Kathmandu

Researchers are investigating a new dental device made of zirconia, called "Dantya Nikhan," cemented with Polymethyl methacrylate (PMMA) bone cement. This study aims to explore if this device can serve as a faster and possibly more affordable treatment option for people with missing teeth, compared to conventional bridges and dental implants. The trial focuses on patients with partial tooth loss (edentulism) and seeks to assess the device's potential for fixed or removable prosthodontic treatment. The study will enroll 48 participants who will receive the zirconia dental device surgically placed and cemented in the area without teeth. After initial Cone Beam Computed Tomography (CBCT) scans and clinical evaluations, the device will be cemented in the jawbone region using PMMA bone cement. Participants will be followed with radiographic and clinical assessments every three months for one year, starting immediately after treatment. The device will be loaded with single crowns or multiple unit bridges made of zirconia within 0 to 15 days. Participants will attend regular check-ups where bone loss around the device will be measured with x-rays and CBCT scans. Researchers will also assess gum health, oral hygiene, pain, discomfort, device stability, and any fractures or cracks through clinical exams, photographs, and validated scales. The total study duration is 16 months to allow for treatment of all participants and completion of follow-up. Safety monitoring and evaluation of treatment outcomes will occur throughout this period.

Researchers are evaluating the antiviral activity of multiple influenza drugs in adults with early symptomatic influenza infection. This Phase 2, randomized, open-label, controlled, adaptive platform trial aims to compare the effectiveness of currently licensed influenza antivirals and those with potential antiviral activity against a no-treatment control group. The study focuses on patients with uncomplicated influenza who have high viral loads, to better understand in-vivo antiviral effects and support guideline development and treatment prioritization. The trial includes several licensed antiviral drugs such as oseltamivir, peramivir, zanamivir, laninamivir, baloxavir, and favipiravir, along with molnupiravir, which has shown antiviral activity in pre-clinical studies. Treatments are administered in various forms including oral, inhaled, and intravenous routes, with dosing schedules ranging from single doses to multiple days of twice-daily dosing. Some treatment arms combine two antivirals. Randomization ensures at least 20% of participants receive no antiviral treatment, with equal allocation among available interventions. Participants will be involved from screening through treatment and monitoring up to five days, during which the rate of viral clearance will be measured. Assessments include symptom evaluation, rapid antigen or RT-PCR testing to confirm influenza infection, and safety monitoring. Participants must be able to walk unaided and adhere to study procedures, including follow-up visits. The overall study duration covers early infection and antiviral response measurement, focusing on understanding drug effects in uncomplicated flu cases.

This research aims to compare the effectiveness and safety of two blood-thinning medications, Rivaroxaban and Warfarin, in treating left ventricular (LV) thrombus after a heart attack (myocardial infarction, MI). The study focuses on patients in Nepal who often arrive late for treatment, increasing the risk of LV thrombus and related complications. While Warfarin is the standard treatment requiring regular blood monitoring and dietary restrictions, Rivaroxaban offers a more convenient alternative without these needs. This study is a phase 4 randomized control trial designed to assess which medication better resolves LV thrombus and their safety profiles. Participants diagnosed with LV thrombus by cardiac MRI will be randomly assigned to receive either Rivaroxaban or Warfarin. Those in the Rivaroxaban group will take 20 mg once daily with the evening meal if kidney function is normal, or 15 mg if kidney function is impaired. The Warfarin group will start with 5 mg daily and adjust the dose to keep blood clotting levels within a target range, requiring frequent blood tests initially and monthly follow-ups later. Both groups will be monitored over a 3-month treatment period, with follow-up visits to check for bleeding or other side effects. During the study, participants will undergo cardiac MRI to assess thrombus resolution at 3 months. Researchers will monitor safety by tracking major bleeding and embolic events. Data will be collected securely and analyzed to determine which treatment offers better outcomes. The total study duration for each participant is 3 months, with careful monitoring to ensure safety and effectiveness of the treatments.

Researchers are evaluating a digital health tool called INCLUDE designed to address the complex issue of intersectional stigma faced by people living with HIV (PLWH) in Nepal. Intersectional stigma arises from overlapping factors like HIV status, mental health conditions, sexual and gender minority status, and ethnic minority status, which negatively impact HIV care outcomes. The study aims to test the acceptability and feasibility of this tool among clients, healthcare workers (HCWs), and ART center leads at four ART centers. INCLUDE is a multi-component digital intervention co-designed with PLWH and HCWs. It includes a dynamic assessment strategy used during clinic visits to collect both quantitative ratings and qualitative client perspectives on stigma. The tool also features a dashboard that integrates stigma data with routine clinical information to link stigma with care engagement and to help identify relevant stigma-reduction activities. Additionally, it offers a repository of culturally appropriate stigma-reduction activities targeting intrapersonal, interpersonal, and clinic levels. Participants will be involved in a pilot trial where data collection includes surveys, app usage analytics, interviews, and focus groups over 9 months. The study will measure outcomes such as acceptability and feasibility of the INCLUDE tool, frequency and duration of assessments, user engagement with the app, implementation of recommended stigma-reduction activities, and rates of conference meetings. These comprehensive evaluations aim to support further refinement and potential expansion of the intervention to improve HIV care outcomes in Nepal and similar settings.

Postpartum hemorrhage and birth asphyxia are major causes of death among mothers and newborns worldwide, especially in low- and middle-income countries. Despite improvements in maternal and neonatal health in Nepal, gaps remain in healthcare providers' skills, likely due to limited clinical experience. This research evaluates the implementation and effectiveness of establishing high-fidelity simulation labs in seven referral hospitals in Nepal to improve care quality for labor, birth, and newborn resuscitation using the RE-AIM framework. The study uses a mixed-methods quasi-experimental design with pre- and post-tests over 15 months. The intervention involves setting up maternal and neonatal health simulation labs in each hospital, each with multiple rooms including simulation and debriefing spaces. Hospital staff receive simulation-based training focusing on essential care during labor and birth, bleeding after birth, and helping babies breathe modules. Training for simulation lab operation and maintenance is also provided. Data collection includes a 6-month pre-test phase, a training implementation phase, and a 6-month post-training follow-up to assess clinical skills and patient outcomes. Participants include women delivering vaginally, their newborns, and maternal and newborn health staff. Researchers collect daily data on postpartum hemorrhage incidence, newborn APGAR scores at 5 minutes, and blood transfusions after hemorrhage. Skills assessments of healthcare providers occur before and six months after training. Additional evaluations cover simulation lab reach, usage, challenges, and maintenance. Both quantitative and qualitative methods analyze outcomes, with safety and effectiveness carefully monitored throughout the study period.

Researchers are evaluating antiviral treatments in adults aged 18 to 60 with early symptomatic COVID-19 who have high viral loads but are otherwise healthy. This phase 2, multi-center, adaptive platform trial aims to measure the antiviral effects of several interventions compared to no treatment, focusing on how quickly the virus clears from the body within the first five days. The study includes small molecule drugs, monoclonal antibodies, and dose-finding for parts of nirmatrelvir/ritonavir to understand their effectiveness in vivo. The trial investigates multiple antiviral treatments including small molecule drugs such as nitazoxanide, nirmatrelvir/ritonavir, hydroxychloroquine, atilotrelvir/ritonavir, and metformin; monoclonal antibodies like sotrovimab, tixagevimab/cilgavimab, and casirivimab/imdevimab; and combination therapies. Participants are randomly assigned to receive one of these treatments or no antiviral treatment (with at least 20% assigned to no treatment). Dosages and schedules vary by treatment, for example, nirmatrelvir/ritonavir is given twice daily for five days, while monoclonal antibodies are given once on day 0. Participants will be involved in assessments including viral clearance measurements over days 0 to 5. Researchers will monitor for viral load reduction as the primary outcome, comparing treated groups to controls. Participants must be able to walk unaided, have oxygen saturation of at least 96%, and agree to follow-up visits. Safety and treatment adherence are monitored throughout, with the study supported by the Wellcome Trust and conducted under controlled conditions to ensure accurate evaluation of antiviral effects.

Researchers are conducting a multinational, prospective observational study called the ICU-related Out-of-Pocket Expenses (ICOPE) study in African and Asian countries. This study aims to measure the financial burden on patients and families related to ICU care, focusing on out-of-pocket expenses and catastrophic health expenditure. The study includes both ventilated and non-ventilated patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. Participants are followed during their ICU stay, which averages about 7 days, and additional follow-ups occur at 30 days and 6 months after admission. The study compares costs between patients receiving invasive mechanical ventilation and those who are not ventilated. It also investigates risk factors for catastrophic health expenditure and documents how families cope with the financial demands of ICU care. Throughout the study, researchers collect data on patient expenses, including direct medical and non-medical costs, as well as indirect costs such as income loss. The main outcomes measured are the out-of-pocket cost per patient episode until ICU discharge and the relative risk of catastrophic health expenditure. The total study duration spans 18 months, allowing for comprehensive assessment of financial impact and coping strategies over time.

Researchers are evaluating the use of a lower INR target range (1.5 to 2.5) in patients who have a mechanical bileaflet heart valve in the aortic position. The study aims to determine whether this lower INR target can reduce the risk of bleeding without increasing the risk of blood clot formation or stroke. This is important because patients with mechanical heart valves need lifelong warfarin treatment, and finding the right INR balance could lessen bleeding complications. Participants will continue warfarin therapy after their mechanical valve replacement, but with different INR target ranges depending on their study group. The study compares the standard higher INR targets to the lower 1.5 to 2.5 range to assess safety and effectiveness. This is a Phase 3 clinical trial focusing on patients who had their bileaflet mechanical heart valve implanted at least three months prior. During the study, participants will be monitored for thrombosis or thromboembolism and major bleeding events over a period expected to last 2 to 3 years. Researchers will regularly measure INR levels to guide warfarin dosing and track outcomes related to bleeding and clotting. The results are intended to help doctors better manage warfarin dosing to reduce bleeding risks while preventing clots in this patient group.

Intimate Partner Violence (IPV), including physical, sexual, and abusive control, affects about 30% of women worldwide and is a major public health issue in low- and middle-income countries like Nepal. IPV is strongly linked to mental health problems such as depression and post-traumatic stress disorder (PTSD), doubling depression rates and increasing PTSD risk. Young married women in Nepal often live in extended households where mothers-in-law play a key role in their autonomy and mental health. This trial aims to evaluate the effectiveness of the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP) in reducing depression, IPV, and PTSD among these women. The study will randomly assign 300 family triads (wife, husband, mother-in-law) into either the MILAP intervention or enhanced usual care group. MILAP consists of nine sessions over nine weeks, beginning with two sessions for mothers-in-law and daughters-in-law focusing on empowerment and reducing IPV, followed by behavioral activation sessions including mothers-in-law to address depression, and concluding with four weekly sessions of behavioral couples therapy for husbands and wives to improve communication and relationship trust. Enhanced usual care involves counseling without these intervention components. Participants will be assessed at baseline, 1 month, and every 3 months up to 12 months for depression, IPV, and PTSD using various validated questionnaires. Data collection includes demographic information, mental health scales, and family relationship measures. Qualitative interviews will explore intervention impact mechanisms. The study also includes a cost-effectiveness analysis of MILAP. Assessments will be conducted privately in local languages, with research staff blinded to group assignments. The goal is to provide evidence for an integrated family approach to improve mental health and reduce IPV in Nepal and similar settings.

Researchers are investigating how high blood sugar (hyperglycemia) affects both short- and long-term outcomes in patients who arrive at the emergency room with acute strokes, also known as cerebrovascular accidents (CVAs). This prospective cohort study focuses on understanding the relationship between hyperglycemia at the time of stroke and mortality and morbidity rates up to one year after the event. The study follows established methodological guidelines and aims to provide insights that could improve care and long-term quality of life for stroke patients. The study enrolls patients with acute strokes confirmed by CT scans who present at the emergency department of Tribhuvan University Teaching Hospital. Participants are selected using systematic random sampling to include 60 individuals, split evenly between those with elevated blood glucose and those with normal levels. Researchers collect baseline clinical data, medical history, demographics, and blood sugar measurements at admission. Follow-up evaluations occur at 1, 3, and 12 months, assessing mortality and functional outcomes using tools like the Modified Rankin Score. There are no treatments or interventions assigned, as this is an observational cohort study. Participants undergo thorough assessments including clinical exams, chart reviews, face-to-face interviews, and laboratory tests such as blood glucose analysis and CT imaging. Stroke severity and type are evaluated using standardized scales like the NIH Stroke Scale and intracerebral hemorrhage score. Mortality and morbidity are tracked at multiple time points to understand the impact of hyperglycemia on stroke outcomes. Data analysis includes various statistical methods to identify factors predicting death and disability over one year.