Xinyi District

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating an AI-driven cognitive digital therapeutics system designed to support people with mild neurocognitive disorder or dementia, aged 50 years and older. The study aims to assess the effects of this digital therapy on daily living activities and cognitive function compared to usual care. The trial is randomized and double-blind, sponsored by Taipei Medical University WanFang Hospital. Participants in the intervention group will receive digital therapeutics sessions three times per week for eight weeks. During each session, patients perform tasks using objects following instructions displayed by a device, while a camera records their performance for analysis. The control group will receive standard care without these digital sessions. Evaluations occur at the start, at week 8, and at week 16 to monitor progress. Throughout the study, participants will be assessed with several cognitive and functional tests including the Instrumental Activities of Daily Living IADL, Montreal Cognitive Assessment MoCA, Mini-Mental State Examination MMSE, Clinical Dementia Rating CDR, and Executive Function Performance Test EFPT. These measurements will be taken at baseline, week 8, and week 16. The study will also monitor safety and adherence, with total participation lasting at least 16 weeks.

Researchers are evaluating Ratutrelvir 83-0060, a drug that inhibits the main protease of SARS-CoV-2, along with Paxlovid Nirmatrelvir plus Ritonavir, to understand their safety and effectiveness in adults with mild to moderate COVID-19 who are not hospitalized. This open-label, randomized Phase 2a study aims to determine a safe and effective dose of Ratutrelvir and compare it with standard care, providing important information on how these treatments may help manage COVID-19 symptoms and recovery. Participants will be assigned to receive either Ratutrelvir or Paxlovid alongside standard care. The study is multicenter and open-label, meaning both researchers and participants know which treatment is given. The trial includes an experimental group receiving Ratutrelvir, a comparator group receiving Paxlovid, and a non-randomized group receiving Ratutrelvir. Treatment is given during the study period, and the research team monitors the drugs concentration in the blood to understand how it behaves in the body. During the 28-day study period, participants will be closely monitored for safety based on the occurrence and severity of any adverse events. The team will assess how long it takes for COVID-19 symptoms to improve and recover fully. Blood samples will be collected up to day 11 to analyze drug levels. Participants will undergo symptom evaluations regularly, and their health will be tracked throughout the study to ensure safety and gather data on treatment effects.

This research aims to evaluate the effects of an intelligent parent-child bonding intervention on the physical, psychological, and social health of parents with premature infants. The study focuses on parents of babies born before 37 weeks of gestation, addressing challenges such as stress, anxiety, depression, and the impact of mother-child separation. Conducted as a three-year randomized controlled trial, it seeks to improve outcomes related to parent-child relationships and family well-being. Participants are randomly assigned to either receive usual care or the intelligent parent-child bonding intervention. The intervention uses web platforms, software, cloud files, and official communication channels to provide knowledge, skills, and support during hospitalization and up to one month after the premature infant returns home. It includes guidance on care, psychological support, sleep routines, nutrition, and relationship management. The usual care group receives standard hospitalization care and general nursing guidance before discharge. Throughout the study, parents will complete questionnaires and biometric assessments at multiple points before the intervention, two weeks after starting, before hospital discharge, and one month after returning home. Researchers will monitor outcomes including sleep quality, fatigue, stress, anxiety, depression, self-efficacy, parent-child bonding, partner relationships, family resilience, and overall quality of life. The total study duration spans hospitalization through the first month post-discharge, with data analyzed to assess the interventions impact.

Researchers are studying chronic kidney disease CKD patients who have a higher risk of developing peripheral artery disease PAD, a condition affecting blood flow in the limbs. The study aims to evaluate the effects of a carbon-based oral adsorbent made from activated bamboo charcoal ABC, with or without added probiotics, on vascular and endothelial function, cardiovascular outcomes, and mortality in these patients. They also plan to explore how circulating long noncoding RNA lncRNA and metabolome profiles may predict adverse cardiovascular events and death, while investigating the link between these biomarkers and gut microbiota imbalance in CKD patients with PAD. This is a randomized, open-label trial lasting 6 months, where 120 CKD patients with PAD and 60 healthy controls without PAD will be assigned to receive either the ABC treatment or no treatment. Participants in the treatment groups will take CharXenPlus containing 2g of ABC three times daily for 6 months. Additionally, probiotics will be given once daily during the last 3 months to some subgroups. Samples of urine, stool, and plasma will be collected and stored for further analysis. The trial includes detailed monitoring of kidney function, vascular health, and microbiota changes. Participants will undergo assessments at the start, at 3 months, and at 6 months, including tests such as the six-minute walk test and ankle-brachial index ABI. Researchers will also measure changes in lncRNA, microbiota composition, endothelial progenitor cells, kidney function eGFR, and albuminuria. The study will track cardiovascular, kidney, and limb health outcomes for up to 3 years. Privacy is protected by coded samples and data storage, with the option for participants to allow long-term storage of their samples for future research.