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Found 13 Actively Recruiting clinical trials
Actively Recruiting
Researchers are collecting detailed information about children with cancer who are treated at pediatric oncology units in French-speaking Africa. This registry aims to provide accurate data on the number of cases, disease stage, treatments, and outcomes to help improve pediatric cancer care and support local and national health planning. The project focuses on children and adolescents under 18 years old diagnosed with any type of cancer. The data includes demographic and socioeconomic details along with clinical status and treatment results. Information on vital status, treatment abandonment, and loss to follow-up is also gathered. Data is entered locally into an online system called REDCap and securely stored by the IT department at Gustave ROUSSY in Paris-Villejuif. Participants are children under 18 who come to participating hospitals for cancer treatment. Researchers track the number of children suspected of having cancer, their health status, treatment progress, and survival over any 12-month period. This ongoing registry helps monitor outcomes and supports efforts to improve pediatric oncology services in the region.
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Healthy Volunteer
Malaria caused by Plasmodium falciparum remains a serious global health problem with severe consequences. Researchers aim to better understand the immune and parasite factors linked to malaria infection and disease, especially in pregnant women and young children. The study focuses on how pregnancy malaria affects birth outcomes like low birth weight and maternal anemia, and how exposure during pregnancy may influence the risk of childhood malaria. The study also explores whether severe childhood malaria parasites have unique characteristics. This research is a large, ongoing cohort study in Ouelessebougou, Mali, an area with intense seasonal malaria transmission. Up to 2000 pregnant women and their newborns, 2000 children aged 0 to 3 years, and 2000 febrile children up to age 10 will be enrolled and followed. Pregnant women and children will have clinical evaluations and blood samples taken periodically. Additional groups include febrile hospitalized and non-hospitalized children and a case-control group of pregnant women to study pregnancy malaria and preeclampsia. Some children from the initial cohorts will be followed up to 10 years to observe long-term outcomes. Participants will undergo regular clinical exams, blood sampling, and monitoring to assess malaria infection and immune responses. Researchers will analyze maternal, placental, parasite, and host factors related to malaria resistance in children up to 5 years old. The study also includes follow-up of children through adolescence to early adulthood for some groups. Data collected will help identify factors affecting infection and disease in mothers and children, aiming to support vaccine development and improve malaria outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effectiveness of a new way to deliver the R21 malaria vaccine alongside seasonal malaria chemoprevention (SMC) in children living in areas with highly seasonal malaria transmission in Burkina Faso and Mali. This Phase 4 trial compares two vaccination strategies in clusters defined by health center areas. The study will measure how well each approach works to reduce malaria cases, vaccine coverage, acceptance, feasibility, and cost-effectiveness. Children in the control groups receive either routine age-based vaccination through the Expanded Program on Immunization (EPI) or an annual campaign of the 3-dose vaccine series before the malaria season alongside SMC. The intervention group receives the 3-dose R21/Matrix-M vaccine series aligned with SMC distribution in children aged 3 to 59 months. The vaccine is given as part of a campaign matched with SMC delivery in each country. Participants will be monitored for malaria incidence over 12 months using routine clinical surveillance and community surveys to check for malaria parasites. The study also assesses how acceptable and feasible the different vaccine delivery methods are, along with measuring vaccine coverage and cost-effectiveness. Written consent is required from parents or guardians, and the total study duration includes follow-up for one year after vaccination.
Actively Recruiting
Healthy Volunteer
Malaria caused by Plasmodium falciparum remains a serious global health issue, especially affecting pregnant women and young children. Pregnancy malaria can lead to complications such as low birth weight, maternal anemia, and gestational hypertension. Researchers are evaluating vaccines designed to prevent malaria infection during pregnancy by studying antibodies raised in animals against vaccine candidates and comparing them to naturally acquired antibodies in pregnant women. This study will be conducted in Mali, West Africa, involving up to 2492 malaria-infected pregnant women aged 15 to 25. Participants will have blood samples taken for in-vitro testing to measure the functional activity of antibodies against pregnancy malaria vaccine candidates. Women who test positive for malaria or anemia will receive treatment as part of the study. During the study, women will provide consent for blood samples to be used for future research and may undergo physical exams. Researchers will assess how well animal-raised antibodies block parasite binding to the placenta and compare these results with naturally acquired antibodies in the participants. The main outcome will be the antibody activity measured approximately one year after sample collection, helping to evaluate the potential effectiveness of the vaccine candidates.
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Healthy Volunteer
This is a case-control study where participants from Bamako in Mali will be screened to identify patients with atopic disease (asthma and atopic dermatitis). Age and sex-matched healthy controls will be selected at a 1:1 ratio. All study participants (including healthy controls) will undergo a clinical evaluation and provide skin swabs, nasal swabs, induced sputum (if successful), blood samples, drinking water samples, stool samples, as well as complete an interviewer-administered questionnaire on environmental exposures. All participants (including healthy controls) will also undergo pulmonary function testing (spirometry and/or oscillometry) and undergo testing of transepidermal electrical impedance (using a Nevisense machine). Samples will be used to evaluate the microbiome diversity in participants with allergy-related diseases (ARDs) compared to healthy controls. Environmental surveys will assess the association between atopy and exposures that are primarily outdoor versus indoor exposures. Temporal and spatial variation in these pollutants will be assessed. Air samples taken from the community and participant home drinking water samples (when available) will be used to assess the presence and variability of pollutants in the environment.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety, immune response, and effectiveness of a new malaria vaccine combination in healthy African children and adults aged 9 to 50 years. This Phase 2, randomized, double-blind, controlled study is conducted in Bancoumana, Mali, and nearby areas, focusing on preventing malaria transmission and clinical malaria. The study compares a Pfs230D1-CRM197 conjugate vaccine combined with the R21 nanoparticle vaccine formulated on Matrix-M1 to other vaccines including a control rabies vaccine. Participants are assigned to different groups receiving either the R21 vaccine alone, the control rabies vaccine, or the combination of Pfs230D1-CRM197 with R21 in various formulations. Vaccines are given as intramuscular injections on days 0, 28, and 56. After the initial three doses, there may be an optional fourth dose about 52 weeks later for some participants. The study includes separate cohorts for ages 9-17 and 18-50 years with different randomization ratios and formulations, and enrollment for adults begins simultaneously with children once safety data from the younger group is reviewed. During the study, participants will be monitored for immediate and longer-term side effects, including local and systemic reactions, serious adverse events, and abnormal lab results. Researchers will measure antibody levels four weeks after the third dose to assess immune response. The study follows participants for up to 24 months after dose three or 12 months after dose four, with blood samples collected and stored for future research upon consent. Overall participation spans multiple visits over more than a year, with close safety and efficacy monitoring throughout.
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Researchers are conducting the 4th Burkitt's Lymphoma (LMB) study led by the French African Pediatric Oncology Group (GFAOP) across at least 14 Sub-Saharan countries, including some new participants. The study aims to improve early diagnosis and treatment evaluation of children with Burkitt's lymphoma, focusing on earlier detection of stage I and II disease and assessing response so treatment changes can be made as needed. Additionally, the study seeks to intensify treatment for children with stage IV disease. Starting from March 15, 2026, rituximab will be introduced to evaluate its toxicity and effectiveness alongside current treatment recommendations. The intervention is observational, monitoring the ability of participating centers to treat according to the protocol and assess outcomes for children with stage I and II disease. The study will compare results with earlier experiences at two GFAOP units in Burkina Faso and Ivory Coast. Rituximab's addition will be prospectively evaluated in terms of safety and treatment response. Participants will be followed for five years to evaluate the number of cases with local disease, disease stage at diagnosis, treatments given, follow-up after treatment, and relapse rates. This long-term monitoring will help understand treatment effectiveness and outcomes in African children with Burkitt's lymphoma, supporting improved care strategies in the region.
Actively Recruiting
Malaria during early pregnancy is a serious health concern affecting both mothers and their babies. This research aims to find effective and safe treatments for uncomplicated malaria in the first trimester of pregnancy. The study compares the current standard treatment, artemether-lumefantrine (AL), with newer antimalarial drugs that may offer advantages like fewer doses and longer protection against malaria. This multi-center Phase 3 trial uses an innovative adaptive design to quickly evaluate these treatments while ensuring safety for both mother and baby. Participants will be randomly assigned to receive either AL taken twice daily for three days, or one of the newer drugs including dihydroartemisinin-piperaquine or pyronaridine-artesunate, each given once daily for three days with weight-based dosing. The trial design allows new treatments to be added over time and includes early stopping rules if safety concerns arise. The study takes place in several African countries where malaria is common. Women in the first trimester with confirmed malaria will be closely monitored over time. They will have daily visits for four days, weekly visits for six weeks, and monthly visits until delivery. After birth, newborns will be followed for six months. Researchers will assess how well the treatments clear malaria by day 42 and monitor pregnancy outcomes, including any pregnancy loss or birth defects. Safety data will be reviewed regularly by an independent board to protect participants throughout the study.
Actively Recruiting
Researchers are studying the natural history and genetic causes of various inherited neurological disorders, including hereditary peripheral neuropathies, myopathies, muscular dystrophies, motor neuron disorders, mitochondrial myopathies, neurocognitive disorders, and other rare conditions affecting the brain, spinal cord, muscles, and nerves. This observational diagnostic study aims to better understand these diseases' genetics, symptoms, progression, treatment, and psychological and behavioral impacts. The study is conducted by the Neurogenetics Branch of the National Institute of Neurological Disorders and Stroke and includes both diagnosed and undiagnosed neurological conditions. Participants include children and adults aged 2 years and older with known or suspected inherited neurological diseases, as well as their unaffected relatives. The study involves collecting detailed medical and family histories, drawing family trees, and performing physical and neurological examinations. Tests may include blood and urine analysis, EEG brain wave recordings, psychological and speech evaluations, genetic testing from blood or skin biopsies, and, depending on symptoms, imaging scans like X-rays, CT, or MRI and muscle and nerve testing. During the study, researchers will gather information to identify genetic causes and better characterize disease features, helping improve diagnosis, treatment, and genetic counseling. Assessments will be ongoing until a genetic diagnosis is made, with a study duration of up to 15 years. The study also aims to train fellows and students. Participants may provide biological samples for future research, and the study expects to enroll up to 3,500 participants including affected individuals and their relatives.
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Researchers are evaluating the esophageal string test (EST) as a simpler and less expensive way to diagnose eosinophilic esophagitis (EoE), a condition that causes inflammation in the esophagus and leads to difficulty swallowing. The study aims to assess whether the EST can accurately detect EoE in adults aged 18 to 65 who have trouble swallowing and were born in Africa or have African parents. The study will take place in Mali and the United States, involving participants undergoing clinically indicated endoscopy. Participants will swallow a capsule containing a nylon string that collects fluid from the esophagus over one hour. This string is then removed for analysis. At a separate visit, participants will have an endoscopic exam where tissue samples from the esophagus, stomach, and small intestine are collected. Additional samples including blood, stool, urine, and skin swabs will also be taken. Participants will complete surveys about their medical history, diet, symptoms, and environment. Samples of drinking water and air from their communities will be collected to study environmental factors. Throughout the study, participants will be monitored through surveys and discussions of test results, either in person, online, or by phone. Researchers will measure the accuracy of the EST by comparing its results to the standard biopsy diagnosis of EoE. The study will also look at the frequency of EoE among participants. The total participant involvement includes screening, testing with the EST and endoscopy, sample collection, and follow-up assessments.
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