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NCT ID: NCT06155448 Active, not recruiting - Malaria Clinical Trials

Perennial Malaria Chemoprevention (PMC) Effect Study

PMCEffect
Start date: August 8, 2023
Phase: N/A
Study type: Interventional

The Malaria Consortium Nigeria (MC) will coordinate a trial of PMC in Osun State, Nigeria with strategic support from the National Malaria Elimination Programme of the Government of Nigeria (NMEP) and financial support from the BMGF. The primary purpose of the study is to provide evidence of the impact of PMC on malaria burden and related clinical outcomes, and its operational feasibility for policy decision and the inclusion of PMC into upcoming programme and funding cycles for its National Malaria Control Strategic Plan. The objectives are: 1. To evaluate the impact of PMC in children aged 2-18 months on key child health outcomes including malaria burden, hospitalisations, and anaemia. 2. To describe indicators of operational feasibility of PMC by identification and measurement of key determinants of successful uptake and implementation of PMC.

NCT ID: NCT05912426 Active, not recruiting - Blood Pressure Clinical Trials

Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt

RAISED
Start date: March 5, 2024
Phase: N/A
Study type: Interventional

The study is a small-scale, short-term unblinded feasibility study to explore the acceptability and feasibility of implementing a reduced-sodium iodised salt intervention in Nigeria. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age.

NCT ID: NCT05709457 Active, not recruiting - Outcome Assessment Clinical Trials

Long Term Effects Of a Maternal Cash Transfer Experiment

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

This is a follow-on study to a cluster randomized trial of maternal conditional incentives conducted in Nigeria. This study found that cash transfers, conditional on women obtaining facility-based prenatal, delivery, and postnatal care, resulted in large, significant effects on maternal and child outcomes (NICHD R01HD083444). This study will answer additional key policy questions. First, are the effects on maternal behavior temporary, or do they result in more sustained behavior change? Second, do measured short run (SR) child health effects persist over the long run? Third, did the program generate spillovers?

NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05438576 Active, not recruiting - Pregnancy Related Clinical Trials

Screening for Pregnancy Related Heart Failure in Nigeria

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.

NCT ID: NCT05142254 Active, not recruiting - Clinical trials for Priapism Due to Sickle Cell Disease

A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

PIN
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

To conduct a randomized controlled internal pilot feasibility trial for the prevention of recurrent ischemic priapism referred to as the Priapism in Nigeria (PIN) trial. The study team will enroll a minimum of 30 participants and a maximum of 200 participants. Study investigators hypothesize that hydroxyurea therapy combined with tadalafil is superior to a combination of hydroxyurea and placebo in the prevention of recurrent ischemic priapism.

NCT ID: NCT04950153 Active, not recruiting - Clinical trials for Adolescent HIV Infection

Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

iCARE
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04904549 Active, not recruiting - COVID-19 Clinical Trials

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

VAT00008
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

NCT ID: NCT04808778 Active, not recruiting - Stroke Clinical Trials

Stroke Prevention in Young Adults With Sickle Cell Anemia

SPIYA
Start date: May 17, 2021
Phase:
Study type: Observational

Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for children with SCA have translated into improved survival of children in both high and low-resource settings. However, more complications of SCD are seen in those who survive to adulthood. Silent cerebral infarcts (SCI) and strokes are among the most devastating complications of SCD, affecting 40% and 10% of children, respectively. The overall goal of this study is to extend the Investigator's successful capacity-building effort in the assessment of neurological morbidity in children with SCD living in northern Nigeria (Kano) to young adults with SCD living in the same region. About 50% of all adults with SCD live in Nigeria. Despite the high prevalence of SCD in Africa, the neurological morbidity is not well characterized, limiting opportunities for primary and secondary stroke prevention strategies. At least 50% of young adults with sickle cell anemia (SCA), the most severe form of the disease, will have SCIs and an estimated 10% will have strokes, based on studies in high-resource settings. In high-resource settings, screening for abnormal transcranial Doppler (TCD) velocities in children with SCA, coupled with regular blood transfusion has resulted in a 92% reduction of relative risk for strokes. Despite this effective strategy, regular blood transfusion therapy does not seem sustainable in sub-Saharan Africa due to shortages and the risk of transfusion transmissible infections. Additionally, there is a lack of evidence-based stroke prevention strategies in young adults with SCA, either in the high-income or in low-resource settings. Based on the foregoing, the Investigators propose to determine the prevalence of neurological injury (overt stroke, transient ischemic attacks, and silent cerebral infarcts) in young adults at the transition age from 16-25 years. The Investigators will also, for the first time, assess conventional risk factors of stroke in the general population to determine whether a different prevention strategy is required to reduce the incidence of neurological injury in this high-risk population.