[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Mozambique\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,46,80,112,158,188,218,253,282,307,328,356,378,406,437,464,484,513,544,572,604,633,667],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100467877","rice-technologies-for-cervical-cancer-screening-and-diagnosis-100467877",false,"NCT05372484","Rice Technologies for Cervical Cancer Screening and Diagnosis","Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center","Inclusion Criteria:\n\n1. 25 - 49 year old women\n2. Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and\u002For positive HPV test)\n3. Women with intact cervix\n4. Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding\n5. Willing and capable of providing informed consent\n\nExclusion Criteria:\n\n1. Women under 25 or over 49 years old\n2. Women who have undergone a total hysterectomy (with removal of the cervix)\n3. Women who are pregnant or breastfeeding","FEMALE","25 Years","49 Years",{"count":20,"type":21},678,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.",[27],"Cervical Cancer",[29,30,31,32],"Human Papilloma virus","Point-of-care HPV Test","Multimodal Optical Imaging","Screening","RECRUITING","2026-08-07",{"date":36,"type":37},"2026-08-10","ACTUAL",{"date":39,"type":37},"2021-03-24",{"date":41,"type":21},"2028-03-30",{"name":43,"class":44},"M.D. Anderson Cancer Center","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100548541","a-rapid-triage-test-to-improve-risk-stratification-of-febrile-children-echilibrist-clinical-trial-1-outpatients-100548541","NCT06422338","A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)","A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission\u002FDischarge Decisions During the First Clinical Assessment of Children With Fever","Inclusion Criteria:\n\n* Age ≥2 months and \\\u003C60 months\n* Written informed consent from the child's parent or caregiver\n* History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \\\u003C35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition).\n* Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study\n* For the RTI sub-study only: presence of respiratory symptoms compatible with RTI.\n\nExclusion Criteria:\n\n* Weight less than 2.5kg\n* Main reason for consultation is an injury, trauma or acute poisoning\n* Enrolled in another clinical trial testing a new drug\n* Enrolled in a vaccine trial in the last 3 months.\n* Any other condition determined by the investigators that makes it unlikely that the participant would complete the study","ALL","2 Months","60 Months",{"count":57,"type":21},5212,[24],"The overall aim of the study is to provide evidence that introducing novel biomarkers evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission\u002Freferral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.",[61,62,63],"Infectious Disease","Febrile Illness","Child, Only",[65,66,67,68,69],"biomarkers","severity","point-of-care","triage","sub-Saharan Africa","2026-07-27",{"date":72,"type":37},"2026-07-28",{"date":74,"type":37},"2025-07-02",{"date":76,"type":21},"2027-08-31",{"name":78,"class":44},"Barcelona Institute for Global Health",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100531694","phase-3-doravirine-versus-dolutegravir-based-antiretroviral-regimens-in-treatment-nave-people-living-with-hiv-1-infection-100531694","NCT06203132","DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","ELDORADO","Inclusion Criteria:\n\n* Be at least 18 years of age on the day of signing the informed consent.\n* Be HIV-1 positive as determined according to national testing strategies\n* Have a plasma HIV-1 RNA ≥1000 copies\u002FmL within 30 days prior to the randomization,\n* Have HIV treatment indication based on physician assessment according to local treatment guidelines\n* Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents\n* For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods\n* Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.\n\nNon-inclusion Criteria:\n\n* Has ongoing (pulmonary or extra-pulmonary) tuberculosis\n* Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.\n* Is infected with HIV-2 or co-infected with HIV-1 and HIV-2\n* Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).\n* Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed\n* Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group\n* Has the following laboratory values at screening visit, within 30 days prior to the randomization:\n\n  * AST (SGOT) and ALT (SGPT) \\>4.0 x upper limit of normal\n  * Estimated glomerular filtration rate at time of screening \\\u003C60 mL\u002Fmin\u002F1.73m², based on the CKD-EPI equation\n* Has participated in a study with an investigational compound\u002Fdevice within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound\u002Fdevice during the course of this study.\n* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study\n* Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol.\n* Has significant hypersensitivity or other contraindication to any of the components of the study drugs.\n* Is pregnant, breastfeeding, or expecting to conceive at any time during the study.\n* Has any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedure.\n* Is a person under guardianship or deprived of freedom by a judicial or administrative decision","18 Years",{"count":90,"type":21},610,[92],"PHASE3","Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.",[95],"HIV-1-infection",[97,98,99,100,101],"HIV-1","ART-naïve","doravirine","dolutegravir","non-inferiority","2026-07-24",{"date":70,"type":37},{"date":105,"type":37},"2025-01-27",{"date":107,"type":21},"2029-01",{"name":109,"class":110},"ANRS, Emerging Infectious Diseases","OTHER_GOV",19,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":53,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100535583","phase-3-shortened-regimen-for-drug-susceptible-tb-in-children-100535583","NCT06253715","Shortened Regimen for Drug-susceptible TB in Children","SMILE-TB","Inclusion Criteria:\n\n* Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee\u002FInstitutional Review Board (EC\u002FIRB) policies and procedures, potential participant is willing and able to provide assent for study participation.\n* At Entry, age of less than 10 years.\n* At Entry, weight 3 kilograms (kg) or greater.\n* At Entry, diagnosed with TB disease, defined as:\n\n  * Pulmonary (including pleural effusion) and\u002For lymph node (extra-thoracic and\u002For intra-thoracic) TB with or without bacteriologic confirmation;\n  * Clinician has decided to treat with standard first-line drug-susceptible TB regimen.\n* Known HIV status or HIV testing in progress based on meeting testing requirements.\n* Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):\n\n  * Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;\n  * Total bilirubin less than or equal to 2.5 times the upper limit of normal;\n  * Potassium level of 3.0 milliequivalent\u002FL or greater;\n  * Hemoglobin level of 7.0 g\u002FdL or greater;\n  * Platelet count of 100,000\u002Fmm3 or greater;\n  * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL\u002Fmin\u002F1.73m2 or higher.\n* For children living with HIV:\n\n  * On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;\n  * Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.\n* For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.\n* For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:\n\n  * Male or female condoms\n  * Diaphragm or cervical cap (with spermicide, if available)\n  * Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)\n* At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if\u002Fwhen applicable, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report.\n\nExclusion Criteria:\n\n* Presumed or documented extra-pulmonary TB involving the central nervous system and\u002For bones and\u002For joints, and\u002For miliary TB, and\u002For pericardial TB and\u002For TB of the gastrointestinal (GI) tract and\u002For renal TB.\n* Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.\n* Any known contraindication to taking any study drug:\n\n  * Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;\n  * Any prohibited medications within three days prior to Entry or planned use within the following 6 months;\n  * Unable to take oral medications;\n  * Known history of prolonged QT syndrome not caused by electrolyte derangements.\n* Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.\n* M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Previously enrolled in this study.\n\nLate Exclusions:\n\n* M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB\u002FRIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and\u002For rifampin and\u002For pyrazinamide and\u002For ethambutol and\u002For fluoroquinolones.\n* Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.","0 Days","9 Years",{"count":122,"type":21},860,[92],"While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.",[126,127,128,129],"Tuberculosis","Tuberculosis, Pulmonary","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[131,132,133,134,135,136,100,137,138,139,140,141,142,143,144,145,146,147,148],"tuberculosis","pediatric","stratified medicine","shortened regimen","rifapentine","moxifloxacin","drug-susceptible","lymph node","pulmonary","infections","TB","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric","2026-07-22",{"date":102,"type":37},{"date":152,"type":37},"2025-01-15",{"date":154,"type":21},"2027-09-30",{"name":156,"class":44},"Johns Hopkins University",9,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100578395","the-womens-screening-and-self-testing-program-prometa-study-100578395","NCT06810739","The Women's Screening and Self-Testing Program (PROMETA) Study","A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique","PROMETA","Inclusion Criteria:\n\n* Women 25-49 years\n* Accessing HIV care and treatment services\n* Not being pregnant\n* Patients with a cervix\n\nExclusion Criteria:\n\n* Physical or mental impairment that inhibits participation in the study\n* Pregnant women or \\\u003C6 weeks post-partum\n* Women who have undergone a total hysterectomy with removal of the cervix",{"count":167,"type":21},8445,[24],"This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.",[171],"Human Papilloma Virus Related Cervical Carcinoma",[173,174,175,176,177],"Human Immunodeficiency Virus","Self swab","Mozambique","Cervical cancer","Implementation science","2026-07-17",{"date":180,"type":37},"2026-07-20",{"date":182,"type":37},"2026-07-13",{"date":184,"type":21},"2028-08-31",{"name":186,"class":44},"Tulane University",1,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":53,"minAge":195,"maxAge":88,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":217},"100236290","phase-2-pharmacokinetic-study-to-evaluate-anti-mycobacterial-activity-of-tmc207-in-combination-with-background-regimen-br-of-multidrug-resistant-tuberculosis-mdr-tb-medications-for-treatment-of-childrenadolescents-with-pulmonary-mdr-tb-100236290","NCT02354014","Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children\u002FAdolescents With Pulmonary MDR-TB","A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to \u003C18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB","Inclusion Criteria:\n\n* Participant must be a boy or girl, aged from birth (0 months) to less than (\\\u003C) 18 years at screening. Participants in Cohort 4 who are \\\u003C6 months of age at screening, gestational age at birth had to be greater than or equal to (\\>=) 37 weeks\n* Participant must weigh \\>3 kilogram (kg) at baseline and be within the 5th and 95th percentiles (inclusive) for the participant's age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height\u002Flength may be used instead of BMI for age according to the local standard of care. Per WHO guidance, for participants aged \\\u003C 2 years in Cohort 4, length will be used to calculate the BMI instead of height\n* For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are of non-childbearing potential, or if they are using effective birth control methods and are willing to continue practicing birth control methods throughout Multidrug Resistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207 treatment, or if they are non-heterosexually active or willing to practice sexual abstinence throughout MDR-TB treatment\n* For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead to pregnancy of the female partner must use at minimum a male condom throughout MDR-TB treatment and for 3 months after stopping TMC207 treatment\n* Participant must have confirmed or probable (clinically diagnosed or presumed) pulmonary and\u002For non-severe extrapulmonary MDR-TB, including pre-extensively drug-resistant TB (pre- extensively drug resistant \\[XDR\\]-TB) or XDR-TB infection, based on the case definitions of pediatric pulmonary and non-severe extrapulmonary TB as described in the International (WHO) guidelines and in accordance with the local standard of care\n* Participants must be starting the initial MDR-TB treatment at Day 1 or have started an MDR-TB treatment within 12 weeks of Day 1 and are willing to modify it if necessary to an acceptable MDR-TB regimen for use with TMC207\n* Participant must be willing to permanently discontinue RMP from at least 7 days before the baseline visit\n* Participant or legally acceptable representative must consent\u002Fassent to human Immunodeficiency virus (HIV) testing of the participant. The mother must also consent to testing of her own HIV status, if the potential participant is a child aged \\\u003C2 years, or if the participant is \\>= 2 years old and being breastfed or was breastfed within the last 8 weeks before screening, unless the mother had HIV test performed within 1 month prior to screening and documentation of HIV status can be provided. When documented HIV-positive status is available prior to screening for participants in Cohort 4 or their mother, HIV testing for the participant and mother is not required\n\nExclusion Criteria:\n\n* Participant has a clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency (except HIV infection), which in the opinion of the investigator would prevent appropriate participation in the study, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical study\n* Participant is a girl who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after stopping TMC207 treatment\n* Participant has known or presumed forms of extrapulmonary TB, other than: Lymphadenopathy (peripheral nodes or isolated mediastinal mass without significant airway compression); Pleural effusion or pleural fibrotic lesions\n* Participant has a significant cardiac arrhythmia that requires medication or risk factors for Torsade de Pointes, example heart failure, hypokalemia, known personal or family history of Long QT Syndrome, and untreated hypothyroidism","0 Months",{"count":197,"type":21},60,[199],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than \\[\\\u003C\\] 18 years of age) diagnosed with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a Background Regimen (BR) of MDR-TB Medications.",[202],"Tuberculosis, Multidrug-Resistant",[204,205,206],"Multidrug-Resistant Tuberculosis","Bedaquiline","TMC207","2026-07-02",{"date":209,"type":37},"2026-07-06",{"date":211,"type":37},"2016-05-03",{"date":213,"type":21},"2028-11-02",{"name":215,"class":216},"Janssen Research & Development, LLC","INDUSTRY",11,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":226,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":227,"targetDuration":229,"studyType":230,"phases":4,"briefSummary":231,"conditions":232,"keywords":236,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100580181","preparing-for-maternal-gbs-vaccine-trials-in-africa-100580181","NCT06833957","Preparing for Maternal GBS Vaccine Trials in Africa","PReparing for OptimalPhase III\u002FIV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)","PROTECT","Inclusion Criteria:\n\n* WP2 Pregnancy Exposure Registries inclusion criteria:\n\nAll women and their infants attending for antenatal and\u002For delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.\n\nWP3 GBS Surveillance inclusion criteria:\n\n* Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.\n* Infants whose parents or guardians provided written informed consent for their participation.\n* Residents in the catchment area of participating health facilities.\n\nWP4 Vaccine Confidence inclusion criteria:\n\n* In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).\n* In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors.\n* Pregnant women who consent to the study and give written consent.\n* Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent.\n\nExclusion Criteria:\n\nWP4 Vaccine Confidence exclusion criteria:\n\n* Pregnant women who are visiting\u002Fnon-resident in the research area.\n* Those who may be unwell and unable to consent to take part in the study.",true,{"count":228,"type":21},18100,"8 Months","OBSERVATIONAL","Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.\n\nFortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths.\n\nThe PReparing for Optimal Phase III\u002FIV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \\& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines.\n\nThe end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.",[233,234,235],"Group B Streptococcus","Invasive Bacterial Diseases (IBD)","Maternal Immunization",[237,238,239,240,233,241,242,243],"Child health","Clinical research","Clinical trials","Infectious diseases","vaccines","maternal immunisation","maternal health","2026-05-19",{"date":246,"type":37},"2026-05-20",{"date":248,"type":37},"2025-03-01",{"date":250,"type":21},"2027-02-28",{"name":78,"class":44},10,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":88,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":187},"100581489","foley-balloon-for-cervical-preparation-before-dilation-and-evacuation-100581489","NCT06850974","Foley Balloon for Cervical Preparation Before Dilation and Evacuation","Inclusion Criteria:\n\n* Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.\n* Portuguese speaking\n\nExclusion Criteria:\n\n* Less than age 18\n* Incarcerated\n* Chorioamnionitis\n* Active heavy bleeding\n* A known bleeding diathesis\n* Hemodynamic instability\n* \\> 2 cm dilation\n* History of cervical cerclage\n* Allergy to any study medications\n* Eclampsia\n* Glasgow Coma Score Less than 15",{"count":260,"type":21},102,[24],"To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\\&E) instead of osmotic dilators (Laminaria).\n\nSpecific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\\&E.\n\nSpecific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion.\n\nSpecific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.",[264,265],"Abortion, Second Trimester","Abortion, Medical",[267,268,269,270,271,272],"second","trimester","abortion","surgical","balloon","Foley","2026-04-26",{"date":275,"type":37},"2026-04-30",{"date":277,"type":37},"2025-02-10",{"date":279,"type":21},"2027-03",{"name":281,"class":44},"Stony Brook University",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":226,"sex":53,"minAge":4,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100515307","rapid-research-in-diagnostics-development-for-tb-network-r2d2-kids-and-assessing-diagnostics-at-poc-for-tb-in-children-adapt-for-kids-100515307","NCT05989802","Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)","Rapid Research in Diagnostics Development for Tuberculosis Network (R2D2 Kids) and Assessing Diagnostics At Point-of-care for Tuberculosis in Children (ADAPT for Kids)","Participant eligibility criteria:\n\nParticipants will include children (age \\\u003C15 years) who present to care with:\n\nA. 2 or more of the following:\n\n* Unexplained cough for any duration\n* TB contact or tuberculin skin test or interferon gamma release assay positive\n* Abnormal chest X-ray (any abnormality) OR\n\nB. Any one of criteria A AND any one of the following:\n\n* Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition\n* Unexplained fever ≥2 weeks\n* Unexplained lethargy or reduced playfulness ≥2 weeks\n\nThe study will exclude participants who:\n\n1. Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);\n3. Are unable to return for follow-up visits; or\n4. Whose parents\u002Fguardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)\n\nAssessment of the usability of novel TB tests:\n\nThe study will also include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). Personnel who are unwilling to provide informed consent will be excluded.","65 Years",{"count":291,"type":21},2100,[24],"Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.",[126,295,296],"Diagnostics","Global Health","2026-03-09",{"date":299,"type":37},"2026-03-11",{"date":301,"type":37},"2024-01-26",{"date":303,"type":21},"2026-09-01",{"name":305,"class":44},"University of California, San Francisco",3,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":53,"minAge":195,"maxAge":55,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":79},"100548834","l-citrulline-to-improve-adverse-outcomes-in-admitted-children-echilibrist-clinical-trial-2-inpatients-100548834","NCT06426147","L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)","A Randomised, Double-blind, Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes","Inclusion Criteria:\n\n* Enrolled in the initial prognostic screening component.\n* Sick children with fever (axillary temperature\\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease.\n* 1m-\\\u003C60 months of age.\n* With an indication for admission, or having already been admitted to hospital due to their illness.\n* With an sTREM-1 PoC result classifying their disease as of \"moderate-high risk\" (\"yellow\" or \"red\") upon study recruitment and within D3.\n* Residents in the study area or willing to be contacted and traced during the study duration.\n* Willing to sign an informed consent document.\n* Willing to undergo and adhere to study procedures as explained in the IC document.\n\nExclusion Criteria:\n\n* Admission to hospital for social reasons (and not on account of their disease).\n* Children for which informed consent document has not been signed.\n* Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet.\n* Concurrent participation in any other clinical trial.\n* Patient under NPO or \"nothing by mouth\" prescription .\n* Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth.\n* Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening.\n* Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study.",{"count":315,"type":21},2200,[24],"In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project (\"Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival\") has the two-fold objective of:\n\n1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the \"prognostic\" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and\n2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\\\u003C60 months identified as \"moderate-to-high risk\" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo.\n\nThis second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \\~888 children 1-\\\u003C60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg\u002Fkg\u002Fday depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.",[61,319,63],"Infections","2026-02-19",{"date":322,"type":37},"2026-02-23",{"date":324,"type":37},"2025-12-08",{"date":326,"type":21},"2027-08-01",{"name":78,"class":44},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":226,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":335,"targetDuration":337,"studyType":230,"phases":4,"briefSummary":338,"conditions":339,"keywords":343,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":187},"100616949","questioning-the-epidemiology-of-asymptomatic-tb-100616949","NCT07312266","Questioning the Epidemiology of Asymptomatic TB","TB QUEST","Index cases:\n\nInclusion Criteria:\n\n1. 18 years of age or older\n2. Documented HIV infection\n3. Presenting at a health facility for routine HIV care\n\nExclusion Criteria:\n\n1. History of TB treatment in the last 12 months\n2. Pregnant women\n3. Refusal to provide consent for study procedures\n4. Contra-indication to any sampling procedure required by the study\n\nStudy 3 will utilize additional inclusion criteria:\n\nInclusion criteria:\n\n1. On ART for less than 6 months\n2. No evidence of viral suppression\n3. Documented CD4 count \\>350 copies\u002Ful\n4. TB-suggestive x-ray\n5. Verified absence of fever and cough, as ascertained through the symptom trackers\n\nContacts:\n\nInclusion criteria: All close contacts (household and close community contacts) will be offered to participate in the study, regardless of age or HIV status.\n\nExclusion criteria:\n\n1. Plans to migrate in the next 12 months\n2. Pregnant women\n3. Currently taking anti-tuberculosis treatment or preventive TB treatment\n4. Contacts with co-prevalent TB identified at baseline",{"count":336,"type":21},6770,"12 Months","Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the disease as the major drivers of the TB epidemic. However, prevalence surveys have shown that about 50% of cases in which Mycobacterium tuberculosis is isolated from sputum but do not report having symptoms. Therefore, asymptomatic TB may play an important role in TB transmission. However, no field study has demonstrated direct transmission from a subclinical TB case to a confirmed secondary case.\n\nTB-QUEST is an ERC-funded epidemiological field study that aims to provide direct evidence of effective transmission from asymptomatic TB cases to their close contacts using advanced genomic methods, and to better characterize the asymptomatic stage of TB within the natural history of disease.",[126,340,341,342],"Tuberculosis (TB)","HIV","HIV (Human Immunodeficiency Virus)",[344,345,346,347],"Asymptomatic tuberculosis","Asymptomatic","Subclinical tuberculosis","Subclinical","2025-12-17",{"date":350,"type":37},"2025-12-31",{"date":352,"type":37},"2025-08-11",{"date":354,"type":21},"2029-05",{"name":78,"class":44},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":306},"100484623","phase-2-tnf-inhibitors-to-reduce-mortality-in-hiv-1-infected-patients-with-tuberculosis-meningitis-100484623","NCT05590455","Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis","ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial","TIMPANI","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV-1 infection\n* Definite or probable tuberculosis meningitis\n* Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines\n* Signed informed consent form by patient or relative.\n\nExclusion Criteria:\n\n* Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis\n* Asymptomatic positive cryptococcal antigen in serum\n* HBsAg positive or anti hepatitis C virus antibodies positive\n* Alanine transaminase (ALT)\\>5 ULN\n* Rifampicin-resistant TB detected by GeneXpert MTB\u002FRIF Ultra\n* History of previous TB treatment in patients with GeneXpert MTB\u002FRIF Ultra negative or unavailable\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped\n* Allergy to study drugs or any of their components\n* Uncontrolled opportunistic infection\n* Moderate to severe cardiac insufficiency (NYHA classes III \u002F IV)\n* Any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedures\n* For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator\n* Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase\n* Person under guardianship, or deprived of freedom by a judicial or administrative decision",{"count":365,"type":21},130,[199],"Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).",[369,370],"Tuberculous Meningitis","HIV I Infection",{"date":372,"type":37},"2025-12-15",{"date":374,"type":37},"2023-04-11",{"date":376,"type":21},"2027-12",{"name":109,"class":110},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100551845","safety-planning-and-cognitive-behavioral-therapy-for-adolescent-suicide-prevention-in-mozambique-100551845","NCT06465381","Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique","Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique: A Hybrid Effectiveness\u002FImplementation Cluster Randomized Trial","Inclusion Criteria:\n\nInclusion criteria for suicide risk screening:\n\n1. Youth enrolled in a secondary school in Sofala Province that is located within 30 minutes of a health facility that hosts both an urgent care and mental health department.\n2. Youth enrolled in 9th and\u002For 10th and\u002For 11th grade.\n3. Legal guardian has provided consent to participate if under 18 or if youth is age 18 or older and has provided consent to participate.\n4. Youth has assented to participation.\n\nInclusion criteria for trial participation and allocation to study arm:\n\n1\\. Youth expresses active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS).\n\nExclusion Criteria:\n\n1. Youth and\u002For guardian has not provided consent to participate, or responsible party is unable to provide informed consent.\n2. Youth is not enrolled in a participating secondary school.\n3. Youth declines to assent.\n4. Youth is a ward of the State or any other agency, institution, or entity.",{"count":291,"type":21},[24],"This implementation research project aims to test the effectiveness and implementation outcomes of suicide safety planning along and a transdiagnostic cognitive behavioral intervention for suicide prevention on decreasing suicidal behaviors in secondary school students in Mozambique. This study will also result in hypothesized mechanisms of intervention effects, costs and cost-effectiveness.",[389],"Suicide Prevention",[391,392,393,394,395],"Suicidal Behavior","Safety Planning Intervention","Transdiagnostic Cognitive Behavioral Therapy for Suicide Prevention","Suicidal Ideation","Depressive Symptoms","2025-12-03",{"date":398,"type":37},"2025-12-05",{"date":400,"type":37},"2025-09-01",{"date":402,"type":21},"2028-12-01",{"name":404,"class":44},"University of Washington",7,{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":289,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":252},"100501295","phase-2-panacea---step2c--01-100501295","NCT05807399","PanACEA - STEP2C -01","A Multiple-arm, Multiple-stage (MAMS), Phase 2B\u002FC, Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental Arms Including Optimised Use of Existing and Introduction of Novel Anti-tuberculosis Drugs, in Adults With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n1. Provide written, informed consent prior to all trial-related procedures including HIV testing.\n2. Male or female, aged between 18 and 65 years, inclusive.\n3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.\n4. Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and\u002For HAIN MTBDR plus. Participants who had a previous history of TB may be enrolled in this trial, if they:\n\n   * had a good treatment response in the opinion of the investigator; i.e. TB symptoms improved sufficiently or resolved suggesting a cure of the past episode; AND\n   * no persistent microbiological positivity is seen (in case microbiological results are available); AND - their treatment course was completed AND\n   * the last dose of treatment was more than 3 months ago.\n5. A chest X-ray (no older than 2 weeks) which shows abnormalities that, in the opinion of the Investigator, are consistent with TB.\n6. Sputum positive on microscopy from concentrated sputum for acid-fast bacilli (at least 1+ on the IUATLD\u002FWHO scale) AND\u002FOR positive GeneXpert MTB\u002FRIF Ultra® semi-quantitative result \"medium\" or \"high\" on at least one sputum sample.\n7. The participant understands the interaction between the study drugs and certain foods and is willing to forgo the consumption of those foods for the period of study medication.\n8. The participant is not of child-bearing potential or is willing to use effective methods of contraception when engaging in heterosexual intercourse, as defined below:\n\n   1. Non-childbearing potential:\n\n   i. Female participant\u002Fsexual partner of male participant: Bilateral oophorectomy, and\u002For hysterectomy or bilateral tubal ligation more than 12 months ago and\u002For has been postmenopausal with a history of no menses for at least 12 consecutive months and confirmed by a FSH test.\n\n   ii. Male participant\u002Fsexual partner of female participant: Vasectomised or has had a bilateral orchidectomy minimally three months prior to screening iii. Male participants having a pregnant female partner or a male sexual partner: At least one barrier method has to be used in this case.\n\n   b. Effective contraception methods: i. Female participants: Two methods, including methods that the participant's sexual partner(s) use. At least one must be a barrier method. Contraception must be practised for at least until 12 weeks after the last dose of experimental treatment. For stage 3, female participants of child-bearing potential must have used contraception if any sexual intercourse has occurred after last menses or within the last 3 weeks (whichever is later) before participation, and agree to use non-user dependent contraception: depo-provera injection\\* or an intrauterine device additional to one barrier method.\n\n   \\*Including a back-up method of contraception for at least 7 days to prevent unintended pregnancy if injection has been administered within the first 5 days of their menstrual cycle. Otherwise, a back-up barrier method of contraception is required for one month to prevent unintended pregnancy.\n\n   ii. Male participants: Two methods, including methods that the participant's female sexual partner(s) use. At least one must be a barrier method. Effective contraception must be ensured for at least 12 weeks after the last dose of experimental treatment.\n\n   Exclusion Criteria:\n\n\u003C!-- -->\n\n1. Circumstances that raise doubt about free, unconstrained consent to study participation (e.g., person in detention or person with mental disability)\n2. Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.\n3. Circumstances (in the opinion of the investigator) that raise doubt about ability to complete the follow-up during the study period.\n4. The participant is pregnant or breast-feeding or planning to become pregnant in the study period.\n5. The participant is infected with HIV with a CD4 count \\\u003C220 cells\u002Fmm3. If \\>220 cells\u002Fmm3, participants will be included only if any of the following is applicable:\n\n   • The participant is antiretroviral (ARV) naïve and able to postpone commencing HIV treatment for 2 months after the trial has started and then restrict regimens to those mentioned in section on ARVs or\n\n   • The participant is ARV experienced (has been on ARV´s a minimum of 5 months), AND: ARV treatment is compliant to, or can be modified as described in the section on Antiretroviral Therapy\n6. The participant has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated.\n7. The participant has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, hepato-biliary, renal, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator, especially:\n\n   a. Neuropathy, or significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required or is anticipated to be required b. Evidence of clinically significant extra-pulmonary TB (e.g. miliary TB, TB meningitis, but not limited lymph node involvement) c. Serious lung conditions other than TB, or significant respiratory impairment in the discretion of the investigator d. Uncontrolled diabetes mellitus or diabetes mellitus receiving\u002Frequiring treatment with metformin or sulfonylureas e. Cardiovascular disease such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension f. Uncontrolled arterial hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure of ≥95 mmHg on two occasions during screening. An attempt at antihypertensive treatment during the screening period is permitted).\n\n   g. Long QT syndrome or family history of long QT syndrome or family history of sudden death of unknown or cardiac-related cause h. Alcohol, regular opiate, or other drug abuse that is sufficient to significantly compromise the safety or cooperation of the participant, that includes substances prohibited by the protocol or has led to significant organ damage at the discretion of the investigator; AND\u002FOR any abuse of methamphetamine.\n\n   i. History of optic neuropathy j. Vitiligo\n8. Any of the following laboratory findings at screening:\n\n   a. Serum amino aspartate transferase (AST) and\u002For alanine aminotransferase (ALT) \\>3x the upper limit of normal (ULN), b. Serum alkaline phosphatase or y-glutamyl transferase \\> 2.5x the ULN, c. Serum total bilirubin level \\>1.5x the ULN d. Estimated creatinine clearance -eCrCl (using the CKD-EPI 2021 creatinine formula):\n\n   \\- Stage 1: Lower than 30 ml\u002Fmin)\n\n   \\- Stage 2: Lower than 30ml\u002Fmin or lower than 60 ml\u002Fmin in participants living with HIV\n\n   \\- Stage 3: Lower than 80ml\u002Fmin e. Proteins in urine dipstick \\>=2+ f. Haemoglobin level \\\u003C7.0 g\u002Fdl g. Platelet count \\\u003C50,000\u002Fmm3, h. Serum potassium below 3 mmol\u002Fl, persisting after correction.\n9. ECG findings in the screening ECG: (one or more):\n\n   1. QTcF of \\>450 milliseconds\n   2. Atrioventricular (AV) block with PR interval \\> 200 milliseconds\n   3. QRS complex \\> 120 milliseconds\n   4. Any other changes in the ECG that are clinically relevant as per discretion of the investigator\n10. Restricted medication:\n\n    1. Treatment with any other investigational drug within 2 month prior to enrolment or enrolment into other clinical (intervention) trials during participation.\n    2. Previous anti-TB treatment with drugs active against MTB within the last 3 months prior to screening.\n    3. Unable or unwilling to abide by the requirements regarding restricted medication or have taken restricted medication. Restricted medication includes the following drug classes, with relevant timing of intake, and possible exceptions. Exceptions may be permissible after discussion with the sponsor medical expert.",{"count":414,"type":21},390,[199],"This is a phase 2B\u002FC, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis.\n\nIn stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1.\n\nIn stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 in a ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.\n\nIn stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2. Enrolment of participants into arm 5 will proceed following review of data from the ENABLE\u002FUNITE-03 (NCT06748937), non-clinical safety data and after endorsement by the DSMB. Thus, arm 5 recruitment might start after arms 6 and 7, which may require an increase in the control arm sample size to ensure controls are recruited concomitantly.",[418,419],"Pulmonary Tuberculosis","Other Specified Pulmonary Tuberculosis",[127,126,421,422,423,424,425,426,427],"Antitubercular Agents","Safety","Tolerability","Pharmacokinetics (PK)","Moxifloxacin","BTZ-043","Rifampicin","2025-10-01",{"date":430,"type":37},"2025-10-07",{"date":432,"type":37},"2023-04-14",{"date":434,"type":21},"2027-12-30",{"name":436,"class":44},"Michael Hoelscher",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":53,"minAge":444,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":447,"conditions":448,"keywords":449,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":157},"100574651","investigating-the-optimal-management-of-dolutegravir-resistance-100574651","NCT06762054","Investigating the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study","Inclusion Criteria:\n\n* Able and willing to provide informed consent (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 1 years\n* Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites\n* On a DTG-based ART regimen for at least six months\n* Most recent HIV-1 RNA ≥ 1,000 copies\u002FmL within 3 months prior to enrolment, taken after at least 6 months on current ART regimen\n\nExclusion Criteria:\n\n* Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen\n* Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death\n* Concomitant NNRTI or PI while on DTG","1 Year",{"count":446,"type":21},6600,"The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.",[95],[341,450,451,452,453,454],"Dolutegravir","Treatment failure","Drug resistant mutations","Dolutegravir resistance","Re-suppression","2025-09-04",{"date":457,"type":37},"2025-09-05",{"date":459,"type":37},"2025-03-03",{"date":461,"type":21},"2026-10",{"name":463,"class":44},"University of Nairobi",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":53,"minAge":471,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":481,"leadSponsor":483,"locationsCount":157},"100573532","phase-3-ndovu-rct-investing-the-optimal-management-of-dolutegravir-resistance-100573532","NCT06747507","Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir","Inclusion Criteria:\n\n* Enrolled in the Ndovu cohort study\n* Able and willing to understand and comply with the protocol requirements, instructions and restrictions\n* Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 3 years\n* Most recent HIV-1 RNA ≥ 200 copies\u002FmL\n* At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K\u002FA\u002FT, 140S\u002FA\u002FC, 148H\u002FR\u002FK, 155H or 263K)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs\n* WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening\n* Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons\n* Investigator opinion that the potential participant should not switch to DRV\u002Fr for clinical reasons","3 Years",{"count":473,"type":21},392,[92],"This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.",[95],[341,450,451,452,453,454],{"date":479,"type":37},"2025-09-11",{"date":400,"type":37},{"date":482,"type":21},"2027-07",{"name":463,"class":44},{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"100483871","phase-3-reducing-mortality-in-adults-with-advanced-hiv-disease-revive-100483871","NCT05580666","Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)","Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial","REVIVE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented HIV infection\n3. CD4 count criteria:\n\n   i. CD4 count ≤ 100 cells\u002Fmm3 within past 4 weeks; or\n\n   ii. Documented CD4 nadir ≤ 100 cells\u002Fmm3 and complete interruption of ART for ≥ 6 months; or\n\n   iii. Documented CD4 count ≤ 100 cells\u002Fmm3 if ART-naive\n4. Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment\n\nExclusion Criteria:\n\n1. Contraindications to azithromycin:\n\n   i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or\n\n   ii. Personal or family history of QT-prolongation\n2. Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)\n3. Off-label azithromycin prophylaxis or requirement for prolonged (\\> 7 days) azithromycin (or macrolide) therapy",{"count":493,"type":21},8000,[92],"A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.",[497],"HIV Disease Progression",[499,500,501,502],"Human immunodeficiency virus","Antiretroviral therapy","Azithromycin","Mortality","2025-08-26",{"date":505,"type":37},"2025-09-03",{"date":507,"type":37},"2023-05-08",{"date":509,"type":21},"2029-05-31",{"name":511,"class":44},"Population Health Research Institute",52,{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":226,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":534,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":306},"100592136","implementation-of-the-community-health-system-innovation-project-in-low--and-middle--income-countries-100592136","NCT06989502","Implementation of the COmmunity HEalth System InnovatiON Project in Low- and Middle- Income Countries","GH Project: NIHR150261 - Implementation of the COmmunity HEalth System InnovatiON Project, COHESION-I","COHESION-I","Inclusion Criteria for PHC users with diabetes, hypertension, and\u002For NTDs:\n\n* Males or females aged 18 years and over, from the selected sites\n* Having used the health services in the previous three months\n* Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis\n* Must be able to listen to radio programs, or other audio material\n\nInclusion Criteria for PHC users without diabetes, hypertension, and\u002For NTDs:\n\n* Males or females aged 18 years and over, from the selected sites\n* Having used the health services in the previous three months\n* Must be able to listen to radio programs, or other audio material\n\nExclusion Criteria for PHC users without diabetes, hypertension, and\u002For NTDs:\n\n\\- Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis\n\nThe criteria mentioned above refer solely to the quantitative evaluation. For the other types of evaluation, some different populations will be included (such as healthcare workers, local authorities and other stakeholders).",{"count":522,"type":21},2094,[24],"The COHESION-I project will evaluate the effects of the co-creation intervention (2016 to 2019) and the co-design intervention (2023 to 2024) on improving (a) health system responsiveness, and (b) patient satisfaction, at the primary health care level, in Peru, Nepal and Mozambique, in relation to chronic diseases (hypertension, and diabetes mellitus), as well as specific neglected tropical diseases. Each intervention has been tailored to the context and characteristics of each one of the aforementioned low- and middle-income countries.\n\nFor this quasi-experimental study, three arms were established: the co-creation (2016 to 2019) + co-design (2023 to 2024) arm; the co-design only (2023 to 2024) arm; and the control group (no intervention; usual care). The evaluation will be composed of four types of evaluations: quantitative; qualitative; economic; and process evaluation",[526,527,528],"Hypertension","Diabetes Mellitus","Neglected Tropical Diseases",[526,527,528,530,531,532,533],"Chronic Disease","Primary Health Care","Implementation Science","Low and Middle Income Countries","NOT_YET_RECRUITING","2025-05-16",{"date":537,"type":37},"2025-05-25",{"date":539,"type":21},"2025-05-17",{"date":541,"type":21},"2026-11-30",{"name":543,"class":44},"Universidad Peruana Cayetano Heredia",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":552,"targetDuration":554,"studyType":230,"phases":4,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":187},"100562778","selection-of-resistant-mutations-to-dolutegravir-in-plwh-treated-in-mozambique-100562778","NCT06607588","Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique","Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé, Mozambique","REDOCH","Inclusion Criteria:\n\n* Patients able to understand and sign the informed consent form.\n* Documented HIV-1 infection.\n* Under the first line TLD for at least 6 months.\n* At least 3 months follow-up with CV \\>200c\u002Fml.\n\nExclusion Criteria:\n\n* Patients \\<18 years of age.\n* Under the first line regime other than TLD.\n* Patients with active neoplastic processes.\n* Patients with active opportunistic diseases.\n* Patients unable to give informed consent.",{"count":553,"type":21},200,"1 Day","The HIV infection not fully controlled, despite being under antiretroviral treatment, could make virus resistance against the antiretroviral treatments, making hardest the well control of HIV infection. The purpose of this research study is to confirm or deny if a not fully good controlled HIV infection could develop virus resistance against antiretroviral drugs that can difficult the good control of the HIV infection.",[341,557],"HIV Antiretroviral Therapy (ART) Adherence",[341,559,560,561,562],"ARV","Resistance","DTG","Africa","2025-05-14",{"date":565,"type":37},"2025-05-15",{"date":567,"type":37},"2024-10-25",{"date":569,"type":21},"2026-09",{"name":571,"class":44},"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia",{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":53,"minAge":88,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":588,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":603},"100424919","remote-ischaemic-conditioning-in-stemi-patients-in-africa-100424919","NCT04813159","Remote Ischaemic Conditioning in STEMI Patients in AFRICA","Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial","RIC-AFRICA","We will be recruiting 3 different strata of STEMI patients.\n\n1. Adult patients (≥18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within \\\u003C12 hours of most severe chest pain onset).\n2. Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (\\\u003C12 hours) but within 24 hours of most severe chest pain onset.\n3. Adult patients (≥18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present ≥24 hours and within 72 hours of most severe chest pain onset.\n\nInterventional arm of the Study: Randomized Control Trial\n\nPatients who are deemed eligible for randomization into the trial on account of presentation with STEMI within 24 hours, will be eligible for the interventional arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads ( ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and\u002For ≥ 0.1mV in other lead); and II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and III. Signed informed consent.\n\nExclusion criteria\n\nI. STEMI patients due to undergo primary percutaneous coronary intervention;\n\nII. STEMI patients presenting with cardiogenic shock or haemodynamic instability as defined by: systolic blood pressure (SBP) measurement of \\\u003C90 mm Hg for ≥30 minutes; or use of pharmacological and\u002For mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of \\\u003C30 mL\u002Fh; altered mental status; and\u002For serum lactate \\>2.0 mmol\u002FL;\n\nIII. Contraindications for the use of RIC or sham-control on either arm such as:\n\n1. severe active skin disease\u002Fburns on both arms; or\n2. bilateral upper limb amputations; or\n3. evidence of acute limb ischaemia on either arm; or\n4. active upper limb gangrene of any digits;\n5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or\n6. bilateral arteriovenous fistulae needed for haemodialysis.\n\nIV. Inter-current disease with an expected life expectancy of less than 24 hours;\n\nV. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (\\\u003C12 hours).\n\nObservational arm of the study\n\nPatients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Signed informed consent; and\n\nII. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:\n\n1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and\n2. Compatible biomarkers (elevated cardiac troponin); and\n3. ECG compatible with recent STEMI; and\u002For\n4. Compatible echocardiography.\n\nExclusion criteria\n\nI. Refusal or inability to sign informed consent.",{"count":581,"type":21},1400,[24],"The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients presenting with STEMI and deemed ineligible for the RIC AFRICA RCT because they present \\>24 hours from MI onset but less than 72 hours, will be recruited into the observational arm of the study with the same endpoints as the trial. The purpose of the RCT is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated predominantly with thrombolytic therapy.",[585,586,587],"STEMI","Remote Ischaemic Conditioning","Myocardial Reperfusion Injury",[589,590,591,592,586,593,585],"Cardioprotection","Ischaemia\u002Freperfusion injury","ST-Elevation myocardial infarction","Hospitalisation for post-myocardial infarction heart failure","Cardiovascular mortality","2025-03-31",{"date":596,"type":37},"2025-04-03",{"date":598,"type":37},"2022-01-12",{"date":600,"type":21},"2027-12-31",{"name":602,"class":44},"University of Cape Town",20,{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":88,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":613,"conditions":614,"keywords":620,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":79},"100536644","increasing-neonatal-hiv-test-and-treat-to-maximize-the-long-term-impact-on-infant-health-and-novel-infant-antiretroviral-treatment-100536644","NCT06267508","Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment","LIFE2Scale","Inclusion Criteria:\n\n1. Voluntary and informed consent of the mother for her own study participation (if applicable);\n2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study;\n3. Mothers\u002Flegal guardians ≥18 years of age;\n4. Documented maternal HIV infection;\n5. Willingness to consent to HIV testing for the child and herself (or just her child); and\n6. Willingness to consent to active tracing including home tracing.\n\n   Exclusion Criteria:\n7. Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her.\n8. Having delivered more than 72h (3 days) ago;\n9. Prisoners;\n10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;\n11. Stillbirths;\n12. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;\n13. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or\n14. Unlikely to comply with protocol as judged by the principal investigator or his designate",{"count":612,"type":21},6000,"This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.",[615,616,617,618,619],"Vertical Human Immunodeficiency Virus Transmission","HIV Infection Pediatric","Infant Death","Infant Morbidity","Infant, Newborn, Diseases",[621,622,623,624],"Prevention of Vertical HIV Transmission (PVHT)","Infant HIV Prophylaxis","Early Infant HIV Diagnosis","Infant Antiretroviral Treatment","2024-11-14",{"date":627,"type":37},"2024-11-18",{"date":629,"type":37},"2024-04-30",{"date":631,"type":21},"2025-12",{"name":436,"class":44},{"id":634,"slug":635,"hasResults":11,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":226,"sex":53,"minAge":641,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":644,"conditions":645,"keywords":649,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":187},"100556755","malaria-molecular-surveillance-in-mozambique-phase-2-100556755","NCT06529237","Malaria Molecular Surveillance in Mozambique (Phase 2)","Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Markers of Antimalarial Drug Resistance, Rapid Tests Diagnostic Failure and Transmission in Mozambique: Phase 2","GenMoz2","A) CHILDREN AT HEALTH FACILITIES\n\nInclusion Criteria:\n\n* Informed, written consent to participate from the guardian\n* Children 2-10 years of age\n* Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours\n* At least one positive parasitological test for malaria diagnosis via RDT (HRP2 or LDH)\n\nExclusion Criteria:\n\n* Unwilling to provide informed, written consent\n* Age \\\u003C2 years or \\>10 years\n* not resident in study area\n* Any symptoms of severe malaria\n* Negative of both (HRP2 and LDH) parasitological test for malaria via RDT\n* History of antimalarial treatment in the last 14 days\n\nB) PREGNANT WOMEN AT ANC\n\nInclusion Criteria:\n\n* Pregnant women attending first antenatal care visit\n* Resident in the study area\n* Pregnant Women older than 12 years old\n* Informed, written consent to participate from participant and\u002For guardian\n\nExclusion Criteria:\n\n* Unwilling to provide informed, written consent\n* Not resident in study area\n* Any symptoms of severe malaria\n\nC) DENSE SAMPLING\n\nInclusion Criteria:\n\n* People \\> 6 months of age\n* Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours\n* Positive parasitological test for malaria diagnosis via RDT\n* Informed, written consent to participate from participant and\u002For guardian\n\nExclusion Criteria:\n\n* Any symptoms of severe malaria\n* Negative parasitological test for malaria via RDT\n* Unwilling to provide informed, written consent\n* History of antimalarial treatment in the last 14 days","6 Months",{"count":643,"type":21},18750,"Mozambique is among the ten countries with the highest burden of malaria worldwide, with an estimated 10.3 million cases in 2021. Malaria transmission is highly heterogeneous across the country, with high burden in the north and very low burden in the south, therefore requiring different strategies for effective control and potential elimination. The GenMoz study (NCT05306067, March 2021-Feb 2024) operationalized a functional malaria molecular surveillance (MMS) system to generate reliable and reproducible temporal genomic data to monitor the effectiveness of rapid diagnostic tests and antimalarials, as well as to continuously characterize transmission levels and sources. The National Malaria Control Program (NMCP) is starting a new strategic cycle (2023-2030) with a plan that includes genomic surveillance for guiding programmatic decisions on six key antimalarial tools : 1. Malaria diagnostics using rapid diagnostic tests (RDTs) based on histidine-rich protein 2 (HRP2); 2. Treatment with artemisinin-based combination therapies (ACTs), including diversification schemes to reduce emergence of resistance; 3. Chemoprevention for pregnant women and children; 4. R21\u002FMatrix-M vaccine rollout; 5. Individual-level interventions in very low transmission settings and 6. Vector control. In Phase 2, the investigators aim to integrate MMS into this wider surveillance framework and scale MMS in Mozambique for quality, timely and appropriate optimization of the public health benefits of the NMCP 2023-2030 strategy in both a proactive and adaptive manner, selecting the combinations of interventions that maximize the impact at the individual and community level.",[646,647,648],"Malaria","Falciparum Malaria","Malaria in Pregnancy",[650,651,652,653,654,655,656,657],"drug resistance","Diagnostic resistance","Surveillance","Genomics","Importation","Genetic diversity","Plasmodium falciparum","Next Generation Sequencing","2024-08-23",{"date":660,"type":37},"2024-08-26",{"date":662,"type":37},"2024-04-01",{"date":664,"type":21},"2027-03-31",{"name":666,"class":44},"Centro de Investigacao em Saude de Manhica",{"id":668,"slug":669,"hasResults":11,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":674,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":688,"locationsCount":187},"100541164","assessment-of-the-effectiveness-of-ta-versus-leep-for-cervical-cancer-risk-reduction-in-wlhiv-in-mozambique-100541164","NCT06326294","Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique","A Randomized Clinical Trial to Assess the Effectiveness of Thermal Ablation Versus Loop Electrosurgical Excision Procedure for Cervical Cancer Risk Reduction in Women Living With Human Immunodeficiency Virus in Mozambique","Inclusion Criteria:\n\n* ages 25-49 years;\n* confirmed HIV infection;\n* physically and mentally willing and able to participate in the study, and provide informed consent.\n\nExclusion Criteria:\n\n* currently pregnant or \\\u003C6 weeks post-partum;\n* had a hysterectomy and no longer have a cervix;\n* a history of cervical cancer or treatment for cervical abnormalities; and\n* any medical, psychiatric, or other condition that would interfere with protocol adherence, assessment of safety, and\u002For ability\u002Fcompetence to provide informed consent.",{"count":675,"type":21},4844,[24],"Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2\u002F3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence.",[679,680,681],"HIV Infections","HPV Infection","CIN 2\u002F3","2024-05-21",{"date":684,"type":37},"2024-05-22",{"date":686,"type":37},"2024-04-17",{"date":376,"type":21},{"name":689,"class":110},"Instituto Nacional de Saúde, Mozambique",""]