1.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
2.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
3.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
4.Effect of an 8-week hot spring water exercise program on body composition, knee isokinetic muscle function, range of motion, and the Korean Western Ontario and Mcmaster Universities index in middle-age females with osteoarthritis in Republic of Korea: experiment study
Ki Hong KIM ; Byung Kwan KIM ; Jae Heon SON ; Jun Sik PARK ; Sang Hyun LEE ; Hwan Jong JEONG
Medical Lasers 2024;13(3):155-165
Background:
This study aimed to investigate the effects of applying the hot spring water exercise for 8 weeks to middle-aged females with knee osteoarthritis.
Methods:
To investigate this, body composition, isokinetic muscle function, and the knee flexion angle K-WOMAC were evaluated before and after the 8-week hot spring water exercise program and analyzed using a mixed-design two-way ANOVA. After analysis, if a significant difference was observed, the Bonferroni method was used as a post hoc method, and the following results were obtained.
Results:
First, among the body composition parameters, the body fat percentage showed a statistically significant reduction after the 8-week hot spring water exercise program in the exercise group (EG) (p = .031).However, there was no significant difference in body weight, muscle mass, body fat mass, and body mass index. Among the isokinetic muscle functions, the peak torque (p = .003, p = .001) and total work (p = .003, p = .003) of the flexion and extension movements, and the average power (p = .007) of the flexion movement significantly increased in the EG, while the average power of the extension movement did not change. The range of joint motion significantly increased after the exercise. The K-WOMAC index significantly decreased after the exercise.
Conclusion
Thus, the 8-week aquatic exercise program utilizing hot springs improved knee extension and flexion muscle strength. Hence, it is believed that it can be used as an interventional therapy for low back pain in the elderly and for obese people who have difficulty with land-based exercises.
5.The Third Nationwide Korean Heart Failure III Registry (KorHF III):The Study Design Paper
Minjae YOON ; Eung Ju KIM ; Seong Woo HAN ; Seong-Mi PARK ; In-Cheol KIM ; Myeong-Chan CHO ; Hyo-Suk AHN ; Mi-Seung SHIN ; Seok Jae HWANG ; Jin-Ok JEONG ; Dong Heon YANG ; Jae-Joong KIM ; Jin Oh CHOI ; Hyun-Jai CHO ; Byung-Su YOO ; Seok-Min KANG ; Dong-Ju CHOI
International Journal of Heart Failure 2024;6(2):70-75
With advancements in both pharmacologic and non-pharmacologic treatments, significant changes have occurred in heart failure (HF) management. The previous Korean HF registries, namely the Korea Heart Failure Registry (KorHF-registry) and Korean Acute Heart Failure Registry (KorAHF-registry), no longer accurately reflect contemporary acute heart failure (AHF) patients. Our objective is to assess contemporary AHF patients through a nationwide registry encompassing various aspects, such as clinical characteristics, management approaches, hospital course, and long-term outcomes of individuals hospitalized for AHF in Korea. This prospective observational multicenter cohort study (KorHF III) is organized by the Korean Society of Heart Failure. We aim to prospectively enroll 7,000 or more patients hospitalized for AHF at 47 tertiary hospitals in Korea starting from March 2018. Eligible patients exhibit signs and symptoms of HF and demonstrate either lung congestion or objective evidence of structural or functional cardiac abnormalities in echocardiography, or isolated right-sided HF. Patients will be followed up for up to 5 years after enrollment in the registry to evaluate long-term clinical outcomes. KorHF III represents the nationwide AHF registry that will elucidate the clinical characteristics, management strategies, and outcomes of contemporary AHF patients in Korea.
6.Korean urobiome platform (KUROM) study for acute uncomplicated sporadic versus recurrent cystitis in women: Clinical significance
Jeong-Ju YOO ; Hee Bong SHIN ; Ji Eun MOON ; Sul Hee LEE ; Hyemin JEONG ; Hee Jo YANG ; Woong Bin KIM ; Kwang Woo LEE ; Jae Heon KIM ; Young Ho KIM
Investigative and Clinical Urology 2024;65(4):378-390
Purpose:
To investigate urine microbiome differences among healthy women, women with recurrent uncomplicated cystitis (rUC), and those with sporadic/single uncomplicated cystitis (sUC) to challenge traditional beliefs about origins of these infections.
Materials and Methods:
Patients who underwent both conventional urine culture and next-generation sequencing (NGS) of urine were retrospectively reviewed. Symptom-free women with normal urinalysis results as a control group were also studied. Samples were collected via transurethral catheterization.
Results:
In the control group, urine microbiome was detected on NGS in 83.3%, with Lactobacillus and Prevotella being the most abundant genera. The sensitivity of urine NGS was significantly higher than that of conventional urine culture in both the sUC group (91.2% vs. 32.4%) and the rUC group (82.4% vs. 16.4%). In urine NGS results, Enterobacterales, Prevotella, and Escherichia/ Shigella were additionally found in the sUC group, while the recurrent urinary tract infection (rUTI)/rUC group exhibited the presence of Lactobacillus, Prevotella, Enterobacterales, Escherichia/Shigella, and Propionibacterium. Moreover, distinct patterns of urine NGS were observed based on menopausal status and ingestion of antibiotics or probiotics prior to NGS test sampling.
Conclusions
Urine microbiomes in control, sUC, and rUTI/rUC groups exhibited distinct characteristics. Notably, sUC and rUC might represent entirely separate pathological processes, given their distinct urine microbiomes. Consequently, the use of urine NGS might be essential to enhancing sensitivity compared to conventional urine culture in both sUC and rUTI/rUC groups.
7.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
8.A Pilot Split-Neck Case Study to Compare the Efficacy of the Long-Pulsed 755 nm Laser and the 532 nm Picosecond Laser for Acrochordon Removal
Jong Heon PARK ; Jae Yeong JEONG ; Hwa Jung RYU ; Il-Hwan KIM
Annals of Dermatology 2023;35(Suppl1):S67-S70
Cutaneous papillomas or acrochorda usually appear after the 4th decade of life in areas with skin folds. Conventional methods of removal are associated with bleeding problems, pain and prolonged sequelae. Thus, acrochorda removal with lasers has gained attention. In this study, we compared the efficacy of two popular laser types with different wavelengths and pulse widths for removal of skin tags. A 60-year-old Korean male noticed skin tags on his neck bilaterally. All tags were treated in a single session, on one side with a picosecond (ps)-domain 532 nm Nd:YAG laser and on the contralateral side with a long-pulsed (LP) 755 nm alexandrite laser. The endpoint for the ps-532 laser was immediate whitening, while that for the LP and quasi-LP (QLP) 755 lasers were visible changes on the surface of the lesion. Antibiotic ointment was applied, dressing was done and clinical photographs were taken. Both lasers effectively removed the skin tags at all settings in a single session without bleeding and with minimal discomfort. Crust formation occurred on both sides with natural shedding within 1 to 2 weeks. Transient erythema lasted longer in the tags treated with the ps-532 laser. At the 5th month of follow-up, residual lesions were detected on the field treated with the ps-532 laser. No persistent side effects such as scarring or postinflammatory hyperpigmentation (PIH) were observed. In conclusion, both the ps-532 nm Nd:YAG and the 755 nm alexandrite lasers ensured safe and effective removal of skin tags in a single session without adverse sequelae.
9.Are We Truly Safe? Unfolding the Final Chapters of COVID-19 Walk-Through Booths
Su Ha HAN ; Minji JUNG ; Heon-Jae JEONG ; JinKwan HONG
Journal of Korean Medical Science 2023;38(34):e290-
This research proposes a safety strategy for coronavirus disease 2019 (COVID-19) walkthrough booths to optimize pandemic preparedness. These booths, designed for respiratory sample collection during the COVID-19 pandemic, effectively reduce infection risk and personal protective equipment-related fatigue among healthcare workers. However, inadequate disinfection and glove management could escalate infection transmission. Using computational fluid dynamics simulations, we analyzed droplet dispersion on booth surfaces and gloves under various wind conditions. Our findings suggest that when setting up COVID-19 walk-through booths, their location should be strategically chosen to minimize the effects of wind. All surfaces of booth gloves must be thoroughly disinfected with a certified disinfectant after nasopharyngeal swab collection. It is also recommended to wear disposable gloves over booth gloves when changing between patient examinations. In wind-affected areas, individuals nearby should not solely rely on the 2-meter distancing rule due to potential droplet spread from walk-through booths. We strongly recommend consistent and proper mask use for effective droplet blocking. Adherence to these guidelines can significantly enhance the safety and efficiency of walk-through booths, particularly in potential future pandemics.
10.Machine Learning-Based Predictor for Treatment Outcomes of Patients With Salivary Gland Cancer After Operation
Min Cheol JEONG ; Yoon Woo KOH ; Eun Chang CHOI ; Jae-Yol LIM ; Se-Heon KIM ; Young Min PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2022;65(6):334-342
Background and Objectives:
The purpose of this study was to analyze the survival data of salivary gland cancer (SGCs) patients to construct machine learning and deep learning models that can predict survival and use them to stratify SGC patients according to risk estimate.Subjects and Method We retrospectively analyzed the clinicopathologic data from 460 patients with SGCs from 2006 to 2018.
Results:
In Cox proportional hazard (CPH) model, pM, stage, lymphovascular invasion, lymph node ratio, and age exhibited significant correlation with patient’s survival. In the CPH model, the c-index value for the training set was 0.85, and that for the test set was 0.81. In the Random Survival Forest model, the c-index value for the training set was 0.86, and that for the test set was 0.82. Stage and age exhibited high importance in both the Random Survival Forest and CPH models. In the deep learning-based model, the c-index value was 0.72 for the training set and 0.72 for the test set. Among the three models mentioned above, the Random Survival Forest model exhibited the highest performance in predicting the survival of SGC patients.
Conclusion
A survival prediction model using machine learning techniques showed acceptable performance in predicting the survival of SGC patients. Although large-scale clinical and multicenter studies should be conducted to establish more powerful predictive model, we expect that individualized treatment can be realized according to risk stratification made by the machine learning model.

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