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NCT ID: NCT05912790 Active, not recruiting - Clinical trials for Aqueous Humor Drainage

eyeTube in Combination With the eyeWatch Implant

Start date: June 6, 2023
Phase: N/A
Study type: Interventional

In this study, the investigators want to investigate the success of aqueous humor shunting in the retrobulbar space, using the eyeTube in combination with the eyeWatch implant. The investigators postulate that posterior aqueous humor shunting would be more effective, as this space offers a larger drainage area and a less aggressive local inflammatory environment than the subconjunctival space close to the limbus, resulting in lower and better-sustained IOP than in the more limited, fibroblast-promoting subconjunctival environment surrounding standard implants.

NCT ID: NCT05872061 Completed - Iron-deficiency Clinical Trials

Senegal Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours

Start date: January 27, 2022
Study type: Observational

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study were 1) to assess the nutritional adequacy of urban Senegalese households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study simulates a market study, the investigators will conduct a product launch, determine market potential based on sales, evaluate marketing strategy to increase market share, and model the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a thorough evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

NCT ID: NCT05658614 Recruiting - Clinical trials for Vaccination; Infection

Anti-Schistosomiasis Sm14-vaccine in Senegal

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval). This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

NCT ID: NCT05608928 Not yet recruiting - Clinical trials for Environmental Enteropathy

Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale phase 2 trial in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT05604248 Not yet recruiting - Vitamin A Clinical Trials

Kinetics of Retinol and TBS Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their TBS and Those of Their Infants

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed. The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.

NCT ID: NCT05544084 Recruiting - Cervical Cancer Clinical Trials

Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The goal of this project is to prevent unnecessary deaths due to cervical cancer in Senegal. This mixed methods research responds to identified intrapersonal- and community-level barriers to early cervical cancer screening uptake, follow-up, and treatment among women there. Investigators will apply the Dynamic Adaptation Process1 (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework1 to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts in Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes. By studying the process of adaptation of a patient navigation program in a low- and middle-income country (LMIC), investigators will build new knowledge while addressing an important public health issue. Our project demonstrates innovation by advancing both adaptation and implementation process knowledge of an evidence-based patient navigation intervention in various contexts within a LMIC with a particular focus on how the adaptation responds to cancer-related stigma, misinformation, and women's autonomy in healthcare decision-making. Investigators will build knowledge through local learning which will further our long-term goal to inform the national cervical cancer prevention and control programs in two areas of Senegal and other similar LMICs.

NCT ID: NCT05501470 Not yet recruiting - Clinical trials for Environmental Enteric Dysfunction

Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal

Start date: December 2022
Phase: Phase 2
Study type: Interventional

Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 were stunted, accounting for 22% of stunting globally. Stunting has short- and long-term consequences of increased morbidity and mortality, impairment of neurocognitive development , impaired responses to oral vaccines, and increased risk of non-communicable diseases. Stunting is partly driven by Environmental Enteric Dysfunction (EED), an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED may help explain why nutritional supplementation either during pregnancy or early childhood has minimal value in correcting childhood stunting. Probiotics may serve to overcome the problem of EED through all mechanisms of pathogenicity, by providing additional bacteria that may help in intestinal decolonization of pathogenic microorganisms (changing the microbiological niche), promoting epithelial healing, improving nutrient absorption, and restoration of an appropriate immune balance between tolerance and responsiveness. This trial will explore the conceptual framework, that a well known probiotic, that can improve the composition of the gut microbiota, can reduce biomarkers of intestinal inflammation and gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.

NCT ID: NCT05405322 Active, not recruiting - HIV Infections Clinical Trials

Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa

Start date: April 7, 2021
Study type: Observational

Context: HIV-positive young people aged 15 to 24 are a heterogeneous population in terms of gender, age, mode of transmission, sexual orientation and risk-taking. This most vulnerable age group is at greater risk of disruption of medical care and poor compliance, and has greater needs for psychosocial support and differentiated health services. It remains highly invisible in West African countries, both in the definition of care policies and in the allocation of resources and community representation. Objectives: The overall objective of the project is to contribute to the improvement of retention in care, health and well-being of adolescents and young adults living with HIV (AYAHIV) and to support their integration into the community space. SO1: Support the operationalisation of the transition of HIV-infected adolescents from paediatrics to adult medical services in a stakeholder inclusive, participatory and responsive approach SO2: Contribute to the empowerment and autonomy of adolescents and young adults living with HIV in the project environment SO3: Contribute to the generation and dissemination of evidence-based information and recommendations on the situation and needs of adolescents and young adults, including key populations, living with HIV Target: Approximately 67 caregivers∙e∙s ≥ 25 years old, of which 64%F, 30 peer-referent associations of 20-24 years old (ratio F/H= 1:1), 700 AYAHIV ≥ 15 years old, of which 47%F, in paediatrics and 500-600 AYAHIV aged 15-24 years old in adult medicine, of which 41%F, and including AYAHIV associations Summary of activities: Based on the capitalisation and pooling of experiences of partner teams, the project proposes to support the implementation of transition in a pragmatic approach, adapted to the needs of adolescents and inclusive of carers, adolescents and community peers. More globally, it contributes to improving the health, empowerment and autonomy of HIV-positive youth, including key populations, in particular through support to training, structuring and community representation of youth associations, documentation of the conditions of entry into care and their specific needs, including digital health, production and availability of evidence and recommendations in this West African context and advocacy building. A multidisciplinary and participatory research-action project, carried out by the IRD in Senegal and financed by Sidaction, accompanies the three specific objectives of the project.

NCT ID: NCT05374837 Completed - Anemia Clinical Trials

Mobile Messaging for Improved Nutrition

Start date: June 10, 2022
Phase: N/A
Study type: Interventional

This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.

NCT ID: NCT05354258 Active, not recruiting - Malaria Clinical Trials

Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

Start date: June 16, 2022
Phase: N/A
Study type: Interventional

Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children