Hyderabad

This trial investigates the effectiveness and safety of apixaban combined with carvedilol compared to carvedilol alone in preventing complications related to portal hypertension in patients with cirrhosis. Conducted in Hyderabad, Pakistan, it enrolls adults with cirrhosis and portal hypertension, focusing on preventing events like variceal bleeding, ascites, hepatic encephalopathy, portal vein thrombosis, and liver-related death. The study is a prospective, randomized, single-blind, placebo-controlled Phase 4 trial aimed at providing local evidence for apixaban use in cirrhosis management. Participants are randomly assigned to receive either apixaban 2.5 mg twice daily plus carvedilol, or placebo plus carvedilol. Carvedilol is started at 6.25 mg once daily and gradually increased every 2-4 weeks to a target dose of 12.5 mg twice daily as tolerated. Apixaban dosing is adjusted based on kidney function and stopped in case of major bleeding or severe liver worsening. The treatment period lasts 12 months, during which safety and adherence are closely monitored. Throughout the 12-month study, participants have visits at baseline, 2 weeks (phone call), and 1, 3, 6, 9, and 12 months for health checks, laboratory tests, ultrasound imaging, and liver stiffness measurements. Researchers track portal hypertension complications as the primary outcome and monitor bleeding events, hospitalizations, mortality, and changes in portal hypertension markers. Safety is overseen by a monitoring board reviewing data mid-study, with adverse events graded using established criteria. A total of 220 participants will be enrolled, with results to be published within a year after completion.

Researchers are evaluating whether a culturally adapted, multicomponent intervention can improve survival and rehabilitation outcomes for adults with accidental burn injuries in Pakistan. This study compares an integrated case management approach to enhanced usual care, aiming to enhance both physical and psychosocial rehabilitation for burn survivors and their families. The trial is conducted across six cities including Karachi, Hyderabad, Lahore, Rawalpindi, Peshawar, and Quetta, using a randomized, parallel group design. Participants in the intervention group receive integrated case management delivered by trained allied health professionals such as nurses, physiotherapists, and psychologists. This includes 8 sessions: six low-intensity sessions lasting 30-60 minutes each, delivered during hospital stay or in the community, and two 30-minute follow-up sessions after discharge to support transition and continued care. The control group receives usual emergency, surgical, and rehabilitation care plus brief written self-help advice. Participants will be assessed at baseline, then at 3, 6, and 12 months after the intervention. Researchers will measure outcomes including all-cause mortality, hospital readmissions, and health-related quality of life using a composite score. The study also monitors treatment adherence and cost-effectiveness over the 12-month follow-up period to understand the impact of the integrated care approach compared to standard care.

Obesity is a significant health issue in Pakistan, contributing to heart disease, metabolic problems, liver disease, high blood pressure, and lowered quality of life. This trial evaluates the safety and effect of low-dose semaglutide, a medication, for weight loss and improving heart and metabolic health in obese Pakistani adults without type 2 diabetes. It is a Phase 4, single-center, open-label pilot study enrolling 60 adults aged 18 or older with a body mass index (BMI) of 27.5 kg/m² or higher, using criteria tailored to Asian populations. Participants will receive once-weekly injections of semaglutide with doses increasing from 0.25 mg weekly for 4 weeks, then 0.5 mg weekly for 4 weeks, followed by 1.0 mg weekly for 16 weeks, totaling 24 weeks of treatment. Alongside medication, all participants will receive guidance on a low-calorie diet with a daily deficit of 500-750 calories and encouragement to engage in at least 150 minutes of moderate exercise weekly. The treatment is supervised, and participants will be trained in proper injection technique and adherence. Throughout the study, participants will have clinical and lab checks at the start, 12 weeks, and 24 weeks to monitor safety and effectiveness. Researchers will measure weight changes as the main outcome and also track body mass index, waist size, blood pressure, cholesterol, liver enzymes, and quality of life. Safety will be closely monitored by recording any side effects or adverse reactions. Data will be analyzed statistically to understand the treatment's impact, supporting future research and clinical use in this population.

Severe pulmonary hypertension caused by rheumatic chronic valvular heart disease is common in low- and middle-income countries and leads to high illness and death rates. Many patients are diagnosed late with advanced disease, which limits surgery options and worsens outcomes. This research investigates whether adding sildenafil, a drug that helps relax blood vessels in the lungs, to standard medical treatment can improve health in these patients. The trial is a double-blind, placebo-controlled study to test sildenafil's safety and effectiveness in this specific group. Participants with severe pulmonary hypertension due to rheumatic valvular disease will be randomly assigned to receive either sildenafil 25 mg three times daily or a placebo, alongside their usual treatments, for six weeks. The study is conducted in adult cardiology and cardiac surgery departments in Pakistan. Randomization is done electronically with concealment, and neither participants nor researchers assessing outcomes will know which treatment is given. The trial excludes patients planning surgery within six weeks or with certain unstable heart conditions or contraindications to sildenafil. During the six-week treatment, participants will be followed regularly to monitor medication adherence and any side effects. The main result measured is the change in the distance walked in six minutes from the start to six weeks. Secondary results include changes in heart function, lung artery pressure, symptoms according to NYHA class, and hospitalizations. Safety is closely monitored with follow-up calls, and the study aims to provide evidence to guide medical care for patients awaiting surgery.