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Found 18 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are conducting a 24-week, prospective, open-label, multicenter, single-arm study to observe the safety and effectiveness of Atectura inhalation capsules in patients with asthma. This study is non-interventional and takes place in real-world clinical settings in Korea, following routine practice without additional diagnostic or monitoring procedures beyond standard care. Participants will use one of three available doses of Atectura inhalation capsules (150/80ug, 150/160ug, or 150/320ug) delivered via Breezhaler as prescribed according to approved label information. Patients already prescribed Atectura before joining the study will be enrolled, and no treatment allocation or changes will be made by the study team. During the 24-week period, researchers will monitor for any adverse events, including serious and unexpected ones, to assess safety. Data collection will include participant consent and follow-up as per routine practice, focusing on real-world use and outcomes of Atectura in asthma management.

Age: 12Years - 100YearsAll Genders
18 locations
A

Actively Recruiting

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Age: 18Years - 75YearsAll GendersPhase 3
186 locations
A

Actively Recruiting

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.

Age: 18Years +All Genders
64 locations
A

Actively Recruiting

This research focuses on patients who have experienced 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 that analyzes ECGs to predict the risk of developing atrial fibrillation (AF). The trial aims to assess how well this AI tool can identify patients at high risk for AF and how this relates to major cardiovascular events over time. Participants will be divided into two groups based on the AI analysis results: a "High Risk" group and a "Low to Intermediate Risk" group. All enrolled patients will have had at least one 12-lead ECG recorded near the time of their ICM implantation. The study will follow these groups to compare the timing and occurrence of AF detected by the ICM and to examine the connection between AI-predicted risk levels and major adverse cardiovascular events. During the study, patients will be monitored with their ICM devices for up to 12 months to track incidents of AF. Researchers will analyze the time until AF events occur and collect data on cardiovascular health outcomes. The study includes assessments of baseline ECGs, ongoing monitoring through ICMs, and evaluation of clinical events to understand the predictive value of the AI ECG tool in managing stroke patients.

Age: 30Years +All Genders
5 locations
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Actively Recruiting

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.

Age: 19Years +All GendersPhase 4
32 locations
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Actively Recruiting

This clinical trial is a multicenter, open-label, phase 2 study focusing on infants diagnosed with leukemia. It aims to improve survival rates by adjusting chemotherapy and hematopoietic stem cell transplantation based on genetic factors at diagnosis and minimal residual disease (MRD) levels after treatment. The study also seeks to clarify which patients need stem cell transplants and to understand long-term effects related to treatments in this vulnerable age group. Patients are divided into low, intermediate, and high risk groups. Treatment plans vary by group, with low and intermediate risk groups receiving induction chemotherapy followed by consolidation and maintenance chemotherapy. The high risk group undergoes induction chemotherapy, consolidation chemotherapy, and then allogeneic hematopoietic stem cell transplantation. Chemotherapy regimens include several drugs such as prednisolone, dexamethasone, vincristine, daunorubicin, and others, administered over weeks to about two years of maintenance therapy. Participants will be closely monitored throughout treatment and follow-up for side effects and treatment response. Researchers will assess outcomes including the 3-year overall survival rate. Data collection includes genetic testing, MRD measurement, side effect tracking, and long-term prognosis evaluation. The study duration includes initial treatment phases and extended observation to capture safety and effectiveness outcomes.

Age: 0 - 2YearsAll GendersPhase 2
8 locations
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Actively Recruiting

Researchers are tracking patients with Fabry disease through an ongoing international, multi-center observational program called the Fabry Registry. This program collects routine clinical data from patients regardless of their treatment status to better understand the disease's variability, progression, and natural history. It also focuses on enhancing patient care by supporting the development of monitoring recommendations and evaluating the long-term safety and effectiveness of Fabrazyme, a treatment for Fabry disease. The study includes a Fabry Pregnancy Sub-registry, which is a voluntary, international, longitudinal observation program that monitors pregnancy outcomes for women enrolled in the Fabry Registry who are pregnant or have been pregnant. This sub-registry collects medical and obstetric history, pregnancy, and birth data, along with infant growth information up to 36 months postpartum, regardless of the specific treatment received. No experimental treatments are administered in either registry; patients continue receiving routine care as determined by their physicians. Participants contribute data through clinical assessments and standard care evaluations performed by their doctors. The study measures long-term outcomes including safety and effectiveness of Fabrazyme over up to 33 years, as well as pregnancy outcomes and infant growth data. The program helps fulfill regulatory requirements and supports research while tracking patient health over extended periods without altering their usual care.

All Genders
283 locations
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Actively Recruiting

Researchers are evaluating whether the 2-year chance of major adverse cardiac events differs between two methods of guiding Percutaneous Coronary Intervention (PCI) in patients with Left Main Coronary Artery disease. The study compares Fractional Flow Reserve (FFR)-guided PCI to angiography-guided PCI to better understand treatment decision-making for this heart condition. Participants will be divided into two groups receiving either FFR-guided PCI or angiography-guided PCI. Both are procedures used to treat significant narrowing in the left main coronary artery. The study involves monitoring each participant's health and event occurrences over a two-year period. Throughout the study, all participants will be closely monitored until their last scheduled visit, which may occur up to two years after treatment. Researchers will check for any major cardiac events during this time to assess differences between the two treatment approaches. The primary measure is the combined rate of these events over the two years.

Age: 20Years +All GendersPhase Not Applicable
48 locations
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Actively Recruiting

Coronary artery disease (CAD) is the most prevalent and lethal disease worldwide. Even though various studies have been performed regarding the prevention or treatment of CAD and its related cardiovascular events, the prevalence of CAD and the incidence of cardiovascular events are increasing. Antiplatelet agents are among the most widely used drugs for preventing cardiovascular events. The efficacy of antiplatelet agents has been extensively proven in secondary prevention for cardiovascular events in CAD patients, and their use has been recommended in current guidelines. However, there is still controversy surrounding the prescription of antiplatelet agents for the primary prevention of cardiovascular events in CAD patients due to their unknown clear efficacy and risk of bleeding complications. Recent studies reported the limited efficacy of aspirin in old patients, diabetes patients, or patients with cardiovascular events risks. However, the efficacy or safety of antiplatelet therapy in patients with subclinical coronary atherosclerosis has not been thoroughly investigated. These patients are at higher risk of cardiac death or myocardial infarction compared to patients without coronary atherosclerosis. In this regard, the investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.

Age: 40Years +All GendersPhase 4
61 locations
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Actively Recruiting

This research focuses on Korean patients diagnosed with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), a genetic small vessel brain disease caused by mutations in the NOTCH3 gene. The study aims to better understand how CADASIL progresses in Korean individuals, who show unique clinical and genetic features compared to other populations. By following these patients over a long period, researchers hope to improve care and develop better treatments for CADASIL worldwide. The study is a nationwide, multicenter, prospective observational cohort enrolling about 500 Korean patients with suspected or confirmed CADASIL. Participants will be followed for 10 years with regular clinical visits. During these visits, they will undergo clinical evaluations, blood tests, neuropsychological assessments, and brain MRI scans to track symptoms, brain changes, and cognitive function. Participants will be monitored closely to observe new stroke events and the development of mild cognitive impairment or dementia over the 10-year period. Data collected include genetic and neuroimaging information, along with clinical and laboratory findings. This comprehensive approach aims to identify factors influencing disease outcomes and establish a biorepository for future research on molecular markers related to CADASIL progression and prognosis.

Age: 19Years +All Genders
1 location

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