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NCT ID: NCT02269462 Completed - HIV Clinical Trials

A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation

Start date: December 2012
Phase: N/A
Study type: Observational

Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. This variability has been associated with single nucleotide polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also result in toxicity. For example, efavirenz is contraindicated in children less than 3 years old or 10kg but transferred to breastfed babies through breast milk. On the other hand, double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity. In the proposed study, the influence of selected SNPs in certain drug disposition genes on the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as the level of infant exposure to both drugs through breast milk, will be studied. Mathematical models will be developed to predict potential dose optimisation strategies during pregnancy, and to predict infant exposure to maternal drugs through breast milk.

NCT ID: NCT02240173 Not yet recruiting - Clinical trials for Schizophrenia and Disorders With Psychotic Features

Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia

Start date: June 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Sorghum bicolor is a naturally growing plant which has been of health benefit to the people of West Africa who traditionally prepare its leaf for various nutritional and health reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates, Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the determinants of mental health are complex, the emerging and compelling evidence for nutrition as a crucial factor in the high prevalence and incidence of mental disorders suggests that diet is as important to psychiatry as it is to cardiology, endocrinology, and gastroenterology. Evidence is steadily growing for the relation between dietary quality (and potential nutritional deficiencies) and mental health, and for the select use of nutrient-based supplements to address deficiencies, or as monotherapies or augmentation therapies. There is currently strong advocacy for the recognition of diet and nutrition as central determinants of both physical and mental health.Its anti-inflammatory and haematocrit boosting properties have been well documented though the precise mechanism of action is still largely unknown. Its use has recently been extended to the field of mental health where findings in animal study suggest it could be of help in relieve of psychosis. The need for this study is therefore aimed at investigating the effect of this drug in patients with schizophrenia which is the prototypical psychotic disorder.

NCT ID: NCT02233530 Completed - Dementia Clinical Trials

IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria

IDEA
Start date: September 2014
Phase: N/A
Study type: Interventional

This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger Identification and Intervention for Dementia in Elderly Africans (IDEA) study. The overall aim of the IDEA study is to set up and evaluate sustainable programmes to facilitate diagnosis of, and therapy for, people with dementia led by local communities in sub-Saharan Africa. The investigators seek to improve quality of life for people with dementia and their caregivers. Within this trial of CST, the investigators hypothesise that CST can significantly improve the quality of people with dementia and their carers living in Africa

NCT ID: NCT02214875 Completed - Retention Clinical Trials

Lafiyan Jikin Mata "Excellent Health for Mothers"

LJM
Start date: July 14, 2014
Phase: N/A
Study type: Interventional

This study aims to address the research question: Will continuous quality improvement, using a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of HIV-infected pregnant women and mothers at six and 12 months postpartum? Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to systematically improve services and health outcomes. The Break Through Series (BTS) is a specific CQI approach is a short-term (6- to 15-month) learning system that brings together teams from several hospitals or clinics ("collaboratives") to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches. Secondary Objectives To assess whether implementation of CQI-BTS initiatives at health facilities increases: 1. Uptake of PMTCT services by HIV-infected pregnant women; 2. Retention-in-care of HIV-infected women at twelve (12) months postpartum; 3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age; 4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected women in health facilities.

NCT ID: NCT02150980 Completed - Clinical trials for Fractures or Dislocations

INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

INORMUS
Start date: April 2014
Phase:
Study type: Observational

Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries. Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.

NCT ID: NCT02150460 Completed - Cataract Clinical Trials

A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria

Start date: October 2012
Phase: Phase 4
Study type: Interventional

The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique. This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.

NCT ID: NCT02149537 Completed - Sickle Cell Disease Clinical Trials

Risk Clinical Stratification of Sickle Cell Disease in Nigeria, Assessment of Efficacy/Safety of Hydroxyurea Treatment

Start date: December 2014
Phase: Phase 4
Study type: Interventional

The vast majority of births with sickle cell disease (SCD) occur in Africa and 90% are thought to die before the age of five. Hydroxyurea (HU) is the only drug approved by the FDA for the treatment of sickle cell anemia. Although HU is used to treat small numbers of patients in Africa, cost, fear of toxicity, and lack of awareness and availability limit its use. The leukopenia that may be seen with HU raises the possibility of increased susceptibility to infection. Risk stratification - i.e., identification of patients most likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is favorable. Several clinical measures of future risk are well defined and findings on modifier genes in the US, primarily related to fetal hemoglobin (HbF), have further improved risk prediction. Whether the genetic variants predict severity in Africa is not known. The investigators have established a SCD cohort in Ibadan, Nigeria. In the first phase of this research the investigators will implement clinical risk examinations and assess the relationship between clinical characteristics (including levels of HbF) and known genetic markers. As a proxy for a birth cohort, the investigators will compare the frequency of the genetic markers in adult patients (i.e., "survivors") to children. In the second phase the investigators will randomize 40 high risk adult patients to fixed low dose HU or no HU treatment in a crossover design and monitor hematologic and physiologic parameters to document hematologic effects and safety. This work will lay the basis for a large-scale trial to document safety and efficacy.

NCT ID: NCT02136264 Recruiting - Clinical trials for Essential Hypertension

Study of Personalized Dietary Intervention for the Control of Essential Hypertension

PCFADASH-HT
Start date: June 2013
Phase: N/A
Study type: Interventional

An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would improve the control of essential hypertension. A randomized controlled clinical trial is proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. They will be comprehensively monitored (including gene expression studies) for two years. Outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.

NCT ID: NCT02124109 Completed - Clinical trials for Rheumatic Heart Disease

The Genetic Basis of Acquired Heart Disease in Africa

Start date: April 3, 2014
Phase:
Study type: Observational

Background: - An acquired heart disease is one that a person gets after they are born. Two of these are rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more commonly in people who live in Africa than in other places in the world. Researchers want to learn more about these diseases. They especially want to know what role genes and other factors play in them. Objective: - To identify genetic risk factors for RHD and EMF in sub-Saharan Africa. Eligibility: - Children and adults with RHD or EMF. - Healthy volunteers over age 10. Design: - Participants will come from existing study groups in Uganda and Nigeria. - Participants may be required to provide a sample of their DNA. They will do this with either a blood or saliva sample or a swab of the mouth. - Collected samples will be labeled with a code and sent to a lab in the United States for analysis. Remaining portions of participants samples will be stored for an unlimited period of time. They may be used in future studies. - Some genetic and health information from participants might be placed into one or more scientific databases. - Participant names and identifying information will be kept private. But there is a small chance someone could trace them from their genetic information.

NCT ID: NCT01952171 Completed - Clinical trials for Congenital Heart Disease

The Genetic Basis of Congenital Heart Disease in Africa

Start date: September 17, 2013
Phase:
Study type: Observational

Recent advances in genomic techniques are making possible a new wave of genetic discovery in congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa at frequencies similar to the rest of the world. In this application, we propose to utilize the unique advantages of Sub-Saharan Africa - a combination of the most genetically diverse populations in the world and of diminished environmental background effects (i.e. low prevalence of smoking, alcohol abuse, obesity in comparison to western countries) - to better understand the genetic basis for congenital heart disease. We will couple next generation genomic techniques with more traditional gene discovery methods to investigate CHD in two African countries: Uganda and Nigeria. The inclusion of syndromic and non-syndromic CHD observed in these populations as well as careful phenotyping (including echocardiography) will greatly enhance our potential to provide insight into the genetic architecture of CHD in African populations. To accomplish this, we plan to enroll families, in whom members have congenital heart malformations consistent with an error of early human development in our research protocol. Patients will be enrolled at the Uganda Heart Institute in Kampala, Uganda, and at the Department of Pediatrics, College of Medicine, University of Lagos, Nigeria, with the potential to include other African sites. High throughput genomic studies will be done at the NIH.