Clinical trials

We hypothesized that in patients undergoing elective hepatobiliary-pancreatic surgery, the group in which anesthesia is induced and maintained with remimazolam during surgery would maintain hemodynamic stability and reduce the incidence of postoperative acute kidney injury compared to propofol. The purpose is to provide practical evidence for perioperative management differentiated from other surgeries for hepatobiliary-pancreatic surgery patients for whom intraoperative fluid therapy is restricted.

A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and/or immunotherapies outside of the approved indications via local clinical practice (Tier 1 \& 2) and clinical trials (Tier 3)

In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.

The purpose of this study is to evaluate the effectiveness of the AI-based application "HiDongDong" in improving articulation development in children aged 2 to under 14 years with suspected articulation delays. The program provides individualized language training based on a personalized assessment of vulnerable speech sounds. This trial aims to determine whether the digital therapeutic solution can enhance articulation skills and inform future strategies for language rehabilitation in children.

The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.

Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

A Study on the Characteristics of Colorectal Cancer by Age and sex.

This clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

The K-PROSE study is a randomized clinical investigation evaluating strategies to prevent contrast-induced acute kidney injury (CI-AKI) in patients hospitalized with acute heart failure and moderate renal dysfunction (eGFR 30-75 mL/min/1.73 m²). Patients requiring contrast-enhanced CT imaging are randomized to either standard intravenous saline hydration or a furosemide-based decongestion strategy. Renal function is assessed using serial measurements of creatinine and cystatin C, before and after contrast exposure. By comparing renal outcomes, congestion status, and safety profiles, this study aims to determine whether a decongestion-focused approach provides superior renal protection compared with conventional hydration in high-risk acute heart failure patients.

This study aims to evaluate the clinical effectiveness of the oXiris® hemofilter in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). While some studies suggest that oXiris® may improve hemodynamic stability by removing endotoxins and cytokines, its impact on survival remains inconsistent.To provide more reliable causal evidence, this multicenter retrospective cohort study utilizes a Target Trial Emulation (TTE) approach. The study will compare patients treated with the oXiris® filter to those treated with standard CRRT filters, focusing on in-hospital mortality and other clinical outcomes such as fluid balance and vasopressor requirements.

The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia. The main question it aims to answer is: \- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients? Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three days after surgery.

This study aims to develop a muscle-specific multimodal artificial intelligence (AI) model for the diagnosis of sarcopenia and to investigate the effects of rehabilitation training on muscle aging. Clinical, functional, and imaging data will be collected from participants with muscle function decline. Multimodal data, including muscle function measurements and clinical assessments, will be integrated to develop and validate an AI-based diagnostic model for sarcopenia. In addition, the effects of rehabilitation training on muscle function and muscle aging-related outcomes will be evaluated. The results of this study are expected to contribute to the development of digital biomarkers and precision rehabilitation strategies for sarcopenia.

This single-group interventional study investigates the safety and physiologic effects of functional electrical stimulation (FES) applied to the tongue and submental muscles in adults at high risk for sleep apnea. Participants will receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order during a single visit. Ultrasound and tongue pressure (IOPI) measurements, as well as subjective assessments of discomfort and perceived effects, will be conducted before, during, and after stimulation. The primary objective is to evaluate changes in muscle thickness, length, and tongue strength across different stimulation frequencies. Secondary objectives include assessing participant discomfort, safety, and subjective treatment effects.

This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.

This exploratory clinical trial aims to investigate the mechanism of sequential muscle contractions during normal swallowing processes, including spoon, straw, and cup feeding, in children aged 2 to under 10 years without swallowing disorders. Surface electromyography (sEMG) will be used to evaluate activation patterns of the orbicularis oris, submental, and hyoid muscles during liquid, semi-solid, and solid intake. The study seeks to characterize the timing, duration, amplitude, and coordination of swallowing-related muscle activity in typically developing children. Findings from this study are expected to provide foundational physiological data to inform the development of pediatric-specific neuromuscular electrical stimulation (NMES) protocols for dysphagia treatment.

The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are: * Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment? Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual. Participants will: * Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years

The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement. The main questions the study will answer are: * What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs? * What clinical or laboratory factors can predict successful withdrawal of levothyroxine? Participants will: * Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine * Have already stopped ICI therapy * Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal * Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg) * Be monitored with thyroid function tests and clinical symptoms at each visit

Clinical Trial Title A Multicenter, Single-Blind, Prospective, Randomized, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of the Digital Therapeutic Device 'Zenicom' for Improving Aphasia in Patients with Subacute Stroke Clinical Trial Objectives To evaluate the efficacy of the digital therapeutic device Zenicom. To evaluate the safety of the digital therapeutic device Zenicom. Clinical Trial Period 6 months from the date of clinical trial plan approval by the Ministry of Food and Drug Safety (MFDS). Target Condition Patients with aphasia resulting from stroke lesions. Target Sample Size Total of 20 subjects (10 in the experimental group and 10 in the control group). Investigational Medical Device Zenicom Clinical Trial Methodology 1. Device Information A) Experimental Device: Digital Speech Therapy Application Group: Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period. B) Control Device: Conventional Speech Therapy Group: Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period. 2. Treatment Duration: Total 2 weeks (10 working days; total usage of 600 minutes or more). 3. Visits: Total of 3 visits including outpatient and therapy room visits. Visit 1 (T-1): Screening Visit 2 (T0): Baseline and Treatment initiation Visit 3 (T1): Post-treatment assessment Inclusion and Exclusion Criteria 1. Inclusion Criteria Patients who satisfy all of the following criteria: Adults aged 19 years or older. Patients confirmed by a specialist to have aphasia caused by a stroke lesion. Patients with first-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI). Patients diagnosed with aphasia based on the Speech Assessment (PK-WAB-R). Patients whose native language is Korean. Patients capable of voluntarily consenting to the study. 2. Exclusion Criteria Patients meeting any of the following criteria will be excluded: Progressive or hemodynamically unstable stroke. Patients with other neurological diseases suspected to affect language ability. Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia). Co-morbid major neurogenic diseases other than stroke. Confirmed history of degenerative neuropathy. Current or past substance or alcohol use disorder. Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower). Intellectual disability. Illiteracy (unable to read and consent). Patients deemed inappropriate for participation for other reasons. Refusal to participate in the study. Suspension and Dropout Criteria 1. Suspension Criteria If circumstances observed during the trial make it judged unreasonable to continue the study. Occurrence of Serious Adverse Events (SAE). 2. Dropout Criteria The subject requests to stop participation or withdraws consent during the trial. The investigator determines that the subject cannot continue the trial due to adverse events (e.g., headache, eye fatigue, nausea, dizziness, etc.). The subject arbitrarily takes medication expected to affect the comparative evaluation of the investigational device during the trial. The dosage of medication that may affect the comparative evaluation of the investigational device is changed during the trial. Discovery of major protocol violations, such as violation of inclusion/exclusion criteria. The subject fails to attend scheduled visits and cannot be contacted. The subject fails to perform the digital speech therapy program for a total of 600 minutes or more. The investigator determines that the trial should be stopped for other reasons. Endpoints (Outcome Measures) 1. Primary Efficacy Endpoint Change in PK-WAB-R scores between T0 and T1 between groups. 2. Secondary Efficacy Endpoints Change in K-BNT scores between T0 and T1 between groups. Change in K-SAQOL-12 scores between T0 and T1 between groups. Statistical Analysis Methods To evaluate the change in PK-WAB-R between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied. To evaluate the changes in K-BNT and K-SAQOL-12 between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.

The goal of this clinical trial is to find out whether levothyroxine reduces complications and improves the prognosis of patients with subclinical hypothyroidism (SCH) undergoing coronary artery bypass grafting (CABG). The main questions this study aims to answer are: • Does levothyroxine reduce major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias, in SCH patients undergoing CABG? Researchers will compare patients who take levothyroxine with those who do not. Participants will: * Be randomly assigned to either receive levothyroxine or not * Start the medication one day before surgery if assigned to the treatment group. * Have regular follow-up visits to check thyroid function and cardiovascular events for up to five years after surgery.

This single-arm pilot study aims to evaluate the feasibility and potential health effects of a Korean-style Mediterranean diet (KORMED) and continuous physical activity measurement in patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The study investigates whether a 12-week KORMED dietary intervention, combined with monitoring of daily step counts using a wearable device, can improve metabolic and inflammatory biomarkers, body composition, gut microbiome diversity, and quality of life. The study seeks to answer the following primary question: Is the KORMED diet feasible and achievable for MGUS/SMM patients, as measured by changes in K-MEDAS adherence scores over 12 weeks? Secondary questions include: 1. Does adherence to KORMED lead to improvements in BMI, inflammatory markers (CRP, IL-6), metabolic indicators (HOMA-IR, FLI), M-protein levels, and gut microbiome diversity? 2. Is increased daily physical activity, measured by step counts, associated with favorable changes in metabolic and clinical parameters? 3. Can combined dietary and activity-based lifestyle modification provide preliminary evidence supporting delayed disease progression in precursor plasma cell disorders?