There are about 300 clinical studies being (or have been) conducted in Nepal. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background: Exposure to high altitudes has been associated with an increased risk of cardiac arrhythmias in healthy subjects and an increased risk of sudden cardiac death. Aim: The aim of the present study is to evaluate the risk and the incidence of cardiac arrhythmias at extreme altitude. Methods: This is a prospective cohort study of healthy volunteers determined to climb Mount Everest. Subjects will be evaluated for eligibility by electrocardiography and echocardiography. All study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. Subsequently, ambulatory rhythm monitoring will be repeated during the ascent from basecamp to the summit of Mount Everest. The primary endpoint will be the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
The rise in chronic diseases is attributed to unhealthy eating high in sugar, salt and saturated fats, which is facilitated by the availability and consumption of these unhealthy foods. The investigators will conduct the Randomized Controlled Trial to evaluate the effect of food procurement policy on the food environment in the public facilities like schools, worksites, hospitals, correctional facilities and care homes of four municipalities of Bagmati Province, Nepal. The investigators will develop food procurement policy and get endorsed from each municipality through their legislative process. In three months, the change in the food environment after implementing the policy in public facilities of the respective municipalities will be measured.
The purpose of the study is to find the effectiveness of Pelvic floor muscle training (PFMT) for urinary incontinence (UI) among Nepalese women. After screening the women who meet the inclusion criteria will be included. Verbal and written consent will be taken from individual participants then the baseline questionnaire data containing socio-demographic variables and questions related to knowledge of UI, PFM and experience with PFMT and ICIQ UI SF will be collected. Then, a women's health physiotherapist will provide education about UI, PFM, PFMT and lifestyle advice. After the education session the randomisation of the participants into either education only (group A) or education plus PFMT (group B) 1:1 by concealed allocation (sealed envelope with A and B). After allocation, the participants will stay in their assigned intervention group for 1 year. After 12 weeks of the supervised intervention again ICIQ UI SF will be administered by a research assistant to both groups. In the 6th month again ICIQ UI SF will be administered by a research assistant to both groups. Finally, in the 12th month again ICIQ UI SF along with self-efficacy and knowledge questions will be assessed to find the effectiveness of the intervention. This data will help in the further development of the protocol or guideline for the Nepalese women.
Nepal and the South Asian sub-continent carry some of the highest rates of burn injury globally, with associated high morbidity and mortality. Nepal currently has one major center equipped for comprehensive burn care, in Kirtipur, Nepal, and receives patients who are referred from around the country. At the time of presentation, most patients with major burns have had minimal to no resuscitation on arrival, and often present hours to days after the burn injury was sustained. Timely fluid resuscitation, initiated as soon as possible after a major burn injury, is the main tenet of acute burn care. Lack of adequate resuscitation in major burn injuries leads to kidney injury, progression of burn injury, sepsis, burn shock, and death. The current standard of care for major burn resuscitation is intravenous fluid resuscitation. However, in low- and middle-income countries such as Nepal, adequately trained and equipped hospitals for the treatment of burn care are not widely available (for a variety of reasons). Additionally, there is no systematic emergency medical transport system available to provide medical care and resuscitation during transport. Enteral-based resuscitation-drinking or administering fluids via the gastrointestinal tract-with substances like the WHO Oral Rehydration Solution (ORS) is recommended by burn experts and professional burn societies when resources and access to intravenous fluid resuscitation are not available. Studies have previously demonstrated the efficacy and safety of enteral-based resuscitation in controlled, high-resource settings, however, there have not been real-world effectiveness trials in resource-constrained settings. Therefore, the investigators seek to ultimately address the problem of pre-hospital and pre-burn center admission resuscitation by studying the effectiveness of enteral resuscitation with Oral Rehydration Solution (ORS) in preventing burn shock. A recent feasibility and pilot study(n=30) of this Enteral-based implementation bundle (EResus) i.e., training resources, protocol, and toolkit were conducted. The pilot study allowed for protocol development and testing, established the feasibility, provided key insights into implementation and helped develop infrastructure and study standard operating procedures at the study site. With the current study, the investigators aim to expand the trial to a full effectiveness-implementation trial, which will allow to further hone the EResus protocol and bundle, generate more effective implementation strategies, and obtain a clearer understanding of efficacy and frequency of specific outcomes. This study examines enteral-based resuscitation (i.e. enteral with/without IV Fluids) versus enhanced standard of care IV Fluids for the treatment of major burn injuries. The intervention portion of the study will entail randomization of patients presenting with acute burn injuries of 15-40% total body surface area (TBSA) to an enteral-based resuscitation versus the standard of care IV fluid resuscitation. The intervention will continue through the acute resuscitation period. The primary study variables will include measures of urine output, vital signs, planned and administered resuscitation volumes, and routes of resuscitation along with frequency, timing, and treatment of any gastrointestinal symptomology, and serious adverse events such as kidney injury and aspiration events Further, there will be a qualitative component to the study with focus group discussions of the bedside healthcare providers (doctors and nurses) caring for the enrolled patients, in order to understand the challenges and facilitators of enteral resuscitation. In-depth interviews will be conducted with enrolled patients and their families to further understand the patient perception, experience and challenges and facilitators. Qualitative analysis will be done to understand the major themes of challenges and facilitators to enteral resuscitation.
The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.
The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.
In Health Posts of rural areas operated by the Government of Nepal, there are limitations of tests to differentiate between bacterial and viral infections. Due to this, health workers are obliged to prescribe antimicrobials (antibacterials) just on the basis of clinical features. This can lead to irrational use of antimicrobials, consequently contributing to antimicrobial resistance. C-reactive protein is the marker of inflammation which rises during bacterial infection but rarely rises during viral infection. The investigators wish to compare the effect on antimicrobial usage of using CRP(C-Reactive Protein) test, a rapid diagnostic test used to differentiate bacterial and viral infection, with usual standard of care, by carrying out a cluster-randomized controlled trial. The investigators plan to carry out this study in eight Health Posts of Resunga, Dhurkot and Gulmi-Durbar Municipalities of Gulmi District. The investigators will randomly allocate four Health Posts (clusters) to the intervention arm- CRP TESTS in addition to Usual Standard of Care, and four Health Posts (clusters) to the control arm- Usual Standard of Care Alone. The investigators plan to study all patients above one year of age presenting with fever or a history of reported fever with a duration of up to 7 days in Health Posts. Primarily, the investigators will assess the rates of antimicrobial use per patient who presents with febrile illness. Secondarily, the investigators will also assess the outcome of illness of the patient such as need for subsequent hospital admission or severe or complicated illness. This testing method will supplement the existing methods to differentiate bacterial and viral infections based on history and clinical examination by health professionals as a part of usual standard of care in the Health Posts included in this study.
Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.
Proposal for Sub-Study to be conducted with the WHO Solidarity Plus Trial: Apart from the data been collected as per the WHO Solidarity Trial Plus protocol, Nepal Health Research Council will conduct a sub-study to evaluate some components which are felt to be important in the local context but have not been included as part of the Solidarity Trial Plus. Rather that conducting a separate study, the following components can be evaluated by collecting additional data as a part of sub-study in the local context.
Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed. The aim of the video is to encourage women to take safety actions, in particular telling someone about the violence experienced. Women in the control group will watch a video on a healthy pregnancy and sign and symptoms of complications and what to to if these occur.The control video was chosen to increase blinding. This study aims to investigate the effect of the video compared to an intervention video.