Clinical trials

This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual antiplatelet therapy (DAPT).

Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized. The European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines recommend lowering low-density lipoprotein-cholesterol (LDL-C) below 55 mg/dL or by at least 50% from baseline as a treatment goal and recommend high-intensity statin therapy (Atorvastatin 40-80 mg, Rosuvastatin 20 mg). Statins have been shown to reduce cardiovascular risk in elderly patients as well. However, these patients exhibit a higher rate of statin intolerance due to side effects associated with high-intensity statins, such as myalgia, hepatotoxicity, cognitive decline, and increased risk of diabetes. Consequently, dose reduction or discontinuation is required more frequently compared to younger patients. Therefore, establishing an appropriate lipid-lowering strategy for elderly patients is necessary, considering not only efficacy but also drug tolerability. Consequently, in elderly patients, reducing the statin intensity from the outset and considering combination therapy with drugs having different mechanisms of action, such as ezetimibe, may be warranted. Pitavastatin is classified as a moderate-intensity statin. Previous studies have confirmed that Pitavastatin demonstrates non-inferior efficacy compared to Rosuvastatin and Atorvastatin. Several observational studies report that Pitavastatin has fewer drug interactions than other statins and lower rates of diabetes onset and elevated liver enzymes. Therefore, Pitavastatin may be an appropriate choice for moderate-intensity statin therapy in elderly patients. Thus, this study aims to evaluate whether combination therapy with Pitavastatin and Ezetimibe (Livalozet 4/10mg) after coronary intervention in patients aged 75 years or older with coronary artery disease is non-inferior to high-intensity statin therapy (Atorvastatin 40-80 mg or Rosuvastatin 20 mg). If this study demonstrates that moderate-intensity statin therapy combined with ezetimibe is non-inferior to high-intensity statin therapy while also having fewer adverse effects, it could provide evidence for an effective and safe cholesterol treatment option for elderly patients.

Sepsis is a leading cause of acute kidney injury (AKI) in critically ill patients, with sepsis-associated AKI accounting for approximately 50% of all AKI cases in the intensive care unit. The pathophysiology of septic AKI involves a complex interplay of inflammation, endothelial dysfunction, and microvascular injury, leading to impaired renal perfusion and tubular damage. Despite advances in critical care, septic AKI remains associated with high mortality rates and significant risk of progression to chronic kidney disease. Continuous renal replacement therapy (CRRT) is the standard extracorporeal treatment for AKI in hemodynamically unstable patients. The Oxiris hemofilter (Baxter/Vantive) is a specialized AN69-based membrane with enhanced adsorptive capacity for cytokines and endotoxins due to a polyethyleneimine surface treatment and heparin grafting. While Oxiris has demonstrated the ability to reduce circulating inflammatory mediators in septic patients, its impact on endothelial cell dysfunction and subsequent renal recovery has not been systematically evaluated. This is a single-center, prospective, open-label, exploratory randomized controlled trial comparing CRRT using the Oxiris filter versus CRRT using a standard filter in patients with sepsis-associated AKI at Samsung Medical Center, Seoul, Korea. A total of 30 patients (15 per group) will be enrolled and allocated using stratified randomization based on SOFA score, baseline renal function, and presence of septic shock. Eligible participants are adult patients (aged 19 years or older) diagnosed with sepsis according to Sepsis-3 criteria who develop AKI (KDIGO stage 2 or higher) requiring CRRT initiation. Key exclusion criteria include end-stage kidney disease, expected survival of less than 24 hours, prior CRRT within 72 hours, and contraindications to heparin-based anticoagulation. CRRT will be maintained for a minimum of 72 hours, with Oxiris filters replaced every 24 hours per manufacturer guidelines. The primary endpoints are changes in endothelial cell function assessed using induced pluripotent stem cell-derived endothelial cells (iPSC-ECs) treated with patient plasma collected at three time points: CRRT initiation (baseline), day 3, and CRRT discontinuation. Endothelial function will be evaluated by tube formation assay (total tube length, branch points, mesh area) and reactive oxygen species (ROS) production. This iPSC-EC-based model provides a reproducible and standardized platform to directly assess the biological effects of Oxiris on vascular endothelial integrity under conditions mimicking the pathophysiological environment of septic AKI. Secondary endpoints include 90-day all-cause mortality, renal recovery (defined as dialysis independence at 90 days), changes in hemodynamic parameters (vasopressor requirements, mean arterial pressure), CRRT duration, and serial measurements of blood and urine biomarkers including NGAL, KIM-1, MCP-1, RANTES, and TGF-beta. These biomarkers reflect inflammatory burden, endothelial dysfunction, and renal tubular injury, providing a comprehensive assessment of the therapeutic effects of Oxiris beyond standard cytokine clearance. As this is an exploratory study, all p-values will be interpreted descriptively and results will be used to generate hypotheses and inform the design of future confirmatory trials. The study aims to provide mechanistic insights into whether enhanced cytokine and endotoxin removal by Oxiris translates into measurable improvements in endothelial function and clinical renal outcomes.

This study investigates the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability in patients with intrinsic PEEP undergoing lung resection surgery, using a randomized, crossover design.

This study investigates the prevalence of acute rehabilitation practices among children in pediatric intensive care units (PICUs).

Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes. However, whether early rhythm control improves prognosis in patients with atrial fibrillation and tricuspid regurgitation remains unclear. This study will compare early rhythm control with usual care in these patients, using a composite outcome of cardiac death, heart failure admission, stroke, and tricuspid valve surgery.

The purpose of this prospective, single-center, phase II study is to evaluate the clinical efficacy and safety of combining first-line systemic therapy plus immunotherapy with personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in patients with unresectable locally advanced gastric cancer.

Background: Dumping syndrome is a common complication for patients who have undergone surgery for esophageal cancer. It occurs when food moves too quickly from the stomach (or the reconstructed gastric tube) into the small intestine. This rapid movement causes various symptoms such as bloating, abdominal pain, dizziness, rapid heartbeat, and sweating. Sometimes, it leads to "late dumping," where blood sugar levels drop significantly, causing tremors, cold sweats, and fatigue. Currently, there is no standardized tool to easily diagnose this condition after esophagectomy. Purpose of the Study: The objective of this study is to evaluate the effectiveness of Continuous Glucose Monitoring (CGM) in diagnosing dumping syndrome. CGM is a small, wearable sensor that tracks glucose levels in real-time. The investigators aim to determine whether CGM can serve as a valuable tool for the early detection of dumping syndrome in patients who have undergone esophagectomy.

This study is for adults with resectable non-small cell lung cancer who are scheduled to receive neoadjuvant chemoimmunotherapy before surgery. Neoadjuvant chemoimmunotherapy can help shrink lung cancer before surgery and may improve treatment outcomes. However, not all patients benefit from this treatment in the same way, and it can sometimes cause side effects, such as immune-related pneumonitis. At present, it is still difficult to predict before or during treatment which patients will have a strong response. The purpose of this study is to find imaging features on chest computed tomography scans that may help predict how well a patient's cancer responds to neoadjuvant chemoimmunotherapy. The study will compare computed tomography findings before treatment and before surgery with pathologic findings from surgery, including pathologic complete response and major pathologic response. The study will also evaluate whether computed tomography-based imaging features are associated with treatment-related side effects and long-term outcomes such as disease progression and survival. This is an observational study. The investigators will not assign participants to a specific cancer treatment. Participants will receive neoadjuvant chemoimmunotherapy and surgery according to standard clinical practice. Chest computed tomography scans will be obtained before treatment and before surgery as part of the study protocol. These computed tomography images will also be reconstructed using a high-resolution deep learning-based computed tomography reconstruction technique to explore whether this approach can improve the development of imaging biomarkers. The results of this study may help develop a noninvasive imaging-based model to identify patients who are more likely to benefit from neoadjuvant chemoimmunotherapy and to better guide treatment planning for resectable non-small cell lung cancer.

This study investigates the clinical efficacy of a non-invasive screening protocol using AI-ECG and CT-ECV analysis for cardiac amyloidosis. The study targets on atrial fibrillation(AF) patients with "red-flag" indicators. Participants are randomized 1:1 into either an early screening or usual care group. * Early screening group : AI- ECG and/or CT-ECV analysis + AF treatment * Usual care group : AF treatment Both groups followed for 2 years to compare CA detection rates and clinical outcomes.

This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. * Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart rate. * Primary Endpoint: Heart failure symptoms, assessed by the Kansas City Cardiomyopathy Questionnaire score. * Hypothesis: In patients with heart failure requiring permanent pacing, an optimized pacing strategy will lead to a significant improvement in heart failure symptoms (Kansas City Cardiomyopathy Questionnaire score) at 12 months compared with the conventional pacing strategy.

This is a Phase 2, single-arm, multicenter study, evaluating the anti-tumor efficacy of tumor-infiltrating lymphocyte (TIL) directed tislelizumab monotherapy (also known as BGB-A317) for refractory solid tumors in approximately 72 patients with centrally confirmed T cell inflamed GEP score ≥ 0.857, who have not been previously exposed to immunotherapy. All patients must provide a tumor specimen for T cell inflamed GEP assessment. Archived tissue slide collected within 2 years from the first dose of study drug must be provided. This study will include a Screening Period, a Treatment Period, and a Follow-Up Period. All patients will complete up to 28 days of screening. During the Treatment Period, patients will receive tislelizumab 200 mg fixed dose once every 3 weeks by intravenous (IV) administration until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. After treatment discontinuation, patients will be follow-up for disease progression and survival status until death, withdrawal of consent, or study closure, whichever occurs first. The end of study will be the timepoint when the final data for the study were collected. Additionally, the Investigator Sponsor has the right to terminate this study at any time.

This is an open label, phase II study to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage IB-IIIA lung adenocarcinoma.

This study designed to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage I lung adenocarcinoma.

This study aims to establish a comprehensive, long-term clinical registry infrastructure for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center. In South Korea, these diseases are a leading cause of death, with a rapidly increasing burden due to an aging population and changing lifestyles. Despite this, there is a lack of large-scale, systematic data specifically focused on the long-term clinical course and unique characteristics of Korean patients. The central hypothesis of this study is that the establishment of a standardized registry infrastructure-integrating both retrospective (historical) and prospective (future) data collection-will provide a more accurate and comprehensive understanding of the natural history and risk factors of heart and brain vascular diseases in the Korean population than currently available fragmented data. By combining existing medical records with ongoing patient follow-up, this infrastructure will serve as a critical scientific platform for developing personalized prevention and precision medicine strategies. By building this organized data collection system, the study will: Construct a robust infrastructure to collect uniform, high-quality clinical data, encompassing both past medical history (retrospective) and future clinical progress (prospective) from a large population of Korean patients. Monitor long-term health outcomes and the progression of diseases by tracking patients over many years. Analyze the interaction between various risk factors and patient outcomes to identify population-specific patterns. Create a scalable platform that can integrate advanced technologies, such as multi-omics and digital health tools, for future research. Ultimately, this integrated registry infrastructure is expected to provide the essential scientific evidence needed to optimize clinical guidelines and improve the long-term quality of life for patients with heart and brain vascular diseases in Korea.

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Glove by comparing the effects between a group using the home-based Neofect Smart Glove and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Board by comparing the effects between a group using the home-based Neofect Smart Board and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.

The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

This prospective study enrolls subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis. The purpose of the study is to evaluate clinical and biological features of adult hemophagocytic lymphohistiocytosis. The enrolled subjects into this study will be evaluated according to the HLH (hemophagocytic lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or chemotherapy. All subjects will be regularly monitored by physicians participating in this study.

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial. This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood. Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue. Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier. This phase I/II study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.

The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.

There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.