Xinzhuang District

Researchers are studying how COVID-19 affects patients with cancer who are receiving different types of anti-cancer treatments. Since cancer patients are more vulnerable to the virus, many countries have prioritized their vaccination, but these patients were not included in the original vaccine trials. This study aims to understand the changes in protective antibodies after vaccination or natural infection in cancer patients undergoing chemotherapy, targeted therapy, or immunotherapy, as well as to explore how aging impacts immune responses. The study enrolls adults over 20 years old who have solid organ cancers and are either receiving anti-cancer therapies or have been disease-free for at least six months. Participants include those fully vaccinated with any COVID-19 vaccine or those who agree to complete vaccination later. The research involves monitoring antibody levels related to COVID-19 over time among these patients to observe trends in immunity. Participants will be followed for up to 12 months, with antibody tests conducted at 3, 6, 9, and 12 months to measure neutralizing and spike protein antibodies. The study collects data on how different cancer treatments affect antibody responses and monitors safety through regular outpatient follow-ups. Participation includes consenting to testing and follow-up visits to support understanding of vaccine efficacy and infection progression in cancer patients.

Researchers are evaluating a new approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have experienced a stroke. This study compares the effects of CAR-ST with strategy training alone and an educational program, aiming to determine if involving caregivers enhances recovery and if these improvements extend beyond activity performance to other areas like participation and impairment. The trial is a randomized controlled study involving community-dwelling stroke survivors with functional limitations. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training only, or an education program. The CAR-ST intervention involves both the stroke survivor and their caregiver working together at home, with caregivers actively supporting and motivating practice. Strategy training alone guides only the stroke survivor, while the education program provides information about stroke types, risk factors, healthy lifestyles, and adaptive skills. Each participant will receive 1 to 2 sessions per week until completing 10 sessions. Throughout the study, participants will be assessed at four time points: before the intervention, immediately after, and at 3-month and 6-month follow-ups. The main measure is the Activity Measure for Post-Acute Care (AM-PAC) outpatient short form, evaluating changes in activity performance. Additional assessments include participation, quality of life, stroke self-efficacy, motor function, cognitive screening, and goal achievement. Researchers will also conduct interviews to gather participant, caregiver, and therapist experiences and satisfaction with the interventions.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying cardiac amyloidosis (CA), a condition where amyloid proteins build up in the heart, focusing on two common types: immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). ATTR can be hereditary (ATTRm) or wild-type (ATTRwt), with a common mutation (A97S) found in Taiwan. Early diagnosis and proper treatment are crucial for a better outlook. The study aims to improve diagnosis and prognosis by analyzing clinical and imaging data, as there is currently limited large-scale research and standardization. The study involves collecting and comparing data from patients suspected or diagnosed with ATTR-CM who have undergone 99mTc-PYP cardiac scans at multiple medical centers in Taiwan. These scans are assessed for quality and visually graded by expert nuclear medicine physicians. Patients with higher grade PYP uptake will have additional genetic testing and serum and urine AL tests. The project uses artificial intelligence to analyze the scan images and key cardiovascular data to develop prediction models for diagnosis and prognosis. Participants will be followed for at least one year after their scans. Researchers will gather clinical information, imaging results, and laboratory tests to validate the significance of the prediction models. The study monitors outcomes including survival at one year. This registry aims to provide real-world data to support better, patient-focused clinical decisions for those with suspected or diagnosed cardiac amyloidosis.