Kathmandu

Researchers are evaluating a new dental device made of zirconia, cemented with Polymethyl methacrylate PMMA bone cement, to explore if it can serve as an additional option for replacing missing teeth. This clinical trial aims to find a faster and possibly more affordable treatment for edentulism, addressing some shortcomings of conventional bridges and dental implants. The study is an early phase interventional trial focusing on fixed prosthodontics. The trial involves placing the zirconia dental device in edentulous areas of the jaw in 48 participants. The device will be cemented with PMMA bone cement and immediately loaded within 0 to 15 days using single crowns or multiple unit bridges made of zirconia, fixed with luting cement. Participants will be randomly assigned to groups based on the location of their missing teeth maxillary anterior, maxillary posterior, mandibular anterior, or mandibular posterior regions. Participants will undergo a Cone Beam Computed Tomography CBCT scan and clinical evaluation before treatment. After device placement, clinical examinations and radiographic evaluations will be conducted every three months for one year to monitor outcomes like bone loss, gum health, oral hygiene, pain, discomfort, dislodgment, and fractures of the dental device. The entire trial spans 16 months, including follow-up periods to assess device performance and safety.

Researchers are evaluating the antiviral effects of various treatments in adults aged 18 to 60 with early symptomatic influenza. This phase 2, multi-centre, adaptive platform trial compares several licensed influenza antiviral drugs and others with potential activity against the virus. The study aims to provide clear comparisons of antiviral activity to help guide treatment decisions and policy development. Participants may receive one of several antiviral drugs such as oseltamivir, favipiravir, zanamivir, baloxavir, molnupiravir, peramivir, laninamivir, or combinations of these medications. There is also a control group that receives no antiviral treatment except paracetamol for fever. Dosages and administration routes vary by drug and include oral, inhaled, and intravenous methods. The trial uses randomization to assign treatments, with at least 20% of participants assigned to the no treatment group. During the first five days, researchers will monitor the rate of viral clearance to assess antiviral activity. Additional measures include symptom relief and fever duration over 14 days. Participants will be closely followed up, with assessments including rapid antigen or PCR tests for influenza, symptom tracking, and safety monitoring. The total study period covers initial treatment and observation up to two weeks after starting treatment.

This research aims to compare the effects of two blood-thinning medications, rivaroxaban and warfarin, in patients who develop a blood clot in the left ventricle of the heart after a heart attack. The study focuses on people who had a delayed hospital visit after their heart attack, a common issue in some regions, which increases the risk of such clots and related complications. The goal is to find out which medication better helps dissolve the clot and is safer to use. Participants will be randomly assigned to receive either rivaroxaban or warfarin. Those in the rivaroxaban group will take 15 to 20 mg doses depending on kidney function once daily with an evening meal. The warfarin group will start at 5 mg daily, adjusted to keep blood clotting levels within a target range, monitored by regular blood tests called INR. The study will last for three months, with follow-up visits scheduled to monitor treatment effects and any side effects. During the study, participants will undergo cardiac MRI scans to check if the blood clot has resolved after three months. Researchers will also monitor for major bleeding events and any embolic complications. Data will be securely collected and analyzed to assess the safety and effectiveness of both treatments. The study includes safety oversight by an independent board and plans to share findings through scientific publications and conferences.

Researchers are evaluating a mobile health mHealth behavioral intervention called TelTex4BP for adults with hypertension in Nepal. The study aims to improve blood pressure control and reduce the risk of cardiovascular disease CVD by delivering lifestyle counseling through phone calls and text messages. This hybrid type 2 effectiveness-implementation randomized controlled trial involves patients, their families, and healthcare providers to tailor the intervention to local culture and needs. Participants in the intervention group will receive structured counseling on healthy diet, physical activity, smoking, alcohol intake, medication adherence, and follow-up reminders via monthly phone calls and 2-3 text messages per week for six months. The control group will receive usual care including antihypertensive medication prescriptions, follow-up advice, and an informational pamphlet. Follow-up assessments will occur at six and twelve months to evaluate both short-term and long-term effects. Throughout the study, participants will undergo blood pressure measurements, assessments of 10-year CVD risk, medication adherence, dietary habits, and physical activity. Researchers will also evaluate how well the intervention is adopted and maintained using the RE-AIM framework. The total participation includes the six months of intervention and six months of follow-up to monitor sustainability and effectiveness of the mHealth support.

Postpartum hemorrhage and birth asphyxia are leading causes of death for mothers and newborns worldwide, especially in low and middle-income countries. While Nepal has improved maternal and neonatal health, gaps remain in healthcare providers knowledge and skills, likely due to limited practical experience. This study evaluates the implementation and effectiveness of simulation-based training centers in seven referral hospitals in Nepal to improve care for labor, bleeding after birth, and newborn resuscitation using a RE-AIM framework and a quasi-experimental pre- and post-test design. The project establishes high-fidelity simulation labs with multiple rooms and equipment in each hospital, providing training focused on Essential Care for Labor and Birth, Bleeding after Birth, and Helping Babies Breathe modules. Training is given to maternal and newborn health staff, including trainers and simulation lab operators. The intervention group receives this training after an initial pre-test phase. Data collection on maternal and neonatal health outcomes continues throughout pre-test, intervention, and post-test phases. Participants include women delivering vaginally, their newborns, and healthcare providers in the selected hospitals. Data collected include postpartum hemorrhage incidence, neonatal APGAR scores at 5 minutes, and blood transfusion rates after hemorrhage. Skills and team performance of providers are assessed before and six months after training. Qualitative interviews and focus groups explore challenges and implementation status. The study uses daily data collection and statistical analyses, with a total participation duration of about 15 months for outcome monitoring and six months for skill assessment.

Researchers are evaluating antiviral treatments for adults with early symptomatic COVID-19 who have high viral loads but are at low risk of severe illness. This Phase 2 trial aims to develop and validate a way to measure how well these treatments reduce the amount of virus in the body. The study compares three types of interventionssmall molecule drugs, monoclonal antibodies, and dose adjustments for nirmatrelvirritonaviragainst a control group that receives no antiviral treatment. The trial is adaptive and is supported by the Wellcome Trust through the COVID-19 Therapeutics Accelerator. The treatments studied include various small molecule drugs like nitazoxanide, nirmatrelvirritonavir, hydroxychloroquine, atilotrelvirritonavir, metformin, and monoclonal antibodies such as sotrovimab and others as they become available. Some treatment arms have been closed after meeting stopping criteria. Participants are randomly assigned to receive one of the available antiviral drugs or no treatment, with at least 20% assigned to the control group. Dosages vary by drug and are typically administered over 5 to 7 days. Participants will be monitored closely over the first 14 days, with daily assessments of viral levels and symptoms. Researchers will measure how quickly the virus clears from the body compared to no treatment or positive control arms. Additional outcomes include fever resolution and symptom improvement. Participants must be able to walk unaided and agree to follow-up visits. The study runs until January 2027 and aims to determine optimal dosing and antiviral effectiveness in early COVID-19 infection.

The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.

This research aims to evaluate the use of a lower international normalized ratio INR target range of 1.5 to 2.5 in patients with a mechanical bileaflet heart valve placed in the aortic position. The study seeks to determine whether lowering the INR target can reduce bleeding risks without increasing the chance of blood clots or stroke. This is important because patients with mechanical heart valves require lifelong warfarin Coumadin treatment to prevent clot formation, but managing the right balance between clot prevention and bleeding risk remains challenging. Participants will be randomly assigned to one of two groups. One group will receive warfarin therapy adjusted to a lower INR target range of 1.5 to 2.5, while the other group will have warfarin adjusted to a standard INR target range as currently recommended. Both groups will receive warfarin after their mechanical valve implant, but the INR targets for blood thinning will differ. The study includes follow-up over an expected mean of 2 to 3 years to monitor outcomes. During the study, participants will be regularly monitored for blood clot events such as thrombosis or stroke, as well as bleeding episodes, including major and minor bleeding. Researchers will track various outcomes like mortality, different types of stroke, heart attacks, pulmonary embolism, and kidney function over the study period. Time in the therapeutic INR range and occurrences of extreme INR values will also be recorded. Participants will be followed through the study duration, which will help determine the safety and risk balance of using a lower INR target in this patient group.

Hypertensive disorders during pregnancy HDP and gestational diabetes GDM are common complications that can cause serious health problems for mothers and babies. Researchers are studying the MOM-HD program, a mobile app-based telemonitoring system, to see if it helps women with HDP and GDM manage their blood pressure and blood glucose better. This study is a randomized controlled trial conducted in real-world hospital settings in Nepal, aiming to assess both the effectiveness and how well the program can be implemented in clinical care. The MOM-HD program includes training for patients and their families, provision of blood pressure monitors and glucometers, and a mobile app for uploading daily readings. Participants also have biweekly tele-visits with nurses who review their data and provide counseling. The study compares standard antenatal care alone to standard care plus the MOM-HD program, from enrollment during pregnancy up to 6 weeks after delivery. The program also involves ongoing technical support, financial assistance for home monitoring, and provider feedback to support sustained use. Participants will be followed from 24 to 30 weeks of pregnancy until 6 weeks postpartum. Researchers will monitor clinical outcomes such as blood pressure and blood glucose levels, and adverse perinatal events like neonatal intensive care admissions and cesarean deliveries. The study collects data through the app and provider portal, with regular telehealth check-ins, and evaluates implementation success and costs. Total participation lasts from enrollment in late pregnancy through the postpartum period, allowing comprehensive assessment of both health and program impact.

Researchers are investigating the effectiveness of a family-based intervention called MILAP to reduce depression, intimate partner violence IPV, and post-traumatic stress disorder PTSD among young married women in Nepal. IPV is a major health issue in low- and middle-income countries, often linked to mental health problems. This study focuses on how ongoing IPV and family dynamics, particularly involving mothers-in-law, impact young womens mental health and aims to evaluate MILAPs ability to improve outcomes and understand how it works. The MILAP intervention consists of nine sessions over nine weeks, involving the young woman, her husband, and mother-in-law. It starts with sessions for mothers-in-law and daughters-in-law to build support and empowerment, followed by sessions addressing depression with behavioral activation. Then, couples participate in behavioral therapy focusing on communication and trust. The final session includes the whole family to review lessons and prepare for challenges. The control group receives enhanced usual care with counseling and support services. Participants will be assessed at the start, after one month, and every three months up to one year using questionnaires covering depression, IPV, PTSD, and other mental health and social measures. Data collection includes interviews and surveys conducted in private settings. Researchers will analyze changes in depression, IPV, and PTSD, explore how the intervention works through mixed methods, and evaluate its cost-effectiveness. The study involves 300 families, each with a wife, husband, and mother-in-law, with half receiving MILAP and half receiving usual care.