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NCT ID: NCT03803735 Recruiting - Pediatric Cancer Clinical Trials

Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa

RFAOP
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

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. Collecting 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.

NCT ID: NCT03795415 Recruiting - HIV/AIDS Clinical Trials

ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali

Start date: May 27, 2019
Phase:
Study type: Observational

The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy".

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: NCT03656237 Completed - Perinatal Mortality Clinical Trials

Low-dose High-frequency Training of Facility Health Care Providers in Mali

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

This 3-arm cluster randomized trial (C-RCT) has the following objectives: Primary Aim To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality. Secondary Aims To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces: - Perinatal morbidity incidence - Post-partum Hemorrhage To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting increases ENC practices: - Early initiation and exclusive breast feeding - Thermal protection (prevention of hypothermia) - Clean cord care - Delayed bathing - Resuscitation-Initiation of breathing To determine if introduction of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting for CHWs decreases: - Delayed Identification of danger signs during pregnancy, labour and perinatal period - Delayed referral of complicated cases during pregnancy, labour and perinatal period To determine the cost effectiveness of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting

NCT ID: NCT03589768 Completed - Tetanus Clinical Trials

Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.

NCT ID: NCT03510481 Completed - Malaria Clinical Trials

Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

Start date: May 14, 2018
Phase: Phase 1
Study type: Interventional

Background: The disease malaria affects many people in Mali and other parts of Africa and the world. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or lead to death if it is not treated promptly. Researchers want to find a safe vaccine that prevents malaria. Objective: To study how safe and tolerable the malaria vaccine called PfSPZ Vaccine is for healthy adults. Eligibility: Healthy adults: - ages 18-35 in Ouelessebougou, Mali - not infected with HIV, hepatitis B, or hepatitis C - for females, not pregnant or breastfeeding and must use reliable birth control during the study Design: Participants will be screened with questions about malaria and will undergo blood, urine, and heart tests. Participants will be randomly assigned to 1 of 4 groups. They will get injections of either the PfSPZ Vaccine or a salt-water placebo. They will not know which one they get. Vaccinations will occur leading into the malaria transmission each year with 3 injections leading into Year 1 (malaria transmission season in 2018) and 1 injection prior to Year 2 (malaria transmission season 2019). One vaccine group and one placebo group will get an injection 3 times over 4 weeks with an additional vaccination ~10 months later. The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks with an additional vaccination ~10 months later. All participants will be treated with an antimalarial medication prior to the third injection and prior to fourth injection. They will be followed for approximately 6 months after third and fourth injection. At vaccine visits, female participants will have a pregnancy test before injection. All participants will have an arm cleaned and the vaccine injected in a vein. They will be watched for 30 minutes. At non-vaccine visits, participants will have a physical exam and be asked how they are feeling. They will usually have blood tests.

NCT ID: NCT03459157 Completed - HIV/AIDS Clinical Trials

Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)

CohMSM-PrEP
Start date: November 20, 2017
Phase: N/A
Study type: Interventional

This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa. An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo. All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.

NCT ID: NCT03457519 Completed - Clinical trials for Acute Respiratory Infection

Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms.

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: NCT03334747 Completed - Malaria Clinical Trials

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.