Yongin Si

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of new treatment combinations for participants with metastatic colorectal cancer (mCRC). This Phase II global study uses a master protocol with substudies focused on participants who have mismatch-repair-proficient (pMMR) or microsatellite stable (MSS) mCRC without liver metastases and who have not previously received systemic treatment for advanced disease. Participants will be randomly assigned to one of two treatment groups: one receiving Volrustomig combined with FOLFIRI (a regimen of irinotecan, fluorouracil, and leucovorin) plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab only. All medications will be given as intravenous infusions. This modular study takes place across multiple centers worldwide. During the approximately three-year participation, researchers will measure progression-free survival and monitor adverse events. Participants will undergo regular evaluations including tumor assessments by RECIST 1.1 criteria and organ function tests. Safety and treatment effects will be closely observed throughout the study period to understand the impact of these new treatment combinations.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the effectiveness and safety of a fixed-dose combination tablet of Pitavastatin and Ezetimibe in adults with hypercholesterolemia. This study focuses on patients previously treated with atorvastatin or rosuvastatin alone and aims to observe the impact of switching to this combination treatment. The goal is to assess how well patients reach their target LDL cholesterol levels 12 months after starting the new therapy. This is a multi-center, prospective, observational study without intervention, where patients who have been stably treated with atorvastatin or rosuvastatin for at least three months switch to the fixed-dose combination tablet based on clinical decisions. Participants must have recent clinical laboratory test results related to cholesterol and liver and kidney function. The study does not involve changing the statin regimen or dosage during the 12 months prior to switching. During the study, participants will be monitored through clinical laboratory tests evaluating cholesterol levels and liver and kidney function. Researchers will measure the rate at which patients reach their LDL cholesterol targets after 12 months on the new treatment. The study includes follow-up assessments to observe safety and effectiveness, ensuring participants' health is carefully tracked throughout the study period.

This research aims to explore the usefulness of an insole-type gait analyzer in adults who experience subjective gait and balance problems. The study focuses on how well this device can collect gait data from patients with gait disturbances, without using a control group. Participants include adults aged 19 and older who report these symptoms and agree to participate. Participants will wear the insole-type gait analyzer while performing the Timed Up and Go test, which measures their mobility. They will also complete several surveys, including a history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire. The gait analyzer collects data from accelerometers and pressure sensors during walking, and the researchers will analyze this data for accuracy and clinical relevance. During the study, participants will be assessed for their ability to walk independently on flat ground. The Timed Up and Go test will last about 5 minutes, and the questionnaires will take 1 to 3 minutes each. Researchers will monitor the data quality from the gait analyzer to identify any missing or unusual recordings. Overall, the study involves baseline evaluations of gait and physical activity to better understand the device's usefulness in this population.

Researchers are evaluating the safety and effectiveness of combining atezolizumab-bevacizumab therapy with stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma, a type of liver cancer. This treatment is intended as a first-line chemotherapy option, aiming to improve the currently low treatment response rate. Eligible patients must have inoperable advanced hepatocellular carcinoma and meet specific liver function and health status criteria. 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 multiple visits for screening, treatment, and follow-up, with careful monitoring during and after SBRT. Treatment effects and safety will be assessed through imaging and laboratory tests, tumor markers, and quality of life questionnaires. During the study, participants will attend scheduled visits involving medical evaluations, scans such as CT, MRI, and optionally PET-CT, blood tests, and stool microbiota analysis. Quality of life will be measured repeatedly using a standardized questionnaire. Safety monitoring includes tracking adverse events throughout treatment and follow-up visits that may last up to 36 months. The main outcome measured is progression-free survival six months after registration.

Researchers are investigating how the phase angle level before surgery relates to functional recovery in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty. The study aims to find out if patients with a low phase angle experience worse recovery of physical function compared to those with a high phase angle and whether postoperative physical function is linked to preoperative phase angle levels. Before surgery, participants complete surveys on their medical history, sarcopenia, and physical activity. They also undergo evaluations including bioelectrical impedance analysis to measure phase angle and body composition, muscle strength testing of the handgrip and knee, and performance tests such as the 10-meter walk, Timed Up and Go (TUG), and Berg Balance Scale (BBS). After surgery, these tests are repeated three months later to compare functional recovery between low and high phase angle groups. Throughout the study, participants undergo assessments of pain, comorbidity, and radiographic severity of knee osteoarthritis. Outcomes measured include timed physical function tests and muscle strength evaluations at baseline and three months post-surgery. The study focuses on understanding the relationship between preoperative phase angle and recovery to guide future care for patients undergoing knee replacement surgery.

Researchers are evaluating whether an educational video created using generative artificial intelligence (AI) can better improve patient understanding and reduce anxiety compared to a conventional video before radiation therapy. This prospective, randomized study involves patients scheduled for radiotherapy and aims to provide evidence about the effectiveness of AI-based tools in patient education and anxiety reduction. Participants will be randomly assigned to one of two groups: an AI-based avatar video group or a conventional video group that uses PowerPoint slides with voice narration. Both videos last about five minutes and contain the same key messages and summary points about radiotherapy procedures, expected side effects, and self-care information. The study is conducted at two institutions and includes a total of 136 patients. After consenting, participants complete questionnaires before and immediately after watching the assigned video, and again during the first week of radiation therapy. Researchers will measure anxiety levels, knowledge understanding, and satisfaction with the educational video. The primary outcome is anxiety score measured right after the intervention, with additional assessments to analyze changes over time and between groups.

This research aims to evaluate the effect of subcutaneous injection of Botulinum toxin A on healing wounds caused by lower leg ischemia, specifically in patients with chronic ulcers or diabetic foot wounds. It focuses on improving blood flow in the lower extremities, which is often compromised due to blocked or narrowed arteries from conditions like arteriosclerosis or blood clots. The study is a Phase 4 trial investigating this treatment's potential to enhance wound healing by increasing blood circulation. Participants receive a subcutaneous injection of Botulinum toxin A around their foot wounds. The toxin is studied for its ability to dilate blood vessels, increase blood flow, promote new blood vessel growth, and reduce muscle spasms related to blood circulation. The injection is given once, and blood flow changes are measured over 7 and 14 days after the injection to assess improvement. During the study, researchers monitor participants' wounds and measure blood oxygen levels at the wound edges using tcPO2 at baseline, 7 days, and 14 days post-injection. Participants must follow visit schedules and allow assessments, including clinical exams and imaging to confirm blood vessel status. The study observes safety and healing progress over this two-week period to determine the treatment's effect on blood flow and wound recovery.

Researchers are evaluating the clinical effects of zastaprazan compared to proton pump inhibitors (PPIs) in patients with chronic coronary syndrome who are receiving dual antiplatelet therapy (DAPT) including clopidogrel after undergoing percutaneous coronary intervention (PCI). This phase 4, randomized double-blind pilot study aims to compare how these medications influence platelet reactivity and to find the best combination that balances antiplatelet effectiveness and stomach protection. Special focus is on comparing zastaprazan with rabeprazole, a PPI known for lower CYP2C19 enzyme inhibition, to understand differences in drug interactions and platelet effects. Participants will be randomly assigned to receive either zastaprazan 20 mg or rabeprazole 10 mg orally once daily for six months, alongside standard DAPT including clopidogrel 75 mg daily. The study compares these two drug regimens directly, monitoring the impact on platelet reactivity. Both groups will continue their prescribed antiplatelet therapy during the treatment period. Throughout the study, researchers will assess platelet reactivity using the VerifyNow assay measuring P2Y12 Reaction Units (PRU) at one month. Participants will be closely monitored for safety and adherence while continuing therapy for six months. This approach helps determine the optimal acid suppression treatment combined with clopidogrel for patients recovering from PCI. Total participation duration spans the six-month treatment period with ongoing evaluations to support study goals.