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NCT ID: NCT04271306 Recruiting - Malaria,Falciparum Clinical Trials

Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.

Start date: May 25, 2021
Phase: Phase 1
Study type: Interventional

A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania

NCT ID: NCT03988491 Recruiting - Clinical trials for End-Stage Renal Disease

Morbidity, Mortality, Short and Long-term Survival of Hemodialysis End-stage Kidney Disease Patients in Central Tanzania

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Background: In the last 2 decades, Tanzania made great improvements in the renal replacement therapy infrastructure and services. However, renal replacement therapy remains a challenge in the developing world in terms of inadequate renal registries, and limited published literature. Objectives: This study will identify predictors of mortality, identify common causes of infection and hospitalization, their incidences, prevalence, and time-to-event analysis and analyze short and long-term survival of end-stage renal disease (ESRD) patients on hemodialysis in two hemodialysis centers in Dodoma, Tanzania. Furthermore, this study will establish a registry to be called Tanzania Registry for Chronic Renal Failure (TRCRF). Methodology: This will be a prospective-observational study (Patient registry). It will be conducted in Tanzania, a developing world country involving two hemodialysis centers, namely Benjamin Mkapa Hospital and UDOM Health center, both affiliated with the University of Dodoma. Data will be collected by accessing patients' records receiving hemodialysis due to ESRD in the two centers from September 2019 to September 2024. Patients' demographics, medical history, investigation findings, and hemodialysis adequacy will be extracted as independent outcomes. In contrast, the outcome (i.e., Death) during the follow-up will be extracted as a primary dependent outcome. Binary logistic regression will be applied to come up with statistically significant predictors of deaths. Other outcomes will be incidences, prevalence, and time-to-event analysis of common causes of infection and re-hospitalization. Kaplan-Meier survival curves will be constructed from statistically significant predictors of deaths, and patients' survival at 1, 3, and 5 years will be illustrated.

NCT ID: NCT03960255 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Start date: February 20, 2021
Phase:
Study type: Observational

Diabetic foot ulcers (DFUs) and their associated complications like amputations are increasingly becoming a problem in low and middle income (LMI) countries. Obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in LMI setting. It is however not certain whether increased adiposity, may make it difficult for DFUs to heal. Investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of DFUs.

NCT ID: NCT03923725 Recruiting - Clinical trials for Plasmodium Falciparum Malaria (Uncomplicated)

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.

DeTACT-Africa
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.

NCT ID: NCT03724214 Recruiting - Gastroschisis Clinical Trials

Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.

NCT ID: NCT03702738 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Adjunctive NAC in Adult Patients With Pulmonary Tuberculosis

NAC-TB
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

To determine if adjunctive N-acetylcysteine 1200 mg twice a day (BID) accelerates sputum culture conversion and normalization of cellular glutathione in tuberculosis (TB), and to assess its potential effects on lung and immune function

NCT ID: NCT03653975 Recruiting - Epilepsy Clinical Trials

Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District

NSEC
Start date: October 2014
Phase:
Study type: Observational

Background: Childhood epilepsy disorders are particular frequent in the area around Mahenge, southern Tanzania and recent studies have described a novel type of epilepsy with repetitive head nodding episodes and often progressive cognitive dysfunction. Despite the disease affecting thousands in Tanzania, Uganda and South Sudan, etiology and pathogenesis of the disorder termed Nodding Syndrome (NS) is still obscure as the phenotype remains imprecisely described. Epidemiological associations with Onchocerca volvulus and Mansonella spp. were noted at different African sites and remain robust even though no evidence for the presence of O. volvulus in CSF or any previous contact with the CSF was found. Hypothesis: With regard to the complex host immune reaction to O. volvulus, the investigators hypothesize that the immune response against filariae might contribute to NS and epilepsy. The investigators further assume that specific genetic traits might play a role in the pathogenesis of NS. Aims In the present study the investigators aim to examine if and how O. volvulus and/or Mansonella spp. contribute to the pathology of NS/epilepsy and therefore intend to analyze the filarial infection and the host immune response in affected children. To identify inherited traits predisposing for epilepsy, NS or specific immune responses, a genetic workup that includes whole-exome sequencing (WES) is performed. The clinical and EEG characteristics are further defined. Cognitive impairment of people with epilepsy and NS is assessed using the Wechsler Nonverbal Scale of Ability (WNV). Study design: A cross-sectional observational (groups I-III) and a case-control (groups I-V) study recruiting in total 250 patients and controls (I: people with NS, n=50; II: people with epilepsy (PWE) and onchocerciasis, n=50; III: PWE without onchocerciasis, n=50; IV: controls with onchocerciasis but otherwise healthy, n= 50; healthy controls without evidence for onchocerciasis, n= 50) is performed to describe the clinical characteristics in children with NS/epilepsy and to evaluate differences in infection and immune response between groups, respectively. The WNV should be validated in 500 healthy controls to obtain reference data in rural Africa. Summary: In summary, the study aims to elucidate clinical characteristics and the pathogenesis of NS/epilepsy in children of southern Tanzania and role of parasitic infection as a cause for NS/epilepsy.

NCT ID: NCT03597243 Recruiting - HIV/AIDS Clinical Trials

Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation

CARE
Start date: October 30, 2017
Phase: N/A
Study type: Interventional

Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behavior. The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques. The study will inform policy makers on the impact of Cash transfer programs in AGYW as a tool to reduce vulnerability to HIV infection in Adolescent Girls and Young women.

NCT ID: NCT03568383 Recruiting - Tuberculosis, MDR Clinical Trials

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

PHOENIx MDR-TB
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

NCT ID: NCT03557021 Recruiting - HIV Drug Resistance Clinical Trials

Impact of HIV Drug Resistance Testing, and Subsequent Change to an Individualized Therapy in Tanzania

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The current therapy regimens in Sub-Saharan countries, consisting of standardized first and second line drug combinations, yield a high rate of treatment failure, even within the first 12 months of therapy (23). These and other facts hint at the need for HIV resistance testing to improve treatment outcomes in resource-limited settings, but no prospective clinical data about this intervention exists. The proposed study aims to evaluate the impact of HIV drug resistance testing, and subsequent change to an individualized (second-line) therapy based on the resistance profile, in Tanzanian patients (children, adolescents and adults) with virological failure of their first-line and second-line therapy. Additionally, prevalence, patterns and clinical impact of HIVDR will be assessed, as well as the effect of enhanced adherence counselling. The results of this study will help doctors to take evidence-based diagnostic and therapeutic decisions at an individual level, and will inform policy-makers in their decisions about future treatment and management concepts for HIV/AIDS.