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NCT ID: NCT03647150 Recruiting - Malnutrition Clinical Trials

Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria

Hi-MAM
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.

NCT ID: NCT03603613 Recruiting - Clinical trials for Mental Health Disorder

Youth FORWARD Phase 1 YRI and EPP Study

Start date: July 31, 2018
Phase: N/A
Study type: Interventional

Objectives: The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of an Interagency Collaborative Team Approach (ICTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth through a pilot study and scale-up intervention study in Sierra Leone. Study population: The study population includes youth participants, ages 18-26, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and Kailhun districts of Sierra Leone. Pilot study design: A cluster randomized three-arm trial will be employed in the pilot phase in the same districts as the scale-up study. Youth participants (N=180, 18-26 years old, 50% female), stratified by gender, will be randomized into the three study arms. Once youth participants are enrolled into the study, they will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. The clusters will then be randomly assigned into the three study arms so that sixty youth participants will be randomized into the youth entrepreneurship training (EPP) arm, sixty youth participants will be randomized into the YRI+EPP arm, and sixty youth participants will be randomized into the control arm . The pilot study will last approximately 12 weeks and data will be collected at baseline and post-intervention. Further, investigators will survey 120 third-party reporters for a total pilot study sample size of 300 participants. Pilot study primary outcomes: The primary outcomes of the pilot study are to assess implementation science aspects related to a new partnership with the Deutsche Gesellschaft für Internationale Zusammenarbeit's (GIZ), who will fund and deliver the entrepreneurship training. This will include pretesting the measures battery, assessing the logistics of integrating the YRI into the entrepreneurship training, and testing use of the Interagency Collaborative Team Approach to training, supervision, and fidelity monitoring.

NCT ID: NCT03407326 Recruiting - Malnutrition Clinical Trials

Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

In this clinical equivalency trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent.

NCT ID: NCT03146897 Recruiting - Clinical trials for Moderate Acute Malnutrition

Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition

Start date: April 11, 2017
Phase: N/A
Study type: Interventional

The research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition. Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone Ministry of Health and Sanitation (MoHS), Project Peanut Butter, Caritas Bo, World Food Programme (WFP), and the United States Agency for International Development (USAID) are collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of food aid commodities in treating moderate acute malnutrition (MAM) in young children. The study comparison is based on a targeted food delivery to children 6-59 months who are screened for MAM. Study participants will receive one of four approximately isoenergetic test foods: 1. Super Cereal Plus (SC+) with amylase 2. Corn-soy Blend Plus (CSB+) and fortified vegetable oil 3. Corn-soy Whey Blend (CSWB) and fortified vegetable oil (CSWB is a new product which is a modified version of CSB) 4. Ready-to-use Supplementary Food (RUSF, lipid-based)

NCT ID: NCT03079388 Recruiting - Pregnancy Clinical Trials

Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

Start date: February 27, 2017
Phase: N/A
Study type: Interventional

Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.

NCT ID: NCT02967003 Recruiting - Clinical trials for Hemorrhagic Fever, Ebola

Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

NCT ID: NCT02876328 Recruiting - Ebola Virus Disease Clinical Trials

Partnership for Research on Ebola VACcinations

PREVAC
Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVĪ”G-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

NCT ID: NCT02575456 Completed - Ebola Disease Clinical Trials

A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine

Start date: October 2015
Phase: Phase 2
Study type: Interventional

A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.

NCT ID: NCT02561949 Completed - Clinical trials for Violence, Non-accidental

Adapting Mental Health Interventions for War-Affected Youth Through Employment Programs

Start date: September 2015
Phase: N/A
Study type: Interventional

The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The research also intends to examine whether youth participating in YRI and complementary income generating activities will fare better than an employment only control group. Finally, the research intends to examine whether utilizing lay health workers are a is cost-effective and scalable method for addressing mental health concerns. The research will investigate the following hypotheses: 1. Participants who are exposed to YRI will demonstrate greater reduction in mental health and behavioral problems than participants who are waitlisted for YRI over the same period; emotion regulation will operate as a major mechanism of YRI improvements; high comorbidity will be a treatment modifier; 2. Improvements in mental health and functioning due to YRI will lead to (mediate) greater employment outcomes and superior economic self-sufficiency over time; and 3. Homelessness, orphanhood, young parenthood, and high problems in emotion regulation co-morbid with other mental health conditions will be major moderators lessening the effectiveness of YRI. 4. Lay and trained practitioners at agencies participating in the combined mental health-employment program will demonstrate high fidelity to evidence-based treatment components and that good satisfaction, social support, and professional exchange of evidence-based practices will emerge.

NCT ID: NCT02509494 Active, not recruiting - Healthy Clinical Trials

Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2

EBOVAC-Salone
Start date: September 30, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.