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NCT ID: NCT05625880 Completed - Jaundice, Neonatal Clinical Trials

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population

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

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

NCT ID: NCT05618886 Recruiting - Clinical trials for Urinary Incontinence

The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05559489 Recruiting - Burn Shock Clinical Trials

Enteral Resuscitation Nepal

Start date: December 8, 2022
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05550597 Completed - Postoperative Pain Clinical Trials

Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block. Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.

NCT ID: NCT05543668 Completed - Pain, Postoperative Clinical Trials

Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy.

Start date: September 16, 2022
Phase:
Study type: Observational

Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative pain, then a more aggressive pain management strategy can be adopted perioperatively. This would improve patient satisfaction and prevent poor outcomes such as chronic pain after surgery. Therefore, our primary aim is to find out whether presence of pre-existing preoperative pain would predict moderate-severe acute pain after laparoscopic cholecystectomy. Moreover, we plan to use Patient Reported Outcomes Measurement Information System (PROMIS) scale to assess preoperative pain intensity and pain-related behaviors. Primary &Secondary Objectives: Primary objectives To investigate the association between preexisting preoperative pain (more than 3 months duration) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy. Secondary objectives .1. To investigate the association between preoperative PROMIS(patient reported outcome measurement and information system) domain (PROMIS pain intensity score, PROMIS pain interference score, PROMIS pain behavioural score) and postoperative moderate-severe acute pain after LC. 2. To examine baseline demographic, clinical, psycho-behavioural features and intraoperative factors in relation to dynamic moderate to severe pain after LC. 3. To identify perioperative predictors for acute postsurgical pain. 4. To find out the incidence of shoulder tip pain after LC.

NCT ID: NCT05525429 Not yet recruiting - Undernutrition Clinical Trials

Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal

Start date: July 2024
Phase: N/A
Study type: Interventional

Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will 1. characterize these barriers in detail 2. conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA). Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls). The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.

NCT ID: NCT05506748 Completed - Mortality Clinical Trials

Association Between Preoperative HALP and Immediate Postoperative Outcomes

Start date: April 20, 2021
Phase:
Study type: Observational

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality. Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

NCT ID: NCT05506358 Completed - Sickle Cell Disease Clinical Trials

Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Sickle cell disease (SCD) is an inherited blood disorder associated with acute illness and organ damage. In high resource settings, early screening and treatment greatly improve quality of life. In low resource settings, however, mortality rate for children is high (50-90%). Low-cost and accurate screening techniques are critical to reducing the burden of the disease, especially in remote/rural settings. The most common and severe form of SCD is sickle cell anemia (SCA), caused by the inheritance of genes causing abnormal forms of hemoglobin (called sickle hemoglobin or hemoglobin S) from both parents. The asymptomatic or carrier form of the disease, known as sickle cell trait (SCT), is caused by the inheritance of only one variant gene from one of the parents. In areas such as Nepal, β-thalassemia (another inherited blood disorder) and SCD are both prevalent, and some combinations of these diseases lead to severe symptoms. The purpose of this study is to determine the accuracy of low-cost point-of-care techniques for screening and detecting sickle cell disease, sickle cell trait, and β-thalassaemia, which will subsequently inform on feasible solutions for detecting the disease in rural, remote, or low-resource settings. One of the goals of the study is to evaluate the feasibility of techniques, such as the sickling test with low-cost microscopy and machine learning, HbS solubility test, commercial lateral-flow assays (HemoTypeSC and Sickle SCAN), and the Gazelle Hb variant test, to supplement or replace gold standard tests (HPLC or electrophoresis), which are expensive, require highly trained personnel, and are not easily accessible in remote/rural settings. The investigators hypothesize that: 1. an automated sickling test (standard sickling test enhanced using low-cost microscopy and machine learning) has a higher overall accuracy than conventional screening techniques (solubility and sickling tests) to detect hemoglobin S in blood samples 2. the automated sickling test can additionally classify SCD, SCT and healthy individuals with a sensitivity greater than 90%, based on morphology changes of red blood cells, unlike conventional sickling or solubility tests that do not distinguish between SCD and SCT cases 3. Gazelle diagnostic device can detect β-thalassaemia and SCD/SCT with an overall accuracy greater than 90%, compared with HPLC as the reference test

NCT ID: NCT05504928 Recruiting - Clinical trials for Rheumatic Heart Disease

Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease

NEPAL4
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05501522 Active, not recruiting - COVID-19 Clinical Trials

Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted With AS03 in Adults Aged 18 Years and Older

Start date: December 9, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.