Sanmin District

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

This research aims to evaluate the effects of a 12-week adapted table tennis program on the physical and mental health of adults with disabilities. Although sports participation among individuals with disabilities has increased due to medical advances and greater societal awareness, about 60% still do not engage in regular physical activity. The study seeks to fill the research gap on the health benefits of adapted table tennis, a sport known for its versatility and accessibility. Participants in the study will either join weekly 2-hour group table tennis sessions led by a professional adapted sports coach for 12 weeks or continue with their usual medical care without exercise training. The sessions will include warm-up exercises, basic techniques, skill practice, and cool-down stretches. Two groups are compared those receiving the adapted training and a control group receiving no exercise intervention. Throughout the study, researchers will assess participants before the program, immediately after 12 weeks, and again 6 months later. Measurements include muscle strength, lung capacity FVC and FEV1, walking or pushing distance in 6 minutes, flexibility, waist circumference, anxiety levels, bone density, blood lab values, body lean mass, and body fat percentage. These assessments aim to evaluate the impact of the adapted table tennis program on overall physical and mental well-being over time.

Researchers are evaluating a new simulation-based ethics education model designed to improve medical students knowledge, moral reasoning, communication skills, and problem-solving abilities. The study involves developing faculty competence, ethics courses, and clinical case scenarios with interdisciplinary experts. Medical students will be randomly assigned to either simulated ethical clinical situations or workshops discussing ethical case scenarios to compare educational outcomes. Participants will be divided into two groups one experiencing a simulated clinical ethical situation with simulation patients as the intervention group, and the other attending workshops discussing clinical ethical case scenarios as the control group. Faculty development and curriculum planning will support these interventions. The study will run over about two years, during which various instruments and strategies will be applied to assess the education models effectiveness. Throughout the study, participants will complete assessments such as the Defining Issues Test, Problem Identification Test, knowledge tests, and clinical ethical decision-making exams. Additional measures include an Objective Structured Clinical Examination and satisfaction questionnaires. These assessments aim to evaluate students ethical reasoning and communication skills. The study is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital and includes follow-up until study completion, averaging two years.

This research aims to develop a safe and systematic exercise assessment and prescription program specifically for cancer survivors who have completed their primary curative treatments at least two months prior. It addresses the challenges cancer patients face when starting exercise due to health risks and seeks to create a personalized, reproducible workflow for exercise prescription based on thorough health evaluations. Participants undergo a comprehensive evaluation led by a physiatrist, including medical history review, cardiovascular risk profiling, functional physical fitness tests, cardiopulmonary exercise testing CPET, and musculoskeletal ultrasound if needed. Based on these assessments, participants are classified into high, moderate, or low exercise risk groups and receive individualized exercise prescriptions involving aerobic, resistance, and flexibility training tailored in intensity, frequency, and duration. The study involves ongoing exercise with continuous monitoring and adjustments. During the study, participants track their exercise progress weekly using training logs and report every four weeks. Full reassessments occur at baseline, three months, and six months to safely adjust exercise prescriptions. Researchers measure outcomes such as handgrip strength, arm curls, chair stands, balance, walking distance, peak oxygen consumption, and quality of life questionnaires. The program includes safety monitoring and data feedback to ensure ongoing participant safety and intervention quality.

Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.

This research aims to evaluate the long-term safety and effectiveness of lentiviral-based gene-edited immune cell therapy in patients who have previously received this treatment. It follows guidance from health authorities recommending observation for delayed adverse events for up to 15 years after gene therapy. The study focuses on patients with various types of large B-cell lymphomas who have undergone this gene-edited immune cell therapy. Participants join this observational study after completing or withdrawing early from another treatment protocol involving Pells lentiviral-based gene-edited immune cells. If patients do not enter the follow-up study immediately, they may still join anytime within 15 years after their last gene-edited immune cell infusion. Some participants might also join other gene-edited immune cell therapy studies during this follow-up while remaining enrolled here as inactive participants. During the study, researchers will monitor for delayed side effects possibly related to the previous gene therapy, check for replication-competent lentivirus, and assess how long the gene-edited immune cells persist in the blood using specialized lab tests over periods up to 15 years. They will also evaluate long-term treatment effectiveness. Participants will provide consent and be followed closely according to the study protocol to ensure thorough safety and efficacy evaluation over the long term.

Overactive bladder OAB is a common condition causing urinary urgency, frequent urination, and nighttime urination, which can greatly impact quality of life. Women with metabolic syndrome, a group of conditions including high blood pressure, high blood sugar, abnormal cholesterol, and abdominal obesity, may have a higher risk of OAB. This study evaluates the safety and effectiveness of low-energy extracorporeal shock wave therapy LiESWT, a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either active LiESWT or a sham inactive procedure that mimics the treatment without delivering shock waves. LiESWT is applied using a focused shock wave device at a specific energy and frequency setting, with 3,000 pulses per session directed at the bladder area. The study is double-blind and sham-controlled to compare outcomes between groups. Participants will complete validated questionnaires measuring OAB symptoms, urinary distress, and impact on daily life at baseline and follow-ups up to 24 weeks. Additional assessments include urine flow rates, bladder ultrasound to measure residual urine volume, and a 3-day voiding diary to track urine output and frequency. These measures will help determine changes in symptoms and bladder function over the study period.

Researchers are evaluating the safety and effectiveness of ADI-PEG 20 in adults with Nonalcoholic Steatohepatitis NASH, a liver condition characterized by fat buildup and inflammation. This phase 2A clinical trial compares ADI-PEG 20 with a placebo to understand its impact on liver fat reduction. The study includes careful monitoring of side effects and laboratory tests to ensure participant safety. Participants receive weekly doses of ADI-PEG 20 or placebo via intramuscular injection at 36 mgm2. The trial is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts 24 weeks, during which liver fat changes are assessed using MRI-PDFF imaging. An independent committee oversees safety by reviewing adverse events and clinical data. During the study, participants undergo regular health evaluations including vital signs, body weight checks, ECGs, and blood tests. Liver fat levels are measured at the start and at week 24 to assess treatment effects. Safety is monitored continuously through adverse event reporting and laboratory tests. The total participation time spans 24 weeks, with ongoing review of safety and efficacy outcomes throughout.