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NCT ID: NCT03440385 Completed - Crohn Disease Clinical Trials

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Start date: March 7, 2018
Phase: Phase 3
Study type: Interventional

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03303963 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

DIAMA
Start date: May 4, 2017
Phase:
Study type: Observational

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

NCT ID: NCT03215732 Completed - Chronic Hepatitis b Clinical Trials

Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal

AMBASS
Start date: October 19, 2017
Phase:
Study type: Observational

This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

NCT ID: NCT03207308 Completed - Infection Clinical Trials

Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status

Start date: February 3, 2017
Phase: N/A
Study type: Interventional

Despite economic growth in developing countries, Sub-Saharan Africa still faces food insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases still remain a public health problem and have a negative impact on health and the economy. They are both directly and indirectly responsible for children morbidity and mortality. Due to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was implemented in Senegal since 1999. A national representative study undertook in 2010 to have biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale oil fortification was launched by government and private industries also fortified bouillon cubes. Furthermore, home fortification is being initiated without evaluation of VAD control strategies existing in the country. In order to assess the impact of national VAD control strategies in Senegalese children, this study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin A total body stores in relation to their infectious status.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT03041766 Completed - Schistosomiasis Clinical Trials

Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

Start date: December 6, 2016
Phase: Phase 2
Study type: Interventional

The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.

NCT ID: NCT02910310 Completed - Clinical trials for Postpartum Hemorrhage

Introduction of UBT for PPH Management in Three Countries

UBT
Start date: October 2016
Phase: N/A
Study type: Interventional

This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.

NCT ID: NCT02805426 Completed - Clinical trials for Postpartum Hemorrhage

Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

Start date: October 2016
Phase: Phase 4
Study type: Interventional

This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm). The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each). The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.

NCT ID: NCT02548078 Completed - Virus Diseases Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children

Start date: November 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.

NCT ID: NCT02536222 Completed - Malaria Clinical Trials

Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts

Start date: September 2015
Phase: Phase 4
Study type: Interventional

The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics but with a slightly lower incidence rate were chosen as controls. It will be implemented in all villages in the six intervention health posts and it will consist of investigating all passively detected cases (index cases) and conducting focal test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a positive RDT. All household members in households with a positive RDT will be treated, regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after comparison and compared to the change in the control health posts and the operational aspects will be assessed for subsequent scale up.