Guishan District

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. The study aims to understand the safety of a treatment called finerenone when used together with standard medicines called ACE inhibitors or angiotensin receptor blockers (ARBs). These medicines help control kidney function and blood pressure by targeting a system called the renin-angiotensin-aldosterone system (RAAS), which is often overactive in CKD. Finerenone may help control this system more effectively alongside ACEI or ARB. Participants will receive finerenone in doses adjusted by age and body weight for up to 18 months. The study is open-label and single-arm, meaning all participants receive the treatment. Some participants already took finerenone in a previous study and will continue, while others will start anew. The treatment period lasts about 540 days with a 1-month follow-up after the last dose. Visits are planned at least 12 times for new finerenone users and 8 times for continuing users. During visits, participants will have their blood pressure, heart rate, temperature, height, and weight measured. Blood and urine samples will be collected to monitor kidney function and protein levels. Heart function will be checked using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use, side effects, and well-being. Researchers will track any medical problems during the study and check health about 30 days after treatment ends. The main focus is safety, including monitoring adverse events, potassium levels, and blood pressure changes over about 19 months.

Researchers are investigating a new treatment approach for children aged 6 months to less than 18 years who have chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. CKD causes the kidneys to work less effectively, leading to waste buildup and high blood pressure. Current treatments include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help regulate a system involved in blood pressure and kidney function. However, these treatments do not work for all patients. This study is focused on seeing if adding finerenone to ACEI or ARB can better control this system and improve kidney function. Participants will receive either finerenone or a placebo for about 180 days, alongside their usual ACEI or ARB medication. The study will adjust finerenone doses based on age and body weight. Before starting treatment, participants will attend up to two screening visits within 104 days to check eligibility. During the treatment phase, participants will make at least seven visits to the study site for ongoing care and monitoring. Throughout the study, doctors will measure participants' blood pressure, heart rate, temperature, height, and weight. They will collect blood and urine samples to monitor kidney function and protein levels. Heart health will be checked using electrocardiograms and echocardiography. Participants or their parents will answer questions about medication use, side effects, and how they feel. Researchers will track any medical problems that occur during the study and will follow up about 30 days after treatment ends. The main goal is to see how much the protein in urine changes from the start to day 180.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

This research investigates how metabolomic profiles can predict treatment response and side effects in patients with locally advanced rectal cancer undergoing total neoadjuvant therapy (TNT), which combines chemotherapy and radiation before surgery. Rectal cancer accounts for a significant portion of colorectal cancer cases in Taiwan, and currently, there is no reliable method to foresee how patients will respond to TNT or develop radiation proctitis, a common treatment side effect. Participants will have blood, urine, tissue, and fecal samples collected at various times: before treatment, during TNT, and after chemoradiotherapy. These samples will be analyzed using liquid chromatography-mass spectrometry (LC-MS) to identify metabolites associated with treatment outcomes and toxicities. Researchers will use advanced statistical methods to find metabolite patterns predicting clinical and pathological responses, as well as radiation-related side effects. Throughout the study, treatment response will be monitored by changes in tumor size and staging, and side effects will be graded using standard criteria. The main outcome is the accuracy of metabolomic profiles in predicting complete response to treatment, assessed from enrollment up to surgery or six months after radiotherapy. This comprehensive approach aims to develop non-invasive biomarkers to guide personalized care for rectal cancer patients.

Researchers are evaluating the Lupus Low Disease Activity State (LLDAS) in patients with Systemic Lupus Erythematosus (SLE), a complex autoimmune disease that affects multiple organs and causes significant health challenges. This international, multi-center prospective study aims to determine whether achieving LLDAS is linked to better health outcomes, including protection from irreversible organ damage over time. The study addresses the difficulty of measuring lupus activity and offers a more achievable target than complete remission, focusing on a low disease activity state that is more practical and meaningful for patients. Patients with SLE will be followed for approximately 5 years, with regular collection of data needed to assess LLDAS, including disease activity and treatment information. Annual evaluations will include recording lupus-related organ damage using the SLICC-ACR Damage Index and assessing quality of life with the Short Form 36 version 2 questionnaire. The study will analyze whether reaching or maintaining LLDAS is associated with reduced organ damage accrual. Participants will provide consent and be monitored regularly through clinical assessments and questionnaires. Researchers will track disease activity, treatment effects, damage progression, and quality of life during the study period. The primary outcome measured is the SLICC-ACR Damage Index over 5 to 10 years, helping to understand the long-term impact of maintaining low disease activity in lupus. This comprehensive approach aims to improve the management and prognosis of SLE patients.