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NCT ID: NCT01418157 Completed - Clinical trials for Acute Mountain Sickness

A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter. This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations. This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue. The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.

NCT ID: NCT01284855 Completed - Snake Bite Clinical Trials

Comparison of Two Dose Regimens of Snake Antivenom for the Treatment of Snake Bites Envenoming in Nepal

Start date: April 2011
Phase: Phase 2
Study type: Interventional

This study aims at comparing two doses of antivenom in the treatment of snake bite envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite victims presenting with one or more sign of neurotoxic envenoming. The objective of the study is to generate enough scientific evidence to improve Nepal's current national guidelines for the management of snake bites.

NCT ID: NCT01276821 Completed - Bronchiolitis Clinical Trials

Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.

Start date: January 2011
Phase: Phase 4
Study type: Interventional

To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.

NCT ID: NCT01186302 Completed - Medical Abortion Clinical Trials

Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal

Start date: April 2009
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the safety, effectiveness, and acceptability of medical abortion provided by doctors and midlevel providers in a developing country where doctors are scarce, such as Nepal. This study is the first to evaluate the independent provision of medical abortion by trained nurses and auxiliary nurse midwives compared to doctors by assessing differences in safety, clinical outcomes, case management decision-making, and acceptability. This study provides scientifically valid data on the administration of medical abortion by midlevel providers working independently in a low-resource, developing country setting. The evidence generated by the study will assist policy makers in developing countries interested in expanding safe abortion services by eliminating the legal requirement limiting prescription of medical abortion to doctors where medical abortion is not restricted by law.

NCT ID: NCT01177111 Completed - Neonatal Sepsis Clinical Trials

Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal

NOMS
Start date: November 1, 2010
Phase: Phase 3
Study type: Interventional

Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings where neonatal mortality rates are high. Infections are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The investigators long term goal is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal mortality risk due to these infections. The investigators team has conducted research in this area for the past 10 years, with specific focus on newborn vitamin A dosing and topical chlorhexidine antisepsis interventions. Previous community-based research by the investigators group of investigators and others demonstrated that newborn vitamin A dosing can reduce early infant mortality by approximately 20%, and that topical applications of chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk by 24%. Evidence is growing that neonatal skin plays an important role in protecting the newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is incomplete in newborn infants, especially those that are pre-term or of low birth weight. Full-body massage of newborns with mustard oil, practiced almost universally (~95%) in communities of south Asia, may further compromise skin barrier function through decreased structural integrity leading to increased trans-epidermal water loss and increased risk of percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen after massage of neonatal skin with alternative topical emollients, including sunflower seed oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin barrier function, improve skin condition, and reduce the risk of both nosocomial infections and neonatal mortality among hospitalized newborns in low-resource settings. The specific hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical applications during full body massage of newborns in the community will reduce neonatal mortality and morbidity by improving overall skin barrier function and reducing exposure to invasive pathogens.

NCT ID: NCT01034254 Completed - Influenza Human Clinical Trials

Field Trial of Maternal Influenza Immunization in Asia

Mothers'Gift
Start date: November 2010
Phase: Phase 3
Study type: Interventional

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.

NCT ID: NCT00997035 Completed - Corneal Ulcer Clinical Trials

The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo

MUTTII
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.

NCT ID: NCT00994734 Completed - Clinical trials for Termination of Pregnancy

Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Start date: May 2009
Phase: N/A
Study type: Interventional

The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.

NCT ID: NCT00825721 Active, not recruiting - Nuclear Cataract Clinical Trials

Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

Start date: November 2007
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract

NCT ID: NCT00786877 Completed - Clinical trials for Acute Lower Respiratory Illness

Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

Start date: August 2009
Phase: Phase 3
Study type: Interventional

At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Low birth weight is highly prevalent in this population as well affecting approximately 30% of live born infants. Low birth weight is a key determinant of neonatal mortality and has also been resistant to cost-effective interventions in resource poor settings. Given the lack of appropriate interventions for poor, rural areas in developing countries and the strong observational association between open burning of biomass fuel sources and ARI in young children and low birth weight, we have designed a community-based randomized trial to determine if reductions in household indoor smoke exposure can reduce the incidence and duration of acute lower respiratory infections in children <36 months of age and low birthweight among newborn infants. Household indoor smoke reduction will be accomplished by replacing the current cook stove in the household with a locally appropriate, inexpensive model that is more efficient and vented to the exterior. In addition, we will assess the impact on respiratory function and symptoms among adults in the household. The project has 2 phases. Phase 1 is a cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural population of southern Nepal. Households will be randomized to receive replacement of their cook stove with an appropriately designed, efficient stove that is vented to the exterior at different time periods during the course of the study. An initial period of surveillance for ARI and low birth weight will establish a baseline rate for all clusters. This will be followed by the randomized, serial replacements of cook stoves over a 12 month period. Surveillance will continue throughout this period and for an additional 6 -18 months depending on when the stove was replaced. Phase 2 is a individually randomized trial in a subset of households that will receive either the improved biomass stove from phase 1 or a LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as phase 1. Measurement of indoor air particulate concentration will be conducted in all households before and after stove replacement. The analysis for both phases will focus on estimating the impact on incidence of ARI in children and low birth weight among live births as a result of stove replacement. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given the expected number of live births to occur in these clusters, we can detect a 50 gram difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have lower power (total of 1800 households).