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NCT ID: NCT03933098 Not yet recruiting - Typhoid Clinical Trials

Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine

Start date: August 2019
Phase: Phase 3
Study type: Interventional

This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.

NCT ID: NCT03930576 Not yet recruiting - Unwanted Pregnancy Clinical Trials

Nepal Turnaway Study

Start date: April 30, 2019
Phase:
Study type: Observational

The objective of this project is to examine the health consequences of unwanted pregnancy and denial of legal pregnancy termination services in Nepal on women and their children. The proposed study will be a large, longitudinal, prospective, quantitative study among women seeking termination services at 14 diverse facilities in 7 provinces (two facilities in each province) of Nepal. Every 6 months following baseline, surveys will cover questions about women's physical and mental health, the health and development of their children, as well as measures of family wellbeing, such as residency, relationship status and quality, and extended family relationships, and financial wellbeing, such as employment status, hours of labor, food security, income, and education.

NCT ID: NCT03926689 Not yet recruiting - Dietary Habits Clinical Trials

SMS Messages to Increase Child Egg Consumption, a C-rct in Nepal

Start date: April 2019
Phase: N/A
Study type: Interventional

Eggs are well-known to be a balanced source of protein, energy, fatty acids, and micronutrients and increasingly identified as an opportunity to improve nutrition of poor populations. Few implementation studies have been done globally, and none in South Asia, to assess the effectiveness of using behavior change programs to motivate households to increase egg consumption. Egg consumption is particularly poor in Nepal, but the government and development partners are implementing at scale policies and programs to address poor diets and other determinants of undernutrition, which is persistently high in Nepal. This cluster-randomized controlled trial (c-RCT) aims to help address the gap in the evidence base regarding how to improve egg consumption. The c-RCT will evaluate the effectiveness of using short message service (SMS) messaging, layered into a large-scale behavior change program, to improve egg consumption and dietary diversity among children 1 to 2 years of age. A two-arm trial will be used to compare the following two strategies: 1) Suaahara II standard multi-sectoral nutrition interventions without any text messages and 2) Suaahara II standard multi sectoral nutrition interventions plus a SMS message campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday.

NCT ID: NCT03917888 Completed - Clinical trials for Ventilator Associated Pneumonia

Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

Start date: September 10, 2017
Phase: N/A
Study type: Interventional

The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.

NCT ID: NCT03886467 Not yet recruiting - Child Malnutrition Clinical Trials

Strategies to Increase Milk Consumption by Young Nepali Children

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Dairy animals are an important source of income, food and nutrition security at the household level. However, substandard animal husbandry practices and limited understanding of disease prevention and control may limit dairy animal productivity. Interventions to address these issues may enhance milk production, substantially improving the well-being of smallholder farmers. In addition to increasing household income, greater milk production may improve the diet quality of household members, particularly children. Previously, the investigators implemented a program in rural Nepal promoting enhanced animal husbandry practices (GHP), focusing on mastitis control. Concurrently, the investigators found child milk intake was strongly linked to better growth and development. However, milk intake was limited and its availability was not examined. The investigators now propose to build on these prior activities and examine strategies to increase child milk consumption. The investigators plan to introduce a nutrition education program into 200 households (with young children) which previously received GHP training. A comparison group of 200 households will serve as the control. Household surveys will be conducted at baseline and endline to assess (1) household milk production and the sustainability of adoption of GHP routines, (2) the relationship of household milk production to child milk consumption, (3) household factors influencing child milk consumption (participation in nutrition education, mother's education, socioeconomic status, etc.), and (4) longitudinal child growth and development. In addition, a pilot study will determine if households can accurately record milk production and child milk intake. The project is designed to enhance understanding of the links between milk availability and child milk consumption in rural Nepal. It aims to explore whether milk consumption is limited by availability or other factors (nutrition awareness, socioeconomic status, maternal education). Additionally, the investigators will examine if optimization of milk consumption by young children can further boost their growth and development, and whether instruction in good animal husbandry practice and mastitis control is sustainable. These findings could more appropriately and efficiently direct resources to improve child nutrition and development and household dairy practices.

NCT ID: NCT03875274 Completed - Postoperative Pain Clinical Trials

Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

NCT ID: NCT03809702 Recruiting - Herpes Zoster Clinical Trials

Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Start date: October 4, 2018
Phase: Phase 4
Study type: Interventional

All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.

NCT ID: NCT03807427 Completed - Mental Disorders Clinical Trials

Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)

READY-Nepal
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

Published research on the development of mental health symptomatology among adolescents has expanded in recent years and indicates the presence of a growing public health concern. The 2015 earthquakes in Nepal are a risk factor for increased psychological distress across all age groups. Prior studies have also demonstrated high chronic risk of suicidal thoughts and behaviors (STBs) among adolescents in Nepal and throughout South Asia. Despite the need for mental health promotion interventions in Nepal, there is a lack of psychological treatments for suicide prevention that have been rigorously evaluated in Nepal. To address this gap, a trans diagnostic, emotion -focused mental health promotion intervention (Regulating Emotions through Adapted Dialectical behavior skills for Youth in NepalÍž READY-Nepal) was developed for delivery in school-based settings. A pilot quasi-experimental trial utilizing a wait-list control group will be used to evaluate the feasibility and acceptability of the intervention in a cohort of school -going adolescents in the Kathmandu Valley. Qualitative methodology will be used to augment quantitative findings via exploration of gender differences in perception and uptake of the program, program feasibility and acceptability, as well as changes in coping skills and explanatory models of stress between baseline and follow- up. This pilot study will aid in modifying the intervention to inform the development of a larger, adequately powered cluster randomized trial (CRT) of READY-Nepal.

NCT ID: NCT03807362 Recruiting - Leprosy Clinical Trials

CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

Start date: January 7, 2018
Phase: Phase 2
Study type: Interventional

This study will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and, if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52 weeks of treatment. A safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.

NCT ID: NCT03775460 Not yet recruiting - Clinical trials for Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

MaPs
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.