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NCT ID: NCT02293694 Completed - Contraception Clinical Trials

Sayana® Press Self-injection Study in Malawi

Start date: September 17, 2015
Phase: N/A
Study type: Interventional

The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.

NCT ID: NCT02258256 Completed - Pre Eclampsia Clinical Trials

Pilot Assessment of an Auto Blood Pressure Monitor

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study. The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use. 20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the subject and the commercially available cuff on the opposite arm. A trained research assistant and the nurse will record the blood pressure measurements and document any alarm indications made by each device. Blood pressure measurements will continue until monitoring is no longer clinically prescribed. The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.

NCT ID: NCT02253095 Completed - Clinical trials for Environmental Enteropathy

Combined Package of Interventions for Environmental Enteropathy

Start date: October 2014
Phase: N/A
Study type: Interventional

Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.

NCT ID: NCT02249962 Completed - HIV Clinical Trials

Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART

S4
Start date: May 2015
Phase:
Study type: Observational

To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.

NCT ID: NCT02246296 Completed - Malnutrition Clinical Trials

Reformulated F75 Milk to Treat Severe Acute Malnutrition

F75
Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high mortality in Africa. This is partly because children are commonly brought for admission because they are seriously ill, rather than being brought to hospital because of malnutrition alone. Mortality rates are especially high where SAM is complicated by HIV or TB. The early phase of inpatient nutritional treatment for severe acute malnutrition is based on a low-protein milk known as F75, which is given to improve metabolic homeostasis prior to the re-feeding to achieve catch-up growth. F75 provides a high proportion of energy from carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of different types of carbohydrates, but lactose in particular, is known to occur in SAM and may lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated with increased mortality. Furthermore, switching from a catabolic state to a high energy diet that consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may lead to severe electrolyte abnormalities and multiple organ dysfunction. The aim of this trial is to determine whether reducing the carbohydrate content of F75, and removing lactose, improves the stabilisation of severely malnourished children. The trial will involve randomising children who are eligible to receive F75 milk to either the current formulation or a revised formulation. Both formulations will be given according to current recommendations regarding frequency of feeding and caloric value. Since the purpose of F75 is to stabilise the child metabolically and biochemically, the primary endpoint of the trial will be time to stabilisation (the end of the first phase of treatment for severe acute malnutrition). Blood and stool samples at admission and after three days will be used to determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding syndrome. Children will be followed up until discharge from hospital. The project has been planned in consultation with the World Health Organisation (WHO) and, if the revised formulation of F75 results in improved outcomes, will lead to a global change in recommendations for its formulation.

NCT ID: NCT02213211 Completed - Malaria Clinical Trials

School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi

Start date: April 2014
Phase: N/A
Study type: Interventional

Malaria is an important contributor to ill-health experienced by school-children and may have profound consequences for their learning and educational achievement, and there is a small, but growing, body of evidence that suggests malaria control can help improve educational outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children. To avert this health burden and potential education consequences, Save the Children in partnership with the Malawian Ministry of Health is providing treatment of symptomatic malaria cases in schools in southern Malawi, as part of the provision of first aid kits (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this intervention, a cluster randomised trial is being conducted among 58 schools in Traditional Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group. The primary outcome is school attendance, with secondary outcomes of grade repetition, school drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The study aims to conduct several quantitative and qualitative assessments to help evaluate the external validity of the findings.

NCT ID: NCT02178800 Completed - HIV Infections Clinical Trials

Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults

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

This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.

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: NCT02149433 Completed - Clinical trials for Pneumonia, Pneumocystis Jerovici

Pneumocystis Jerovici Pneumonia in Infants and Steroids

Start date: May 2012
Phase: N/A
Study type: Interventional

This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.

NCT ID: NCT02127983 Completed - HIV Clinical Trials

Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)

Triage
Start date: January 2009
Phase: N/A
Study type: Interventional

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.