[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Benin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":300},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,58,84,111,141,168,195,218,248,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100562326","phase-4-post-discharge-malaria-chemoprevention-implementation-trial-in-benin-100562326",false,"NCT06601712","Post-discharge Malaria Chemoprevention Implementation Trial in Benin","Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: a Cluster Randomised Controlled Implementation Trial in Benin","PDMC-SL","Inclusion Criteria:\n\n* Aged below 10 years of both sexes\n* Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g\u002Fdl or PCV below 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection\n\nExclusion Criteria:\n\n* Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)\n* Sickle cell anaemia\u002Fsickle cell disease\n* Body weight below 5 kg\n* HIV infection and cotrimoxazole prophylaxis are not exclusion criteria","ALL","9 Years",{"count":20,"type":21},648,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The proposed research aims to conduct implementation trials in Benin, co-designed with national stakeholders, to evaluate different delivery strategies for optimizing health system delivery of post-discharge malaria chemoprevention (PDMC) drugs and adherence to PDMC. This chemoprevention strategy is effective in reducing hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. The current trial will provide evidence-based data on acceptability, feasibility, and cost-effectiveness to aid decision-makers. The evidence generated will be used to support the effective implementation and scale-up of PDMC in high malaria-endemic areas such as Benin.",[27,28],"Severe Malaria","Severe Anaemia",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Children","Antimalarial","Prevention","Chemoprevention","Caregivers","Patient discharge","Health care providers","Health economics","Qualitative research","Feasibility","Cost-effectiveness","Benin","Artemisinins","School age","Pre-school","RECRUITING","2026-08-10",{"date":48,"type":49},"2026-08-12","ACTUAL",{"date":51,"type":49},"2025-07-02",{"date":53,"type":21},"2026-12-31",{"name":55,"class":56},"Institut de Recherche Clinique du Benin","OTHER",2,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100513292","phase-3-stroke-minimization-through-additive-anti-atherosclerotic-agents-in-routine-treatment-ii-study-smaart-ii-100513292","NCT05963568","Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)","Inclusion Criteria:\n\n* Above the age of 18 years; male or female\n* Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible\n* Subjects with stroke may present with at least one of the following additional conditions:\n\nDocumented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n\n* Legally competent to sign informed consent.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindications to any of the components of the polypill\n* Hemorrhagic stroke\n* Severe cognitive impairment\u002Fdementia or severe global disability limiting the capacity of self-care\n* Severe congestive cardiac failure (NYHA III-IV)\n* Severe renal disease, eGFR \\\u003C30ml\u002Fmin\u002F1.73m2), renal dialysis; awaiting renal transplant or transplant recipient\n* Cancer diagnosis or treatment in past 2 years\n* Need for oral anticoagulation at the time of randomization or planned in the future months;\n* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)\n* Nursing\u002Fpregnant mothers\n* Do not agree to the filing, forwarding and use of his\u002Fher pseudonymized data.","18 Years","100 Years",{"count":67,"type":21},1000,[69],"PHASE3","The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.",[72,73],"Stroke","Medication Adherence","2026-07-01",{"date":76,"type":49},"2026-07-06",{"date":78,"type":49},"2026-04-01",{"date":80,"type":21},"2029-02-01",{"name":82,"class":56},"Northern California Institute of Research and Education",4,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100606215","phase-2-efficacy-and-safety-study-of-dovramilast-in-people-with-leprosy-type-2-reaction-100606215","NCT07172659","Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction","A 12-week, Open-label, Randomized, Standard of Care Controlled, Dose-ranging Safety and Efficacy Study of Dovramilast in People With Moderate to Severe Acute or Recurrent Leprosy Type 2 Reaction","Inclusion Criteria:\n\n1. Aged 18 years of age or older.\n2. Provision of written informed consent.\n3. Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection.\n4. Leprosy type 2 reaction meeting the following criteria:\n\n   * Either:\n\n     i. Acute (first episode and no treatment initiated) or ii. Recurrent (at least one further episode occurring 28 days or more after withdrawal of leprosy type 2 reaction treatment).\n   * Presence of at least 10 leprosy type 2 reaction tender papular and\u002For nodular skin lesions (not including scars).\n   * An ENLIST score of at least 9.\n5. If a woman of reproductive potential, agree to the use of two reliable contraceptive measures (at least one of which is a highly effective form of contraception) from Screening until at least 4 weeks after completion of treatment with dovramilast or standard of care. Refer to Special Considerations for additional information.\n6. If male (including those who have had a successful vasectomy), agree to using a latex condom during any sexual contact with women of reproductive potential from Screening until at least 4 weeks after completion of treatment with dovramilast or standard of care.\n\nExclusion Criteria:\n\n1. Chronic leprosy type 2 reaction, defined as the reaction occurring for 24 weeks or more during which a subject has required treatment either continuously or where any treatment free period had been \\\u003C 28 days.\n2. Receipt of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (\\> 50 mg\u002Fday), apremilast or any other phosphodiesterase (PDE) 4 inhibitor, or immunosuppressive\u002Fimmunomodulatory treatment within 28 days of Baseline.\n3. Receipt of an investigational agent within 28 days of Baseline or 5 half-lives of the investigational agent (whichever is longer).\n4. Leprosy type 2 reaction with orchitis, uveitis, iritis, or severe neuritis (Grade 3 or greater severe neuritis).\n5. Current diagnosis of leprosy type 1 reaction or Lucio's phenomenon.\n6. Current tuberculosis, malaria, cutaneous or visceral leishmaniasis or other serious bacterial, viral, or parasitic infection at Screening or Baseline.\n7. Active systemic fungal infection requiring or undergoing treatment.\n8. Other than leprosy type 2 reaction, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.\n9. Other than leprosy type 2 reaction, any other dermatological condition that could, in the opinion of the Investigator, interfere with the study assessments.\n10. Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus (HIV) positive.\n11. Pregnant women or breastfeeding mothers.\n12. Use (or planned use) of antimetabolites or alkylating agents, rifampin use more frequent than monthly, phenobarbital, carbamazepine, phenytoin, traditional or herbal preparations (including St. John's wort), foods (including grapefruit) known to affect activity of the cytochrome (CYP)3A4 enzyme or use (or planned use) of all strong CYP3A and P-gp inhibitors including ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, ritonavir, cobicistat, diltiazem. Substrates of CYP3A4, CYP2C9, CYP2C19, and P-gp should be used with caution when concomitantly administered with dovramilast.\n13. Known or suspected active substance abuse or a history of substance abuse within 6 months prior to Screening.\n14. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or Randomization, or major psychiatric illness requiring hospitalization within the last 3 years.\n15. Current diagnosis of depression, and\u002For history of suicide ideation\n16. History of or presence of cardiac disease, including:\n\n    * Clinically significant abnormal electrocardiogram\n    * QTcF \\> 450 msec\n17. Receipt of a vaccination within 7 days of Baseline.\n18. Known or suspected hypersensitivity to: PDE4 inhibitors including dovramilast or apremilast; thalidomide; prednisolone, or; excipients used in the formulation of dovramilast, thalidomide or prednisolone.\n19. Body Mass Index \\\u003C 15 kg\u002Fm\\^2 or \\> 35 kg\u002Fm\\^2.\n20. Unable to, or significant difficulty with, swallowing tablets\u002Fcapsules.\n21. Anemia requiring transfusion.\n22. History of or current pancreatitis.\n23. Known or suspected cirrhosis of the liver.\n24. The following laboratory abnormalities:\n\n    * White blood cells (WBC) \\\u003C 2.5 x 10\\^9\u002F L.\n    * Neutrophils (granulocytes) \\\u003C 1.0 x 10\\^9\u002FL.\n    * Platelets \\\u003C 80 x 10\\^9\u002FL.\n    * Aspartate aminotransferase or alanine aminotransferase \\> 2 times the upper limit of reference range.\n    * Albumin \\\u003C 30 mg\u002FdL.\n    * Bilirubin \\> 2 mg\u002FdL\n    * Calculated creatinine clearance (Cockcroft Gault) \\\u003C 50 milliliter (mL)\u002Fminute.\n    * Lipase ≥ 1.6 times the upper limit\n25. Previous participation in this study\n26. Unwilling, unlikely or unable to comply with all protocol specified assessments, including photographic assessments\n27. Enrolled in another leprosy type 2 reaction treatment study",{"count":92,"type":21},45,[94],"PHASE2","Dovramilast has not been approved for leprosy type 2 reaction (erythema nodosum leprosum, ENL) or any other disease anywhere in the world. In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction. Specifically, this study aims to assess the efficacy of 100mg or 150 mg dovramilast compared with standard treatments (also known as standard of care). This study also aims to assess the safety of two strengths in adults with leprosy type 2 reaction.",[97],"Erythema Nodosum Leprosum",[99,100],"Leprosy type 2 reaction","dovramilast","2026-05-21",{"date":103,"type":49},"2026-05-26",{"date":105,"type":21},"2026-05-25",{"date":107,"type":21},"2027-12",{"name":109,"class":56},"Medicines Development for Global Health",6,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100554386","phase-2-shorter-and-safer-treatment-regimens-for-latent-tb-100554386","NCT06498414","Shorter and Safer Treatment Regimens for Latent TB","SSTARLET: Shorter and Safer Treatment Regimens for Latent TB","SSTARLET","Inclusion Criteria:\n\n* Adults, and children aged ≥5 years with weight of \\> 15Kg.\n* Positive test for TB infection: either Tuberculin test (\\>5mm, or \\>10mm, based on epidemiologic and clinical factors and interpreted following local guidelines) or interferon gamma release assay based on Manufacturer's criteria; and,\n* Recommended for Tuberculosis Preventive Treatment (TPT), following Canadian guidelines (for Canadian sites), and World Health Organization (WHO) guidelines (for international sites).\n\nExclusion Criteria:\n\n* Current tuberculosis (TB) disease - detected pre-enrolment with symptom screen, chest x-ray, and confirmatory microbiological (culture or genotypic) testing as needed; Prior to referral to research staff (research clinic) for consideration as potential participants, all persons must undergo symptoms screen and a chest Xray. If chest Xray is not available, then a negative results from a GeneXpert MTb RIF Ultra of spontaneous (expectorated) sputum will be considered sufficient to exclude TB disease pre-referral. If Chest Xray is abnormal or symptoms consistent with TB disease are present then at least two AFB smears and mycobacterial cultures must be done, and must be negative, or one GeneXpert MTb Rif Ultra must be negative before enrolment\n* Children aged 0-4 years;\n* Persons weighing \\\u003C15 kg.\n* Women who are pregnant or breast-feeding;\n* Women of child-bearing potential and not willing to take an effective form of contraception (non-hormonal) during the treatment phase;\n* Documented prior treatment for tuberculosis (TB) infection or disease;\n* Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE);\n* Rifampin or rifapentine contra-indicated - due to allergy\u002Fhypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage;\n* Have a prolonged QT interval on routine ECG pre-enrolment or take any medications that may prolong the QT interval and that are not recommended to take with a fluroquinolone. (See APPENDIX 5 in supplement for list of medications contra-indicated to take with Levofloxacin);\n* Household contacts (HHC) of index TB patients with phenotypic or genotypic resistance to Rifampin or Levofloxacin. HHC may be enrolled, then excluded post-randomization, if resistance is identified later. Note that all sites routinely test Rifampin resistance in all people newly diagnosed to have TB disease, but do not test routinely for susceptibility to Levofloxacin unless Rifampin resistance is detected. Hence HHCs may be enrolled if their Index TB patient is Rifampin susceptible, even if Drug Susceptibility Testing to Levofloxacin is not done and\u002For not available.","5 Years",{"count":121,"type":21},1800,[94,69],"Our study rationale is based on:\n\n1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe;\n2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs;\n3. 4 months of Rifampin 10mg\u002Fkg (4R10) is the safest regimen, but is completed by \\\u003C80% of patients;\n4. The safety of 2 months of Rifampin 20mg\u002Fkg (2R20) is similar to that of 4 months of Rifampin 10mg\u002Fkg (4R10), but completion is a concern;\n5. 1-month regimens have promising efficacy;\n6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg\u002Fkg (4R10), and head-to-head with each other.\n\nOBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial.\n\nSpecific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg\u002Fkg\u002Fday for 4 months (4R10); Experimental: 1) Rifampin at 20 mg\u002Fkg\u002Fday for 2 months (2R20); (2) one month Levofloxacin and Rifapentine (1LP). At a later stage a 3rd experimental regimen will be selected and added: one another novel 1-2-month regimen identified from pre-clinical and clinical studies. When selected, this will be explained fully including preliminary data on safety and efficacy in an amended protocol and consent - which will be submitted for ethics and regulatory approval at that time).",[125],"Tuberculosis Infection, Latent",[127,128,129,130],"Tuberculosis infection","Rifampin","Short treatment for latent tuberculosis","High dose rifampin","2026-05-06",{"date":133,"type":49},"2026-05-11",{"date":135,"type":49},"2025-06-10",{"date":137,"type":21},"2029-06-01",{"name":139,"class":56},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",14,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100322140","phase-2-assessment-of-the-safety-tolerability-and-effectiveness-of-rifapentine-given-daily-for-ltbi-100322140","NCT03474029","Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI","Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness","ASTERoiD","Inclusion Criteria\n\n1. Persons with LTBI who do not have evidence of TB disease (see exclusion criteria) and are at increased risk of progression to TB. LTBI or M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Details of testing definitions and requirements for each risk factor are further described in the MOOP. Persons with LTBI at increased risk of progression to TB are those with at least one of the following:\n\n   1. Household and other close contacts (\\> 4 hours of exposure in a one-week period) within 2 years prior to enrollment, of persons with bacteriologically confirmed TB.\n\n      o Acceptable testing approaches for bacteriologic confirmation are 1) culture with rifamycin DST; or, 2) nucleic acid amplification tests (NAATs) that detect M. tuberculosis and detect mutations associated with rifamycin resistance. Additional details on bacteriologic confirmation, including accepted NAATs, will be included in the MOOP.\n   2. Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who have a conversion by IGRA may require additional evaluation to rule out a false conversion. Additional guidance and definitions of conversion are in the MOOP.\n   3. HIV co-infection (with CD4+ T-lymphocyte count \\> 100 cells\u002Fmm3)\n   4. ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.\n   5. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB.\n   6. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB \\> 150 per 100,000 (see Appendix D) and either a positive IGRA or a TST ≥15 mm (TST \\> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).\n   7. Recent (within 3 years prior to enrollment) immigration and seeking refugee\u002Fasylum status (see MOOP for additional details) to the United States or other country with low to moderate incidence from a country with an estimated incidence rate of TB \\> 75 per 100,000 (see Appendix E) and either a positive IGRA or a TST ≥15 mm (TST \\> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).\n   8. Individuals with an increased risk of TB due to medical conditions such as end-stage renal disease.\n   9. Individuals currently using immunosuppressive medications such as chronic steroids.\n   10. Individuals with planned use of TNF-α inhibitors.\n   11. Individuals with planned solid organ or hematologic transplantation\n2. Willing to provide signed informed consent, or parental permission and participant assent.\n3. For the following special populations, both inclusion criteria above must be met AND the criteria below depending on stage:\n\n   1. Pregnant women in their second or third trimester (≥14 weeks gestation).\n\n      * Stage 1: Include only those who agree to participate in the semi-intensive PK component.\n      * Stage 2: Include regardless of semi-intensive PK component participation.\n   2. Children aged less than 12 years\n\n      * Stage 1: Include only those who agree to participate in the semi-intensive PK component, based on enrollment strategy presented in Appendix I.\n      * Stage 2: Include regardless of semi-intensive PK component participation, based on PK findings and enrollment strategy described in Appendix I.\n\nExclusion Criteria\n\n1. Failure to document positive IGRA or TST\n2. Current breastfeeding.\n3. Women who are currently pregnant in their first trimester (\\\u003C14 weeks gestation) or intend to become pregnant within 120 days of enrollment.\n4. Non-pregnant women of childbearing potential who refuse to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from activities that could lead to pregnancy.\n5. Current culture-positive TB, clinical TB, or suspected current TB. (Includes cases in which active TB cannot be excluded with reasonable clinical certainty by the site investigator. If sputum samples have been collected AND site investigators have suspicion of active TB, site investigators must wait to review culture results prior to enrollment.)\n6. TB resistant to any rifamycin in the source case\n7. A history of treatment for \\> 7 consecutive days (if daily dosing) with a rifamycin or \\>1 week (if weekly dosing) with a rifamycin and INH or \\> 30 consecutive days with INH within 2 years prior to enrollment.\n8. A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative.\n9. History of allergy or intolerance to rifamycins.\n10. Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) \\> 5x upper limit of normal among persons in whom screening ALT or AST is determined.\n11. Receiving concomitant medications that are known to be contraindicated with any study drug.\n12. Weight \\\u003C 25 kg for participants ≥ 12 years, and weight \\\u003C 3kg for participants \\\u003C 12 years",{"count":150,"type":21},3400,[94,69],"This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI).\n\nThis trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care.\n\nThe hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm).\n\nParticipants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment.\n\nAfter completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.",[154],"Latent Tuberculosis",[156,157],"latent tuberculosis","rifapentine","2026-05-04",{"date":131,"type":49},{"date":161,"type":49},"2019-08-01",{"date":163,"type":21},"2029-12-31",{"name":165,"class":166},"Centers for Disease Control and Prevention","FED",21,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100559548","emus-enhanced-monitoring-using-sensors-after-surgery-100559548","NCT06565559","EMUs: Enhanced Monitoring Using Sensors After Surgery","EMUs","Participant Inclusion Criteria:\n\n* Adults 18 years and older.\n* Undergoing an elective or emergency major surgery procedure with a planned skin incision of 5 cm or greater. Any indication for surgery can exist, including benign, malignant, and trauma.\n* Willing and able to provide written informed consent.\n\nParticipant Exclusion Criteria:\n\n* Those under the age of 18.\n* A documented or suspected allergy to adhesive dressings.\n* Obstetric patients\n* Unwilling or unable to provide written informed consent.",{"count":176,"type":21},1332,"OBSERVATIONAL","Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study:\n\n1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.\n2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment.\n3. To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration.\n\nThis registration focuses on the shadow-mode cohort study.\n\nParticipants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.",[180,181],"Surgery","Inpatients",[180,183,184],"Wearable Devices","Global Surgery","2026-02-06",{"date":187,"type":49},"2026-02-10",{"date":189,"type":49},"2024-02-28",{"date":191,"type":21},"2027-07-31",{"name":193,"class":56},"University of Edinburgh",17,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":202,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100327317","pathophysiological-explorations-of-red-blood-cells-100327317","NCT03541525","Pathophysiological Explorations of Red Blood Cells","GR-Ex","Inclusion Criteria:\n\n* To be affected or have a family history of disease bound to the red blood cell,\n* For adult subjects, have signed an informed consent form,\n* For minor or major under legal safeguard subjects, the form must be signed by both parents (for minors) or by the legal representative,\n* Be affiliated to health insurance.\n\nExclusion Criteria:\n\n* Being deprived of freedom",true,{"count":204,"type":21},3750,"GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.",[207],"Red Blood Cell Disorder","2025-04-29",{"date":210,"type":49},"2025-04-30",{"date":212,"type":49},"2017-10-16",{"date":214,"type":21},"2037-10-15",{"name":216,"class":56},"Imagine Institute",25,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100587766","reducing-deaths-after-surgery-in-low--and-middle-income-countries-a-pilot-cluster-randomised-trial-100587766","NCT06932653","Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS","Inclusion criteria:\n\n* Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm\n* Patient must not be pregnant\n* Adults only (greater than or equal to 18 years old)\n\nExclusion criteria:\n\n* Minimally invasive surgery\n* Surgery for appendicitis",{"count":227,"type":21},300,[229],"NA","SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.",[232],"Post-operative Complications",[234,235,236],"pilot","cluster","surgical safety","NOT_YET_RECRUITING","2025-04-10",{"date":240,"type":49},"2025-04-17",{"date":242,"type":21},"2025-06-01",{"date":244,"type":21},"2026-01-31",{"name":246,"class":56},"University of Birmingham",5,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":255,"targetDuration":257,"studyType":177,"phases":4,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100575570","a-global-prospective-cohort-study-on-outcomes-of-appendicectomy-for-appendicitis-100575570","NCT06774001","A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis","AlliGatOr","Inclusion Criteria:\n\n* Age: There are no age restrictions, although, if appropriate participating hospitals can choose to only include children or only adults, based on an age cut-off of their choice.\n* Procedure: All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes patients who went theatre with suspect appendicitis even if the intraoperative or pathology results found a different diagnosis, so long as an appendicectomy was performed. It also includes patients who went to theatre for reasons other than suspected appendicitis but were found to have appendicitis intraoperatively and underwent appendicectomy. This includes interval appendicectomy and right hemicolectomy if performed for acute appendicitis.\n* Approach: Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.\n\nExclusion Criteria:\n\n* Indication: Appendicectomy for any indication other than suspected or confirmed appendicitis should be excluded. For example, patients having appendicectomy for known appendiceal neoplasm.\n* Procedure: Patients having appendectomy as part of another surgical procedure should be excluded. For example, patients having removal of appendix as part of a colon cancer procedure are not eligible for inclusion.\n* Approach: Natural orifice surgery and endoscopic treatment for suspected appendicitis are excluded.\n* Previous appendicectomy: Patients having surgery for stump appendicitis are excluded.\n* Return to theatre: Patients should be entered into study only once. A patient returning to theatre after appendectomy should not be re-entered as a new patient.",{"count":256,"type":21},14000,"30 Days","This study aims to assess and improve the global management of appendicitis, the most common emergency surgery, by examining various aspects of emergency care systems worldwide. Appendicitis is a time-sensitive condition, and delays in diagnosis or treatment can lead to complications, affecting patient outcomes and increasing healthcare costs. The study uses appendicitis as a \"tracer condition\" to explore how different healthcare systems manage emergency care, focusing on factors like access, quality, and efficiency. By gathering data from hospitals worldwide, the study seeks to identify areas where emergency surgical care can be improved, particularly in low- and middle-income countries (LMICs).\n\nThe main goal is to identify gaps in emergency care systems, using a set of key performance measures (KPMs) that assess access to care, the quality of surgical treatment, and patient safety. These include factors like the time from symptom onset to first surgical assessment, the rate of appendectomy performed via minimally invasive (laparoscopic) surgery, and postoperative complications. The study aims to collect data on at least 14,000 patients from around 500 hospitals globally between February and May 2025. The data will be analyzed by hospital income group (from low to high) to understand how different resource levels impact outcomes and to help guide future policy and practice improvements.\n\nThe study also includes two sub-studies that focus on specific issues in surgical care. The Sustainability and Waste Management sub-study aims to explore how hospitals manage waste and sustainability practices in operating theatres. This sub-study is part of global efforts to reduce carbon emissions in healthcare settings. The Financing sub-study examines the financial burden of appendicectomy, particularly the out-of-pocket costs for patients in LMICs. It will explore how the costs of open vs. laparoscopic surgery differ and investigate the impact of these costs on patients.\n\nBy combining global data on clinical outcomes with information on hospital resources and patient finances, this study hopes to provide valuable insights into how to improve emergency surgical care across diverse settings, making recommendations that can lead to better access to safe, timely, and affordable treatment for appendicitis worldwide.",[260,261],"Appendicitis","Appendectomy",[263,260,261],"Appendicectomy","2025-03-27",{"date":266,"type":49},"2025-04-02",{"date":268,"type":49},"2025-02-03",{"date":270,"type":21},"2025-12",{"name":246,"class":56},7,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":272},"100551885","a-stratified-multi-arm-multi-site-randomised-platform-trial-aiming-to-reduce-the-incidence-of-post-operative-ssi-100551885","NCT06465901","A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI","MARLIN: Stratified, Multi-arm, Multi-stage Factorial Randomised Platform Trial Aiming to Reduce the Incidence of Post-operative Surgical Site Infection (SSI).","MARLIN","Inclusion Criteria:\n\n* Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated, or dirty surgical wound. Definitions and examples of contamination are given in Table 1.\n* Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.\n* Any operative indication for abdominal surgery (excluding caesarean section; see exclusion criteria).\n* Patient able and willing to provide written informed consent (signature or a fingerprint) prior to surgery (including emergency cases).\n* Patients aged 5 years and over. (This criteria MUST be made country-specific. Each country will decide the lower (and upper, if applicable according to local regulations age limit for the trial. This will be dependent on country-specific regulatory approvals. Age eligibility will vary by country.)\n\nExclusion Criteria:\n\n* Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).\n* Patients undergoing clean surgical procedures.\n* Patients undergoing an obstetrics procedure, including caesarean sections.",{"count":282,"type":21},10092,[229],"MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).",[286],"Surgical Site Infection",[288,289,290,291],"surgery","global surgery","SSI","surgical site infection","2024-06-18",{"date":294,"type":49},"2024-06-20",{"date":296,"type":21},"2024-09-01",{"date":298,"type":21},"2026-09-30",{"name":246,"class":56},""]