Yongin Si

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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.

Researchers are evaluating the safety and effectiveness of new treatments and combinations in adults with metastatic colorectal cancer CRC. This Phase II, global, open-label study includes a master protocol with substudies to test these treatments in participants who have not received prior systemic therapy for advanced disease and whose cancer is mismatch-repair-proficient pMMR or microsatellite stable MSS without liver metastases. Participants will be randomly assigned to one of two groups one receiving volrustomig combined with FOLFIRI a chemotherapy regimen of irinotecan, fluorouracil, and leucovorin plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab alone. All treatments are given as intravenous infusions. The study aims to compare these combinations over approximately three years. During the trial, participants will undergo regular assessments including tumor measurements, safety monitoring through adverse event tracking, and laboratory tests. Researchers will evaluate progression-free survival, overall survival, response rates, and drug concentrations in the body. The study includes monitoring for immune responses and other side effects, with total participation lasting up to about three years.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the effectiveness and safety of a fixed-dose combination of Pitavastatin and Ezetimibe in adults with hypercholesterolemia. This observational study specifically looks at patients who have previously been treated with either atorvastatin or rosuvastatin monotherapy and have been switched to the combination tablet. The goal is to understand how well this combination helps patients reach target LDL cholesterol levels over time. Participants in this study will be patients who have already been stably treated with atorvastatin or rosuvastatin for at least three months and have clinical decisions to switch to the fixed-dose combination pill of PitavastatinEzetimibe. The study will observe these patients prospectively, without any intervention from the researchers, to monitor their response to the new medication under normal clinical practice. During the study, patients will be monitored for lipid levels and safety through clinical laboratory tests, including total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, liver enzymes, and kidney function tests. The primary outcome is the rate of patients achieving their target LDL cholesterol level 12 months after starting the fixed-dose combination. Participants will be followed over this period to assess effectiveness and safety, ensuring their usual care continues alongside study observations.

This research aims to develop and validate a model that predicts heart function, especially the left ventricular ejection fraction LVEF, by combining echocardiography results with body composition data from the QCCUNIQ BC 720 device. The study focuses on adults with and without heart failure to better understand how body composition relates to heart health and to enhance early detection of cardiac dysfunction. Participants will undergo standard echocardiographic exams to measure heart function and body composition analysis using the QCCUNIQ BC 720 device within one week of their heart scan. The study includes 2,000 adults split evenly between those with normal heart function LVEF 6550% and those with heart failure LVEF below 50%. Researchers will analyze these data using traditional and advanced machine learning methods to create a predictive model. Throughout the study, participants will have their heart function and body composition assessed, with data collected on parameters like fat mass, muscle mass, and total body water. The study will track outcomes such as LVEF within one week and evaluate the models accuracy through statistical validation. The goal is to find a non-invasive method to identify individuals at risk for heart problems, potentially reducing reliance on complex diagnostics and improving personalized care.

Researchers are evaluating the usefulness of an insole-type gait analyzer in adults who experience subjective gait and balance disorders. The study focuses on how well this device collects gait data from patients with walking disturbances, aiming to explore the datas clinical value without using a control group. This trial is sponsored by Yonsei University and includes adults aged 19 and older who report gait or balance issues. Participants will wear the insole-type gait analyzer while performing the Timed Up and Go test, which measures walking speed and balance. Before this, they will complete a history survey, a sarcopenia screening questionnaire, and the International Physical Activity Questionnaire. The insole device records data from accelerometers and pressure sensors to detect missing or unusual readings and to explore optimal data collection and analysis methods. During the study, participants will be assessed through baseline tests including the Timed Up and Go test lasting about 5 minutes, the Korean version of the Sarcopenia Screening Questionnaire about 1 minute, and the Korean version of the International Physical Activity Questionnaire about 3 minutes. Researchers will monitor the quality of data collected from the insole during walking and analyze it for clinical significance. The total participation timeline depends on these assessments and data evaluations.

Researchers are evaluating the combination of atezolizumab and bevacizumab with stereotactic body radiotherapy SBRT for patients with advanced hepatocellular carcinoma. This study aims to improve the treatment response rate of the current first-line chemotherapy, which has shown low response rates. Participants have advanced liver cancer that cannot be operated on and are eligible for this combination therapy. Participants will receive SBRT targeting one to five sites of primary or metastatic cancer lesions within two months before or after starting the atezolizumab-bevacizumab combination therapy. The study includes several visits screening, during and after SBRT, chemotherapy cycles, and follow-up visits lasting up to 36 months to monitor treatment effects and safety. During the study, participants will undergo medical history reviews, physical exams, imaging tests like CT or MRI, blood tests including tumor markers and biomarkers, stool microbiota analysis, and quality of life questionnaires. Researchers will monitor adverse events and assess progression-free survival at 6 months as the primary outcome, alongside secondary outcomes such as overall survival, tumor response, and safety over 36 months.

Researchers are studying patients with end-stage knee osteoarthritis OA to understand how their phase angle level before surgery relates to their recovery after total knee arthroplasty. The study aims to find out if patients with a low phase angle have worse functional recovery compared to those with a high phase angle, and whether preoperative phase angle is linked to postoperative physical function. This observational study compares physical function and muscle strength in these groups to identify associations with recovery outcomes. Participants undergo several assessments before and three months after surgery. The pre-surgical evaluation includes surveys on medical history, sarcopenia, and physical activity. Functional tests include bioelectrical impedance analysis to measure phase angle and body composition, handgrip strength tests, isokinetic knee strength measurement, and performance-based tests such as the 10-meter walk test, Timed Up and Go TUG test, and Berg Balance Scale BBS. Radiographic assessments evaluate knee osteoarthritis severity and alignment. During the study, participants complete the same series of tests at baseline and three months post-surgery to track changes in function and strength. Researchers monitor outcomes like TUG, 10-meter walk, and BBS scores to assess recovery. Muscle strength and phase angle measurements are also recorded at both time points. The total participation spans from preoperative screening through a three-month follow-up after the knee replacement procedure.

Researchers are evaluating the radiation exposure to operators during percutaneous coronary intervention PCI by comparing two different access points the left distal radial artery LDRA and the right conventional radial artery RTRA. This study aims to understand which approach may result in less radiation exposure to the medical personnel performing the procedure. The trial is a multicenter, randomized study sponsored by Yonsei University and focuses on radiation safety during coronary interventions. Participants will undergo PCI using either the left distal radial artery approach or the right radial artery approach. The study compares radiation exposure to the operator measured by dosimeters placed on the left wrist, left head, and left chest during the procedure. The procedures and associated use of fluoroscopy, procedure time, and contrast medium volume are monitored and recorded. This study does not involve any masking or placebo controls and allocates participants randomly to one of the two study groups. During the study, participants will receive PCI as planned with one of the two arterial access methods. Researchers will measure cumulative radiation exposure to the operator and secondary outcomes such as crossover rate, fluoroscopy time, procedure time, and contrast medium volume during and up to 24 hours after the procedure. Participation involves standard PCI procedures with additional radiation monitoring. The study is expected to continue until April 2029, with ongoing assessment of radiation safety outcomes.