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NCT ID: NCT06377098 Not yet recruiting - Development, Infant Clinical Trials

Intrapartum Sildenafil in Laboring Mothers

PRISM
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources. The main questions it aims to answer are: - What are the fetal heart rate monitoring practices in a low-resource setting? - What are the indications for operative delivery in a low-resource? - What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil? - What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting? Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected. Participants will: - Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor - Have the (mothers & babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag & mask ventilation, Apgar scores, and seizures. - Have a neonatal neurological assessment prior to discharge - Have phone call assessments for re-hospitalization or mortality 7 days post-delivery - Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.

NCT ID: NCT06350851 Not yet recruiting - Healthy Volunteers Clinical Trials

Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination

Obi1
Start date: April 2024
Phase: N/A
Study type: Interventional

Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission. To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.

NCT ID: NCT06203132 Not yet recruiting - HIV-1-infection Clinical Trials

DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

ELDORADO
Start date: April 2024
Phase: Phase 3
Study type: Interventional

Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.

NCT ID: NCT04035174 Not yet recruiting - Diagnoses Disease Clinical Trials

Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa

EOLoa
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study aims at evaluating the diagnosis performances of the LTS-2 DEC patch for onchocerciasis compared to the gold standard which are the skin snips. This study will be conducted in Cameroon in two different areas : Ngog-Mapubi and Bafia Health Districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).

NCT ID: NCT02142270 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design

Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims > 15 years old. Investigators will use the definition of established SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. After approval from institutional boards, Investigators will record demographic, clinical, electrocardiographic and biological variables of SCD victims (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout countries. Conclusion This study will provide comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.