[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"London School of Hygiene and Tropical Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":324},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,73,100,135,171,191,215,245,268,296],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641163","phase-4-evaluation-of-the-impact-of-oral-ivermectin-on-musca-sorbens-flies-putative-vector-of-trachoma-100641163",false,"NCT07657143","Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma","Evaluation of the Impact of Oral Ivermectin (150 Micrograms\u002Fkg) on Musca Sorbens, the Putative Vector of Trachoma","IVERMUSC","Inclusion Criteria:\n\n* Able and willing to give fully informed consent\n* Able to understand and comply with the study procedures\n* Able to produce a stool on most days\n* Consider themselves to be in good general health\n* Aged 18 to 65 years\n\nExclusion Criteria:\n\n* Suspected or known to be sensitive or allergic to ivermectin\n* Women who are pregnant, nursing or intending to become pregnant\n* Aware of having any neurological disorders or recent history of seizures\n* History of travel to a region endemic for Loa loa.\n* Currently taking acenocoumarol, warfarin or levimasole",true,"ALL","18 Years","65 Years",{"count":22,"type":23},12,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","Trachoma is caused by repeated Chlamydia trachomatis infection in the eye. Routes of infection include close person-to-person contact and contaminated clothing. In addition, the bazaar fly Musca sorbens has been implicated in transmission. These flies frequently visit the faces of children and have been found positive for C. trachomatis, which may be transferred from the body of the flies or their regurgitated or defecated material.\n\nThis study aims to give recruited healthy volunteers a safe dose of oral ivermectin. Their faeces will be collected over subsequent days to determine whether ivermectin excreted from the body results in faecal concentrations that are high enough to prevent emergence of M. sorbens developing in faeces. It will also quantify ivermectin concentrations in tears secretions and faecal samples for up to 30 days post-treatment.",[29],"Survival of Flies Developing in Faecal Samples",[31,32,33],"Trachoma","Ivermectin","Musca flies","NOT_YET_RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":23},"2026-07",{"date":42,"type":23},"2026-12",{"name":44,"class":45},"London School of Hygiene and Tropical Medicine","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100586886","phase-2-comprehensive-ambulatory-antibiotics-for-the-treatment-of-congenital-syphilis-100586886","NCT06921213","Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis","Cares-1","Inclusion Criteria:\n\n1. Infants at risk of congenital syphilis at birth defined as:\n\n   1. an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.\n\n      AND\n   2. the mother is untreated in the current pregnancy defined as:\n\n   i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery\n\n   OR c. the mother is inadequately treated in the current pregnancy defined as:\n\n   i. Having received a non-penicillin based treatment regimen; and\u002For ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \\> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).\n2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)\n3. Infants who are less than \\\u003C= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).\n4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.\n\nExclusion Criteria:\n\n\\- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.\n\n2\\. They have a birthweight \\\u003C2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly","0 Days","7 Days",{"count":57,"type":23},90,[59],"PHASE2","CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with \"all-risk\" asymptomatic congenital syphilis.",[62],"Syphilis, Congenital","RECRUITING","2026-05-06",{"date":66,"type":38},"2026-05-11",{"date":68,"type":38},"2026-05-04",{"date":70,"type":23},"2027-06-30",{"name":44,"class":45},3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":17,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":4},"100635384","building-cognitive-resilience-to-vaccine-misinformation-using-ai-in-europe-100635384","NCT07551986","Building Cognitive Resilience to Vaccine Misinformation Using AI in Europe","Building Cognitive Resilience to Vaccine Misinformation Using Conversational AI: Evidence From a Multi-Country European Randomised Trial","Inclusion Criteria:\n\n* Parents or caregivers with children under 18 years old in the five target countries (UK, Netherlands, Croatia, Latvia, and Slovakia); and\n* Those who have regular access to a digital device and the internet\n\nExclusion Criteria:\n\n* Participants who do not meet the inclusion criteria.","20 Years",{"count":82,"type":23},5000,[84],"NA","This multi-country trial evaluates an AI chatbot designed to counter cognitive biases and inoculate parents against vaccine misinformation, embedded within a large survey across five European countries (n=5,000). Scaled from a 2026 single-country study, outcomes compare behavioural and attitudinal responses against standard-of-care materials (e.g., UNICEF infographics) to identify effective, scalable misinformation interventions.",[87],"Healthy",[89,90,91,92],"childhood vaccine","AI","chatbot","randomized controlled trial","2026-04-27",{"date":95,"type":38},"2026-05-01",{"date":97,"type":23},"2026-04",{"date":97,"type":23},{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100634021","understanding-mpxv-viral-clearance-transmission-dynamics-and-mpox-vaccine-effectiveness-in-west-africa--guinea-100634021","NCT07534267","Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea","Understanding MPXV Viral Clearance in Mpox Patients and Evaluating Transmission Dynamics of MPXV and Mpox Vaccine Effectiveness in West Africa : The Republic of Guinea","MOVIE-TRACE-WA","Inclusion Criteria:\n\n1. MOVIE-West Africa\n\n   * Individuals of any sex and age.\n   * Confirmed Mpox cases who tested positive for MPXV by PCR.\n   * Symptom onset within the 10 days prior to the baseline assessment.\n   * Willingness and ability to comply with study procedures and attend scheduled follow-up visits for up to two months.\n   * Availability for follow-up throughout the study period.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for minors or individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n2. TRACE-West Africa\n\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n3. VE-West Africa\n\n   * The inclusion criteria for Mpox cases in VE-West Africa are same as those in MOVIE-West Africa.\n   * The inclusion criteria for contacts of Mpox cases in VE-West Africa are as follows.\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Individuals living, working or studying in a community where mpox vaccination is being offered.\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n\nExclusion Criteria:\n\n(1) MOVIE-West Africa\n\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.\n\n  (3) VE-West Africa\n* The exclusion criteria for Mpox cases in VE-West Africa are as follows.\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.",{"count":109,"type":23},992,"56 Days","OBSERVATIONAL","This study has three primary objectives to address the public health challenges of the Mpox outbreak in Guinea, West Africa. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of Monkeypox virus (MPXV) elimination from the human body in Mpox cases. Objective 2 (TRACE-West Africa) aims to determine the MPXV transmission dynamics between Mpox cases and their contacts. Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease.",[114,115],"Mpox (Monkeypox)","Monkeypox",[117,115,118,119,120,121,122,123,124,125,126,127],"Mpox","MPXV","transmission dynamics","vaccine effectiveness","secondary attack rate","MVA-BN","Guinea","sub-Saharan Africa","West Africa","MOVIE-TRACE","viral clearance","2026-04-10",{"date":130,"type":38},"2026-04-16",{"date":130,"type":23},{"date":133,"type":23},"2027-08",{"name":44,"class":45},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":18,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":24,"phases":146,"briefSummary":148,"conditions":149,"keywords":154,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100587069","phase-3-serological-testing-and-treatment-for-plasmodium-vivax-malaria-a-trial-in-ethiopia-and-madagascar-100587069","NCT06923592","Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar","Serological Testing and Treatment for Plasmodium Vivax Malaria: a Cluster-Randomised Trial in Ethiopia and Madagascar","PvSTATEM","Inclusion Criteria:\n\n* Participant will remain in the study area for at least the next month.\n* Participant is older than 12 months\n\nExclusion Criteria:\n\n• Participant is unwilling to participate.","12 Months",{"count":145,"type":23},19200,[147],"PHASE3","The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Relapses account for a majority of recurrent infections and clinical cases of P. vivax malaria, and therefore have a significant effect on morbidity at the individual level.\n\nWith current technology, it is not possible to directly measure hypnozoite biomarkers. Rather than directly detecting hypnozoites, our team developed an indirect approach by measuring antibodies induced by the primary blood-stage infection. Antibodies to different blood-stage antigens decay at different rates. Measuring antibodies to a carefully selected panel of P. vivax antigens can aid to identify individuals who have been infected within the previous 9 months (approximately the lifespan of hypnozoites).\n\nA serological test based on selected P. vivax antigens can detect recent exposure and predict future relapses. Coupling this test with a safe and efficacious primaquine treatment regimen, results in a population-based intervention to target the hypnozoite reservoir. This intervention is referred to as Plasmodium vivax Serological Testing and Treatment (PvSeroTAT).\n\nPvSTATEM is a cluster randomised trial in Madagascar and Ethiopia. This study will provide insights into the feasibility, acceptability, and efficacy of the PvSeroTAT approach. In this study, individuals, randomised by clusters, will be tested for the presence of serological markers of a recent P. vivax infection, followed by a targeted drug treatment intervention aimed at killing P. vivax hypnozoites.",[150,151,152,153],"Malaria Vivax","Malaria Falciparum","Plasmodium Vivax","Plasmodium Falciparum",[155,156,157,141,158,159,160,161],"Plasmodium vivax","Vivax","PvSeroTAT","Primaquine","serology","Cluster randomised trial","G6PD","2026-03-19",{"date":164,"type":38},"2026-03-24",{"date":166,"type":38},"2025-05-12",{"date":168,"type":23},"2027-04-28",{"name":44,"class":45},2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":17,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":4},"100630537","building-cognitive-resilience-to-vaccine-misinformation-using-ai-evidence-from-a-randomised-trial-100630537","NCT07488962","Building Cognitive Resilience to Vaccine Misinformation Using AI: Evidence From a Randomised Trial","Building Cognitive Resilience to Vaccine Misinformation Using Conversational AI: Evidence From a UK Randomised Trial","Inclusion Criteria:\n\n* Parents or primary caregivers of at least one child under 18 years of age in the UK who is able to answer questions about their child's vaccination status;\n* Those who have basic literacy in English;\n* Those who have regular access to a digital device and the internet; and\n* Those who provide informed consent and agree to participate in the trial\n\nExclusion Criteria:\n\n* Those who have a visual\u002Freading disability that could prevent their participation in or completion of the study activities",{"count":179,"type":23},1000,[84],"This study aims to understand how parents and caregivers in the United Kingdom engage with information about childhood vaccination (routine vaccines for children and adolescents, excluding tetanus or international travel-related vaccines) and how tailored digital health tools can help address childhood vaccine misinformation.",[87],[89,90,91,92],"2026-03-18",{"date":186,"type":38},"2026-03-23",{"date":188,"type":23},"2026-03",{"date":188,"type":23},{"name":44,"class":45},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":170},"100402562","phase-3-clinical-randomisation-of-an-anti-fibrinolytic-in-symptomatic-mild-head-injury-in-older-adults-100402562","NCT04521881","Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults","Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial","CRASH-4","Inclusion Criteria:\n\n* 50 years or older (actual or estimated)\n* History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)\n* GCS ≥ 13\n* Has one or more of the following:\n\n  1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)\n  2. nausea or vomiting\n* Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)\n* Not living in a nursing home, mental health institution or prison\n* Patient will be conveyed to or is admitted to a participating hospital\n\nExclusion Criteria:\n\n\\- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)","50 Years",{"count":82,"type":23},[147],"Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury",[204],"Traumatic Brain Injury",[206],"Traumatic brain injury, tranexamic acid, older adults","2026-03-09",{"date":209,"type":38},"2026-03-12",{"date":211,"type":38},"2021-04-18",{"date":213,"type":23},"2028-01-31",{"name":44,"class":45},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":223,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":46},"100482482","phase-3-tranexamic-acid-to-prevent-heavy-bleeding-after-childbirth-in-women-at-higher-risk-100482482","NCT05562609","Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk","Tranexamic Acid by the Intramuscular or Intravenous Route for the Prevention of Postpartum Haemorrhage in Women At Increased Risk: a Randomised, Double-blind, Placebo-controlled Trial","I'M-WOMAN","Inclusion Criteria:\n\n* Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH\n\nExclusion Criteria:\n\n* Women who have a clear indication or contraindication for TXA","FEMALE",{"count":225,"type":23},30000,[147],"Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.",[229],"Postpartum Hemorrhage",[231,232,233,234,235,236],"tranexamic acid","postpartum haemorrhage","bleeding","pregnancy","antifibrinolytic","intramuscular","2025-03-07",{"date":239,"type":38},"2025-03-11",{"date":241,"type":38},"2024-04-22",{"date":243,"type":23},"2025-09",{"name":44,"class":45},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":17,"sex":223,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100493671","healthy-mums-healthy-babies-multiple-micronutrient-supplementation-in-ethiopia-100493671","NCT05708183","Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia","Healthy Mums, Healthy Babies in Ethiopia: a Cluster-randomized Trial to Evaluate the Programme Effectiveness of a Multiple Micronutrient Supplement Delivered to Pregnant Women Through Routine Antenatal Care to Improve Newborn Birthweight","Inclusion Criteria:\n\n* For the primary outcome, mothers who deliver a liveborn child in enrolled health facilities and who are willing\u002Fconsent to participate in the study.\n* For the secondary objectives, all antenatal care staff and women attending for routine antenatal care during the survey periods will be included.\n\nExclusion Criteria:\n\n* For the primary outcome, stillbirths will be excluded. Data for any newborn who subsequently dies while still in the facility will be excluded from all secondary analyses.","15 Years","49 Years",{"count":255,"type":23},25620,"Background: This programme effectiveness study responds to the need for evidence on the effect on birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. A 2019 meta-analysis of trial data reported a mean improvement of 35g in newborn birthweight amongst newborns born to women who took MMS in pregnancy compared to those who took IFA. Responding to this evidence, in 2020 the World Health Organisation updated its global guideline on MMS from 'not recommended' to 'recommended in the context of rigorous research'. The guideline identifies priority research being 'to establish the impact of switching routine antenatal IFA to MMS on important health outcomes, equity, acceptability, feasibility, sustainability and health-care resources in different country settings.' In 2022 the Ministry of Health of Ethiopia (MoH), will change from MMS to IFA in a set of pilot districts. EPHI and LSHTM have been asked to evaluate the effect of this change on mean birthweight and propose the current trial for this purpose.\n\nThe overall aim is to evaluate the programme effectiveness on mean birthweight of providing MMS as part of routine antenatal care, compared to providing IFA.\n\nFindings will support the MoH to make evidence-informed decisions about the large-scale implementation of MMS in Ethiopia and also contribute to the global evidence base on the effectiveness of MMS in a programmatic setting.\n\nMethods: A two-arm cluster randomized trial will be used to estimate the effect of the programme change on mean birthweight, with cost-effectiveness and process evaluations embedded in the trial design.\n\nWomen aged 15-49 who deliver a live born child in a study district health facility (mother\u002Finfant dyads) will be eligible for enrolment in the study.\n\nThe primary outcome measure will be birthweight, recorded in facilities at the time of birth as part of the routine maternity care.\n\nSecondary objectives include costs of providing MMS, acceptability of MMS, adherence to antenatal micronutrient supplementation and implementation challenges.",[258],"Birth Weight","2024-12-09",{"date":261,"type":38},"2024-12-12",{"date":263,"type":38},"2023-01-01",{"date":265,"type":23},"2025-08-31",{"name":44,"class":45},6,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":17,"sex":18,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":24,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":170},"100560547","phase-3-seasonal-r21-mass-vaccination-for-malaria-elimination-100560547","NCT06578572","Seasonal R21 Mass Vaccination for Malaria Elimination","SERVAL","Inclusion Criteria:\n\n1. Age≥ 5 months.\n2. Willingness to comply with trial procedures.\n3. Individual written informed consent obtained at the beginning of the study.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.\n3. Any history of anaphylaxis in relation to vaccination.\n4. Known chronic illness.\n5. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.","5 Months","99 Years",{"count":278,"type":23},16200,[147],"This is a cluster randomized trial to determine the impact of seasonal R21\u002FMM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.\n\nThe primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses).\n\nSecondary objectives are:\n\n1. To assess the safety and tolerability of R21 through spontaneously reported adverse events.\n2. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses).\n3. To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses).\n4. To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21.\n5. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21.\n6. To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21.\n7. To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors\n8. To estimate the cost of seasonal mass vaccination with R21 administration.\n9. To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures.\n\nThe exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.",[282],"Malaria",[282,284,285,286,287],"Malaria vaccine R21\u002FMatrix M","Mass vaccination","The Gambia","Burkina Faso","2024-08-27",{"date":290,"type":38},"2024-08-29",{"date":292,"type":38},"2024-05-30",{"date":294,"type":23},"2025-12-31",{"name":44,"class":45},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":223,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":24,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":323,"locationsCount":4},"100556002","phase-3-tranexamic-acid-for-anaemia-trial-100556002","NCT06519422","Tranexamic Acid for Anaemia Trial","The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia","WOMAN-3","Inclusion Criteria:\n\n* Adult women (aged 18 years and older)\n* Having menstrual periods every 21 to 38 days that last 2 to 9 days\n* Having anaemia (Hb \\\u003C 120 g\u002FL) according to point-of-care finger prick screening test\n* Willing to provide informed consent and able to attend study visits during the trial period\n\n(Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)\n\nExclusion Criteria:\n\n* Planning to get pregnant during trial period\n* Already taking TXA\n* Known to have contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)",{"count":305,"type":23},4000,[147],"Anaemia is a common health problem in women. It is often due to iron deficiency. Anaemia is a particular problem during pregnancy and is bad for the mother and baby. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Heavy menstrual periods are a common cause of iron deficiency and even if women do take iron, because they lose so much iron in their periods, they still become iron deficient. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)",[309],"Anemia",[311,312,313,314,315,316],"Tranexamic acid","Antifibrinolytic","Anaemia","Menstrual health","Menstruation","Bleeding","2024-07-19",{"date":319,"type":38},"2024-07-25",{"date":243,"type":23},{"date":322,"type":23},"2028-09",{"name":44,"class":45},""]