Clinical trials

This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for myocardial injury after non-cardiac surgery (MINS) and major adverse cardiovascular events (MACE) within 30 days after surgery in patients undergoing non-cardiac surgery for urologic cancer.

This multicenter, prospective, open-label randomized controlled trial evaluates the efficacy and safety of CART BP Pro-guided blood pressure management in Korean patients with uncontrolled hypertension. CART BP Pro is a wearable cuffless blood pressure monitoring device based on photoplethysmography technology that enables continuous ambulatory blood pressure monitoring. Eligible participants with uncontrolled hypertension despite ongoing antihypertensive therapy will be randomly assigned in a 1:1 ratio to either a CART BP Pro-guided management group or a usual care group based on conventional office blood pressure measurements. Antihypertensive treatment in both groups will follow guideline-based therapy using standard agents including angiotensin receptor blockers, calcium channel blockers, and thiazide diuretics. The primary efficacy endpoint is the between-group difference in 24-hour mean systolic blood pressure at 24 weeks measured using ambulatory blood pressure monitoring. Safety will be assessed by the incidence of treatment-emergent adverse events during the study period.

The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes. The main questions it aims to answer are: Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups? Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device. Participants will: * Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection

The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms. The main questions it aims to answer are: * Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP? * Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes? Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring. Participants will: * Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization. * Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂). * Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols. * Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.

Background Patients with metastatic colorectal cancer who have progressed after treatment with oxaliplatin- and irinotecan-based chemotherapy, as well as anti-EGFR monoclonal antibodies (cetuximab or panitumumab) according to RAS mutation status, or anti-angiogenic agents (bevacizumab, ramucirumab, or aflibercept), have limited therapeutic options in the third-line setting. The phase III SUNLIGHT trial evaluating TAS-102 (trifluridine/tipiracil) in combination with bevacizumab demonstrated promising outcomes, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 10.8 months. However, approximately 30% of patients in that study had not previously received bevacizumab during first- or second-line treatment, indicating that a proportion of patients had not been fully exposed to current standard therapies for metastatic colorectal cancer. Therefore, there remains an unmet need to evaluate additional therapeutic strategies in patients who have received optimal prior standard treatments. This study aims to evaluate the efficacy and safety of fruquintinib as a third-line treatment in this population. Hypothesis Proactive and comprehensive supportive care will not only help manage fruquintinib-related toxicities (e.g., hypertension, hand-foot syndrome, proteinuria, and fatigue), but also enable patients to maintain treatment, thereby potentially prolonging progression-free survival (PFS). Study Design This is a multicenter, single-arm, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with supportive care in patients with metastatic colorectal cancer who are intolerant to second-line standard chemotherapy. All subjects will receive fruquintinib treatment in combination with supportive care. Supportive care refers to medical interventions aimed at preventing and managing adverse events associated with fruquintinib, including but not limited to hypertension, proteinuria, diarrhea, fatigue, and hand-foot syndrome.

This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.

This is a prospective, double-blind, randomized controlled clinical trial study to investigate short- and long-term effects of mother-infant skin-to-skin contact in healthy term infants, in order to provide supporting data for emphasizing mother-infant skin contact and family-centered care in South Korea.

The goal of this clinical trial is to learn whether an app-based, patient-centered prehabilitation program improves preoperative functional capacity in adults scheduled for elective cancer surgery. The main questions it aims to answer are: Does the program increase the six-minute walk distance (6MWD) measured on the preoperative day (within 24-48 hours before surgery)? Compared with usual care, does the program improve preoperative adherence to home 6MWT practice and patient-reported anxiety/depression (HADS)? Researchers will compare an app-based prehabilitation program to usual care to see if the program improves preoperative functional capacity. Participants will: Use a study app to perform weekly home six-minute walk tests (6MWT) and complete brief daily check-ins (exercise, nutrition, psychological status) before surgery. Attend routine preoperative admission (no extra visit) for in-hospital 6MWT (primary endpoint) and brief assessments (grip strength, Timed Up \& Go, HADS, skeletal muscle mass by InBody where available/fee-free). Attend one routine postoperative outpatient visit at 3 or 6 months (site-standard timing) for follow-up assessments. No additional study-specific clinic visits are required outside usual care.

This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the percentage change in coronary atheroma volume (PAV) assessed by grayscale IVUS, with secondary outcomes including changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. The study plans to enroll 408 patients undergoing coronary intervention across 7 domestic institutions, with rigorous follow-up protocols and adherence to international research guidelines.

The purpose of this clinical trial is to evaluate the initial safety and efficacy of the ExAblate Model 4000 Type 2.1 surgical device for nucleus accumbens (NAc) neuromodulation in patients with psychostimulant use disorder (PUD).

The goal of this study is to analyze the effects of enavogliflozin on heart function and coronary microvascular function in obese patients compared to a placebo, and to evaluate the improvement in cardiopulmonary exercise capacity in these patients.

The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.

This study aimed to investigate the feasibility of repetitive transcranial magnetic stimulation (rTMS) on the occipital lobe in patients with Lewy body dementia. This is a proof-of-concept study to evaluate the safety and effect of occipital lobe stimulation in patients with Lewy body dementia. Over a period of two weeks, participants will receive rTMS to the primary visual cortex three times a week during visits. For the remaining 10 weeks, maintenance therapy will be administered with rTMS once a week during visits. Efficacy assessments will be conducted on the day of the final stimulation session and again four weeks later.

This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.

The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed in patients with non-obstructive coronary artery disease

Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears

The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.

The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration

This clinical trial is designed to evaluate the initial safety and efficacy of opening the blood brain barrier (BBB) in patients with Alzheimer's disease using the ExAblate 4000 Type 2.1, a MR guided high-intensity focused ultrasound surgical device that disrupts brain tissue.

This observational study investigates the correlation between home blood pressure variability (BPV) and arteriosclerosis, alongside metabolic indicators, in hypertensive patients over a three-year period. The research specifically focuses on the predictive value of home BPV for major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and heart failure hospitalizations. Utilizing a mobile application called Healthscan for daily BP monitoring, the study aims to enhance the understanding of how BPV impacts cardiovascular and metabolic health in a real-world setting.

Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.

Heart diseases known as the second cause of death in Koreans are coronary artery diseases such as angina and myocardial infarction. Coronary artery disease occurs when fat components, such as cholesterol, accumulate in the body. When these fat components are deposited in blood vessels, blood vessels' walls become thick, and the blood vessels narrow, which interferes with circulation. Without smooth circulation, the heart muscle does not function properly because the supply of oxygen and nutrient-rich blood, which is necessary for the heart to function normally, is not properly supplied. It leads to angina pectoris and chest pain and can cause myocardial infarction or even heart attack. Coronary artery disease in various aspects has a high mortality rate when it occurs in old age. The methods currently used for diagnosis and treatment are coronary angiography, percutaneous coronary intervention (PCI), and myocardial partial blood flow reserve history. There is a wide variety of tests (Fractional Flow Reserve, FFR), near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS). In addition to the various aspects and treatment methods of this disease, treatment is often difficult, so the clinical significance is great. In the case of PCI, one of the methods of examination and treatment, the National Cardiovascular Data Registry (NCDR) has been established to establish guidelines for improving patient prognosis after surgery in the United States. NCDR, which started with the American College of Cardiology (ACC) initiative, is currently in an indispensable position for establishing clinical practice guidelines such as monitoring treatment-related indicators, quality improvement (QI), and clinical research. In charge. Besides, in recent years, the use of new drugs or new devices (Post-Market Surveillance), real-time risk estimation, and personalized planning is increasing. Research to analyze the prognosis of various aspects of coronary artery disease, tests, and procedures has been constantly conducted, but comprehensive studies that can be used to improve the overall treatment are considered to be insufficient. At this point, a comprehensive study is required to establish clinical guidelines and to develop them continuously. In particular, the area that needs research is whether or not future events can be prevented using vascular imaging. Studies have shown that if lipids are actively treated with statins, the lipid component of atherosclerotic plaques can be significantly reduced in just a few weeks. Suggests. According to the results of a YELLOW (Reduction in Yellow Plaque by Aggressive Lipid-Lowering Therapy) study published in 2012 based on a near-infrared spectroscopy-vascular ultrasound analysis, the active treatment group of statins showed the lipid-core burden index compared to the standard treatment group. ) showed a significant decrease. Accordingly, this study collects all comprehensive indicators such as test methods, test results, procedures, and treatment results for all patients undergoing near-infrared spectroscopy-vascular ultrasound treatment in Korea, including this institution, A comprehensive study of the disease registry related to the near-infrared spectroscopy-vascular ultrasound procedure is conducted to determine the type of disease, the number of affected vessels, and disease-related indicators.

Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing

In this clinical trial, Rivaroxaban of standard dose (20mg) and reduced dose (15mg) will be administeted in non-valvular atrial fibrillation patients without severe renal dysfunction. It is a randomized, open-label, and phase 4 clinical trial to compare and evaluate efficacy and safety of Rivaroxaban. After obtaining informed consent to participate in this trial, screening is performed (Screening visit). Screening includes baseline 12-lead electrocardiography and laboratory tests to exclude severe end-organ dysfunction (such as renal dysfunction, liver dysfunction, or anemia). Baseline visits are available on the same day. After screening, subjects eligible for the trial will be randomly assigned (1:1 ratio) to Group 1 (15 mg of Rivaroxaban) or Group 2 (20 mg of Rivaroxaban) (Baseline visit). The study drug (Rivaroxaban 15mg or 20mg daily) will be administered for 12 months. During study period, a total of six visits (3,6,9,12 months) will be made, and follow-up test and outcome measurement will be done in each visit.