Biratnagar

Researchers are evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

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.

Depression and anxiety are major contributors to disability among adolescents worldwide, often leading to serious challenges like impaired learning and social issues. This research focuses on promoting mental health in adolescents aged 12 to 19 in Nepal by using sports groups as a way to engage and support them. The study aims to test whether this sports-based mental health promotion intervention is feasible, acceptable, and useful in community settings with limited resources. The trial uses a cluster-randomized controlled design with four geographic village clusters, two receiving the sports-based intervention and two serving as controls. The intervention will last about 10 months and is open to all adolescents in the selected communities. After initial baseline surveys, the program will be conducted, followed by endline data collection to assess changes in mental wellbeing. The study also includes training and supervision of facilitators, and gathers feedback from participants, parents, and trainers. Participants will be interviewed at home using surveys on smartphones or tablets at the start and end of the study. Researchers will monitor how well the intervention is delivered and accepted, track mental health trends, and evaluate costs. Additional data will be collected through group discussions and interviews to understand the experience and feasibility. The primary outcome measured is the change in mental wellbeing from the beginning to 10 months after the intervention.