Ren Ai District

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are evaluating the effectiveness of NBI-1065845 compared with a placebo as an additional treatment to delay the return of depressive symptoms in people with major depressive disorder MDD. This Phase 3 study focuses on maintaining the treatment effect in participants diagnosed with recurrent moderate or severe MDD or persistent depressive disorder who have not fully responded to oral antidepressants. Participants first receive NBI-1065845 during an open-label treatment period. Then, in a randomized, double-blind phase, participants are assigned to either continue NBI-1065845 or switch to a matching placebo. The study uses oral tablets for both NBI-1065845 and placebo treatments and follows a parallel study model. Throughout the trial, participants will be monitored for relapse of depressive symptoms using the Hamilton Depression Rating Scale and other assessments. The primary outcome is the time from randomization until relapse or study end, lasting up to approximately 32 months. Participants must continue their antidepressant treatments at the same dose during the study and comply with all procedures and restrictions. Safety and adherence are closely observed by the investigators during the entire study period.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating whether the overall adenoma detection rate ADR can be a reliable alternative to the screening ADR in colonoscopy procedures. This prospective multicenter study involves 18 colonoscopists from five hospitals in Taiwan and plans to recruit 2,700 participants aged 50 to 80 years over two years. The study includes patients undergoing colonoscopy for screening, surveillance, diagnostic reasons, or positive fecal immunochemical test FIT results. The goal is to compare ADRs across these groups and explore correlations between screening ADR and overall ADR including or excluding FIT-positive cases. Participants will be grouped based on their colonoscopy indication screening asymptomatic with no or negative prior colonoscopy, surveillance with prior colon neoplasms, diagnostic symptomatic or abnormal test findings, and FIT-positive positive FIT results regardless of recent colonoscopy. The study will compare ADRs using traditional screening definitions and combined indications, including the impact of adding FIT-positive patients to overall ADR calculations. During the study, participants will undergo colonoscopy according to their indication. Researchers will measure the adenoma detection rate within 7 days as the primary outcome. Data collection will include categorizing patients and analyzing ADR correlations. The study will monitor participants throughout the procedure and follow-up as needed, with a total study duration of two years and study completion planned by September 2026.

Researchers are evaluating the combination of CVM-1118, a new small molecule anti-cancer drug, with nivolumab, an immune checkpoint inhibitor, in people with unresectable advanced hepatocellular carcinoma HCC. This phase 2 study aims to further investigate the effectiveness of this combination treatment after safety was established in earlier studies. The trial focuses on HCC that cannot be removed by surgery and has progressed despite prior therapies, addressing a significant need for advanced liver cancer care. Participants receive nivolumab intravenously every two weeks at 240 mg, with an option to increase to 480 mg every four weeks from cycle 3 based on safety and tolerability. CVM-1118 is given orally twice daily starting at 200 mg, with a possible increase to 300 mg twice daily after safety assessment. Treatment cycles last 28 days and continue until disease progression, unacceptable side effects, or withdrawal of consent. During the study, participants undergo regular assessments including imaging scans to measure tumor response, laboratory tests, vital sign monitoring, and evaluation of side effects. The main outcome is the objective response rate measured 24 weeks after the last participant begins CVM-1118. Secondary outcomes include duration of response, progression-free and overall survival, safety assessments, and drug concentration levels. Follow-up continues for up to one year after the last dose to monitor long-term effects and safety.

Researchers are evaluating a Dyadic Co-learning Intervention designed for patients with prostate cancer and their spouses to help them better cope with the challenges of cancer. This study aims to improve physical symptoms, emotional well-being, and resilience through shared learning and support. The trial uses a randomized controlled design to compare routine care alone with routine care plus the new co-learning program. Participants will be randomly assigned to either a control group receiving routine care or an experimental group receiving routine care plus an 8-week Dyadic Co-learning Intervention. This intervention includes a co-learning handbook, a mobile app, and professional support. The program encourages patients and their spouses to learn and support each other together over the course of 8 weeks. Participants will complete questionnaires at the start of the study, and again at 10 and 16 weeks after baseline to measure outcomes such as family resilience, physical symptoms, fatigue, loneliness, subjective well-being, and satisfaction with the intervention. The study monitors both patients and spouses to assess the interventions effects on their health and well-being over time.

Researchers are evaluating two educational approaches to improve the use of the My Health Bank App, a personal health record system in Taiwan, among adults aged 50 and older. The study aims to address the digital divide faced by older adults by comparing the effectiveness of intensive guided learning versus flexible self-study using AI-co-created educational materials. The trial is designed as a randomized controlled study to assess improvements in digital health literacy, self-efficacy, and app usage behavior. The study is conducted over 18 months and divided into three phases. The first phase involves developing AI-collaborative educational materials and testing their feasibility in a pilot trial. The second phase enrolls participants in a formal randomized controlled trial where they are assigned to either an intensive guided learning group with instructor support or a flexible self-study group using the same materials independently. The final phase focuses on data analysis and reporting. Both groups use the My Health Bank App and educational content designed to enhance digital health skills. Participants will undergo assessments at baseline, one week, and four weeks post-intervention, including measurements of eHealth literacy and general self-efficacy. Researchers will track changes in these scores and app usage behavior to evaluate the interventions. The study includes cognitive screening and monitoring of participants ability to install and use the app. Data will be collected and analyzed to identify effective strategies for improving digital health management among adults over 50.

This research aims to evaluate how two different virtual reality-based preoperative education methods affect anxiety, learning, self-care ability, and cognitive load in patients undergoing urolithiasis surgery. The trial compares routine education, standard virtual reality education, and an enhanced two-tier virtual reality education approach. The study addresses common preoperative anxiety and aims to improve patient preparation using immersive, interactive VR technology combined with knowledge testing and feedback. Participants are randomly assigned to one of three groups routine preoperative education provided by nursing staff, standard virtual reality education featuring immersive 360-degree content about the surgery and self-care, or two-tier virtual reality education that adds interactive questioning and feedback to improve understanding and engagement. These educational interventions are delivered before the urolithiasis surgery. During the study, participants anxiety levels are measured before and after the intervention and on the first day after surgery using established anxiety scales. Knowledge about urolithiasis surgery, self-care abilities, and cognitive load are also assessed at various points. The study monitors how well patients learn and manage self-care and tracks their anxiety through the perioperative period. Participation involves completing questionnaires and using virtual reality equipment before surgery.