online survey on clinical knowledge of sepsis among healthcare professionals in seven countries in sub-Saharan Africa. The survey is to be repeated every 12-24 months.",[634],"Sepsis",{"date":636,"type":33},"2026-02-24",{"date":638,"type":33},"2026-02-20",{"date":640,"type":22},"2027-07-31",{"name":642,"class":123},"Claudia Spies",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":652,"conditions":653,"keywords":656,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":665,"locationsCount":667},"100559548","emus-enhanced-monitoring-using-sensors-after-surgery-100559548","NCT06565559","EMUs: Enhanced Monitoring Using Sensors After Surgery","EMUs","Participant Inclusion Criteria:\n\n* Adults 18 years and older.\n* Undergoing an elective or emergency major surgery procedure with a planned skin incision of 5 cm or greater. Any indication for surgery can exist, including benign, malignant, and trauma.\n* Willing and able to provide written informed consent.\n\nParticipant Exclusion Criteria:\n\n* Those under the age of 18.\n* A documented or suspected allergy to adhesive dressings.\n* Obstetric patients\n* Unwilling or unable to provide written informed consent.",{"count":651,"type":22},1332,"Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study:\n\n1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.\n2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment.\n3. To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration.\n\nThis registration focuses on the shadow-mode cohort study.\n\nParticipants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.",[654,655],"Surgery","Inpatients",[654,657,658],"Wearable Devices","Global Surgery","2026-02-06",{"date":661,"type":33},"2026-02-10",{"date":663,"type":33},"2024-02-28",{"date":640,"type":22},{"name":666,"class":123},"University of Edinburgh",17,{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":168,"sex":18,"minAge":675,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":23,"phases":678,"briefSummary":679,"conditions":680,"keywords":685,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":124},"100622856","assessing-the-feasibility-of-combining-dihydroartemisinin-piperaquine-and-primaquine-for-malaria-mass-drug-administration-in-high-endemic-communities-in-the-eastern-region-of-ghana-100622856","NCT07389057","Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana","Implementation Research to Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana","Inclusion Criteria:\n\n* must be aged 3 months and above and\n* be resident in the communities for the period of the study,\n* completed and signed a consent form from the parent or guardian of children below 18 years\n* Completed and signed assent for 12-17 years old children.\n* Completed and signed consent for those from age 18 years and above.\n\nExclusion Criteria:\n\n* Pregnant women\n* individual with a life-threatening illness (excluding malaria)\n* less than 10Kg body weight (or less than 1 year old)\n* individuals who had experienced adverse effects related to primaquine or\n* known to be G6PD deficient .","3 Months",{"count":677,"type":22},9000,[105],"Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria.\n\nA pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines.\n\nTo better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures.\n\nThe study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.",[681,682,683,684],"Malaria Asymptomatic Parasitaemia","Malaria Falciparum","Malaria Infection","Malaria Transmission",[686,687,236,688,689],"Malaria","Mass drug administration","Feasibility","Implementation Research","2026-01-30",{"date":692,"type":33},"2026-02-05",{"date":694,"type":33},"2023-11-01",{"date":696,"type":22},"2026-11-30",{"name":698,"class":123},"Noguchi Memorial Institute for Medical Research",""]