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NCT ID: NCT03783143 Recruiting - Clinical trials for Lassa Virus Infection

Prevalence and Incidence of Lassa Virus Infection in Southern Mali

Start date: December 4, 2020
Phase:
Study type: Observational

Background: The disease Lassa fever mostly affects people in Western Africa. It is very similar to other diseases that cause fever, like malaria and yellow fever. People get Lassa fever from mice infected with Lassa virus. It can also be spread from body fluids of people with the disease. Researchers want to learn more about this virus in Mali so they can develop better tools to diagnose and prevent it. Objective: To find out how many people in certain areas of southern Mali have ever had Lassa fever and count how many people get the disease every year. Eligibility: People ages 6 months to 99 years who live in certain areas of Mali Design: Women who are could become pregnant will have a urine pregnancy test at each visit. Participants will be asked questions about their age, if they have ever had a fever, and if they have ever seen mice in or around their home. This will take about 20 minutes. Participants will give a blood sample using a needle in a vein in the arm. Young children will give it by pricking a finger or heel with a needle. Patients with a fever illness will have a medical history and physical exam. They will give blood and nasal swabs 3 times over 21 days. Participants may be asked to come back 1 time each year for up to 3 more years to take another sample of blood and answer more questions.

NCT ID: NCT03352986 Recruiting - Sickle Cell Disease Clinical Trials

Substudy of CADRE: for People With Extreme Phenotype: BIOCADRE

BIOCADRE
Start date: May 15, 2017
Phase: N/A
Study type: Observational

BIOCADRE is a CADRE substudy and aims to characterize more precisely the sickle cell patients with extreme phenotype.

NCT ID: NCT03114137 Recruiting - Sickle Cell Disease Clinical Trials

Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose

CADRE
Start date: March 2012
Phase:
Study type: Observational [Patient Registry]

The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.

NCT ID: NCT02646410 Recruiting - Anemia Clinical Trials

Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery

SMC
Start date: August 2014
Phase: N/A
Study type: Interventional

Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The goals are to identify the most effective method to deliver SMC, and to obtain more information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC delivery; 2) to compare quantitative measures of immunity in children who do and do not receive SMC. A cluster-randomized design will be sued. The target population will be children aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. In Year 3, children in the selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. A survey will be conducted collect data on mortality and hospital admission and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.

NCT ID: NCT02471378 Recruiting - Malaria Clinical Trials

Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

Start date: July 28, 2015
Phase:
Study type: Observational

Background: - Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy. Objectives: - To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women. Eligibility: - Pregnant women ages 15 25 Design: - The study site is an area in Mali, West Africa. - Participants: - Will have blood drawn. - Will give consent for the blood sample to be used for future research. - May have a physical exam. - Participants who have malaria or anemia will get treatment.

NCT ID: NCT01314404 Recruiting - Clinical trials for Human Papillomavirus

KAP/WTP and HPV Prevalence Studies in a Developing World Setting (Bamako, Mali)

HPV
Start date: March 2011
Phase: N/A
Study type: Observational

The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA Vaccine Foundation or GAIA VF) proposes to carry out a Knowledge, Attitudes, and Practices (KAP) study in conjunction with a Willingness To Participate (WTP) evaluation to establish the prevalence of cervical dysplasia, to and perform Human Papillomavirus (HPV) subtyping studies in Bamako and in Sikoro-Mekin, a village within the perimeter of Bamako, the capital of Mali, West Africa. Working with experienced collaborators, we propose to carry out an HPV prevalence study (among women diagnosed with cervical cancer at Hôpital Touré), coupled with a study of Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study among individuals living in Sikoro-Mekin. These studies will lay the groundwork for a phase IV study of Gardasil® at the same site, which would be an important step forward for West Africa.

NCT ID: NCT01168271 Recruiting - Malaria Clinical Trials

Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali

Start date: August 30, 2010
Phase:
Study type: Observational

Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed, and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Childhood malaria is a major cause of mortality, and we have found that risk of childhood malaria is related to in utero exposure to pregnancy malaria, as well as other host factors like iron status and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding phenotype, and as our primary hypothesis in this study we speculate that severe childhood malaria parasites may also have distinct features. A longitudinal cohort study will be conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000 pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples obtained. In addition, 2000 febrile children up to age 10 years will be enrolled at the Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) Pediatric Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. Clinical, parasitologic and host response (including immunologic) endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine factors associated with infection and disease in pregnant woman and young children.

NCT ID: NCT00652275 Recruiting - Malaria Clinical Trials

Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

Start date: May 2008
Phase: Phase 2
Study type: Interventional

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.

NCT ID: NCT00431808 Recruiting - Malaria Clinical Trials

Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

Start date: May 2007
Phase: Phase 1
Study type: Interventional

This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.

NCT ID: NCT00004568 Recruiting - Clinical trials for Motor Neuron Disease

Study of Inherited Neurological Disorders

Start date: February 18, 2000
Phase:
Study type: Observational

This study is designed to learn more about the natural history of inherited neurological disorders and the role of heredity in their development. It will examine the genetics, symptoms, disease progression, treatment, and psychological and behavioral impact of diseases in the following categories: hereditary peripheral neuropathies; hereditary myopathies; muscular dystrophies; hereditary motor neuron disorders; mitochondrial myopathies; hereditary neurocognitive disorders; inherited neurological disorders without known diagnosis; and others. Many of these diseases, which affect the brain, spinal cord, muscles, and nerves, are rare and poorly understood. Children and adults of all ages with various inherited neurological disorders may be eligible for this study. Participants will undergo a detailed medical and family history, and a family tree will be drawn. They will also have a physical and neurological examination that may include blood test and urine tests, an EEG (brain wave recordings), psychological tests, and speech and language and rehabilitation evaluations. A blood sample or skin biopsy may be taken for genetic testing. Depending on the individual patient s symptoms, imaging tests such as X-rays, CT or MRI scans and muscle and nerve testing may also be done. Information from this study may provide a better understanding of the genetic underpinnings of these disorders, contributing to improved diagnosis, treatment, and genetic counseling, and perhaps leading to additional studies in these areas.