Chuncheon

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet (Filgotinib Maleate) at doses of 100 mg and 200 mg in Korean adults with rheumatoid arthritis or ulcerative colitis. The study focuses on tracking serious adverse events, adverse drug reactions, unexpected events, and other safety-related issues during real-world use following marketing approval in Korea. Participants will not receive any interventions as this is a non-interventional observational study. The study observes patients being treated with Jyseleca according to the Korean approved label, which includes adults with moderately to severely active rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior therapies. The medication may be used alone or with methotrexate in rheumatoid arthritis, but not with biological DMARDs or other JAK inhibitors. During the study, participants will be monitored for safety outcomes such as serious and non-serious adverse events and adverse drug reactions up to 24 weeks after enrollment. Effectiveness measures include changes in disease activity scores for rheumatoid arthritis and ulcerative colitis at 12 and 24 weeks. Researchers will collect and evaluate all safety and efficacy-related information under typical use conditions in Korea.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the effect of low-dose aspirin (100 mg daily) on preventing gastric cancer in patients who have early-stage gastric cancer or high-grade dysplasia and have undergone endoscopic submucosal dissection. This study focuses specifically on patients with negative Helicobacter pylori status or those who have successfully eradicated H. pylori. The study is a phase 3, multi-center, double-blind, randomized, placebo-controlled trial designed to provide clear evidence on aspirin's role in gastric cancer prevention, as previous studies lacked sufficient sample size or follow-up for cancer outcomes. Participants are randomly assigned to receive either a daily 100 mg aspirin tablet or a daily placebo tablet for 5 years. Both groups will be monitored during this treatment period to compare the incidence of gastric cancer between them. This long-term treatment approach aims to provide definitive data on whether aspirin can help prevent metachronous gastric cancer after endoscopic resection. During the study, participants will undergo regular assessments including clinical evaluations and monitoring for side effects or complications. Researchers will track the development of gastric cancer until the last enrolled patient completes the 5-year medication period. Safety monitoring and adherence checks are included to ensure participant well-being and accurate measurement of outcomes over the entire study duration.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are evaluating the use of machine learning-based models derived from coronary angiography and intravascular ultrasound (IVUS) to improve decision making and stent optimization in patients with coronary artery disease. This multicenter, prospective study plans to enroll 3,000 patients from 15 centers in South Korea between January 2020 and June 2025. The study focuses on both treated coronary lesions requiring stent implantation and deferred lesions with more than 30% stenosis to assess the models' diagnostic performance and clinical impact. Participants will undergo percutaneous coronary intervention (PCI) guided by IVUS to implant stents. The study uses supervised machine learning algorithms to predict fractional flow reserve (FFR), characterize plaques, predict stent expansion, and forecast stent failure after implantation. Both culprit (treated) and nonculprit (deferred) coronary lesions will be monitored, with the primary goal of evaluating target vessel failure (TVF) related to these lesions over two years. During the study, participants will be closely followed for two years after their stent implantation. Researchers will assess clinical outcomes related to treated and deferred lesions, focusing on the occurrence of target vessel failure. The study involves detailed imaging and algorithm evaluation to determine the prognostic impact of the new AI technologies on event reduction following PCI.

This clinical trial is a phase III study evaluating the effectiveness and safety of Cellgram-LC, an autologous mesenchymal stem cell treatment, in patients with alcoholic liver cirrhosis. The trial aims to assess the treatment's benefits over a period of 60 months after a single dose. Participants have alcoholic cirrhosis diagnosed through alcohol history, imaging, pathology, and clinical symptoms, and belong to Child-Pugh grade B or C with a score of 7 or more. Participants will receive a single injection of Cellgram-LC through the hepatic artery using catheterization. The treatment is delivered once, and the study monitors the long-term effects and safety over five years. This open-label, randomized trial is conducted across multiple centers to gather data on the treatment's impact on patients with this liver condition. During the study, participants will undergo regular assessments for transplant-free survival over three years, safety monitoring, and other clinical evaluations as per protocol. Researchers will evaluate liver function, disease progression, and any adverse effects throughout the follow-up period. The total participant involvement includes screening, treatment, and extended observation to comprehensively understand the treatment's efficacy and safety.

Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.

Researchers are evaluating ALZGUARD, a smartphone-based digital therapeutic application that uses artificial intelligence to analyze cognitive function and assist in diagnosing dementia and major neurocognitive disorders. This study aims to compare the accuracy of ALZGUARD's diagnosis with traditional evaluations performed by medical doctors. The study is conducted across multiple sites and includes participants aged 55 to 85 years. Participants will use the ALZGUARD application, which provides a digital aid for diagnosing dementia. This is a single-arm, single-blind, prospective study where all participants will undergo evaluation with ALZGUARD. The primary measure to assess efficacy is the Area Under the Curve (AUC) over up to 8 months, which will quantify diagnostic performance compared to standard methods. During the study, participants' cognitive function will be assessed through the ALZGUARD application using their smartphones. Researchers will monitor safety and effectiveness throughout the study period. Participants must be able to use a smartphone or have assistance to do so, and all will be followed to measure how well the digital tool aids diagnosis over time.

Researchers are evaluating the safety and effectiveness of drug-coated balloon (DCB) treatment compared to drug-eluting stents (DES) in patients with large coronary artery disease. This international, randomized, open-label trial focuses on patients with new lesions in large coronary arteries (3.0 mm or larger in diameter). The study aims to show that DCB treatment is not worse than current-generation DES in terms of clinical outcomes for these patients. Participants will receive either treatment with the SeQuent4 Please NEO drug-coated balloon catheter or a current-generation drug-eluting stent. The treatments target new lesions in native large coronary arteries. Before randomization, lesions must be properly prepared with balloon angioplasty to meet specific criteria. The study includes follow-up visits at 30 days, 6 months, 12 months, 24 months, and 36 months to monitor patient progress. During the study, participants will be assessed for adverse clinical events occurring within one year, with safety and other clinical outcomes closely monitored. The study collects clinical evidence of angina or myocardial ischemia, and patients must be able to comply with the study schedule. The researchers will evaluate net adverse clinical events at one year to compare the two treatments' effectiveness and safety over time.

Researchers are evaluating the potential effects of repeated use of gadolinium-based contrast agents (GBCAs) on motor and cognitive functions in neurologically normal adults over a period of five years. This Phase 4 study involves adults up to 65 years old who are likely to need at least yearly MRI or other imaging scans. The goal is to compare changes in body movement and mental skills between participants exposed to GBCAs multiple times and a matched group not exposed to GBCAs. Participants will undergo annual motor and cognitive tests to assess their functions. Unenhanced MRI scans of the brain will be performed at the start and after five years to check for abnormalities. Blood and urine samples will be collected yearly to measure gadolinium levels. The GBCAs administered during clinical care include various agents such as Gadoxetate disodium, Gadobenate dimeglumine, Gadodiamide, Gadoterate meglumine, Gadobutrol, and Gadoteridol. The study itself does not assign or control GBCA use; this is based on the participants' medical needs. Over the five-year study, participants will visit the study doctor at least seven times for physical exams, lab tests, and motor and cognitive assessments. Imaging tests like MRI, CT scans, or x-rays will be conducted annually. Researchers will measure changes in motor and cognitive performance compared to baseline and between GBCA-exposed and non-exposed groups. Safety and adverse events will also be monitored throughout the study period.