[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Democratic Republic of the Congo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":716},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,46,78,108,142,172,194,247,274,294,310,328,357,386,425,451,482,513,538,560,585,612,639,662,693],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100591516","implementation-and-evaluation-of-vector-control-methods-in-kinshasa-the-case-of-aedes-100591516",false,"NCT06981442","Implementation and Evaluation of Vector Control Methods in Kinshasa: The Case of Aedes","Implementation and Evaluation of Vector Control Methods in Kinshasa: The Case of Aedes, Vectors of Arboviruses.","At household level:\n\nInclusion Criteria:\n\n* Belong to a household in one of the 4 health areas selected as study arms\n* From 18 years of age to consent for household enrollment and participation in the serosurvey\n* Consenting\n\nExclusion Criteria:\n\n* Not belong to a household in one of the 4 health areas selected as study arms\n* Under 18 years of age\n* Non-consenting\n\nAt health facility level:\n\nInclusion Criteria:\n\n* From 18 years of age\n* Resident of the health zone of Mont Ngafula 1\n* Consenting\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not resident in the health zone of Mont Ngafula 1\n* Seriously ill and hospitalized, requiring transfusion, presence of blood clotting disorders, allergies resulting from injections, adverse events associated with previous blood sampling, pregnancy\n* Non-consenting",true,"ALL","18 Years",{"count":21,"type":22},2050,"ESTIMATED","INTERVENTIONAL",[25],"NA","Arboviral diseases are viral diseases transmitted by mosquitoes of the Aedes genus and are constantly spreading throughout the world, constituting a significant threat to public health.\n\nIn Africa, there is very little data on the epidemiological situation of Aedes-borne diseases and programs for monitoring these diseases are very limited. In the Democratic Republic of the Congo (DRC), several epidemics of yellow fever, dengue fever, chikungunya and Zika cases have been reported. In particular, in Kinshasa, the dengue and chikungunya viruses have previously been detected in patients with undifferentiated fevers and several studies have shown entomological transmission indices above the criteria and standards of the World Health Organization (WHO).\n\nThe aim of our study is to implement and evaluate different strategies to control Aedes mosquitoes at different stages of their life cycle in the city of Kinshasa.\n\nIn particular, a before-and-after interventional study will be piloted and tested in the health zone of Kinshasa, with the aim of providing preliminary evidence of the impact of vector control tools.\n\nInterventions will be implemented in 400 households for each arm for 12 months. Before, after and during the interventions, entomological surveys will be conducted in 160 households in each arm to define the density of the vectors. Mosquitoes will be tested for the possible presence of arbovirus RNA (dengue, chikungunya, Zika, yellow fever). During the pre-intervention period, a serological survey for the same diseases transmitted by the Aedes mosquito will be conducted on a sample of 450 people included in two health centers of reference for the health zone of Mont Ngafula 1. A questionnaire will also be administered before and after the intervention implementation to assess the community's knowledge, attitudes and practices towards Aedes mosquito vector control and Aedes-borne diseases.\n\nThe integration of the data collected within the scope of this study will provide an assessment of the feasibility and impact of the tested methods on entomological indicators, as well as determining the exposure and knowledge of Aedes-borne diseases in the Mont Ngafula 1 area.",[28],"Aedes-borne Diseases",[30,31,32],"Vector control","Aedes mosquitoes","Democratic Republic of the Congo","RECRUITING","2026-08-18",{"date":36,"type":37},"2026-08-19","ACTUAL",{"date":39,"type":37},"2025-03-26",{"date":41,"type":22},"2026-12-31",{"name":43,"class":44},"Institute of Tropical Medicine, Belgium","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100622127","phase-2-a-randomized-clinical-trial-investigating-the-safety-reactogenicity-and-immunogenicity-after-immunization-with-an-mrna-based-mpox-vaccine-candidate-in-africa-100622127","NCT07379580","A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa","Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial","Key Inclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Are male or female individuals ≥18 years of age at the time of giving informed consent:\n\n  * Cohort 1: ≥18 to ≤45 years of age\n  * Cohort 2: ≥18 to ≤64 years of age\n* Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).\n* Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).\n\nKey Exclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).\n* Have a contraindication, warning and\u002For precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information\u002FEuropean Union Summary of Product Characteristics) and BNT166 Investigator Brochure.\n* Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.\n* Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.\n* Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* Have a body mass index ≤18.5 kg\u002Fm\\^2 or ≥35 kg\u002Fm\\^2.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","64 Years",{"count":55,"type":22},310,[57],"PHASE2","This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.",[60,61,62],"Mpox (Monkeypox)","Smallpox","Orthopoxvirus Infection",[64,65,66],"Monkeypox virus (MPXV)","Active immunization","Ribonucleic acid (RNA) vaccine","2026-08-10",{"date":69,"type":37},"2026-08-11",{"date":71,"type":37},"2026-02-20",{"date":73,"type":22},"2027-06",{"name":75,"class":76},"BioNTech SE","INDUSTRY",6,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":45},"100579206","surveillance-of-amr-in-drc-100579206","NCT06821282","Surveillance of AMR in DRC","Surveillance of Antimicrobial Resistance in Semirural Kinshasa, Democratic Republic of Congo: a Feasibility Study","SARKIN","Patients older than six months who present with a clinically suspected bloodstream infection upon admission to the hospital, or who have been hospitalized for less than 48 hours, and provide written consent (or consent from their caregiver\u002Flegal guardian) to participate will be included. Patients with a significant history of healthcare exposure and those with any contraindications for phlebotomy as determined by the clinician's judgment, will be excluded.","6 Months",{"count":88,"type":22},210,"OBSERVATIONAL","This study addresses knowledge gaps regarding antimicrobial resistance (AMR) in sub-Saharan Africa, focusing on evaluating the feasibility of AMR surveillance and enhancing local research capacity. Conducted at a general referral hospital in semirural Kinshasa, DRC, the study will investigate bacterial infections, their resistance profiles, and related risk factors, including co-infections such as malaria.",[92],"Bacteremia",[94,95,96,97,98],"Antimicrobial resistance (AMR)","Surveillance","Malaria","Africa","Democratic Republic of Congo","2026-07-21",{"date":101,"type":37},"2026-07-23",{"date":103,"type":37},"2024-11-11",{"date":105,"type":22},"2026-09-30",{"name":107,"class":44},"University of Oxford",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":17,"sex":116,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100645180","ai-blind-sweep-ultrasound-for-antenatal-screening-by-non-specialist-health-workers-in-rural-dr-congo-100645180","NCT07677670","AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo","Diagnostic Accuracy and Implementation Feasibility of AI-Assisted Blind Ultrasound Sweep (SPAQ E-con AI) for Antenatal Screening by Non-Specialist Health Workers in Rural Democratic Republic of the Congo","FS2","Inclusion Criteria:\n\n* Pregnant women\n* Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment\n* Informed consent obtained (16-17 years with parent\u002Fguardian consent)\n\nExclusion Criteria:\n\n* Emergency presentation\n* Multiple pregnancy\n* Duplicate re-registration of an already-enrolled woman\n* Lacking capacity to consent\n* Planned relocation outside Kwango province during the study period\n* Refusal of consent","FEMALE","16 Years",{"count":119,"type":22},3000,"FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural Democratic Republic of the Congo. Primary outcomes are gestational age mean absolute error (Trimester 2 and Trimester 3) with 95% confidence intervals and AI confidence calibration. The reference standard is manual measurement by a reference reader (early ultrasound first; manual BPD if unavailable; last menstrual period is not used). Target enrollment is approximately 1,430 (IRB-approved ceiling 3,000), with early termination permitted upon achievement of pre-specified analysis-plan thresholds. The study is a multi-center prospective Hybrid Type 1 Effectiveness-Implementation design and includes a pre-specified adaptive model-update (Batch 2 cut) plan following FDA PCCP and STARD-AI guidance.",[122,123,124,125,126],"Antenatal Care","Maternal Health","Gestational Age","Placenta Praevia","Diagnostic Imaging",[128,129,130,131,132],"blind sweep ultrasound","artificial intelligence","point-of-care ultrasound","task-shifting","DRC","2026-06-24",{"date":135,"type":37},"2026-07-01",{"date":137,"type":37},"2026-06-19",{"date":139,"type":22},"2027-06-13",{"name":141,"class":76},"SOIK Corporation Sarl",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":171},"100581807","phase-3-caffeine-for-hypoxic-ischemic-encephalopathy-100581807","NCT06855108","Caffeine for Hypoxic Ischemic Encephalopathy","Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)","CHIME","Participant Inclusion Criteria:\n\nInfants who meet all the following criteria are eligible for enrollment as study participants:\n\n1. Liveborn infants ≥36 weeks\n2. Birth weight ≥1800 grams\n3. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria:\n\n   1. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n\n      * pH \\\u003C7.0; or\n      * Base Deficit ≥16 mmol\u002FL; or\n      * Lactate \\>8 mmol\u002FL.\n   2. Criterion #2: Participant must meet all of the following three criteria:\n\n   i. Moderate acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n   * POC pH 7.0-7.15; or\n   * Base Deficit 10.0-15.9 mmol\u002FL; or\n   * Lactate 6-8 mmol\u002FL.\n\n   ii. Evidence of an acute perinatal event (i.e., placental abruption, intrapartum hemorrhage, cord prolapse, severe fetal heart rate abnormality, uterine rupture).\n\n   iii. Any of the following criteria:\n   * 10-minute Apgar \\\u003C5; or\n   * Need for assisted ventilation initiated at birth and continued for ≥10 minutes\n4. Meets neurologic criteria for moderate to severe HIE, defined as a physical exam conducted between one and six hours after birth that meets either of the following criteria:\n\n   1. Moderate to severe encephalopathy in at least three out of six modified Sarnat categories (level of consciousness, spontaneous activity, muscle tone, posture, primitive reflexes, autonomic function); or\n   2. A clinical diagnosis of seizure in the first six hours after birth.\n\nParticipant Exclusion Criteria:\n\nInfants who meet any of the following criteria are not eligible for enrollment as study participants:\n\n1. Home births\n2. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery\n3. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment.\n4. Infants for whom medical care will not be provided based on the severity of their condition or any other condition that would preclude participation per clinical judgement.\n5. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.\n6. Infants who will be unavailable to complete follow-up visits.\n7. Infants who have received caffeine after delivery.\n8. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol.\n9. Enrollment in another trial that will impact participation in this trial.","6 Hours",{"count":152,"type":22},830,[154],"PHASE3","CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \\[\\\u003C1 hour\\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg\u002Fkg dose of oral caffeine followed by two additional 10 mg\u002Fkg doses at 24-hour intervals or placebo of the same regimen (three total doses).\n\nThe goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.",[157],"Hypoxic Ischemic Encephalopathy (HIE)",[159,160,161,162],"Caffeine","Hypoxic Ischemic Encephalopathy","HIE","AKI",{"date":133,"type":37},{"date":165,"type":37},"2026-04-08",{"date":167,"type":22},"2030-07",{"name":169,"class":170},"NICHD Global Network for Women's and Children's Health","NETWORK",7,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":179,"targetDuration":181,"studyType":89,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":45},"100643071","validation-of-sds-edta-treated-chromatography-paper-strips-for-mpox-sampling-and-transport-in-drc-100643071","NCT07634081","Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC","Use of SDS\u002FEDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection","Inclusion Criteria:\n\n* Patients presenting with clinical signs compatible with mpox infection according to national case definition.\n* Written informed consent obtained.\n* Presence of at least two skin lesions in a similar stage of evolution suitable for paired sampling.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.\n* Presence of only one suitable lesion for sampling.\n* Lesions at markedly different stages of evolution.\n* Inability to safely obtain paired samples.",{"count":180,"type":22},150,"1 Day","The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field conditions in the Democratic Republic of the Congo (DRC).\n\nThe study is conducted among patients with suspected mpox infection presenting to healthcare facilities in South Kivu, DRC. For each participant, paired samples are collected simultaneously using the standard swab method and the SDS-EDTA strip method. Samples are analyzed using locally available molecular diagnostic platforms.",[184],"Mpox","2026-06-09",{"date":187,"type":37},"2026-06-11",{"date":189,"type":37},"2026-05-01",{"date":191,"type":22},"2026-07-31",{"name":193,"class":44},"Universitaire Ziekenhuizen KU Leuven",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":221,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100631921","early-detection-and-ai-based-management-of-skin-related-neglected-tropical-diseases-in-sub-saharan-africa-by-frontline-health-workers-100631921","NCT07506967","Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers","Early Detection and Management of SKIN-related negleCted Tropical Diseases Using Artificial Intelligence in Sub-saharan afRica (SkincAIr)","SkincAIr","1. Frontline Health Workers (FHWs) Age Group\n\n   * Age Range: 18 years and above o Justification: FHWs must be adults, legally eligible to provide healthcare services and consent to participate in the study Sex Distribution\n   * Male and Female FHWs o Justification: Both male and female FHWs will be included to reflect the actual workforce distribution and to ensure generalizability of the results across genders.\n\n   Inclusion criteria for FHWs:\n   1. Professional Role:\n\n      o Must be working as a FHW at one of the selected health centers at the time of the validation study.\n\n      ▪ Justification: The study aims to assess the diagnostic performance of those directly involved in primary patient care in the targeted settings.\n   2. Willingness to Participate:\n\n      o Willing to provide written informed consent to participate in the study.\n\n      ▪ Justification: Ethical standards require voluntary participation with informed consent.\n   3. Smartphone Usage:\n\n      o Willing and able to use a smartphone during the study.\n\n      ▪ Justification: The SkincAIr app is smartphone-based; therefore, FHWs must be willing to use and have access to such devices.\n   4. No Specialized Dermatology Training:\n\n      * FHWs without specialised training in dermatology or extensive experience in skin disease diagnosis.\n\n        * Justification: The study aims to evaluate the app's effectiveness among generalist healthcare workers who would benefit most from diagnostic support tools.\n\n   Exclusion criteria for FHWs:\n\n   1\\. Prior Specialised Training in dermatology:\n\n   o FHWs with formal education or extensive experience in dermatology.\n   * Justification: Including specialists could skew results, as their baseline diagnostic accuracy may already be high, reducing the observable impact of the app.\n\n     2\\. Refusal or Inability to Consent:\n     * FHWs unwilling or unable to provide written informed consent.\n   * Justification: Ethical compliance requires informed consent for participation. 3. Inability to Use the App: o FHWs unable to use a smartphone due to technical limitations, physical impairments, or lack of familiarity with the technology.\n   * Justification: Effective use of the app is essential for the intervention; inability to use it would prevent meaningful participation.\n2. Patients with Skin complaints Size\n\n   ● Total Patients: \\~750 patients Age Group\n\n   ● All Age Groups:\n\n   o Justification: Skin-NTDs affect individuals of all ages; including all age groups enhances the generalizability of the findings and assesses the app's effectiveness across the lifespan.\n\n   Sex Distribution\n   * Male and Female Patients\n   * Justification: Both sexes are included to capture the full spectrum of the disease burden and ensure the app's diagnostic accuracy is effective regardless of sex.\n\n   Inclusion Criteria for Patients with Skin complaints:\n\n   1\\. Presenting with Skin Complaints:\n\n   o Patients presenting to participating health centres with symptoms suggestive of skin-NTDs (e.g., visible skin lesions, nodules, ulcers) but have not been diagnosed by a specialist for that specific skin condition.\n   * Justification: The study aims to evaluate the app's effectiveness in real-world conditions, including all patients with potential skin-NTDs 2. Willingness to Participate: o Patients (or guardians, in the case of minors) willing to provide written informed consent for participation.\n   * Justification: Ethical standards require informed consent from patients or their legal guardians.\n\n     3\\. Ability to Comply with Study Procedures:\n\n     o Patients are able to follow study instructions and attend necessary follow-up appointments.\n   * Justification: Ensures complete data collection and accurate assessment of outcomes.\n\n     4\\. Patients with Co-morbid conditions:\n   * Justification: Immunosuppression that occurs in some comorbid conditions e.g. HIV\u002FAIDS or severe malnutrition can reveal the Skin disease and can affect both the clinical progression and even severity of the Skin NTD. This also includes patients with multiple skin-NTDs.\n\n   Exclusion Criteria for Patients with Skin complaints:\n   1. Refusal or Inability to Consent:\n\n      o Patients (or guardians) unwilling or unable to provide written informed consent.\n\n      ▪ Justification: Ethical compliance requires informed consent for participation.\n   2. Non-Skin-Related Complaints:\n\n      o Patients presenting with complaints unrelated to skin conditions.\n\n      ▪ Justification: The study focuses on skin-NTDs; including unrelated cases would not contribute to the study objectives.\n   3. Previous Participation in the Study:\n\n      o Patients who have already participated in the study.\n\n      ▪ Justification: To avoid duplicate data and potential bias in outcomes.\n\n      Additional Considerations:\n\n      Diversity and Representation ● Geographical Diversity:\n\n      o Including health centres from different regions within each country ensures that the findings are representative of various settings (urban, peri-urban, rural).\n\n      ● Cultural and Socioeconomic Factors:\n\n      o The study acknowledges that cultural beliefs and socioeconomic status may influence healthcare-seeking behaviour and disease presentation. By including a diverse patient population, the study aims to capture these variations.\n\n      Ethical Justification ● Inclusivity:\n      * Including all age groups and both sexes aligns with ethical principles of justice and fairness, ensuring that the benefits of the research are accessible to all segments of the population.\n\n        * Vulnerable Populations:\n      * While including minors and potentially vulnerable adults, the study will implement additional safeguards to protect their rights and well-being, following ethical guidelines and obtaining consent from guardians when necessary.","0 Years",{"count":204,"type":22},2420,[25],"Skin-related Neglected Tropical Diseases (Skin NTDs) affect about 1.8 billion people worldwide, particularly in poor and rural communities where healthcare access is limited. Many people rely on frontline health workers (FHWs) for treatment, but these workers often lack specialized training in skin diseases, making diagnosis difficult. To address this challenge, the SkincAIr project is testing whether a mobile app powered by artificial intelligence (AI) can help FHWs improve their ability to detect Skin NTDs. The study will be conducted in two arms. In the first clinical image data collection arm (36 months), dermatologists in 5 countries (Kenya, Ethiopia, Senegal, Democratic Republic of Congo and Nigeria) will collect images of skin NTD and other skin conditions that will be used for development and training of the AI model within the SkincAIr app before it is tested among FHWs. The second validation study arm will take place in 3 countries (Kenya, Ethiopia and Senegal), and will involve 50 FHWs and around 750 patients in each country over 24 months. During the first 12 months (Phase A), FHWs will diagnose patients using standard methods without the app, establishing baseline performance on key indicators including diagnostic accuracy, time to diagnosis, referral patterns, and cost implications of improved primary-level diagnosis. For the following 6 months (Phase B), FHWs will use the SkincAIr app with AI functionality activated to support diagnosis and enable real-time geolocated disease mapping and hotspot identification. In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills. We will summarize the results using simple numbers and charts to show how often things happen and what the average results look like. Researchers will evaluate how well the app improves diagnosis by FHWs and whether FHWs retain their improved skills even after AI support is removed, by comparing their results with those of a skin specialist (dermatologist). Interviews and group discussions will be recorded, written down, organized into key ideas, and carefully reviewed using a computer program to understand the main themes. Study findings will be shared with National Ministries of Health, presented at local and international conferences, and reported to relevant institutional and regulatory authorities. If successful, this AI tool could boost early detection of skin diseases, enhance disease tracking, and improve healthcare in underserved areas.",[208,209,210,211,212,213,214,215,216,217,218,219,220],"Skin and Connective Tissue Diseases","Neglected Tropical Diseases","Leprosy","Buruli Ulcer","Cutaneous Leishmaniasis","Scabies","Mycetoma","Lymphatic Filariasis","Onchocerciasis","Tungiasis","Post Kala-Azar Dermal Leishmaniasis","Yaws","Podoconiosis",[222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,32],"Skin-related neglected tropical diseases","Artificial Intelligence","Mobile Health","mHealth","Frontline Health Workers","Diagnostic Accuracy","Sub-Saharan Africa","Skin NTDs","Digital Health","AI Diagnostic Tool","Capacity Building","Kenya","Ethiopia","Senegal","Nigeria","NOT_YET_RECRUITING","2026-03-27",{"date":240,"type":37},"2026-04-02",{"date":189,"type":22},{"date":243,"type":22},"2030-05-31",{"name":245,"class":44},"Kenya Medical Research Institute",5,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":45},"100606368","testing-of-a-new-rapid-antigen-test-for-plague-in-ituri-democratic-republic-of-the-congo-100606368","NCT07174648","Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.","Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR Congo","RAPID-IT","Inclusion Criteria:\n\n* All participants (aged ≥5 year old) within Rethy, Logo and Aru health zones, presenting with possible symptoms of bubonic and\u002For pneumonic plague according to WHO definition\n* Willing to provide voluntary consent (or voluntary assent and parental consent in case of minors.\n\nExclusion Criteria:\n\n* Participants not eligible, able, or willing to undergo study procedures\n* Children \\\u003C5 years of age\n* Participants on antibiotic treatment ≥48h prior to recruitment","5 Years",{"count":257,"type":22},300,"This study is being done to learn more about the disease in Ituri and to evaluate a new rapid test that may help doctors find the disease more quickly. This research includes characterisation of clinical presentations and pathology of plague, as well as identification of circumstances that may increase the risk of infection. Biological samples collected include blood, mouth swab, saliva, a bubo aspirate and a sputum sample (the latter only in case of plague in the lungs). These samples will be used to test the performance of the new rapid study test.",[260,261,262],"Plague","Bubonic; Plague, Skin","Plague, Pneumonic",[260,264,265,266,132,267],"Bubonic Plague","Pneumonic Plague","Ituri","Antigen rapid diagnostic test","2026-03-24",{"date":238,"type":37},{"date":189,"type":22},{"date":272,"type":22},"2029-01-02",{"name":43,"class":44},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":281,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":171},"100395158","therapeutic-recommendations-for-the-treatment-of-children-with-a-retinoblastoma-100395158","NCT04425434","Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma","GFARB12019","Inclusion Criteria:\n\n* Unilateral intraocular Retinoblastoma (RB)\n* Unilateral extraocular intraorbital (RB)\n* Bilateral intraocular (RB)\n* bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.\n\nExclusion Criteria:\n\n* Externalized tumor mass\n* massive extension to optic nerve up to optical channeltumor\n* intracranial extension leptomeninges\n* cerebral parenchyma\n* extension to regional lymph nodes and\u002For remote metastases.\n* cerebrospinal fluid involvement.\n* Trilateral RB\n* Incapacity to followed the whole treatement.",{"count":119,"type":22},"As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.",[284],"Retinoblastoma","2026-02-27",{"date":287,"type":37},"2026-03-02",{"date":289,"type":37},"2020-11-01",{"date":291,"type":22},"2030-12-31",{"name":293,"class":44},"French Africa Pediatric Oncology Group",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":301,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":309,"locationsCount":171},"100395157","recommendations-for-the-treatment-of-children-with-burkitts-lymphoma-100395157","NCT04425421","Recommendations for the Treatment of Children With Burkitt's Lymphoma","GFALMB2019","Inclusion Criteria:\n\nClinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.\n\n\\-\n\nExclusion Criteria:\n\nNot a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.",{"count":302,"type":22},1000,"This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.",[305],"Burkitt Lymphoma",{"date":287,"type":37},{"date":289,"type":37},{"date":291,"type":22},{"name":293,"class":44},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":19,"enrollmentInfo":318,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":171},"100395008","therapeutic-recommendations-for-nephroblastoma-100395008","NCT04423484","Therapeutic Recommendations for Nephroblastoma","Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.","GFANEPHRO20","Inclusion Criteria:\n\nUnilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.\n\n.\n\nExclusion Criteria:\n\nBilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal",{"count":302,"type":22},"The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.",[321],"Nephroblastoma",{"date":287,"type":37},{"date":324,"type":37},"2020-07-01",{"date":326,"type":22},"2030-12-30",{"name":293,"class":44},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":45},"100624963","effectiveness-of-malaria-vaccines-in-reducing-the-risk-of-invasive-non-typhoidal-salmonella-disease-100624963","NCT07416461","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)","VINS","Inclusion Criteria:\n\n1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR\n2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation",{"count":337,"type":22},10000,"The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.",[340,96,341],"Invasive Non-Typhoidal Salmonella Disease","Malaria Vaccine",[96,343,344,340,132,98,345,346,347],"Vaccine effectiveness","iNTS","Malaria vaccine","Effectiveness","R21\u002FMatrix-M","2026-02-10",{"date":350,"type":37},"2026-02-18",{"date":352,"type":37},"2025-10-27",{"date":354,"type":22},"2027-02",{"name":356,"class":44},"International Vaccine Institute",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":385},"100580769","phase-3-ebola-post-exposure-prophylaxis-100580769","NCT06841614","EBOla Post-Exposure Prophylaxis","Evaluation of the Efficacy of a Post-exposure Prophylaxis (PEP) Strategy in Contacts at High Risk of Developing Ebola Virus Disease (EVD)","EBO-PEP","Inclusion criteria\n\n* Last high-risk contact within the last 5 days\n* No sign or symptoms of EVD\n* Signed and dated informed consent from participants over the age of majority to participate in the trial or from a representative of parental authority for minor participants.\n\nNon-inclusion criteria\n\n* History of vaccination with Ervebo or any other EVD vaccine within the last 5 years (self-reported by the participant)\n* History of confirmed EVD within the last 5 years (self-reported by the participant)\n* Hypersensitivity to any of the experimental medical products (IMP) or their excipients (self-reported by the participant)\n* Participation in another therapeutic or vaccine trial for EVD\n* Any other reason that, at the investigator's discretion, could compromise the participant's safety and cooperation in the trial.",{"count":366,"type":22},160,[154],"EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.\n\nThe trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD.\n\nParticipants will be randomized (1:1) into one of two trial arms:\n\n* Arm 1 (ERV): Ervebo D0 (72 million PFU IM)\n* Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg\u002Fkg) D0 + Ervebo D56 (revaccination)\n\nDefinition of high-risk:\n\nDirect contact with a person with EBOV PCR-confirmed EVD with diarrhea, vomiting or external bleeding (\"wet symptoms\"), or with their body fluids; Direct contact with the dead body of a person with confirmed or probable EVD; Needlestick with a syringe contaminated by the blood of a person with confirmed or probable EVD; Or a child born to or breastfed by an individual with EVD\n\nTrial follow-up All participants are monitored daily for a minimum of 21 days.\n\nSome visits are conducted in person at the investigation site, also called the Post-Exposure Prophylaxis (PEP) center:\n\n* at Day 5, Day 10, and Day 21 for the ERV arm,\n* at Day 5, Day 10, Day 21, and Day 56 for the ERV+IMZ arm. Other visits are conducted at home or by phone, in collaboration with the Ministry of Health's surveillance team.\n\nParticipants in the ERV+IMZ arm have an in-person visit at Day 56 to be revaccinated with the Ervebo vaccine to compensate for potential inhibition of the vaccine response when Ervebo is administered simultaneously with Inmazeb.\n\nParticipants in the ERV arm have a phone visit at Day 56. For all participants, a phone visit is scheduled at Day 60. It corresponds to the last visit for all trial participants.\n\nFollow-up in Case of Hospitalisation In case of clinical signs suggestive of EVD, participants enter the suspected case management pathway at the Ebola Treatment Center (ETC).\n\nIf EVD is confirmed by EBOV PCR, participants are allowed at the ETC, and their study samples are discontinued. They continue to be followed by the research team, and daily data are collected throughout their stay at the ETC until they are discharged alive or deceased. The day of discharge from the ETC marks the end of follow-up in the study for these participants.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nIf EVD is not confirmed, participants continue to be followed up by the PEP center according to the protocol.",[370],"Ebola Virus Disease",[370,372,373,374],"EBOV","High-Risk contact","Post-Exposure Prophylaxis","2026-01-21",{"date":377,"type":37},"2026-01-22",{"date":379,"type":22},"2026-09",{"date":381,"type":22},"2028-08-01",{"name":383,"class":384},"ANRS, Emerging Infectious Diseases","OTHER_GOV",4,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":17,"sex":116,"minAge":19,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":404,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":171},"100571679","phase-3-asymptomatic-bacteriuria-in-pregnancy-in-low--and-middle-income-countries-100571679","NCT06723392","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research","ABLE","Inclusion Criteria:\n\nIndividuals who meet the following criteria are eligible for randomization:\n\n* Enrolled in GN MNHR\n* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and\u002For clinical assessment and\u002For ultrasonography\n* Age: 18 years (or lower limit age eligible\\*) to 49 years\n\n  \\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.\n* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up\n* Able to provide informed consent\n* Presence of a single bacterial isolate (\\>105 colony forming unit (CFU)\u002FmL) in urine at enrollment\n* Intent to remain in study area for at least 42 days PP\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for randomization:\n\n* Gestational age \\\u003C12 weeks or \\>20 weeks\n* Received treatment with any antibiotic within 14 days before screening visit\n* Current symptoms of UTI\n* History of allergy to nitrofurantoin\n* Pregnancy loss \u002F miscarriage prior to randomization\n* Currently taking magnesium-containing antacid\n* Any illness \u002F condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment\n* Enrollment in another trial that per the study MOP will impact this trial","49 Years",{"count":396,"type":22},1134,[154],"This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \\[End preventable deaths of newborns and children under 5 years of age\\] by examining the potential impact of this practice to reduce the incidence of SVN\u002FSB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).",[400,401,402,403],"Preterm Birth","Small for Gestational Age (SGA)","Stillbirth","Bacteriuria (Asymptomatic) in Pregnancy",[405,406,407,408,409,410,411,412,413,414,415,98,416,417],"asymptomatic bacteriuria","small vulnerable newborn","preterm birth","small for gestational agea","still birth","SVN\u002FSB","oral nitrofurantoin monohydrate\u002Fmacrocrystals","Global Network","Bangladesh","India","Pakistan","Zambia","Guatemala","2026-01-20",{"date":377,"type":37},{"date":421,"type":37},"2025-12-08",{"date":423,"type":22},"2028-11",{"name":169,"class":170},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100138497","maternal-newborn-health-registry-100138497","NCT01073475","Maternal Newborn Health Registry","Global Network for Women's and Children's Health Research Maternal Newborn Health Registry","MNH","Inclusion Criteria:\n\n* Community-level\n\n  * Appropriate for long-term registry data collection and the conduct of ongoing Global Network research\n  * At least 300 deliveries per year\n* Participant-level\n\n  * Pregnant women intending to deliver within study cluster\n  * Women who deliver within the study cluster\n  * Women who reside in the community but are transferred for care at delivery\n\nExclusion Criteria:\n\n* Participant-level\n\n  * Opt out of consent to include data in the study",{"count":434,"type":22},950000,"The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.",[437],"Pregnancy Outcome Trends in Low-resource Geographic Areas",[439,440,441,402,442,443],"Pregnancy","Maternal mortality","Neonatal mortality","Maternal Cause of Death","Neonatal Cause of Death",{"date":375,"type":37},{"date":446,"type":37},"2008-05",{"date":448,"type":22},"2030-05",{"name":169,"class":170},15,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":17,"sex":18,"minAge":459,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":45},"100619489","clinical-aspects-management-and-surveillance-of-febrile-illnesses-in-drc-100619489","NCT07345286","Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC","Aspects Cliniques, Prise en Charge et Surveillance Des Maladies fébriles en RDC","FI-CARE","Inclusion Criteria:\n\n* Ongoing fever objectified at presentation, or documented at home or other health center within 24 hours prior to presentation, defined as: axillary or tympanic temperature \\> 37.5°C, or oral or rectal temperature \\> 38°C.\n* Opportunity for contact between patient (or designated relative) and study team on days 7, 14 and 21.\n* Informed consent to participate signed by the patient (adult) or a legally acceptable representative (child or patients whose condition does not allow them to sign informed consent), with the assent of children aged 12 and over, wherever possible.\n\nExclusion Criteria:\n\n* Child less than two months old.\n* Hospitalization of \\> 48h in the last 14 days.","2 Months",{"count":461,"type":22},500,"The epidemiology and outcome of febrile illnesses in the Democratic Republic of Congo (DRC) is poorly documented. The FIKI² study, a prospective observational study of community-acquired febrile illnesses coordinated by ITM and INRB and conducted at 2 clinical sites from 2021 to 2023, has deepened the knowledge of clinical presentation, etiology, outcome and profile of inflammatory\u002Finfectious biomarkers (white blood cells and C-reactive protein, or CRP).\n\nThe management of febrile illnesses remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies, including FIKI². A number of initiatives are underway to address this problem, such as the use of biomarkers, the development of treatment guidelines and electronic decision support systems. The FIKI² study highlighted the potential role of CRP in rationalizing antibiotic use. In parallel, the 'AWARE antibiotic book' was published at the end of 2022 by the WHO, providing recommendations on the choice (or otherwise) of antibiotic therapy for over 30 common clinical infections, in both primary care and hospital settings.\n\nBased on the results of the FIKI² study, the main aim of the FI-CARE study is to investigate the impact of these new tools (CRP biomarker, AWARE antibiotic book, and electronic decision support systems) on first-line antibiotic use. Secondly, the study will consolidate previous results from FIKI² sites in terms of monitoring the etiologies of community-acquired febrile illnesses (particularly arboviruses); and reinforce this monitoring at new sites (depending on opportunities). This complementary study will also pursue FIKI²'s strategic objectives of strengthening clinical research capacity and consolidating biobanks in the DRC.\n\nFI-CARE is a prospective, observational, multicenter cohort study of adults and children presenting to the emergency department or outpatient clinic with community-acquired febrile illness. A laboratory component with sample storage in a biobank is added in a modular fashion according to laboratory and research capacities, epidemiological interest and available funds.",[464,465,95],"Febrile Illness Acute","Biomarkers",[467,468,469,470,471,472,473],"febrile illness","CRP","biomarkers","surveillance","clinical characteristics","Subsaharan Africa","malaria","2026-01-09",{"date":476,"type":37},"2026-01-15",{"date":478,"type":37},"2025-01-20",{"date":480,"type":22},"2027-01-01",{"name":43,"class":44},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":490,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":499,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":45},"100614784","nutritional-intervention-with-tenebrio-molitor-powder-in-children-with-chronic-malnutrition-in-the-democratic-republic-of-the-congo-100614784","NCT07284095","Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo","SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo","SANTE","Inclusion Criteria:\n\n* Children diagnosed with chronic malnutrition (weight-for-height or BMI below -2 SD according to WHO standards).\n\nChildren whose families agree to participate in the intervention and sign the informed consent form.\n\nExclusion Criteria:\n\n* Children with severe acute illnesses that may interfere with the intervention.\n* Children with known allergies to the ingredients of the nutritional products provided.","2 Years","10 Years",{"count":493,"type":22},40,[25],"The goal of this clinical trial is to evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years.\n\nThe main questions it aims to answer are:\n\n• Does regular supplementation with Tenebrio molitor flour improve chronic malnutrition status\n\nResearchers will compare the intervention group (children receiving Tenebrio molitor flour supplement) with the control group (children receiving a traditional maize-soy flour supplement) to assess differences in biochemical and anthropometric outcomes after the intervention period.\n\nParticipants will:\n\n* Participate in baseline and follow-up anthropometric and blood sample assessments (hemoglobin, albumin, zinc, iron, calcium, magnesium, vitamin A, folic acid, vitamin B12, prealbumin).\n* Consume a daily dietary supplement (either Tenebrio molitor flour or maize-soy flour) for the duration of the intervention.\n* Provide information on dietary intake and general health status through structured questionnaires administered by the research team.",[497,498],"Chronic Malnutrition","Stunting of Growth",[497,500,501,502,503],"Stunting","Tenebrio Molitor","Food Security","Sustainable Foods","2025-12-15",{"date":506,"type":37},"2025-12-16",{"date":508,"type":22},"2026-02-01",{"date":510,"type":22},"2026-08",{"name":512,"class":44},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":537},"100452080","preventative-intervention-for-cholera-for-7-days-100452080","NCT05166850","Preventative Intervention for Cholera for 7 Days","Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo","PICHA-7","Inclusion Criteria:\n\n* Diarrhea patients presenting with three or more loose stools over a 24h period\n* Having no running water inside of their home\n* Plan to reside in Bukavu for the next 12 months\n* Have a child \\\u003C5 years in their household\n* Have a working mobile phone in the household\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference\n* Presenting at the health facility with a fever (COVID-19 prevention)",{"count":522,"type":22},2900,[25],"The first objective of our study is to develop a theory-driven evidence-based targeted water, sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and community engagement. The second objective is to conduct a randomized controlled trial of 2,320 household members of 580 severe diarrhea patients to evaluate the effectiveness of the developed targeted WASH intervention in terms of: 1. reducing diarrheal diseases household members of cholera and severe diarrhea patients; and 2. increasing WASH behaviors.",[526,527,528],"Cholera","Water-Related Diseases","Diarrhea Infectious","2025-12-09",{"date":531,"type":37},"2025-12-17",{"date":533,"type":37},"2021-12-22",{"date":41,"type":22},{"name":536,"class":44},"Johns Hopkins Bloomberg School of Public Health",2,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":181,"maxAge":19,"enrollmentInfo":546,"targetDuration":547,"studyType":89,"phases":4,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100347437","hospital-based-registry-of-childhood-cancer-in-pediatric-oncology-units-in-french-speaking-africa-100347437","NCT03803735","Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa","French African Pediatric Oncology Registry","RFAOP","Inclusion Criteria:\n\n1. Any child presenting at any one of the participating units for treatment\n2. Any child with any type of cancer\n3. Any child or adolescent less than 18 years of age.\n\nExclusion Criteria:\n\n1. No cancer found\n2. Age greater than 18 years -",{"count":337,"type":22},"12 Months","The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population.\n\nCollecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.",[550],"Pediatric Cancer","2025-09-29",{"date":553,"type":37},"2025-10-03",{"date":555,"type":37},"2016-01-01",{"date":557,"type":22},"2030-12",{"name":293,"class":44},14,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":17,"sex":18,"minAge":568,"maxAge":4,"enrollmentInfo":569,"targetDuration":571,"studyType":89,"phases":4,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":45},"100600130","evaluation-of-effectiveness-and-safety-of-lc16m8-mpox-vaccine-in-the-democratic-republic-of-congo-drc-100600130","NCT07093489","Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)","Evaluation of the Effectiveness and Safety of the LC16m8 Mpox Vaccine in Individuals Aged One Year and Older in the Democratic Republic of Congo (DRC)","MPX-001","1. Vaccination:\n\n   Inclusion criteria\n   * Individuals aged 12 months and above\n   * Living in the study catchment area\n   * Written informed consent\u002Fassent (if applicable)\n\n   Exclusion criteria\n   * Prior receipt of any mpox vaccine dose\n   * Women known to be pregnant or breast feeding\n   * Individuals suffering from any spreading skin disease\n   * Immunocompromised individuals with known severe immuno-deficiency conditions (example, HIVAIDS, individuals being on chronic use of systemic steroids (\\>2 mg\u002Fkg\u002Fday or \\>20 mg\u002Fday prednisolone equivalent for periods exceeding 10 days, cytotoxic or other immunosuppressive drugs)\n   * Individuals with known underlying uncontrolled chronic diseases such as diabetes mellitus, cardiovascular disease, renal disease, hepatic disease, hematological disease, and developmental disturbance\n   * Individuals with a history of hypersensitivity caused by a component of the vaccine\n\n   Temporary exclusion criteria\n   * Individuals with objective fever (Frontal temperature ≥ 38.5°C) or axillary temperature \\> 37.5 °C\n   * Individuals suffering from acute illness within 48 hours prior to vaccination and based on investigator judgement.\n   * Receipt of any live vaccine injection within the previous 27 days (measles vaccine, rubella vaccine, mumps vaccine, varicella vaccine, BCG vaccine, yellow fever vaccine...).\n2. Cohort Event Monitoring (CEM):\n\n   Inclusion criteria\n   * Written informed consent\n   * Individual who receives single dose of LC16m8 vaccine at one of the vaccination centers participating in the study.\n   * Must be reachable by phone (must have an active phone number of his\u002Fher own or in the household) throughout study participation.\n\n   Exclusion criteria\n\n   • Individual\u002Fparent\u002Fguardian unable to comply with the study procedures\n3. Mpox surveillance (VE):\n\nGeneral Inclusion Criteria:\n\n* Patients (with any vaccination status) presenting to a sentinel surveillance health facility with clinical signs and symptoms consistent with mpox disease (probable or suspected)\n* Reside in the study area prior to testing.\n* Eligible to receive LC16m8 vaccine during the vaccination.\n* Give consent\u002Fassent (if applicable) to participate in the study.\n\nExclusion Criteria\n\n* Individuals meeting any of the following criteria are not eligible for testing and enrollment in the study:\n* Known contraindications for LC16m8 vaccine.\n* As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all the inclusion\u002Fexclusion criteria mentioned above.","1 Year",{"count":570,"type":22},11990,"12 Weeks","This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC.\n\nThis study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out:\n\n* Community engagement\n* Enhanced health facility-based mpox disease surveillance\n* Vaccination using the LC16m8 vaccine\n* Safety monitoring following immunization\n* LC16m8 Vaccine effectiveness evaluation using a TND\n\nStudy Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.",[60,184],[575,184,346,576,132],"LC16m8","Safety","2025-09-08",{"date":579,"type":37},"2025-09-15",{"date":581,"type":22},"2025-09-30",{"date":583,"type":22},"2027-12-31",{"name":356,"class":44},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":17,"sex":116,"minAge":592,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":611},"100526016","global-burden-estimation-of-human-papillomavirus-globe-hpv-100526016","NCT06129253","Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)","HPV","Inclusion Criteria:\n\n1. 9 to 50 years old (for urban and rural CSSs) at the time of enrollment.\n2. Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers).\n3. Able to understand the purpose of the study and study procedures.\n4. If aged 18 years or older or legally considered an emancipated minor, able and willing to provide consent to participate in the study including sample collection.\n5. If aged \\\u003C18 years (and not considered an emancipated minor), supported in their participation by a parent or guardian who is able and willing to provide consent, and\n6. If aged \\\u003C18 years (and not considered an emancipated minor), able and willing to provide assent to participate in the study.\n\nExclusion Criteria:\n\n1. Decline consent to participate any activity of the study.\n2. A medical condition or other reason, not directly related to HPV infection or HPV-related diseases, in the opinion of the investigator, precludes enrolment in the study.","9 Years","50 Years",{"count":595,"type":22},29750,"This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and\u002For create barriers that shape girls\u002Fwomen access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.",[598],"HPV Infection",[600,598,601,602],"HPV Positivity","High Risk (HR) HPV","Cervical Cancer","2025-07-15",{"date":605,"type":37},"2025-07-16",{"date":607,"type":37},"2023-11-23",{"date":609,"type":22},"2027-12",{"name":356,"class":44},8,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":620,"targetDuration":621,"studyType":89,"phases":4,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":537},"100580712","epidemiological-and-pathophysiological-insights-through-a-cross-sectional-survey-epic-100580712","NCT06840860","Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)","Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)","MBOTE-EPIC","Inclusion Criteria:\n\n* Apply to be tested for VMPX at HGR or another test center.\n* Patients of all ages and sexes. However, minors under the age of 12 are excluded from questions on sex life.\n* The patient or his\u002Fher culturally acceptable representative is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n* NA",{"count":302,"type":22},"10 Days","This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.",[624],"Monkeypox (Mpox)",[626,627,98,628,629,630],"Monkeypox","Poxviridae Infections","Infections","Virus Diseases","DNA Virus Infections","2025-04-29",{"date":633,"type":37},"2025-05-02",{"date":635,"type":37},"2025-03-28",{"date":637,"type":22},"2027-02-28",{"name":43,"class":44},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":593,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":537},"100525829","phase-3-safety-and-immunogenicity-of-ervebo-and-zabdeno-booster-vaccines-against-ebola-virus-following-previous-vaccination-with-the-zabdenomvabea-or-ervebo-vaccine-schedules-in-drc-100525829","NCT06126822","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC","Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno\u002FMvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT","EBO-BOOST","Inclusion Criteria:\n\n* Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\\&J) more than 4 months prior to recruitment\n* Subjects between 18 and 50 years of age at time of randomization\n* Subject must be willing and able to provide informed consent\n* The subject must be in possession of an identification card (or other identification document)\n* Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination\n* Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant\n\nExclusion Criteria:\n\n* Participants who previously experienced active Ebola Virus Disease (EVD)\n* Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment\n* Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine\n* Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\\&J) vaccine\n* Administration of immunoglobulins and\u002For any blood products within three months prior to recruitment.\n* Fever (\\>38°C) within last 24 hours prior to recruitment.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.\n* Severe and\u002For uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed)\n* History of anaphylaxis, allergic disease or reactions to any component of the study vaccines\n* History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture\n* History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)\n* Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data\n* Suspected or known alcohol or drug dependency\n* Subject is not readily available by telephone, email or physical address\n\nThe non-vaccinated control group will also adhere to all the above in- and exclusion criteria, with exemption of:\n\n* Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination\n* Subjects who received either the Ervebo® vaccine, or the full Zabdeno, Mvabea® vaccine regimen more than 4 months prior to recruitment\n\nThe latter is rather introduced as an additional exclusion criteria:\n\n* Subjects who received either the Ervebo® vaccine or the full Zabdeno, Mvabea® vaccine regimen",{"count":648,"type":22},624,[154],"The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno\u002FMvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules.\n\nParticipants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.",[370],[653],"Ebola vaccines","2025-03-13",{"date":656,"type":37},"2025-03-18",{"date":658,"type":37},"2025-02-25",{"date":660,"type":22},"2026-10",{"name":43,"class":44},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":116,"minAge":670,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":23,"phases":674,"briefSummary":676,"conditions":677,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":691,"locationsCount":45},"100567781","phase-1-tolerance-and-effectiveness-of-c14-on-hpv-infection-100567781","NCT06672653","Tolerance and Effectiveness of C14 on HPV Infection","PREPAP Study: Tolerance and Effectiveness of the Monoterpenoid Zinc Tetra-ascorbo-camphorate (C14) on the Genital Load of Oncogenic HPV (HR-HPV) and Precancerous Cervical Lesions: Research With Direct Individual Benefit","PREPAP","Inclusion Criteria:\n\n* sexually-active women\n* aged at least 30 years old\n* who will give their informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant\n* breastfeeding and post-partum women will not be accepted in the study.\n* previous cervical surgery, medical history of any severe diseases, intake or application of other antivirals\n* known or suspected allergic or adverse response to the investigational product or its components\n* women who are unable to follow the study protocol.","30 Years","65 Years",{"count":673,"type":22},66,[675,57],"PHASE1","The zinc monoterpenoid tetra-ascorbo-camphorate possesses broad-spectrum anti-viral properties in vitro, particularly against HIV, HSV and HPV. Its C14 formulation could be a promising candidate for in vivo clinical evaluation as a potential microbicide or therapeutic drug.\n\nThe aim of this clinical trial is to determine whether C14 is effective in reducing the genital viral load of HR-HPV and in treating low-grade dysplastic lesions of the cervix. It will also determine the tolerability of C14. The main questions to be answered by the clinical trial are as follows:\n\nDoes C14 reduce the genital HR-HPV viral load in participants with persistent HR-HPV infections? What medical problems do participants experience when taking C14? Researchers will compare C14 to a placebo (a similar substance that contains no drug) to see if C14 is effective in reducing genital C14 viral load and in treating low-grade dysplastic lesions of the cervix.\n\nParticipants will\n\nreceive four monthly treatments (5ml of C14 dissolved in distilled water administered twice daily \\[morning and evening\\] for seven days via vaginal syringe during the follicular phase) of C14 or placebo for 4 months and visit the clinic once every 2 weeks for examinations and tests. They will keep a diary of their symptoms and the number of times they keep the hospital appointment.",[678,679,680,681,682,683,684],"HPV-induced Cancers","HPV Infections","HIV","Cervical Cancers","Trial","C14","Monoterpenoid Zinc Tetra-ascorbo-camphorate","2024-11-01",{"date":687,"type":37},"2024-11-04",{"date":689,"type":22},"2024-11-15",{"date":603,"type":22},{"name":692,"class":76},"MGB Pharma",{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":698,"acronym":4,"eligibilityCriteria":699,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":700,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":702,"conditions":703,"keywords":704,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":714,"locationsCount":45},"100427989","impact-study-of-cholera-vaccination-in-endemic-areas---clinical-surveillance-100427989","NCT04853186","Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance","Cholera Control in Endemic Regions of Africa: Clinical Surveillance and Cholera Shedding Study in the Context of Mass Vaccination Campaigns, Democratic Republic of the Congo","For Surveillance in study CTCs\n\nInclusion Criteria:\n\n* All patients presenting at the time of the study to any selected Cholera Treatment Center\u002FCholera Treatment Unit (CTC\u002FCTU), matching the case definition and giving his\u002Fher consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.\n\nExclusion Criteria:\n\n* Patients who decline to participate will be excluded from the study.\n\nFollow up of individuals with active cholera shedding:\n\nInclusion Criteria:\n\n1. present to any selected CTC\u002FCTU, match the case definition, participate to the clinical surveillance activity and test positive to RDT OR\n2. Be a household member of a person respecting inclusion criteria 1. AND for whom the head of the household has provided verbal consent to participate AND giving his\u002Fher consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.\n\nExclusion Criteria:\n\n\\- Individuals who decline to participate will be excluded from the study, as well as households for whom the head of the household (and his or her representative) decline the participation of his\u002Fher household.",{"count":701,"type":22},6000,"This project aims to fill this essential knowledge gap by assessing the impact of oral cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this protocol. The evidence generated from this project will be key to develop future strategies regarding cholera vaccine use in endemic settings, including places with higher burden in terms of cholera mortality.",[526],[705,706,707],"Cholera incidence rates","Mass vaccination campaign","V.Cholerae","2024-09-11",{"date":710,"type":37},"2024-09-19",{"date":712,"type":37},"2021-05-11",{"date":41,"type":22},{"name":715,"class":44},"Epicentre",""]