Chuncheon

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet Filgotinib Maleate 100 mg and 200 mg in Korean participants using it in real-world conditions. The study focuses on monitoring serious and non-serious adverse events and drug reactions, including unexpected ones, as well as changes in disease activity scores related to rheumatoid arthritis and ulcerative colitis. Participants prescribed Jyseleca according to Korean approved therapeutic indications will be observed without additional intervention. They will be followed for up to 24 weeks or until they stop treatment due to adverse events or other reasons. The study includes adults with rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior treatments. During the study, researchers will track adverse events and reactions from enrollment through 24 weeks. They will also measure changes in disease activity scores at baseline, week 12, and week 24. Participants will have regular monitoring visits as part of their usual care, with data collected about safety and treatment effects. The total participation time is up to 24 weeks.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the effects of aspirin and high-intensity statin therapy in people with severe coronary calcification, defined as a coronary calcium score of 300 or higher. The trial aims to understand how these treatments may help prevent atherosclerotic cardiovascular disease ASCVD events in this population. This phase 4, randomized, open-label trial uses a factorial design to assess both aspirin use and statin intensity. Participants are assigned to one of four groups aspirin 100 mgday with high-intensity statin therapy no aspirin with high-intensity statin therapy no aspirin with guideline-directed statin therapy or aspirin 100 mgday with guideline-directed statin therapy. Statin intensity follows the 2026 ACCAHA Guideline on the Management of Dyslipidemia. The study treatment lasts for 3 years, during which participants take the assigned medications. Throughout the trial, participants will be monitored for cardiovascular events and safety outcomes over 3 years. The main outcome is the rate of a composite of ASCVD events. Secondary outcomes include rates of individual cardiovascular events, death from any cause, hospitalization for heart failure, major bleeding, and safety endpoints. Participants will provide informed consent and follow the study protocol with scheduled clinical follow-ups to assess these outcomes.

Researchers are evaluating the effect of low-dose aspirin 100 mg daily on preventing gastric cancer in patients with early gastric cancer or high-grade adenoma who have undergone endoscopic resection and have a negative or eradicated Helicobacter pylori status. This randomized, placebo-controlled Phase 3 trial addresses limitations in previous studies by focusing specifically on gastric cancer prevention with appropriate sample size and follow-up. Aspirin is commonly used to reduce cardiovascular risks, and some evidence suggests it may also lower gastrointestinal cancer risk, but more targeted research is needed. Participants will be randomly assigned to receive either enteric-coated aspirin 100 mg daily or a placebo tablet for five years. This double-blind study compares the incidence of gastric cancer between the aspirin and placebo groups. The trial includes a treatment period of five years, during which participants take the assigned medication daily. The study also monitors secondary outcomes like mortality, cardiovascular events, occurrence of other cancers, gastric dysplasia, aspirin-related complications, and gastric tissue improvements. During the study, participants will undergo regular assessments including pathology reviews after endoscopic resection and monitoring for adverse events. Researchers will track the primary outcome of gastric cancer incidence throughout the treatment period. Secondary outcomes such as cardiovascular disease rates and overall survival will also be evaluated. The total participant involvement includes screening, a five-year medication period, and ongoing monitoring to assess treatment effects and safety.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating the diagnostic performance and clinical impact of coronary angiography and intravascular ultrasound IVUS-based machine learning ML models in patients with coronary artery disease undergoing percutaneous coronary intervention PCI. This multicenter, prospective study aims to validate these AI-driven tools for decision making and stent optimization by assessing their prognostic effects on treated and deferred coronary lesions. The study will enroll 3,000 patients from 16 centers between January 2020 and June 2027. Participants will undergo coronary angiography with or without fractional flow reserve FFR measurement and IVUS imaging. The study evaluates ML algorithms including angiography- and IVUS-based models predicting FFR, plaque characterization, stent expansion, and post-stenting stent failure. The trial focuses on two primary objectives the impact of the integrated ML model on 2-year target vessel failure TVF related to treated culprit lesions and deferred nonculprit lesions. During the study, researchers will monitor participants over two years after stent implantation to measure outcomes such as culprit- and nonculprit-related TVF. Additional outcomes include death from any cause, repeat revascularization, stroke, and bleeding events. Data from coronary imaging, clinical evaluations, and follow-up visits will be collected to assess the clinical value of the AI models and their influence on patient outcomes.

Researchers are evaluating the efficacy and safety of autologous Mesenchymal Stem Cells MSC injected into the hepatic artery for patients with alcoholic liver cirrhosis. This phase III clinical trial aims to assess the effects of a single dose of Cellgram-LC on patients with this condition, focusing on outcomes up to 60 months after treatment. The study is sponsored by Pharmicell Co., Ltd. and involves patients diagnosed with alcoholic cirrhosis who meet specific clinical criteria. Participants are randomly assigned to one of two groups one receiving best supportive care without intervention, and the other receiving a single injection of 7x107 autologous bone marrow-derived mesenchymal stem cells Cellgram-LC delivered directly into the liver through the hepatic artery. The injection is performed within one month after bone marrow extraction. This open-label study monitors patients over several years to evaluate long-term outcomes. During the trial, participants undergo various assessments including survival evaluations, liver function tests, fibrosis measurements, and quality of life questionnaires at multiple time points up to 36 months. Researchers monitor transplant-free survival as the primary outcome over three years. Secondary outcomes include changes in liver severity scores, liver enzyme levels, fibrosis indicators, and health status measures. Safety and efficacy are evaluated throughout the study period, which extends up to five years from treatment.

Researchers are evaluating the best treatment for patients with antiphospholipid syndrome APS who have experienced an ischemic stroke. APS is linked to stroke, but the best way to prevent further strokes in these patients is unclear. Current guidelines suggest warfarin, but these are based on older studies and expert opinions rather than strong new evidence. This study aims to compare warfarin with clopidogrel-based antiplatelet therapy to find the optimal secondary prevention method for APS-related stroke. In this study, adult patients with confirmed APS and a history of ischemic stroke will be randomly assigned to one of two groups. One group will receive clopidogrel 75 mg daily and may also use other antiplatelet drugs if the doctor decides. The other group will be treated with warfarin, with a target blood clotting measure INR between 2.0 and 3.0. The study will follow participants for at least four years to assess outcomes. Participants will be monitored for any deaths, major cardiovascular problems, blood clots, and major bleeding events during the follow-up. The main outcome is a combined measurement of these serious events over four years. The study will provide important information to guide future treatment decisions for preventing strokes in APS patients. Throughout the study, safety and health will be closely observed by the researchers.

Researchers are evaluating the effectiveness and safety of ALZGUARD, a smartphone-based digital therapeutic application designed to assist in diagnosing major neurocognitive disorders such as dementia. This study compares ALZGUARDs diagnostic accuracy with traditional evaluations conducted by medical doctors. The study involves participants aged 55 to 85 years and aims to measure how well ALZGUARD identifies dementia compared to standard methods. All participants will use the ALZGUARD application to assess cognitive function. The study follows a single-arm design where everyone uses this digital tool. The primary measure of success is the Area Under the Curve AUC over up to 8 months, which evaluates the diagnostic performance of ALZGUARD. Secondary measures include sensitivity and specificity of the diagnosis. Participants will be monitored during the study period, which lasts up to eight months, to collect diagnostic data from the ALZGUARD application. Researchers will assess the applications ability to detect dementia accurately. Safety and diagnostic effectiveness are tracked throughout, with no masking or placebo groups involved. This multi-center study is overseen by HAII corp.ltd to ensure thorough evaluation and participant safety.