Clinical trials

Shoulder surgery often causes severe pain after the operation. To control this pain, doctors commonly perform a nerve block (interscalene brachial plexus block), which numbs the shoulder area. However, when the effect of a single-injection nerve block wears off, many patients experience sudden, intense pain known as "rebound pain". One way to prevent rebound pain is to place a thin catheter near the nerves so that local anesthetic can be given continuously for a longer period (continuous nerve block). However, this method is technically demanding and can cause problems such as catheter dislodgement, infection, and inconvenience for patients. Another simpler option is to give a single-injection nerve block together with an intravenous (IV) injection of dexamethasone, a steroid medication known to prolong the effect of nerve blocks and reduce rebound pain. The purpose of this study is to determine whether a single-injection nerve block combined with IV dexamethasone (5 mg) is not inferior to a continuous nerve block in preventing rebound pain after shoulder surgery. A total of 92 adult patients scheduled for elective shoulder surgery will be randomly assigned to one of the two groups. The main outcome is the rebound pain score, defined as the difference between the last pain score recorded in the recovery room (while the nerve block is still working) and the highest pain score reported within the first 24 hours after the nerve block. The investigators expect that the simpler single-injection method with IV dexamethasone will provide comparable pain control while avoiding the complications and inconvenience of catheter-based continuous nerve blocks.

The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia. The main questions it aims to answer are: Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing? Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability? Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time. Participants will: * Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen. * Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor. * Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).

This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa. The goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens. The main questions this trial aims to answer are: * Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens? * Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens? Researchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis. Participants will: * Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment. * Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases. * Attend study visits during treatment and after treatment is stopped. * Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests. * Be followed for 12 months after treatment is stopped.

The goal of this clinical trial is to evaluate accuracy of continuous glucose monitoring device called 'Dexcom G7' in patients undergoing cardiac surgery.

This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.

The goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia. The main questions it aims to answer are: * Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation? * Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient/surgeon satisfaction? Researchers will compare the PCS group to the CCS group to see if the patient-controlled method leads to a reduction in total remimazolam consumption while maintaining effective sedation. Participants will: * Be randomly assigned to either the PCS group or the CCS group. * In the PCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval. * In the CCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.

Comparison of the incidence of major cardiovascular events between the combination of percutaneous intervention and optimal drug therapy and the optimal drug therapy alone in patients with chronic coronary syndrome. * Main RCT (Randomized Clinical Trial): Patients with chronic coronary syndrome enrolled in the study will be randomized in a 1:1 ratio to either 1) PCI(Percutaneous Coronary Intervention) plus optimal medical therapy or 2) optimal medical therapy alone, with clinical outcomes assessed during follow-up. (2,301 participants) * Nested RCT: An embedded randomized supplementary study was conducted on a subset (220 participants) of the total subjects. In patients who have decided to use beta-blockers for the control of angina, additional 1:1 randomization evaluates the efficacy of carvedilol sustained-release (SR) and immediate-release (IR) formulations. Both formulations are targeted for use up to the maximal tolerated dose, taking into account patient symptoms.

This randomized, double-blinded, placebo-controlled clinical trial aims to evaluate the efficacy and safety of naltrexone in reducing nonsuicidal self-injurious behavior among individuals with nonsuicidal self-injury. Participants will be randomly assigned to receive either naltrexone plus treatment as usual or placebo plus treatment as usual for 6 weeks. The primary objective is to determine whether naltrexone reduces the frequency of nonsuicidal self-injurious behavior compared with placebo. Secondary objectives include evaluating changes in clinical severity, suicidal ideation, self-injury-related urges, ecological momentary assessment measures, and safety outcomes.

The goal of this observational study is to compare the vaccine response to the 2 doses of the adjuvanted herpes zoster subunit vaccine(HZ/su, "Shingrix") in patients with SLE and the age-, sex-, ethnicity-matched controls without autoimmune disease.

This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty. Participants are randomly assigned to receive Livact granules 4.15 g three times daily for 3 months after surgery or to receive standard postoperative care without branched chain amino acid administration. Skeletal muscle mass index, physical function, patient reported outcomes, laboratory findings, medication compliance, and adverse events are assessed at baseline, 5 weeks, and 15 weeks after surgery.

This randomized controlled trial aims to evaluate the effectiveness of an Agentic AI-based personalized dietary management algorithm among adults undergoing health screening. Participants will be assigned to a control group, a static goal AI intervention group, or an adaptive goal AI intervention group and followed for 12 weeks.

This study aims to compare the analgesic efficacy of two different ultrasound-guided nerve blocks-the External Oblique Intercostal (EOI) block and the Subcostal Transversus Abdominis Plane (TAP) block-in patients undergoing minimally invasive hepatectomy. All participants will receive standardized general anesthesia and perioperative care at Seoul National University Hospital. Following anesthesia induction, patients will be randomly assigned to receive either an EOI block or a subcostal TAP block with 0.375% ropivacaine to provide regional pain relief. Postoperative pain will be managed using a combination of scheduled non-opioid analgesics and a fentanyl-based patient-controlled analgesia (PCA) device. The primary objective is to evaluate which regional technique more effectively reduces cumulative opioid consumption during the first 24 hours after surgery. Additionally, the study will assess pain intensity using the Numerical Rating Scale (NRS), the incidence of postoperative nausea and vomiting, and the overall recovery profile, including the time to first ambulation.

The goal of this observational study is to evaluate the real-world impact of applying the revised aldosterone-to-renin ratio (ARR) cutoff recommended in the 2025 primary aldosteronism guideline in adults with hypertension and biochemical findings suggestive of an intermediate probability of lateralizing primary aldosteronism (PA). The main questions it aims to answer are: * What is the number needed to test (NNT) to diagnose one case of primary aldosteronism when using the revised ARR cutoff (\>20)? * What is the optimal ARR cutoff for diagnosing PA in Korean patients? * What is the biochemical treatment response rate at 6 months after treatment for confirmed PA? Participants will: * Undergo standardized ARR testing after protocol-based medication adjustment and controlled sampling conditions. * Undergo confirmatory testing using the saline infusion test (SIT). * Receive standard clinical management for confirmed PA according to institutional practice. * Be followed for assessment of biochemical outcomes after treatment.

The goal of this clinical trial is to compare the effect of use of reversal agents for neuromuscular blockade in critically ill patients on time for neurological assessment after endotracheal intubation The main questions it aims to answer are: * The use of reversal agents for neuromuscular blockade after endotracheal intubation may reduce the time for neurological assessment. * The types of reversal agents for neuromuscular blockade may affect the time for neurological assessment. Participants will receive different reversal agents or no medications based on the assigned groups. Thirty minutes after intubation using rocuronium, medication is administered, and the time of initial confirmation of eye opening and movement is recorded. Researchers will compare 3 groups (sugammadex, neostigmine and control(no medication) to see the difference of time for neurological assessment after endotracheal intubation.

This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

The purpose of this study is to evaluate the effects of binaural beats on patient satisfaction and intraoperative comfort in patients aged 65 years or older undergoing cataract surgery (phacoemulsification and posterior chamber intraocular lens implantation) under monitored anesthesia care (MAC) with propofol. Participants are randomly assigned to either a binaural beat group or a control group. The binaural beat group will wear earphones and listen to binaural beats from the time they arrive at the operating room until the surgery is completed. The control group will wear identical earphones but will not receive any auditory stimulus. During the procedure, standard vital signs and the bispectral index (BIS) will be continuously monitored in both groups. Following the surgery, the investigators will assess the patients' overall satisfaction using a 7-point Likert scale. Secondary assessments include patient preference for the anesthesia method, intraoperative pain intensity, sedation level, anxiety level, and quality of life (EQ-VAS) measured by a visual analogue scale. Any surgery-related discomfort or adverse events will also be recorded and compared between the two groups.

The purpose of this study is to evaluate Long-Term Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease

While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still. Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety. This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.

This study aims to investigate the effect of reducing ablation time for a hybrid approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.

This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.

The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease

The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.

Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision. The main questions it aims to answer are: * Does adding consolidation chemotherapy increase the rate of pathologic complete response? * What medical problems or side effects do participants have during and after treatment? Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes. Participants will: * Receive TNT for stage I rectal cancer * Be randomly assigned to one of two treatment groups * Undergo local excision after preoperative treatment * Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs

\<Study Design\> This study is a cluster-randomized, stratified, non-inferiority trial designed to evaluate the feasibility, efficacy, and educational effectiveness of HEROS 4.0, a mixed-reality (MR)-based cardiopulmonary resuscitation (CPR) training system, compared with conventional instructor-led CPR training. \<Objective \& Hypothesis\> The primary objective is to determine whether MR-based HEROS 4.0 CPR training is non-inferior to standard video- and instructor-based CPR training in improving CPR performance quality. The central hypothesis is that participants trained using HEROS 4.0 will achieve comparable CPR quality to those trained using traditional methods, while benefiting from enhanced immersion, scalability, and accessibility. \<Participants\> A total of 120 adults aged 18-50 years who have not received CPR training within the previous 12 months will be recruited. Participants will be assigned to one of two clusters and randomized in a 1:1 ratio to either the HEROS 4.0 MR training group or the conventional CPR training group. \<Intervention \& Control\> Participants will undergo CPR training according to their assigned group: Intervention group (HEROS 4.0): Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training. As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit. After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth. Control group (Conventional CPR training): Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice. \<Outcomes\> Immediately after training, all participants will undergo a standardized cardiac arrest simulation using a CPR quality-measurement manikin. This simulation will assess objective CPR performance metrics as well as subjective outcomes through questionnaires. To evaluate knowledge retention and skill durability, all assessments will be repeated 6 months after training using the same simulation scenario and outcome measures. The primary outcome is chest compression fraction measured during the standardized simulated cardiac arrest scenario. Secondary outcomes include quantitative measures of CPR quality and participant-reported outcomes based on survey.