Ren Ai District

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment to delay the return of depressive symptoms in adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have had moderate to severe recurrent MDD or persistent depressive disorder and have not responded adequately to oral antidepressant treatments. The goal is to maintain the positive effects of treatment and prevent relapse over a period of up to approximately 32 months. Participants receive either the study drug NBI-1065845 or a placebo in oral tablet form, both given alongside their ongoing oral antidepressant medications. They must continue their current antidepressant treatment at the same dose and frequency throughout the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatments. During the study, participants are monitored from the time of randomization until relapse or the study end, which may last up to 32 months. Researchers assess the time it takes for depressive symptoms to return, using measures such as the Hamilton Depression Rating Scale. Participants are expected to comply with all study procedures and restrictions, and safety monitoring is conducted throughout the study period.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating whether measuring the overall adenoma detection rate (ADR) during colonoscopy can reliably replace the standard screening ADR. This prospective study involves patients aged 50 to 80 undergoing colonoscopy for various reasons including screening, surveillance, diagnosis, or positive fecal immunochemical test (FIT). The study is conducted across five hospitals in Taiwan with 18 colonoscopists and aims to recruit 2700 participants over two years to compare ADRs across these different indication groups and explore their correlations. The study compares ADRs using the traditional screening-only definition against combined indications excluding FIT (overall-non-FIT) and including FIT (overall-FIT). Colonoscopies will be performed as usual, and ADRs will be calculated for each indication category. The study design includes collaboration with an expert from the USA who will assist with data analysis and reporting. Participants will undergo colonoscopy with data collected on adenoma detection rates within 7 days as the primary outcome. The study gathers information on colonoscopy indications and patient characteristics. Safety and eligibility are monitored, with patients excluded for high-risk colorectal cancer family history, certain syndromes, inflammatory bowel disease, large neoplastic polyp removal, colon obstruction, bleeding, other study participation, hospitalization, mental retardation, pregnancy, or refusal to consent. The total participation period involves the colonoscopy and follow-up for outcome measurement.

Researchers are investigating the combination of CVM-1118 and nivolumab for treating subjects with unresectable advanced hepatocellular carcinoma (HCC). CVM-1118 is a new small molecule developed as a potential anti-cancer drug that promotes cancer cell death and delays tumor growth. Nivolumab is a monoclonal antibody that helps the immune system attack cancer by blocking specific proteins that prevent T cells from attacking tumors. This phase 2 trial aims to assess the effectiveness of this combination therapy based on prior safety data and the potential complementary actions of both drugs. In the study, participants receive CVM-1118 orally twice a day, starting at 200 mg with the option to increase to 300 mg based on safety assessments from the first group of subjects. Nivolumab is given intravenously at 240 mg every two weeks, with an option to switch to 480 mg every four weeks from the third treatment cycle depending on safety and tolerability. The treatment targets advanced HCC tumors that cannot be surgically removed, focusing on overcoming mechanisms like vasculogenic mimicry that contribute to tumor growth and spread. Participants will undergo regular assessments including imaging to measure tumor response using modified RECIST criteria at 24 weeks after the last subject begins CVM-1118 treatment. Safety will be closely monitored along with laboratory tests, physical exams, and performance status evaluations. The main outcome measured is the objective response rate to the combination therapy. The study includes adult participants with advanced liver cancer who meet specific liver function and health criteria, and they will be followed throughout the treatment period to evaluate the effects of the drugs.

Researchers are evaluating an 8-week Dyadic Co-learning Intervention designed to support patients with prostate cancer and their spouses in managing the challenges of cancer together. This study aims to improve physical symptoms, emotional well-being, and resilience for both patients and their partners. The study uses a randomized controlled design to compare the new co-learning program combined with regular care against regular care alone. Participants will be assigned to one of two groups: one receiving standard care, and the other receiving standard care plus the Dyadic Co-learning Intervention. This intervention includes a co-learning handbook, a mobile app for shared learning, and professional support to guide participants through weekly learning topics over eight weeks. Both patients and their spouses will be involved in the program and its activities. Participants will complete questionnaires at the start of the study, and again at 10 and 16 weeks, to measure family resilience and other health outcomes. The study collects baseline data before the intervention, with follow-up assessments to evaluate changes in physical and emotional health. The total involvement period spans 16 weeks, allowing researchers to monitor the impact of the intervention over time.

Researchers are evaluating how two different educational methods can improve the use of the "My Health Bank" App, a personal health record system in Taiwan, among adults aged 50 and older. This study aims to address the digital divide faced by older adults by comparing a one-on-one intensive guided learning approach with a flexible self-study method that uses materials co-created with Generative AI. The goal is to find effective and scalable ways to boost digital health literacy, self-confidence in using health apps, and actual app usage behavior. The study spans 18 months and is divided into three phases. The first phase focuses on developing and validating AI-assisted educational materials and conducting a pilot trial with 60 participants to test the materials' feasibility. The second phase involves a full randomized controlled trial with 160 participants who will be assigned to either the intensive guided learning group or the flexible self-study group, with follow-up data collected at three time points. The final phase centers on data analysis and preparing the study's results for publication. Participants will be involved in learning how to use the "My Health Bank" App through either instructor-led sessions or self-study using AI-generated materials. Researchers will assess changes in digital health literacy using the eHealth Literacy Scale at the start, one week after, and four weeks after the intervention. They will also monitor how often participants use the app and their confidence in managing their digital health. The study aims to provide evidence on the best ways to support older adults in managing their health digitally.

Researchers are evaluating the safety and effectiveness of JNJ-90301900 (NBTXR3) combined with radiation therapy, with or without cetuximab, in elderly patients who have locally advanced head and neck squamous cell carcinoma (LA-HNSCC) and are not eligible for platinum-based chemotherapy. This Phase 3, global, open-label, randomized study focuses on treatment-naive participants aged 60 and older with this specific type of cancer. The study compares two treatment approaches: one group receives JNJ-90301900 (NBTXR3), an investigational drug made of inert hafnium oxide particles designed to enhance the effect of radiation, combined with intensity-modulated radiation therapy (IMRT) delivering 70 Gray over 35 fractions in 7 weeks, plus the option of cetuximab; the other group receives radiation therapy with or without cetuximab according to the investigator's choice. Participants receive their assigned treatments during the study period. Participants will be closely monitored through 30 months after the first randomized participant to assess progression-free survival based on independent central review. Researchers will evaluate treatment safety and effectiveness, including regular assessments of cancer progression and patient health status. The study includes detailed eligibility screening and ongoing follow-up to ensure patient well-being throughout the trial.