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NCT ID: NCT03304158 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

Community Based Management of Diabetes in Nepal

COBIN-D
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Type 2 diabetes is the largest growing concern across the globe, and this is particularly apparent in developing countries, including Nepal. Despite the growing burden and chronic nature of diabetes, prevention and control of this disease is far from adequate setting in Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population approach on reducing blood glucose level among diabetes persons. The main aim of this study is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based health education and screening on blood sugar level in adults at community level in Nepal. This is a community-based cluster randomized controlled trial involving family based health education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for participation in the study. FCHVs will conduct family based health education and fasting blood glucose measurements in the treatment arm vs not any interventions in the control arm. Independent assessors will conduct the baseline and end line assessment of the intervention. Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. For individual outcomes, proportions will be compared using Chi-square test and continuous measures will be compared using t-tests. Random effect mixed regression analysis will be adjusted for age and sex. Since randomisation will be at the cluster level in the study, a random-effect model will be used to account for clustering effect. Effectiveness of the intervention will be tested by analysis of covariance, which will allow us to adjust for baseline differences between groups. It is anticipated that the study can give valuable information regarding effectiveness, acceptability, and feasibility of an innovative way to improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute to develop a policy that can be scaled-up to a national level.

NCT ID: NCT03285399 Completed - Clinical trials for Malnutrition, Infant

Bhaktapur Maternal and Child Micronutrient Study

Start date: January 12, 2008
Phase: N/A
Study type: Observational

Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

NCT ID: NCT03275935 Completed - COPD Asthma Clinical Trials

Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)

Start date: March 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.

NCT ID: NCT03231761 Recruiting - Depression Clinical Trials

Impact of Video Presentations on Medical Students' Attitudes Toward Mental Illness

Start date: August 21, 2017
Phase: N/A
Study type: Interventional

This is a randomized controlled trial examining the impact of videos on medical students' implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical students are randomized to one of three conditions: (a) no video, (b) a didactic video based on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and (c) videos with personal testimonials from mental health service users with depression and psychosis.

NCT ID: NCT03071666 Recruiting - Anemia Clinical Trials

Vitamin B12 Supplementation During Pregnancy on Cognitive Development

VitaPreg
Start date: March 27, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes. Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio. Study participants and site: 600 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy. Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth. Comparator: Placebo, identical to the vitamin B12 supplements. Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers. Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.

NCT ID: NCT03071029 Completed - Health Behavior Clinical Trials

PAFP Provider Feedback Trial in Nepal

Start date: July 2016
Phase: N/A
Study type: Interventional

A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The purpose of the RCT is to test the effectiveness of a peer comparison intervention at increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP uptake among clients who receive a safe abortion at a Marie Stopes International Nepal. The total sample size will be ~12,000 safe abortion clients. The primary outcome of interest is LARCs among safe abortion clients at Marie Stopes Centres in Nepal. The secondary outcome is to evaluate the impact of behaviorally designed intervention on the service providers' engagement in discussing measures to increase PAFP LARC uptake among women.

NCT ID: NCT03000517 Recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

PK of Levofloxacin in MDR-TB Patients

Start date: May 2016
Phase: N/A
Study type: Observational

The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various factors contributing to the development of drug resistance, low drug exposure is well recognized. To overcome this, either new drugs have to be developed or the dose of currently used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired drug resistance to these drugs could complicate and narrow down the available options, and further exacerbate to pre-XDR and XDR-TB. Objective: The main objective of this prospective clinical study is to understand the pharmacokinetics of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body weight and correlate drug exposure, with treatment outcomes. Study design: A prospective pharmacokinetic study Study population: 20 MDR-TB patients Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on the body weight, under MDR-TB treatment regimen of Nepal. Main study parameters/end points: The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated in plasma and in oral fluid

NCT ID: NCT02981251 Completed - Hypertension Clinical Trials

Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the effect of health education on blood pressure reduction compared to usual care among uncontrolled hypertensive patients of suburban community of Surkhet district of Nepal.

NCT ID: NCT02968264 Recruiting - Clinical trials for Congenital Heart Disease

Tetralogy of Fallot for Life

TOF-LIFE
Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample size and methodology will result in statistically powerful results to allow for evidence-based change to current TOF surgical practices.

NCT ID: NCT02912611 Recruiting - Acute Kidney Injury Clinical Trials

Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project

Start date: October 2016
Phase: N/A
Study type: Interventional

This feasibility study will be conducted at 4 international sites located in Asia (Dhahran, Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba, Bolivia). Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1 regional referral hospital) that service the population around the site area. Patients presenting at a health care clinic or hospital emergency department with signs and symptoms associated with high and moderate risk of developing AKI will undergo a point of care (POC) test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who meet the study inclusion criteria will be approached for consent. Patients enrolled in the study will be followed throughout the health care evaluation and tracked through their course by location i.e. health care center, hospital, and home. Outcomes will be recorded through 6 months following the health care evaluation. The protocol will have an initial observation phase, during which relevant healthcare staff and the research team will be trained to identify patients at moderate or high risk of AKI and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked throughout the health care evaluation, however the teleconsultation will not be implemented and no specific guidance for managing the patient will be provided. During the subsequent intervention phase, the research team will interact with the local healthcare providers to and the teleconsultation physician, providing guidance on the management of the patient based on a standardized protocol. Protocols for patient care will be pre-specified, with minor adjustments to meet local requirements.