Cheju

This prospective, open-label, multicenter, single-arm, non-interventional, observational surveillance is designed to assess the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice. Three different doses of Atectura inhalation capsule will be prescribed via Breezhaler according to the approved label information in Korea. No additional diagnostic or monitoring procedures will be conducted specifically for this study.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

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.

This research focuses on patients who have had an Embolic Stroke of Undetermined Source ESUS and have received an Implantable Cardiac Monitor ICM. It evaluates the use of an artificial intelligence tool called SmartECG-AF, which analyzes standard 12-lead ECGs taken during normal heart rhythm to predict the risk of developing atrial fibrillation AF. The study aims to understand if this AI tool can help identify which patients are more likely to experience AF and major cardiovascular events after ESUS. Participants will be divided into two groups based on the AIs risk assessment a High Risk group and a Low to Intermediate Risk group. The study will follow these groups over time to compare the frequency and timing of AF events detected by the ICM. This multicenter, prospective study will also explore the relationship between the AI risk scores and the occurrence of major adverse cardiovascular events, helping to assess the value of AI-guided risk stratification. During the study, patients baseline ECGs will be analyzed by the AI algorithm, and their heart rhythm will be monitored continuously through the ICM. Researchers will track the time to AF events and record any major cardiovascular incidents over a follow-up period of up to 12 months. Participants will be monitored for safety and clinical outcomes, providing data on how well the AI tool predicts cardiac risks in this population.

This research aims to collect long-term safety and disease progression data on patients diagnosed with atypical hemolytic-uremic syndrome aHUS, including those treated or untreated with the drugs eculizumab or ravulizumab. The study is observational and involves multiple centers and countries, focusing on real-world information after these treatments have been marketed. Participants include patients of any age diagnosed with aHUS, regardless of whether they have identified complement genetic variants or antibodies. The study gathers data without administering new treatments, monitoring patients who may or may not have received eculizumab or ravulizumab. The registry collects information over extended periods to understand safety events and disease course. During the study, researchers track safety-related events over 10 years and the timing of these events within 5 years. Data collection involves reviewing patient health status and disease progression without altering their usual care. The study relies on informed consent and may include minors with appropriate assent. Participation duration varies, with continuous observation to gather comprehensive post-marketing safety data.

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.

This clinical trial is a phase 2, open-label, multicenter study focused on infants diagnosed with leukemia. It aims to improve survival rates by tailoring the use of chemotherapy and hematopoietic stem cell transplantation based on genetic features at diagnosis and minimal residual disease MRD levels after treatment. The study also seeks to clarify which patient groups need stem cell transplantation and to understand long-term side effects and outcomes related to treatment in infants. Participants are divided into low, intermediate, and high risk groups based on genetic markers and MRD results. Each group receives a specific treatment plan low risk patients undergo induction chemotherapy followed by several consolidation chemotherapy phases and maintenance therapy intermediate risk patients receive induction and high-risk consolidation chemotherapy followed by maintenance high risk patients receive induction, high-risk consolidation chemotherapy, and then hematopoietic stem cell transplantation. Chemotherapy regimens include various drugs such as prednisolone, dexamethasone, vincristine, daunorubicin, and others, delivered over several weeks, with maintenance chemotherapy lasting about two years. During the study, participants will be closely monitored with assessments of overall survival at three years as the primary outcome, along with secondary measures including event-free survival, transplantation rates, recurrence, and treatment-related death rates up to five years. Side effects and long-term effects will be prospectively collected during and after treatment. The total participation period extends up to five years, allowing for comprehensive follow-up to evaluate treatment impact and safety.

Researchers are investigating treatments for children and young adults with relapsed acute lymphoblastic leukemia ALL, including cases with bone marrow recurrence. This phase 2, open-label, multi-center study evaluates outcomes based on risk groups determined by next-generation sequencing minimal residual disease NGS MRD after induction therapy. The risk groups are standard risk, high risk, and very high risk, with classification depending on specific leukemia types and MRD levels. Participants receive treatment plans tailored to their risk group, including combinations of chemotherapy drugs such as prednisolone, vincristine, L-asparaginase, idarubicin, methotrexate, and cytarabine, as well as blinatumomab therapy and hematopoietic stem cell transplantation when appropriate. Treatment phases include reinduction, consolidation, intensification, possible blinatumomab courses, and maintenance, following specific schedules lasting weeks to months depending on the regimen. Throughout the study, participants undergo regular assessments including blood tests, imaging, and performance status evaluations to monitor safety and treatment efficacy for an average of nine years. Outcomes measured include disease-free survival rates, treatment-related death and toxicity rates, and overall safety. The study requires compliance with protocol procedures and informed consent, with ongoing monitoring and care throughout participation.

Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

Researchers are evaluating whether the risk of major adverse cardiac events over two years differs between two methods of guiding Percutaneous Coronary Intervention PCI in patients with Left Main Coronary Artery LMCA disease. The study compares Fractional Flow Reserve FFR-guided PCI and angiography-guided PCI to understand which approach may better influence treatment decisions and outcomes for this condition. Participants will be randomly assigned to receive either FFR-guided PCI or angiography-guided PCI. Both procedures involve using drug-eluting stents to treat significant LMCA disease and may include patients with other coronary artery diseases. The study will monitor participants for two years after their procedure, capturing various heart-related events and treatment outcomes during this period. During the two-year follow-up, participants will have clinical visits and assessments to track events such as death, heart attacks, hospitalizations, repeat procedures, stroke, bleeding, and stent problems. Researchers will also evaluate hospital stay length, procedure details, heart function, quality of life related to angina and health, and medication use. The study aims to provide comprehensive information on the safety and effectiveness of both PCI guidance strategies over this time frame.