Hwaseong Si

This research aims to evaluate the safety of Beyfortus Nirsevimab in children up to 24 months old in South Korea. It is conducted as part of a local risk management plan to collect real-world safety information on Beyfortus when used according to approved indications. The study focuses on children who have received Beyfortus in regular clinical practice and is sponsored by Sanofi. Participants in this single-arm, non-interventional study will be children up to 24 months of age who are scheduled to receive Beyfortus via intramuscular injection as per approved guidelines. The study does not assign treatments but observes children receiving Beyfortus naturally during clinical care. Follow-up will continue for 180 days after the administration of Beyfortus to monitor safety. During the study, participants will be monitored for adverse events, serious adverse events, adverse events of special interest, adverse drug reactions as noted in the product label, and occurrences of respiratory syncytial virus lower respiratory tract infection. Data will be collected through clinical practice visits over the 180-day follow-up period. The study aims to gather comprehensive safety information under real-world conditions for up to nearly four years.

Researchers are evaluating the use of rimegepant for intermittent prevention of menstrual migraine in women aged 18 to 45 who experience migraine attacks related to their menstrual cycle. This Phase 3, double-blind, randomized study compares rimegepant with placebo to assess its efficacy and safety during the peri-menstrual period. The study focuses on migraine frequency and severity in women with a history of menstrual migraine and regular menstrual cycles. Participants receive either rimegepant 75 mg orally disintegrating tablets for 7 days during each peri-menstrual period or a matching placebo, along with standard care for acute migraine treatment as needed. The study treatment cycles are repeated over 5 menstrual cycles in the double-blind treatment phase. The study also includes an acute treatment dosing option with rimegepant as needed. During the study, participants will be monitored for changes in the number of migraine and headache days, use of migraine medications, and functional disability related to migraine. Cognitive function is also assessed. Researchers will conduct evaluations over 5 months, covering 5 menstrual cycles, and measure outcomes related to migraine frequency and severity during the peri-menstrual period. Safety and tolerability will be closely monitored throughout the study.

Researchers are evaluating the preliminary effectiveness and safety of Cerogrin, a medical device designed for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. This study addresses the limited availability of effective drug treatments for these conditions by assessing whether non-invasive stimulation can improve cognitive function. It is a randomized, double-blind feasibility trial conducted by Neurogrin Inc. to explore a potential new therapeutic option. Participants will be randomly assigned to two groups one will use the active Cerogrin device that delivers electrical stimulation to the vagus nerve on the outer ear, while the other will use a sham device that looks identical but provides no stimulation. Each participant will use their assigned device daily at home for 30 minutes over a four-week intervention period. The study includes baseline assessments, the intervention period, and follow-up monitoring, lasting up to three months in total. During the study, participants will undergo evaluations of cognitive function using various tests such as the Clinical Dementia Rating, Korean Montreal Cognitive Assessment, and Alzheimers Disease Assessment Scale. Brain imaging with MRI and functional assessments with EEG will also be performed to monitor neural activity. Safety and adherence will be closely observed throughout the study, with outcome measurements taken at baseline, after the four-week intervention, and at follow-up up to eight weeks post-intervention.

This research focuses on children aged 5 to less than 9 years with myopia. It aims to study the rebound effect, where myopia progression may accelerate after stopping treatment, and to evaluate the long-term safety of SAT-001, a Software as a Medical Device designed to slow myopia progression in pediatric patients. This study serves as an extension to a previous trial that initially tested SAT-001s effects on myopia progression. Participants from the earlier trial, including both those who received SAT-001 plus single vision spectacles and those who only wore spectacles, will be followed for 6 months. During this extension phase, all participants continue wearing single vision spectacles but will no longer receive SAT-001 treatment. The study will monitor changes in eye measurements to assess any rebound in myopia and to observe safety outcomes after stopping SAT-001. Childrens eye health will be regularly evaluated through measurements of spherical equivalent refractive error and axial length at baseline, 12 weeks, and 24 weeks. Researchers will also observe any adverse effects related to stopping SAT-001. The total participation time in this extension study is 6 months following the completion of the initial trial, allowing for close monitoring of myopia progression and safety.

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.

Researchers are studying whether the Neuclare medical device can temporarily improve executive function, such as planning and problem-solving, in adults aged 55 to 90 years with mild cognitive impairment or early Alzheimers disease. This multicenter, randomized, double-blind, parallel-group trial evaluates the devices safety and efficacy alongside participants usual cognitive medications. The study is sponsored by Deepsonbio and aims to confirm the devices effect on cognitive abilities using established diagnostic criteria for these conditions. Participants continue their current cognitive therapy medications and are randomly assigned to one of two groups one receives the Neuclare device and the other a sham device that looks and feels similar but does not deliver therapeutic ultrasound. The device is applied to the brain three times per week for four weeks, with each session lasting less than 30 minutes. Both participants and study staff are unaware of group assignments to ensure unbiased results. During the trial, researchers will assess attention, cognitive function, activities of daily living, brain imaging using Amyloid PET-CT, blood biomarkers, and quality of life through questionnaires. Safety and adverse effects will be closely monitored throughout the study. The primary measurement is the change in completion time on the Trail Making Test-A from the start to week 5. Participant involvement lasts about five weeks, including treatment and assessments.

This research focuses on adults in Korea who have chronic or episodic migraine, a neurological condition causing moderate to severe headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. The study aims to evaluate the safety and effectiveness of atogepant, a medication approved for preventing migraines, when used in regular clinical settings. Participants will take atogepant oral tablets as prescribed by their doctors, following the approved local guidelines. The study involves approximately 3000 adults who will be observed during their routine medical care while using this medication. There are no additional treatments or burdens beyond what their physicians recommend. During the study, participants will attend their usual clinic or hospital visits up to 12 weeks. Researchers will monitor and record any adverse events, including serious or unexpected reactions, as well as common side effects. The main outcomes focus on safety measures related to atogepant use. The study will continue until May 2029, ensuring thorough observation of participants under typical care conditions.

Researchers are studying the effectiveness and safety of a new type of drug called a potassium-competitive acid blocker P-CAB, specifically tegoprazan 50 mg taken once daily, compared to a standard proton pump inhibitor PPI, rabeprazole 20 mg once daily. This study focuses on patients with known heart and blood vessel diseases who are at high risk of gastrointestinal GI bleeding because they take long-term antithrombotic medications. The main goal is to see if the P-CAB is at least as good as the PPI in preventing GI problems over a 12-month period after starting treatment. The trial includes two groups one receives tegoprazan 50 mg plus a placebo for rabeprazole, and the other receives rabeprazole 20 mg plus a placebo for tegoprazan. Before randomization, there is a safety surveillance phase with 300 patients taking tegoprazan alone for 6 months to monitor potential side effects like liver problems, high gastrin levels, or infections. If no safety concerns arise, 3,100 patients will be randomly assigned to one of the two study groups and treated for 12 months while being closely monitored. Participants will be involved in regular assessments during the treatment period, where researchers will track the time until the first GI event occurs, including bleeding or ulcers confirmed by tests like endoscopy or CT scans. Other outcomes include rates of various GI complications, cardiovascular safety events, and any side effects related to the drugs. The study carefully monitors safety and effectiveness over one year to provide important data about these treatments for patients at high GI bleeding risk.

Researchers are studying how the lymphatic system changes before and after radiotherapy in female patients with stage I-III breast cancer. This observational study aims to understand early lymphatic changes that could lead to breast-cancer-related lymphedema BCRL and to help identify patients who might benefit from early preventive rehabilitation. The study is led by Inah Kim and focuses on measuring lymphatic flow and vessel function using a special imaging technique called indocyanine green ICG lymphography. Participants will undergo ICG lymphography before starting radiotherapy and again within 4 to 6 weeks after completing the treatment. Some participants may also have follow-up imaging at 3, 6, or 12 months to monitor long-term changes. The ICG test involves a small injection of dye under the skin, followed by near-infrared imaging to visualize lymphatic flow. All participants will receive radiotherapy as part of their standard breast cancer care, with no experimental treatments or comparison groups involved. During the study, participants will have their lymphatic function assessed using ICG lymphography at multiple time points. Researchers will also measure arm circumference and volume and collect patient-reported information about arm discomfort or swelling. These data will help identify early signs of radiation-induced lymphatic problems. Participants will continue their usual medical and rehabilitation care throughout the study. The total participation duration may extend up to 12 months for those who undergo long-term follow-up imaging.

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 have limited effects, so new treatments are needed. This trial investigates the use of repetitive transcranial magnetic stimulation rTMS, a non-invasive brain stimulation method, to help improve motor recovery in patients with hemiplegic stroke. Participants will be randomly assigned to receive one of three types of rTMS treatments applied to the side of the brain opposite the stroke traditional theta burst stimulation TBS, a modified TBS version, or a sham placebo stimulation. These treatments are based on previous studies and aim to stimulate brain areas to restore function. The study uses a single-blind design to compare these approaches. Throughout the trial, participants will undergo assessments including a keyboard tapping test to measure motor function one day after treatment. The study includes patients at least 18 years old who have had a stroke with motor weakness for more than two weeks. Safety and consent are carefully monitored. The trial is sponsored by Dongtan Sacred Heart Hospital and will continue through December 2040.