Hwaseong Si

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are studying the safety and effectiveness of a drug called DWN12088 in people diagnosed with Idiopathic Pulmonary Fibrosis (IPF), a lung condition. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. The goal is to see how DWN12088 compares to a placebo in patients who meet specific lung function criteria and have stable disease under current standard treatments or no treatment. Participants will receive either DWN12088 tablets or placebo tablets twice daily. The study treatment period lasts 24 weeks. Throughout this time, patients continue their local standard care for IPF if applicable, such as pirfenidone or nintedanib, provided the dose has been stable for at least 3 months before screening. The study carefully monitors the participants for any side effects and how their lung function changes over the 24 weeks. During the study, participants will undergo various assessments including medical history, physical exams, vital signs, ECG, and laboratory tests to confirm their stability and eligibility. Researchers will track lung function decline and record any treatment-related adverse events from the start of treatment through 24 weeks. This helps evaluate both the safety and benefits of DWN12088 in managing IPF over this period.

Researchers are evaluating Cerogrin, a medical device developed for auricular vagus nerve stimulation, to see if it can improve cognitive function in patients with vascular dementia or vascular mild cognitive impairment. This clinical trial addresses the lack of effective drug treatments by testing a non-invasive neuromodulation method. The study aims to assess the preliminary effectiveness and safety of Cerogrin in this population. Participants will be randomly assigned to use either the active Cerogrin device or a sham device that looks identical but does not provide stimulation. They will use their assigned device daily at home for 30 minutes over a four-week period. The study includes a baseline assessment, the four-week intervention period, and a follow-up period extending up to three months total. During the trial, researchers will monitor changes in cognitive function through various tests such as the Clinical Dementia Rating, Korean Montreal Cognitive Assessment, and Alzheimer’s Disease Assessment Scale. Safety and neural activity will also be assessed. Participants will be evaluated at baseline, at the end of the intervention period (week 4), and at follow-up (week 8), with the entire study lasting up to three months.

This research aims to collect data on the rebound effect and long-term safety of SAT-001, a software device under development to slow myopia progression in children aged 5 to less than 9 years. The study focuses on pediatric patients who completed a previous trial evaluating this device, as myopia progression can continue for over two years and may accelerate after stopping treatment. Understanding this rebound effect is important for developing effective treatment strategies for childhood myopia. This multi-center, open-label, controlled observational extension study follows 40 participants from both treatment and control groups of the prior trial. Participants will continue wearing single vision spectacles, the conventional treatment for myopia, during the 6-month extension period after completing the original study. The trial excludes those with less than 70% compliance in the previous study and does not provide other myopia treatments besides glasses. During the 6-month follow-up, researchers will measure changes in the refractive error of the eye and axial length at 12 and 24 weeks compared to baseline to assess the rebound effect and safety of SAT-001. Participants and their guardians will provide informed consent, and safety and long-term outcomes will be closely monitored throughout the study duration.

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.

This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease. Participants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study. During the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L). The goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.

Researchers are evaluating the effectiveness and safety of a new drug called tegoprazan, a potassium-competitive acid blocker (P-CAB), compared to a standard proton pump inhibitor (PPI), rabeprazole, for protecting against upper gastrointestinal (GI) events in patients with heart and vascular diseases who are at high risk of GI bleeding and are taking antithrombotic medications. This Phase 4 study aims to see if tegoprazan is not worse than rabeprazole in reducing GI events over a 12-month period after randomization. The study begins with a safety surveillance phase including 300 patients taking tegoprazan 50 mg daily for 6 months to monitor specific adverse events related to the liver, hormone levels, and infections. If no safety concerns arise, a larger randomized, double-blind trial of 3,100 patients will follow, comparing once-daily tegoprazan 50 mg with rabeprazole 20 mg, each with matching placebos, over 12 months. Participants will be assigned to one of the two treatment groups to assess the protection against GI bleeding and ulcer disease. Participants will be monitored throughout the study for any upper GI clinical events, with the primary outcome being the time until the first GI event during the 12-month treatment. Researchers will also evaluate safety by tracking liver function, hormone levels, and infections. Patients will be closely observed for any side effects or adverse events related to the treatments, and data from the initial safety phase will not be included in the main analysis. The study involves regular assessments to ensure thorough safety and effectiveness evaluation over the one-year treatment period.

Researchers are investigating how the lymphatic system changes before and after radiotherapy in female patients with breast cancer. The study focuses on early lymphatic changes that might lead to breast-cancer-related lymphedema (BCRL) and aims to help identify patients who could benefit from early preventive rehabilitation. It examines how lymphatic flow and vessel function are affected by radiotherapy using indocyanine green (ICG) lymphography imaging. Participants will receive ICG lymphography before starting radiotherapy and again within 4-6 weeks after completing radiotherapy. A small injection of ICG dye is given under the skin, followed by near-infrared imaging to visualize lymphatic flow. Some participants may also have follow-up imaging at 3, 6, and 12 months after radiotherapy to monitor long-term lymphatic changes. All participants continue their usual medical and rehabilitation care throughout the study. During the study, researchers will collect imaging data from ICG lymphography, measure arm circumference and volume, and gather patient-reported outcomes on arm discomfort or swelling. These measurements will be taken at baseline, 4-6 weeks post-radiotherapy, and optionally at later follow-ups. The study does not involve experimental treatments and uses approved diagnostic methods considered safe. The findings may help develop personalized strategies to prevent or reduce lymphedema after breast cancer treatment.

Stroke is a leading cause of death worldwide, and many survivors experience lasting effects such as hemiplegia, or weakness on one side of the body. Current rehabilitation therapies often have limited effects, so this study aims to explore new treatment options. Specifically, it evaluates the use of repetitive transcranial magnetic stimulation (rTMS), a non-invasive technique that stimulates targeted brain areas to help restore motor function after stroke. Participants in this study will receive one of three types of rTMS treatments: Traditional Theta Burst Stimulation (TBS), Modified TBS rTMS, or Sham rTMS as a control. These devices deliver magnetic pulses to stimulate brain activity and potentially improve motor recovery in patients with hemiplegic stroke. The study focuses on observing the effects of these different stimulation methods. During the study, participants will complete assessments including the Keyboard Tapping Test conducted on a single day to measure motor function. Researchers will monitor and evaluate how rTMS affects motor recovery following stroke. Participants must be at least 18 years old and able to provide informed consent. The overall participation duration and additional monitoring details are not specified.

Researchers are evaluating the safety and effectiveness of Neuclare, a medical device designed to improve walking ability in patients with Idiopathic Normal Pressure Hydrocephalus (iNPH). This condition involves symptoms like walking difficulties, cognitive problems, and urinary incontinence. The study uses tests such as the Timed Up & Go Test, 10-meter walking test, and iNPH grading scale to measure changes in gait before and after using Neuclare. The Neuclare device stimulates the brain for a certain period aimed at assessing improvements in walking for patients with iNPH. This is a single-arm, open-label trial without randomization. Participants will use Neuclare as part of the study to observe any changes in gait and cognitive function. During the study, participants will be evaluated using clinical tests like the Timed Up & Go Test to measure walking ability, along with other assessments related to gait and cognition. Researchers will monitor safety and effectiveness throughout the trial. The main outcome measured is the change in the Timed Up & Go Test from the start of the study to one week after the intervention. Participants are adults aged 60 to 90 years with specific inclusion criteria related to iNPH symptoms and diagnosis.